Sweden Cosmetic Product Registration

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 description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;
• The cosmetic product safety report referred to in Article 10(1);
• A description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;
• Data on any animal testing performed by the manufacturer, his 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.

3. The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.

Notification

Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission:

(a) The category of cosmetic product and its name or names, enabling its specific identification.

(b) The name and address of the responsible person where the product information file is made readily accessible.

(c) The country of origin in the case of import.

 (d) The Member State in which the cosmetic product is to be placed on the market.

 (e) The contact details of a physical person to contact in the case of necessity.

 (f)  The presence of substances in the form of nanomaterials and:

 (i)  Their identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI to this Regulation.

 (ii) The reasonably foreseeable exposure conditions.

(g) The name and the Chemicals Abstract Service (CAS) or EC number of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008.

 (h) The frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties