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**Table of contents**
[**A. Interpretation (Rules) 15**](#_heading=)
> [EU Information System for Aligned Decision-Making (Authorities and
> Certification Bodies)
> 15](#eu-information-system-for-aligned-decision-making-authorities-and-certification-bodies)
>
> [National Information Systems for Interpretation and Guidance
> 16](#national-information-systems-for-interpretation-and-guidance)
>
> [Product or Process Classification Procedures
> 16](#product-or-process-classification-procedures)
>
> [Binding Interpretations by Implementing Acts
> 17](#binding-interpretations-by-implementing-acts)
>
> [Empowerment for Guidance 18](#empowerment-for-guidance)
>
> [Reference to Commission, Agency or “Board/Body” for Binding
> Interpretation or Arbitration
> 18](#reference-to-commission-agency-or-boardbody-for-binding-interpretation-or-arbitration)
>
> [Reference to Courts for Binding Interpretation
> 19](#reference-to-courts-for-binding-interpretation)
>
> [Standards, International and Informal Document to guide
> Interpretation
> 20](#standards-international-and-informal-document-to-guide-interpretation)
>
> [Recitals to guide Interpretation
> 21](#recitals-to-guide-interpretation)
[**B. Scope, Application and Harmonisation Approaches 23**](#_heading=)
> [Empowerment to clarify Applicability of an Act
> 23](#empowerment-to-clarify-applicability-of-an-act)
>
> [Member State to be exempted under Conditions
> 23](#member-state-to-be-exempted-under-conditions)
>
> [Member State “Opt-Out” from Marginal Scope
> 24](#member-state-opt-out-from-marginal-scope)
>
> [Member State “Opt-ins” 25](#member-state-opt-ins)
>
> [Member States to exempt Outermost Regions
> 26](#member-states-to-exempt-outermost-regions)
>
> [Exemptions in Case of “Public Interest Override”
> 26](#exemptions-in-case-of-public-interest-override)
>
> [“Flexibility Clauses” – Adaptation to Local Contexts
> 27](#flexibility-clauses-adaptation-to-local-contexts)
>
> [Micro-Enterprise and De Minimis Exemptions
> 28](#micro-enterprise-and-de-minimis-exemptions)
>
> [Compatibility (“Coherence”) or Collision Clauses
> 28](#compatibility-coherence-or-collision-clauses)
>
> [“Without Prejudice” Clauses 29](#without-prejudice-clauses)
>
> [Multi-Function Product/Service: Intended Use Declaration
> 31](#multi-function-productservice-intended-use-declaration)
>
> [Extreme Variety of Products / Services / Situations
> 32](#extreme-variety-of-products-services-situations)
>
> [Preventing “Gold Plating”, Distinguishing “Harmonised Sphere” and
> Aspects not covered
> 33](#preventing-gold-plating-distinguishing-harmonised-sphere-and-aspects-not-covered)
>
> [Maximum Harmonisation Clauses / Approach
> 34](#maximum-harmonisation-clauses-approach)
>
> [Minimum Harmonisation Clauses / Approach
> 35](#minimum-harmonisation-clauses-approach)
>
> [Equivalence/Mutual Recognition—Within EU
> 35](#equivalencemutual-recognitionwithin-eu)
>
> [Regulatory Sandboxes and Experimentation Clauses
> 36](#regulatory-sandboxes-and-experimentation-clauses)
>
> [Sunset Clauses and Review Triggers
> 37](#sunset-clauses-and-review-triggers)
>
> [Rules for Direct Installation or Direct Use
> 38](#rules-for-direct-installation-or-direct-use)
>
> [Products Offered as a Service 38](#products-offered-as-a-service)
[**C. Definitions and Connected Rules 40**](#_heading=)
> [Empowerment to Amend Legal Definitions
> 40](#empowerment-to-amend-legal-definitions)
>
> [Indicative Lists and Exclusion Lists
> 40](#indicative-lists-and-exclusion-lists)
>
> [Dynamic Reference to other Acts for Definitions
> 41](#dynamic-reference-to-other-acts-for-definitions)
[**D. Authorisation/Licensing Procedures 43**](#_heading=)
> [Mandatory Pre-Market Notification
> 43](#mandatory-pre-market-notification)
>
> [Mandatory Electronic Application
> 43](#mandatory-electronic-application)
>
> [Mandatory Application Content / Form
> 44](#mandatory-application-content-form)
>
> [“One Stop Shop” Registration/Notification Systems
> 45](#one-stop-shop-registrationnotification-systems)
>
> [In advance Administrative Decisions (“Advance Rulings”)
> 46](#in-advance-administrative-decisions-advance-rulings)
>
> [Deadlines for Decision-Making 46](#deadlines-for-decision-making)
>
> [Silence = Automatic Consent 47](#silence-automatic-consent)
>
> [Specification of Language of Application / Documentation
> 48](#specification-of-language-of-application-documentation)
>
> [Conditional and Provisional Authorisations
> 48](#conditional-and-provisional-authorisations)
>
> [Automatic Expiry of Non-Implemented Permits
> 49](#automatic-expiry-of-non-implemented-permits)
>
> [Merging Assessment Procedures 50](#merging-assessment-procedures)
>
> [Integration of Parallel Legislation Requirements in Single Procedure
> 50](#integration-of-parallel-legislation-requirements-in-single-procedure)
>
> [Fulfilment of Obligations of other Acts as Fulfilment of own Act
> 52](#fulfilment-of-obligations-of-other-acts-as-fulfilment-of-own-act)
>
> [Recognition of Previous Authorisation for Identical Substance or Item
> 52](#recognition-of-previous-authorisation-for-identical-substance-or-item)
>
> [Common Procedures for Identical Products or Services
> 53](#common-procedures-for-identical-products-or-services)
>
> [Decentralised Manufacturing or Services
> 54](#decentralised-manufacturing-or-services)
>
> [Company Group Licensing or Recognition
> 54](#company-group-licensing-or-recognition)
>
> [“Forum Shopping” Avoidance Provisions
> 56](#forum-shopping-avoidance-provisions)
>
> [Temporary “Safe Harbours” or “Sandboxes”
> 56](#temporary-safe-harbours-or-sandboxes)
>
> [Approval and Oversight of Entrusted/Authorised Economic Operators
> 57](#approval-and-oversight-of-entrustedauthorised-economic-operators)
>
> [Simplified Procedures for Custom or Heritage Products or Services
> 58](#simplified-procedures-for-custom-or-heritage-products-or-services)
>
> [Fast-Track or Simplified Procedures for Minor Cases
> 58](#fast-track-or-simplified-procedures-for-minor-cases)
>
> [Fast-Track or Simplified Procedures for Urgent Cases
> 59](#fast-track-or-simplified-procedures-for-urgent-cases)
>
> [“Digital Green Channels” (Automated Regulatory Processing) for
> Low-Risk Activities
> 59](#digital-green-channels-automated-regulatory-processing-for-low-risk-activities)
>
> [Authorisation for New Economic Operators
> 61](#authorisation-for-new-economic-operators)
>
> [Direct EU Agency or Commission Oversight for High-Risk
> Sectors/Services/Products
> 61](#direct-eu-agency-or-commission-oversight-for-high-risk-sectorsservicesproducts)
>
> [Comparative Assessments in View of Goals
> 62](#comparative-assessments-in-view-of-goals)
>
> [Voluntary Agreements as Compliance Tools
> 63](#voluntary-agreements-as-compliance-tools)
>
> [Priority Procedure for Sustainable or Strategic Products or Services
> 64](#priority-procedure-for-sustainable-or-strategic-products-or-services)
>
> [Digital “Credential Wallets” for Operator/Staff
> Approval/Certification
> 65](#digital-credential-wallets-for-operatorstaff-approvalcertification)
[**E. Certification by Private Conformity Assessment Bodies
67**](#_heading=)
> [Third-Party (Conformity) Assessment System
> 67](#third-party-conformity-assessment-system)
>
> [Stringency correlating to Risk Classes
> 68](#stringency-correlating-to-risk-classes)
>
> [Requirements for Designating Authorities— Separation of Functions
> 68](#requirements-for-designating-authorities-separation-of-functions)
>
> [Separation of Certification Bodies’ Tasks from other Tasks of the
> same Body
> 69](#separation-of-certification-bodies-tasks-from-other-tasks-of-the-same-body)
>
> [Impartiality and Remuneration Rules
> 70](#impartiality-and-remuneration-rules)
>
> [Ownership Links between Bodies and Economic Operators
> 70](#ownership-links-between-bodies-and-economic-operators)
>
> [Conflicts of Interest for Certification Bodies
> 71](#conflicts-of-interest-for-certification-bodies)
>
> [Quality Management System Requirements for Certification Bodies
> 72](#quality-management-system-requirements-for-certification-bodies)
>
> [External Testing Facilities 73](#external-testing-facilities)
>
> [Accreditation for Certification Bodies or Laboratories
> 74](#accreditation-for-certification-bodies-or-laboratories)
>
> [Documentation for Application as Body
> 75](#documentation-for-application-as-body)
>
> [Requirements for Permanent Technical Staff, Decision-Makers and
> Operational Staff
> 75](#requirements-for-permanent-technical-staff-decision-makers-and-operational-staff)
>
> [Qualification Matrices for Body Personnel
> 76](#qualification-matrices-for-body-personnel)
>
> [On-Site Audits of Bodies and Economic Operators
> 77](#on-site-audits-of-bodies-and-economic-operators)
>
> [Notification Procedure—EU Commission as Final Arbiter in Case of
> Member States’ Objection
> 78](#notification-procedureeu-commission-as-final-arbiter-in-case-of-member-states-objection)
>
> [Periodic Reassessment of Bodies 79](#periodic-reassessment-of-bodies)
>
> [Ongoing Monitoring and For-Cause-Audits of Bodies
> 79](#ongoing-monitoring-and-for-cause-audits-of-bodies)
>
> [Mandatory Coordination Group for Bodies
> 80](#mandatory-coordination-group-for-bodies)
>
> [Alignment of Bodies’ Practices 80](#alignment-of-bodies-practices)
>
> [Peer Reviews of Bodies 81](#peer-reviews-of-bodies)
>
> [Peer Reviews of Notifying/Designating Authorities
> 82](#peer-reviews-of-notifyingdesignating-authorities)
>
> [Rules for “De-Designation” 82](#rules-for-de-designation)
>
> [Publication of Certification/Assessment Results
> 84](#publication-of-certificationassessment-results)
>
> [Confidentiality and Data Handling by Bodies
> 85](#confidentiality-and-data-handling-by-bodies)
>
> [Reporting Requirements for Bodies
> 85](#reporting-requirements-for-bodies)
>
> [Recognition of Previous Tests, Certification or Authorisation in
> Modular Assessment
> 86](#recognition-of-previous-tests-certification-or-authorisation-in-modular-assessment)
[**F. International Matters 88**](#_heading=)
> [“Extraterritorial” Scope Covering Companies abroad Targeting the EU
> Market
> 88](#extraterritorial-scope-covering-companies-abroad-targeting-the-eu-market)
>
> [Inspections and Enforcement outside the EU
> 89](#inspections-and-enforcement-outside-the-eu)
>
> [Reporting Duties for Third-Country Operators
> 89](#reporting-duties-for-third-country-operators)
>
> [Third Country Access to EU Databases
> 90](#third-country-access-to-eu-databases)
>
> [International Data Sharing (General)
> 91](#international-data-sharing-general)
>
> [Enforcement and Implementation Data Sharing
> 92](#enforcement-and-implementation-data-sharing)
>
> [Enforcement on behalf of Third Countries
> 92](#enforcement-on-behalf-of-third-countries)
>
> [Risk Classification of Third Countries
> 93](#risk-classification-of-third-countries)
>
> [Dialogue with Non-Government Actors in Third Countries
> 94](#dialogue-with-non-government-actors-in-third-countries)
>
> [Information-Sharing, Training, and Staff Exchange Access for Third
> Countries
> 95](#information-sharing-training-and-staff-exchange-access-for-third-countries)
>
> [Regulatory International Alignment
> 95](#regulatory-international-alignment)
>
> [Member States’ International Cooperation Agreements
> 96](#member-states-international-cooperation-agreements)
>
> [Recognition of International Test Reports, Certificates or Approvals
> 97](#recognition-of-international-test-reports-certificates-or-approvals)
>
> [Adequacy or Equivalence Decisions
> 98](#adequacy-or-equivalence-decisions)
>
> [“Passport” as Means for Cross-Border Activities
> 99](#passport-as-means-for-cross-border-activities)
[**G. Obligations of (Economic) Actors 101**](#_heading=)
> [“State of the Art” or “Best Available Technique” as Legal Benchmark
> 101](#state-of-the-art-or-best-available-technique-as-legal-benchmark)
>
> [Power to Adapt Technical / Legal Requirements
> 102](#power-to-adapt-technical-legal-requirements)
>
> [Dynamic Link/Reference to Future Innovations
> 102](#dynamic-linkreference-to-future-innovations)
>
> [“Retirement” of Outdated Technical Norms
> 103](#retirement-of-outdated-technical-norms)
>
> [Reference/Alignment with International Standards
> 104](#referencealignment-with-international-standards)
>
> [COM to Assess Standards for Legal Compliance
> 105](#com-to-assess-standards-for-legal-compliance)
>
> [COM to Substitute or Correct Standards
> 106](#com-to-substitute-or-correct-standards)
>
> [COM to make Standards Mandatory
> 107](#com-to-make-standards-mandatory)
>
> [Presumption of Conformity for Standards and COM Specifications
> 108](#presumption-of-conformity-for-standards-and-com-specifications)
>
> [Standards or COM Specifications to be Followed by Default
> 109](#standards-or-com-specifications-to-be-followed-by-default)
>
> [Obligations Tiered by Risk / Value / Volume
> 110](#obligations-tiered-by-risk-value-volume)
>
> [Catalogue of Detailed Obligations for Economic Operators
> 111](#catalogue-of-detailed-obligations-for-economic-operators)
>
> [Outsourcing of Obligations: Limits and Conditions
> 112](#outsourcing-of-obligations-limits-and-conditions)
>
> [Responsibility Organisations of Economic Actors
> 113](#responsibility-organisations-of-economic-actors)
>
> [Guarantee for Fulfilment of Obligations
> 113](#guarantee-for-fulfilment-of-obligations)
>
> [Withdrawal, Recall, and Corrective Action
> 114](#withdrawal-recall-and-corrective-action)
>
> [Obligations for Brokers and Platform Operators
> 115](#obligations-for-brokers-and-platform-operators)
>
> [E-Commerce and Digital Market-Specific Provisions
> 115](#e-commerce-and-digital-market-specific-provisions)
>
> [Coverage of New / Atypical Economic Operators
> 116](#coverage-of-new-atypical-economic-operators)
>
> [Coverage of 3D-Printing or Blue Print Selling
> 117](#coverage-of-3d-printing-or-blue-print-selling)
>
> [Permalinks for Electronic Documentation
> 118](#permalinks-for-electronic-documentation)
>
> [Reporting/Information on Alignment with Standards
> 119](#reportinginformation-on-alignment-with-standards)
>
> [Quality Management Systems 119](#quality-management-systems)
>
> [Factory Production or Service Control Requirements
> 120](#factory-production-or-service-control-requirements)
>
> [Periodic Sample Testing Obligation
> 121](#periodic-sample-testing-obligation)
>
> [Compliance Checks by Digital Twins or Simulations
> 122](#compliance-checks-by-digital-twins-or-simulations)
>
> [“Technical Dossiers” of Service Providers
> 122](#technical-dossiers-of-service-providers)
>
> [Technical Documentation and Event Records Keeping
> 123](#technical-documentation-and-event-records-keeping)
>
> [Reduced Technical Documentation for Individually Manufactured or
> Non-Series Products
> 124](#reduced-technical-documentation-for-individually-manufactured-or-non-series-products)
>
> [Traceability Requirements 124](#traceability-requirements)
>
> [Digital Identification / Know-Your-Customers Rules
> 125](#digital-identification-know-your-customers-rules)
>
> [Internet Platforms and Brokers to cooperate with Authorities
> 126](#internet-platforms-and-brokers-to-cooperate-with-authorities)
>
> [Electronic and Bundled Declaration of Conformity
> 127](#electronic-and-bundled-declaration-of-conformity)
>
> [Detailed Declaration of Conformity and Performance
> 127](#detailed-declaration-of-conformity-and-performance)
>
> [Labels for Product Information 128](#labels-for-product-information)
>
> [Mandatory “Key Characteristics” Indication
> 129](#mandatory-key-characteristics-indication)
>
> [Right to Information for Customers / Consumers / End-Users
> 129](#right-to-information-for-customers-consumers-end-users)
>
> [Precontractual Information Obligations
> 130](#precontractual-information-obligations)
>
> [Information Accessibility for End Users
> 131](#information-accessibility-for-end-users)
>
> [Plain Language and Accessibility of Information
> 131](#plain-language-and-accessibility-of-information)
>
> [Mandatory Language Requirements
> 132](#mandatory-language-requirements)
>
> [Parallel Trade / Dissemination of Products Beyond Intended Member
> State(s) with Language/Packaging Adaptation
> 133](#parallel-trade-dissemination-of-products-beyond-intended-member-states-with-languagepackaging-adaptation)
>
> [Conformity Marking Systems (e.g. CE)
> 134](#conformity-marking-systems-e.g.-ce)
>
> [Detailed CE Marking Information
> 134](#detailed-ce-marking-information)
>
> [No Mimicking and Interfering Markings
> 135](#no-mimicking-and-interfering-markings)
>
> [“Batch” and Serial Number Marking
> 136](#batch-and-serial-number-marking)
>
> [Statutory “Claims Rules” 136](#statutory-claims-rules)
>
> [Ban on Misleading Claims and Marketing Practices
> 137](#ban-on-misleading-claims-and-marketing-practices)
>
> [Obligation to Provide Samples or to Grant Access
> 139](#obligation-to-provide-samples-or-to-grant-access)
>
> [Suppliers / Service Providers to Cooperate for Compliance
> 139](#suppliers-service-providers-to-cooperate-for-compliance)
>
> [Contact Details for Accidents/Incidents/Safety Issues
> 140](#contact-details-for-accidentsincidentssafety-issues)
>
> [Transparency on Rules and Procedures
> 141](#transparency-on-rules-and-procedures)
>
> [Complaints Handling and Recording
> 141](#complaints-handling-and-recording)
>
> [Cyber Incident or Security Breach Notification
> 142](#cyber-incident-or-security-breach-notification)
>
> [Information and Audit Obligations proportionate to Operator Size and
> Risk
> 143](#information-and-audit-obligations-proportionate-to-operator-size-and-risk)
>
> [Annual Reporting of Operators 143](#annual-reporting-of-operators)
>
> [“Benchmarking” and “League Table” Publication
> 144](#benchmarking-and-league-table-publication)
>
> [Importer/Distributor to Verify and Inform
> 145](#importerdistributor-to-verify-and-inform)
>
> [Responsible Person for Regulatory Compliance
> 145](#responsible-person-for-regulatory-compliance)
>
> [Regulatory Compliance Department with High-level Head
> 146](#regulatory-compliance-department-with-high-level-head)
>
> [Governance Requirements for Compliance
> 147](#governance-requirements-for-compliance)
>
> [Authorised/Legal Representatives: Detailed Obligations, Tasks, and
> Liability
> 147](#authorisedlegal-representatives-detailed-obligations-tasks-and-liability)
>
> [Change of Authorised/Legal Representative
> 148](#change-of-authorisedlegal-representative)
>
> [Authorised/Legal Representatives: Right of Action Against
> Non-compliant Manufacturers/Service Providers
> 149](#authorisedlegal-representatives-right-of-action-against-non-compliant-manufacturersservice-providers)
>
> [Duties where Product/Service is Modified or Intended Purpose Changed
> 150](#duties-where-productservice-is-modified-or-intended-purpose-changed)
>
> [Economic Operators to be Identified by Labels
> 150](#economic-operators-to-be-identified-by-labels)
>
> [Supply Chain Operators to Cooperate for Conformity Assessment
> Procedures
> 151](#supply-chain-operators-to-cooperate-for-conformity-assessment-procedures)
>
> [Use of Previous Test Results / Certificates
> 152](#use-of-previous-test-results-certificates)
>
> [Modular or System-Based Conformity Assessment
> 152](#modular-or-system-based-conformity-assessment)
>
> [Non-discrimination and Equal Access Clauses
> 153](#non-discrimination-and-equal-access-clauses)
>
> [Open API / Third-Party Access in Digital Services
> 154](#open-api-third-party-access-in-digital-services)
>
> [“Clean Break” Transfers Following Service or Supplier Change
> 154](#clean-break-transfers-following-service-or-supplier-change)
>
> [Minimum Training Requirement 155](#minimum-training-requirement)
>
> [Custom or Heritage Product Regimes
> 156](#custom-or-heritage-product-regimes)
>
> [Surplus or Non-Installed Products
> 156](#surplus-or-non-installed-products)
>
> [Remanufactured and Used Products
> 157](#remanufactured-and-used-products)
>
> [Producer Responsibility Schemes
> 158](#producer-responsibility-schemes)
>
> [Product or Service “Passports” 158](#product-or-service-passports)
>
> [Transparency Registers for Market Actors
> 159](#transparency-registers-for-market-actors)
>
> [Voluntary Certification/Approval of Parts
> 160](#voluntary-certificationapproval-of-parts)
>
> [Mandatory Certification/Approval of Key Parts or Ingredients
> 160](#mandatory-certificationapproval-of-key-parts-or-ingredients)
>
> [Obligations for Parts and Components Distinct from Accessories
> 161](#obligations-for-parts-and-components-distinct-from-accessories)
>
> [Imported Used Products Checked as New Products
> 162](#imported-used-products-checked-as-new-products)
>
> [Voluntary Conformity Assessment for Used Products Not Subject to
> Mandatory Assessment
> 163](#voluntary-conformity-assessment-for-used-products-not-subject-to-mandatory-assessment)
>
> [Re-labelled, Re-purposed, or Misdeclared and “Pseudo” Products
> 163](#re-labelled-re-purposed-or-misdeclared-and-pseudo-products)
>
> [Manufacturer to Define/Certify Precise Product Type
> 164](#manufacturer-to-definecertify-precise-product-type)
>
> [Detailed and Logically-Ordered Declaration of Conformity
> 165](#detailed-and-logically-ordered-declaration-of-conformity)
>
> [Life Cycle Assessment (LCA) of Effects
> 165](#life-cycle-assessment-lca-of-effects)
>
> [Labelling Schemes 166](#labelling-schemes)
>
> [Discontinuity Notification 167](#discontinuity-notification)
>
> [Obligation to offer Repairs and Spares
> 167](#obligation-to-offer-repairs-and-spares)
>
> [Requirements for Supply Chain Due Diligence
> 168](#requirements-for-supply-chain-due-diligence)
>
> [End-of-Life “Product Stewardship”
> 169](#end-of-life-product-stewardship)
>
> [“Do No Significant Harm” Clauses
> 169](#do-no-significant-harm-clauses)
>
> [Pre-Market Risk Assessment in High-Risk Sectors
> 170](#pre-market-risk-assessment-in-high-risk-sectors)
[**H. Liability of Actors 171**](#_heading=)
> [Liability for Defective Products or Services
> 171](#liability-for-defective-products-or-services)
>
> [Liability for Conformity or Compliance (not just Responsibility)
> 171](#liability-for-conformity-or-compliance-not-just-responsibility)
>
> [Liability for Correctness of Information
> 172](#liability-for-correctness-of-information)
>
> [Liability of Authorised/Legal Representative
> 173](#liability-of-authorisedlegal-representative)
>
> [Liability Insurance for Certification Services
> 173](#liability-insurance-for-certification-services)
>
> [Multiple Liable Persons 174](#multiple-liable-persons)
[**I. Risk Management and Technology Ethics 176**](#_heading=)
> [Risk-Based Supervision/Control Requirements
> 176](#risk-based-supervisioncontrol-requirements)
>
> [Risk Management System Requirements
> 177](#risk-management-system-requirements)
>
> [Joint or Centralised Technology Assessment
> 177](#joint-or-centralised-technology-assessment)
>
> [Notification and Scrutiny for Emerging Risks
> 179](#notification-and-scrutiny-for-emerging-risks)
>
> [COM as Risk Assessment Arbiter 179](#com-as-risk-assessment-arbiter)
>
> [Incentives for Risk Reduction 180](#incentives-for-risk-reduction)
>
> [Risk Communication and Public Information
> 180](#risk-communication-and-public-information)
>
> [Risk Assessment Methodology 181](#risk-assessment-methodology)
[**J. Public Ensurance of Compliance / Implementation 183**](#_heading=)
> [Confidential Two-Way Digital Communication Channels
> 183](#confidential-two-way-digital-communication-channels)
>
> [Authentication of Signatures and Documents
> 184](#authentication-of-signatures-and-documents)
>
> [Implementation Coordination Group
> 184](#implementation-coordination-group)
>
> [Peer Review of Enforcement Authorities
> 186](#peer-review-of-enforcement-authorities)
>
> [Annual Public Enforcement Reporting
> 186](#annual-public-enforcement-reporting)
>
> [Public Access to Enforcement Data
> 187](#public-access-to-enforcement-data)
>
> [Compliance Visualisation (“Heat Maps”)
> 188](#compliance-visualisation-heat-maps)
>
> [Multi-annual National Control Plans
> 188](#multi-annual-national-control-plans)
>
> [Enforcement Database 189](#enforcement-database)
>
> [EU-Wide Registers 190](#eu-wide-registers)
>
> [Standardised Procedures for Surveillance and Inspections
> 190](#standardised-procedures-for-surveillance-and-inspections)
>
> [Border Control of Products 191](#border-control-of-products)
>
> [Continuous Improvement Obligation
> 192](#continuous-improvement-obligation)
>
> [Minimum Frequency/Number of Checks
> 192](#minimum-frequencynumber-of-checks)
>
> [Minimum Enforcement Resources 193](#minimum-enforcement-resources)
>
> [Enforcement Delegation within Member States
> 194](#enforcement-delegation-within-member-states)
>
> [Artificial Intelligence to Detect Diverging Practice or Infringements
> 195](#artificial-intelligence-to-detect-diverging-practice-or-infringements)
>
> [Testing Infrastructure (Physical, Artificial Intelligence or other
> Software)
> 195](#testing-infrastructure-physical-artificial-intelligence-or-other-software)
>
> [Mandatory Software, Software Component(s) or Datasets
> 196](#mandatory-software-software-components-or-datasets)
>
> [Notification of Draft National Measures/Deviations
> 197](#notification-of-draft-national-measuresdeviations)
>
> [National Focal Points and Coordinating Authorities
> 198](#national-focal-points-and-coordinating-authorities)
>
> [EU-Wide Rapid Alert Systems 199](#eu-wide-rapid-alert-systems)
>
> [EU Joint Investigation Teams 199](#eu-joint-investigation-teams)
>
> [Shared Roles and Joint Decision-Making of Authorities Cross-Border
> 200](#shared-roles-and-joint-decision-making-of-authorities-cross-border)
>
> [Multi-Country Enforcement Operations
> 201](#multi-country-enforcement-operations)
>
> [Enforcement Assistance among Member States
> 201](#enforcement-assistance-among-member-states)
>
> [Control of Entities active in different Member States
> 202](#control-of-entities-active-in-different-member-states)
>
> [Responsibility Collision Rules 203](#responsibility-collision-rules)
>
> [Coordination/Consultation Procedures with Supervisory or Regulatory
> Agencies
> 204](#coordinationconsultation-procedures-with-supervisory-or-regulatory-agencies)
>
> [Legal Personality and Independence for Regulatory Agencies
> 204](#legal-personality-and-independence-for-regulatory-agencies)
>
> [Direct Control and Enforcement by COM
> 205](#direct-control-and-enforcement-by-com)
>
> [Disruption in a Member State’s Control System
> 206](#disruption-in-a-member-states-control-system)
>
> [Training and Capacity-Building for Authorities
> 206](#training-and-capacity-building-for-authorities)
>
> [Exchanges and “Twinning” Among Member State Authorities
> 207](#exchanges-and-twinning-among-member-state-authorities)
>
> [Compliance Cooperation with Other Actors
> 207](#compliance-cooperation-with-other-actors)
>
> [Sampling of Produced Items or Provided Services
> 208](#sampling-of-produced-items-or-provided-services)
>
> [Early Regulatory Dialogue / “Pre-Notification” of Measures
> 209](#early-regulatory-dialogue-pre-notification-of-measures)
>
> [Serious Incidents / Corrective Actions to Be Notified
> 210](#serious-incidents-corrective-actions-to-be-notified)
>
> [Certification Bodies to Report on Infringements
> 210](#certification-bodies-to-report-on-infringements)
>
> [Model Forms, Templates, and IT Tools
> 211](#model-forms-templates-and-it-tools)
>
> [Enforcement Funding and Cost Recovery
> 211](#enforcement-funding-and-cost-recovery)
>
> [Definition of Technical Protocols and Test Methods
> 212](#definition-of-technical-protocols-and-test-methods)
>
> [Prevention of Test Cheating 213](#prevention-of-test-cheating)
>
> [Testing Laboratories’ Equipment and Procedures
> 214](#testing-laboratories-equipment-and-procedures)
>
> [European Reference Laboratories
> 214](#european-reference-laboratories)
>
> [Contact Points/Digital Gateways 215](#contact-pointsdigital-gateways)
>
> [Social Partners in Regulatory Committees
> 216](#social-partners-in-regulatory-committees)
>
> [Information-Sharing among Certification Bodies and Authorities
> (Obligations and Empowerments)
> 216](#information-sharing-between-certification-bodies-and-authorities-obligations-and-empowerments)
>
> [EU-Wide Training / Learning for Practitioners
> 217](#eu-wide-training-learning-for-practitioners)
>
> [Mandating Good Administrative Practices
> 218](#mandating-good-administrative-practices)
>
> [Capping of Compliance Costs 218](#capping-of-compliance-costs)
>
> [Incentives/Prizes for Voluntary Over-Compliance, Innovation, or
> Social Good
> 219](#incentivesprizes-for-voluntary-over-compliance-innovation-or-social-good)
[**K. Enforcement Powers 221**](#_heading=)
> [Proactive Surveillance and Own-Initiative Audits
> 221](#proactive-surveillance-and-own-initiative-audits)
>
> [“Stress Tests” and Real-Time Audits
> 221](#stress-tests-and-real-time-audits)
>
> [Proportional/Graduated Enforcement Toolkit / Comprehensive
> Empowerment Catalogue
> 223](#proportionalgraduated-enforcement-toolkit-comprehensive-empowerment-catalogue)
>
> [Layered Administrative, Civil, Criminal Enforcement
> 224](#layered-administrative-civil-criminal-enforcement)
>
> [Targeted Information Interventions by Authorities
> 225](#targeted-information-interventions-by-authorities)
>
> [“Blacklisting” and “Shaming” of Persons or Businesses
> 225](#blacklisting-and-shaming-of-persons-or-businesses)
>
> [Blocking Access to Non-Compliant Products or Services
> 226](#blocking-online-access-to-non-compliant-products-or-services)
>
> [Market Withdrawal Notification to Users/Consumers
> 227](#market-withdrawal-notification-to-usersconsumers)
>
> [Coordinated Market Withdrawal or Remediation Measures (“Union
> Safeguard Procedure”)
> 227](#coordinated-market-withdrawal-or-remediation-measures-union-safeguard-procedure)
>
> [Coherent Handling of Risky or Non-compliant Products or Services
> across EU
> 228](#coherent-handling-of-risky-or-non-compliant-products-or-services-across-eu)
>
> [Authorities to Inform Bodies of Non-Compliant or Risky Products
> 229](#authorities-to-inform-bodies-of-non-compliant-or-risky-products)
>
> [Powers for “Recall” of Digital Content or Correction of Published
> Errors
> 230](#powers-for-recall-of-digital-content-or-correction-of-published-errors)
>
> [Power to Impose Corrective Advertising / Publication
> 231](#power-to-impose-corrective-advertising-publication)
>
> [Economic Powers Catalogue
> 231](#economic-powers-catalogue---external-administrator)
>
> [Fees, Charges, Cost-Sharing for Regulatory Services
> 232](#fees-charges-cost-sharing-for-regulatory-services)
>
> [Measures targeting Company Groups
> 233](#measures-targeting-company-groups)
>
> [Precise Delegation for Enforcement Powers
> 233](#precise-delegation-for-enforcement-powers)
>
> [Criteria for Selection of Enforcement or Sanctions
> 234](#criteria-for-selection-of-enforcement-or-sanctions)
>
> [Sanctions for Failure to Cooperate with Authorities
> 235](#sanctions-for-failure-to-cooperate-with-authorities)
>
> [Power to Define Methods for Calculating Fines
> 235](#power-to-define-methods-for-calculating-fines)
>
> [Complete Penal System— including Whistleblower and Witness Protection
> 236](#complete-penal-system-including-whistleblower-and-witness-protection)
>
> [Administrative and Collateral Sanction Package
> 237](#administrative-and-collateral-sanction-package)
>
> [Penalty Regime with Proportionality and Discretion
> 238](#penalty-regime-with-proportionality-and-discretion)
>
> [Precise Catalog of Infringements
> 238](#precise-catalog-of-infringements)
>
> [Ban on Double Penalties by different Member States
> 239](#ban-on-double-penalties-by-different-member-states)
[**L. Third-Party Enforcement Assistance 241**](#_heading=)
> [Right to Comment in Procedures and Public Registers
> 241](#right-to-comment-in-procedures-and-public-registers)
>
> [Public Complaint and Whistleblower Mechanisms
> 242](#public-complaint-and-whistleblower-mechanisms)
>
> [Protection of Informants / Whistleblowers / Witnesses
> 242](#protection-of-informants-whistleblowers-witnesses)
>
> [EU Complaint Portal with Re-routing
> 243](#eu-complaint-portal-with-re-routing)
>
> [Right—and Obligation (in Serious Risk)—to Inform Authorities of
> Infringements by Others
> 244](#rightand-obligation-in-serious-riskto-inform-authorities-on-infringements-by-others)
>
> [Actors to Inform on Suspected Criminal Acts
> 244](#actors-to-inform-on-suspected-criminal-acts)
>
> [Trusted Flaggers to Inform on Suspected Non-conformities / Filtering
> Non-compliance Notices
> 245](#trusted-flaggers-to-inform-on-suspected-non-conformities-filtering-non-compliance-notices)
>
> [Third-Party Rights (Standing) in Regulatory Appeals
> 246](#third-party-rights-standing-in-regulatory-appeals)
>
> [Invalidity Clauses for Contravening Private Acts
> 246](#invalidity-clauses-for-contravening-private-acts)
[**M. Dispute Resolution and Appeals 248**](#_heading=)
> [Third Party Standing and Representation Rules
> 248](#third-party-standing-and-representation-rules)
>
> [Transparency regarding Appeals 249](#transparency-regarding-appeals)
>
> [Right to be Heard prior to Adverse Decisions
> 249](#right-to-be-heard-prior-to-adverse-decisions)
>
> [Central Oversight or Appeals Bodies
> 250](#central-oversight-or-appeals-bodies)
>
> [Ex ante Judicial Approval 251](#ex-ante-judicial-approval)
>
> [Reverse Burden of Proof 251](#reverse-burden-of-proof)
>
> [Victim/Complainant Assistance Provisions
> 252](#victimcomplainant-assistance-provisions)
>
> [Alternative Dispute Resolution (ADR) Pathways
> 253](#alternative-dispute-resolution-adr-pathways)
[**N. Data, Information and Artificial Intelligence 255**](#_heading=)
> [Access to Own File within Administration
> 255](#access-to-own-file-within-administration)
>
> [Open Data and Access to Public Sector Information
> 256](#open-data-and-access-to-public-sector-information)
>
> [Retention and Deletion of Data 256](#retention-and-deletion-of-data)
>
> [Right to Correct Data in Official Databases
> 257](#right-to-correct-data-in-official-databases)
>
> [Data Portability and Interoperability
> 258](#data-portability-and-interoperability)
>
> [Transparency Requirements for Algorithmic Systems
> 258](#transparency-requirements-for-algorithmic-systems)
>
> [Right to Human Review of Automated Decisions
> 259](#right-to-human-review-of-automated-decisions)
>
> [Prohibition of “Dark Patterns” in Digital Interfaces
> 260](#prohibition-of-dark-patterns-in-digital-interfaces)
>
> [Protection of “Know-How” and Trade Secrets
> 260](#protection-of-know-how-and-trade-secrets)
[**O. Emergencies 262**](#_heading=)
> [Power for Emergency/Provisional Measures
> 262](#power-for-emergencyprovisional-measures)
>
> [Rapid Regulatory Adaptation via Emergency / Temporary Delegated Acts
> 262](#rapid-regulatory-adaptation-via-emergency-temporary-delegated-acts)
>
> [Periodic Disaster Risk Assessment, Exercise or Audit
> 263](#periodic-disaster-risk-assessment-exercise-or-audit)
>
> [Temporary Legal Derogation During Crisis
> 264](#temporary-legal-derogation-during-crisis)
>
> [Safeguard Regimes for “Critical” Infrastructure, Institutions,
> Enterprises or other Actors
> 264](#safeguard-regimes-for-critical-infrastructure-institutions-enterprises-or-other-actors)
[**P. Financial Implementation and General Planning 266**](#_heading=)
> [Imposing Regional Cooperation 266](#imposing-regional-cooperation)
>
> [Multiannual Programming/Planning Obligations (e.g., in Funding or
> Implementation)
> 266](#multiannual-programmingplanning-obligations-e.g.-in-funding-or-implementation)
>
> [Mandatory Financing by Commission
> 267](#mandatory-financing-by-commission)
>
> [Combination of Funding: Compatibility and Collision
> 268](#combination-of-funding-compatibility-and-collision)
>
> [Joint Procurement or Buying Schemes
> 269](#joint-procurement-or-buying-schemes)
>
> [Procurement Rules Integrating Product Compliance
> 269](#procurement-rules-integrating-product-compliance)
>
> [Procurement Rules Furthering Political Goals
> 270](#procurement-rules-furthering-political-goals)
[**Q. Final Provisions / Miscellaneous 272**](#_heading=)
> [Gradual Phase-in of Regulatory Obligations
> 272](#gradual-phase-in-of-regulatory-obligations)
>
> [COM to decide on Application Date / Fulfilment of Conditions
> Necessary for Application
> 272](#com-to-decide-on-application-date-fulfilment-of-conditions-necessary-for-application)
>
> [Member States’ Postponement Option
> 273](#member-states-postponement-option)
>
> [Transitional Product / Service Approval or “Grandfathering” of
> Existing Approvals
> 274](#transitional-product-service-approval-or-grandfathering-of-existing-approvals)
>
> [Remedies for Overregulation or Regulatory Overlap
> 274](#remedies-for-overregulation-or-regulatory-overlap)
>
> [Expert Consultation 275](#expert-consultation)
>
> [Whole Society Consultation 276](#whole-society-consultation)
>
> [Stakeholder Forum 277](#stakeholder-forum)
>
> [Impact and Progress Assessment or Reporting
> 278](#impact-and-progress-assessment-or-reporting)
>
> [Joint Programming and Co-Regulatory Roadmapping with Stakeholders /
> Industry
> 278](#joint-programming-and-co-regulatory-roadmapping-with-stakeholders-industry)
>
> [Binding Sectoral Roadmaps/Action Plans
> 279](#binding-sectoral-roadmapsaction-plans)
>
> [Voluntary Agreements on Top of Law
> 280](#voluntary-agreements-on-top-of-law)
>
> [Regulatory Correction Following CJEU/ECJ Rulings
> 280](#regulatory-correction-following-cjeuecj-rulings)
>
> [Table of Contents 281](#table-of-contents)
[**Further Tools 282**](#further-tools)
[**Training and Advice 282**](#training-and-advice)
# A. Interpretation (Rules)
## **EU Information System for Aligned Decision-Making (Authorities and Certification Bodies)**
**Regulatory Function:\**
Consistency in Interpretation and Implementation Across the Union
**Problem:\**
Divergent national authorities or certification body practice creates
market barriers and non-level playing fields.
**Solution(s):\**
Establish a legally mandated, interoperable information system to share
legal and interpretative decisions, case law, and authorisation /
certification outcomes.
**Reference(s):\**
Article 71(1)-(4), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Article 97, Regulation (EU)
[2023/1114](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1114-20240109)
(Crypto Assets), OJ L 150, 9.6.2023, p. 40–178.
**Note(s):\**
-
\
-
## **National Information Systems for Interpretation and Guidance**
**Regulatory Function:\**
Consistency, Correct and Efficient Day-to-Day Compliance
**Problem:\**
Operators, certification bodies and local authorities may misinterpret
rules in the absence of a central source.
**Solution(s):\**
Require Member States to create and maintain accessible national
interpretative and guidance systems, linked to the EU platform (previous
entry).
**Reference(s):\**
Article 71(5)-(7), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Creates uniform guidance and continual feedback, ideal for
fast-changing, technical or decentralised regulatory areas.
## **Product or Process Classification Procedures**
**Regulatory Function:\**
Classification Consistency and Predictability
**Problem:\**
Conflicting or ambiguous classification impedes enforcement and market
entry.
**Solution(s):\**
Define detailed procedures, with Commission powers to clarify
classification where needed.
**Reference(s):\**
Article 4, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Article 84, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
The approach supports legal certainty and reduces friction between
member state authorities and certification bodies.
## **Binding Interpretations by Implementing Acts**
**Regulatory Function:\**
Legal Clarity and Best Practice Support
**Problem:\**
Operators need clear, up-to-date guidance to comply across languages and
Member States.
**Solution(s):\**
Right for the Commission to adopt binding interpretations by
Implementing Acts, where guidance/FAQs, or other interpretative
communications do not suffice.
**Reference(s):\**
Article 30, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Also see the often overlooked instrument of Recommendations in
accordance with Art. 292
[TFEU](https://eur-lex.europa.eu/eli/treaty/tfeu_2012/oj/eng).
## **Empowerment for Guidance**
**Regulatory Function:\**
Legal Clarity and Best Practice Support
**Problem:\**
Operators need clear, up-to-date guidance to comply across languages and
Member States. However, it is sometimes argued that only the ECJ has the
authority to set up interpretations.
**Solution(s):\**
Explicit right for the Commission (services) to adopt guidance
documents.
**Reference(s):\**
Article 77, Regulation (EC) No
[1107/2009](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:32009R1107)
(Plant Protection Products), OJ L 309, 24.11.2009, p. 1–50.
**Note(s):\**
See also the often overlooked instrument of Recommendations in
accordance with Art. 292
[TFEU](https://eur-lex.europa.eu/eli/treaty/tfeu_2012/oj/eng).
## **Reference to Commission, Agency or “Board/Body” for Binding Interpretation or Arbitration**
**Regulatory Function:\**
Conflict amongst Member States on Application / Interpretation
**Problem:\**
Unresolved legal ambiguities lead to conflicts, delayed implementation
and unequal enforcement.
**Solution(s):\**
Allow national authorities to make “preliminary references” to the
Commission or an EU agency or “board/body” with legal personality for
official/binding interpretation.
**Reference(s):\**
Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng),
Art. 64 and 65 (Data Protection);
Article 59, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102;
Article 13, Regulation (EU)
[2019/1149](https://eur-lex.europa.eu/legal-content/DE/ALL/?uri=CELEX:32019R1149)
(European Labour Authority), OJ L 186, 11.7.2019, p. 21-56.
**Note(s):\**
Similar: New Legislative Framework product legislation contains
so-called “safeguard clauses”, according to which measures taken by a
Member State can be challenged by other Member States. The confirmatory
decision or opinion of the Commission mostly needs to be transposed by
all the Member States or is even directly applicable in all Member
States. See “Coherent Handling of Risky or Non-compliant Products or
Services across EU” in Chapter K.
## **Reference to Courts for Binding Interpretation**
**Regulatory Function:\**
Legal Uncertainty or Conflict amongst Member States on Application /
Interpretation
**Problem:\**
Unresolved legal ambiguities lead to conflicts, delayed implementation
and unequal enforcement.
**Solution(s):\**
Allow reference to a court in view of a “preliminary ruling”.
**Reference(s):\**
Article [267
TFEU](https://eur-lex.europa.eu/eli/treaty/tfeu_2016/art_267/oj/eng).
**Note(s):\**
Can also be established by secondary legislation (to be checked).
Similar mechanisms can be found in various constitutions or laws of the
Member States.
## **Standards, International and Informal Document to guide Interpretation**
**Regulatory Function:\**
Clarity and Predictable Implementation
**Problem:\**
Vague or ambiguous legal provisions risk inconsistent application.
**Solution(s):\**
Refer to documents that can help to interpret a vague term or provision,
without establishing a strict obligation to follow any of the documents.
In the selected reference, the following documents are referred to:
“(a) European standards other than those the references of which have
been published in the Official Journal of the European Union in
accordance with Article 10(7) of Regulation (EU) No
[1025/2012](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32012R1025);
\(b\) international standards;
\(c\) international agreements;
\(d\) voluntary certification schemes or similar third-party conformity
assessment frameworks, in particular those conceived to support Union
law;
\(e\) Commission recommendations or guidelines on product safety
assessment;
\(f\) national standards drawn up in the Member State in which the
product is made available;
\(g\) the state of the art and technology, including the opinion of
recognised scientific bodies and expert committees;
\(h\) product safety codes of good practice in force in the sector
concerned; …”
**Reference(s):\**
Article 8, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.
**Note(s):\**
Please note the subtle wording in Article 8: “... when assessing whether
a product is safe, the following elements in particular shall be taken
into account, when available: …”. This wording does not bind the
interpretation to any of the documents referred to. Binding the
interpretation would be legally problematic.
## **Recitals to guide Interpretation**
**Regulatory Function:\**
Clarity and Predictable Implementation
**Problem:\**
Vague or ambiguous legal provisions risk inconsistent application.
**Solution(s):\**
Use detailed recitals with examples, interpretative principles and
explicit guidance on intended meaning.
**Reference(s):\**
Recitals 19, 26, 36, and 39, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
Some hold that recitals should only be used to justify the provisions.
Even though recitals can often be formulated in a way that pursues both
purposes.
##
# B. Scope, Application and Harmonisation Approaches
## **Empowerment to clarify Applicability of an Act**
**Regulatory Function:\**
Legal Certainty, Scope and Applicability
**Problem:\**
Uncertainty arises as to whether a legislative act applies in borderline
or evolving scenarios.
**Solution(s):\**
Empowerment for the Commission to clarify the applicability via binding
acts.
**Reference(s):\**
Article 4(1) and (2), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Helps ensure regulatory certainty and enforceability in fields with
rapidly evolving products, services or other processes and social
realities.
## **Member State to be exempted under Conditions**
**Regulatory Function:\**
Flexibility for Divergent National Situations and Interests
**Problem:\**
Political goals can sometimes be better pursued with more flexibility
regarding the means. Whilst default means are needed, alternative paths
can be more suitable in certain circumstances.
**Solution(s):\**
Permit exemptions under certain conditions and with strict control by
the Commission, expiry of exemption in case of non-fulfilment of
obligations.
**Reference(s):\**
Articles 50(5)-(7) and 52(2) and (3), Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40.
**Note(s):\**
Article 52 is unclear as to whether the Commission needs to exempt the
Member States or whether the Member States may exempt themselves under
certain conditions. Article 50 is preferable.
## **Member State “Opt-Out” from Marginal Scope**
**Regulatory Function:\**
Flexibility for Divergent National Interests
**Problem:\**
A certain number of Member States need a regulatory element some others
do not want.
**Solution(s):\**
Permit Members to opt out of marginal areas of EU regulation, avoiding
unnecessary blocking of wider harmonisation.
**Reference(s):\**
Article 2(1), last sentence, Proposal for a Regulation on the marketing
of construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final.
**Note(s):\**
-
## **Member State “Opt-ins”**
**Regulatory Function:\**
Flexibility for Divergent National Interests
**Problem:\**
A certain number of Member States need a regulation or directive that
others do not want.
**Solution(s):\**
Permit Members to opt in, avoiding unnecessary blocking of wider
harmonisation.
**Reference(s):\**
The legal frameworks for the Schengen area and the single currency
(Euro) are formally opt-out regimes, but new Member States can de facto
decide on whether they wish to join–in which case they have to fulfil
certain conditions–or not.
**Note(s):\**
Argentina and Australia have developed easier to handle types of
opt-ins: (1) Argentina – “ley convenio” technique (as recognised in
constitutional [Article
75](https://www.congreso.gob.ar/constitucionSeccion1Cap4_ingles.php)
and Senate analyses), where a federal law establishes a national regime
in an area of shared or provincial competence and explicitly invites
provinces to adhere by their own legislation. Provinces that do not
adhere remain outside that regime, while the framework can still operate
for adhering provinces. (2) Australia – [Mutual Recognition Act
1992](https://www.legislation.gov.au/C2004A04489/latest/text) (Cth);
Automatic Mutual Recognition
([AMR](https://www.wa.gov.au/organisation/service-delivery/automatic-mutual-recognition))
schemes for regulated professions have been adopted by some states and
territories
([NSW](https://www.nsw.gov.au/business-and-economy/licences-and-credentials/automatic-mutual-recognition),
Victoria, ACT, Western Australia, …), but not by all.
## **Member States to exempt Outermost Regions**
**Regulatory Function:\**
Tailoring Regulation for Non-Continental Markets
**Problem:\**
EU rules may be misaligned or overly burdensome for distant territories
(outermost regions).
**Solution(s):\**
Permit Member States to exempt such regions or sectors, requiring
notification and assurance that no market spill-over occurs.
**Reference(s):\**
Article 2(3), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Exemptions in Case of “Public Interest Override”**
**Regulatory Function:\**
Balancing Rights and Interests
**Problem:\**
Absolute rules may bar vital actions in cases of overriding public
interest (e.g., national security, civil protection).
**Solution(s):\**
Greater good exemptions defined and allowed through precise procedures,
with transparency and accountability safeguards.
**Reference(s):\**
Article 23, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;\
Article 9, Directive (EU)
[2016/943](https://eur-lex.europa.eu/eli/dir/2016/943/oj/eng)
(Trade Secrets), OJ L 157, 15.6.2016, p. 1–18.
**Note(s):\**
-
## **“Flexibility Clauses” – Adaptation to Local Contexts**
**Regulatory Function:\**
Subsidiarity/Proportionality
**Problem:\**
One-size-fits-all regulation may not fit Member State circumstances.
**Solution(s):\**
Legal flexibility for alternative methods or timings, subject to
criteria and notification.
**Reference(s):\**
Article 22, Directive
[2008/50/EC](https://eur-lex.europa.eu/eli/dir/2008/50/oj/eng)
(Air Quality), OJ L 152, 11.6.2008, p. 1–44.
**Note(s):\**
-
## **Micro-Enterprise and De Minimis Exemptions**
**Regulatory Function:\**
Proportionality and Administrative Burden Reduction
**Problem:\**
Full compliance burden may overwhelm micro-enterprises.
**Solution(s):\**
Explicit exemption or simplified regime for micro-enterprises or
activities below a quantitative threshold.
**Reference(s):\**
Commission Recommendation
[2003/361/EC](https://eur-lex.europa.eu/eli/reco/2003/361/oj/eng)
(SME), OJ L 124, 20.5.2003, p. 36–41;\
Article 30(5), Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
-
## **Compatibility (“Coherence”) or Collision Clauses**
**Regulatory Function:\**
Legal Certainty and Avoidance of Conflict
**Problem:\**
Potential inconsistencies if parallel sectoral legislation applies.
**Solution(s):\**
Stipulate which provision or act prevails or define in another way the
relationship between two acts.
**Reference(s):\**
Article 1(2)(a), Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025;
Articles 95 and 96, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;\
Article 2(1), Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131;
Article 9, Regulation (EU)
[2023/1230](https://eur-lex.europa.eu/eli/reg/2023/1230/oj/eng)
(Machinery), OJ L 165, 14.6.2023, p. 1–151.
**Note(s):\**
- Ensures a predictable legal order for both authorities and regulated
actors. The classic collision rules (lex posterior derogat lex anterior;
lex specialis derogat lex generalis) may lead to unclear results;
therefore clear collision rules are preferable;
\- The first reference contains the following quite unique rule on the
relationship of two acts of secondary legislation: “2. This Regulation:
| \(a\) | specifies and complements the rights laid down in Regulation (EU) [2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng) … “. |
|----|----|
## **“Without Prejudice” Clauses**
**Regulatory Function:\**
Legal Clarity and Cross-Regime Compliance
**Problem:\**
Regulators and operators face uncertainty when obligations overlap
(e.g., competition, data protection, trade secrets).
**Solution(s):\**
Explicit reference that provisions must be applied “without prejudice”
to specific other laws (e.g., GDPR, trade secrets).
**Reference(s):\**
Article 2(4), Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;\
Article 2(4), Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.
**Note(s):\**
The meaning of “without prejudice” is not always clear. Please check
whether more precise wordings can be found in your case.
**Cross-Sectoral “Regulatory Alignment” Panels for Multi-Use
Products/Services**
**Regulatory Function:\**
Clarifying Interlocking Legal Regimes
**Problem:\**
Products and services may fall under multiple potentially conflicting
sectoral rules.
**Solution(s):\**
Panels to clarify alignment, publish common guides, resolve
cross-sectoral issues.
**Reference(s):\**
Article 4(4) and Annex IX, Sections 5.2 to 5.4, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Such panels have emerged as an administrative practice in the medical
sector to cover borderline products and combined products. However, each
potentially applicable legislation must have its own provisions.
## **Multi-Function Product/Service: Intended Use Declaration**
**Regulatory Function:\**
Legal Certainty for Complex Goods/Services and in Overlapping Sectors
**Problem:\**
Products/services serving several markets risk being caught in legal
conflict where different intended uses trigger diverging requirements.
On the other hand, requirements are circumvented by denying that they
have a certain intended use. Finally, products with different intended
uses need to be in conformity with the requirements applicable to the
various intended uses.
**Solution(s):\**
Require a clear declaration of the intended use, as well as fulfilment
of the various requirements applicable to the intended use(s) in
question. The intended use must be respected and declared throughout the
distribution chain to minimise the risk of products/services being used
for unintended purposes.
**Reference(s):\**
Article 31(1) and (2), Proposal for a Regulation on the marketing of
construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final.
**Note(s):\**
-
## **Extreme Variety of Products / Services / Situations**
**Regulatory Function:\**
Appropriate Coverage of Extreme Variety
**Problem:\**
Some pieces of EU legislation aim to cover a large variety of products,
services, situations or processes so that the appropriate requirements
and other provisions cannot all be laid down in the regulation or
directive.
**Solution(s):\**
Shift the establishment of tailor-made requirements and other provisions
to Delegated Acts.
**Reference(s):\**
Articles 4-8, Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Eco-design for Sustainable Products), OJ L 1781, 28.6.2024, p. 1.
**Note(s):\**
The Council / Member States often prefer Implementing Acts wherefore the
Articles 290 and 291
[TFEU](https://eur-lex.europa.eu/eli/treaty/tfeu_2012/oj/eng) are
sometimes slightly squeezed or stretched. See also this
[interinstitutional
agreement](https://eur-lex.europa.eu/eli/agree_interinstit/2016/512/oj/eng).
\
-
## **Preventing “Gold Plating”, Distinguishing “Harmonised Sphere” and Aspects not covered**
**Regulatory Function:\**
Harmonising Implementation, Fairness, Level Playing Field
**Problem:\**
Member States may add requirements beyond EU law (“gold plating”),
fragmenting the single market. Partly, they regard aspects not or not
appropriately covered by EU law.
**Solution(s):\**
Clearly define which aspects are harmonised by EU law and which are not
(define the 'harmonised sphere'). Directly prohibit or condition
national additions, or require justification or notification. Set up a
technical updating mechanism to cover any new or previously overlooked
aspects.
**Reference(s):\**
Article 11, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Articles 14 to 18, Directive
[2006/123/EC](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32006L0123)
(Services Directive), OJ L 376, 27.12.2006, pp. 36–68.
**Note(s):\**
In order to prevent the erosion of EU law, the ECJ legally presumes that
EU law is exhaustive, i.e. that it covers all relevant aspects, even
when this is not the case. This creates a discrepancy between law and
reality that can give rise to safety, environmental and other policy
issues. Therefore, it is preferable to clearly define the 'harmonised
sphere'.
\
-
## **Maximum Harmonisation Clauses / Approach**
**Regulatory Function:\**
Free circulation of products, other items, services, capital and
workforce
**Problem:\**
Member States tend to add-on new requirements and sharpen common
requirements, partly to protect their population, partly to protect
their national economy.
**Solution(s):\**
Establish upper limits of what Member States can request from operators,
institutions or citizens.
**Reference(s):\**
Article 4, Regulation (EU)
[2023/1230](https://eur-lex.europa.eu/eli/reg/2023/1230/oj/eng)
(Machinery), OJ L 165, 14.6.2023, p. 1–151.
**Note(s):\**
- See also the previous entry. The solution proposed there mitigates the
legal uncertainty arising from ambiguous wording such as that in Article
4.
\- Article 4 of the referenced Machinery Regulation sets out the maximum
that Member States can request. However, the Machinery Regulation also
establishes minimum requirements, thereby adopting the so-called 'full
harmonisation' approach. 'Full harmonisation', whereby upper and minimum
limits are set for Member States at one precise level, is dominant in EU
legislation today.
\- Minimum and maximum harmonisation can also be combined to create a
corridor of lawful action for Member States. In practice, however, the
alternative approach of mandating a default approach and permitting
exemptions under certain conditions is preferred. The alternative
approach expresses better where the Union should head to, whilst
providing enough flexibility.
## **Minimum Harmonisation Clauses / Approach**
**Regulatory Function:\**
Minimum Protection of Values or Policy Goals combined with Regulatory
Flexibility upwards
**Problem:\**
Member States require flexibility to introduce or maintain higher
standards while ensuring a common EU minimum.
**Solution(s):\**
Include explicit clauses allowing stricter national provisions beyond
the EU minimum without (disproportionately) compromising internal market
objectives.
**Reference(s):\**
Article 16, Directive
[2004/35/EC](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32004L0035)
(Environmental Liability), OJ L 143, 30.4.2004, p. 56–75;
Article 5, Directive (EU)
[2022/2555](https://eur-lex.europa.eu/eli/dir/2022/2555/oj)
(Cyber Security), OJ L 333, 27.12.2022, p. 80–152;
Article 4, Directive (EU)
[2024/1760](https://eur-lex.europa.eu/eli/dir/2024/1760/oj?uri=CELEX:32024L1760)
(Corporate Sustainability Due Diligence), OJ L, 2024/1760, 5.7.2024.
**Note(s):\**
See the note of the previous entry regarding the combination of maximum
and minimum harmonisation (‘full harmonisation’ or creation of a
corridor of lawful action of Member States).
## **Equivalence/Mutual Recognition—Within EU**
**Regulatory Function:\**
Free circulation of products, other items, services, capital and
workforce
**Problem:\**
Differing national rules still cause barriers for goods/services/other
processes/professional and other qualifications.
**Solution(s):\**
Mandatory mutual recognition for goods, services or professional
qualifications lawful in other Member States.
**Reference(s):\**
Regulation (EU)
[2019/515](https://eur-lex.europa.eu/eli/reg/2019/515/oj/eng)
(Mutual Recognition of Goods), OJ L 91, 29.3.2019, p. 1–29.
**Note(s):\**
- Also widely adopted in (financial) services and vocational
recognition provisions. But leading to disputes, uneven playing field
and absorption of scarce enforcement capacities; thus only second best
to harmonised rules.
\- Accreditation can be set up as a precondition for mutual recognition.
## **Regulatory Sandboxes and Experimentation Clauses**
**Regulatory Function:\**
Innovation Facilitation
**Problem:\**
Traditional frameworks may restrict the emergence of new technologies or
business models.
**Solution(s):\**
Allow temporary, controlled derogations or pilot regimes, with
safeguards for experimenting with new concepts.
**Reference(s):\**
Regulation (EU)
[2022/858](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022R0858)
(Distributed Ledger Technology Markets), OJ L 153, 3.6.2022, p. 46–84;
Article 57, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 12.7.2024, p. 1–225.
**Note(s):\**
See also this
[article](https://anzsog.edu.au/research-insights-and-resources/research/designing-regulatory-sandboxes/?utm_medium=email&utm_campaign=The%20Bridge%20%20Edition%20137%20%205%20November%202025&utm_content=The%20Bridge%20%20Edition%20137%20%205%20November%202025+CID_303ff40a3286dcf515a082e51ceeb5f0&utm_source=NRCoP%20tracking&utm_term=Read%20our%20brief%20on%20the%20article)
on the design of regulatory sandboxes.
## **Sunset Clauses and Review Triggers**
**Regulatory Function:\**
Time-Limited Regulation and Feedback
**Problem:\**
Rules may outlive their suitability; periodic review is often neglected.
**Solution(s):\**
Automatic expiry (sunset), or mandatory evaluation/review deadlines
built in.
**Reference(s):\**
Articles 16 and 17, Regulation (EU)
[2021/953](https://eur-lex.europa.eu/eli/reg/2021/953/oj/eng)
(Digital COVID Certificate), OJ L 211, 15.6.2021, p. 1–22.
**Note(s):\**
Incentivises regular legislative updating; but sunset clauses create
unnecessary burden for Commission and legislators where continuity is
necessary.
\
-
## **Rules for Direct Installation or Direct Use**
**Regulatory Function:\**
Clear Demarcation of Scope
**Problem:\**
Some operators supply products for direct installation without ever
“placing them on the market” in the usual sense. Others make the
products available for use without “placing them on the market”.
**Solution(s):\**
Define and separate the concepts of “placing on the market” and “direct
installation” or “putting into service” and clarify obligations for
each. Define “placing on the market” so as to include “making available
for use”.
**Reference(s):\**
Articles 3(5) and 5, Proposal for a Regulation on the marketing of
construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final;
Article 1(1), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;\
Article 2(2), Regulation (EU)
[2016/424](https://eur-lex.europa.eu/eli/reg/2016/424/oj/eng)
(Cableways Installations), OJ L 81, 31.3.2016, p. 1–36.
**Note(s):\**
-
## **Products Offered as a Service**
**Regulatory Function:\**
Ensuring Full Regulatory Coverage for Service-Based Business Models
**Problem:\**
If only products sold (not leased/offered as a service) are regulated,
“as a service” business models could avoid compliance obligations.
**Solution(s):\**
State that devices offered, for example as a service, are deemed “put
into service” and hence subject to all regulatory obligations.
**Reference(s):\**
Articles 1(1) and 3(4), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
# C. Definitions and Connected Rules
## **Empowerment to Amend Legal Definitions**
**Regulatory Function:\**
Legal Clarity and Adaptation to Technical Progress
**Problem:\**
Definitions may become inadequate over time as technology or practice
evolves.
**Solution(s):\**
Empower the European Commission to amend or update legal definitions via
delegated acts.
**Reference(s):\**
Article 3, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):**
\-
##
## **Indicative Lists and Exclusion Lists**
**Regulatory Function:\**
Legal Clarity and Alignment of Interpretation
**Problem:\**
Definitions may be unclear if very abstract or unintendedly excluding
important cases when drafted in a very concrete way.
**Solution(s):\**
Use an “indicative list” of items or situations covered by a certain
expression / term. Also use exclusion lists.
**Reference(s):\**
Annex II, Tables 1 and 2, Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40;
Annex II, Regulation (EU)
[2023/1230](https://eur-lex.europa.eu/eli/reg/2023/1230/oj/eng)
(Machinery), OJ L 165, 14.6.2023, p. 1–151;
Article 7(2) and (3), Council Implementing Regulation (EU) No
[282/2011](https://eur-lex.europa.eu/eli/reg_impl/2011/282/oj/eng),
OJ L 77, 23.3.2011, pp. 1–22.
**Note(s):\**
The last reference contains in paragraph (2) an indicative list and in
paragraph (3) an exclusion list.
## **Dynamic Reference to other Acts for Definitions**
**Regulatory Function:\**
Alignment and dynamic Adaptation
**Problem:\**
Definitions diverging between different acts create legal uncertainty.
At the same time, some definitions need to be adapted over time.
**Solution(s):\**
Create a dynamic reference to the definitions of other acts.
**Reference(s):\**
Article 2 (at the end), Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Eco-design for Sustainable Products), OJ L 1781, 28.6.2024, p. 1.
**Note(s):\**
The reference to another EU act is by default dynamic. If you wish to
avoid the dynamism, you need to refer to a precise version of the act
referred to.
