Ukrainian manufacturers have great potential to trade with EU member states. To benefit from these opportunities, manufacturers need to understand the technical requirements and procedures of the world’s biggest market.
- Which EU directives and regulations are relevant for your product?
You can find all the directives on the European Commission’s website here. It is possible for one product to be subject to several different directives. For example, a machine with electric appliances and remote control is covered by the “Machinery Directive,” the “Low Voltage Directive,” and the “Directive on Electro Magnetic Compatibility.” In these cases, one (the Machinery Directive in this example), is the “leading” directive and the conformity assessment has to be carried out according to this directive. However, the relevant essential requirements from the other directives must also be taken into account.
- How can I find out what relevant health and safety requirements my product must fulfil?
Manufacturers are required carry out a risk assessment in parallel with the design phase. For example, Annex I of the Machinery Directive contains the following general principle: “The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery.” The relevant technical regulation stipulates how the risk assessment should be carried out. In this case it is ISO/TR 14121-2.
- What harmonised EU standards apply to my product? Are these also Ukrainian standards?
The titles and other bibliographic data of harmonised EU standards relevant to specific directives are published by the European Commission in the Official Journal of the European Union.
A list of these standards is available here.
In Ukraine, a number of harmonised European standards have been adopted as Ukrainian standards. A list of those harmonised standards is published here.
- Do I want to apply these standards?
It is up to the manufacturer to decide if he wants to apply harmonised European standards wholly, partially, or not at all. This freedom of choice makes further technological development much easier than if the application of standards were mandatory.
If the manufacturer applies wholly harmonised European standards and if these standards cover all relevant essential health and safety requirements identified by a risk assessment, he profits from the presumption of conformity. This means that if there are any doubts as to whether or not the product fulfils all relevant essential health and safety requirements, it is up to the market surveillance authorities to prove that the product does not fulfil them.
- What conformity assessment procedures must be or can be applied?
Depending on the level of risk associated with the use of a product, the European directives may contain very different conformity assessment procedures. In some cases, two different conformity assessment procedures are described in one directive. The manufacturer must chose one procedure depending on the category of the product and the risk associated with the use of this product. An overview and detailed description of all possible conformity assessment procedures is provided in Annex II of DECISION NO 768/2008/EC.
- Do I have to involve a European “Notified Body”? If so, where can I find one?
Depending on the risk associated with the use of a given product, the conformity assessment procedures may require the involvement of a Notified Body. This body certifies product compliance with the EU requirements. If a Notified Body has to be involved, the manufacturer is free to choose one that is designated for the product group concerned from any country in the EU.
A complete list of Notified Bodies as well as the product groups is available on the NANDO web page of the European Commission.
- What is the “EC Declaration of Conformity”? Who has to prepare it?
The EC Declaration of Conformity is a legal statement by the manufacturer or his authorised representative. It attests that the product concerned complies with all of the relevant provisions of the directive concerned.
The EC Declaration of Conformity must be drawn up by the manufacturer or by his authorised representative in the EU and must accompany the product until it reaches the user. The EC Declaration of conformity must be drafted in one or more of the official EU languages.
- How do I CE-mark my product before exporting it into the EU?
The EU directives require that, prior to putting products on the market, the manufacturer mark these products with the CE conformity marking. Depending on the directive, the CE conformity marking may also contain the identification number of the Notified Body that was involved in the conformity assessment procedure or that assessed and supervised the quality management system.
- What are my obligations as a manufacturer before and after exporting products to the EU?
The manufacturer has responsibility for the conformity of the product to the applicable EU legislation, whether he designed and manufactured the product himself or is considered as a manufacturer because the product is placed on the market under his name or trademark. Where subcontracting takes place, the manufacturer must retain overall control of the product.
Under certain legislation, the manufacturer may be required to perform sample testing at the end of the production chain or for products already on the market.
Where the product presents a risk, manufacturers must immediately inform the competent national authorities of the member states in which the product is available. The manufacturer must provide the competent national authority with all the information and documentation necessary to demonstrate the conformity of a product.
A person who places second-hand products from a third-party country on the EU market, or any product not designed or manufactured for the EU market, must assume the role of the manufacturer. If an importer or distributor modifies a product or supplies it under his name, then he is to be considered the manufacturer.
Learn more about EU requirements applicable to non-food products on the website.