The European Cosmetics Regulation

Key facts:

Any cosmetic product made available on the EU market must comply with Regulation (EC) 1223/2009, namely the EU Cosmetics Regulation
This Regulation was issued on November 30, 2009, and became fully applicable in the EU on July 11, 2013, and is the primary legal framework for cosmetic products
Non-EU manufacturers wishing to place their products on the EU market must appoint an EU Responsible Person (RP)
Cosmetic products’ compliance must be stated through the Product Information File (PIF)

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Choose Obelis as your Responsible Person

European Responsible Person (EU RP):

For cosmetic products, Regulation (EC) 1223/2003 states that it is mandatory to designate a Responsible Person (Article 4(1)). The RP will be responsible for ensuring that all the obligations related to product conformity have been carried out before placing the product on the European Market. It will also act as the Cosmeto-Vigilance contact point in Europe in case of any undesirable effects.

As your EU RP, Obelis will:

• Perform a Formulation Review

• Compile your Product Information File (PIF)

• Conduct a Labelling Review

• Validate your Claims

• Connect you with our partners for Safety Assessment & Tests

• Complete your cosmetic product notification (CPNP)

• Provide support with language requirements & translation of labels

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On November 30, 2009, the European Commission issued the EU Cosmetics Regulation (Regulation (EC) 1223/2009). It then became fully applicable on July 11, 2013, completely replacing the previous law, the Cosmetics Directive 76/768/EEC.

The general objective of this Regulation is to cover the gaps from the previous Directive and to harmonize the European Market. It aims at ensuring the free movement of cosmetic products within the EEA market and the safety of users in Europe.

Since a regulation does not require to be transposed into national legislation, Member States cannot add or remove requirements. Hence, Regulation 1223/2009/EC brings the EU cosmetics market even greater uniformity.

Amongst the requirements of the EU Cosmetics Regulation, there is the need to prove product conformity with the requirements through the Product Information File. Additionally, it assigns greater responsibility to the EU Responsible Person (RP) since cosmetic products may be placed on the EU market only if an EU RP has been designated for them.

Finally, the Regulation brings a new centralized pre-market notification system. It implies that all cosmetic products must be notified to the Cosmetic Products Notification Portal (CPNP) before being placed on the EU market and that one notification covers the whole EU. Once the RP notifies a product to the CPNP, the product may circulate in all EU Member States, provided that they meet the national languages requirements.

The European Cosmetics Regulation in detail

Why should you choose Obelis?

We have more than 35 years of business experience

Located in Brussels, Belgium, at the heart of the European Union, we are active members of EU Associations and EU Commission working groups.

We are ISO 9001:2015 certified

Ensuring the highest quality of service for your business in Europe.

Co-founder of the European Responsible Person Association (ERPA). With a strong international network, Obelis Group supports your business in 18 global markets accross the world.

Creating compliance for safer markets is in our roots.

At Obelis, we registered over 15,000 cosmetic products in Europe, helping more than 3,000 companies over 70 countires to sell their products on the European market.