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

guidance · European Union · 52022XC0629(04)

1097 provisions in 1826 nodes

Defined terms · All instruments · EU Member State · EU law · European standard · Internet · Product liability · Russia · Ukraine · accounting

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COMMISSION NOTICE

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

(Text with EEA relevance)

1. REGULATING THE FREE MOVEMENT OF GOODS

1.1. A historical perspective

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1.1.1. The ‘Old Approach’

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

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

1.2. The ‘New Legislative Framework’

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1.2.1. The modernisation of market surveillance provisions

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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

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1.2.2.2. Decision No 768/2008/EC

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1.2.3. How the system fits together

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1.3. The General Product Safety Directive

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1.4. The legislation on product liability

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1.5. Scope of the Guide

2. WHEN DOES UNION HARMONISATION LEGISLATION ON PRODUCTS APPLY?

2.1. Product coverage

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The product scope in Union harmonisation legislation

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Repairs and modifications to products

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Software

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2.2. Making available on the market

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2.3. Placing on the market

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

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2.5. Products imported from countries outside the EU

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2.6. Putting into service or use (and installation)

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2.7. Simultaneous application of Union harmonisation acts

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2.8. Reasonably foreseeable and intended use / misuse

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

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2.9.1. Member States and Overseas countries and territories

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2.9.2. EEA EFTA States

2.9.2.1. Basic elements of the Agreement on the European Economic Area

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2.9.2.2. Safeguard clause procedure

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2.9.3. Monaco, San Marino and Andorra

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2.9.4. Turkey

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2.9.5. Withdrawal of the United Kingdom from the EU (81)

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2.9.5.1. Relevant separation provisions

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2.9.5.2. Legal situation as of the end of the transition period

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a) Economic operators

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b) Conformity assessment procedures and notified bodies (87)

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c) Accreditation (89)

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2.9.6. Northern Ireland

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

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2.11. Transitional arrangements for the EU Declaration of Conformity

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2.12. Summary examples

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3. THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS

3.2. Authorised representative

3.5. Fulfilment Service Providers

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3.6. The economic operator referred to in Article 4 of Regulation (EU) 2019/1020 (163)

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

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4.1.2. Conformity with the essential requirements: harmonised standards

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4.1.2.1. Definition of a harmonised standard

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4.1.2.2. Role of harmonised standards

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Flowchart 1

The role of harmonised standards in complying with relevant essential requirements identified by a manufacturer - a generic philosophy for cases where a manufacturer needs to identify relevant essential requirements

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4.1.2.3. The Presumption of conformity

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4.1.2.4. Withdrawal, restriction or prevention of the presumption of conformity

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4.1.2.5. Revision of harmonised standards

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4.1.3. Conformity with the essential requirements: other possibilities

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4.2. Traceability requirements

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4.2.1. Why does Traceability matter?

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4.2.2. Traceability provisions

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4.2.2.1. The requirement to indicate name and address for manufacturers

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4.2.2.2. The requirement to indicate name and address for importers

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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

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4.2.2.4. Possible scenarios

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4.2.2.5. Identification element

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The product consists of several parts/components

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The product consists of one assembled item

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The product consists of one item which has not been assembled of several parts

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4.2.2.6. Identification of economic operators

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4.3. Technical documentation

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4.4. EU declaration of conformity

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4.5. Marking requirements

4.5.1. CE marking

4.5.1.1. Definition and role of the CE marking

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4.5.1.2. Relationship to existing legislation

4.5.1.3. Who must (not) affix the CE marking

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4.5.1.4. Principles of affixing the CE marking

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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

4.5.2. Other mandatory markings

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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

Conformity Assessment

5.1.4. Modules and their variants

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

5.1.6. Modules based on quality assurance

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5.1.7. Overview of modules

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5.1.8. Overview of procedures

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5.1.9. Rationale for selecting the appropriate modules

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5.2. Conformity assessment bodies

5.2.1. Conformity assessment bodies and notified bodies

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5.2.2. Roles and responsibilities

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5.2.3. Competence of notified bodies

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5.2.4. Coordination between notified bodies

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5.2.5. Subcontracting by notified bodies

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5.2.6. Accredited in-house bodies (258)

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5.3. Notification

5.3.1. Notifying authorities

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5.3.2. Notification process

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5.3.2.1. Principles of notification

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5.3.2.2. Assessment of conformity assessment bodies

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5.3.2.3. Accreditation under Regulation (EC) No 765/2008

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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

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5.3.3. Publication by the Commission – the NANDO website

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

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6. ACCREDITATION

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6.1. Why accreditation?

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6.2. What is accreditation?

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6.3. Scope of accreditation

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

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6.4.1. National accreditation bodies

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

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6.5. The European accreditation infrastructure

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6.5.1. Sectoral accreditation schemes

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6.5.2. Peer evaluation

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6.5.3. Presumption of conformity for national accreditation bodies

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

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6.6. Cross-border accreditation

6.7. Accreditation in the international context

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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

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7. MARKET SURVEILLANCE

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7.1. Why do we need market surveillance?

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7.2. Scope of Regulation (EU) 2019/1020

7.3. Organisation of market surveillance

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7.3.1. National infrastructures

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7.3.2. National market surveillance strategies

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7.3.3. Public information

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7.3.4. Sanctions

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7.4. Checks by Market Surveillance authorities

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7.4.1. Market surveillance activities

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7.4.1.1. Requesting compliance documentation

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7.4.2. Market surveillance measures

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7.4.2.1. Process

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7.4.2.2. Different types of non-compliance and actions

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7.5. Control on products from third countries

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7.5.1. Role of border authorities

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7.5.2. Principles of border controls

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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

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7.5.3.2. Decision by market surveillance authorities

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7.5.3.3. Follow-up by border authorities

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7.6. Cooperation among Member States and with the European Commission

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7.6.1. EU-wide action on non-compliance

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7.6.2. The application of the safeguard clause

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7.6.2.1. Compulsory restrictive measure taken

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7.6.2.2. Notification to the Commission and other Member States

7.6.2.3. Management of the safeguard procedures by the Commission

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7.6.2.4. Compliant products presenting a risk

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

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7.6.3.1. Mutual assistance

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7.6.3.2. Administrative cooperation groups

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7.6.3.3. EU Product Compliance Network

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

7.6.6. Medical devices: vigilance system

8. FREE MOVEMENT OF PRODUCTS WITHIN THE EU (317)

8.1. Free movement clause

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8.2. Limits and restrictions

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9. INTERNATIONAL ASPECTS OF THE EU LEGISLATION ON PRODUCTS

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

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9.2. Mutual recognition agreements (MRAs)

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9.2.1. Main characteristics

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9.2.2. EU-Swiss MRA

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

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9.2.4. CETA Protocol on conformity assessment

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9.3. The Trade and Cooperation agreement with the UK

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Note

ANNEX 1

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

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ANNEX 2

Additional guidance documents

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

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Note

ANNEX 5

Frequently Asked Questions on CE marking

What does the CE marking on a product indicate?

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Is a product affixed with the CE marking always produced in the EU?

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Are all CE marked products tested and approved by authorities?

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Can I, as a manufacturer, affix my products with the CE marking myself?

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Where should the CE marking be affixed?

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What is a manufacturer’s Declaration of Conformity?

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Is CE marking mandatory, and if so; for what products?

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What is the difference between the CE marking and other markings, and can other markings be affixed on the product if there is a CE marking?

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Who supervises the correct use of the CE marking?

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What are the sanctions for counterfeiting the CE marking?

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What implications may the affixing of the CE marking have for the manufacturer/importer/distributor?

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Where can I find more information?

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