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.
Overview of Cosmetics Regulation (EC) No 1223/2009
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.
Definition of Cosmetics
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.
Product Safety Assessment
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).
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:
(a) a description of the cosmetic product
(b) the cosmetic product safety report
(c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice;
(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, 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.
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.
The information required in the notification includes:
(a) the category of cosmetic product and its name or names;
(b) the name and address of the responsible person;
(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 Abstracts 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.
(k) Notification to the EC of the original labelling, and, where reasonably legible, a photograph of the corresponding packaging
Requirements on Ingredients
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.
Annex II - list of banned substances
Annex III - list of restricted substances
Annex IV - list of allowed colorants
Annex V - list of allowed preservatives
Annex VI - list of allowed UV-filters
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.
Animal Testing Ban
The EU cosmetics regulation implements two types of bans:
Testing ban – prohibition to test finished cosmetic products and cosmetic ingredients on animals;
Marketing ban – prohibition to market finished cosmetic products and ingredients in the EU which were tested on animals.
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:
the name or registered name and the address of the responsible person
the nominal content at the time of packaging, given by weight or by volume
date of minimum durability: best use before end of xxxx
particular precautions to be observed in use
the batch number of manufacture or the reference for identifying the cosmetic product the function of the cosmetic product, unless it is clear from its presentation
Labeling shall not imply that these products have characteristics or functions which they do not have.
How to Comply
You need to do the following things to comply with the EU cosmetics regulation.
Review cosmetic ingredients and only use compliant cosmetic ingredients
Manufacture cosmetics in accordance with GMP
Appoint a responsibel person in EU
Carry out product safety assessment
Prepare a compliant product label
Responsible person notifies a product to the EC before launch
Responsible person prepares and keeps product information file
Comply with animal test ban
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products - consolidated text
Ban on Animal Testing