S.L. 427.55 Art. 6Procedures for the application of RAPEX. S.L. 427.14

(1) RAPEX shall cover products as defined in article 2 of the Act that pose a serious risk to the health and safety of consumers.

(2) RAPEX is essentially aimed at a rapid exchange of information between Member States in the event of a serious risk. Subregulations (3) to (7) defines specific criteria for identifying serious risks.

(3) When a notification is being effected under regulation 5(3), all available details shall be provided in such manner that -

(a) in particular, the notification shall contain the information stipulated in the guidelines referred to in subregulation (7), and including:

(i) information enabling the product to be identified;

(ii) a description of the risk involved, including a summary of the results of any tests and, or analyses and of their conclusions which are relevant to assessing the level of risk;

(iii) the nature and the duration of the measures or action taken or decided on, if applicable;

(iv) information on supply chains and distribution of the product, in particular on destination countries;

(b) such information shall be transmitted using the special standard notification form and by the means stipulated in the guidelines in subregulation (7);

(c) when the measure notified pursuant to regulation 5(1) or 5(3) seeks to limit the marketing or use of a chemical substance or preparation, either a summary or the references of the relevant data relating to the substance or preparation considered and to known and available substitutes, where such information is available, shall be provided as soon as possible. The anticipated effects of the measure on consumer health and safety together with the assessment of the risk carried out in accordance with the general principles for the risk evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No 793/93(3) in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC - transposed by virtue of the Dangerous Substances (Notification)

Regulations - in the case of a new substance shall also be communicated. The guidelines referred to in subregulation (7) shall define the details and procedures for the information requested in that respect.

(4) When the Director has informed the Director of Market Surveillance, in accordance with regulation 5(5), of a serious risk before deciding to adopt measures, the Director of Market Surveillance shall inform the Commission within forty-five days whether this information has been confirmed or modified.

(5) Upon receipt of any notification referred to in regulation 5, the Director of Market Surveillance shall inform the Commission, at the latest within the set period of time stipulated in the guidelines referred to in subregulation (7), of the following:

(a) whether the product has been marketed in the Maltese territory;

(b) what measures concerning the product in question are being adopted in the light of the country’s circumstances, stating the reasons, including any differing assessment of risk or any other special circumstance justifying the decision, in particular lack of action or of follow-up;

(c) any relevant supplementary information he has obtained on the risk involved, including the results of any tests or analyses carried out: Provided that the guidelines, referred to in subregulation (7), shall provide precise criteria for notifying measures limited to the national territory and shall specify how to deal with notifications concerning risks which are considered by the Member State not to go beyond its territory.

(6) The Commission shall be immediately informed of any modification or lifting of any measure or action in question.

(7) Guidelines concerning the management of RAPEX by the Commission and the Member States shall be prepared and regularly updated. The procedure used shall be that laid down in Article 15(3) of the Directive.