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Commission Implementing Decision (EU) 2019/417Show full title

Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (notified under document C(2018) 7334)

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3.2. Content of notifications U.K.
3.2.1. Scope of data U.K.

Notifications sent to the Commission through the RAPEX application include the following types of data:

(a)

Information enabling the notified product to be identified, i.e. product category, product name, brand, model and/or type number, barcode, batch or serial number, customs code, description of the product and its packaging accompanied by pictures showing the product, its packaging and labels. Detailed and accurate product identification is a key element for market surveillance and enforcement, as it allows national authorities to identify the notified product, to distinguish it from other products of the same or similar type or category that are available on the market and to find it on the market and take or agree on appropriate measures.

(b)

Information establishing the product's origin, i.e. country of origin, name, address and contact details, such as telephone number and e-mail address, of a manufacturer and exporters. In particular, Member States provide all available information on manufacturers and exporters located in third countries that cooperate closely with the EU on product safety. The following documents are also to be attached to the form where available: copies of orders, sales contracts, invoices, shipping documents, customs declarations, etc. These documents should be transmitted in pdf format or any other format accepted by the application. Detailed information on third country producers allows the Commission to promote more effective enforcement in those countries and helps to reduce the number of products posing a risk to consumers exported into the EU.

(c)

Wherever possible, information about where exactly the product has been made available (a major store, local shop or market, online, etc.).

(d)

Information on the safety requirements applicable to the notified product, including the reference number and name of the applicable legislation and standards.

(e)

A risk description of the notified product, including a description of the results of laboratory or visual tests, test reports and certificates proving non-compliance of the notified product with the safety requirements, a complete risk assessment with conclusions and information on known accidents or incidents (see Part I Chapter 3.3.1 of these Guidelines).

(f)

Information on the supply chains of the notified product in the Member States and, in particular, information on the countries of destination, plus information on importers and also, if available, on distributors of the notified product in Europe.

(g)

Information on measures taken, in particular, the type (compulsory or voluntary), category (e.g. withdrawal from the market, recall from consumers), scope (e.g. national, local), and date of entry into force and duration of the measure (e.g. permanent, temporary).

(h)

Indication of whether a notification, part of it and/or attachment(s) are covered by confidentiality. Requests for confidentiality are always accompanied by a justification clearly stating the reasons for such a request.

(i)

Information on whether the product is counterfeit, when available. For this purpose, the Commission will provide Member States with any specific tools available at European level to facilitate the identification of counterfeit products.

(j)

Information on reported accidents related to the product, indicating when possible the reasons for the accident (risk related to the use made by the user or inherent to the product).

(k)

Additional information on whether the notification has been submitted in the context of a coordinated enforcement activity at European level.

(l)

Information on whether the authorities of a Member State envisage sending other notifications related to the same product or similar products. This should be indicated in the original notification.

Member States are encouraged to look for and provide information on the supply chains of the notified product in non-EU countries that cooperate closely with the EU on product safety.

3.2.2. Completeness of data U.K.

Notifications should be as complete as possible. The elements to be contained in the notification are listed in Appendix 1 to these Guidelines and are included in the RAPEX application. All fields of the notification template should be completed with the required data. Where the required information is not available at the time a notification is submitted, this is clearly indicated and explained on the form by the notifying Member State. Once the missing information becomes available, the notifying Member State updates its notification. The updated notification is examined by the Commission before being validated and distributed through the system.

RAPEX Contact Points provide all national authorities that participate in the RAPEX network with instructions on the scope of data required to complete the notification. This helps to ensure that the information provided by these authorities to the RAPEX Contact Point is correct and complete (see Part II, Chapter 5.1).

Where part of the information required by these Guidelines is not yet available, Member States should nonetheless comply with the established deadlines and not delay sending a RAPEX notification on a product that poses a life-threatening risk to the health and safety of consumers or other end-users and/or where a RAPEX notification requires emergency action by Member States.

Before submitting a notification, the RAPEX Contact Point checks (to avoid any unnecessary duplication) that the product concerned has not already been notified through the RAPEX application by another Member State. If the product has already been notified, rather than creating a new notification, the RAPEX Contact Point submits a follow-up notification to the existing notification and provides any additional information that may be relevant for authorities in other Member States, such as additional vehicle identification numbers, a detailed list of importers and distributors, additional test reports, etc. (See also Part II, Chapter 5.1).

3.2.3. Updating of data U.K.

The notifying Member State informs the Commission (as soon as possible and not later than by the deadlines specified in Appendix 4 to these Guidelines) of any developments that require changes to a notification transmitted through the RAPEX application. In particular, Member States inform the Commission of any changes (e.g. following a ruling by a court during an appeal procedure) to the status of the notified measures, to the risk assessment and to new decisions regarding confidentiality.

The Commission examines the information provided by the notifying Member State and updates the information concerned in the RAPEX application and on the RAPEX website, where necessary.

3.2.4. Responsibility for the information transmitted U.K.

Responsibility for the information provided lies with the notifying Member State(1).

The notifying Member State and the national authority responsible ensure that all data provided through the RAPEX application are accurate so as to avoid any confusion with similar products of the same category or type that are available on the EU market.

The authority(ies) involved in the notification procedure (e.g. by performing the risk assessment of the notified product or by providing information on distribution channels) take responsibility for the information provided through the RAPEX application. The RAPEX Contact Point checks and validates all notifications received from the authorities responsible before transmitting them to the Commission (See also Part II, Chapter 5.1).

Any action taken by the Commission, such as examining notifications, validating and distributing them through the RAPEX application and publishing them on the RAPEX website, does not imply any assumption of responsibility for the information transmitted, which remains with the notifying Member State.

(1)

See point 10 of Annex II of Directive 2001/95/EC.

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