COMMISSION NOTICE The ‘Blue Guide’ on the implementation of EU product rules 2022 · Lexiara

COMMISSION NOTICE The ‘Blue Guide’ on the implementation of EU product rules 2022

guidance · European Union · 52022XC0629(04)

181 provisions

Defined terms · All instruments

1 REGULATING THE FREE MOVEMENT OF GOODS

1.1 A historical perspective

1.1.1 The ‘Old Approach’

1.1.2 Mutual Recognition and Regulation (EU) 2019/515 on the Mutual Recognition of Goods

1.1.3 The ‘New Approach’ and the ‘Global Approach’

1.2 The ‘New Legislative Framework’

1.2.1 The modernisation of market surveillance provisions

1.2.2 The legal nature of the NLF acts and the Market Surveillance legislation and their relationship to other EU legislation

1.2.2.1 Regulation (EC) No 765/2008 and Regulation (EU) 2019/1020

1.2.2.2 Decision No 768/2008/EC

1.2.3 How the system fits together

1.3 The General Product Safety Directive

1.4 The legislation on product liability

1.5 Scope of the Guide

2 WHEN DOES UNION HARMONISATION LEGISLATION ON PRODUCTS APPLY?

2.1 Product coverage

2.2 Making available on the market

2.3 Placing on the market

2.4 Making available and placing on the market in case of distance and online sales

2.5 Products imported from countries outside the EU

2.6 Putting into service or use (and installation)

2.7 Simultaneous application of Union harmonisation acts

2.8 Reasonably foreseeable and intended use / misuse

2.9 Geographical application (EEA EFTA States, Overseas Countries and Territories (OCTs), Turkey)

2.9.1 Member States and Overseas countries and territories

2.9.2 EEA EFTA States

2.9.2.1 Basic elements of the Agreement on the European Economic Area

2.9.2.2 Safeguard clause procedure

2.9.3 Monaco, San Marino and Andorra

sec_withdrawal_of_the_united_kingdom_from_the_eu Withdrawal of the United Kingdom from the EU

2.9.5.1 Relevant separation provisions

2.9.5.2 Legal situation as of the end of the transition period

2.9.6 Northern Ireland

2.10 Transitional periods in the case of new or revised EU rules

2.11 Transitional arrangements for the EU Declaration of Conformity

2.12 Summary examples

3 THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS

3.1 Manufacturer

3.2 Authorised representative

3.4 Distributor

3.5 Fulfilment Service Providers

sec_the_economic_operator_referred_to_in_article_4_o The economic operator referred to in Article 4 of Regulation (EU) 2019/1020

3.7 Other intermediaries: Intermediary service providers under the E-Commerce Directive

4 PRODUCT REQUIREMENTS

4.1 Essential product requirements

4.1.1 Definition of essential requirements

4.1.2 Conformity with the essential requirements: harmonised standards

4.1.2.1 Definition of a harmonised standard

4.1.2.2 Role of harmonised standards

4.1.2.3 The Presumption of conformity

4.1.2.4 Withdrawal, restriction or prevention of the presumption of conformity

4.1.2.5 Revision of harmonised standards

4.1.3 Conformity with the essential requirements: other possibilities

4.2 Traceability requirements

4.2.1 Why does Traceability matter?

4.2.2 Traceability provisions

4.2.2.1 The requirement to indicate name and address for manufacturers

4.2.2.2 The requirement to indicate name and address for importers

4.2.2.3 The requirement to indicate the name and address of the economic operator referred to in Article 4 of Regulation (EU) 2019/1020

