The 'Blue Guide' on the implementation of EU product rules 2016

The 'Blue Guide' on the implementation of EU product rules 2016

The Guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) was published in 2000. Since then, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the New Legislative Framework.
Much of the 2000 edition of the “Blue Guide” is still valid but it requires updating to cover new developments and to ensure the broadest possible common understanding on implementation of the New Legislative Framework (NLF) for the marketing of products. It is also necessary to take account of the changes introduced by the Lisbon Treaty (in force since 1st December 2009) with regard to the legal references and terminology applicable to EU-related documents, procedures, etc.
This new version of the Guide will therefore build on the past edition, but include new chapters, for example on the obligations of economic operators or accreditation, or completely revised chapters such as those on standardisation or market surveillance. The Guide has also been given a new title reflecting the fact that the New Legislative Framework is likely to be used, at least in part, by all types of Union harmonisation legislation and not only by the so-called “New Approach” directives.

This Guide is intended to contribute to a better understanding of EU product rules and to their more uniform and coherent application across different sectors and throughout the single market. It is addressed to the Member States and others who need to be informed of the provisions designed to ensure the free circulation of products as well as a high level of protection throughout the Union (e.g. trade and consumer associations, standardisation bodies, manufacturers, importers, distributors, conformity assessment bodies and trade unions).

This is intended purely as a guidance document – only the text of the Union harmonisation act itself has legal force. In certain cases, there may be differences between the provisions of a Union harmonisation act and the contents of this Guide, in particular where slightly divergent provisions in the individual Union harmonisation act cannot be fully described in this Guide. The binding interpretation of EU legislation is the exclusive competence of the Court of Justice of the European Union. The views expressed in this Guide cannot prejudge the position that the Commission might take before the Court of Justice. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information.

This Guide applies to the EU Member States but also to Iceland, Liechtenstein and Norway as signatories of the Agreement on the European Economic Area (EEA), as well as Turkey in certain cases. References to the Union or the single market are, accordingly, to be understood as referring to the EEA, or to the EEA market.
As this Guide reflects the state of the art at the time of its drafting, the guidance offered may be subject to later modification1. In particular, more specific reflections are ongoing regarding various aspects of the Union legal framework applicable to online sales and this Guide is without prejudice to any future specific interpretation and guidance which may be developed on those matters.

CONTENT : 