# D. Authorisation/Licensing Procedures
## **Mandatory Pre-Market Notification**
**Regulatory Function:\**
Early Detection of Non-compliances, Risk Management
**Problem:\**
Without advance notice, authorities may be unprepared for risks linked
to new products/services.
**Solution(s):\**
Obligate manufacturers or service providers to notify authorities before
entering the market.
**Reference(s):\**
Article 29, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Mandatory Electronic Application**
**Regulatory Function:\**
E-Government, Efficiency, and Accessibility
**Problem:\**
Paper-based submission increases delay, error, and cost.
**Solution(s):\**
Require or permit the use of online (secure) platforms for applications,
reporting, notifications, and data sharing.
**Reference(s):**\
Article 29, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Article 1(3), Commission Implementing Regulation (EU) No
[1352/2013](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02013R1352-20251124)
as last amended.
**Note(s):\**
-
## **Mandatory Application Content / Form**
**Regulatory Function:\**
Efficiency and Fairness
**Problem:\**
Non-standardised applications are more difficult to assess fairly. They
often omit important information.
**Solution(s):\**
Ensure that all applications contain certain information and are in a
specific order, or make a certain form mandatory.
**Reference(s):\**
Annexes, Commission Implementing Regulation (EU)
[2025/1126](https://eur-lex.europa.eu/eli/reg_impl/2025/1126/oj)
(Authorisation to offer Asset-referenced Tokens), OJ L, 2025/1126.
**Note(s):\**
This can be combined with an electronic application (see previous
entry). Uniform forms can sometimes also be used to harmonise the
practice in the Member States where there is no proper EU competence,
thereby achieving harmonisation via the backdoor of information
standardisation.
## **“One Stop Shop” Registration/Notification Systems**
**Regulatory Function:\**
Administrative Simplification and Cost Reduction
**Problem:\**
Multiple registrations and notifications across Member States or within
the same Member State for different laws increase costs and complexity
for businesses and authorities.
**Solution(s):\**
Implement a single EU-wide “one stop shop” system for registration or
notification (e.g., for data processing, VAT, chemicals, devices).
Implement “one stop shop” systems by which various types of
authorisation or notification procedures to be submitted in the same
jurisdiction are bundled.
**Reference(s):\**
Articles 56 and 60, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection) – Single representative/registration for non-EU
controllers, OJ L 119, 4.5.2016, p. 1–88 (for the first type of “one
stop shop”);
Article 12, Regulation (EU)
[2016/796](https://eur-lex.europa.eu/eli/reg/2016/796/oj/eng)
(Railways Agency), OJ L 138, 26.5.2016, pp. 1–43 (for the second type of
“one stop shop”).
**Note(s):\**
The two types of “one stop shop” systems can be combined, as implicitly
done by Articles 12, 19, 20 and 21, Regulation (EU)
[2016/796](https://eur-lex.europa.eu/eli/reg/2016/796/oj/eng).
## **In advance Administrative Decisions (“Advance Rulings”)**
**Regulatory Function:\**
Legal Certainty, Reliability, Trust
**Problem:\**
Actors sometimes need to know how administrations would decide under
certain conditions (e.g. on a certain investment).
**Solution(s):\**
Authorise in advance / hypothetical administrative decisions.
**Reference(s):\**
Articles 33 and 34, Regulation (EU) No
[952/2013](https://eur-lex.europa.eu/eli/reg/2013/952/oj/eng)
(Union Customs Code), OJ L 269, 10.10.2013, p. 1–101 (Binding Tariff
Information and Binding Origin Information).
**Note(s):\**
This technique stems from fiscal law and is still widely spread in
fiscal law.
## **Deadlines for Decision-Making**
**Regulatory Function:\**
Predictable Administration
**Problem:\**
Open-ended administrative procedures cause costly uncertainty.
**Solution(s):\**
Legally prescribe maximum time periods within which authorities must
issue decisions, approvals or refusals.
**Reference(s):\**
Article 20(5), Regulation (EU) No
[536/2014](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536)
(Clinical Trials), OJ L 158, 27.5.2014, p. 1–76.
**Note(s):\**
-
## **Silence = Automatic Consent**
**Regulatory Function:\**
Reducing Administrative Delay
**Problem:\**
Administrative bottlenecks can unduly delay legal authorisation or
product release.
**Solution(s):\**
Allow authorisation if the competent authority does not refuse or
comment within a set deadline.
**Reference(s):\**
Article 20(8), Regulation (EU) No
[536/2014](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0536)
(Clinical Trials), OJ L 158, 27.5.2014, p. 1–76.
**Note(s):\**
-
## **Specification of Language of Application / Documentation**
**Regulatory Function:\**
Legal Certainty and Non-Discrimination
**Problem:\**
Operators face cost or exclusion when required to use arbitrary
languages.
**Solution(s):\**
State explicitly the languages that may or must be used for official
applications, certifications, or documents.
**Reference(s):\**
Article 41, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
See also the elegant language regimes of:
- Article 37(3), Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327;
- Article 22(6), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
## **Conditional and Provisional Authorisations**
**Regulatory Function:\**
Managing Uncertainty and Urgency
**Problem:\**
Urgent societal needs (e.g., COVID-19 medicines) require provisional
market access before full data is available.
**Solution(s):\**
Permit time-limited or conditional authorisation subject to ongoing
monitoring, obligations and withdrawal provisions.
**Reference(s):\**
Articles 13(3), (8) and (14-a), Regulation (EC) No
[726/2004](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32004R0726)
(EU Medicines Marketing Authorisation), OJ L 136, 30.4.2004, p. 1–33.
**Note(s):\**
-
## **Automatic Expiry of Non-Implemented Permits**
**Regulatory Function:\**
Administrative Clean-Up
**Problem:\**
Unused authorisations or obsolete rules clutter legal systems and
markets.
**Solution(s):\**
Create “use it or lose it” provisions—if not acted upon within a set
time, the permit or measure lapses.
**Reference(s):\**
Article 14(4), Regulation (EC) No
[726/2004](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32004R0726)
(EU Medicines Marketing Authorisation), OJ L 136, 30.4.2004, p. 1–33.
**Note(s):\**
-
## **Merging Assessment Procedures**
**Regulatory Function:\**
Simplification and Burden Reduction
**Problem:\**
Conformity assessment bodies and economic operators often need to
undergo various procedures under various EU acts. This leads to
cumulative burden and unnecessary double assessments of certain aspects.
**Solution(s):\**
Create an option to combine various procedures.
**Reference(s):\**
Article 1 (10), Proposal for a Regulation amending Regulations (EU)
2024/1689 and (EU) 2018/1139 as regards the simplification of the
implementation of harmonised rules on artificial intelligence (Digital
Omnibus on AI), [COM(2025)
836](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025PC0836)
final.
**Note(s):**
\-**\**
## **Integration of Parallel Legislation Requirements in Single Procedure**
**Regulatory Function:\**
Avoiding double procedures
**Problem:\**
Various EU regulations and directives regulate different or overlapping
aspects in parallel procedures, creating multiple procedural burdens.
**Solution(s):\**
Integrate requirements of parallel legislation and exempt from
obligation to undergo the procedure of the parallel legislation.
**Reference(s):\**
Article 1(7) to (10), (12), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Article 18(6) and Recital 51, Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Eco-design for Sustainable Products), OJ L 1781, 28.6.2024, p. 1;
Articles 36(4), 25 and 27, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025;
Article 148, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142.
**Note(s):\
-** The exemption of medical devices from parallel procedures is set out
in the relevant legislation (e.g. on pharmaceuticals and tissues).
Conversely, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
exempts combination products where the medical device function is not
primary.
\- See, in particular, the fine-tuned suspension relationship between
Regulations (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction products) and (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Eco-design for sustainable products). Construction products are not
exempt from the scope of Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
per se, but its application is suspended for as long as Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
equally efficiently regulates environmental aspects. This mechanism
incentivises the construction products system to match the level of
environmental protection established by Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng).
\- The last reference is interesting in that it introduces requirements
for another product group without amending its legislation.
## **Fulfilment of Obligations of other Acts as Fulfilment of own Act**
**Regulatory Function:\**
Avoiding double procedures
**Problem:\**
Various EU regulations and directives regulate in parallel procedures,
creating multiple procedural burdens. Sometimes they regulate similar
aspects.
**Solution(s):\**
Empower the Commission to determine, in Delegated Acts, the conditions
under which the fulfilment of obligations under other Union law also
fulfils certain obligations under the (own) act.
**Reference(s):\**
Article 12, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
In particular useful where future Delegated or Implementing Acts make
the fabric of obligations ever more dense.
## **Recognition of Previous Authorisation for Identical Substance or Item**
**Regulatory Function:\**
Assessment Efficiency and Avoidance of Redundancy
**Problem:\**
Testing and authorisations may be unnecessarily repeated for substances
or items already reliably tested.
**Solution(s):\**
Allow manufacturers to rely on prior compatible test results and
authorisations.
**Reference(s):\**
Article 61(1), Regulation (EC) No
[1107/2009](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:32009R1107)
(Plant Protection Products), OJ L 309, 24.11.2009, p. 1–50.
**Note(s):**
Particularly useful where testing involves humans or animals.
## **Common Procedures for Identical Products or Services**
**Regulatory Function:\**
Efficient Parallel Processing
**Problem:\**
Duplicated applications for identical products/services waste resources
and foster divergent decisions. Product or service identity is
determined by the identity of the economic actor. Where two actors offer
the same product or service, two procedures are needed.
**Solution(s):\**
Enable joint application channels and “single assessment to multiple
decision” legal routes or recognise certificates/approvals issued for an
identical product or service.
**Reference(s):\**
Article 62, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Decentralised Manufacturing or Services**
**Regulatory Function:\**
Bundling various Authorisations / Licences / Certifications
**Problem:\**
Procedures often depend on the location of manufacture or service.
Accordingly, multiple procedures must be followed.
**Solution(s):\**
Establish provisions, particular requirements and checks for
decentralised manufacturing or decentralised provision of services.
**Reference(s):\**
Article 26a, [Council Mandate for
Negotiations](https://data.consilium.europa.eu/doc/document/ST-9285-2025-INIT/en/pdf)
regarding the proposed Regulation on Medicinal Products for Human Use.
**Note(s):\**
Decentralised manufacturing or services are implicitly authorised where
there are no particular process requirements and where the manufacturing
or service providing site is not subject to any conformity assessment.
## **Company Group Licensing or Recognition**
**Regulatory Function:\**
Efficiency for Multinational Operation
**Problem:\**
Mergers and group operations complicate authorisation under divergent
Member State rules.
**Solution(s):\**
Introduce EU-wide or mutual group licensing or recognition of groups for
specified sectors/activities.
**Reference(s):\**
Article 37(2), Directive
[2014/25/EU](https://eur-lex.europa.eu/eli/dir/2014/25/oj/eng)
(Utilities Procurement), OJ L 94, 28.3.2014, p. 243–374.
**Note(s):\**
-
\
-
## **“Forum Shopping” Avoidance Provisions**
**Regulatory Function:\**
Consistent Application Across Member States
**Problem:\**
Operators may seek out countries with laxer enforcement or
interpretation.
**Solution(s):\**
Stipulate application of rules based on place of use/effect, or provide
for centralised control.
**Reference(s):\**
Article 56, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88 (single mandatory
One-Stop-Shop).
**Note(s):\**
A similar issue exists with regard to certification bodies. India avoids
forum shopping by attributing certain bodies to certain economic
operators.
## **Temporary “Safe Harbours” or “Sandboxes”**
**Regulatory Function:\**
Risk-Managed Pilots
**Problem:\**
Legal uncertainty deters new business models and technologies.
**Solution(s):\**
Designate safe harbour periods or regimes protecting participants from
authorisation procedures contingent on compliance with basic process and
reporting requirements.
**Reference(s):\**
Article 57, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024.
**Note(s):\**
See also this
[article](https://anzsog.edu.au/research-insights-and-resources/research/designing-regulatory-sandboxes/?utm_medium=email&utm_campaign=The%20Bridge%20%20Edition%20137%20%205%20November%202025&utm_content=The%20Bridge%20%20Edition%20137%20%205%20November%202025+CID_303ff40a3286dcf515a082e51ceeb5f0&utm_source=NRCoP%20tracking&utm_term=Read%20our%20brief%20on%20the%20article)
on the design of regulatory sandboxes.
## **Approval and Oversight of Entrusted/Authorised Economic Operators**
**Regulatory Function:\**
Facilitating Secure and Compliant Trade
**Problem:\**
Businesses with a strong compliance record should benefit from
streamlined controls and lower administrative burdens.
**Solution(s):\**
Establishment of Entrusted / Authorised Economic Operator status with
formal approval, audits, and periodic review.
**Reference(s):\**
Articles 38–39, Regulation (EU) No
[952/2013](https://eur-lex.europa.eu/eli/reg/2013/952/oj/eng)
(Union Customs Code), OJ L 269, 10.10.2013, p. 1–101.
**Note(s):\**
-
\
-
## **Simplified Procedures for Custom or Heritage Products or Services**
**Regulatory Function:\**
Proportionality and Burden Reduction
**Problem:\**
Complex standard compliance is excessive for minor or unique cases.
**Solution(s):\**
Allow for “Specific Technical Documentation” as an alternative to full
conformity assessment in justified cases.
**Reference(s):\**
Article 14, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Fast-Track or Simplified Procedures for Minor Cases**
**Regulatory Function:\**
Administrative Efficiency and Flexibility
**Problem:\**
Resource-intensive procedures hinder low-impact operations.
**Solution(s):\**
Provision of fast-track or summary procedures (short deadlines, reduced
documentation).
**Reference(s):\**
Authorisation), OJ L 136, 30.4.2004, p. 1–33;\
Articles 59 to 61, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Fast-Track or Simplified Procedures for Urgent Cases**
**Regulatory Function:\**
Administrative Efficiency and Flexibility
**Problem:\**
Resource-intensive procedures hinder urgent operations.
**Solution(s):\**
Provision of fast-track emergency or summary procedures (short
deadlines, reduced documentation).
**Reference(s):\**
Article 14(9), Regulation (EC) No
[726/2004](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32004R0726)
(EU Medicines Marketing Authorisation), OJ L 136, 30.4.2004, p. 1–33.
**Note(s):\**
-
## **“Digital Green Channels” (Automated Regulatory Processing) for Low-Risk Activities**
**Regulatory Function:\**
Administrative Efficiency
**Problem:\**
Low-risk operators face unnecessary procedural burdens.
**Solution(s):\**
Permit digital fast-tracking or green channels with spot verification
for low-risk cases.
**Reference(s):\**
Article 22, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
-
\
-
## **Authorisation for New Economic Operators**
**Regulatory Function:\**
Inclusion and Clarification
**Problem:\**
Regulatory frameworks must keep pace with new business models or
roles—e.g., 3D-printing service providers, digital-only intermediaries.
**Solution(s):\**
Define in law the obligations and rights of novel actors and assign
their treatment/obligations and authorisation procedure to one or
several existing categories of actors or set up new obligations and
procedures.
**Reference(s):\**
Article 2(1)(a) and (b), Proposal for a Regulation on the marketing of
construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final;
Article 2(47) and (48), Articles 27 to 29, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Article 3(g), Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102.
**Note(s):\**
Avoids regulatory “dark zones”.
## **Direct EU Agency or Commission Oversight for High-Risk Sectors/Services/Products**
**Regulatory Function:\**
Uniform High-Level Risk Control, Weak or Biased Member States
**Problem:\**
Devolved enforcement may be inadequate in high-risk or critical areas.
**Solution(s):\**
EU-level agencies or Commission given overriding or direct
regulatory/supervisory powers for specific cases.
**Reference(s):\**
Regulation (EU)
[2019/1242](https://eur-lex.europa.eu/eli/reg/2019/1242/oj/eng)
(CO2 Emissions/Heavy Duty Vehicles), OJ L 198, 25.7.2019, p. 202–240;
Article 1 (25)(c)(1c), p. 28, Proposal for a Regulation amending
Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the
simplification of the implementation of harmonised rules on artificial
intelligence (Digital Omnibus on AI), [COM(2025)
836](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025PC0836)
final.
**Note(s):\**
The second reference authorises the Commission to delegate tests to
conformity assessment bodies - an interesting combination of state
authorisation and certification approach that we can also observe in
other jurisdictions like Canada.
## **Comparative Assessments in View of Goals**
**Regulatory Function:\**
Optimising Regulatory Goals
**Problem:\**
Some policy goals merit being pursued in the best possible way. Setting
a benchmark will mostly lag behind the optimal solution.
**Solution(s):\**
Create a legal base for authorising only the best or least harmful
products, substances, services, processes or actors.
**Reference(s):\**
Article 23, Regulation (EU) No
[528/2012](https://eur-lex.europa.eu/eli/reg/2012/528/2024-06-11)
(Biocidal Products), OJ L 167 27.6.2012, p. 1.
**Note(s):\**
This approach is particularly relevant for environmental and health
aspects. The comparative assessment as a procedural step can be matched
by an obligation to optimise, incumbent on actors; see e.g. the
obligation to reduce risks as much as possible in Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng).
## **Voluntary Agreements as Compliance Tools**
**Regulatory Function:\**
Alternative Pathways to Compliance / (Partial) Replacement of
Authorisation Procedures
**Problem:\**
Not all regulatory objectives are efficiently achieved through classic
mandatory rules to be examined in authorisation procedures.
**Solution(s):\**
Allow voluntary agreements (e.g., self-regulation, codes of conduct) to
be recognised as evidence of compliance if they meet set standards and
are monitored. Recognise the fulfilment of the voluntary agreement as a
(partial) replacement of an authorisation procedure.
**Reference(s):\**
Articles 56 and 95, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L 2024/1689, 12.7.2024;
Article 9, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;
Article 17, Directive 2009/125/EC (Ecodesign), OJ L 285, 31.10.2009, p.
10–35;\
Articles 40 and 41, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
See also the labour law conventions elaborated and agreed by trade
unions which are thereafter generalised by EU directives.
## **Voluntary (Stricter) Conformity Procedure as Compliance Enhancement**
**Regulatory Function:\**
Compliance Ensurance
**Problem:\**
Actors sometimes do not know how to ensure compliance.
**Solution(s):\**
Offer a voluntary conformity procedure or a voluntary stricter
conformity procedure.
**Reference(s):**
Article 52(4) last subparagraph and corresponding Annexes, Regulation
(EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Article 2(1)(b), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Priority Procedure for Sustainable or Strategic Products or Services**
**Regulatory Function:\**
Innovation & Strategic Autonomy
**Problem:\**
Critical or green innovations can be blocked by administrative delays.
**Solution(s):\**
Fast-track or elevate priority for sustainable, strategic, or green
applications in administrative procedures.
**Reference(s):\**
Article 15, Regulation (EU)
[2024/1735](https://eur-lex.europa.eu/eli/reg/2024/1735/oj/eng)
(Net-Zero Industry), OJ L 2024/1735, 29.6.2024;
Article 10, Regulation (EU)
[2024/1252](https://eur-lex.europa.eu/eli/reg/2024/1252/oj/eng)
(Critical Raw Materials), OJ L 2024/1252, 3.5.2024, p. 1–58.
**Note(s):\**
-
## **Digital “Credential Wallets” for Operator/Staff Approval/Certification**
**Regulatory Function:\**
Streamlined Credential Verification
**Problem:\**
Traditional paper or isolated digital certificates impede mobility and
trust.
**Solution(s):\**
Mandate or permit use of verifiable digital wallets for staff/operator
qualifications.
**Reference(s):\**
Regulation (EU)
[910/2014](https://eur-lex.europa.eu/eli/reg/2014/910/oj/eng)
(Electronic Identification) OJ L 257, 28.8.2014, p. 73–114.
**Note(s):\**
Also see India – Information Technology (Preservation and Retention of
Information by Intermediaries Providing Digital Locker Facilities)
[Rules
2016](https://upload.indiacode.nic.in/showfile?actid=AC_CEN_45_76_00001_200021_1517807324077&type=rule&filename=ru_cen_45_0_00017_1519397233311.pdf),
with additional [Rule 9A](https://indiankanoon.org/doc/8414178/)
(notified February 8, 2017, G.S.R. 711(E)): deem issued documents in
[DigiLocker
system](https://egovstandards.gov.in/sites/default/files/2023-05/DigiLocker%20Deck%2025%20Mar%202022.pdf)
to be at par with original physical documents, with Rule 9A(1) enabling
issuers to issue and requesters to accept digitally signed certificates
or documents shared from subscribers' Digital Locker accounts at par
with physical documents, and Rule 9A(2) deeming documents issued by
issuer and accessed by requester through URI as shared directly in
electronic form, enabling digital storage of identity documents
(Aadhaar, Driving License, PAN, Passport), academic credentials
(degrees, diplomas), and professional certificates (professional
certificates, skill certificates, employment documents) with regulatory
recognition through Ministry of Finance PMLA Guidelines and RBI/SEBI
Master KYC Circular accepting DigiLocker e-Docs as valid Officially
Valid Documents, thereby establishing digital public infrastructure
credential wallet with legal equivalence to physical documents under
Information Technology Act 2000 framework.
**Also see the following Chapter E, which contains elements suitable for
authorisation procedures.**
# E. Certification by Private Conformity Assessment Bodies
**Also see the previous Chapter D, which contains elements suitable for
certification by private conformity assessment bodies (‘certification
bodies’).**
## **Third-Party (Conformity) Assessment System**
**Regulatory Function:\**
Assurance of Independence and Credibility
**Problem:\**
Self-certification may not engender trust or ensure safety.
**Solution(s):\**
Require third-party conformity assessment by notified/accredited
certification bodies for defined products or risks.
**Reference(s):\**
Articles 42–58 and corresponding Annexes, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Articles 35-50 and corresponding Annexes, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Other comprehensive third-party assessment systems can be found in the
transportation sector and in the food and feed control area.
## **Stringency correlating to Risk Classes**
**Regulatory Function:\**
Proportionate Certification Intensity and Stringency
**Problem:\**
Not all products or services merit the maximum intensity and stringency
of verification.
**Solution(s):\**
Define risk classes and link more or less intense and stringent
conformity assessment procedures to these classes.
**Reference(s):\**
Articles 51-55, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Requirements for Designating Authorities— Separation of Functions**
**Regulatory Function:\**
Impartial Appointment and Oversight of Conformity Bodies
**Problem:\**
Risk of bias if those who assess also notify/designate conformity
assessment bodies.
**Solution(s):\**
Designating authorities must be organised so that designation decisions
are made independently from those performing assessments.
**Reference(s):\**
Article 44, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Separation of Certification Bodies’ Tasks from other Tasks of the same Body**
**Regulatory Function:\**
Impartiality
**Problem:\**
Lack of separation of functions may allow conflict of interest.
**Solution(s):\**
Distinct documented procedures for assessments, walling off tasks as
certification body vs. other business; ongoing monitoring of
staff/subcontractor assignments.
**Reference(s):\**
Annex VII Sections 1.2.2 and 1.2.6, Regulation (EU)
[2017/746](https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng) (In
Vitro Diagnostic Medical Devices), OJ L 117, 5.5.2017, p. 176–332;
Article 46(4), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Impartiality and Remuneration Rules**
**Regulatory Function:\**
Avoiding Conflict of Interest in Certification
**Problem:\**
Financial dependence on volume or assessment outcome creates risks to
impartiality.
**Solution(s):\**
Remuneration of top management/assessment staff not to depend on volume
or results of assessments; explicit impartiality guarantees.
**Reference(s):\**
Annex VII Section 1.2.5, Regulation (EU)
[2017/746](https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng) (In
Vitro Diagnostic Medical Devices), OJ L 117, 5.5.2017, p. 176–332;
Article 46(9), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\
-**
## **Ownership Links between Bodies and Economic Operators**
**Regulatory Function:\**
Conflict of Interest Prevention
**Problem:\**
Notified bodies with capital links to manufacturers or economic
operators risk captured assessments.
**Solution(s):\**
Direct prohibition on capital links between notified bodies and relevant
market operators.
**Reference(s):\**
Article 46(3), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Conflicts of Interest for Certification Bodies**
**Regulatory Function:\**
Independence and Market Confidence
**Problem:\**
Certification bodies engaged in commercial activities may not act
impartially.
**Solution(s):\**
Statutory rules barring conflicts of interest and ensuring
organisational, financial, and staff independence.
**Reference(s):\**
Annex VII Sections 1.2.3 and 1.2.4, Regulation (EU)
[2017/746](https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng) (In
Vitro Diagnostic Medical Devices), OJ L 117, 5.5.2017, p. 176–332.
**Note(s):\**
-
## **Quality Management System Requirements for Certification Bodies**
**Regulatory Function:\**
Stable Performance
**Problem:\**
Assessment bodies may lack internally harmonised procedures and
improvement loops.
**Solution(s):\**
Legal requirement for a (certified) quality management system.
**Reference(s):\**
Annex VII Sections 2, Regulation (EU)
[2017/746](https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng) (In
Vitro Diagnostic Medical Devices), OJ L 117, 5.5.2017, p. 176–332.
**Note(s):\**
-
**Limiting the Use of Subcontractors and External Staff by Bodies**
**Regulatory Function:\**
Transparency and clear Responsibility
**Problem:\**
Uncontrolled outsourcing and use of external consultants may reduce
accountability for certification bodies. Bodies tend to list as “staff”
persons who work also for various other bodies, without clear primary
loyalty to the certification body. Both phenomena lead to the emergence
of ‘empty shell’ bodies.
**Solution(s):\**
Regulate, require disclosure/registration, and in some cases limit use
of subcontractors. Reserve core and decision-making functions to staff
employed under labour law.
**Reference(s):\**
Articles 46(8) and 48, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Annex VII, Section 3.4, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Similar considerations apply to external laboratories and facilities,
see the next entry.
## **External Testing Facilities**
**Regulatory Function:\**
Ensuring Quality and Reliability of Test Results
**Problem:\**
Tests performed outside the certification body’s own laboratory risk
loss of traceability, comparability and result quality.
**Solution(s):\**
External test facilities must have calibrated equipment; traceability
and quality of measurements must be ensured.
**Reference(s):\**
Article 49, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Accreditation for Certification Bodies or Laboratories**
**Regulatory Function:\**
Quality of Assessors
**Problem:\**
Divergence in the reliability of notified bodies undermines outcomes.
Member States’ authorities are not necessarily good at checking the
quality systems of bodies.
**Solution(s):\**
All certification bodies should be accredited against harmonised EU
requirements (not standards).
**Reference(s):\**
Regulation (EC) No
[765/2008](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32008R0765)
(Accreditation and Market Surveillance), OJ L 218, 13.8.2008, p. 30–47;\
Article 50(2), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Accreditation is often based on standards rather than applicable legal
requirements. Furthermore, accreditation usually relates to a group of
legal entities rather than a specific body. Therefore, verification by
the relevant authorities is also required. The highest quality of
certification bodies is achieved through systems in which both
accreditation bodies and authorities supervise certification bodies.
Accreditation bodies tend to be better at assessing quality systems,
while authorities tend to be better at assessing compliance with
sector-specific provisions.
##
## **Documentation for Application as Body**
**Regulatory Function:\**
Transparency in Body Notification
**Problem:\**
Without full documentation relating to the precise applicant legal
person, assessing notification eligibility is impossible.
**Solution(s):\**
Application must include CVs, contracts, and accreditation documentation
corresponding precisely to the legal person applying.
**Reference(s):\**
Article 50(2), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Article 38(2) and Annex VII, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Promotes professionalisation and prevents ‘empty shell’ notifications.
## **Requirements for Permanent Technical Staff, Decision-Makers and Operational Staff**
**Regulatory Function:\**
Assuring Internal Expertise and Continuity
**Problem:\**
Over-reliance on subcontractors/external experts risks loss of internal
knowledge/control.
**Solution(s):\**
Set minimum employed technical staff: at least one for every four
non-employed staff/experts, all fully integrated at headquarters. At
least one person for quality assessment and one for product or service
category. Require documentation through CVs and employment contracts.
**Reference(s):\**
Annex VII Section 3.3.2, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Article 46(8), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Best to be combined with a qualification matrix (see the next entry).
## **Qualification Matrices for Body Personnel**
**Regulatory Function:\**
Competence Assurance
**Problem:\**
Opaque or insufficient qualifications in certification bodies risk poor
quality assessments. Complex bodies and bodies recruiting from a large
pool of external staff should demonstrate exactly who has what skills
for which functions.
**Solution(s):\**
Require certification bodies to maintain and submit a qualification
matrix matching person, status, task, competence, and product family.
**Reference(s):\**
Annex VII Section 3.3.2, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Article 50(6)(b), Proposal for a Regulation on the marketing of
construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final.
**Note(s):\**
The requested model matrix should be made available by the Commission.
## **On-Site Audits of Bodies and Economic Operators**
**Regulatory Function:\**
Depth in Oversight Procedures
**Problem:\**
Paper assessments may not reveal real operational quality.
**Solution(s):\**
Commission/Member States can require on-site audits of certification
bodies, including subsidiaries and subcontractors, and of economic
operators.
**Reference(s):\**
Article 55(3), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110, for the on-site assessment of
manufacturers by notified bodies;
Article 39(3), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175, for the on-site
assessment of certification bodies by designating/notifying authorities;
Article 32(2), Directive (EU)
[2022/2555](https://eur-lex.europa.eu/eli/dir/2022/2555/oj)
(Cyber Security), OJ L 333, 27.12.2022, p. 80–152, for audits of other
operators, even outside certification.
**Note(s):\**
Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
takes it a step further by mandating so-called 'observed audits', in
which notified bodies assess manufacturers under the supervision of the
designating/notifying authorities.
## **Notification Procedure—EU Commission as Final Arbiter in Case of Member States’ Objection**
**Regulatory Function:\**
Ultimate Quality Control of Notified Bodies
**Problem:\**
Disputes between Member States risk stalling authorisations or letting
problematic bodies operate.
**Solution(s):\**
Commission decides—by implementing act—on contested notifications, after
investigation; decisions published.
**Reference(s):\**
Article 54, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
See also Article 51(5) thereof: valid designation/notification only
where there is no objection by the Commission or another Member State.
This is a smart rule that hinders unqualified bodies from being
designated/notified in the first place.
## **Periodic Reassessment of Bodies**
**Regulatory Function:\**
Quality Assurance of Conformity/Assessment Bodies
**Problem:\**
Bodies may lose competence or impartiality over time.
**Solution(s):\**
Mandatory periodic review, re-accreditation or re-designation of
certification bodies.
**Reference(s):\**
Article 44, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Consider mandating onsite-audits as part of the reassessment. Consider
giving the Commission the possibility to attend onsite-audits.
## **Ongoing Monitoring and For-Cause-Audits of Bodies**
**Regulatory Function:\**
Quality Assurance of Conformity/Assessment Bodies
**Problem:\**
Bodies may lose competence or impartiality over time.
**Solution(s):\**
Mandate ongoing monitoring and For-Cause-Audits, based on:
- Market surveillance data;
- Sampling and scrutiny of certificates for the same category of
products / services / processes;
- Information on non-compliance of bodies, or economic actors operating
under control of the bodies.
**Reference(s):\**
Article 44, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Should be combined with provisions on periodic reassessment.
## **Mandatory Coordination Group for Bodies**
**Regulatory Function:\**
Inter-Body Alignment, Dissemination of Best Practices
**Problem:\**
Fragmentation of assessment approaches/staff skills over time.
**Solution(s):\**
Bodies subjected to mandatory participation in a coordination group.
**Reference(s):\**
Article 58, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\
-**
## **Alignment of Bodies’ Practices**
**Regulatory Function:\**
Inter-Body Alignment, Dissemination of Best Practices
**Problem:\**
Fragmentation of assessment approaches/staff skills over time.
**Solution(s):\**
Clear catalogue of obligations, precise conformity assessment tasks.
**Reference(s):\**
Inter alia Article 52 and Annexes IX to XI, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Inter alia Articles 55–56 and Annex IX, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Further tasks can be found in other provisions of the two regulations
referred to.
## **Peer Reviews of Bodies**
**Regulatory Function:\**
Inter-Body Alignment, Dissemination of Best Practices
**Problem:\**
Fragmentation of assessment approaches/staff skills over time.
**Solution(s):\**
Bodies subjected to peer review by other bodies, or coordinated EU-level
peer review procedures.
**Reference(s):\**
Article 10, Regulation (EC) No
[765/2008](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32008R0765)
(Accreditation and Market Surveillance), OJ L 218, 13.8.2008, p. 30–47
(for accreditation bodies);\
European Cooperation for Accreditation (EA) [Peer Evaluation
Rulebook](https://european-accreditation.org/wp-content/uploads/2018/10/ea-2-02.pdf).
