28. November 2013
The EU’s Regulation on cosmetic products came into force on 11.07.2013. The aim of the regulation is to ensure a high standard of security for consumers, whilst at the same time guaranteeing the free movement cosmetic products. Here is an overview of its main provisions.
Cosmetic products and EU law
The EU’s Regulation on Cosmetic Products ((EC) No 1223/2009) replaces previous EU law and domestic legal provisions on the topic.
The regulation applies to producers of cosmetics and also places tough obligations on distributors of cosmetic products.
The main aims of the regulation are to provide increased safety and security for consumers’ health, to ensure consumers are well informed about the products they use and to improve animal protection.
A distinctive feature of the regulation, and indeed all EU regulations, is its direct applicability in member states. That means member states are not required to transpose the provisions into domestic law.
A further distinctive feature is that the regulation applied as soon as it came into effect. There was no transitional period or grace period to allow cosmetic businesses time to adjust. Only products which had already been delivered were exempt from the provisions of the regulation and therefore did not need to be adapted.
Producers of cosmetic products must fulfil strict obligations. Under the new rules, all products, whether they are creams, mascara or toothpaste, are subject to a product-related notification process. Some of producers’ obligations include:
- Before placing a product on the market, notification must be given so that it can be registered in a database.
- The details that must be provided include the frame formulation, the responsible producer, the Member State in which the cosmetic product is to be placed on the market, and in cases where the cosmetic product is to be imported, the country of origin.
- Whereas it was sufficient under previous legislation for a product to not endanger consumers’ health, producers must now be certain of that fact and may be asked to provide evidence.
Stricter labelling obligations
The regulation also tightens labelling obligations. The following information must now be displayed on the labelling of the product packaging:
- The company or person responsible for the product
- The function of the cosmetic product
- The best-before-end date
- Particular precautions to be observed when using the product
- Nominal content at the time of packaging, given by weight or by volume, except where the product is less than five grams or five millilitres, or is a free sample or single-application pack
- The batch number or reference number
These details must be easily legible, visible and indelible. Where the cosmetic product is to be sold in Germany, the details must be written in German.
As almost all cosmetic products on the market in Germany are contained in packaging that displays this information, it is reasonable to assume that little has changed for producers in this respect.
Distributors’ monitoring obligations
For distributors of cosmetic products, however, the story is different. Before they place a product on the market for sale in a shop or online, they must check that:
- the relevant information is displayed on the label
- the information is in German
- the best-before-end date has not expired
Where the cosmetic product to be placed on the market does not conform to the above-mentioned criteria, the distributor is prohibited from selling the product until conformity has been achieved.
Furthermore, where a cosmetic product presents a risk to human health, distributors must immediately inform the producer and the competent national authorities of the Member States in which the product is to be made available.
Consequences of breaching the provisions of the cosmetics regulation
The cosmetic products regulation does not yet provide for specific offences. Breaches of its provisions, however, can lead to distributors being punished under competition law provisions. As many of the rules contained in the regulation are concerned with market behaviour, competitor business are also able to send warning letters to businesses that breach the provisions and they can claim reimbursement of the legal fees for doing so.
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Categories: Medical Law