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General

Commission publishes guidelines on product compliance (GEN – 1222.00)

24 March 2021

3 min read
European Policy
General

Commission publishes guidelines on product compliance (GEN – 1222.00)

24 March 2021

3 min read

GEN – 1222.00. The European Commission has published guidelines for economic operators and market surveillance authorities on the practical implementation of Article 4 of the Market Surveillance Regulation. The document notably clarifies the scope and duties of economic operators regarding products placed on the EU market.

Article 4

Article 4 of the Market Surveillance Regulation stipulates that products covered by EU harmonised legislation may only be placed on the EU market if there is an economic operator established in the EU who is responsible for the declaration of conformity and liaising with market surveillance authorities.

Manufacturers must comply with Article 4 by 16 July 2021. If an economic operator has not been designated for a product according to Article 4 by that date, that product may not be placed on the EU market anymore.

Scope

There are harmonised product requirements covering electrical equipment, radio equipment, electromagnetic compatibility, restricting hazardous substances in electrical and electronic equipment (‘RoHS’), energy-related products (‘ecodesign’), gas appliances, construction products, machinery, outdoor equipment (‘outdoor noise’), equipment for use in potentially explosive atmospheres (ATEX), pressure equipment, and simple pressure vessels, among others.

The guidelines identify four kinds of economic operators which can be designated as per article 4 and the differences between them:

  • An authorised representative in the EU with a written mandate from the manufacturer
  • Or else, the manufacturer itself if established in the EU
  • Or else, an importer established in the EU if the manufacturer is not
  • Or else, a fulfilment service provider established in the EU in case none of the above applies

If a product is shipped from outside the EU directly to an end-user in the EU, an authorised representative in the EU must be duly mandated by the manufacturer for that product.

The name and postal address of the economic operator must be indicated either on the product, its packaging, the parcel, or the accompanying documentation. It is also recommended to include a website address, an email address, and a phone number. If there are multiple economic operators with different roles, it is advised to specify this.

Article 4 applies to products sold on online marketplaces as well. Online marketplaces can be economic operators if they are also fulfilment service providers.

Duties

The duties of economic operators as per Article 4 include:

  • Verifying that the declaration of conformity is drawn up and keeping it for 10 years
  • Verifying that the technical documentation is drawn up and ensuring that it can be made available to market surveillance authorities on request

If the operator believes that the product presents a risk, it must:

  • Inform the relevant market surveillance authorities in each Member States in which the product has been made available
  • Ensure that the necessary corrective action is taken immediately

Operators also have to duty to act within a reasonable timeframe if requested to do so by a market surveillance authority including to provide all relevant information and documentation, and generally to cooperate with the authorities.

If an operator is unable to fulfil its duties, it should cease to handle or place the products on the market and/or end its relationship with the manufacturer. It could also face sanctions.

The manufacturer remains responsible for the compliance of the product with sector-specific legislation and retains any legal obligations it has as regards products, guarantees, liability for defective products, etc.

Recommended actions

Manufacturers are advised to closely study the Commission guidance document to make sure they correctly implement Article 4 of the Market Surveillance Regulation by 16 July 2021. It is important to note that the document is purely for guidance and has no legal force.

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