1. REGULATING THE FREE MOVEMENT OF GOODS 6
1.1. A historical perspective 6
1.1.1. The 'Old Approach' 6
1.1.2. Mutual Recognition 7
1.1.3. The 'New Approach' and the 'Global Approach' 7
1.2. The 'New Legislative Framework' 9
1.2.1. The concept 9
1.2.2. The legal nature of the NLF acts and their relationship to other EU legislation 10
1.2.3. How the system fits together 11
1.3. The General Product Safety Directive 11
1.4. The legislation on product liability 12
1.5. Scope of the Guide 13
2. WHEN DOES UNION HARMONISATION LEGISLATION ON PRODUCTS APPLY? 16
2.1. Product coverage 16
2.2. Making available on the market 18
2.3. Placing on the market 19
2.4. Products imported from countries outside the EU 21
2.5. Putting into service or use (and installation) 21
2.6. Simultaneous application of Union harmonisation acts 22
2.7. Intended use / misuse 23
2.8. Geographical application (EEA EFTA states, Overseas Countries and Territories (OCTs), Turkey) 24
2.8.1. Member States and Overseas countries and territories 24
2.8.2. EEA EFTA states 24
2.8.3. Monaco, San Marino and Andorra 25
2.8.4. Turkey 25
2.9. Transitional periods in the case of new or revised EU rules 26
2.10. Transitional arrangements for the EU Declaration of Conformity as a result of the alignment to Decision No 768/2008/EC 27
3. THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS 28
3.1. Manufacturer 28
3.2. Authorised representative 31
3.3. Importer 32
3.4. Distributor 33
3.5. Other intermediaries: Intermediary service providers under the E-commerce Directive 35
3.6. End-user 36
4. PRODUCT REQUIREMENTS 38
4.1. Essential product requirements 38
4.1.1. Definition of essential requirements 38
4.1.2. Conformity with the essential requirements: harmonised standards 39
4.1.3. Conformity with the essential requirements: other possibilities 48
4.2. Traceability requirements 50
4.2.1. Why does Traceability matter? 50
4.2.2. Traceability provisions 50
4.3. Technical documentation 53
4.4. Eu declaration of conformity 54
4.5. Marking requirements 56
4.5.1. CE marking 56
4.5.2. Other mandatory markings 61
5. CONFORMITY ASSESSMENT 62
5.1. Modules for conformity assessment 62
5.1.1. What is a conformity assessment? 62
5.1.2. The modular structure of conformity assessment in Union harmonisation legsilation 62
5.1.3. Actors in conformity assessment – Positioning of conformity assessment in the supply chain 63
5.1.4. Modules and their variants 66
5.1.5. One- and two-module procedures – Procedures based on type (EU-type examination) 66
5.1.6. Modules based on quality assurance 67
5.1.7. Overview of modules 68
5.1.8. Overview of procedures 70
5.1.9. Rationale for selecting the appropriate modules 72
5.2. Conformity assessment bodies 73
5.2.1. Conformity assessment bodies and notified bodies 73
5.2.2. Roles and responsibilities 73
5.2.3. Competence of Notified bodies 75
5.2.4. Coordination between notified bodies 76
5.2.5. Subcontracting by notified bodies 76
5.2.6. Accredited in-house bodiees 78
5.3. Notification 78
5.3.1. Notifying authorities 78
5.3.2. Notification process 79
5.3.3. Publication by the commission – the NANDO web site 82
5.3.4. MONITORING of the COmpetence of notified bodies- Suspension – withdrawal - appeal 82
6. ACCREDITATION 84
6.1. Why accreditation? 84
6.2. What is accreditation? 85
6.3. Scope of Accreditation 85
6.4. Accreditation according to Regulation (EC) NO 765/2008 86
6.4.1. National accreditation bodies 86
6.4.2. Non-competition and non-commerciality of national accreditation bodies 87
6.5. The European acreditation infrastructure 88
6.5.1. Sectoral accreditation schemes 88
6.5.2. Peer evaluation 89
6.5.3. Presumption of conformity for national accreditation bodies 89
6.5.4. EA’s role in supporting and harmonising accreditation practice across europe 90
6.6. Cross-border accreditation 90
6.7. Accreditation in the international context 92
6.7.1. Cooperation between accreditation bodies 92
6.7.2. The impact on trade relations in the field of conformity assessemnt between the EU and Third Countries 93
7. MARKET SURVEILLANCE 94
7.1. Why do we need market surveillance? 94
7.2. controls by Market Surveillance authorities 95
7.3. Control of products from third countries by customs 97
7.4. Member States responsibilities 99
7.4.1. National infrastructures 99
7.4.2. National Market Surveillance Programmes (NMSP) and reviews of activities 100
7.4.3. Public information 100
7.4.4. Market surveillance procedures 101
7.4.5. Corrective measures – bans – withdrawals – recalls 102
7.4.6. Sanctions 103
7.5. Cooperation between the Member States and the European commission 104
7.5.1. safeguard mechanisms 104
7.5.2. The application of safeguard mechanisms step by step 105
7.5.3. Mutual assistance, AdministrATive Cooperation and exchange of information among Member States 107
7.5.4. Rapid Alert SYstem for non-food products presenting a risk 109
7.5.5. ICSMS 110
7.5.6. Medical devices: vigilance system 111
8. FREE MOVEMENT OF PRODUCTS WITHIN THE EU 112
8.1. Free movement clause 112
8.2. Limits and restrictions 112
9. INTERNATIONAL ASPECTS OF THE EU LEGISLATION ON PRODUCTS 113
9.1. Agreements on Conformity Assessment and Acceptance (ACAAs) 113
9.2. Mutual recognition agreements (MRAs) 114
9.2.1. Main characteristics 114
9.2.2. EU-Swiss MRA 115
9.2.3. EEA EFTA States: Mutual recognition agreements and Agreements on Conformity Assessment and Acceptance 115
10. ANNEXES 117
10.1. Annex 1 – EU legislation referred to in the Guide (non-exhaustive list) 117
10.2. Annex 2 – Additional guidance documents 122
10.3. Annex 3 – Useful web addresses 124
10.4. Annex 4 – Conformity assessment procedures (modules from Decision No 768/2008/EC) 125
10.5. Annex 5 – Relation between ISO 9001 and modules requiring a quality assurance system 136
10.6. Annex 6 – Using Harmonised Standards to assess the competence of Conformity Assessment Bodies 137
10.7. Annex 7 – Frequently Asked Questions on CE marking 142