**Note(s):\**
-
## **Peer Reviews of Notifying/Designating Authorities**
**Regulatory Function:\**
Inter-authority Alignment, Dissemination of Best Practices
**Problem:\**
Fragmentation of assessment approaches/staff skills over time.
**Solution(s):\**
Designating/notifying authorities subjected to peer review by other
authorities, or coordinated EU-level peer review procedures.
**Reference(s):\**
Article 48, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Rules for “De-Designation”**
**Regulatory Function:\**
Quality Assurance
**Problem:\**
Non-performing bodies must be removed to guarantee credibility. Where
bodies stop their activities for whatever reason, the validity of
certificates and the take-over of continuous monitoring tasks of the
body have to be regulated
**Solution(s):\**
Lay out notification, appeal, and enforcement mechanisms for withdrawing
designation. Set out consequences, including for certification and
continuous monitoring tasks of notified bodies. Give preference to
agreements between the parties, but set up fall-back solutions by
intervention of authorities.
**Reference(s):\**
Articles 46-47, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Articles 53–54, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
See also the next entry which is connected to this.
**Transfer and Continuity of Certificates when Bodies’ stop Activity**
**Regulatory Function:\**
Legal Continuity and Supply Chain Integrity
**Problem:\**
Certifications might be lost when a business is transferred to a new
legal entity or simply phased out. At the same time, there can be safety
/ monitoring loopholes.
**Solution(s):\**
If 100% control passed to another legal person, certificates and test
reports remain valid; if not, six-month validity after de-notification.
**Reference(s):\**
Article 58, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Articles 53(2) and 55(7), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Please contact us for detailed advice on this ultra-complex issue. The
references do not provide the full range of measures needed to ensure
business continuity and safety.
## **Publication of Certification/Assessment Results**
**Regulatory Function:\**
Public Trust
**Problem:\**
Hidden or proprietary assessment results can undermine confidence and
impede cross-border supervision.
**Solution(s):\**
Require the publication of (non-confidential) results of certification
body activities, including certificates and withdrawal/suspension
status.
**Reference(s):\**
Article 47(1), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Confidentiality and Data Handling by Bodies**
**Regulatory Function:\**
Protection of Commercial Confidentiality
**Problem:\**
Sensitive business data must be protected without obstructing regulatory
clarity.
**Solution(s):\**
Enshrine confidentiality as a rule, with dedicated transparency
provisions (see previous and next entry) as exceptions.
**Reference(s):\**
Article 46(4), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Reporting Requirements for Bodies**
**Regulatory Function:\**
Transparency and Compliance
**Problem:\**
Authorities need timely, full information to ensure oversight and
compliance.
**Solution(s):\**
Notified bodies must report refusals, suspensions, key changes, and
respond to all information requests by authorities.
**Reference(s):\**
Article 58, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Includes documentation and confidential information sharing for
supervision.
## **Recognition of Previous Tests, Certification or Authorisation in Modular Assessment**
**Regulatory Function:\**
Assessment Efficiency and Avoidance of Redundancy
**Problem:\**
Testing may be unnecessarily repeated for products/modules already
reliably tested.
**Solution(s):\**
Allow manufacturers to rely on prior compatible test results for
essential components, interim products, characteristics or modules,
under specific conditions.
**Reference(s):\**
Article 62, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Article 22, Regulation (EU)
[2023/1230](https://eur-lex.europa.eu/eli/reg/2023/1230/oj/eng)
(Machinery), OJ L 165, 14.6.2023, p. 1–151;
Article 61(1), Regulation (EC) No
[1107/2009](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:32009R1107)
(Plant Protection Products), OJ L 309, 24.11.2009, p. 1–50.
**Note(s):\**
-
# F. International Matters
## **“Extraterritorial” Scope Covering Companies abroad Targeting the EU Market**
**Regulatory Function:\**
Enforcement in the Digital Age
**Problem:\**
Foreign providers can evade regulation despite substantial EU impact.
**Solution(s):\**
Explicitly extend law to non-EU actors offering services or selling in
the EU.
**Reference(s):\**
Article 3, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;\
Article 1(2), Regulation (EU)
[2022/1925](https://eur-lex.europa.eu/eli/reg/2022/1925/oj/eng)
(Digital Markets), OJ L 265, 12.10.2022, p. 1–66;
Article 4, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, pp. 1–51.
**Note(s):\**
-
\
-
## **Inspections and Enforcement outside the EU**
**Regulatory Function:\**
Global Supply Chain Control
**Problem:\**
Product ingredients, parts, or data processed outside the EU require
direct oversight for safety and compliance.
**Solution(s):\**
Grant EU bodies or authorities explicit legal powers to audit or inspect
facilities/information outside the Union.
**Reference(s):\**
Articles 120 to 123, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142.
**Note(s):\**
Under international public law, the activities of states on the
territory of another state need to be authorised by the latter. The same
applies to the Union.
## **Reporting Duties for Third-Country Operators**
**Regulatory Function:\**
Level Playing Field Across Borders
**Problem:\**
Non-EU actors otherwise evade reporting requirements by operating solely
abroad.
**Solution(s):\**
Mandate third-country operators addressing the EU market to appoint
EU-based representatives for reporting/communication.
**Reference(s):\**
Article 27, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;\
Article 23, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Third Country Access to EU Databases**
**Regulatory Function:\**
International Regulatory Engagement
**Problem:\**
Trusted third country partners may need access to facilitate mutual
regulatory oversight.
**Solution(s):\**
Grant conditional access to regulatory information systems, with strict
safeguards (confidentiality, data protection, engagement).
**Reference(s):\**
Article 14(7), Regulation (EU)
[2022/2371](https://eur-lex.europa.eu/eli/reg/2022/2371/oj/eng)
(Health Threats), OJ L 320, 22.12.2022, p. 1–86;
Article 75(5), Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025;
Article 45, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
-
## **International Data Sharing (General)**
**Regulatory Function:\**
Global Data Collaboration
**Problem:\**
Lack of framework for data sharing with third countries damages public
policy and cross-border users.
**Solution(s):\**
Legal basis for sharing data internationally, allowing access.
**Reference(s):\**
Articles 88-91, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
**Note(s):\**
-
\
-
## **Enforcement and Implementation Data Sharing**
**Regulatory Function:\**
Global Regulatory Collaboration
**Problem:\**
Lack of framework for data exchange necessary for enforcement and
implementation with third countries damages public policy and
cross-border users.
**Solution(s):\**
Legal basis for sharing data with foreign authorities, allowing access
to EU information (systems).
**Reference(s):\**
Article 81, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Enforcement on behalf of Third Countries**
**Regulatory Function:\**
Mutual Enforcement and Regulatory Diplomacy, indirect Support of Own
Enforcement abroad
**Problem:\**
Enforcement synergies with aligned third countries are hampered by lack
of legal basis.
**Solution(s):\**
Legally permit authorities to support third countries or even to use
their enforcement powers on behalf of third countries, contingent on
mutual support agreements or de facto reciprocity. Consider establishing
rule of law requirements.
**Reference(s):\**
Article 124, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142;
Article 82(5), Proposal for a Regulation on the marketing of
construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final;
Article 48, Directive
[2013/36/EU](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32013L0036)
(CRD IV - Capital Requirements), OJ L 176, 27.6.2013, p. 338–436;
Article 93(11), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Articles 77 and 78, Regulation (EU)
[2021/23](https://eur-lex.europa.eu/eli/reg/2021/23/oj/eng)
(Recovery and Resolution of Central Counterparties), OJ L 22, 22.1.2021,
pp. 1–102;
Articles 89 and 90, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025;
Articles 76 and 77, Directive (EU)
[2025/1](https://eur-lex.europa.eu/eli/dir/2025/1/oj/eng)
(Recovery and Resolution of Insurances), OJ L, 2025/1, 8.1.2025.
**Note(s):\**
See in particular the last three references covering foreign
administrative decisions and judgments.
## **Risk Classification of Third Countries**
**Regulatory Function:\**
Unequal Non-compliance Risks
**Problem:\**
Third countries and their actors are not equally performing and equally
able to apply EU law correctly.
**Solution(s):\**
Classify third countries in a dialogue procedure.
**Reference(s):\**
Article 29, Regulation (EU)
[2023/1115](https://eur-lex.europa.eu/eli/reg/2023/1115/oj/eng)
(Deforestation), OJ L 150, 9.6.2023, p. 206–247.
**Note(s):\**
-
## **Dialogue with Non-Government Actors in Third Countries**
**Regulatory Function:\**
Global Regulatory Collaboration and Convergence
**Problem:\**
The application of EU law in third countries sometimes requires the
involvement of actors other than the governments of the third countries.
**Solution(s):\**
Establish an open dialogue with business associations and other private
/ non-governmental actors.
**Reference(s):\**
Article 30, Regulation (EU)
[2023/1115](https://eur-lex.europa.eu/eli/reg/2023/1115/oj/eng)
(Deforestation), OJ L 150, 9.6.2023, p. 206–247.
**Note(s):\**
-
## **Information-Sharing, Training, and Staff Exchange Access for Third Countries**
**Regulatory Function:\**
Global Regulatory Collaboration and Convergence
**Problem:\**
International partners voluntarily recognise/apply EU law but receive no
formal recognition or benefit.
**Solution(s):\**
Allow entry of such third countries into information sharing, training,
and regulatory staff exchange mechanisms.
**Reference(s):\**
Article 40, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, pp. 1–51.
**Note(s):\**
-
## **Regulatory International Alignment**
**Regulatory Function:\**
Global Regulatory Alignment
**Problem:\**
Isolated EU standards may impede participation in the global economy.
**Solution(s):\**
Obligation to consult, inform, or align with international bodies (e.g.,
WHO, Codex, ISO, UNECE) or informal alignment bodies (e.g. International
Medical Devices Regulatory Forum).
**Reference(s):\**
Articles 4(7), 5(5) and 13(1), Regulation (EU)
[2022/2371](https://eur-lex.europa.eu/eli/reg/2022/2371/oj/eng)
(Health Threats), OJ L 320, 22.12.2022, p. 1–86;
Article 50(6), Regulation (EC) No
[178/2002](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002R0178)
(General Food Law), OJ L 31, 1.2.2002, p. 1–24;
Article 1 (90), Proposal for a Regulation amending Regulations (EU)
2017/745 and (EU) 2017/746 as regards simplifying and reducing the
burden … , [COM(2025)
1023](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2025:1023:FIN)
final.
**Note(s):\**
See also the many empowerments to adapt requirements in view of
international alignment in the last reference, e.g. in Article 1 (5),
(9), (28), (41), (43), (44) and (52).
## **Member States’ International Cooperation Agreements**
**Regulatory Function:\**
Legal Certainty, Subsidiarity
**Problem:\**
In particular where there are detailed provisions on international
cooperation of the Union, it is often questionable to what extent Member
States may themselves establish international cooperation agreements
with third countries or international organisations. Such agreements may
conflict with the Union's own international cooperation.
**Solution(s):\**
Establish conditions for international cooperation agreements of Member
States.
**Reference(s):\**
Article 75(1), Directive (EU)
[2025/1](https://eur-lex.europa.eu/eli/dir/2025/1/oj/eng)
(Recovery and Resolution of Insurances), OJ L, 2025/1, 8.1.2025.
**Note(s):\**
-
## **Recognition of International Test Reports, Certificates or Approvals**
**Regulatory Function:\**
Burden Reduction, Cheaper Production / Services
**Problem:\**
Industry produces for the world market, but is burdened by test reports,
certificate and approval requirements of many different jurisdictions.
Products and services become more expensive than necessary.
**Solution(s):\**
Recognition of test reports, certificates or approvals where these are
issued in accordance to international agreements or even informal
international cooperation that the EU has adhered to (e.g. UNECE or
OECD).
**Reference(s):\**
Articles 49 and 50, Regulation (EU) No
[167/2013](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32013R0167)
(Agricultural Vehicles), OJ L 60, 2.3.2013, p. 1–51;
Article 2(6), Regulation (EU) No
[528/2012](https://eur-lex.europa.eu/eli/reg/2012/528/2024-06-11)
(Biocidal Products), OJ L 167 27.6.2012, p. 1;
Article 1 (90), Proposal for a Regulation amending Regulations (EU)
2017/745 and (EU) 2017/746 as regards simplifying and reducing the
burden … , [COM(2025)
1023](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2025:1023:FIN)
final.
**Note(s):\**
See also the following entry.
## **Adequacy or Equivalence Decisions**
**Regulatory Function:\**
International Data/Service/Goods Transfer
**Problem:\**
Other jurisdictions often recognise EU approvals or certificates if
their own are recognised. De facto mutual recognition - outside
cumbersome international agreements - is in the interest of both sides.
Furthermore, certain third countries should be smoothly integrated into
the EU system.
**Solution(s):\**
Empower the European Commission to issue adequacy/equivalence decisions
for cross-border flows of products, services and data or foreign
authorities assessing products, services and data. Allow formal
assessment of foreign regimes for equivalence, often leading to
simplified procedures for compliant imports.
**Reference(s):\**
Article 45, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;\
Article 129, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, p. 1–142;
Articles 46 to 48, Regulation (EU)
[2018/848](https://eur-lex.europa.eu/eli/reg/2018/848/oj/eng)
(Organic Production), OJ L 150, 14.6.2018, p. 1–92;
Article 47, Regulation (EU) No
[600/2014](https://eur-lex.europa.eu/eli/reg/2014/600/oj/eng)
(Financial Markets), OJ L 173, 12.6.2014, p. 84–148.
**Note(s):\**
Ensures trusted cross-border flows while upholding EU standards. Easier
to manage than international agreements, whilst de facto reciprocity can
be requested as precondition. Also suitable to integrate third countries
voluntarily applying EU law.
## **“Passport” as Means for Cross-Border Activities**
**Regulatory Function:\**
Fostering the Internal Market
**Problem:\**
Duplicative national licences obstruct the cross-border supply of
products and services.
**Solution(s):\**
Ensure operators authorised in one Member State can operate in other
Member States and in third countries on strength of a single
registration or approval (“passport” regime).
**Reference(s):\**
Articles 9-15, Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Ecodesign for Sustainable Products), OJ L1781, 28.6.2024;
Articles 75-81, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Articles 34-35, Directive
[2014/65/EU](https://eur-lex.europa.eu/eli/dir/2014/65/oj/eng)
(Financial Instruments), OJ L 173, 12.6.2014, p. 349–496.
**Note(s):\**
Can also be used among Member States. The last reference (MiFID II
Directive) is, historically, referred to as (one of the) first passport
regimes, whilst resembling more to a classic mutual recognition regime.
**See also “Enforcement Assistance among Member States” in Section J
which could be used for international cooperation as well.**
# G. Obligations of (Economic) Actors
## **“State of the Art” or “Best Available Technique” as Legal Benchmark**
**Regulatory Function:\**
Ensuring Up-to-Date Performance and Safety
**Problem:\**
Legal standards can become outdated or may not reflect the latest
technological or safety advances.
**Solution(s):\**
Define “state of the art” or “best available technique” as a substantive
legal benchmark, with guidance on how this is to be regularly assessed
and referenced.
**Reference(s):\**
Article 3(28), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Article 2(10), Directive
[2010/75/EU](https://eur-lex.europa.eu/eli/dir/2010/75/oj/eng)
(Industrial Emissions), OJ L 334, 17.12.2010, p. 17–119.
**Note(s):\**
“Best available techniques” is more stringent than “state of the art”.
See for more details our [Handbook ‘How to
Regulate?’](https://www.howtoregulate.org/wp-content/uploads/2024/10/H2R_hanbook_2024.pdf),
Sections 3.3.1, 8.13 and 8.14.
## **Power to Adapt Technical / Legal Requirements**
**Regulatory Function:\**
Technical Detail and Adaptive Implementation
**Problem:\**
Primary law cannot anticipate all future details or change.
**Solution(s):\**
Explicit empowerment in accordance with Articles 290/291
[TFEU](https://eur-lex.europa.eu/eli/treaty/tfeu_2012/oj/eng) to
adopt delegated (policy-detailed) or implementing (technical) acts.
**Reference(s):\**
Articles 290–291, Treaty on the Functioning of the European Union
([TFEU](https://eur-lex.europa.eu/eli/treaty/tfeu_2012/oj/eng)),
OJ C 202, 7.6.2016, p. 47-199;\
Articles 7(8) and 89, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
The Council often prefers Implementing Acts, since Member States have a
stronger say in the 'examination' procedures of the Committee. However,
Delegated Acts are legally safer.
## **Dynamic Link/Reference to Future Innovations**
**Regulatory Function:\**
Automated Future-Proofing
**Problem:\**
Statutory reference to technical standards or protocols is quickly
outdated.
**Solution(s):\**
Allow “dynamic referencing” so that references always point to the
latest version of a standard or protocol adopted under defined EU or
international schemes.
**Reference(s):\**
Regulation (EU)
[2018/858](https://eur-lex.europa.eu/eli/reg/2018/858/oj/eng)
(Motor Vehicles), OJ L 151, 14.6.2018, pp. 1–218, Annex II Part II “List
of UN Regulations recognised as an alternative to the Directives or
Regulations referred to in Part” … “Any further amendment to the UN
Regulations listed in the following table (
[15](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02018R0858-20240701#E0018)
) shall also be deemed to be equivalent to an EU type-approval, subject
to the Decision referred to in Article 4(2) of Decision 97/836/EC.” -
“(15) For subsequent amendments, see UNECE TRANS/WP.29/343.”
**Note(s):\**
Distinct from static reference clauses. Legally only permitted where the
acts referred to (or the accession thereto) are under legal control by
EU institutions empowered to regulate.
## **“Retirement” of Outdated Technical Norms**
**Regulatory Function:\**
Regulatory Hygiene and Simplification
**Problem:\**
Obsolete or excessively complex norms create hidden barriers.
**Solution(s):\**
Mandate periodic review, sunset or simplification, and open procedure
for “retiring” old standards.
**Reference(s):\**
Articles 5(9), 8(6) and 34(2), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
The references only empower updates; they do not mandate them.
## **Reference/Alignment with International Standards**
**Regulatory Function:\**
International Interoperability and Best Practice
**Problem:\**
Unnecessary divergence from widely-accepted international standards
increases barriers and costs.
**Solution(s):\**
Mandate or facilitate the use of international standards where
compatible (e.g., ISO, IEC).
**Reference(s):\**
Articles 3 and 13, Regulation (EU)
[1025/2012](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32012R1025)
(European Standardisation), OJ L 316, 14.11.2012, p. 12–33.
**Note(s):\**
-
\
-
## **COM to Assess Standards for Legal Compliance**
**Regulatory Function:\**
Pre-Emptive Legal Review and Legal Certainty
**Problem:\**
Whatever use is made of standards, there is a potential for harmonised
standards to conflict with primary law, secondary law or general
principles of law.
**Solution(s):\**
Require the Commission to check legal conformity (including with regard
to the act in question, fundamental rights and general principles of law
or other Union law) before publication of standard references in the OJ.
**Reference(s):\**
Articles 5(7) and 34(1), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Articles 34(4) and Article 38(4), Proposal for a Regulation on the
marketing of construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final.
**Note(s):\**
Necessary in view of ECJ case law (e.g. James Elliott ruling
[C-613/14](https://curia.europa.eu/juris/liste.jsf?language=en&num=C-613/14))
regarding harmonised standards as part of the EU law. Moreover, the
Commission should be empowered to reject standards which:
\- are not are not compatible with the relevant standardisation
requests, including its basic principles and reference points (Article
5(8), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng));
\- are not compatible with other harmonised standards cited in the
Official Journal,
\- provide an unjustified advantage to certain manufacturers or are
discriminatory to certain types of economic operators and namely SME,
\- are technically inaccurate, or
\- establish requirements that are not needed for the fulfilment of
legal requirements.
Instead of rejecting, the Commission should have the possibility to
limit in scope or overrule the respective standards for purposes of
legal effects under the act in question, see the next entry.
## **COM to Substitute or Correct Standards**
**Regulatory Function:\**
Standardisation, Rule of Law and Legal Certainty
**Problem:\**
Incomplete, erroneous or outdated standards can impede legal compliance
and market innovation. Standards developed by European Standardisation
Bodies are often (legally) deficient and cannot be referred to for that
reason, whilst their correction would take time and is sometimes even
impossible, namely where the standards are based on ISO/IEC standards.
See also the deficiencies referred to in the “Note” to the previous
entry. Finally, the participants to technical committees of the
standardisation organisations sometimes simply fail to agree.
**Solution(s):\**
Empower the Commission to:\
a) Issue EU technical specifications in the absence of—or to
override—harmonised standards;\
b) Specify that only the legal effects of a standard—not its content—are
overridden;
c\) Publish references to standards only “with restrictions”.
**Reference(s):\**
Article 6, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Articles 4(3) and 34(4), Proposal for a Regulation on the marketing of
construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final;
Article 9, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
First invented for medical devices, this approach is now broadly
accepted across product sectors and even rolled-out via a so-called
“Omnibus” amendment.
## **COM to make Standards Mandatory**
**Regulatory Function:\**
Standardisation and Equal Application of Requirements
**Problem:\**
It is difficult to establish regulation for all technical details. At
the same time, the application of generic law varies widely.
**Solution(s):\**
One way to strike a balance is to make standards mandatory. This can be
achieved through a reference to a specific version of a standard in
secondary legislation. However, this approach requires the secondary
legislation to be updated periodically, which is inconvenient due to the
immense administrative burden it entails. An alternative is to empower
the Commission to make standards mandatory through Delegated or
Implementing Acts.
**Reference(s):\**
Article 5(8), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110 (for the Implementing Acts
approach);
Annex of Commission Implementing Regulation (EU)
[2025/1533](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32025R1533)
(Marine Equipment), OJ L, 2025/1533, 14.8.2025 (for the Implementing
Acts approach);
Article 4(1), Directive
[2014/40/EU](https://eur-lex.europa.eu/eli/dir/2014/40/oj/eng)
(Tobacco Products), OJ L 127, 29.4.2014, pp. 1–38 (for the secondary
legislation approach).
**Note(s):\**
Should be combined with the approach described in the previous entry. It
is not commendable to rely on standardisation organisations without a
fall-back solution, as they sometimes fail to deliver standards that can
be referred to, see the problem description of the previous entry.
## **Presumption of Conformity for Standards and COM Specifications**
**Regulatory Function:\**
Standardisation, Legal Certainty and Equal Application of Requirements
**Problem:\**
It is difficult to establish regulation for all technical details. At
the same time, the application of generic law creates legal uncertainty
and varies widely. Operators need legal certainty on how they can be on
the safe side with regard to compliance.
**Solution(s):\**
Empower the Commission to:\
a) Issue detailed mandates to Standardisation Organisations, setting out
the basic principles, but also the technical reference points;\
b) Control and correct submitted standards (see separate entry);
c\) Provide a presumption of conformity with certain, precisely defined
legal requirements by means of citation of the standards in the Official
Journal on the basis of an Implementing Act;
d\) Adopt own technical specifications by Implementing Acts in case that
the Standardisation Organisations do not provide citable standards.
**Reference(s):\**
Articles 36 and 37, Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40;
Articles 7 and 8, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Article 9(2), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Common practice for the letters a) and c), but commendable also for the
letters b) and d). The voluntary character of the standard gives
operators some leeway, in particular for atypical products, services or
processes. However, Certification Bodies often unlawfully request
operators to apply standards even if they are voluntary. Take
precautionary measures in that regard.
## **Standards or COM Specifications to be Followed by Default**
**Regulatory Function:\**
Standardisation, Legal Certainty and Equal Application of Requirements
**Problem:\**
It is difficult to establish regulation for all technical details. At
the same time, the application of generic law creates legal uncertainty
and varies widely. In some areas, technical specifications should be
followed except in atypical cases.
**Solution(s):\**
Empower the Commission to:\
a) Issue detailed mandates to Standardisation Organisations, setting out
the basic principles, but also the technical reference points;\
b) Control and correct submitted standards (see separate entry);
c\) Render the standards mandatory by default, but permitting exceptions
for atypical cases or when justified by the operator;
d\) Adopt own technical specifications by Implementing Acts in case that
the Standardisation Organisations do not provide citable standards, and
render them applicable by default whilst permitting exceptions for
atypical cases or when justified by the operator.
**Reference(s):\**
Article 9(3), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
This approach can be combined with the presumption of conformity
described in the previous entry. Of course, it is also possible to
provide only for standards or only for Commission specifications.
However, the combination suggested here provides the utmost flexibility.
To avoid disputes over whether the Standardisation Organisations have
failed to deliver citable standards, it would be better to formulate the
empowerment in letter d) more generically. In any case, the COM will
prioritise the development of standards over its own technical
specifications wherever possible, since standards are less burdensome.
## **Obligations Tiered by Risk / Value / Volume**
**Regulatory Function:\**
Proportionate Burden and Risk Management
**Problem:\**
Uniform due diligence or other obligations can impose excessive burdens.
**Solution(s):\**
Structure requirements with intensity/complexity fitting the scale of
risk or the operator’s market volume.
**Reference(s):\**
Article 4(4) and (5) and Article 13, Regulation (EU)
[2023/1115](https://eur-lex.europa.eu/eli/reg/2023/1115/oj/eng)
(Deforestation), OJ L 150, 9.6.2023, p. 206–247;
Article 1, Directive (EU)
[2025/2](https://eur-lex.europa.eu/eli/dir/2025/2/oj/eng),
inserting Article 29a onwards into Directive
[2009/138/EC](https://eur-lex.europa.eu/eli/dir/2009/138/oj/eng)
(Insurances Solvency), OJ L, 2025/2, 8.1.2025;
Article 3, Regulation (EU)
[2025/1355](https://eur-lex.europa.eu/eli/reg/2025/1355/oj/eng)
(Systemically Important Payment Systems), OJ L, 2025/1355.
**Note(s):\**
-
## **Catalogue of Detailed Obligations for Economic Operators**
**Regulatory Function:\**
Role-Specific Clarity and Responsibility
**Problem:\**
Legal uncertainty can result when roles in the supply chain are
ill-defined. Moreover, Member States’ enforcement is not sufficient in
many instances if there is no support by economic operators with regard
to compliance.
**Solution(s):\**
All relevant economic operator categories’ obligations and relations are
precisely detailed. This should include mutual control of and by
economic operators for certain formal compliance aspects.
**Reference(s):\**
Articles 20–30, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Articles 10–23, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Helps guarantee traceability and compliance throughout the chain.
## **Outsourcing of Obligations: Limits and Conditions**
**Regulatory Function:\**
Compliance
**Problem:\**
Some actors outsource compliance tasks and thereby lose control.
**Solution(s):\**
Establish limits and conditions for the outsourcing of compliance
obligations.
**Reference(s):\**
Article 73, Regulation (EU)
[2023/1114](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1114-20240109)
(Crypto Assets), OJ L 150, 9.6.2023, p. 40–178;
Article 22, Regulation (EU)
[2025/1355](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32025R1355)
(Systemically Important Payment Systems), OJ L, 2025/1355.
**Note(s):\**
-
\
-
## **Responsibility Organisations of Economic Actors**
**Regulatory Function:\**
Compliance
**Problem:\**
It is sometimes difficult for a single economic operator to fulfil
certain legal obligations alone, on its own.
**Solution(s):\**
Permit or mandate the creation of “responsibility organisations” that
take over the obligations of a pool of economic operators.
**Reference(s):\**
Article 46, Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40.
**Note(s):\**
See also the following entry.
## **Guarantee for Fulfilment of Obligations**
**Regulatory Function:\**
Compliance
**Problem:\**
Some functions are systemically important. Failure to fulfil
obligations, e.g. following insolvency, might cause important damage.
**Solution(s):\**
Require a performance guarantee, including in case of insolvency, e.g.
as part of an authorisation or certification.
**Reference(s):\**
Article 47(6), Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40.
**Note(s):\**
See also the previous entry which constitutes a case where such a
guarantee might be suitable.
## **Withdrawal, Recall, and Corrective Action**
**Regulatory Function:\**
Public Safety and Market Order
**Problem:\**
Non-compliant or dangerous products or services must be rapidly
controlled, removed or corrected.
**Solution(s):\**
Obligation for rapid market withdrawal, recall, or other corrective
measures—triggered by defined risks.
**Reference(s):\**
Articles 14 and 16, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;\
Articles 65–67, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
See also our “[List of Powers and
Obligations](https://www.howtoregulate.org/list-of-powers-for-authorities-list-of-obligations/#more-1778)”
with several hundred empowerments useful for enforcement.
## **Obligations for Brokers and Platform Operators**
**Regulatory Function:\**
Adapting Rules to the Digital/Supply Chain Shift
**Problem:\**
Platforms, brokers or other intermediaries exploit loopholes as neither
conventional retailers nor manufacturers. Classic economic operators can
hide behind platforms, brokers or other intermediaries so that
authorities cannot get hold of them.
**Solution(s):\**
Explicitly define duties and liability of intermediaries, “marketplaces”
and online service providers.
**Reference(s):\**
Chapter III, Sections 3 to 5, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102;
Article 22, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, pp. 1–51;\
Article 28, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
See also our model law on [Cross-border internet activities and
virtual
worlds](https://www.howtoregulate.org/internet_rels/#more-1560).
## **E-Commerce and Digital Market-Specific Provisions**
**Regulatory Function:\**
Digital-Readiness and Effective Enforcement
**Problem:\**
Online market structures evade enforcement under traditionally
formulated laws.
**Solution(s):\**
Set obligations and liabilities specifically tailored for online
marketplaces, interfaces, and digital intermediaries.
**Reference(s):\**
Articles 19-21, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, pp. 1–51;\
Article 29, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Articles 6 and 6a, Directive
[2011/83/EU](https://eur-lex.europa.eu/eli/dir/2011/83/oj/eng)
(Consumer Rights), OJ L 304, 22.11.2011, p. 64–88;
Chapter III, Sections 3 to 5, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102.
**Note(s):\**
Should be combined with international cooperation so as to ensure
enforcement abroad. See also our model law on [Cross-border internet
activities and virtual
worlds](https://www.howtoregulate.org/internet_rels/#more-1560).
## **Coverage of New / Atypical Economic Operators**
**Regulatory Function:\**
Adapting Regulation to new Forms of Operation
**Problem:\**
The markets produce ever new forms of economic operators. Legislation
often lags behind.
**Solution(s):\**
Try to learn from other sectors and jurisdictions and also integrate
types of economic operators that have emerged in other sectors or
jurisdictions. Moreover, establish a set of basic obligations for
“economic operators” whilst defining this term in an open way, not just
by referencing the currently known types of actors.
**Reference(s):\**
Articles 20 and 26-29, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110; (for the definition of
“economic operators”, better see the next reference)
Articles 3(9), 19 and 26-30, Proposal for a Regulation on the marketing
of construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final.
**Note(s):\**
Since the late 1990s, 'fulfilment service providers' have emerged in one
sector after another, leaving the relevant authorities unable to cope.
Even today, some sector legislation does not cover them. And ever new
roles have emerged since.
## **Coverage of 3D-Printing or Blue Print Selling**
**Regulatory Function:\**
Adapting Regulation to new Forms of Operation and Closing Safety
Loopholes
**Problem:\**
The obligations of manufacturers and the many safety guarantees linked
to that role are not applicable when one party simply provides the
dataset or blueprint, another party manufactures and sells the
3D-printing material, and a third party provides the 3D printer.
**Solution(s):\**
Assign the following responsibilities to the three types of actors:
\- Responsibility for design (as quasi-manufacturer) to the first type
of actor.
\- Responsibility for the appropriateness of the printing material to
the second type of actor.
\- Responsibility for compatibility to both types of actor.
\- Responsibility for indicating legal requirements to the commercial
provider of the 3D printer.
Together, these responsibilities ensure a minimum level of product
safety.
**Reference(s):\**
Recitals 9 and 52, Articles 2(1)(a) and (b), 2(4), 3(9), (10), (11) and
(13), 10(1), 28, and 90(2)(m), Proposal for a Regulation on the
marketing of construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final.
**Note(s):\**
See also [this
article](https://www.howtoregulate.org/decentralized-3d-printing-a-regulatory-challenge/#more-23).
## **Permalinks for Electronic Documentation**
**Regulatory Function:\**
Digital Simplification and Traceability
**Problem:\**
Paper documentation is hard to access and keep up-to-date in
cross-border trade.
