Products that are unsafe and fail to comply with EU legislation may not be placed on the market within the European Union. In order to prevent these products from reaching the market, the European Commission has set out a conformity assessment procedure involving testing by an independent body for certain cases. How, though, does this procedure work for manufacturers in countries outside the EU wishing to market their products in the EU?
Under EU product safety regulations, responsibility for certifying a product's compliance with the legislation and applying CE marking generally lies with the manufacturer of the product. For some products however, the conformity assessment procedures require testing by an independent, notified body. These conformity assessment bodies are appointed ("notified") by the EU Member States and listed in an information system maintained by the European Commission (VNANDO database of all currently notified bodies). There are currently 1429 notified bodies in the EU (205 of them in Germany) for all product groups.
The regulations governing notification of the conformity assessment bodies and the requirements to be met by them are set out in Decision 768/2008/EC, Chapter R4. They must be independent, impartial third parties that have no connection whatsoever with the product that is to be assessed. They must for example not be involved in the product's design, construction or marketing. They must also demonstrate technical expertise and financial independence. These and numerous other requirements are assessed and compliance with them regularly monitored by the notifying authorities. Notified bodies may offer conformity assessment activities to any economic operator within or outside the EU. The manufacturers are also free to choose any conformity assessment body.
Arrangements for non-EU countries
The Agreement on the European Economic Area (EEA) unites the EU Member States and the EFTA states (European Free-Trade Association: Iceland, Liechtenstein, Norway, Switzerland) – with the exception of Switzerland – in a common single market. It guarantees the participating countries the same rights and obligations, including those concerning notification and conformity assessment.
Other countries (Switzerland, USA, Canada, Australia, Japan, New Zealand and Israel) have concluded bilateral agreements with the EU. Through these "Mutual Recognition Agreements" (MRAs), third countries – whose products are of course also subject to the EU legislation governing the placing of products on the market in the EU – are granted simplified access to the EU's Single Market. This would for example also be an option for the United Kingdom following Brexit.
The aspects regulated by MRAs include recognition of certification by conformity assessment bodies located in the country from which a product is exported. Following such certification, no further technical assessments or administrative steps are required in the EU. Each MRA relates to one or several particular product groups. The MRAs make provision for the responsible authorities in the third country to determine and notify suitable conformity assessment bodies. The criteria and procedures for notification are set out in the MRAs, and are largely identical to the criteria for notified bodies in the EU Member States.
Where third-party assessment is required, importing products into the European Single Market is much more complex for manufacturers in countries that are not members of the EEA or have not reached an MRA with the EU. Notified bodies do not exist in these countries. The manufacturers must therefore take their products out of the country for the purpose of testing, or have them tested locally by a foreign body at great expense.
However, the option also exists in such cases of subcontracting testing to subsidiaries or subcontractors (Decision 768/2008/EC, Article R20). This arrangement enables bodies notified by the EU to assign the task of testing to other conformity assessment bodies in any country. The subcontracting notified body is responsible for ensuring that the subcontractor observes the EU's requirements concerning notified bodies. It must also inform the notifying authority of the procedure, and is fully responsible for the task assigned. The customer must agree to testing being subcontracted. The benefit of this arrangement for the customer is clear: he does not have to have his products tested in another country.
head of unit DGUV Test