Article by Bernd Gruner
On 29 June 2022 the Commission published a revised version of the Blue Guide on the interpretation of product rules. The Blue Guide is not a legally binding document but serves as guidance for businesses and national authorities to improve the understanding of harmonised product rules and facilitate their uniform application throughout the EU. The revision of the last version guide from 2016 was necessary due to developments in the legal field and in the market, as some explanations became obsolete and others needed to be updated.
The Union legislation of interest for electrical wholesalers to which the guide particularly relates are the following:
Electrical equipment designed for use within certain voltage limits (Low Voltage Directive 2014/35/EU)
Radio Equipment (Directive 2014/53/EU)
The restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) (Directive 2011/65/EU)
Energy labelling (Regulation (EU) 2017/1369 and all implementing regulation for specific products adopted under this Framework Regulation)
Ecodesign requirements for energy related products (Directive 2009/125/EC and all implementing Regulations for specific product groups adopted under this Framework Directive)
Electromagnetic compatibility (Directive 2014/30/EU)
Machinery (Directive 2006/42/EC)
The revised Blue Guide is based on the old version and does not fundamentally change its core structure and concept. It integrates the new provisions on market surveillance (Regulation (EU) 2019/1020) and clarifies in a new section 3.6 the new role of the responsible economic operator as duty holder in Article 4. The main changes in the guide concern guidance on the application of EU product legislation to online sales, the responsibilities of fulfilment centers, software, repairs and modified products and the implications of the Brexit.
Online sales
The blue guide clarifies in a new section 2.4 when products sold online or by other means of distance sales are deemed to be made available on the EU market and must comply with EU product rules. Products offered online are deemed to be placed on the EU market if the offer is targeted at end users in the Union, which is the case if the relevant economic operator directs its activities to a Member State. The assessment of the latter has to be made on a case-by-case basis taking into account any relevant factors such as the geographical areas to which dispatch is possible, and the languages available used for the offer or for ordering and payment possibilities. When an online interface provides for delivery in the EU, accepts payment by EU consumers/end-users and uses EU languages, then it can be considered that the operator has expressly chosen to supply products to EU consumers or other end-users. The physical delivery to end-users in the EU of a product ordered from a given online seller based outside the EU gives irrefutable confirmation that a product is placed on the EU market.
The Blue Guide suggest now that for products sold online, it is useful that the CE marking and any required warnings according to applicable legislation are indicated in that website and visible before the end user is carrying out the purchase.
Responsibilities of fulfilment service providers
A new section 3.5 of the guide clarifies the obligations of the fulfilment service providers. The Guide reaffirms that the end consumers importing directly products sold online cannot have product compliance obligations and reasserts the need to have an accountable economic operator. In cases where there is no manufacturer, importer or authorized representative established in the EU, the fulfilment service provider becomes the "economic operator" with respect to a product placed on the EU market. As such, the fulfilment center must 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.
Repairs and modification to products
The guide clarifies when a product that has been significantly modified since it was placed on the market is considered to be a new product and must comply with the applicable legislation when it is placed on the market again. Three cumulative conditions have to be assessed on a case-by-case basis:
its original performance, purpose or type is modified, without this being foreseen in the initial risk assessment;
the nature of the hazard has changed, or the level of risk has increased in relation to the relevant Union harmonization legislation;
the product is made available (or put into service if the applicable legislation also covers putting into service within its scope).
Where a modified product is considered to be a new, 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.
Guidance is also provided on how repaired products should be treated. A repaired product is not to be considered as new, if the repair does not modify the intended use, the range of performance and the maintenance originally conceived at the design stage of the product.
Software
A new section on software has been added to the guide explaining that the manufacturer of the final product has the obligation to foresee the risks the software integrated in that product may pose at the time of its placing on the market. 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 the Brexit
A new section 2.9.5 on the UK withdrawal from the EU summarizing the separation provisions relevant to industrial products and the legal situation after the end of the transition period on 1 January 2021 relating to product compliance. It underlines that there is no mutual recognition agreement with the UK, and UK accreditation bodies have lost their status as EU Notified Bodies. A new section 2.9.6 on Northern Ireland explains the Protocol on Ireland/Northern Ireland as from 1 January 2021 how the EU rules continue to apply to Northern Ireland, including for products imported there from Great Britain. A new section – Section 9.3 – summarizes the provision of the EU-UK Trade and Cooperation Agreement.
Further changes in the Blue Guide concern:
The Declaration of Conformity
The Declaration of conformity must be kept up to date. For example, when a manufacturer starts using a revised Harmonised Standard, or when its contact details change, products produced after that date must be accompanied by an updated version of the Declaration.
Provision of product instructions 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.
Reasonably foreseeable and intended use
The effect of climate change on products intended for outdoor use must explicitly be considered by manufacturers. The manufacturer must consider how projections about the changing climate in the EU will affect the safety and performance of the product during its use.
Products that are imported from third countries into the EU and need to be further processed in order to comply with European product specifications
In chapter 2.5 the Blue Guide expresses itself clearly on the question whether it is admissible to import product that are not yet compliant with EU rules. 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.
Components, spare parts or sub-assemblies
Where components, spare parts or sub-assemblies are considered are regarded as finished product within the terms of specific harmonized legislation, they are considered to be placed on the market when they are first suppled for distribution, consumption or use on the Union market. The manufacturer placing on the Union market a product incorporating one of these products into another product has to ensure the compliance of the complete product.
Definition of an end user
For the first time, the Blue Guide attempts to define the term “end user” (section 3.8). According to the definition, the end user is any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities.
The ‘Blue Guide’ on the implementation of EU product rules 2022 has been published in the Official Journal C 247 on 29 June 2022 and is available in all linguistic versions of the EU.