**Solution(s):\**
Allow/require use of secure digital links or electronic documentation as
the official record.
**Reference(s):\**
Articles 16(2)(f) and 18(2), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Reporting/Information on Alignment with Standards**
**Regulatory Function:\**
Transparency and Quality Control
**Problem:\**
Users lack information if a certain product or service meets certain
standards (e.g. green taxonomy).
**Solution(s):\**
Oblige companies to disclose to what extent they align with certain
standards (e.g. EU Green Taxonomy).
**Reference(s):\**
Articles 3-8, Regulation (EU)
[2020/852](https://eur-lex.europa.eu/eli/reg/2020/852/oj/eng)
(Taxonomy), OJ L 198, 22.6.2020, p. 13–43;
Article 7, Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Eco-design for Sustainable Products), OJ L 1781, 28.6.2024, p. 1;
Article 22(1) and (2) and Annex V, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Quality Management Systems**
**Regulatory Function:\**
Internal Quality Control by Manufacturers or Service Providers
**Problem:\**
Manufacturers’ and service providers’ processes require reliable
internal systems to assure constant compliance.
**Solution(s):\**
Mandate the use of a comprehensive quality management system, be it
tailor-made, be it based on an international standard.
**Reference(s):\**
Article 17, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L 2024/1689, 12.7.2024;
Article 10(9), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Factory Production or Service Control Requirements**
**Regulatory Function:\**
Internal Quality Control by Manufacturers or Service Providers
**Problem:\**
Manufacturers’ and service providers’ processes require reliable
internal systems to assure constant compliance.
**Solution(s):\**
Legal obligation for documented, continuous ‘factory production control’
(FPC) or ‘services control’ procedures.
**Reference(s):\**
Annex IX Section 3 “System 2+”, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Annex XI, Regulation (EU)
[2017/746](https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng) (In
Vitro Diagnostic Medical Devices), OJ L 117, 5.5.2017, p. 176–332;
Annex II, Modules A, C, D and H, Decision No
[768/2008/EC](https://eur-lex.europa.eu/eli/dec/2008/768(1)/oj/eng)
(New Legislative Framework), OJ L 218, pp. 82–128.
**Note(s):\**
Decision No
[768/2008/EC](https://eur-lex.europa.eu/eli/dec/2008/768(1)/oj/eng)
has been replicated and adapted in many directives and regulations.
## **Periodic Sample Testing Obligation**
**Regulatory Function:\**
Active Post-Market Surveillance
**Problem:\**
Product failures may emerge only after placement on the market.
**Solution(s):\**
Manufacturers (and sometimes importers/distributors) should be required
to perform regular sample testing of products on the market.
**Reference(s):\**
Article 22(4) and Annex IX, Sections 1, 2, 3 and 6, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Article 52(14), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Compliance Checks by Digital Twins or Simulations**
**Regulatory Function:\**
Innovation in Testing and Approval
**Problem:\**
Physical testing can be costly, slow, and environmentally burdensome.
**Solution(s):\**
Allow digital twins/simulation data in compliance, provided quality
criteria are met.
**Reference(s):\**
Permitted by Annex IV, Part A, Section (g) “reports and/or results of
the design calculations”, Regulation (EU)
[2023/1230](https://eur-lex.europa.eu/eli/reg/2023/1230/oj/eng)
(Machinery), OJ L 165, 14.6.2023, p. 1–151.
**Note(s):\**
Better to refer precisely to digital twins or simulations.
## **“Technical Dossiers” of Service Providers**
**Regulatory Function:\**
Traceability and Legal Accountability
**Problem:\**
Service operations can be as safety-critical as goods, but lack equal
traceability.
**Solution(s):\**
Service providers maintain full technical records, parallel to
manufacturers.
**Reference(s):\**
Article 7(2) and (3), Directive
[2014/33/EU](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0033)
(Lifts), OJ L 96, 29.3.2014, p. 251–308.
**Note(s):\**
-
## **Technical Documentation and Event Records Keeping**
**Regulatory Function:\**
Traceability, Evidence, and Ex-Post Controls
**Problem:\**
Verification and incident response require robust documentation both on
the technical characteristics and particular events.
**Solution(s):\**
Obligation for economic operators to keep specified technical
documentation, typically for at least 10 years. Obligation to keep
records on usage for a certain time.
**Reference(s):\**
Article 10(8), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175
Article 26(6) Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024;
Article 30, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
-
## **Reduced Technical Documentation for Individually Manufactured or Non-Series Products**
**Regulatory Function:\**
Proportionality in Assessment Methods
**Problem:\**
Full systematic conformity assessment is excessive for custom or
single-use products.
**Solution(s):\**
Allow assessment via Specific Technical Documentation equivalent to
formal harmonised requirements.
**Reference(s):\**
Article 14, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Traceability Requirements**
**Regulatory Function:\**
Tracking for Safety, Market Order, and Effective Recalls
**Problem:\**
Inadequate traceability hinders rapid response to safety or compliance
concerns.
**Solution(s):\**
Impose traceability duties (batch/serial numbers, supply chain linkage,
data requirements; customer, supplier and service provider recording).
Impose “know-your-customer” rules.
**Reference(s):\**
Annex I Chapter III Section 23(2)(g) and Annex VI, Part C, Section 3.5,
Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;\
Article 22, Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40;
Articles 20(3) and 22(5), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Article 19, Regulation (EU)
[2023/1230](https://eur-lex.europa.eu/eli/reg/2023/1230/oj/eng)
(Machinery), OJ L 165, 14.6.2023, p. 1–151.
**Note(s):\**
-
## **Digital Identification / Know-Your-Customers Rules**
**Regulatory Function:\**
Secure Digital Access and Fraud Prevention
**Problem:\**
Growing fraud, non-compliance and money laundering risk, plus the need
for cross-border digital trust.
**Solution(s):\**
Mandate or enable the use of secure digital identity (eID) and
harmonised Know-Your-Customers procedures.
**Reference(s):\**
Regulation (EU)
[910/2014](https://eur-lex.europa.eu/eli/reg/2014/910/oj/eng)
(Electronic Identification) OJ L 257, 28.8.2014, p. 73–114;\
Regulation (EU)
[2023/1113](https://eur-lex.europa.eu/eli/reg/2023/1113/oj/eng)
(Information on Transfers of Funds and Crypto-assets), OJ L 150,
9.6.2023, p. 1–37;
Article 20(3), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Internet Platforms and Brokers to cooperate with Authorities**
**Regulatory Function:\**
Supply Chain Traceability and Enforcement
**Problem:\**
Enforcement is weak regarding economic operators offering products and
services via internet platforms or brokers.
**Solution(s):\**
Specific cooperation obligations of internet platforms and other
brokers.
**Reference(s):**
Article 22, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, pp. 1–51.
**Note(s):\**
-
## **Electronic and Bundled Declaration of Conformity**
**Regulatory Function:\**
Burden Reduction
**Problem:\**
Accompanying each individual product with a paper declaration of
conformity is cumbersome.
**Solution(s):\**
Permit electronic declarations of conformity under certain conditions.
Permit that only one paper copy is handed out where the same client
acquires several identical products.
**Reference(s):\**
Article 16, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Detailed Declaration of Conformity and Performance**
**Regulatory Function:\**
Consumer / User Information and Market Transparency
**Problem:\**
Inconsistent or absent declarations obstruct rational choices.
**Solution(s):\**
Require clear, standardised declarations of conformity and performance.
**Reference(s):\**
Article 15 and Annexes II, IV and V, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
In the context of construction products, performance characteristics
have a specific function. However, certain characteristics merit being
declared for virtually all other products. See also the second entry
below.
Declarations of conformity and performance also have an important
compliance function. Economic operators are obliged to work through the
points listed in the declaration model. The declaration model thus
serves as a compliance checklist.
## **Labels for Product Information**
**Regulatory Function:\**
Consumer / User Information and Market Transparency
**Problem:\**
Inconsistent or absent labelling obstructs sustainable choices, safety
choices and product traceability.
**Solution(s):\**
Require clear, standardised labels showing sustainability, performance,
or regulatory status.
**Reference(s):\**
Article 22(6), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Mandatory “Key Characteristics” Indication**
**Regulatory Function:\**
User-Friendly Regulatory Disclosure
**Problem:\**
Complex documentation obscures the most important facts.
**Solution(s):\**
Require standardised summary tables of “key characteristics” in
technical and user documentation.
**Reference(s):\**
Article 22(6) and Annexes II, IV and V, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Right to Information for Customers / Consumers / End-Users**
**Regulatory Function:\**
Transparency, Consumer Choice, Safety
**Problem:\**
Customers / consumers / end users cannot make informed decisions without
access to accurate compliance and safety information.
**Solution(s):\**
Right to request, receive and access all prescribed information,
including online.
**Reference(s):\**
Articles 5–8, Directive
[2011/83/EU](https://eur-lex.europa.eu/eli/dir/2011/83/oj/eng)
(Consumer Rights), OJ L 304, 22.11.2011, p. 64–88.
**Note(s):\**
Extends to both pre- and post-purchase, and to complex services.
Particularly important: information on the limitation of the product or
service to professional users, see Article 22(5), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
## **Precontractual Information Obligations**
**Regulatory Function:\**
Transparency, Consumer Choice, Safety
**Problem:\**
Customers / consumers / end users cannot make informed decisions without
access to accurate compliance and safety information.
**Solution(s):\**
Detail mandatory, easy-to-understand pre-contractual information
requirements.
**Reference(s):\**
Articles 5–6a, Directive
[2011/83/EU](https://eur-lex.europa.eu/eli/dir/2011/83/oj/eng)
(Consumer Rights), OJ L 304, 22.11.2011, p. 64–88;
Article 22(5) last sentence, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Information Accessibility for End Users**
**Regulatory Function:\**
Safety
**Problem:\**
End users may not have access to accurate, up-to-date compliance or
safety data.
**Solution(s):\**
Obligation for free, user-friendly access to compliance documentation
and product status.
**Reference(s):\**
Article 22(6), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Article 10(11), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Article 22(5) last sentence of Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
contains the complementary obligation to provide precontractual
information.
## **Plain Language and Accessibility of Information**
**Regulatory Function:\**
Public Usability and Inclusion
**Problem:\**
Complex legal and technical documents exclude non-specialists or people
with disabilities.
**Solution(s):\**
Oblige that notices, forms, and digital content conform to plain
language and accessibility requirements.
**Reference(s):\**
Directive (EU)
[2016/2102](https://eur-lex.europa.eu/eli/dir/2016/2102/oj?uri=CELEX:32016L2102)
(Accessibility of Public Bodies’ Websites), OJ L 327, 2.12.2016, p.
1–15;\
Chapter III, Regulation (EU)
[2018/1724](https://eur-lex.europa.eu/eli/reg/2018/1724/oj/eng)
(Single Digital Gateway), OJ L 295, 21.11.2018, p. 1–38.
**Note(s):\**
-
## **Mandatory Language Requirements**
**Regulatory Function:\**
Accessibility for All EU Users
**Problem:\**
Users, authorities, and operators must be able to understand legal and
technical information.
**Solution(s):\**
Make translations into required official languages obligatory for all
key materials.
**Reference(s):\**
Article 22(6), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Article 41, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Essential, but always to be balanced with SME capabilities. Recommended
compromise: “language commonly understood”.
## **Parallel Trade / Dissemination of Products Beyond Intended Member State(s) with Language/Packaging Adaptation**
**Regulatory Function:\**
Ensuring Internal Market and Product Access Regardless of Manufacturer’s
Plans
**Problem:\**
Manufacturers may attempt to block cross-border trade through
restrictive distribution or packaging/language policies.
**Solution(s):\**
Permit economic operators, under certain safeguards, to change or
translate packaging/instructions for use to serve new markets, even
without manufacturer consent.
**Reference(s):\**
Article 53, Regulation (EU) No
[528/2012](https://eur-lex.europa.eu/eli/reg/2012/528/2024-06-11)
(Biocidal Products), OJ L 167 27.6.2012, p. 1;
Article 26(3)-(4), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Codifies the European Court of Justice parallel trade approach in all
sectors.
## **Conformity Marking Systems (e.g. CE)**
**Regulatory Function:\**
Market Access and User Assurance
**Problem:\**
Lack of clear badges of conformity impedes free movement and user
confidence.
**Solution(s):\**
Institute mandatory labelling/marking (such as CE) for compliant
products.
**Reference(s):\**
Articles 17 and 18, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
To be distinguished from quality marks. “CE” stands for conformité
européenne = European conformity.
## **Detailed CE Marking Information**
**Regulatory Function:\**
Consumer / User Information and Market Transparency
**Problem:\**
CE marking is often lacking essential information and thus does not
provide crucial information to customersInconsistent or absent
declarations obstruct rational choices.
**Solution(s):\**
Require clear, standardised information linked to the CE marking.
**Reference(s):\**
Article 18, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **No Mimicking and Interfering Markings**
**Regulatory Function:\**
Clarity of Markings
**Problem:\**
Non-EU marks can obscure, mislead, or dilute the impact of EU conformity
marks. Unofficial or lookalike markings can confuse consumers and
undermine trust in certification systems.
**Solution(s):\**
Explicitly ban all markings that interfere, cause confusion, or are
placed too close to Union marks; stipulate required minimum distance on
products.
**Reference(s):\**
Article 19, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Key for technical, digital, food/label-heavy sectors.
## **“Batch” and Serial Number Marking**
**Regulatory Function:\**
Traceability and Recall Effectiveness
**Problem:\**
Lack of batch/serial numbers makes targeted withdrawal impossible.
**Solution(s):\**
Mandate legible and durable batch, lot or item-level labelling.
**Reference(s):\**
Article 15(5), Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40;
Article 22(5), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
See also the entry “Traceability Requirements” above.
## **Statutory “Claims Rules”**
**Regulatory Function:\**
Fair Comparison and Credibility
**Problem:\**
Unregulated claims mislead consumers.
**Solution(s):\**
Define category-specific rules for e.g. product footprint,
eco-labelling, and environmental claims.
**Reference(s):\**
Article 28, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025;
Article 14, Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40;
Regulation (EU)
[2017/1369](https://eur-lex.europa.eu/eli/reg/2017/1369/oj/eng)
(Energy Labelling), OJ L 198, 28.7.2017, p. 1–23.
**Note(s):\**
-
## **Ban on Misleading Claims and Marketing Practices**
**Regulatory Function:\**
Consumer/Market Protection and Safety
**Problem:\**
Misleading environmental, safety or compliance claims distort
competition and lower the average level of safety.
**Solution(s):\**
Statutory ban on misleading claims; clarification of
permitted/unpermitted terms and verification requirements.
**Reference(s):\**
Article 7, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Articles 5–7, Directive
[2005/29/EC](https://eur-lex.europa.eu/eli/dir/2005/29/oj/eng)
(Unfair Commercial Practices), OJ L 149, 11.6.2005, p. 22–39.
**Note(s):\**
-
\
-
## **Obligation to Provide Samples or to Grant Access**
**Regulatory Function:\**
Facilitating Oversight and Safety Checks
**Problem:\**
Lack of access to products and services or their documentation hinders
investigation and enforcement.
**Solution(s):\**
Operators must provide samples or grant access to products or services
upon request by competent authorities, for free or at cost.
**Reference(s):\**
Article 10(14), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Article 21(2), Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024.
**Note(s):\**
First reference for samples, second for access.
## **Suppliers / Service Providers to Cooperate for Compliance**
**Regulatory Function:\**
Compliance
**Problem:\**
A main economic actor cannot always fulfil its compliance obligations
without cooperation of upstream economic actors.
**Solution(s):\**
Give economic actors and certification bodies the right to request
cooperation.
**Reference(s):\**
Article 21, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024.
**Note(s):\**
-
## **Contact Details for Accidents/Incidents/Safety Issues**
**Regulatory Function:\**
Rapid Risk Detection and Stakeholder Engagement
**Problem:\**
Authorities and other users/affected persons lack a simple channel to
report safety problems.
**Solution(s):\**
Mandatory 24/7 contact interface (e.g., hotline or portal) for the
public and authorities to report safety incidents and complaints.
**Reference(s):\**
Article 15(6), Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40;
Article 20(5), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Transparency on Rules and Procedures**
**Regulatory Function:\**
Compliance and Protection of the Interests of Clients
**Problem:\**
The operations of economic operators are often opaque.
**Solution(s):\**
Impose a duty to publish internal rules and procedures.
**Reference(s):\**
Article 27, Regulation (EU)
[2025/1355](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32025R1355)
(Systemically Important Payment Systems), OJ L, 2025/1355.
**Note(s):\**
The reference encompasses the obligation to publish key market data.
## **Complaints Handling and Recording**
**Regulatory Function:\**
Responsiveness to Market Information, Safety, Compliance
**Problem:\**
Complaints may be ignored or inadequately processed, risking persistent
harms.
**Solution(s):\**
All relevant economic operators must have explicit systems to receive,
evaluate, and document complaints, including obligations to act where
necessary.
**Reference(s):\**
Articles 31 and 71, Regulation (EU)
[2023/1114](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1114-20240109)
(Crypto Assets), OJ L 150, 9.6.2023, p. 40–178;
Article 20, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102;
Chapter VII, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Cyber Incident or Security Breach Notification**
**Regulatory Function:\**
Resilience and Prevention
**Problem:\**
Authorities, users and market actors must be able to respond quickly to
security failures.
**Solution(s):\**
Mandatory notification of incidents/breaches within specified
timeframes.
**Reference(s):\**
Article 23, Directive (EU)
[2022/2555](https://eur-lex.europa.eu/eli/dir/2022/2555/oj)
(Cyber Security), OJ L 333, 27.12.2022, p. 80–152;\
Articles 33 and 34, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
-
## **Information and Audit Obligations proportionate to Operator Size and Risk**
**Regulatory Function:\**
Avoiding Unnecessary Burden
**Problem:\**
Uniform obligations may disproportionately hurt smaller operators and
low-risk sectors.
**Solution(s):\**
Legally scale requirements by risk profile and size, with published
thresholds.
**Reference(s):\**
Article 30(5), Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;\
Articles 11(1), 43, 55, 57(9)(g), and Chapters III and IV in general,
Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024.
**Note(s):\**
The AI Act is complicated, but particularly instructive as it crosses
size and risk parameters.
## **Annual Reporting of Operators**
**Regulatory Function:\**
Compliance and Transparency
**Problem:\**
Authorities cannot easily know to what extent operators ensure
compliance or fulfil policy goals.
**Solution(s):\**
Establish an annual reporting obligation.
**Reference(s):\**
Article 31, Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40.
**Note(s):\**
-
## **“Benchmarking” and “League Table” Publication**
**Regulatory Function:\**
Driving Performance and Transparency
**Problem:\**
Without comparative data, users and regulators cannot assess market or
regulatory outcomes.
**Solution(s):\**
Obligation for benchmarking and regular “league table” publication of
regulated operator or authority performance.
**Reference(s):\**
Article 14, Directive (EU)
[2019/944](https://eur-lex.europa.eu/eli/dir/2019/944/oj/eng)
(Electricity Market), OJ L 158, 14.6.2019, p. 125–199.
**Note(s):\**
-
\
-
## **Importer/Distributor to Verify and Inform**
**Regulatory Function:\**
Ensuring Compliance Throughout the Supply Chain
**Problem:\**
Distributors and importers are often closest to the market but may not
ensure products comply with EU requirements.
**Solution(s):\**
Importers and distributors must verify key aspects of product compliance
before placing on the market and must inform authorities of known
non-compliances.
**Reference(s):\**
Articles 17-19, Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40;
Articles 32 and 33, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025;
Articles 24, 25 and 27 Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Articles 13, 14, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Responsible Person for Regulatory Compliance**
**Regulatory Function:\**
Enhancing Compliance, Individual Accountability
**Problem:\**
Anonymous corporate actors make enforcement and compliance culture
difficult.
**Solution(s):\**
Require the appointment of a named natural person responsible for
conformity and regulatory compliance.
**Reference(s):\**
Article 15, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
See also the next entry.
## **Regulatory Compliance Department with High-level Head**
**Regulatory Function:\**
Enhancing Compliance
**Problem:\**
Those in charge of compliance do not always have the standing to enforce
compliance necessities.
**Solution(s):\**
Mandate the creation of a regulatory compliance department with a
high-level head (“compliance function”).
**Reference(s):\**
Article 41, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102.
**Note(s):\**
See also the previous entry.
## **Governance Requirements for Compliance**
**Regulatory Function:\**
Enhancing Compliance
**Problem:\**
Governance structures are not always appropriate to ensure compliance
and to address risks.
**Solution(s):\**
Set up governance requirements that ensure compliance and ability to
address risks. See the reference for illustration of how such
requirements can be cast.
**Reference(s):\**
Article 9, Regulation (EU)
[2025/1355](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32025R1355)
(Systemically Important Payment Systems), OJ L, 2025/1355.
**Note(s):\**
See also the previous entry.
## **Authorised/Legal Representatives: Detailed Obligations, Tasks, and Liability**
**Regulatory Function:\**
Accountability in Indirect Representation
**Problem:\**
Manufacturers based outside the EU often operate through authorised
representatives, potentially leading to gaps in liability or unclear
roles.
**Solution(s):\**
Define in law the detailed obligations, tasks, and liability of
authorised representatives, making them jointly and severally liable
alongside the manufacturer for non-compliance.
**Reference(s):\**
Article 31, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025;
Article 11, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Article 23, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Change of Authorised/Legal Representative**
**Regulatory Function:\**
Continuity of Representation and Market Oversight
**Problem:\**
Changing authorised representatives can interrupt regulatory oversight
or documentation availability.
**Solution(s):\**
Require notification to authorities and explicit processes to ensure
seamless transfer of obligations and records to the new representative,
with clear liability overlap during transition.
**Reference(s):\**
Article 12, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Authorised/Legal Representatives: Right of Action Against Non-compliant Manufacturers/Service Providers**
**Regulatory Function:\**
Empowering Effective Compliance Enforcement
**Problem:\**
Representatives may be blocked by manufacturers or service providers
from fulfilling compliance obligations.
**Solution(s):\**
Grant authorised representatives explicit rights in dealings with their
clients (manufacturers or service providers) where compliance is at
stake, including right to withhold services or report non-compliance.
**Reference(s):\**
Article 17(2)(e), Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40;
Article 11(3)(h) and (6), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Duties where Product/Service is Modified or Intended Purpose Changed**
**Regulatory Function:\**
Continuous Product Compliance
**Problem:\**
Products can lose compliance after market placement if modified or their
intended purpose changes post-sale.
**Solution(s):\**
Legally require manufacturers’ or service provider’s obligations to
re-apply when products or services are significantly altered or their
use changes, reactivating conformity duties.
**Reference(s):\**
Article 16(1), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;\
Article 26(1), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Economic Operators to be Identified by Labels**
**Regulatory Function:\**
Clarity and Traceability in the Supply Chain
**Problem:\**
Authorities and users need to identify responsible parties quickly.
**Solution(s):\**
Legal obligation for labels to include clear data on manufacturer,
importer, and relevant compliance contact.
**Reference(s):\**
Article 24(6), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Article 13(3), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Supply Chain Operators to Cooperate for Conformity Assessment Procedures**
**Regulatory Function:\**
Compliance
**Problem:\**
Main economic operators often cannot ensure compliance without
cooperation of suppliers or upstream service providers.
**Solution(s):\**
Supplier to cooperate in conformity assessment, at least by providing
information.
**Reference(s):\**
Article 17, Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40.
**Note(s):\**
-
## **Use of Previous Test Results / Certificates**
**Regulatory Function:\**
Efficiency and Resource Use
**Problem:\**
Duplicate testing is wasteful and can slow market access.
**Solution(s):\**
Allow prior test results to be used in conformity/compliance assessment,
under clear criteria.
**Reference(s):\**
Article 62, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Necessary to ensure that the 2nd assessment body is informed
when the 1st assessment body withdraws or limits the
certificate or test report.
## **Modular or System-Based Conformity Assessment**
**Regulatory Function:\**
Reflecting Industry Practice/Flexibility
**Problem:\**
Rigid, item-by-item approaches do not fit “systems” or kits.
**Solution(s):\**
Enable conformity assessment on a modular or system basis.
**Reference(s):\**
All automotive industry legislation (whole-vehicle type approval based
on type-approval of parts), e.g. Regulation (EU)
[2018/858](https://eur-lex.europa.eu/eli/reg/2018/858/oj/eng)
(Motor Vehicles), OJ L 151, 14.6.2018, pp. 1–218.
**Note(s):\**
-
## **Non-discrimination and Equal Access Clauses**
**Regulatory Function:\**
Market Fairness/Integrity
**Problem:\**
Favouritism or exclusion based on nationality, location, or other
grounds undermines the Single Market.
**Solution(s):\**
Mandate non-discrimination, equal access and proportionality in
regulatory measures.
**Reference(s):\**
Article 5, Regulation (EU)
[2018/302](https://eur-lex.europa.eu/eli/reg/2018/302/oj/eng)
(Geo-blocking), OJ L 601, 16.3.2018, p. 1–15;
Articles 5–7, Regulation (EU)
[2022/1925](https://eur-lex.europa.eu/eli/reg/2022/1925/oj/eng)
(Digital Markets Act), OJ L 265, 12.10.2022, p. 1–66.
**Note(s):\**
-
## **Open API / Third-Party Access in Digital Services**
**Regulatory Function:\**
Technical Interoperability and Competition
**Problem:\**
Closed digital environments hinder innovation and competition.
**Solution(s):\**
Statutory obligation for open API (application programming interfaces)
and secure third-party access for defined markets.
**Reference(s):\**
Article 6(10), Regulation (EU)
[2022/1925](https://eur-lex.europa.eu/eli/reg/2022/1925/oj/eng)
(Digital Markets), OJ L 265, 12.10.2022, p. 1–66.
**Note(s):\**
-
## **“Clean Break” Transfers Following Service or Supplier Change**
**Regulatory Function:\**
User Control and Market Switching
**Problem:\**
Technical or contractual lock-in stifles competition and user choice.
**Solution(s):\**
Mandate clear procedures for smooth, transparent transfer or porting of
data, funds, or services, with deadlines and non-blocking covenants.
**Reference(s):\**
Article 20, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
-
##
## **Minimum Training Requirement**
**Regulatory Function:\**
Baseline Competence/EU-Wide Standards
**Problem:\**
Inconsistent training undermines outcomes and hinders mobility.
**Solution(s):\**
EU harmonised basic safety/competence training requirements and mutual
recognition.
**Reference(s):\**
Article 15(1), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Custom or Heritage Product Regimes**
**Regulatory Function:\**
Proportional Regulation
**Problem:\**
Generic rules cannot be applied to unique, heritage, or custom-made
products without undue burden.
**Solution(s):\**
Tailor requirements or allow derogations for individually manufactured,
custom, or historic products.
**Reference(s):\**
Article 14, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Surplus or Non-Installed Products**
**Regulatory Function:\**
Resource Efficiency and Market Flexibility
**Problem:\**
Surplus or unused products should be re-marketable, subject to
safety/proof conditions. The same applies to remanufactured products
**Solution(s):\**
Define procedures for surplus/non-installed product validation and
re-launch.
**Reference(s):\**
Article 11(7) and (8), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Remanufactured and Used Products**
**Regulatory Function:\**
Circular Economy, Re-use, and Product Life-Cycle Extension
**Problem:\**
Legal uncertainty can impede the legitimate placement of remanufactured
or previously used products back on the market.
**Solution(s):\**
Define tailored rules for remanufactured and used products, specifying
when and how these products may be marketed or declared conformant.
**Reference(s):\**
Articles 2(20) and (25), 21(3) and 26(2), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
See also, as example for a simple coverage of used products, Article
2(3), Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.-
\
-
## **Producer Responsibility Schemes**
**Regulatory Function:\**
Waste Management/Circularity
**Problem:\**
End-of-life management falls on the public sector unless producers
retain responsibility.
**Solution(s):\**
Impose extended producer responsibility (EPR) obligations for
collection, recycling, or take-back.
**Reference(s):\**
Articles 8 and 8a, Directive
[2008/98/EC](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02008L0098-20251016)
(Waste), OJ L 312, 22.11.2008, p. 3–30.
**Note(s):\**
-
## **Product or Service “Passports”**
**Regulatory Function:\**
Traceability and Transparency
**Problem:\**
Regulatory and market actors need reliable, transferable data on the
product’s characteristics and compliance history.
**Solution(s):\**
Mandate provision of digital product passports/database entries,
accessible to authorities and market operators.
**Reference(s):\**
Articles 9-15, Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Eco-design for Sustainable Products), OJ L 1781, 28.6.2024, p. 1;
Articles 75-80, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Articles 77 and 78, Regulation (EU)
[2023/1542](https://eur-lex.europa.eu/eli/reg/2023/1542/oj/eng)
(Batteries), OJ L 191, 28.7.2023, p. 1–131.
**Note(s):\**
The third reference was the pioneer for the first two references.
## **Transparency Registers for Market Actors**
**Regulatory Function:\**
Market Integrity and Public Confidence
**Problem:\**
Opaque market participants may obscure true interests or relationships.
**Solution(s):\**
Dedicated open registers listing actors, roles and beneficial owners in
regulated sectors.
**Reference(s):\**
Articles 30–31, Directive (EU)
[2015/849](https://eur-lex.europa.eu/eli/dir/2015/849/oj/eng)
(Anti-Money Laundering), OJ L 141, 5.6.2015, p. 73–117.
**Note(s):\**
-
\
-
## **Voluntary Certification/Approval of Parts**
**Regulatory Function:\**
Reducing Reporting and Compliance Burden
**Problem:\**
Parts should often be checked as well. Full duplicate testing/approval
for assemblies using already-certified parts is wasteful.
**Solution(s):\**
Enable voluntary certification of parts, ideally with a legal mechanism
for products to “build-on” that certificate when seeking product-level
approval.
**Reference(s):\**
Articles 2(1)(e), 67, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Automotive industry legislation, e.g. Regulation (EU) No
[167/2013](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32013R0167)
(Agricultural Vehicles), OJ L 60, 2.3.2013, p. 1–51.
**Note(s):\**
-
## **Mandatory Certification/Approval of Key Parts or Ingredients**
**Regulatory Function:\**
Ensuring Safety and Environmental Performance at the Subsystem Level
**Problem:\**
Critical component failures may cause systemic hazards.
**Solution(s):\**
Designate “key parts” requiring mandatory certification/approval prior
to use in end products.
**Reference(s):\**
Article 2(1)(d), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Automotive industry legislation, e.g. Regulation (EU) No
[167/2013](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32013R0167)
(Agricultural Vehicles), OJ L 60, 2.3.2013, p. 1–51;
Article 7, Regulation (EU)
[2023/1230](https://eur-lex.europa.eu/eli/reg/2023/1230/oj/eng)
(Machinery), OJ L 165, 14.6.2023, p. 1–151;
Article 1(3) and Section II, [Council Mandate for
Negotiations](https://data.consilium.europa.eu/doc/document/ST-9285-2025-INIT/en/pdf)
regarding the proposed Regulation on Medicinal Products for Human Use.
**Note(s):\**
-
## **Obligations for Parts and Components Distinct from Accessories**
**Regulatory Function:\**
Safety and Functional Integrity of Products
**Problem:\**
Replacement parts, consumables, or components used for repair may bypass
regulatory controls.
**Solution(s):\**
Define and regulate “parts” and “components” as distinct categories,
with clear legal obligations for conformity and traceability.
**Reference(s):\**
Article 23, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;
Articles 2(1) and 17(2), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Require full new certification or approval where the parts lead to
substantial change.
## **Imported Used Products Checked as New Products**
**Regulatory Function:\**
Closing Compliance Loopholes on Imports
**Problem:\**
Used imports may never have met EU standards, posing risks to
safety/environment.
**Solution(s):\**
Explicit rule that imported used products must fulfil the same
regulatory requirements as new products.
**Reference(s):\**
Articles 2(1), 11(1) and 26(2), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
This is a partial and fine-tuning codification of the so-called
“[Blue
Guide](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2022:247:TOC)”,
the main guidance document for EU product legislation.
## **Voluntary Conformity Assessment for Used Products Not Subject to Mandatory Assessment**
**Regulatory Function:\**
Enhancing Market Acceptance for Safe Used Products
**Problem:\**
Lack of conformity assessment options blocks legitimate used goods from
being re-placed on the market where the market requires up-to-date
certification.
**Solution(s):\**
Permit voluntary full or “reduced” conformity assessment for used
products, tailored to reduced or different intended use.
