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Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)
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1.In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred:
(a)all serious undesirable effects which are known to him or which may reasonably be expected to be known to him;
(b)the name of the cosmetic product concerned, enabling its specific identification;
(c)the corrective measures taken by him, if any.
2.Where the responsible person reports serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States.
3.Where distributors report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States and to the responsible person.
4.Where end users or health professionals report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information on the cosmetic product concerned to the competent authorities of the other Member States and to the responsible person.
5.Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.
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