4.2.2.4 Possible scenarios

4.2.2.5 Identification element

4.2.2.6 Identification of economic operators

4.3 Technical documentation

4.4 EU declaration of conformity

4.5 Marking requirements

4.5.1 CE marking

4.5.1.1 Definition and role of the CE marking

4.5.1.2 Relationship to existing legislation

4.5.1.3 Who must (not) affix the CE marking

4.5.1.4 Principles of affixing the CE marking

4.5.1.5 Affixing CE marking together with the identification number of the notified body

4.5.1.6 Which products must (not) be CE marked

4.5.1.7 CE marking and other markings

4.5.1.8 Sanctions

4.5.2 Other mandatory markings

5 CONFORMITY ASSESSMENT

5.1 Modules for conformity assessment

5.1.1 What is a conformity assessment?

5.1.2 The modular structure of conformity assessment in Union harmonisation legislation

5.1.3 Actors in conformity assessment – Positioning of conformity assessment in the supply chain

sec_conformity_assessment Conformity Assessment

5.1.4 Modules and their variants

5.1.5 One- and two-module procedures – Procedures based on type (EU-type examination)

5.1.6 Modules based on quality assurance

5.1.7 Overview of modules

5.1.8 Overview of procedures

5.1.9 Rationale for selecting the appropriate modules

5.2 Conformity assessment bodies

5.2.1 Conformity assessment bodies and notified bodies

5.2.2 Roles and responsibilities

5.2.3 Competence of notified bodies

5.2.4 Coordination between notified bodies

5.2.5 Subcontracting by notified bodies

sec_accredited_in_house_bodies Accredited in-house bodies

5.3 Notification

5.3.1 Notifying authorities

5.3.2 Notification process

5.3.2.1 Principles of notification

5.3.2.2 Assessment of conformity assessment bodies

5.3.2.3 Accreditation under Regulation (EC) No 765/2008

5.3.2.4 Article 5(2) of Regulation (EC) No 765/2008

5.3.2.5 Steps in the notification of a notified body

5.3.3 Publication by the Commission – the NANDO website

5.3.4 Monitoring of the competence of notified bodies – Suspension – withdrawal – appeal

6 ACCREDITATION

6.1 Why accreditation?

6.2 What is accreditation?

6.3 Scope of accreditation

6.4 Accreditation according to Regulation (EC) No 765/2008

6.4.1 National accreditation bodies

6.4.2 Non-competition and non-commerciality of national accreditation bodies

6.5 The European accreditation infrastructure

6.5.1 Sectoral accreditation schemes

6.5.2 Peer evaluation

6.5.3 Presumption of conformity for national accreditation bodies

6.5.4 EA’s role in supporting and harmonising accreditation practice across Europe

6.6 Cross-border accreditation

6.7 Accreditation in the international context

6.7.1 Cooperation between accreditation bodies

6.7.2 The impact on trade relations in the field of conformity assessment between the EU and Third Countries

7 MARKET SURVEILLANCE

7.1 Why do we need market surveillance?

7.2 Scope of Regulation (EU) 2019/1020

7.3 Organisation of market surveillance

7.3.1 National infrastructures

7.3.2 National market surveillance strategies

7.3.3 Public information

7.3.4 Sanctions

7.4 Checks by Market Surveillance authorities

7.4.1 Market surveillance activities

7.4.1.1 Requesting compliance documentation

7.4.2 Market surveillance measures

7.4.2.1 Process

7.4.2.2 Different types of non-compliance and actions

7.5 Control on products from third countries

7.5.1 Role of border authorities

7.5.2 Principles of border controls

7.5.3 Applicable procedures

7.5.3.1 Suspension by border authorities of products suspected to be non-compliant or to present serious risk and notification to market surveillance authorities

7.5.3.2 Decision by market surveillance authorities

7.5.3.3 Follow-up by border authorities

7.6 Cooperation among Member States and with the European Commission

7.6.1 EU-wide action on non-compliance

7.6.2 The application of the safeguard clause

7.6.2.1 Compulsory restrictive measure taken

7.6.2.2 Notification to the Commission and other Member States

7.6.2.3 Management of the safeguard procedures by the Commission

7.6.2.4 Compliant products presenting a risk

7.6.3 Mutual assistance, Administrative Cooperation and the EU product compliance network

7.6.3.1 Mutual assistance

7.6.3.2 Administrative cooperation groups

7.6.3.3 EU Product Compliance Network

7.6.4 Rapid Alert System for non-food products presenting a risk (RAPEX)

7.6.5.2 Structure

7.6.6 Medical devices: vigilance system

sec_free_movement_of_products_within_the_eu FREE MOVEMENT OF PRODUCTS WITHIN THE EU

8.1 Free movement clause

8.2 Limits and restrictions

9 INTERNATIONAL ASPECTS OF THE EU LEGISLATION ON PRODUCTS

9.1 Agreements on Conformity Assessment and Acceptance of industrial products (ACAAs)

9.2 Mutual recognition agreements (MRAs)

9.2.1 Main characteristics

9.2.2 EU-Swiss MRA

9.2.3 EEA EFTA States: Mutual recognition agreements and Agreements on Conformity Assessment and Acceptance

9.2.4 CETA Protocol on conformity assessment

9.3 The Trade and Cooperation agreement with the UK

sec_annex_1 ANNEX 1

sec_eu_legislation_referred_to_in_the_guide_non_exha EU legislation referred to in the Guide (non-exhaustive list)

sec_annex_2 ANNEX 2

sec_additional_guidance_documents Additional guidance documents

sec_annex_3 ANNEX 3

sec_useful_web_addresses Useful web addresses

sec_annex_4 ANNEX 4

sec_conformity_assessment_procedures_modules_from_de Conformity assessment procedures (modules from Decision No 768/2008/EC)

sec_annex_5 ANNEX 5

sec_frequently_asked_questions_on_ce_marking Frequently Asked Questions on CE marking