EU’s new Blue Guide – Interpretation guidance for legal practice?

On 29 June 2022, the EU Commission published the Guide on the implementation of the product rules 2022 (Blue Guide) in the Official Journal of the EU.

The legally non-binding guidance document on the EU’s product law harmonisation rules is intended as an interpretation aid for authorities and economic operators. However, its application is still not straightforward. To the extent that the guidance document simply repeats the legal text of the European harmonisation regulations, it offers only limited benefits to economic operators. Where the EU Commission expands legal definitions or areas of application beyond the wording of the relevant legal provisions under the guise of “interpretative guidance” (most recently, for example, in interpreting the concept of placing on the market in online trade), it is claiming legislative powers it does not have. The Guide’s own reference to its legally non-binding nature sometimes comes across as a formulaic disclaimer in view of its frequently unquestioned use, even in the official environment.

The revision of the document, which was last updated in 2016, had become necessary because the European legislator has since enacted numerous new legal provisions that have made the explanations in the previous version obsolete or in need of adaptation. In addition, there are the special difficulties with product compliance in Europe due to Brexit.

The main changes compared to the previous version from 20216 cover the following topics:

EU Market Surveillance Regulation (EU) 2019/1020

The new EU Market Surveillance Regulation (EU) 2019/1020 replaces Regulation (EC) No. 765/2008 and harmonises the enforcement work of market surveillance authorities in the surveillance of non-food products across Europe for the first time since 16 July 2021. From a legal perspective, this was welcome. Numerous rules in that Regulation were previously found in the old version of the Blue Guide – sometimes difficult to find, awkwardly worded and legally non-binding. While these rules are now binding throughout Europe, they were previously considered wishful thinking by the EU Commission in the application of the law. See our news article of 9 July 2021 for the main points of the Market Surveillance Regulation.

The Guide therefore looks extensively at the EU legislator’s response in the Market Surveillance Regulation to the huge challenge of e-commerce, which until recently the market surveillance authorities in Europe were largely powerless and lacking the authority to tackle.

End users, material change and intended use

As long as you always keep in mind the non-committal nature of the EU Commission’s pronouncements, the new Blue Guide certainly contains helpful interpretative approaches. For example, the issue of when a product that has been substantially changed since it was placed on the market can be regarded as a new product and has to comply with the provisions of the legislation in force at the time when it placed on the market again.

The comments on the reasonably foreseeable use and intended use of a product are also interesting. The new Blue Guide states that for products intended for outdoor use, consideration should be given to how predictions of climate change in the EU could affect the safety and performance of the product during use.

For the first time, the Blue Guide also attempts to define the term “end user”, which is hugely important in EU product law but is not legally defined. According to the EU Commission, this means any natural or legal person resident or established in the Union to whom a product is made available, either as a consumer outside of its industrial, business, trade or professional activity or as a professional end user as part of its commercial or professional activity. If the legislator had integrated this definition into the relevant legal acts (such as the EMC Directive 2014/30/EU), its applicability to purely B2B components might be clearer.

Cross-border activity and accreditation of conformity assessment bodies

The Blue Guide also contains a new specification of the opportunities for conformity assessment bodies to delegate certain tasks to subcontractors. It also clarifies that under certain conditions these bodies can also carry out activities outside the Member State they are established in and maintain staff there, and explains how the cross-border assessment of competence (known as accreditation) can be done.

Mutual recognition within and outside the EU

Of course, the new Blue Guide also takes into account Regulation (EU) 2019/515 on the mutual recognition of goods, which has been in force since 19 April 2020 – a widely underestimated piece of legislation that replaced the corresponding rules from Regulation (EC) No 764/2008.

In the non-European context, the new Guide also provides some background on the Protocol on Mutual Recognition of Results of Conformity Assessment foreseen under the Comprehensive Economic and Trade Agreement (CETA). This will make it easier for the EU and Canada to export goods through the mutual recognition of conformity assessment certificates.

As a result of Brexit, which took place on 1 February 2020, the United Kingdom is no longer a Member State of the EU, but a “third country” under European law. The withdrawal agreement provided for a transition period ending on 31 December 2020. In this context, the new Blue Guide contains explanations on the legal consequences of Brexit, including the Trade and Cooperation Agreement (TCA) concluded between the EU and the United Kingdom on 24 December 2020, which has been provisionally applicable since 1 January 2021. In the context of Brexit, the new Blue Guide also provides explanations of the Northern Ireland protocol, applicable since 1 January 2021, which states that some provisions of EU law are also applicable to the United Kingdom and in the United Kingdom in relation to Northern Ireland.

Products imported from third countries that are not (yet) compliant

Fortunately, the new Blue Guide for the first time expresses itself very clearly on the practically relevant question of whether it is admissible to import products that are not yet compliant into the EU. Products that have entered the territory of the Union and require further processing there in order to comply with the Union’s harmonisation legislation may be transferred to an appropriate customs procedure that allows such processing. However, the products may not be released for free circulation until they comply with the rules. This clarification of the legal situation, which is admittedly not new, will be useful to some product importers in future in their frequent disputes with the customs and market surveillance authorities.

Conclusion – Practical interpretation guidance for economic operators?

Since its update, the EU Commission’s Blue Guide is still the most well known and generally accessible interpretation aid for the European harmonisation regulations on non-food products. The practical benefit is primarily that it prepares the essential regulatory subjects of the European legislation on non-food products for the reader in a thematically structured form and thus makes the legal texts more accessible, especially for the legal layman. However, the Guide does not offer a genuine interpretation of the legal provisions based on the case law of the courts and the enforcement practice of the European authorities. This task will therefore have to be taken on in the future by the technical legal literature and the legal commentaries on the key legal provisions, so that companies can make legally reliable decisions in grey areas regarding the marketability of their products.

If you are interested, a document highlighting the changes compared to the previous version in colour can be requested from Arun Kapoor.