Revised EU “Blue Guide” on product rules zooms in on e-commerce, modifications/repairs, assembling, software and Brexit
6 min read
On 29 June 2022, the European Commission revealed its updated Blue Guide on the implementation of product rules in the EU. This contains some important changes, reflecting current market surveillance rules, and fills some gaps related to online sales, software and modified/repaired/assembled products, and how EU rules work in Northern Ireland post-Brexit.
In late June 2022, the European Commission (the "Commission") published a revised version of the Blue Guide1, which for over 20 years has served as authoritative guidance for the implementation of European Union ("EU") product rules. The role of the Blue Guide is to help the business community better understand the EU product rules set out in numerous EU Directives and Regulations for consumer items, machinery, medical devices, etc., and facilitate their uniform application throughout the EU. The new version still relies heavily on past editions, but has been heralded by the Commission as a "substantial update".2 It reflects recent changes in legislation and in particular, the adoption of a new EU Market Surveillance Regulation3, and very explicitly aims to address challenges posed by e-commerce and online trade. It also clarifies certain concepts including making product available or placing it on the market4 and explains the legal consequences of Brexit for this area.
Online sales and responsibilities of fulfilment centers
The Blue Guide clarifies in a dedicated new section when products sold online are considered to be placed on the EU market (and must therefore comply with EU product rules), and explains the obligations of "fulfilment service providers", as defined in the Market Surveillance Regulation. The Guide reflects the need to have an accountable EU business and reaffirms that the end consumer acting as importer cannot have product compliance obligations. Therefore, a fulfilment service provider becomes the "economic operator" with respect to a product placed on the EU market in cases where there is no manufacturer, importer or authorised representative established in the EU. As such, the fulfilment service provider must also indicate its contact details on the product or its packaging/accompanying document (along with those of the non-EU manufacturer), take responsibility when it finds or has reason to believe that a product presents a risk, and fully cooperate with market surveillance authorities, e.g. with respect to recall operations. The Blue Guide now also suggests that it is "useful" that CE marking and any required warnings are indicated on that website and visible before the end user concludes a purchase.
Modified and repaired products
The updated guidance clarifies when modifications are sufficient to consider a product as a "new product", and therefore needs to comply with applicable legislation when made available on the market or put into service. The test consists of three cumulative conditions to be assessed on a case-by-case basis. If a modified product is considered to be a "new product", the new manufacturer must indicate its name and contact details on the product and draw up a new declaration of conformity for the modified product. The Blue Guide also clarifies how repaired products should be treated, and explains when these products might be considered to be new products, and therefore subject to a new assessment. This may be the case if the repair modifies the original performance of the product and will depend on the intended use and maintenance envisaged during the design stage of the product. For example, if the performance of a product is improved merely because the original spare parts are no longer available and current spare parts are better due to technical progress, no new assessment will normally be required.
Components, sub-assemblies and spare parts vs. complete products
Where spare parts, sub-assemblies or components are regarded as finished products, they are considered to be placed on the market when they are first supplied for distribution, consumption or use on the EU market. A manufacturer responsible for incorporating these items must ensure the compatibility of the complete product with the applicable legislation.
A new section on software explains that at the time of placing on the market final product integrating software (e.g. medical devices), the manufacturer is required to have foreseen the risks such software may pose. This includes mechanical, electrical, chemical and cyber risks, as well as risks related to the loss of connectivity of devices. As is the case for physical repairs or modifications to products, the Blue Guide clarifies when a product will be considered as substantially modified by a software change, and hence requires to be assessed again.
Implications of Brexit
The Blue Guide summarises the provisions under the EU-UK Trade and Cooperation Agreement relating to product compliance, underlining that there is no mutual recognition agreement with the UK, and UK accreditation bodies have lost their status as EU Notified Bodies. It also explains how post-Brexit, the EU rules continue to apply to Northern Ireland, including for products imported there from Great Britain.
Some other changes
- The Guide now explicitly indicates that imported products not (yet) compliant upon arrival in the EU cannot be released into free circulation before they are fully compliant, and that this must be done under customs supervision.
- The Declaration of Conformity must be kept up to date. For example, when a manufacturer starts using a revised Harmonized Standard, or when its contact details change, products produced after that date must be accompanied by an updated version of the Declaration.
- Product instructions may now be provided on a website and must remain accessible there for a reasonable period after the product was placed on the market depending on the intended use of the product. However, a paper copy must still be available to consumers upon simple request, and safety information still needs to be provided on paper.
- The effect of climate change on products intended for outdoor use must explicitly be considered by manufacturers, who must consider how projections about the changing climate in the EU will affect the safety and performance of the product during use.
The updated Blue Guide is an important tool assisting businesses involved in the product supply chain in the EU to better understand how their obligations and some fundamental EU product law concepts should be interpreted. The inclusion of certain new elements, in particular e-commerce and software in products, is important. Since this guidance is extensively used and referred to by Member State surveillance authorities, companies should ensure they fully grasp the novelties reflected in the latest edition.
1 See European Commission Notice "The 'Blue Guide' on the implementation of EU product rules 2022".
2 See press release of 29 June 2022.
3 See "Regulation (EU) 2020/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EU) No 305/2011".
4 See useful practical examples in section 2.12.
This publication is provided for your convenience and does not constitute legal advice. This publication is protected by copyright.
© 2022 White & Case LLP