New Blue Guide published by the European Commission
27 June 2014
In April of this year, the European Commission published "The 'Blue Guide' on the implementation of EU product rules 2014" (the New Blue Guide). The New Blue Guide updates the "Guide to the implementation of directives based on the New Approach and the Global Approach" (the Old Blue Guide), published in 2000.
The New Blue Guide builds on the Old Blue Guide, as the Old Blue Guide required updating to cover new developments and to ensure a common understanding on the implementation of the so-called "new Legislative Framework" (the NLF).
The package of measures known as the NLF was adopted on 9 July 2008 and includes, among other things, measures to improve the functioning of the internal market and to strengthen and modernise the conditions for placing a wide range of industrial products on the Union market (such as the improvement of market surveillance rules, the quality of the conformity assessment of products, a clarification of the meaning of CE marking and the establishment of a common legal framework for industrial products).
The New Blue Guide aims to include the changes introduced by the NLF, and to take into account the modifications introduced by the Lisbon Treaty, which entered into force in December 2009. The New Blue Guide includes several new chapters, on issues such as the obligations of economic operators and accreditation, as well as several revised chapters, such as those on standardisation and market surveillance.
1.1 Scope and relevant actors
The New Blue Guide relates to non-food and non-agricultural products referred to as industrial products or products for use by consumers or professionals. These are subject to common EU rules which are in the process of being harmonised (Union Harmonisation Legislation). The New Blue Guide includes an updated list of Union Harmonisation Legislation falling within its scope. It now clearly states that it does not cover the Directive on General Product Safety, Union legislation on motor vehicles, construction products, REACH and chemicals.
According to the New Blue Guide, the Union Harmonisation Legislation applies when a product is 'placed on the market' (ie when the product is made available for the first time on the Union market), as well as to any subsequent operation which constitutes 'making the product available' (ie when the product is supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge), until it reaches the end-user.
The New Blue Guide states that the Union Harmonisation Legislation applies both to newly manufactured products and to used or second-hand products imported from third countries when these products enter the Union market for the first time. It further clarifies the definitions of the different actors in the supply chain (ie manufacturers, authorised representatives, importers, distributors and end-users) and their related obligations. Relevant changes relate, among other things, to "distributors" whose obligations are now (unlike under the Old Blue Guide and New Approach directives) clearly outlined. The New Blue Guide applies to finished products. In this regard, it specifies that if, and to the extent that, a product has been subject to significant changes overhauling or modifying its original performance, purpose or type, this product may be considered as a new product and the person carrying out the changes will be deemed to be the manufacturer.
1.2 Product requirements
The New Blue Guide includes clarification of "essential (product) requirements" and "harmonised standards", by referring to the definitions included in Regulation (EU) No 1025/2012.
Unlike the Old Blue Guide, the New Blue Guide now sets out the procedure leading to a harmonised standard by creating a presumption of conformity (as well as rules in relation to the withdrawal, restriction or prevention of the presumption of conformity, and for the revision of harmonised standards).
Union Harmonisation Legislation anticipates requirements for the traceability of products placed on the Union market, without stipulating how to achieve or implement these requirements. Regulation (EC) No 765/2008 sets out the requirements for accreditation and market surveillance relating to the marketing of products, and Decision No 768/2008/EC on a common framework for the marketing of products establishes the current practices regarding traceability by requiring specific traceability labels.
The New Blue Guide provides further details on these elements, as well as the requirements regarding the CE marking. Whereas the Old Blue Guide required manufacturers or authorised representatives to draw up an EU Declaration of Conformity in one of the official languages of the Community, the New Blue Guide now requires a translation into the language or languages required by the Member State in which the product is placed or made available on the Union market.
1.3 Conformity assessment and accreditation
Any manufacturer must carry out a conformity assessment to demonstrate whether the specified requirements of a product have been met. The New Blue Guide specifies that, under Union Harmonisation Legislation, the conformity assessment procedures consist of one or two conformity assessment modules. The legislator selects the most appropriate one(s) from these modules or procedures (which are laid down under Decision No 768/2008/EC) to address the specific needs of the relevant sector. In this regard, the New Blue Guide provides details on the modules for the conformity assessment, the conformity assessment bodies, the notifying authorities and the notification process.
Although the Old Blue Guide briefly touched upon the system of accreditation, the New Blue Guide gives extensive guidance on this concept (ie attestation by an accreditation body that a conformity assessment body has the technical competence to perform a specific conformity assessment activity). The New Blue Guide also touches on the legislative framework set out by Regulation (EC) No 765/2008 (including the rationale and scope of accreditation); the accreditation bodies, and (the tasks of) the European Cooperation for Accreditation.
1.4 Market surveillance
Regulation (EC) No 765/2008 sets out the regulatory framework for the market surveillance of products, to ensure that these products fulfil requirements providing a high level of protection of public interests, such as health and safety in general or at the workplace, the protection of consumers, the environment and security, while ensuring that the free movement of products is not restricted to any greater extent than that which is allowed under the Union Harmonisation Legislation. The New Blue Guide not only outlines market surveillance activities, but also gives extensive guidance on the responsibilities of the Member States (including the cooperation and exchange of information between the Member States and the European Commission).
Only the texts of the Union Harmonisation Legislation (and its implementing legislation) have legal force, and it remains to be seen how the (national) enforcement authorities will ensure compliance with this legislation (and whether this approach will ultimately be approved by the European Court of Justice). Nevertheless, the New Blue Guide serves as a useful guidance document and will hopefully achieve its purpose of creating a more uniform approach.