Do you supply CE marked goods or products, including machinery, into the European Union (EU)?
If yes, there is a new Regulation 2019/1020 on market surveillance and compliance of products that comes into force on 16 July 2021.
This Regulation prohibits the placing on the market of certain goods unless there is an ‘economic operator’ established in the EU, with responsibility for ensuring the conformity documentation is available, co-operating with market surveillance authorities and informing authorities, if there are reasons to believe that a product presents a risk.
Economic operators are defined as:
- The manufacturer of the goods
- The importer (where the manufacturer is not established in the EU)
- A fulfilment service provider when none of the above are established in the EU
- An authorised representative
These are defined as
- Manufacturer: means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark
- Importer: means any natural or legal person established within the Union who places a product from a third country on the Union market
- Fulfilment service provider: means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council ( 31), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council ( 32), and any other postal services or freight transport services
- Authorised representative: means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation
For machinery manufacturers, based outside of the EU, there must currently be a person to ‘compile’ the Technical File, identified on the Declaration of Conformity, effectively someone to provide the Technical File within the EU. This person has no responsibility other than providing a Technical File on reasoned request from authorities, such as Trading Standards and the Health & Safety Executive.
From July 2021, the new regulation requires an authorised representative, with a mandate to co-operate with the authorities, if there is no other economic operator.
The requirements apply to products affected by Directives listed in Annex I of 2019/1020.
A Union Product Compliance Network is being established from 1 January 2021, the purpose of the Network is to ‘serve as a platform for structured coordination and co-operation between enforcement authorities of the member states and the Commission, and to streamline the practices of market surveillance within the Union, thereby making market surveillance more effective’.
Producers based in the EU are regarded as economic operators. However, producers located outside the EU and who do not appoint an importer or authorised representative to perform this role, the responsibility automatically falls to an online marketplace or fulfilment house, where one is involved in arranging the transaction.
This information was supplied to the PPMA by Hold Tech Files, who can compile Technical Files for the Machinery Directive. They can also act as authorised representative for any of the Directives listed in Annex I.
For more information, visit: www.holdtechfiles.eu