On 29 June 2022, the European Commission published an updated ‘Blue Guide on the implementation of the product rules 2022’ (“Blue Guide”). The Blue Guide serves to further cover new developments since it was last revised in 2016, contributes to a better understanding of EU product rules and facilitates their uniform and coherent application across different sectors throughout the EU single market. Notable changes include the Blue Guide defining new terms, providing additional guidance on which economic operators will take the responsibility for compliance in a complex product supply chain, and incorporating the Regulation (EU) 2019/1020 on market surveillance and compliance of products.
The European Commission has published the most recent version of the Blue Guide on 29 June 2022. This is “the” authoritative text covering a wide range of product laws in the EU. Laws within scope, among other laws, include:
Radio Equipment Directive (Directive 2014/53/EU);
Low Voltage Directive (Directive 2014/35/EU);
Restriction of Hazardous Substances Directive (Directive 2002/95/EC);
Regulation on Personal Protective Equipment (Regulation (EU) 2016/425); and
General Product Safety Directive (Directive 2001/95/EC).
In January 2020, Hogan Lovells made submissions to the European Commission with respect to areas of the Blue Guide ripe for clarification. We are pleased to see that the Blue Guide includes some further areas of detail which will help product companies. Hogan Lovells’ Global Products Law team, covering product compliance, regulation and safety, will provide a full update shortly in relation to key changes in the Blue Guide. For the time-being, here is a breakdown of some key items for your radar:
New guidance on which economic operators will be responsible for the compliance with relevant obligations in the context of (i) a finished product incorporating another product, or (ii) two or more finished products made available in the same package that do not constitute a single finished product but are intended to function together, being placed on the EU market
Additional situations where repairs and modifications to a product (also applicable to a situation where products are substantially modified by a software change) could be deemed as “important changes or overhaul” that cause the product to be considered as a “new product”. Accompanying implications and obligations on economic operators provided, such as the preparation of the technical documentation and drawing up an EU declaration of conformity
Factors to consider when trying to assess whether products offered for sale online or through distance sales are targeting EU end-users and thus qualify as “making available” or “placing on the market”
The definition and conditions to qualify as “fulfilment service providers“
Additional guidance on the CE marking, such as how to present the CE marking before end-users purchase products online
A clear indication that the Blue Guide has incorporated the Regulation (EU) 2019/1020 on market surveillance and compliance of products, and guidance on accompanying implications and obligations on economic operators, such as sanctions
More guidance to follow soon; including on how this shapes up with the regulatory landscape in the UK. You can read a copy of the Blue Guide here.
Authored by Valerie Kenyon and Daniel Lee.
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