Market surveillance and product conformity

Regulation 765/2008 and the Product Directive in the light of the new features of Regulation (EU) 2019/1020 for products that are imported from non-EU countries. AC&E (internationally accredited laboratory in the field of safety, validation and testing) provides elucidation on this issue.

Even in Europe, where there is a very competitive and regulated market, it has been decided to implement its supervision, increasing the number of checks on products and their compliance. Therefore, barriers have begun to be put in place, which economic operators have wanted to highlight.

On July 16, 2021 the new European Regulation 2019/1020 came into force, which aims to fill a gap in the control of products imported from non-EU countries regulated by product Directives but which, until now, did not provide for the figure of the authorized representative.

Fundamental news in fact is that every non-EU manufacturer will no longer be able to export goods within the EU without first defining and identifying an Authorized Representative or an Authorized Representative; furthermore, all documentation attesting to the CE conformity of the product must reside within the European Union.

The Regulation identifies the economic operators, i.e. the subjects to whom the provisions of the Regulation apply, involved in the process of placing the product on the market:

• EU-based  manufacturer;
• importer, if the manufacturer is not established in the EU;
• an authorized representative who has received a written mandate from the manufacturer;
• a logistics  service provider established in the EU, with respect to products handled by it if no other economic operator is established in the EU.

Questions and Answers

What changes for importers and logistics service providers?

It becomes the obligation of one of the economic operators mentioned above, i.e. the importer and the logistics operator in the absence of a representative, to ensure that all the documentation and declarations of conformity required by the product regulations are presented when the product is placed on the market. It is also established the obligation to keep such documentation at their premises or a specific address and to make this documentation available to the authorities if requested. The Regulation does not specify the requirements for individual products, but refers to the various applicable directives, thus leaving it up to the economic operator to know the requirements of the products he is importing.

What are the risks?

The risks involved in importing activities or logistics services change radically with this update of the European regulations; penalties for the mere lack of technical documentation range from 30,000.00 to 60,000.00 euros; penalties for fatal accidents caused by products potentially fall on the importer, the economic operator or the authorized representative.

Is E-commerce included in the new Regulations?

Yes, the Regulation establishes in Art. 6 that products sold through distance channels are to be considered as available on the market if the offer is intended for end users in the European Union.