The Responsible Person in the EU
Only cosmetic products for which a Responsible Person is designated in the European Union can be placed on the EU market. The Responsible Person must ensure full compliance with the European Cosmetic Regulation.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

WHAT IS A RESPONSIBLE PERSON?

According to the European Regulation on Cosmetic Products (Regulation (EC) No 1223/2009, Article 4), only cosmetic products for which a legal or natural person is designated as a “Responsible Person” can be placed on the EU market. So, the Responsible Person (RP) is an entity established in one of the Member States of the EU.

The manufacturer of domestic products (company who manufacturers or orders the manufacturing under their name) is by default the RP. On the other hand, when a cosmetic product is imported (i.e., manufactured outside the EU), each importer is by default the RP for the specific product he places on the market. However, the manufacturer or importer may contractually appoint a third party to become the RP, who must accept it in writing (written mandate).

When a distributor places a cosmetic product on the market under his name or trademark or modifies a product beyond label translation, he becomes the RP of the such product.

RP RESPONSABILITIES

The RP is fully responsible for safety and legal compliance.

Before placing a cosmetic product on the EU market, the RP must ensure that it has undergone a safety assessment and that the cosmetic product is considered safe for human health when used under normal and reasonable foreseeable conditions of use.

The electronic notification of the cosmetic product in the Cosmetic Product Notification Portal (CPNP), before making the product available on the market, shall be made by the RP. (see previous post)

The RP needs to keep a Product Information File (PIF) and make it readily accessible to the competent authority of the Member State in which the file is kept.

This entity must be clearly identified (name and address) to authorities and consumers through product notification and labelling. This means that the name (or registered name) and the address of the Responsible Person must be indicated in the label of the cosmetic product. Products without and identified RP will be stopped at customs or withdrawn from the market.

Post-market surveillance, such as reporting serious undesirable effects to the competent authority, is also a responsibility of the RP.

Some other obligations of the RP are related to: restrictions for substances; animal testing requirements; product claims; labelling requirements; and others.

In sum, each cosmetic product placed in the EU market must have a Responsible Person, who shall ensure full compliance with Regulation (EC) No 1223/2009 on cosmetic products.

If you need any information regarding this or other subjects, fell free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.

further
reading

cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »
medical devices

EUDAMED – harmonized practices and alternative solutions for IVDR until the database is fully functional

EUDAMED is one of the key aspects of the new rules on in vitro diagnostic medical devices – Regulation (EU) 2017/746. However, it is only expected to achieve full functionality by the second quarter of 2024. Until then, how is the information submitted and/or exchanged between manufacturers, notified bodies and competent authorities?

Read More »
medical devices

EUDAMED – update on timelines

EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.

Read More »
cosmetic products

UK OPSS call for data on six cosmetic ingredients

On 14 July 2022, the Office for Product Safety and Standards (OPSS – the UK regulator for cosmetic products) issued a call for data on the safety of the following six cosmetic ingredients to investigate any suspected endocrine disrupting properties. 

Read More »
cosmetic products

European Commission Recommendation on the Definition of Nanomaterial

Nanomaterials are increasingly used in cosmetics and personal care products. They are similar to other chemicals/substances, but with specific risks associated to their use. The European Commission has published a new Recommendation to clarify the definition of ‘nanomaterial’. This definition may serve different policy, legislative and research purposes when addressing materials or issues concerning products of nanotechnologies.

Read More »
cosmetic products

Expected Restriction on the Use of Methyl Salicylate

The European Commission has notified the World Trade Organization (WTO) of a draft amendment to the Regulation (EC) No. 1223/2009 on cosmetic products. Annex III to Regulation will be amended, and the use of Methyl Salicylate in cosmetic products will be restricted.

Read More »