Regulation (EC) 1223/2009 came into force on 11 July 2013, changing the regulation of cosmetics in the EU and applying directly to all Member States. The Regulation focuses on consolidation - both in terms of legislative obligations and of information - and on enhancing consumer safety.

Key changes

From 11 July 2013, manufacturers will be required to notify their products online via the EU Cosmetic Products Notification Portal. This requirement will apply in respect of both new and existing products.

Each cosmetic product must have a designated responsible person who ensures conformity with the Regulations. In addition, distributors are bound by certain articles which pertain to product safety. Not only are responsible persons and distributors required to verify compliance with labelling, language and durability requirements, they must also refrain from making products available (or recall products, as the case may be) where they have reason to believe that they are not in conformity with the Regulation. Further to this, where non-conformity presents a risk to human health, the responsible person or distributor is required to inform the competent national authority of the market in which the product was made available for sale, giving details of the non-compliance and of the corrective measures taken. A statutory obligation to cooperate with the relevant national authorities has been imposed.

In order to enhance supply chain safety, both responsible persons and distributors will be required, for a period of three years from the date on which the batch of the cosmetic product was made available, to monitor to whom they have made supplies.

Information keeping requirements have been bolstered, as the Regulation requires product information to be kept by a responsible person for a period of ten years following the date on which the last batch of the cosmetic product was released.

Specific requirements around product claims in advertising of cosmetic products have been introduced, mandating that product claims shall not be used to imply that cosmetic products have characteristics or functions which they do not actually have. The Commission has established a list of common criteria which all claims made in respect of cosmetic products must conform to from 12 July 2013 onwards.

Nanomaterials must be clearly indicated in the ingredients list with the name of such ingredients followed by the world 'nano' in brackets.

The Regulation also prohibits the use of animal testing in the European Union for finished products, ingredients or combinations of ingredients.

Conclusion

In the UK, penalties for breach of the Regulation have been addressed by the Cosmetic Products Enforcement Regulations 2013, which increases the maximum level of fine from GBP 5,000 to GBP 20,000 for some offences (e.g. labelling, identification within supply chain, distributor's obligations), and doubles the maximum imprisonment sentence on indictment for the most serious offences to 12 months.

Through the Regulation, cosmetic products could now be said to be regulated more in line with how medical devices and pharmaceutical products are regulated. The greater transparency around supply chains, safety information and product labelling introduced will no doubt be welcomed by consumers, giving them greater confidence in their cosmetic products. For manufacturers and distributors, the Regulation presents an increased regulatory burden and current practices will need to be carefully reviewed and new practices put in place to ensure compliance with the new requirements.