**Reference(s):\**
Article 12 (in particular paragraph (6)), Proposal for a Regulation on
the marketing of construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final.
**Note(s):\**
-
## **Re-labelled, Re-purposed, or Misdeclared and “Pseudo” Products**
**Regulatory Function:\**
Combatting Regulatory Evasion by Misleading Declaration
**Problem:\**
Products may be falsely declared for another use to avoid regulation.
**Solution(s):\**
Explicit legal duties for economic operators handling ambiguous or
“pseudo” products; authorities empowered to reclassify as regulated
products.
**Reference(s):\**
Article 31, Proposal for a Regulation on the marketing of construction
products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final.
**Note(s):\**
-
## **Manufacturer to Define/Certify Precise Product Type**
**Regulatory Function:\**
Clear Targeting for Market Surveillance and Certification
**Problem:\**
Ambiguous declarations enable evasion and confusion across operators.
**Solution(s):\**
Manufacturers must define a precise “product type” and not use
over-broad or fuzzy labels; notified bodies must verify this
determination.
**Reference(s):\**
Article 22(1) and Annex V (testing and certification procedures),
Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Foundation for precision in market recalls and enforcement.
## **Detailed and Logically-Ordered Declaration of Conformity**
**Regulatory Function:\**
Enhanced Legal Certainty and Market Clarity
**Problem:\**
Confusing, incomplete, or ill-ordered declarations hinder enforcement
and market function.
**Solution(s):\**
Set clear steps: compliance check, then declaration of conformity, then
CE marking, then market placement.
**Reference(s):\**
Articles 13–18, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Guides best practice online, for digital/AI, green and safety
declarations.
## **Life Cycle Assessment (LCA) of Effects**
**Regulatory Function:\**
Holistic Longterm Policy
**Problem:\**
Environmental and other impacts can be “offshored” or hidden unless the
whole value and use chain is considered.
**Solution(s):\**
Legal requirement for full life-cycle assessment (LCA), e.g. for
environmental product declarations or labelling.
**Reference(s):\**
Annex II, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Annexes I to III, Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Eco-design for Sustainable Products), OJ L 1781, 28.6.2024, p. 1.
**Note(s):\**
Best practice for construction, chemicals, batteries, finance, and more.
## **Labelling Schemes**
**Regulatory Function:\**
Consumer Information and Green Marketing
**Problem:\**
Consumers and professionals lack reliable information e.g. on
environmental or social attributes of products/services.
**Solution(s):\**
Establish, regulate, or mandate the use of harmonised
environmental/social labelling.
**Reference(s):\**
Regulation (EC) No
[66/2010](https://eur-lex.europa.eu/eli/reg/2010/66/oj/eng) (EU
Ecolabel), OJ L 27, 30.1.2010, p. 1–19.
**Note(s):\**
-
## **Discontinuity Notification**
**Regulatory Function:\**
Access to Crucial Products or Services
**Problem:\**
Economic operators sometimes stop their activities from one day to the
next and thereby cause the collapse of a certain market. In some cases,
crucial products or services cannot be accessed anymore. In others,
prices jump.
**Solution(s):\**
Oblige economic operators to notify their intention to discontinue their
activity in advance so that authorities can react.
**Reference(s):\**
Article 10a, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Obligation to offer Repairs and Spares**
**Regulatory Function:\**
Consumer Protection and Circular Economy
**Problem:\**
Lack of timely approval or access to repair information locks product
users into new purchases.
**Solution(s):\**
Impose duties for timely registration/approval of replacement parts and
access to repair manuals or even repair.
**Reference(s):\**
Article 22(2), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Article 14, Directive (EU)
[2019/771](https://eur-lex.europa.eu/eli/dir/2019/771/oj/eng)
(Sale of Goods), OJ L 136, 22.5.2019, p. 28–50.
**Note(s):\**
-
## **Requirements for Supply Chain Due Diligence**
**Regulatory Function:\**
Responsible Trade and Upstream Control
**Problem:\**
Lax control allows risks and abuses deep in the supply chain.
**Solution(s):\**
Impose detailed due diligence obligations extending to sub-suppliers and
service providers.
**Reference(s):\**
Article 4, Regulation (EU)
[2023/1115](https://eur-lex.europa.eu/eli/reg/2023/1115/oj/eng)
(Deforestation), OJ L 150, 9.6.2023, p. 206–247;\
Articles 5-12, Directive (EU)
[2024/1760](https://eur-lex.europa.eu/eli/dir/2024/1760/oj?uri=CELEX:32024L1760)
(Corporate Sustainability Due Diligence), OJ L, 2024/1760, 5.7.2024.
**Note(s):\**
-
## **End-of-Life “Product Stewardship”**
**Regulatory Function:\**
Life-Cycle Environmental Protection
**Problem:\**
Products can cause harm at the end of life if not managed by those best
placed to mitigate risks.
**Solution(s):\**
Statutory duty for producers/importers to manage product collection,
recycling, or disposal.
**Reference(s):\**
Chapter VIII, Regulation (EU)
[2023/1542](https://eur-lex.europa.eu/eli/reg/2023/1542/oj/eng)
(Batteries), OJ L 191, 28.7.2023, p. 1–131.
**Note(s):\**
-
## **“Do No Significant Harm” Clauses**
**Regulatory Function:\**
Mainstreaming Sustainability
**Problem:\**
A sector’s advances may undermine environmental/social goals elsewhere.
**Solution(s):\**
Prohibit actions likely to cause significant harm to defined social or
environmental interests, as assessed against official DNSH criteria.
**Reference(s):\**
Article 3(b), Regulation (EU)
[2020/852](https://eur-lex.europa.eu/eli/reg/2020/852/oj/eng)
(Taxonomy), OJ L 198, 22.6.2020, p. 13–43.
**Note(s):\**
-
## **Pre-Market Risk Assessment in High-Risk Sectors**
**Regulatory Function:\**
Precaution and Responsible Innovation
**Problem:\**
Some products/services are placed on the market without prior assessment
of broader impacts.
**Solution(s):\**
Compulsory ex ante (e.g. environmental/social/health/safety/rights) risk
assessment for certain categories.
**Reference(s):\**
Articles 4–8, Directive
[2011/92/EU](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32011L0092)
(Environmental Impact Assessment), OJ L 26, 28.1.2012, p. 1–21;
Article 27, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L 2024/1689, 12.7.2024.
**Note(s):\**
-
# H. Liability of Actors
## **Liability for Defective Products or Services**
**Regulatory Function:\**
Accountability and Consumer Protection
**Problem:\**
Injuries and losses occur when services or products are defective;
ambiguity about who is liable slows compensation and undermines trust.
**Solution(s):\**
Explicit provision on the liability of service providers and of
manufacturers (and, if relevant, importers or even distributors) for
harm caused by defective products.
**Reference(s):\**
Article 5, Directive (EU)
[2024/2853](https://eur-lex.europa.eu/eli/dir/2024/2853/oj/eng)
(Product Liability), OJ L, 2024/2853, 18.11.2024.
**Note(s):\**
Consider also mandatory liability insurance.
## **Liability for Conformity or Compliance (not just Responsibility)**
**Regulatory Function:\**
Closing Loopholes on Payment/Compensation, incentivising for compliance
**Problem:\**
The term “responsibility” generates legal ambiguity, especially in
cross-border cases.
**Solution(s):\**
Use “liability” to refer to all economic operators and other actors,
subjecting them to full national and EU civil law consequences.
**Reference(s):\**
Article 6, Directive (EU)
[2024/1203](https://eur-lex.europa.eu/eli/dir/2024/1203/oj/eng)
(Environmental Crime), OJ L, 2024/1203, 30.4.2024;
Articles 13(2), 17(3) and 20(7), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Consider also mandatory liability insurance.
## **Liability for Correctness of Information**
**Regulatory Function:\**
Consumer and User Protection, Safety
**Problem:\**
Actors do not always stick to the truth in their communication. This can
trick consumers and other clients into purchasing a product or service.
This can also trigger sub-optimal safety choices.
**Solution(s):\**
Establish a liability for the correctness, completeness and fairness of
information provided.
**Reference(s):\**
Articles 15 and 26, Regulation (EU)
[2023/1114](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1114-20240109)
(Crypto Assets), OJ L 150, 9.6.2023, p. 40–178.
**Note(s):\**
-
## **Liability of Authorised/Legal Representative**
**Regulatory Function:\**
Increasing Compliance by Liability and ensuring Liability
**Problem:\**
Manufacturers and Service Providers are difficult to sue.
**Solution(s):\**
Making authorised representatives jointly and commonly liable, together
with the manufacturer or service provider.
**Reference(s):\**
Article 11(5), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Consider also mandatory liability insurance.
## **Liability Insurance for Certification Services**
**Regulatory Function:\**
Accountability and User Protection
**Problem:\**
Member States law on liability applies to Certification Bodies and other
certification services. However, some bodies might not be able to cover
large damages. Assessment/certification errors may cause substantial
harm.
**Solution(s):\**
Mandatory liability insurance for certification services, unless the
state takes over liability.
**Reference(s):\**
Article 31(9), Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024;
Article 46(10), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Multiple Liable Persons**
**Regulatory Function:\**
Legal Clarity, Effective Protection of Victims
**Problem:\**
The law of Member States varies as to the question who is liable when
different persons have contributed to a damage.
**Solution(s):\**
Establish joint and common/several liability and recourse rules.
**Reference(s):\**
Article 12, Directive (EU)
[2024/2853](https://eur-lex.europa.eu/eli/dir/2024/2853/oj/eng)
(Product Liability), OJ L, 2024/2853, 18.11.2024.
**Note(s):\**
See also Article 13 of the referenced directive.
# I. Risk Management and Technology Ethics
**See also the last entry of Section G.**
## **Risk-Based Supervision/Control Requirements**
**Regulatory Function:\**
Efficient Oversight and Prioritisation
**Problem:\**
Resources of authorities are too scarce to cover all products, services
or processes.
**Solution(s):\**
Impose a duty to apply “risk-based” principles not only for approvals
and certification, but also for surveillance, inspections, and
supervision.
**Reference(s):\**
Article 11, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;\
Title II Chapter II, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, p. 1–142.
**Note(s):\**
Establishment of a concrete risk is very cumbersome whilst formal
non-compliance may indicate inaccurate work methods and thus risks.
Hence it is often preferable to start with formal checks of high risk
products, services or processes.
## **Risk Management System Requirements**
**Regulatory Function:\**
Efficient Oversight and Risk Reduction
**Problem:\**
Without a systemic approach to risks, authorities and other actors
cannot identify and reduce risks in the best possible way.
**Solution(s):\**
Impose a duty to apply a risk management system or framework, be it
tailor-made or be it based on an international risk management standard.
**Reference(s):\**
Articles 10, 11, 13 and 18-21, Regulation (EU)
[2025/1355](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32025R1355)
(Systemically Important Payment Systems), OJ L, 2025/1355;
Article 9, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L 2024/1689, 12.7.2024;
Article 10(2) and Annex I Section 3, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Joint or Centralised Technology Assessment**
**Regulatory Function:\**
Joint Assessment and Avoidance of Fragmentation
**Problem:\**
Member State fragmentation in assessing new products, services or
technologies delays market entry and burdens applicants.
**Solution(s):\**
Establish EU-level or multi-country joint assessment mechanisms,
coordinated by nominated bodies, EU agencies or the Commission.
**Reference(s):\**
Regulation (EU)
[2021/2282](https://eur-lex.europa.eu/eli/reg/2021/2282/oj/eng)
(Health Technology Assessment), OJ L 458, 22.12.2021, p. 1–76;\
Articles 54 and 55, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
##
**Ethics Panels or Committees**
**Regulatory Function:\**
Upholding Societal Values in Novel/Emerging Fields
**Problem:\**
Technical or automated rules may lack sufficient protection for ethics
or fundamental rights.
**Solution(s):\**
Set up independent ethics panels for AI, biomedical, or data processing
proposals.
**Reference(s):\**
Article 62(3), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175, for national ethics
committees.
**Note(s):\**
-
## **Notification and Scrutiny for Emerging Risks**
**Regulatory Function:\**
Proactive and Adaptive Regulation
**Problem:\**
Conventional provisions may miss new or rapidly evolving risks (e.g.,
AI, nanotechnology, gene-editing).
**Solution(s):\**
Develop/adapt “watching” or notification mechanisms for emerging risks
and scrutiny mechanisms or panels.
**Reference(s):\**
Articles 45(5), 87-92, 105 and 106, Annex XIV, Part B, 6.1(c),
Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
\
**COM as Risk Assessment Arbiter**
----------------------------------
**Regulatory Function:\**
Alignment of Member States in risk matters
**Problem:\**
Member States may have diverging views on the assessment of a specific
risk.
**Solution(s):\**
Give the Commission the right to decide in case of diverging views.
**Reference(s):\**
Article 29, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, pp. 1–51.
**Note(s):\**
Similar to classic safeguard procedures in product legislation. Creates
an incentive for Member States to find a compromise among themselves.
## **Incentives for Risk Reduction**
**Regulatory Function:\**
Risk Reduction
**Problem:\**
Without incentives, actors do not necessarily reduce risks.
**Solution(s):\**
Impose a duty to create risk reduction incentives or create them in the
regulation.
**Reference(s):\**
Article 10(3), Regulation (EU)
[2025/1355](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32025R1355)
(Systemically Important Payment Systems), OJ L, 2025/1355.
**Note(s):\**
-
## **Risk Communication and Public Information**
**Regulatory Function:\**
Risk Governance and Trust
**Problem:\**
Failure to inform the public weakens risk prevention and can cause panic
or mistrust.
**Solution(s):\**
Impose duties for timely, comprehensible, and proportionate public
information when risks are detected.
**Reference(s):\**
Articles 14 and 34, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;\
Chapter VIII, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.
**Note(s):\**
-
## **Risk Assessment Methodology**
**Regulatory Function:\**
Complexity of Risk Assessment, Harmonisation of Practices
**Problem:\**
Risk assessment is extremely complex. Authorities are not necessarily
familiar with respective methodologies.
**Solution(s):\**
Mandate or recommend a common risk assessment methodology.
**Reference(s):\**
Section “Risk Assessment Guidelines for Consumer Products” in
Implementing Decision (EU)
[2019/417](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02019D0417-20230517)
(RAPEX), OJ L 73, 15.3.2019, p. 121-187;
Annex II, Commission Delegated Regulation (EU)
[2024/3173](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R3173)
(Safety Gate Rapid Alert System), OJ L, 2024/3173, 13.12.2024.
**Note(s):\**
The first reference has been superseded by the second, but is partly
more detailed. See also Chapter 8 of our [Handbook ‘How to
Regulate?’](https://www.howtoregulate.org/wp-content/uploads/2024/10/H2R_hanbook_2024.pdf).
**See also the entry “Coherent Handling of Risky or Non-compliant
Products or Services across EU” in Chapter K.**
# J. Public Ensurance of Compliance / Implementation
## **Confidential Two-Way Digital Communication Channels**
**Regulatory Function:\**
Responsive, Transparent Administration
**Problem:\**
Unidirectional communication leads to missed information,
misunderstanding, delays.
**Solution(s):\**
Mandate digital, secure two-way communication platforms for regulatory
filings, notifications, alerts and appeals.
**Reference(s):\**
Article 67, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016;\
Article 51, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Chapter III, Directive (EU)
[2019/1937](https://eur-lex.europa.eu/eli/dir/2019/1937/oj/eng)
(Whistleblowing), OJ L 305, 26.11.2019, p. 17–56.
**Note(s):\**
-
\
-
## **Authentication of Signatures and Documents**
**Regulatory Function:\**
Legal Security in E-Administration
**Problem:\**
Disputes about authenticity/acceptance of electronic documents.
**Solution(s):\**
Explicitly require/refer to qualified electronic signatures or mandates
under eIDAS and national law.
**Reference(s):\**
Section 4, Regulation (EU)
[910/2014](https://eur-lex.europa.eu/eli/reg/2014/910/oj/eng)
(Electronic Identification), OJ L 257, 28.8.2014, p. 73–114.
**Note(s):\**
-
## **Implementation Coordination Group**
**Regulatory Function:\**
Mutual Checks of Commission and Member States
**Problem:\**
Implementation by Commission needs checks and national input,
implementation by Member States needs supervision and support by
Commission.
**Solution(s):\**
Coordination Group with co-ownership of Member States and Commission
measures and clear rules on its functioning.
**Reference(s):\**
Articles 65 and 66 Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024;
Article 103, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Complements the classic “Comitology”; no duplication or substitution
thereof if correctly established and managed.
## **EU Enforcement Information System**
**Regulatory Function:\**
Strengthening Enforcement in Member States
**Problem:\**
When uncoordinated, Member States enforce in an inconsistent and
inefficient way.
**Solution(s):\**
EU Enforcement Information System, collecting all relevant data, from
individual cases to comprehensive national strategies.
**Reference(s):\**
Article 34, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;
Article 100, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Such systems are mostly implemented by databases.
## **Peer Review of Enforcement Authorities**
**Regulatory Function:\**
Benchmarking and Progressive Improvement of Enforcement
**Problem:\**
Enforcement / Implementation quality assessment is biased when conducted
by own staff.
**Solution(s):\**
Establish periodic peer review by authorities of other Member States.
**Reference(s):\**
Article 12, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
-
## **Annual Public Enforcement Reporting**
**Regulatory Function:\**
Benchmarking and Progressive Improvement
**Problem:\**
Enforcement quality is unmeasurable without transparent reporting.
**Solution(s):\**
Oblige authorities to publish annual statistics and analysis on
enforcement actions, risks, and trends, best in accordance with a
predetermined format to ensure comparability.
**Reference(s):\**
Article 113, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, p. 1–142;
Article 59, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;
Article 34(4), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
-
## **Public Access to Enforcement Data**
**Regulatory Function:\**
Market Trust and Deterrence
**Problem:\**
Enforcement outcomes are opaque; operators may underestimate compliance
risks.
**Solution(s):\**
Publish data on inspection, enforcement, compliance, and penalties with
privacy exclusions.
**Reference(s):\**
Article 114, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, p. 1–142.
**Note(s):\**
-
## **Compliance Visualisation (“Heat Maps”)**
**Regulatory Function:\**
Transparency, Market Intelligence, and Risk Prevention
**Problem:\**
Operators, consumers, and authorities cannot easily integrate
non-compliance or incident patterns.
**Solution(s):\**
Mandate visual presentation of compliance patterns.
**Reference(s):\**
Article 34, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131;
Implementing Decision (EU)
[2019/417](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02019D0417-20230517)
(RAPEX), OJ L 73, 15.3.2019, p. 121-187.
**Note(s):\**
The references permit the publication of compliance information in
general terms, but do not refer to a specific visualisation.
## **Multi-annual National Control Plans**
**Regulatory Function:\**
Harmonised and Strengthened Enforcement
**Problem:\**
Inconsistent national surveillance leads to gaps in consumer and market
protection.
**Solution(s):\**
Mandate multi-annual national control plans, compare and evaluate them.
**Reference(s):\**
Title V (Articles 109 to 115), Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142;
Article 13, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
Control plans like this can also help to balance uneven enforcement
across Member States, especially in federal Member States.
## **Enforcement Database**
**Regulatory Function:\**
Coordination of Enforcement
**Problem:\**
Lack of accessible data on which enforcement actions have happened and
the results thereof; unnecessary double controls.
**Solution(s):\**
Create an EU-wide database for enforcement actions.
**Reference(s):\**
Article 100, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175
Articles 131 to 134, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142.
**Note(s):\**
-
## **EU-Wide Registers**
**Regulatory Function:\**
Transparency, Oversight, and Enforcement
**Problem:\**
Lack of accessible data for compliance, enforcement, and cross-border
operations.
**Solution(s):\**
Mandate creation and/or participation in EU-wide registers/databases for
regulated products, service providers or activities.
**Reference(s):\**
Article 33, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
Consider “Digital Passports” as an alternative.
## **Standardised Procedures for Surveillance and Inspections**
**Regulatory Function:\**
Harmonised Enforcement
**Problem:\**
Inconsistent national surveillance leads to gaps in consumer and market
protection.
**Solution(s):\**
Define inspections, sampling, and reporting procedures, with EU-level
consolidation of results.
**Reference(s):\**
Many Articles and Sections (e.g. Articles 65-70), Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142;
Chapter VII, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
is most granular.
## **Border Control of Products**
**Regulatory Function:\**
Compliance Verification
**Problem:\**
Once products are inside the EU, they are difficult to control. At the
same time, products originating from third countries have a much higher
non-compliance rate than EU products.
**Solution(s):\**
Set up a precise border control system, with dedicated own human
resources.
**Reference(s):\**
Title II Chapter V Sections II and III, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142;
Article 25, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
Relying on generic border control by customs authorities does not result
in the frequent detection of non-compliant products. The first reference
is exemplary in that it covers many aspects of border control, including
organisational requirements, frequency, and procedures.
## **Continuous Improvement Obligation**
**Regulatory Function:\**
Better Pursuit of Objectives
**Problem:\**
State actors tend to become complacent.
**Solution(s):\**
Oblige them to continuously improve.
**Reference(s):\**
Article 6(10) last subparagraph, Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40, 22.1.2025.
**Note(s):\**
-
## **Minimum Frequency/Number of Checks**
**Regulatory Function:\**
Ensuring Effective Enforcement
**Problem:\**
Under-resourced or infrequent checks enable persistent non-compliance.
**Solution(s):\**
Set binding minimum frequency/number of enforcement checks per product
group per period.
**Reference(s):\**
Article 54, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142;
Article 11(4), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
-
## **Minimum Enforcement Resources**
**Regulatory Function:\**
Ensuring Effective Enforcement
**Problem:\**
Under-resourced or infrequent checks enable persistent non-compliance.
Understaffing is often the root cause thereof.
**Solution(s):\**
Set binding minimum full-time equivalences for enforcement authorities
or empower the Commission to set them.
**Reference(s):\**
Article 64(4) (in relation to (3)(a)), Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142;
Article 73(1), Proposal for a Regulation on the marketing of
construction products, [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final.
**Note(s):\**
Abstract wording like “sufficient resources” do not suffice in practice
as they create too much legal uncertainty. Parameters for setting up
minimum resources requirements (full-time equivalents) may include:
population of Member States; number of economic actors active towards
clients of the Member State or active on its territory; number of
product or service types; number of products or service interactions;
complexity of the products or services; complexity of the respective
legislation; dynamic of technology and markets. Minimum resources
requirements should be set up in such a way that staff attributed to a
certain task have no other responsibilities.
## **Enforcement Delegation within Member States**
**Regulatory Function:\**
Ensuring Effective Enforcement
**Problem:\**
Under-resourced authorities cannot enforce alone.
**Solution(s):\**
Set rules on delegation of enforcement activities.
**Reference(s):\**
Title II, Chapter III, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142.
**Note(s):\**
-
## **Artificial Intelligence to Detect Diverging Practice or Infringements**
**Regulatory Function:\**
Data-Driven Oversight and Harmonisation
**Problem:\**
Without systematic monitoring, divergences in regulatory/certification
practice and infringements go undetected.
**Solution(s):\**
Empower and/or require national authorities, EU agencies or bodies and
the Commission to use AI/machine learning to detect interpretive or
procedural divergences across Member States and bodies and to detect
infringements.
**Reference(s):\**
Article 14(5), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
We did not find any explicit empowerment. However, the reference may be
understood as covering the use of artificial intelligence.
## **Testing Infrastructure (Physical, Artificial Intelligence or other Software)**
**Regulatory Function:\**
Enhancing Compliance, facilitating Enforcement
**Problem:\**
Products and processes can be extremely cumbersome or difficult to test,
both for operators and authorities.
**Solution(s):\**
Empower EU agencies or bodies and the Commission to develop a testing
infrastructure, mandate or encourage its use.
**Reference(s):\**
Article 40, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
Article 84, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024.
**Note(s):**
Consider mandating the use of the testing infrastructure.
## **Mandatory Software, Software Component(s) or Datasets**
**Regulatory Function:\**
Enhancing Compliance, facilitating Enforcement, Interoperability,
Comparability
**Problem:\**
Compliance, comparability of products or services, interoperability and
easy enforcements are often hampered by the use of a variety of software
or, in particular in the case of artificial intelligence, of datasets.
**Solution(s):\**
Mandate the use of a certain software, software component or dataset.
**Reference(s):\**
Article 25, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
**Note(s):**
\-
## **Notification of Draft National Measures/Deviations**
**Regulatory Function:\**
Legal Certainty, Single Market Control
**Problem:\**
Unannounced national deviations fragment the Single Market.
**Solution(s):\**
Require Member States to notify draft measures to the Commission and
other Member States prior to adoption.
**Reference(s):\**
Directive (EU)
[2015/1535](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015L1535)
(Information on Technical Regulations), OJ L 241, 17.9.2015, p. 1–15.
**Note(s):\**
“TRIS” system for technical barriers; is also used for digital,
environmental, and consumer protection fields.
**COM as Arbiter in case of Member States Dissent**
**Regulatory Function:\**
Alignment of Member States
**Problem:\**
Member States may have diverging views on concrete matters relevant for
various Member States.
**Solution(s):\**
Give the Commission the right to decide in case of diverging views.
**Reference(s):\**
Article 29, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.
**Note(s):\**
It is similar to the classic safeguard procedures found in product
legislation. It creates an incentive for Member States to reach a
compromise among themselves.
## **National Focal Points and Coordinating Authorities**
**Regulatory Function:\**
Efficient Regulatory Management
**Problem:\**
Information flow is inefficient or blocked where roles are unclear at
national level.
**Solution(s):\**
Member States must nominate and maintain clear focal points for liaison.
**Reference(s):\**
Article 64, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Particularly important for Federal States.
## **EU-Wide Rapid Alert Systems**
**Regulatory Function:\**
Consumer & Market Protection
**Problem:\**
Delayed risk communication increases harm and market distortion.
**Solution(s):\**
Establish rapid alert IT systems for safety or compliance failures
(e.g., SAFETY GATE / RAPEX).
**Reference(s):\**
Article 34, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;\
Article 34, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131;
Commission Delegated Regulation (EU)
[2024/3173](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R3173)
(Safety Gate Rapid Alert System), OJ L, 2024/3173, 13.12.2024.
**Note(s):\**
See also the [Rapid Alert System for Food and
Feed](https://food.ec.europa.eu/food-safety/rasff_en).
## **EU Joint Investigation Teams**
**Regulatory Function:\**
Cross-Border Enforcement
**Problem:\**
Fraud, cheating or risks often cross Member States’ borders.
**Solution(s):\**
Empower the creation of joint investigation teams by the EU or with
Member States’ authorities, with harmonised procedures.
**Reference(s):\**
Article 13, Regulation (EU)
[2017/1939](https://eur-lex.europa.eu/eli/reg/2017/1939/oj/eng)
(European Public Prosecutor’s Office), OJ L 283, 31.10.2017, p. 1–71.
**Note(s):\**
-
## **Shared Roles and Joint Decision-Making of Authorities Cross-Border**
**Regulatory Function:\**
Efficient and Specialised Cross-Member State Regulation
**Problem:\**
Some Member States lack capacity or expertise for specialised sectors.
**Solution(s):\**
Allow authorities of different Member States to share regulatory
roles—enabling specialisation and efficiency.
**Reference(s):\**
Article 74, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Articles 5 and 6, Regulation (EU)
[2025/38](https://eur-lex.europa.eu/eli/reg/2025/38/oj/eng)
(Cyber Threats), OJ L, 2025/38, 15.1.2025.
**Note(s):\**
This is useful for any sector requiring pooled expertise. Legalises
Malta–Italy, Luxembourg–France and Cyprus–Greece (supposedly slightly
parenting) cooperation, as well as the cooperation of Scandinavian
Member States in certain sectors.
## **Multi-Country Enforcement Operations**
**Regulatory Function:\**
Coordinated Crisis Response
**Problem:\**
Fragmented, asynchronised enforcement leaves market gaps.
**Solution(s):\**
EU coordination of planned multi-country investigations, checks or
“sweeps”—including reporting and publication.
**Reference(s):\**
Article 32(2)(c), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;
Article 30(3)(b) and (d), and Article 32, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.
**Note(s):\**
See also the first entry of Chapter P: “Imposing Regional Cooperation”.
## **Enforcement Assistance among Member States**
**Regulatory Function:\**
Pan-EU Enforcement Power
**Problem:\**
Member States do not necessarily enforce in the interest of other Member
States.
**Solution(s):\**
Establish procedure and obligation for mutual assistance of enforcement
authorities, including the obligation to alert each other.
**Reference(s):\**
Articles 28 to 36, Directive
[2006/123/EC](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32006L0123)
(Services Directive), OJ L 376, 27.12.2006, pp. 36–68;
Articles 102 to 108, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142;
Articles 22 to 24, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44. 23;
Article 95, Regulation (EU)
[2023/1114](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1114-20240109)
(Crypto Assets), OJ L 150, 9.6.2023, p. 40–178.
**Note(s):\**
Could also be used for international cooperation.
## **Control of Entities active in different Member States**
**Regulatory Function:\**
Pan-EU Enforcement Power
**Problem:\**
Some companies and other actors are active in different Member States.
**Solution(s):\**
Establish information sharing and cooperation procedures.
**Reference(s):\**
Annex, Section ARGH.OVS.330, Commission Implementing Regulation (EU)
[2025/23](https://eur-lex.europa.eu/eli/reg_impl/2025/23/oj/eng)
(Ground Handling Services Oversight), OJ L, 2025/23.
**Note(s):\**
-
## **Responsibility Collision Rules**
**Regulatory Function:\**
Ensuring Effective Enforcement
**Problem:\**
Several Member States might feel responsible or no Member State might
feel responsible, namely where an operator is based in a third country.
**Solution(s):\**
Set rules on who is responsible.
**Reference(s):\**
Article 26, Directive (EU)
[2022/2555](https://eur-lex.europa.eu/eli/dir/2022/2555/oj)
(Cyber Security), OJ L 333, 27.12.2022, p. 80–152.
**Note(s):\**
Other legislation obliges third country operators to nominate an
authorised representative from the outset and link the responsibility to
its place of business; see Chapter G. But this technique does not close
the loophole for EU operators present and active in various Member
States and those operators of third countries that do not nominate an
authorised representative.
## **Coordination/Consultation Procedures with Supervisory or Regulatory Agencies**
**Regulatory Function:\**
Holistic and Informed Decision-Making
**Problem:\**
Overlapping mandates can cause conflicting directives or gaps in
supervision.
**Solution(s):\**
Statutory requirements for coordination and consultation between
relevant agencies (at EU or national level) and arbitrage mechanisms.
**Reference(s):\**
Article 65, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Articles 19 and 20, Regulation (EU)
[1093/2010](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:32010R1093)
(Banking Authority), OJ L 331, 15.12.2010, p. 12–47.
**Note(s):\**
-
## **Legal Personality and Independence for Regulatory Agencies**
**Regulatory Function:\**
Robust and Impartial Enforcement
**Problem:\**
Bodies tasked with supervision may lack formal legal personality or
operational independence. This can create a bottle-neck at the level of
the Commission.
**Solution(s):\**
Statute-based grant of legal personality and functional independence.
**Reference(s):\**
Article 1, Regulation (EU)
[1093/2010](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:32010R1093)
(Banking Authority), OJ L 331, 15.12.2010, p. 12–47.
**Note(s):\**
The opposite issue is even more difficult to handle: Agencies and bodies
becoming so powerful that the Commission loses control over them. This
is particularly problematic when the agency or body has the power to set
rules.
## **Direct Control and Enforcement by COM**
**Regulatory Function:\**
Pan-EU Enforcement Power
**Problem:\**
Member States are not necessarily very performing in terms of control
and enforcement.
**Solution(s):\**
Establish a supplementary Commission competence for control and
enforcement.
**Reference(s):\**
Articles 116 to 119, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142.
**Note(s):\**
-
## **Disruption in a Member State’s Control System**
**Regulatory Function:\**
Regulatory Quality and Efficiency
**Problem:\**
Authorities in Member States lacking human resources or will to enforce
EU law.
**Solution(s):\**
Empower the Commission to take compensation or mitigation measures.
**Reference(s):\**
Article 141, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, p. 1–142.
**Note(s):\**
Might also be relevant in the context of emergencies. Consider also the
attribution of tasks of the Member State affected by disruption to
another Member State, e.g. regarding notified bodies.
