The European Commission Blue Guide to the Implementation of EU Product Rules - Expected Updates

 The EU Blue Guide on the implementation of the EU product rules have become one of the main reference documents that explains how to implement the applicable EU legislation based on the New Approach, or New Legislative Framework. This document is invaluable to consultants like me. The current version is the 2016 revision, which is becoming outdated in some aspects. A lot of what is contained in the 2016 version will remain valid, but it is necessary to take account of the changes in legislation introduced by the Lisbon Treaty that came into force on 2009/12/01 with regard to legal references and terminology applicable to EU related documents, procedures, etc. This was the main reason for the publishing of the 2016 version of the Blue Guide, which was built on the 2000 version, but which included new chapters, e.g. the obligations of economic operators, etc. There were also some revised chapters, e.g. those on standardization and market surveillance. But things have changed in the meantime and there is a need for a new revision.

The Blue Guide is intended to contribute to a better understanding of the EU product rules and to their more uniform and coherent application across different sectors and throughout the EU market.

The document applies to the EU member states, as well as Iceland, Liechtenstein and Norway. These three countries are signatories of the Agreement on the European Economic Area (EEA). It also applies to Turkey in certain cases. References to the Union or the single market are, accordingly, to be understood as referring to the EEA.

The 2016 version of the Blue Guide is becoming outdated. In an article published by Reed Smith LLP, a global relationship law firm with offices in the US, Europe, Asia and the Middle East I have found the following information that I have included in this blog regarding the anticipated changes. The changes are driven by progress in digital trading, software and e-commerce. The updates also relate to re-manufacturing and the treatment of used goods, certain legal implications of BREXIT, and the coherence with the EU’s ongoing enhancement of its market surveillance and enforcement regime, as well as including a number of changes for clarification purposes, e.g. around the position of “end user” and “own use” of products. It is expected that the new version may appear at any time from now on (mid 2021), in other words, soon.

Not everything is changing, of course. It is not going to be a complete rewrite, which is a relief for consultants like me, and, of course, organizations that handle their own CE marking, etc. Most of the current definitions are staying the same, e.g. “making available”, “placing on the market” and “putting into service”. The definitions for “manufacturer”, “authorized representative”, “importer” and “distributer” also stay the same.

E-Commerce

There are few amendment anticipated to bring the Blue Guide up to date in respect of the increased prevalence of e-commerce, including rules for products sold online.

An important aspect is that products that have not yet been manufactured are not considered as “placed on the market” in the EU until it has actually been manufactured. This is valid even if persons in the EU have access to electronic platforms advertising such products. But for already manufactured products the “placing on the market” occurs the moment it is offered for distribution, consumption or use on the EU market. The legal consequence is that, when the offer does not concern a product that has already been manufactured, the obligations on the relevant economic operator to cooperate with the market surveillance authorities will not apply until after manufacturing has been completed.

Fulfilment Service Providers (FSPs)

The current definition of a fulfilment service provider provided is that they are regarded as distributors.

Market Surveillance Regulations 2019/1020 defines FSPs as any natural or legal person offering, in the course of commercial activity, at least two of the following services:

• Warehousing
• Packaging
• Addressing and dispatching

The important point is that the FSP do not have ownership of the product involved. Excluded from this definition are postal services, package delivery services and any other postal or freight transport services.

According to the new draft, FSPs are considered as economic operators who must cooperate with enforcement authorities to address issues of noncompliance with the product they handle. Enforcement can be brought on them.

The definition of “economic operator” is a natural or legal person or public entity which offers to execute works, supply products or provide services. The term is used to cover suppliers, contractors and service providers.

Responsible Economic Operators (REOs)

The market surveillance regulation of the EU specifies that, for certain product categories, there has to be an economic operator inside the EU who is able to carry out a number of tasks. One of these tasks is to cooperate with the market surveillance authorities.

Market surveillance is defined as the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonized legislation and to ensure protection of the public interest covered by that legislation.

The draft of the Blue Guide includes a new section on REOs. It lists the possible candidates, which includes an FSP established in the EU where there is no eligible EU-based manufacturer, importer or authorized representative. The draft goes on to say that when the REO is an authorized representative, or an FSP, they do not have to take corrective action or mitigate risk themselves, but they will need to ensure that the necessary action is undertaken, as required by the market surveillance authorities. It could be done by requesting the manufacturer to follow up and verify whether it has done so.

Note that, according to the Market Surveillance Regulation, it is stated that “for certain products, there should be an economic operator, established in the Union so that market surveillance authorities have someone to whom requests can be addressed, including requests for information regarding a product’s compliance with Union harmonized legislation, and who can cooperate with market surveillance authorities in making sure immediate corrective action is taken to remedy instances of noncompliance. The economic operators who should perform those tasks are the manufacturer, or the importer when the manufacturer is not established in the Union, or an authorized representative mandated by the manufacturer for this purpose, or a fulfilment service provider established in the Union for products handled by it when no other economic operator is established in the Union”. More information on this requirement is contained in the relevant product directives or regulations.

Another important point in the draft is that the name and contact details of the REO must be indicated on the product or its packaging. Again one should refer to the relevant product directives and regulations in this regard.

Software

The major addition in this category is that the concept of product safety includes protection against all kinds of risk arising from the product, including mechanical, chemical and electrical risks, and also cyber risks and risks related to loss of connectivity of devices. It also points to current legislation such as the Radio Equipment Directive and Medical Device Regulations to demonstrate how safety standards of stand-alone software can be regulated.

Instructions and Safety Information

There is small, but important amendment in relation to the obligation to accompany products placed on the market with instructions and safety information.

The draft states that safety information needs to be provided on paper. But it also states that, unless otherwise provided for in specific legislation, the full set of instructions may be provided in an easily accessible manner through a website, electronic label or QR Code, by prompting the end-user to read on a webpage or download the full documentation in the language of their choice, or through other electronic formats.

The draft requires that a paper version must always be available free of charge for consumers who request it.

Modifications

The current version of the Blue Guide makes it clear that, if a product is subject to post-manufacture changes that modify its safety performance to an extent which impacts on its conformity with applicable EU product safety requirements, it is considered as a new product placed on the market.

This means that the modifier becomes the manufacturer and a new conformity assessment and CE marking process must be undertaken before it can be marketed in the EU.

According to the draft new Blue Guide, modified products will not be made available on the market, i.e. if the product is used exclusively by the person making the modification, it will not be subject to EU product compliance laws. This applies only to products which are modified for “own use”.

I hope that this information is useful, especially to organizations exporting products to the EEA countries. Note that a number of EU legislative reviews are currently under way and are expected to make changes to EU product laws in the near future.

Feel free to let me know if you need any information regarding CE Marking, and I will be glad to assist. I can be contacted at koosgouws10@gmail.com, or leave a comment or use the contact page on this website (if you are viewing this blog on www.sheq-management-system.webnode.com).

Regards

Koos