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Product Information

ARTICLE 8

1. The company or person responsible for placing the cosmetic product in the market shall keep the following information readily accessible to the regulatory authority of the Member State concerned at the address specified on the label in accordance with Article 6 of this Directive:

a) the qualitative and quantitative composition of the product; in case of perfume compositions, the name and code number of the composition and the identity of the supplier;

b) specifications of the raw materials and finished product;

c) the method of manufacture complying with the good manufacturing practice as laid down in the ASEAN Guidelines For Cosmetic Good Manufacturing Practice appearing as Appendix VI; the person responsible for manufacture or importation into the market must possess adequate knowledge or experience in accordance with the legislation and practice of the Member State which is the place of manufacture or importation;

d) assessment of the safety for human health of the

e) existing data on undesirable effects on human health resulting from use of the cosmetic product; and

g) supporting data for claimed benefits of cosmetic products should be made available; to justify the nature of its effect.

2. The information referred to in paragraph 1 of this Article must be available in the national language or languages of the Member State concerned, or in a language readily understood by the regulatory authority.

3. A Member State may, for purposes of prompt and appropriate medical treatment in the event of difficulties, require that appropriate and adequate information on substances used in cosmetic products be made available to the regulatory authority which shall ensure that this information is used only for the purposes of such treatment.

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