(8) Upon receipt of a notification from the European Commission under article 12(2) of the GPS Directive, the Secretary of State shall notify the Commission of the following—
- (a) whether the product the subject of the notification has been marketed in the United Kingdom;
- (b) what measure concerning the product the enforcement authorities in the United Kingdom may be adopting, stating the reasons, including any differing assessment of risk or any other special circumstance justifying the decision as to the measure, in particular lack of action or follow-up; and
- (c) any relevant supplementary information he has obtained on the risk involved, including the results of any test or analysis carried out.
(9) The Secretary of State shall notify the European Commission without delay of any modification or withdrawal of any measures notified to it under paragraph (8)(b).
(10) In this regulation—
- (a) references to a product excludes a second hand product supplied as an antique or as a product to be repaired or reconditioned prior to being used, provided the supplier clearly informs the person to whom he supplies the product to that effect;
- (b) “pharmaceutical product” means a product falling within Council Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(a)[1].
Provisions supplemental to regulation 33
34.—(1) A notification under regulation 33(2) to (6), (8) or (9) to the Secretary of State or the Commission shall be in writing and shall provide all available details and at least the following information—
- (a) information enabling the product to be identified,
- (b) a description of the risk involved, including a summary of the results of any test or analysis and of their conclusions which are relevant to assessing the level of risk,
- (c) the nature and the duration of the measures or action taken or decided on, if applicable,
- (d) information on supply chains and distribution of the product, in particular on destination countries.
(2) Where a measure notified to the Commission under regulation 33 seeks to limit the marketing or use of a chemical substance or preparation, the Secretary of State shall provide to the Commission as soon as possible 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. The Secretary of State shall also notify the Commission of 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 Council Regulation (EEC) No. 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(b)[2], in the case of an existing substance, or in article 3(2) of Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (c)[3] in the case of a new substance.
(3) Where the Commission carries out an investigation under paragraph 5 of Annex II to the GPS Directive, the Secretary of State shall supply the Commission with such information as it requests, to the best of his ability.
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