The hotly-anticipated revision of the European Commission's Blue Guide has been published. Here's our take on why this matters to anyone involved in the manufacture, import or sale of products in the EU.
The European Commission has published its revised 2022 Blue Guide (available here). The Blue Guide is a key guidance document for EU product rules and the Commission describes the revision as "a substantial update". In this blog, we provide a quick summary of some of the headline changes.
The Blue Guide is a key European Commission guidance document
for EU product rules and applies to a wide range of products
covered by Union harmonisation legislation (i.e., generally,
CE-marked products). These include radio equipment, electrical and
electronic equipment, medical devices, toys, machinery and PPE,
amongst many others. More information can be found in our bitesize introduction to the Blue Guide.
The Blue Guide's broad scope and detailed guidance also make it influential in other areas. Whilst not legally-binding, it provides meaningful interpretation guidance on many areas of product regulation, and in practice is relied upon heavily by market surveillance authorities. The Blue Guide was first published more than two decades ago, in 2000, and was updated in 2014 and 2016. The latest revision has been a while in the pipeline, with work commencing in late 2019.
Why does it matter?
The 2022 Blue Guide includes changes to address new regulations, perceived challenges of new technologies and new marketing structures (particularly, the rise of online sales). It also signals important reinterpretation of some fundamental principles of European law – including the potential safety and compliance implications of the "right to repair", as well as the question of how software updates to products are to be dealt with under EU product safety regimes. There is also a rethink of aspects of the concept of "placing on the market", with some relaxations in the previous Blue Guide now removed.
Products stakeholders will need to consider whether changes in the 2022 Blue Guide have a material effect on their products and procedures. In particular, companies that have been relying on advice based on the Blue Guide for certain business practices will need to carefully reevaluate if these remain viable, or whether existing practices need to be changed.
The 2022 Blue Guide – Key Changes
The amendments made are extensive. Headline changes include:
- 'Placing on the market': this concept
is important because it's what triggers many of the regulatory
requirements for products. There are a number of amendments to this
section in the 2022 Blue Guide, including:
- Own use exemption. The 2022 Blue Guide now includes some useful examples of when a product is deemed to be placed on the market (see paragraph 2.12). However, the sixth example has implications for the "own use" exemption, suggesting that a product would be placed on the market where a manufacturer supplies the products it manufacturers for the use of its own employees. This appears to conflict with long-standing guidance, still retained in the 2022 Blue Guide that placing on the market is considered not to take place where a product is manufactured for own use.
- Online sales. The 2022 Blue Guide retains the provisions that suggest a product sold online will be deemed to have been 'placed on the market' when it is targeted towards EU end users. Guidance for when an "online offer" is deemed to be targeting end users in the EU has been updated in the 2022 Blue Guide in light of the Market Surveillance Regulation (EU) 2019/1020. However, the revised guidance also goes further by adding that "the physical delivery to end-users in the EU of a product ordered from a given online seller based outside the EU, including by a fulfilment service provider, gives irrefutable confirmation that a product is placed on the EU market". It also suggests that companies who are offering products for sale online are required to cooperate with market surveillance authorities on request.
- C2C sales on online marketplaces. Previous guidance that C2C sales are generally not considered to be commercial activities has been removed in the 2022 Blue Guide. The removal of this guidance in the 2022 Blue Guide gives broader scope to argue that products are made available on online platforms, listings and marketplaces, even where this supply is C2C.
- Right to repair: a number of changes have been
made in the 2022 Blue Guide with a view to addressing perceived
issues concerning aftermarket repairs, which are expected to
increase as a result of the Commission's drive for a broader
right to repair for consumer products.
- Components and spare parts: new guidance has been added that where components or spare parts are regarded as finished products under the applicable EU product rules, they will need to comply with applicable legislation at the time the spare part or component is placed on the market (and / or put into service).
