On 11 July 2013 Regulation (EC) No 1223/2009 (Regulation) will replace the Cosmetics Directive of 1976 that used to rule cosmetic products in the European Union. Major aims of the Regulation are health protection, animal protection and consumer protection.

Background

Some parts of the new Regulation have already been in force, but the major portion will enter into effect on July 11. The Regulation does not contain transition provisions.

The fact that the new law is a regulation instead of a directive means the provisions apply directly in the Member States, without implementation measures being necessary.

Compared to food and pharmaceutical products, cosmetics were scarcely regulated in terms of product safety and consumer information. The new Regulation aims at increasing product safety with regard to cosmetic products.

Significant Changes

Market Surveillance

Similar to the regime under the Cosmetics Directive, a manufacturer has to designate a responsible person established in the European Community for every product placed in the common market. This person is responsible for the product’s compliance with EU law. The responsible person has to maintain a product information file available for inspection by the authorities, and the responsible person—as well as all other persons in the supply chain—has to be able to identify distributors to whom cosmetic products were supplied for a period of at least three years after the supply. If a product is found not compliant, the responsible person has to take the necessary steps to either achieve the product’s compliance or arrange for market withdrawal and recall, if necessary. Responsible persons and distributors have to cooperate with the Member States’ authorities if a product presents a risk to human health.

Furthermore, according to Art. 23 of the Regulation, responsible persons and distributors have to notify any serious undesirable effects of a product to the competent authority of the Member State where the undesirable effect occurred. To ensure compliance with this provision and to facilitate cooperation within the supply chain, a system should be implemented that clearly defines responsibilities in this regard in contractual agreements.

Before a cosmetic product is placed on the market, the responsible person has to notify certain information to the European Commission. This includes, among other data, the category of the product, the country of origin, the Member State, where the product is to be placed on the market and the use of certain ingredients. As opposed to the regime under the Cosmetics Directive, the new system is centralised and electronic. The Commission has created an online portal, the Cosmetic Products Notification Portal (CPNP), for the notification procedure. Any cosmetic products that are on the EU market have to be notified via CPNP by 11 July 2013.

Limitations for Several Substances

The annexes of the Regulation contain substances that are prohibited for the use in cosmetic products and substances that are restricted. This concerns in particular substances that are recognized as carcinogenic, mutagenic or toxic for reproduction (CMR). CMR are generally prohibited in cosmetic products, but a substance under CMR-category 2 may be used if it has been evaluated by the Scientific Committee on Consumer Safety and found safe for use in cosmetic products.

Consumer Information and Advertising

The Regulation broadens the manufacturer’s duties with regard to labelling of cosmetic products. The most important new addition is the duty to label nanomaterials. This has been welcomed by consumer protection organisations, as nanomaterials are still regarded with some suspicion.

The Regulation contains a specific provision on advertising of cosmetic products (Art. 20). Before the new Regulation, advertising for cosmetic products had not been specifically regulated in EU law, though misleading advertising was prohibited by general law. Now, the Regulation calls for the creation of a list of criteria for claims, which may be used in respect to cosmetic products. On 11 July 2016, the Commission will, together with the European Council and Parliament, compare the claims used in advertising of cosmetic products with the criteria created under Art. 20. If it is found that the used claims are not in conformity with the common criteria, the Commission, in cooperation with the Member States, will take further measures to ensure conformity.

Furthermore, under the new Regulation, the responsible person must make information on the cosmetic product available to the public (Art. 21). This concerns the composition of the product and the identity of the supplier, as well as available data on undesirable effects. The provision claims that this be applied without prejudice to the protection of commercial secrecy and intellectual property (IP) rights, but does not state clearly where access to information for the public has to end to protect these rights. This has given rise to concerns if it will be possible to ensure effective protection of IP rights under the Regulation.

Prohibition of Animal Testing

The Regulation prohibits the performance of animal testing in the European Union for finished products as well as for ingredients. Furthermore, it prohibits products to be placed on the EU market if the final formulation has been the subject of animal testing or the product contains an ingredient or a combination of ingredients that has been subject to animal testing. In exceptional cases, Member States can try to obtain an exemption from the Commission regarding ingredients in wide use. If no animal testing was performed in connection with the product, Art. 20 allows for the use of the fact that a product is manufactured without any animal testing as a claim in advertising.

As the Regulation applies directly in the Member States, no implementation steps have to be taken. In Germany, where cosmetic products used to be governed by a national regulation, the national law will be replaced by the new EU Regulation. In France, many of the provisions of the new Cosmetics Regulation already form part of the French Public Health Code (FPHC). In the future, the EU Regulation will apply alongside the FPHC.