Today, 20 April 2016, seven pieces of EU legislation setting the minimum requirements for making manufactured products available throughout the EU are becoming applicable. These pieces of EU legislation cover a wide range of products such as electrical equipment, civil explosives, simple pressure vessels, measuring & weighting instruments and equipment to be used in potentially explosive atmospheres.
This is a rather rare instance, given that the EU has already a robust regulatory framework in this field. Over the past forty years, the EU has gradually replaced the national rules by EU-wide harmonised rules making it simpler for products to circulate throughout the EU, as they have to abide only to a single set of rules instead of 28 different ones.
Changes induced by this revision
The parallel revision of pieces of EU legislation will not affect the requirements concerning strictly the design and functioning of products, known as “essential requirements”. Nevertheless, it introduces several new administrative requirements, such stating on all products the manufacturer’s address and establishing sample testing procedures for products on distributors’ selves.
Moreover, the revision changed the reference number of these pieces of EU legislation. Therefore, manufacturers should ensure that the declarations of conformity of products placed on the market after the 20 of April are published with the new reference numbers. Any harmonised standards used should also refer to the new numbers.
Interested manufacturers, distributors and importers can seek detailed information about these changes at the European Commission’s guide for the implementation of EU product rules, as well as the guides for the transition for certain pieces of legislation (see for example the transition guides for the Low Voltage Directive and the Directive for equipment used in potentially explosive atmospheres).
Why is this revision taking place?
This revision is the result of a broader exercise to draft all the aspects of the product harmonisation legislation – besides the product-specific parts – with a single set of wording (Decision 768/2008/EC).
Indeed, this exercise is slightly increasing the administrative requirements for manufacturers, distributors and importers of products in the EU. However, it also contributes to bringing clarity to their roles, to the application of CE marking and to their rights and responsibilities towards market surveillance authorities.
This exercise is expected to improve the predictability of the EU legislative framework, as companies can know in advance the horizontal aspects of their responsibilities regardless of the specific pieces of legislation that might apply to their products.
Moreover, this exercise establishes a robust legislative framework for market surveillance and accreditation of the conformity assessment bodies. For example, it obliges EU countries to draft and exchange annual market surveillance plans, as well as information on a more regular basis.
Nevertheless, few implementation difficulties are already revealed. For example, the definition of importers is not easy to adapt to the e-commerce reality. Furthermore, distributors of own-brand products have difficulties to fulfil their obligations.
This exercise has already affected ten pieces of EU legislation plus the ones to become applicable now, but it will not be limited to them. For example, the new regulations on gas appliances, cableways and on personal protective equipment, which will apply from 2018 onwards, are also based on the same template. Moreover, the revision of the Machinery Directive, which may result from the ongoing evaluation study, will also be based on this template.
Possibilities to get involved in the procedure
Manufacturers, distributors and importers of such products are not passive recipients of these changes.
The European Commission is currently finalising the guides for the application of these Directives. This exercise is important, as the guides will establish a common understanding for the implementation of the legislation throughout the EU. As such, companies can provide input to improve these guides and the application of the legislation as a whole.
Finally, companies affected by pieces of legislation that will be revised in the future can express their views to policymakers in various ways. By becoming involved in the legislative procedure, companies can contribute to preventing vague provisions that could cause legal uncertainty and unnecessary administrative requirements. Given that the rules are set at EU level, it is important to get involved as soon as possible and it is certainly late to react only once the national administrations are transposing the Directives into national law.