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Regulation (EC) No 1223/2009 of the European Parliament and of the CouncilShow full title
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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- Revised 03/12/20202.77 MB
- Revised 01/05/20202.66 MB
- Revised 18/12/20192.59 MB
- Revised 27/11/20192.54 MB
- Revised 13/08/20192.44 MB
- Revised 17/06/20192.55 MB
- Revised 01/08/20182.09 MB
- Revised 11/07/20182.08 MB
- Revised 25/12/20172.08 MB
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- Revised 12/08/20162.01 MB
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- Revised 29/08/20142.36 MB
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- Revised 11/07/20133.61 MB
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Changes over time for: Article 11
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Article 11U.K.Product information file
1.When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
2.The product information file shall contain the following information and data which shall be updated as necessary:
(a)a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
(b)the cosmetic product safety report referred to in Article 10(1);
(c)a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;
(d)where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
(e)data on any animal testing performed by the manufacturer, [F1their] agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
[F23.The responsible person must make the product information file readily accessible to a competent authority in an electronic or other format at the address notified in accordance with Article 13 as the address at which the product information file is kept.]
[F34.The information contained in the product information file must be in English.]
Textual Amendments
F1Word in Art. 11(2)(e) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 34 para. 11(a) (as amended by S.I. 2020/676, regs. 1(1), 3); 2020 c. 1, Sch. 5 para. 1(1)
F2Art. 11(3) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 34 para. 11(b) (as amended by S.I. 2020/676, regs. 1(1), 3); 2020 c. 1, Sch. 5 para. 1(1)
F3Art. 11(4) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 34 para. 11(c) (as amended by S.I. 2020/676, regs. 1(1), 3); 2020 c. 1, Sch. 5 para. 1(1)
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