The market regulation of the European Union (EU) 20191020 has enforced EU’s Responsible Person

October 11 16:56 2021


On 16 July 2021, the new EU commodity safety regulation, EU Market Regulation (EU)2019/1020, entered into force and became enforceable. The new regulations require that products bearing the CE mark need to have a person in the EU as the compliance contact (referred to as the “EU responsible person”). This requirement also applies to products sold online. With the exception of medical devices, civil explosions and certain lift and ropeway devices, all goods bearing the CE mark are covered by this regulation. If you are selling goods bearing the CE mark and manufactured outside the EU, you need to ensure by 16 July 2021 that:

• such goods have a responsible person in the European Union;

• merchandise with the CE logo bears the contact information of responsible person. Such labels may be attached to merchandise, merchandise packages, packages, or accompanying documents.EU’s Responsible Person

• A manufacturer or trademark established in the EU·

• An importer (by definition established in the EU), where the manufacturer is not established in the Union·

• An authorised representative (by definition established in the EU) who has a written mandate from the manufacturer designating the authorised representative to perform the tasks on the manufacturer’s behalf·

• A fulfillment service provider established in the EU where there is no manufacturer, importer or authorised representative established in the Union The act of the EU responsible person

• keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities,providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority.

• when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof.

• cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with the requirements. Any violation of the requirements of EU responsible person will be considered a violation of the law and the product will be suspended from the EU market.

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