Little Pro on 2018-10-19
Regulation (EC) No 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products placed on the EU market. It repeals the EU cosmetics Directive (Directive 76/768/EC) and comes into force on 11 July 2013. The regulation not only impacts manufacturers and importers of cosmetic products, but also affects suppliers of cosmetic ingredients. In this article, we will summarize how to comply with EU cosmetics regulation from different perspectives.
The regulation requires manufacturers of cosmetics to prepare a product safety report prior to placing a product on the market and notify their products via the EU Cosmetic Products Notification Portal (CPNP). Anyone who wishes to place finished cosmetics on EU market must appoint a legal or natural person within the EU to undertake compliance obligations. In addition, the regulation prohibits the placing on the EU market of cosmetic products where the final formulation, ingredients or combinations of ingredients, and/or finished products have been the subject of animal testing.
A cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
A responsible person is usually the manufacturer or importer of finished cosmetic products based in EU. Non-EU manufacturers of cosmetics shall appoint a legal person or natural person within the EU to undertake regulatory obligations such as carrying out product safety assessment, submitting product notifications, keeping product information file (PIF) and reporting serious undesirable effects.
The responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment by taking into account of the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients. The assessment shall be carried out by a person in possession of a diploma or other evidence of formal qualifications.
The cosmetic product safety report shall be included as part of product information file (PIF).
When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it for a period of ten years following product launch.
The product information file shall contain the following information and data which shall be updated as necessary:
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.
Prior to placing on the market, the Responsible Person shall submit electronically a product notification to the European Commission via EU Cosmetic Products Notification Portal (CPNP).
The information required in the notification includes:
The regulation has set out banned and restricted substances in cosmetics. For colorants, preservatives and UV-filters, only those on positive lists can be used.
Those lists can be searched via EU Cosmetic Ingredient Database (EU CosIng).
In addition, the use of substances classified as CMR substances, of category 1 or category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 are also prohibited except some category 2 substances that have been evaludated by SCCS and found safe.
It is expected that the use of substances with endocrine-disrupting properties in cosmetics will also be banned.
Cosmetic products containing nanomaterials (other than listed colourants, preservatives and UV-filters) shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market. Data needed includes the identification and specification of the naomaterials, toxicological profiles, safety data and reasonably foreseeable exposure conditions.In addtion, In addition, product labels must clearly indicate any ingredients in the form of nanomaterials ('nano' in brackets). Nanomaterials must be authorised by the European Commission prior to their use in cosmetic products.
Up until now, the Commission has authorised 3 UV-filters as nanomaterials: titanium dioxide, zinc oxide and tris-biphenyl triazine. It has also allowed carbon black (nano) for use as a colourant in cosmetic products.
The Catalogue of nanomaterials used in cosmetic products can be downloaded here.
The EU cosmetics regulation implements two types of bans:
The testing ban on finished cosmetic products applies since 11 September 2004; the testing ban on ingredients or combination of ingredients applies since 11 March 2009.
The marketing ban applies applies to all human health effects since 11 March 2013, irrespective of the availability of alternative non-animal tests.
The following information needs to be indicated on product labels:
Labeling shall not imply that these products have characteristics or functions which they do not have.
You need to do the following things to comply with the EU cosmetics regulation.
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