## **Training and Capacity-Building for Authorities**
**Regulatory Function:\**
Regulatory Quality and Efficiency
**Problem:\**
Authorities’ competence may lag behind policy or market developments.
**Solution(s):\**
Impose continuing training and capacity-building obligations, including
for coordinated pan-EU implementation.
**Reference(s):\**
Article 73, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Inter alia Articles 49(5) and 130, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, p. 1–142, but many more
references to “training” spread in the text.
**Note(s):\**
-
## **Exchanges and “Twinning” Among Member State Authorities**
**Regulatory Function:\**
Exchange of Best Practice and Consistency
**Problem:\**
Fragmented national approaches slow down harmonisation.
**Solution(s):\**
Mandate, fund, or encourage structured exchanges and “twinning.”
**Reference(s):\**
Article 130(5), Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017.
**Note(s):\**
-
## **Compliance Cooperation with Other Actors**
**Regulatory Function:\**
Compliance and Information
**Problem:\**
Authorities in charge are often too weak to ensure compliance alone.
**Solution(s):\**
Empower or mandate cooperation with public and private institutions,
associations etc.
**Reference(s):\**
Article 9, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
-
## **Sampling of Produced Items or Provided Services**
**Regulatory Function:\**
Compliance Verification
**Problem:\**
Even if the technical documentation and the certified or approved type
or service are compliant, the items produced or services provided may
still be non-compliant.
**Solution(s):\**
Set rules for the systematic and documented sampling of produced items
or provided services.
**Reference(s):\**
Annex IX, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Articles 48(13), 88(1), 100(2) and (5), Annex VII Sections 2.3, 3.2,
3.4, 3.5, 3.7, 4.12, 4.13, Annex X Sections 1 and 2, Annex XI Section 5,
Regulation (EU)
[2017/746](https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng) (In
Vitro Diagnostic Medical Devices), OJ L 117, 5.5.2017, p. 176–332;
Title II Chapter IV, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142.
**Note(s):\**
-
## **Early Regulatory Dialogue / “Pre-Notification” of Measures**
**Regulatory Function:\**
Anticipatory Implementation
**Problem:\**
Operators can be surprised by enforcement measures and might be ready to
comply with obligations once informed of the authority’s concerns.
**Solution(s):\**
Duty on authorities to pre-notify compliance concerns prior to taking
enforcement measures.
**Reference(s):\**
Article 18(3), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;
Article 65, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Serious Incidents / Corrective Actions to Be Notified**
**Regulatory Function:\**
Central Learning and Prevention
**Problem:\**
Repeated mistakes or hazards go undetected unless reported and evaluated
centrally.
**Solution(s):\**
Obligation of economic operators and certification bodies to notify the
authorities of serious incidents and recalls.
**Reference(s):\**
Articles 87-89 and 92, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;\
Article 20(6), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Certification Bodies to Report on Infringements**
**Regulatory Function:\**
Better Information of Authorities
**Problem:\**
Authorities are not necessarily aware of infringements committed by
operators.
**Solution(s):\**
Mandate certification bodies to report on infringements they happen to
observe.
**Reference(s):\**
Article 56(4), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Model Forms, Templates, and IT Tools**
**Regulatory Function:\**
Uniformity and Efficiency
**Problem:\**
Variation in reporting or documentation increases burden and confusion.
**Solution(s):\**
Mandatory use or EU-level endorsement of forms, templates or digital
tools for reporting and declaration.
**Reference(s):\**
Article 34(7) and (8), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;\
Annex V, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Aids interoperability, multilingualism, and data quality.
## **Enforcement Funding and Cost Recovery**
**Regulatory Function:\**
Resourcing Enforcement
**Problem:\**
Underfunded authorities cannot carry out effective enforcement or
surveillance. Understaffing is to be observed in many small Member
States, but not only in small Member States.
**Solution(s):\**
Rules on how costs may be recovered from non-compliant actors, market
fees, or earmarked public funding. Minimum human resources requirements
to be set up by the Commission.
**Reference(s):\**
Article 69, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110; and Articles 73(2) and 75 of
its proposal [COM(2022)
144](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52022PC0144)
final;\
Article 43, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102;
Articles 79 to 84, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142.
**Note(s):\**
Can also be used to finance EU institutions or bodies, see the second
reference.
## **Definition of Technical Protocols and Test Methods**
**Regulatory Function:\**
Adaptive and Future-Proof Norms
**Problem:\**
Technical methods/protocols need to evolve with science and practice.
**Solution(s):\**
Empower Commission (or agencies) to specify protocols and standards via
delegated/implementing acts, regularly updated.
**Reference(s):\**
Articles 5(3) and 39, Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Eco-design for Sustainable Products), OJ L 1781, 28.6.2024, p. 1.
**Note(s):\**
-
## **Prevention of Test Cheating**
**Regulatory Function:\**
Legal Certainty, Fairness and Enforcement
**Problem:\**
Operators tend to interpret provisions on testing in their own, not
necessarily intended way. Operators sometimes try to cheat.
**Solution(s):\**
Ban certain behaviours or measures related to tests.
**Reference(s):\**
Article 40, Regulation (EU)
[2024/1781](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng)
(Eco-design for Sustainable Products), OJ L 1781, 28.6.2024, p. 1.
**Note(s):\**
-
\
-
## **Testing Laboratories’ Equipment and Procedures**
**Regulatory Function:\**
Reliability and Comparability of Test Results
**Problem:\**
Inadequately equipped or biased labs can undermine regulatory
confidence.
**Solution(s):\**
Set minimum technical requirements and quality assurance/traceability
for test laboratories.
**Reference(s):\**
Article 100(4) and (8), Regulation (EU)
[2017/746](https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng) (In
Vitro Diagnostic Medical Devices), OJ L 117, 5.5.2017, p. 176–332.
**Note(s):\**
Consider reference to EN ISO 17065.
## **European Reference Laboratories**
**Regulatory Function:\**
Benchmarking and Consistency of Testing
**Problem:\**
Fragmented or inconsistent testing undermines market confidence and
fairness. The more laboratories are active in a certain sector, the more
methodological divergence can be observed. Moreover, the knowledge and
expertise is fragmented where there are many laboratories.
**Solution(s):\**
Designate a limited number of European Reference Laboratories to provide
highest-level comparative testing and arbitration.
**Reference(s):\**
Article 100, Regulation (EU)
[2017/746](https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng) (In
Vitro Diagnostic Medical Devices), OJ L 117, 5.5.2017, p. 176–332.
**Note(s):\**
-
## **Contact Points/Digital Gateways**
**Regulatory Function:\**
Market Access Assistance and (Compliance) Support
**Problem:\**
SMEs and cross-border operators struggle to obtain reliable information
on national provisions, namely with regard to compliance.
**Solution(s):\**
Member States provide fully accessible product contact points and
digital “one-stop-shops”.
**Reference(s):\**
Article 72, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Regulation (EU)
[2018/1724](https://eur-lex.europa.eu/eli/reg/2018/1724/oj/eng)
(Single Digital Gateway), OJ L 295, 21.11.2018, p. 1–38.
**Note(s):\**
-
## **Social Partners in Regulatory Committees**
**Regulatory Function:\**
Inclusive and Balanced Governance
**Problem:\**
Labour, employer and civil society interests need structured voices
alongside technical authority.
**Solution(s):\**
Mandate participation rights for social partners in formal and advisory
committees.
**Reference(s):\**
Articles 152, 154 and 155, Treaty on the Functioning of the European
Union
([TFEU](https://eur-lex.europa.eu/eli/treaty/tfeu_2012/oj/eng)),
OJ C 202, 7.6.2016, p. 47-199;
Council Decision [2003/C
218/01](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=oj:JOC_2003_218_R_0001_01)
(Advisory Committee on Safety and Health at Work), OJ C 218, 13.9.2003,
p. 1-4;
Article 17(1)(d), Regulation (EU)
[2019/1149](https://eur-lex.europa.eu/legal-content/DE/ALL/?uri=CELEX:32019R1149)
(European Labour Authority), OJ L 186, 11.7.2019, p. 21-56.
**Note(s):\**
-
## **Information-Sharing between Certification Bodies and Authorities (Obligations and Empowerments)**
**Regulatory Function:\**
Supervisory Consistency and Quality Control
**Problem:\**
Authorities need to learn from auditors or certification bodies “on the
ground”, whilst the latters’ activities can easily become inconsistent
if done in isolation.
**Solution(s):\**
Impose and empower detailed information-sharing mechanisms between
certification bodies and authorities at EU and national level.
**Reference(s):\**
Articles 56 and 65(1) last subpara, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **EU-Wide Training / Learning for Practitioners**
**Regulatory Function:\**
Institutional Learning and Upkeep
**Problem:\**
Diverse administrative cultures and knowledge levels can lead to uneven
enforcement and misinterpretation.
**Solution(s):\**
Impose a legal obligation for the Commission and/or national competent
authorities to organise regular training, joint learning opportunities,
and practitioner exchanges targeting consistent, high-quality
implementation.
**Reference(s):\**
Article 73, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Article 130, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, p. 1–142.
**Note(s):\**
Can be extended to reference laboratories.
## **Mandating Good Administrative Practices**
**Regulatory Function:\**
Fairness, Efficiency and Compliance
**Problem:\**
Administrations do not always behave in a fair and efficient way.
**Solution(s):\**
Mandate the respect of good administrative practice (codes).
**Reference(s):\**
Article 99, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **Capping of Compliance Costs**
**Regulatory Function:\**
Market Fairness and Access
**Problem:\**
High prices for compliance procedures, standards or technical documents
act as barriers to compliance.
**Solution(s):\**
Set legal maximum prices for essential procedures or standards/documents
to ensure all actors can comply.
**Reference(s):\**
Articles 3 and 4, Regulation (EU)
[2015/751](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R0751)
(Card-based Payments), OJ L 123, 19.5.2015, pp. 1–15.
**Note(s):\**
See also the obligation to make notified bodies’ fees transparent in
Article 50 Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
## **Incentives/Prizes for Voluntary Over-Compliance, Innovation, or Social Good**
**Regulatory Function:\**
Promoting Exceedance of Minimum Standards
**Problem:\**
Minimum compliance does not reward extra effort or innovator-early
adopters.
**Solution(s):\**
Recognition schemes, simplified procedures, or reduced audits for
documented superior performance.
**Reference(s):\**
Article 50(11), Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40 (exemption of Annex X
where the 90% goal is reached before deadline);
Article 82, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Article 43, Regulation (EU)
[2021/695](https://eur-lex.europa.eu/eli/reg/2021/695/oj/eng)
(Horizon Europe), OJ L 170, 12.5.2021, p. 1–68.
**Note(s):\**
See also the Section on incentives in our [Handbook “How to
regulate?”](https://www.howtoregulate.org/wp-content/uploads/2024/10/H2R_hanbook_2024.pdf).
**See also the first two entries of Section P and the first three
entries of the following Section K.**
# K. Enforcement Powers
## **Proactive Surveillance and Own-Initiative Audits**
**Regulatory Function:\**
Risk Detection and Preventive Action
**Problem:\**
Authorities previously acted almost solely on complaints or “signals”.
**Solution(s):\**
Legal basis for authorities to conduct surveillance or audits without
exogenous triggers.
**Reference(s):\**
Article 11(3), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;
Article 32(2), Directive (EU)
[2022/2555](https://eur-lex.europa.eu/eli/dir/2022/2555/oj)
(Cyber Security), OJ L 333, 27.12.2022, p. 80–152.
**Note(s):\**
-
## **“Stress Tests” and Real-Time Audits**
**Regulatory Function:\**
Risk Detection and Preventive Action
**Problem:\**
Paper compliance may miss vulnerabilities; only real-world tests expose
failures.
**Solution(s):\**
Empower/require authorities to commission or perform stress tests and
real-time (“live”) audits.
**Reference(s):\**
Article 76, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024;
Article 44(5), Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;\
Article 18, Directive (EU)
[2022/2557](https://eur-lex.europa.eu/eli/dir/2022/2557/oj/eng)
(Resilience of Critical Entities), OJ L 333, 27.12.2022, p. 164–197.
**Note(s):\**
-
## **Authority to Test as Client (e.g. Mystery Shopping)**
**Regulatory Function:\**
Real-World Compliance Checks
**Problem:\**
Manufacturers or sellers might present compliant samples to authorities
while offering different (non-compliant) products on the market.
Services and other processes might be executed with less care when no
inspection is expected.
**Solution(s):\**
Grant explicit power to authorities to carry out tests as
clients—including covert or “mystery shopping”—to verify real-world
compliance.
**Reference(s):\**
Article 14(4)(j), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
-
## **Proportional/Graduated Enforcement Toolkit / Comprehensive Empowerment Catalogue**
**Regulatory Function:\**
Proportional Enforcement and Deterrence
**Problem:\**
Rigid enforcement can be unfair or unworkable. Effective enforcement
depends on having powers to act appropriately in all situations of
non-compliance.
**Solution(s):\**
Legally set out a range of enforcement actions—from warnings to fines,
recalls and withdrawals—matched to risk/gravity. Establish a
comprehensive catalogue of empowerments.
**Reference(s):\**
Articles 94, 103 and 104, Regulation (EU)
[2023/1114](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1114-20240109)
(Crypto Assets), OJ L 150, 9.6.2023, p. 40–178;
Articles 65-68 and 138, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142;
Articles 57 and 58, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;
Articles 14 and 16, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44;
Article 74, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024;\
Article 22(4) and (5), Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.
**Note(s):\**
See also our “[List of Powers and
Obligations](https://www.howtoregulate.org/wp-content/uploads/2025/02/List-Powers-Obligations-Dec-2024.docx.pdf)”
with several hundred empowerments useful for enforcement.
## **Layered Administrative, Civil, Criminal Enforcement**
**Regulatory Function:\**
Proportionate and Effective Enforcement
**Problem:\**
One channel of enforcement may be too weak or inflexible.
**Solution(s):\**
Enable various pathways (administrative, civil, criminal) for different
levels of breach, defined by law.
**Reference(s):\**
Article 6 for civil liability, other articles for penal responsibility,
Directive (EU)
[2024/1203](https://eur-lex.europa.eu/eli/dir/2024/1203/oj/eng)
(Environmental Crime), OJ L, 2024/1203, 30.4.2024;
See the references of the previous entry for administrative measures.
**Note(s):\**
See also our “[List of Powers and
Obligations](https://www.howtoregulate.org/wp-content/uploads/2025/02/List-Powers-Obligations-Dec-2024.docx.pdf)”
with several hundred empowerments useful for enforcement and the
parallel “[List of Sanctions and Collateral
Measures](https://www.howtoregulate.org/wp-content/uploads/2025/02/List-Sanctions-Dec-2024.docx.pdf)”.
## **Targeted Information Interventions by Authorities**
**Regulatory Function:\**
Tailored Risk Communication
**Problem:\**
Generic warnings are ignored or misunderstood.
**Solution(s):\**
Allow for special, sectoral, or real-time targeted warnings issued via
regulatory platforms or media.
**Reference(s):\**
Article 33(1), Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.
**Note(s):\**
-
## **“Blacklisting” and “Shaming” of Persons or Businesses**
**Regulatory Function:\**
Effective Sanctions, Prevention of future Non-compliance
**Problem:\**
Ordinary sanctions might not suffice to deter effectively.
**Solution(s):\**
Explicit exclusion mechanisms or “blacklisting” or “shaming” in public
databases.
**Reference(s):\**
Article 83, Regulation (EU)
[2021/23](https://eur-lex.europa.eu/eli/reg/2021/23/oj/eng)
(Recovery and Resolution of Central Counterparties), OJ L 22, 22.1.2021,
pp. 1–102;
Article 59(2)(a), Directive (EU)
[2015/849](https://eur-lex.europa.eu/eli/dir/2015/849/oj/eng)
(Terrorism and Money-Laundering), OJ L 141, 5.6.2015, S. 73-117;
Articles 135-137, Regulation (EU, Euratom)
[2018/1046](https://eur-lex.europa.eu/eli/reg/2018/1046/oj/eng)
(Financial Regulations), OJ L 193, 30.7.2018, S. 1-222;
Articles 84 and 85, Directive (EU)
[2025/1](https://eur-lex.europa.eu/eli/dir/2025/1/oj/eng)
(Recovery and Resolution of Insurances), OJ L, 2025/1, 8.1.2025.
**Note(s):\**
-
## **Blocking Online Access to Non-Compliant Products or Services**
**Regulatory Function:\**
Effectiveness in the Digital Economy
**Problem:\**
Authorities lack the ability to block online access to non-compliant
products or services.
**Solution(s):\**
Give powers for temporary or permanent digital blocking, subject to
proportional safeguards.
**Reference(s):\**
Article 9, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102.
**Note(s):\**
-
## **Market Withdrawal Notification to Users/Consumers**
**Regulatory Function:\**
Cross-Border Consumer Protection
**Problem:\**
Limited language coverage and variable formats can lead to missed or
misunderstood safety recalls.
**Solution(s):\**
Procedural, language and format requirement for multilingual
recall/withdrawal notifications.
**Reference(s):\**
Articles 35 and 36, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.
**Note(s):\**
-
## **Coordinated Market Withdrawal or Remediation Measures (“Union Safeguard Procedure”)**
**Regulatory Function:\**
Pan-EU Protective Action
**Problem:\**
Ineffective or uncoordinated actions can leave risks in the market or
duplicate removal efforts.
**Solution(s):\**
Enshrine a Union-wide notification, consultation, and decision procedure
for serious safety or compliance risk responses, with automatic
extension to the Union in case of non-objection by Member States.
**Reference(s):\**
Article 65-67, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
See also the next entry which contains further refinements.
## **Coherent Handling of Risky or Non-compliant Products or Services across EU**
**Regulatory Function:\**
Enhancing Compliance, Countering Risks
**Problem:\**
Measures taken in one Member State need to be replicated, if justified,
in other Member States. The distinction between products/services
presenting a risk and those being non-compliant can be tricky. The
burden of proof is on the side of the authorities wherefore they often
do not dare to act.
**Solution(s):\**
To reduce the difficulty of proof, extend the procedure for risky
products/services to products/services for which there was a serious
incident. Align the procedures for the two cases so that risk and
non-compliance can be processed in the same procedure or two totally
parallel procedures.
**Reference(s):\**
Articles 44-46, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
**Note(s):**
The reference is better than any other we found, but does not make the
last step: merger of the two procedures into one. Please contact us if
you are interested in obtaining a draft for a merged procedure.
See also Article 102, Regulation (EU)
[2023/1114](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1114-20240109)
(Crypto Assets), OJ L 150, 9.6.2023, p. 40–178. This Article deals only
with the coordination of two Member States, but also reduces the burden
of proof in its first paragraph (“suspecting”).
## **Authorities to Inform Bodies of Non-Compliant or Risky Products**
**Regulatory Function:\**
Feedback Loops for Certification Improvement
**Problem:\**
Certification bodies may not be alerted to recurring or systemic
non-conformities or risks in their certified products.
**Solution(s):\**
Where non-compliance/risk is found, market surveillance authorities must
inform relevant certification bodies.
**Reference(s):\**
Article 65(1), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Powers for “Recall” of Digital Content or Correction of Published Errors**
**Regulatory Function:\**
Digital Era Consumer/Market Protection
**Problem:\**
Unlawful, misleading, or dangerous digital content can spread rapidly
with lasting damage.
**Solution(s):\**
Statute-based power for authorities to order removal or correction of
digital content or services.
**Reference(s):\**
Article 9, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102.
**Note(s):\**
-
\
-
## **Power to Impose Corrective Advertising / Publication**
**Regulatory Function:\**
Remedying the Effects of Misleading Actions
**Problem:\**
Consumers or businesses may have been misled or harmed by non-compliant
marketing or claims.
**Solution(s):\**
Express power for authorities to require corrective advertising or
notices to reach affected audiences.
**Reference(s):\**
Article 11(2) last subpara, Directive
[2005/29/EC](https://eur-lex.europa.eu/eli/dir/2005/29/oj/eng)
(Unfair Commercial Practices), OJ L 149, 11.6.2005, p. 22–39.
**Note(s):\**
-
## **Economic Powers Catalogue - External Administrator**
**Regulatory Function:\**
Enforcement Ensurance in Complex or Difficult Business Settings and
(Threat of) Insolvency
**Problem:\**
Enforcement is difficult or impossible where the targeted operator is in
a complex or difficult business setting or even under threat of
insolvency.
**Solution(s):\**
Select some of the powers from the references, and in particular the
right to impose external administration or “to assume control”.
**Reference(s):\**
Chapter IV, Regulation (EU)
[2021/23](https://eur-lex.europa.eu/eli/reg/2021/23/oj/eng)
(Recovery and Resolution of Central Counterparties), OJ L 22, 22.1.2021,
pp. 1–102;
Article 15(5) and Title III (in particular Chapter IV), Directive (EU)
[2025/1](https://eur-lex.europa.eu/eli/dir/2025/1/oj/eng)
(Recovery and Resolution of Insurances), OJ L, 2025/1, 8.1.2025.
**Note(s):\**
- These powers are here recommended as means to ensure the fulfilment
of obligations other than those established in recovery and resolution
legislation.
\- Less invasive than an external administrator: external inspector
integrated into the operations.
## **Fees, Charges, Cost-Sharing for Regulatory Services**
**Regulatory Function:\**
Fair and Effective Resourcing
**Problem:\**
Regulation is hampered if costs fall solely on the public purse or are
distributed unfairly.
**Solution(s):\**
Set transparent rules for levying fees for approvals, surveillance, or
market controls.
**Reference(s):\**
Title II Chapter VI and Article 138(4), Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, p. 1–142;
Article 111, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;\
Article 15, Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
-
## **Measures targeting Company Groups**
**Regulatory Function:\**
Efficiency of Enforcement, Risk Reduction
**Problem:\**
Deficiencies and risks are often spreading over several companies
belonging to the same group (covering at least all mother, daughter or
sister companies).
**Solution(s):\**
Introduce empowerments to act against an entire company group on the
basis of a presumed non-compliance or risk.
**Reference(s):\**
Articles 10, 11, 14, 16 and 17 and Title IV, Directive (EU)
[2025/1](https://eur-lex.europa.eu/eli/dir/2025/1/oj/eng)
(Recovery and Resolution of Insurances), OJ L, 2025/1, 8.1.2025.
**Note(s):\**
If there was a full proof of non-compliance or risk, this specific
empowerment would not be needed. See in particular the complex joint
decision-making mechanism in Title IV.
## **Precise Delegation for Enforcement Powers**
**Regulatory Function:\**
Strengthening Enforcement and institutional balancing
**Problem:\**
Vague or excessive delegation may bypass checks and balances.
**Solution(s):\**
Explicitly define what may / may not be delegated, with limits and
procedures for subdelegation.
**Reference(s):\**
Articles 15(6), 18(10), 19(4), 20(4), 21(7), 22(4), 24(5), 26(1) and (4)
and Title II Chapter III, Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142.
**Note(s):\**
-
## **Joint Multidisciplinary Inspections**
**Regulatory Function:\**
Burden Reduction and Efficiency
**Problem:\**
Multiple Inspections create more burden and detect less
non-conformities.
**Solution(s):\**
Permit (and thereby encourage) or mandate joint multidisciplinary
inspections.
**Reference(s):\**
Article 47, Regulation (EU) No
[952/2013](https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013R0952)
(Union Customs Code), OJ L 269, 10.10.2013, p. 1;
Article 9(1), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
-
## **Criteria for Selection of Enforcement or Sanctions**
**Regulatory Function:\**
Fairness and Effectiveness of Enforcement and Sanctions
**Problem:\**
Authorities do not necessarily select fair and effective enforcement
measures or sanctions.
**Solution(s):\**
List criteria for the selection of measures.
**Reference(s):\**
Article 32(7), Directive (EU)
[2022/2555](https://eur-lex.europa.eu/eli/dir/2022/2555/oj)
(Cyber Security), OJ L 333, 27.12.2022, p. 80–152.
**Note(s):\**
See also the entry “Penalty Regime with Proportionality and Discretion”
below.
## **Sanctions for Failure to Cooperate with Authorities**
**Regulatory Function:\**
Enforcement and Deterrence
**Problem:\**
Operators concerned, but also their partners, clients and employees may
simply refuse to cooperate with market surveillance or investigation.
**Solution(s):\**
Express penalties for non-cooperation, especially where information or
access is legally required.
**Reference(s):\**
Article 59(1)(b), Directive (EU)
[2015/849](https://eur-lex.europa.eu/eli/dir/2015/849/oj/eng)
(Terrorism and Money-Laundering), OJ L 141, 5.6.2015, S. 73-117;
Article 23(1)(a), Council Regulation (EC) [No
1/2003](https://eur-lex.europa.eu/eli/reg/2003/1/oj/eng) (Rules on
Competition), OJ L 1, 4.1.2003, S. 1-25.
**Note(s):\**
-
## **Power to Define Methods for Calculating Fines**
**Regulatory Function:\**
Legal Certainty and Predictability for Penalties
**Problem:\**
Arbitrary or excessive fines undermine legitimacy and may be challenged.
**Solution(s):\**
Entrust Commission (or national bodies) with establishing harmonised
fine-calculation methods.
**Reference(s):\**
Article 83, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
-
## **Complete Penal System— including Whistleblower and Witness Protection**
**Regulatory Function:\**
Enhancing enforcement, harmonising too diverging penal practices
**Problem:\**
The current default wording in EU law regarding sanctions leads to a
wide variety of national provisions and an even more diverse practice.
The deterring effect of sanctions is undermined by the possibility of
operating from more lenient Member States.
**Solution(s):\**
Establish a complete system of penal and other sanctions, as well as
protection, support and rewards for whistle-blowers and witnesses.
**Reference(s):\**
Directive (EU)
[2024/1203](https://eur-lex.europa.eu/eli/dir/2024/1203/oj/eng)
(Environmental Crime), OJ L, 2024/1203, 30.4.2024 and its Proposal
[COM/2021/851
final](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52021PC0851).
**Note(s):\**
Recent DG JUST proposals follow this excellent example. See also our
“[List of Sanctions and Collateral
Measures](https://www.howtoregulate.org/wp-content/uploads/2025/02/List-Sanctions-Dec-2024.docx.pdf)”.
Regarding the protection of whistle-blowers and witnesses: Directive
(EU)
[2019/1937](https://eur-lex.europa.eu/eli/dir/2019/1937/oj/eng)
contains loopholes. See our “[Cross-sectoral Standard
Provisions](https://www.howtoregulate.org/wp-content/uploads/2024/11/Standard-Provisions-VF.pdf)”,
Sections 68 to 70, and our [articles on whistleblower
protection](https://www.howtoregulate.org/whistleblower-regulations-update/#more-935).
## **Administrative and Collateral Sanction Package**
**Regulatory Function:\**
Enhancing enforcement, harmonising too diverging penal practices
**Problem:\**
The current default wording in EU law regarding sanctions does not
really target legal persons.
**Solution(s):\**
Establish a complete system of administrative and collateral sanctions
that includes, inter alia, the following: public statements on
infringements; administrative fines of at least twice the profit made or
loss avoided; maximum administrative fines of at least X % of the annual
turn-over, including the turn-over of mother or daughter companies;
disgorgement of the profits gained or losses avoided due to the
infringement; withdrawal or suspension of the authorisations; temporary
ban preventing any member of the management body, or any other natural
person who is held responsible for the infringement, from exercising
management functions.
**Reference(s):\**
Article 111, Regulation (EU)
[2023/1114](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1114-20240109)
(Crypto Assets), OJ L 150, 9.6.2023, p. 40–178.
**Note(s):\**
See also our much more complete “[List of Sanctions and Collateral
Measures](https://www.howtoregulate.org/wp-content/uploads/2025/02/List-Sanctions-Dec-2024.docx.pdf)”.
## **Penalty Regime with Proportionality and Discretion**
**Regulatory Function:\**
Effective Deterrence
**Problem:\**
Unreasonably harsh or fixed penalties can discourage compliance or
distort competition.
**Solution(s):\**
Set criteria for the proportionality of fines/sanctions, possibly with
escalation scales.
**Reference(s):\**
Directive (EU)
[2024/1203](https://eur-lex.europa.eu/eli/dir/2024/1203/oj/eng)
(Environmental Crime), OJ L, 2024/1203, 30.4.2024;
Article 83, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
-
## **Precise Catalog of Infringements**
**Regulatory Function:\**
Legal Certainty and Fairness
**Problem:\**
In practice, it is often disputed whether a certain behaviour
constitutes an infringement or not.
**Solution(s):\**
Precise catalog defining infringements.
**Reference(s):\**
Annex X, Proposal for a European Space Act, [COM(2025)
335](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025PC0335)
final.
**Note(s):\**
-
## **Ban on Double Penalties by different Member States**
**Regulatory Function:\**
Legal Certainty and Fairness
**Problem:\**
Operators risk cumulative sanctions in multiple Member States for the
same factual breach.
**Solution(s):\**
Legal protection against double sanctions (“ne bis in idem”) for
single-subject enforcement.
**Reference(s):\**
Article 50, [Charter of Fundamental Rights of the
EU](https://www.europarl.europa.eu/charter/pdf/text_en.pdf), OJ C
326, 26.10.2012, p. 391–407;
Article 56, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88 (One-Stop-Shop, applies
also to sanctions);\
Article 25(2)(c), [Regulation (EU) No
596/2014](https://eur-lex.europa.eu/eli/reg/2014/596/oj/eng) (Market
Abuse), OJ L 173, 12.6.2014, S. 1-61.
**Note(s):\**
None of the references is a perfect match. The second comes closest.
**See also our “[List of Powers and
Obligations](https://www.howtoregulate.org/wp-content/uploads/2025/02/List-Powers-Obligations-Dec-2024.docx.pdf)”
with several hundred empowerments useful for enforcement and the
parallel “[List of Sanctions and Collateral
Measures](https://www.howtoregulate.org/wp-content/uploads/2025/02/List-Sanctions-Dec-2024.docx.pdf)”.**
# L. Third-Party Enforcement Assistance
## **Right to Comment in Procedures and Public Registers**
**Regulatory Function:\**
Transparency and Broad Information Base
**Problem:\**
Public procedures and public registers may have a sub-optimal
information base.
**Solution(s):\**
Right to comment, reply, annotate, or supply evidence to procedures and
entries in official registers.
**Reference(s):\**
Articles 9 to 12, Regulation
[1367/2006](https://eur-lex.europa.eu/eli/reg/2006/1367/oj/eng)
(Aarhus Convention), OJ L 264, 25.9.2006, S. 13-19;
Article 34, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, pp. 1–51;
Have-your-say-portal of the European Commission.
**Note(s):\**
-
\
-
## **Public Complaint and Whistleblower Mechanisms**
**Regulatory Function:\**
Integrity of Enforcement and Compliance
**Problem:\**
Regulators may miss breaches without inside or third-party reporting
systems.
**Solution(s):\**
Impose robust complaint procedures and protect/reporting structures
(including whistleblower protection).
**Reference(s):\**
Chapter III, Directive (EU)
[2019/1937](https://eur-lex.europa.eu/eli/dir/2019/1937/oj/eng)
(Whistleblowing Directive), OJ L 305, 26.11.2019, p. 17–56;
Article 67, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016;\
Article 63, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
Directive (EU)
[2019/1937](https://eur-lex.europa.eu/eli/dir/2019/1937/oj/eng)
contains loopholes. See our “[Cross-sectoral Standard
Provisions](https://www.howtoregulate.org/wp-content/uploads/2024/11/Standard-Provisions-VF.pdf)”,
Sections 68 to 70, and our [articles on whistleblower
protection](https://www.howtoregulate.org/whistleblower-regulations-update/#more-935).
## **Protection of Informants / Whistleblowers / Witnesses**
**Regulatory Function:\**
Integrity and Detection
**Problem:\**
Potential informants and witnesses fear retribution, limiting the
detection of wrongdoing.
**Solution(s):\**
Comprehensive sectoral and cross-sectoral whistleblower and witness
protection statutes.
**Reference(s):\**
Directive (EU)
[2019/1937](https://eur-lex.europa.eu/eli/dir/2019/1937/oj/eng)
(Whistleblower Protection), OJ L 305, 26.11.2019, p. 17–56.
**Note(s):\**
Directive (EU)
[2019/1937](https://eur-lex.europa.eu/eli/dir/2019/1937/oj/eng)
contains loopholes. See our “[Cross-sectoral Standard
Provisions](https://www.howtoregulate.org/wp-content/uploads/2024/11/Standard-Provisions-VF.pdf)”,
Sections 68 to 70, and our [articles on whistleblower
protection](https://www.howtoregulate.org/whistleblower-regulations-update/#more-935).
## **EU Complaint Portal with Re-routing**
**Regulatory Function:\**
Streamlined Market Intelligence and Redress
**Problem:\**
Fragmented complaints handling creates blind spots for enforcement.
**Solution(s):\**
Establish an EU-level portal for complaints, with automated routing to
responsible national authorities—except when the complaint concerns that
authority.
**Reference(s):\**
Article 63, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Right—and Obligation (in Serious Risk)—to Inform Authorities on Infringements by Others**
**Regulatory Function:\**
Peer-Controlled Market Supervision
**Problem:\**
Operators may have knowledge of competitor wrongdoing, but no route or
obligation to notify.
**Solution(s):\**
Right for operators to inform authorities on presumed infringements by
others, and mandatory duty to do so when serious risks are identified.
**Reference(s):\**
Article 20(6), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Actors to Inform on Suspected Criminal Acts**
**Regulatory Function:\**
Preventing and Countering Criminality
**Problem:\**
Authorities rarely become aware of criminal acts.
**Solution(s):\**
Oblige (economic) actors to report on suspected criminal acts.
**Reference(s):\**
Article 18, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102.
**Note(s):\**
Can be extended to severe non-conformities. However, when extended to
all non-conformities, the authorities might obtain too many notices.
## **Trusted Flaggers to Inform on Suspected Non-conformities / Filtering Non-compliance Notices**
**Regulatory Function:\**
Preventing and Countering Non-conformities
**Problem:\**
Authorities rarely become aware of non-conformities, but risk becoming
flooded with low-quality notices if anybody was to report.
**Solution(s):\**
Establish a Trusted Flaggers system in which the Trusted Flaggers filter
the notices coming from non-experts.
**Reference(s):\**
Article 22, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102.
**Note(s):\**
-
\
-
## **Third-Party Rights (Standing) in Regulatory Appeals**
**Regulatory Function:\**
Access to Justice and Better Enforcement
**Problem:\**
Only directly regulated companies often have formal standing in
regulatory challenges and at court, whilst authorities do not have the
administrative capacities to address all non-compliances.
**Solution(s):\**
Legally enable broader third-party participation (competitors, NGOs,
affected parties) in appeals and reviews. Authorise third-parties to sue
non-compliant actors at court for injunction, repair and compensation.
**Reference(s):\**
Article 11, Directive
[2011/92/EU](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32011L0092)
(Environmental Impact Assessment), OJ L 26, 28.1.2012, p. 1–21;
Article 80, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016.
**Note(s):\**
-
## **Invalidity Clauses for Contravening Private Acts**
**Regulatory Function:\**
Opens access to private law courts, indirectly supporting enforcement
**Problem:\**
Rules/decisions adopted in breach of the applicable Regulation/Directive
could otherwise cause confusion.
**Solution(s):\**
Legal provision annulling actions taken in breach (e.g., without
procedure or out-of-scope).
**Reference(s):\**
Article 25, Directive
[2011/83/EU](https://eur-lex.europa.eu/eli/dir/2011/83/oj/eng)
(Consumer Rights), OJ L 304, 22.11.2011, S. 64-88.
**Note(s):\**
-
##
**See also the first entry of the next Section M.**
# M. Dispute Resolution and Appeals
## **Third Party Standing and Representation Rules**
**Regulatory Function:\**
Access to Justice, Access to Procedures
**Problem:\**
Public authorities lack resources for enforcement. Individuals may be
unable to enforce rights where collective action is essential.
**Solution(s):\**
Define which organisations/groups can represent the public interest or
claimants collectively in court or administrative procedures. Permit and
encourage private natural and legal persons to use administrative and
court procedures to counter infringements of the law.
**Reference(s):\**
Articles 9 to 12, Regulation
[1367/2006](https://eur-lex.europa.eu/eli/reg/2006/1367/oj/eng)
(Aarhus Convention), OJ L 264, 25.9.2006, S. 13-19;
Article 4, Directive (EU) 2020/1828 (Collective Interests of Consumers),
OJ L 409, 4.12.2020, p. 1–27.
**Note(s):\**
-
\
-
## **Transparency regarding Appeals**
**Regulatory Function:\**
Access to Justice
**Problem:\**
Individuals and NGOs cannot contribute to appeals when they are not
aware of them.
**Solution(s):\**
Institutions and bodies to publish all requests for internal reviews or
appeals, and final decisions online.
**Reference(s):\**
Article 11a, Regulation
[1367/2006](https://eur-lex.europa.eu/eli/reg/2006/1367/oj/eng)
(Aarhus Convention), OJ L 264, 25.9.2006, S. 13-19.
**Note(s):\**
-
## **Right to be Heard prior to Adverse Decisions**
**Regulatory Function:\**
Procedural Rights and Good Administration
**Problem:\**
Operators should be able to present their case and defend themselves
before sanctions or adverse decisions.
**Solution(s):\**
Oblige authorities to hear affected parties and provide reasons for
decisions.
**Reference(s):\**
Article 41, [Charter of Fundamental Rights of the European
Union](https://www.europarl.europa.eu/charter/pdf/text_en.pdf), OJ C
326, 26.10.2012, p. 391–407;
Article 18(3), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
-
## **Central Oversight or Appeals Bodies**
**Regulatory Function:\**
Consistency and Judicial Review
**Problem:\**
Decisions by notified/accredited bodies or national authorities may be
inconsistent or challenged as arbitrary.
**Solution(s):\**
Set up EU-level or cross-country appeals/oversight bodies.
**Reference(s):**\
The “[Board of
Appeal](https://www.eba.europa.eu/about-us/organisation-and-governance/governance-structure-and-decision-making/joint-board-appeal)”,
a joint body of the European Banking Authority (EBA), the European
Insurance and Occupational Pensions Authority (EIOPA) and the European
Securities and Markets Authority (ESMA), collectively known as the three
European Supervisory Authorities (ESAs).
**Note(s):\**
-
\
-
## **Ex ante Judicial Approval**
**Regulatory Function:\**
Legal Protection, Reliability and Stability of Decisions
**Problem:\**
Administrative decisions are often reversed by later judicial decisions.
This creates important damage and reduces trust in the state’s action.
**Solution(s):\**
Permit or mandate ex ante judicial approval.
**Reference(s):\**
Article 67(1), Directive (EU)
[2025/1](https://eur-lex.europa.eu/eli/dir/2025/1/oj/eng)
(Recovery and Resolution of Insurances), OJ L, 2025/1, 8.1.2025.
**Note(s):\**
-
## **Reverse Burden of Proof**
**Regulatory Function:\**
Effective Redress
**Problem:\**
Injured parties struggle to prove complex or hidden harms.
**Solution(s):\**
Statutory presumption of liability/reversing burden where required for
justice (e.g., product liability).
**Reference(s):\**
Article 10, Directive (EU)
[2024/2853](https://eur-lex.europa.eu/eli/dir/2024/2853/oj/eng)
(Product Liability), OJ L, 2024/2853, 18.11.2024.
**Note(s):\**
-
## **Victim/Complainant Assistance Provisions**
**Regulatory Function:\**
Access to Redress
**Problem:\**
Users, consumers, or affected parties struggle to pursue claims or
protections in complex sectors.
**Solution(s):\**
Require authorities or market actors to provide independent helpdesks,
legal support, or compensation schemes.
**Reference(s):\**
Article 14, Directive
[2013/11/EU](https://eur-lex.europa.eu/eli/dir/2013/11/oj/eng)
(Alternative Dispute Resolution for Consumers), OJ L 165, 18.6.2013, p.
63–79;
Articles 10 and 12, Directive (EU)
[2020/1828](https://eur-lex.europa.eu/eli/dir/2020/1828/oj/eng)
(Collective Redress), OJ L 409, 4.12.2020, p. 1–27.
**Note(s):\**
-
**Representation of Victims/Claimants by NGOs**
**Regulatory Function:\**
Protection of Rights
**Problem:\**
Individuals have difficulties in defending their rights, whilst lawyers
are expensive.
**Solution(s):\**
Allow legal representation by non-profit organisations.
**Reference(s):\**
Article 101, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
**Note(s):\**
-
## **Alternative Dispute Resolution (ADR) Pathways**
**Regulatory Function:\**
Efficient Resolution of Market and Consumer Disputes
**Problem:\**
Judicial litigation is lengthy and costly for SMEs and end users.
**Solution(s):\**
Commission or Member States mandate, facilitate, or operate
ADR/mediation as an option or obligation prior to judicial litigation.
**Reference(s):\**
Directive
[2013/11/EU](https://eur-lex.europa.eu/eli/dir/2013/11/oj/eng)
(Alternative Dispute Resolution for Consumers), OJ L 165, 18.6.2013, p.
63–79;\
Regulation (EU)
[524/2013](https://eur-lex.europa.eu/eli/reg/2013/524/oj/eng)
(Online Dispute Resolution for Consumers), OJ L 165, 18.6.2013, p. 1–12;
Article 21, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102.
**Note(s):\**
-
# N. Data, Information and Artificial Intelligence
## **Access to Own File within Administration**
**Regulatory Function:\**
Transparency and Fairness
**Problem:\**
During investigations and the preparation of authority measures, persons
concerned are mostly left in the dark. Hence they cannot properly defend
themselves. Moreover, they cannot provide crucial information that would
probably even stop the investigation or the preparation of authority
measures. This leads to a waste of resources on the side of the
authority.
**Solution(s):\**
Mandatory release of investigative files on request, with protection of
the identity of informants.
**Reference(s):\**
Article 5, Regulation (EU)
[2025/1355](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32025R1355)
(Systemically Important Payment Systems), OJ L, 2025/1355.
**Note(s):\**
Not appropriate for all sectors or matters. Beware of the repercussions
on the informants.
\
-
## **Open Data and Access to Public Sector Information**
**Regulatory Function:\**
Transparency and Reusability
**Problem:\**
Restrictive or paywalled access to public data stifles innovation and
accountability.
**Solution(s):\**
Mandatory proactive release of public sector data and digital
accessibility under open licences.
**Reference(s):\**
Directive (EU)
[2019/1024](https://eur-lex.europa.eu/eli/dir/2019/1024/oj/eng)
(Open Data), OJ L 172, 26.6.2019, p. 56–83.
**Note(s):\**
-
## **Retention and Deletion of Data**
**Regulatory Function:\**
Privacy and Data Protection
**Problem:\**
Unrestricted retention increases risks to privacy and unnecessary
regulatory burden.
**Solution(s):\**
Specify strict rules for the periods for which data may/must be retained
and when it must be deleted.
**Reference(s):\**
Articles 5(1)(b) and (e) and 17, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;
Article 20(4), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Right to Correct Data in Official Databases**
**Regulatory Function:\**
Accuracy, Correction, and Fairness
**Problem:\**
Inaccurate database entries can cause market exclusion or legal issues.
**Solution(s):\**
Statutory right of concerned operators to correct or contest official
regulatory database entries.
**Reference(s):\**
Articles 5(1)(c) and (d) and 16, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88.
**Note(s):\**
For further rights of individuals regarding data, see Chapter II Section
1, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
## **Data Portability and Interoperability**
**Regulatory Function:\**
Switching, Competition, and User Rights in Digital Markets
**Problem:\**
Closed systems lock users into providers and hamper competition.
**Solution(s):\**
Legal right to receive and transfer data between systems, and mandates
for technical interoperability.
**Reference(s):\**
Article 20, Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;\
Articles 4 and 6, Regulation (EU)
[2018/1807](https://eur-lex.europa.eu/eli/reg/2018/1807/oj/eng)
(Free Flow of Non-personal Data), OJ L 303, 28.11.2018, p. 59–68.
**Note(s):\**
For further rights of individuals regarding data, see Chapter II Section
1, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
## **Transparency Requirements for Algorithmic Systems**
**Regulatory Function:\**
Accountability in Automated Decision-Making
**Problem:\**
Algorithms create risks of bias, error, or unfairness whilst the use of
algorithms is often even not known.
**Solution(s):\**
Mandate clear disclosure of (1) use of automated systems and (2)
automated systems’ logic, criteria, and operation, especially where
affecting rights or access to services.
**Reference(s):\**
Articles 13(2)(f), 14(2)(g), Regulation (EU)
[2016/679](https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng)
(Data Protection), OJ L 119, 4.5.2016, p. 1–88;\
Article 13, Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 12.7.2024, p. 1–225.
**Note(s):\**
-
## **Right to Human Review of Automated Decisions**
**Regulatory Function:\**
Redress for Individuals
**Problem:\**
Automated rejection or profiling can harm individuals without
transparency or recourse.
**Solution(s):\**
Require clear explanation and avenue for human review of significant
automated decisions.
**Reference(s):\**
Article 14, in particular (4)(d), Regulation (EU)
[2024/1689](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng)
(Artificial Intelligence), OJ L, 2024/1689, 12.7.2024.
**Note(s):\**
-
## **Prohibition of “Dark Patterns” in Digital Interfaces**
**Regulatory Function:\**
Upholding Fairness in Digital Markets
**Problem:\**
Manipulative digital design tricks (“dark patterns”) undermine user
autonomy and trust.
**Solution(s):\**
Statutory prohibition and definition, with monitoring duties for
platforms.
**Reference(s):\**
Articles 25-27, Regulation (EU)
[2022/2065](https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng)
(Digital Services), OJ L 277, 27.10.2022, p. 1–102.
**Note(s):\**
-
## **Protection of “Know-How” and Trade Secrets**
**Regulatory Function:\**
Commercial Confidentiality
**Problem:\**
Assessment procedures may force companies to reveal confidential
innovation or trade secrets.
**Solution(s):\**
Mandatory protections and secure handling arrangements for confidential
business information during regulatory assessment and publication.
**Reference(s):\**
Article 32(2)(b), Annex VI Section 1, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Directive (EU)
[2016/943](https://eur-lex.europa.eu/eli/dir/2016/943/oj/eng)
(Trade Secrets), OJ L 157, 15.6.2016, p. 1–18.
**Note(s):\**
-
**For other aspects regarding data, please check the quite progressive
and comprehensive Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.**
# O. Emergencies
## **Power for Emergency/Provisional Measures**
**Regulatory Function:\**
Risk Management and Crisis Response
**Problem:\**
Standard procedures are too slow for urgent threats, and powers not
necessarily sufficient.
**Solution(s):\**
Allow the European Commission and/or other authorities to set emergency,
time-limited measures, also with regard to legal requirements.
**Reference(s):\**
Articles 85 to 88, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Rapid Regulatory Adaptation via Emergency / Temporary Delegated Acts**
**Regulatory Function:\**
Short-term, Targeted Crisis Response
**Problem:\**
Full legislative revision is too slow to address fast-moving emergencies
or innovation shocks.
**Solution(s):\**
Commission empowered to adopt temporary or emergency delegated acts
subject to review/expiry.
**Reference(s):\**
Article 13, Regulation (EU)
[2021/953](https://eur-lex.europa.eu/eli/reg/2021/953/oj/eng)
(Digital COVID Certificate), OJ L 211, 15.6.2021, p. 1–22.
**Note(s):\**
-
## **Periodic Disaster Risk Assessment, Exercise or Audit**
**Regulatory Function:\**
Preparedness and Resilience
**Problem:\**
Crisis laws are untested until a real event, risking failure.
**Solution(s):\**
Require risk assessments, simulation exercises or external audits of
emergency regulatory and coordination procedures.
**Reference(s):\**
Article 12, Directive (EU)
[2022/2557](https://eur-lex.europa.eu/eli/dir/2022/2557/oj/eng)
(Resilience of Critical Entities), OJ L 333, 27.12.2022, p. 164–197;
Article 8, Regulation (EU)
[2022/2371](https://eur-lex.europa.eu/eli/reg/2022/2371/oj/eng)
(Health Threats), OJ L 320, 22.12.2022, p. 1–86.
**Note(s):\**
-
## **Temporary Legal Derogation During Crisis**
**Regulatory Function:\**
Flexible Market Stability Management
**Problem:\**
Sudden supply chain or health crises require extraordinary regulatory
steps.
**Solution(s):\**
Time-limited derogations for essential goods/services, subject to
reporting and review.
**Reference(s):\**
Articles 12 and 25, Regulation (EU)
[2022/2371](https://eur-lex.europa.eu/eli/reg/2022/2371/oj/eng)
(Health Threats), OJ L 320, 22.12.2022, p. 1–86.
Article 1a, [Council Mandate for
Negotiations](https://data.consilium.europa.eu/doc/document/ST-9285-2025-INIT/en/pdf)
regarding the proposed Regulation on Medicinal Products for Human Use.
**Note(s):\**
-
## **Safeguard Regimes for “Critical” Infrastructure, Institutions, Enterprises or other Actors**
**Regulatory Function:\**
Resilience and Special Risk Mitigation
**Problem:\**
Generic rules may not address risks/vulnerabilities for critical
infrastructure.
**Solution(s):\**
Dedicated safeguard regimes, with enhanced obligations, oversight, and
reporting.
**Reference(s):\**
Directive (EU)
[2022/2557](https://eur-lex.europa.eu/eli/dir/2022/2557/oj/eng)
(Resilience of Critical Entities), OJ L 333, 27.12.2022, p. 164–197.
**Note(s):\**
-
##
##
# P. Financial Implementation and General Planning
## **Imposing Regional Cooperation**
**Regulatory Function:\**
Increasing Efficiency
**Problem:\**
Member States planning on their own without consulting their neighbors
miss efficiency opportunities.
**Solution(s):\**
Mandate regional cooperation of Member States.
**Reference(s):\**
Article 12, Regulation (EU)
[2018/1999](https://eur-lex.europa.eu/eli/reg/2018/1999/oj)
(Energy Union Governance), OJ L 328, 21.12.2018, p. 1–77.
**Note(s):\**
-
## **Multiannual Programming/Planning Obligations (e.g., in Funding or Implementation)**
**Regulatory Function:\**
Stability and Predictability
**Problem:\**
Stop-start annual planning undermines longer-term regulatory, funding,
or supply stability.
**Solution(s):\**
Mandate multiannual implementation and funding plans, with review/update
requirements.
**Reference(s):\**
Article 3, Regulation (EU)
[2018/1999](https://eur-lex.europa.eu/eli/reg/2018/1999/oj)
(Energy Union Governance), OJ L 328, 21.12.2018, p. 1–77;
Title V (Articles 109 to 115), Regulation (EU)
[2017/625](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0625-20250105)
(Food and Feed Controls), OJ L 95, 7.4.2017, pp. 1–142.
**Note(s):\**
-
## **Mandatory Financing by Commission**
**Regulatory Function:\**
Ensuring Efficiency of the Law, namely with regard to Implementation
**Problem:\**
Financial resources are scarce. The implementation of regulation suffers
from insufficient financial means on the side of the Commission.
**Solution(s):\**
Mandate the financing of certain activities.
**Reference(s):\**
Article 41(1), Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131;\
Article 36 (1), (3) and (4), Regulation (EU)
[2019/1020](https://eur-lex.europa.eu/eli/reg/2019/1020/oj/eng)
(Market Surveillance), OJ L 169, 25.6.2019, p. 1–44.
**Note(s):\**
Reinforces the position of the respective Commission Directorate General
in the annual budget negotiations. Might be legally problematic to the
extent that it aims at binding the future budget legislator.
## **Combination of Funding: Compatibility and Collision**
**Regulatory Function:\**
Legal Certainty and Efficiency
**Problem:\**
Various funding sources, including EU funding sources, might be suitable
for the same activity.
**Solution(s):\**
Set out compatibility or collision rules and rules avoiding the double
coverage of identical costs.
**Reference(s):\**
Article 15, Regulation (EU)
[2021/695](https://eur-lex.europa.eu/eli/reg/2021/695/oj/eng)
(Horizon Europe), OJ L 170, 12.5.2021, p. 1–68.
**Note(s):\**
-
\
-
## **Joint Procurement or Buying Schemes**
**Regulatory Function:\**
Leveraging Scale, Reducing Prices and Ensuring Availability
**Problem:\**
Crisis or specialised markets benefit from aggregated purchasing power.
**Solution(s):\**
Enable EU/joint Member State procurement, including legal structure and
allocation of goods/services.
**Reference(s):\**
Article 12, Regulation (EU)
[2022/2371](https://eur-lex.europa.eu/eli/reg/2022/2371/oj/eng)
(Health Threats), OJ L 320, 22.12.2022, p. 1–86.
**Note(s):\**
-
## **Procurement Rules Integrating Product Compliance**
**Regulatory Function:\**
Compliance
**Problem:\**
Non-compliant products could be purchased with public money if
procurement rules don’t check regulatory compliance.
**Solution(s):\**
Procurement authorities must verify and ensure that only compliant
products (and economic operators) are considered.
**Reference(s):\**
Article 83, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Article 85, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
**Note(s):\**
-
## **Procurement Rules Furthering Political Goals**
**Regulatory Function:\**
Making Procurement a Political Means
**Problem:\**
Non-compliant products could be purchased with public money if
procurement rules don’t check regulatory compliance.
**Solution(s):\**
Permit or mandate that sector specific procurement rules require a
higher level than the legal minimum.
**Reference(s):\**
Article 50(5)-(7), Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40.
**Note(s):\**
-
**For other aspects regarding the financial implementation of EU law and
also as reference for regulations setting out financing programs, we
recommend Regulation (EU)
[2021/695](https://eur-lex.europa.eu/eli/reg/2021/695/oj/eng)
(Horizon Europe), OJ L 170, 12.5.2021, p. 1–68; of course to be read
with the generic Financial Regulations: Regulation (EU, Euratom)
[2018/1046](https://eur-lex.europa.eu/eli/reg/2018/1046/oj/eng),
OJ L 193, 30.7.2018, S. 1-222. Regulation (EU)
[2021/695](https://eur-lex.europa.eu/eli/reg/2021/695/oj/eng)
(Horizon Europe) contains a rich variety of inspiring tools.**
# Q. Final Provisions / Miscellaneous
## **Gradual Phase-in of Regulatory Obligations**
**Regulatory Function:\**
Supporting SMEs and Sectors Undergoing Transition
**Problem:\**
Sudden full entry into force may overwhelm some market actors.
**Solution(s):\**
Stepwise or staged application dates for different categories of
actor/product/type.
**Reference(s):\**
Articles 95 and 96, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;\
Articles 120 and 123, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175.
**Note(s):\**
-
## **COM to decide on Application Date / Fulfilment of Conditions Necessary for Application**
**Regulatory Function:\**
Application dates adapted to reality
**Problem:\**
The application of certain provisions might be subject to certain
conditions that are not yet fulfilled at the time of adoption of the act
adopted by the legislators.
**Solution(s):\**
Let the Commission decide on whether and when the necessary conditions
are fulfilled by a Commission act that triggers the application of the
legislators’ act.
**Reference(s):\**
Article 1 (31)(a), p. 30, Proposal for a Regulation amending Regulations
(EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the
implementation of harmonised rules on artificial intelligence (Digital
Omnibus on AI), [COM(2025)
836](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025PC0836)
final.
**Note(s):\**
-
## **Member States’ Postponement Option**
**Regulatory Function:\**
Balance between Ambitious Goals and Feasibility / Flexibility
**Problem:\**
The same deadlines might not be suitable in all Member States.
**Solution(s):\**
Give Member States a postponement option under control of the
Commission, to avoid abuse.
**Reference(s):\**
Article 52(2) and (3), Regulation (EU)
[2025/40](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng)
(Packaging and Packaging Waste), OJ L, 2025/40, 22.1.2025.
**Note(s):\**
-
## **Transitional Product / Service Approval or “Grandfathering” of Existing Approvals**
**Regulatory Function:\**
Transition Management
**Problem:\**
Existing/legacy products, processes, or certifications may require a
transition path to the new regime.
**Solution(s):\**
Explicit “grandfathering” clauses for licences, certificates, or
products lawfully authorised under prior rules.
**Reference(s):\**
Article 120, Regulation (EU)
[2017/745](https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng)
(Medical Devices), OJ L 117, 5.5.2017, p. 1–175;\
Article 95, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Remedies for Overregulation or Regulatory Overlap**
**Regulatory Function:\**
Regulatory Simplification
**Problem:\**
Layered or competing requirements create legal uncertainty and cost.
**Solution(s):\**
Petition or appeal rights for operators or citizens where cumulative or
conflicting requirements exist.
**Reference(s):\**
Practiced by the European Commission in the framework of its
“[REFIT](https://commission.europa.eu/law/law-making-process/evaluating-and-improving-existing-laws/refit-making-eu-law-simpler-more-efficient-and-future-proof_en)”
program.
**Note(s):\**
Could also be laid down in legislation, with more specific procedures
namely for Implementing and Delegated Acts exempting from cumulative or
conflicting provisions.
## **Expert Consultation**
**Regulatory Function:\**
Expertise for Technically or Legally complicated Regulation
**Problem:\**
Rules adopted without expert knowledge may falter in practice.
**Solution(s):\**
Consultation with defined stakeholder groups or experts before adoption
of rules or delegated acts.
**Reference(s):\**
Article 42, Regulation (EU)
[2018/1725](https://eur-lex.europa.eu/eli/reg/2018/1725/oj/eng)
(Union Data Processing), OJ L 295, 21.11.2018, p. 39–98;\
Article 89(4), Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110;
Article 36(5) and (6), Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
**Note(s):\**
The last reference mandates the consultation of expert groups
established under other regulations.
## **Whole Society Consultation**
**Regulatory Function:\**
Increasing the Knowledge Base, enhancing Engagement
**Problem:\**
Important change processes require the involvement of the whose society,
not just of administrations and certain stakeholders.
**Solution(s):\**
Consultation mechanism covering the entire society.
**Reference(s):\**
Articles 10 and 11, Regulation (EU)
[2018/1999](https://eur-lex.europa.eu/eli/reg/2018/1999/oj)
(Energy Union Governance), OJ L 328, 21.12.2018, p. 1–77;\
Article 9, Regulation (EU)
[2021/1119](https://eur-lex.europa.eu/eli/reg/2021/1119/oj/eng)
(European Climate Law), OJ L 243, 9.7.2021, p. 1–17.
**Note(s):\**
-
## **Stakeholder Forum**
**Regulatory Function:\**
Increasing the Knowledge Base, enhancing Engagement
**Problem:\**
Important change processes and good implementation require the
involvement of stakeholders.
**Solution(s):\**
Create a forum for stakeholders.
**Reference(s):\**
Article 93, Regulation (EU)
[2025/327](https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng)
(European Health Data Space), OJ L, 2025/327, 5.3.2025.
**Note(s):\**
-
\
-
## **Impact and Progress Assessment or Reporting**
**Regulatory Function:\**
Evidence-Based and Sustainable Law Making and Implementation
**Problem:\**
Lack of robust analysis can yield counterproductive or unsustainable
regulation or other measures.
**Solution(s):\**
Require integrated progress reports and impact assessments (including
social, environmental, digital, and fundamental rights dimensions) by
secondary law.
**Reference(s):\**
Article 18, Directive (EU)
[2019/1024](https://eur-lex.europa.eu/eli/dir/2019/1024/oj/eng)
(Open Data), OJ L 172, 26.6.2019, p. 56–83;\
Articles 140-142, Regulation (EU)
[2023/1114](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023R1114-20240109)
(Crypto Assets), OJ L 150, 9.6.2023, p. 40–178;
Article 29, Regulation (EU)
[2018/1999](https://eur-lex.europa.eu/eli/reg/2018/1999/oj)
(Energy Union Governance), OJ L 328, 21.12.2018, p. 1–77.
**Note(s):\**
High administrative burden, absorbing scarce human resources. Preferable
with precise metrics / performance indicators.
## **Joint Programming and Co-Regulatory Roadmapping with Stakeholders / Industry**
**Regulatory Function:\**
Forward-Looking Policy Coordination
**Problem:\**
Regulators and industry often work on different time-frames and with
misaligned expectations.
**Solution(s):\**
Mandate public joint programming/roadmapping exercises on mid- and
long-term regulatory needs.
**Reference(s):\**
Article 10 and, to some extent, Article 6(6), Regulation (EU)
[2021/695](https://eur-lex.europa.eu/eli/reg/2021/695/oj/eng)
(Horizon Europe), OJ L 170, 12.5.2021, p. 1–68;
Article 4, Regulation (EU)
[2024/3110](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng)
(Construction Products), OJ L 2024/3110.
**Note(s):\**
-
## **Binding Sectoral Roadmaps/Action Plans**
**Regulatory Function:\**
Structured Forward-Looking Policymaking
**Problem:\**
Sectoral reform intentions may not bind unless legally formalised.
**Solution(s):\**
Mandate public, revisable, and enforceable sectoral roadmaps with clear
reporting.
**Reference(s):\**
Article 4, Regulation (EU)
[2021/1119](https://eur-lex.europa.eu/eli/reg/2021/1119/oj/eng)
(European Climate Law), OJ L 243, 9.7.2021, p. 1–17.
**Note(s):\**
Climate, energy, and digital transition sectors currently leading.
## **Voluntary Agreements on Top of Law**
**Regulatory Function:\**
Furthering Policy Goals
**Problem:\**
Pursuing all policy goals by legislation is not always possible or
appropriate.
**Solution(s):\**
Establish a two-tiered system, with one tier laid down in legislation
and a second pursued by voluntary agreements.
**Reference(s):\**
Article 38, Regulation (EU)
[2023/988](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng)
(General Product Safety), OJ L 135, 23.5.2023, p. 1–131.
**Note(s):\**
-
## **Regulatory Correction Following CJEU/ECJ Rulings**
**Regulatory Function:\**
Alignment with EU Law
**Problem:\**
Declared invalid or misapplied rules may linger and be enforced contrary
to Court rulings.
**Solution(s):\**
Statutory obligations to withdraw, amend, or invalidate rules
post-judgment automatically.
**Reference(s):\**
Article 266 Treaty on the Functioning of the European Union
([TFEU](https://eur-lex.europa.eu/eli/treaty/tfeu_2012/oj/eng)),
OJ C 202, 7.6.2016, p. 47-199.
**Note(s):\**
Rules in secondary legislation should not duplicate Article 266
[TFEU](https://eur-lex.europa.eu/eli/treaty/tfeu_2012/oj/eng).
However, not all provisions affected by CJEU/ECJ rulings are covered by
Article 266 TFEU. Moreover, rules in secondary legislation may help to
create legal certainty where the applicability of Article 266 TFEU is
not ascertained.
## **Table of Contents**
**Regulatory Function:\**
Better Information of Users, Clarity
**Problem:\**
EU Regulations and Directives are often long and difficult to
understand, structure-wise.
**Solution(s):\**
Create a table of contents, to be placed after the Recitals and before
the enacting terms.
**Reference(s):\**
Council Directive
[2006/112/EC](https://eur-lex.europa.eu/eli/dir/2006/112/oj/eng)
(Value Added Tax), OJ L 347, 11.12.2006, p. 1–118.
**Note(s):\**
Unfortunately rarely used in the EU, whilst common place in many
jurisdictions around the world.
#
# **Further Tools**
If you haven’t found what you were looking for or if you wish further
inspiration, please check our [Cross-sectoral Standard
Provisions](https://www.howtoregulate.org/wp-content/uploads/2024/11/Standard-Provisions-VF.pdf),
our “[List of Powers and
Obligations](https://www.howtoregulate.org/wp-content/uploads/2025/02/List-Powers-Obligations-Dec-2024.docx.pdf)”,
our “[List of Sanctions and Collateral
Measures](https://www.howtoregulate.org/wp-content/uploads/2025/02/List-Sanctions-Dec-2024.docx.pdf)”
and our sector model provisions which also contain many generic
provisions: [Protection of vulnerable persons and persons with
special
needs](https://www.howtoregulate.org/model-provisions-on-the-protection-of-vulnerable-persons-and-persons-with-special-needs/#more-1804);
[Food and drinks
legislation](https://www.howtoregulate.org/model-provisions-for-food-and-drinks-legislation/#more-1836).
For methodological questions regarding the conception of legislation,
including quality control, see our [Handbook ‘How to
Regulate?’](https://www.howtoregulate.org/wp-content/uploads/2024/10/H2R_hanbook_2024.pdf)
and our introductory [Training Video ‘How to
Regulate?’](https://www.howtoregulate.org/our-taining-video-how-to-regulate/).
# **Training and Advice**
For all other questions or issues, advice or custom-made training,
please contact:
[manager@regulatoryinstitute.org](mailto:manager@regulatoryinstitute.org).