- Repairs and modifications to products: under EU product regulations, it is considered that if a product is "substantially modified" after sale, it could trigger a need to undertake fresh compliance assessment. Guidance on when a product subject to a repair or modification is considered to be substantially modified (and therefore a "new" product triggering obligations under the applicable EU product rules) has been updated in the 2022 Blue Guide to a three point test. A product will be considered "new" where: i) the product's original performance, purpose or type is modified, without this being foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased in relation to the relevant EU product rules; and iii) the product is made available (or put into service if the applicable EU product rules also cover putting into service within its scope). Where the product is deemed to be a "new" product due to the modification or repair, the guidance clarifies that the "new" manufacturer's name and contact address must be indicated on the product. Some changes to the guidance around the requirements to update technical documentation, assessing conformity and drawing-up the Declaration of Conformity for such "new" products have also been made.
- Replacements: wording that appeared in the 2016 guidance that exchanges of entire identical units (e.g. following a defect) would not be considered to be "new" products has been removed. This means that replacement products will no longer benefit from this exemption and will arguably need to comply with laws at the time of replacement.
- Software: a new, specific section on software
has been inserted in the 2022 Blue Guide. It suggests that:
- there is an obligation on the manufacturer of the final product to "foresee the risks" of software integrated into the product at the time of its placing onto the market as part of the initial risk assessment. It suggests that the concept of product safety includes protection against "safety-related aspects of cyber risks" and "risks related to the loss of connectivity of devices", among other risks.
- there is a three point test for whether software updates or changes would be considered to be a substantial modification and trigger obligations for the product as a "new" product under the applicable EU product rules. Namely, the product would be considered new following the software update if: i) it modifies the original intended functions, type or performance of the product and this was not foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased because of the software update; and iii) the product is made available (or put into service where this is covered by the specific EU product rules).
- Instructions and safety information: in a move that will be frustrating for some industry stakeholders, the 2022 Blue Guide continues to require all safety information to be provided on paper. As in previous guidance, other instructions can be provided electronically and a website has been expressly added as one of the permissible means of providing instructions (in our view, a website was already covered by the 2016 guidance, so we don't see the change as significant). A new requirement has been introduced that where the full set of instructions is provided using an electronic or other data storage format or website, it must remain accessible for a reasonable period after the product was placed on the market, depending on the intended use of the product.
- CE marking: new guidance has been added in the 2022 Blue Guide that for products requiring assembly, the CE marking should remain visible after assembly, but does not need to be visible after final installation and in normal use. We do not consider this to be a useful addition, as it lacks clarity.
- Traceability labelling (name and address of economic operators): again, the opportunity to move towards e-labelling has not been taken. Whilst some may argue the 2022 Blue Guide is a missed opportunity for wider adoption of e-labelling, we understand that this is one of the issues in scope for the evaluation of the New Legislative Framework (the template for CE-marked product legislation) currently underway, with a supporting study published earlier this year that supported e-labelling.
- DoCs: new wording has been added in relation to the requirement under existing EU product rules to keep a Declaration of Conformity (DoC) continuously updated. The guidance explains that the DoC is specific to each individual product, even if they are manufactured in series and that, in practice, the same version of the DoC may be applicable to many individual products manufactured in series. As soon as any of the elements of the DoC changes, the version of the DoC will have to be updated for products placed on the market after that change and gives the following examples – changes in the legislation, changes in the versions of the harmonised standards or changes in the contact details of the manufacturer or authorised representative.
- Changes as a result of the new Market Surveillance Regulation: a number of changes have been made as as a result of the Market Surveillance Regulation (EU) 2019/1020, including guidance on the role and obligations of fulfilment service providers and a new section on the role of the responsible economic operator in the EU (also known as the Responsible Person), which is a requirement introduced under the Market Surveillance Regulation).
- Formal non-compliance. Whilst the 2022 Blue Guide still recognises that non-compliance can be "formal" only (i.e. not present a safety risk), there has been an attempt to narrow the scope of its application. In particular, the 2022 Blue Guide removes specific guidance in previous versions that for formal non-compliance only (e.g. incorrect affixing of the CE mark), a recall or withdrawal of products would not usually be required (unless no result was achieved after EU authorities requested the economic operator to remedy the non-compliance for future products).
- Brexit: a new section on the UK's withdrawal from the EU has been added including the legal status of economic operators, conformity assessment procedures and notified bodies after the transition period and the Northern Ireland Protocol.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.