Responsible Person for Cosmetic Products

Article 4 of the EU Cosmetics Regulation requires each cosmetic product placed on the market to have a designated Responsible Person. Read on to understand what does it mean to your cosmetic business.

Who can be designated as a Responsible Person

The regulation states that the Responsible Person may be a natural person (an individual) or a legal person (a company). The Responsible Person must be based in the European Union.

• If you are a brand owner (a natural person) or a manufacturer (a legal person) located within EU you can be a Responsible Person for products manufactured/sold by your company/brand.

• In case cosmetic products you sell are manufactured outside of the EU and are imported and subsequently placed on the market by you (an importer), the importer becomes Responsible Person for these products. Please note there may be several importers of the same cosmetic product. Each importer shall be the responsible person for the specific cosmetic product he/she imports and places on the market.

• The distributor of cosmetic products can also be Responsible Person. This happens when the distributor places a cosmetic product on the market under his/her name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.

• The manufacturer, importer or a brand can also nominate by a written mandate another person/company to act as a Responsible Person on their behalf. The nominated Responsible Person has to accept the mandate in writing.

What are the obligations of Responsible Person

The Responsible Person for a cosmetic product takes the overall responsibility for the safety and regulatory compliance of the cosmetic products he/she is responsible for.

This includes:

• notifying cosmetic product on CPNP Portal,

• having access to Product Information File written in a language easily understood by the relevant authority,

• cooperate with Regulatory Authorities in case any compliance issues,

• inform relevant Regulatory Authorities of non-compliance and take action to bring cosmetic products placed on the EU market back into compliance,

• ensure good manufacturing practice (GMP) is followed,

• ensure correct labelling of cosmetic products placed on the market,

• make sure all claims made are substantiated and truthful,

• establish a system to monitor, collect and follow-up any undesirable effects associated with cosmetic products he/she is responsible for.

Brexit Implications

Once the transition period ends on 31 December 2020 UK based Responsible Person will no longer be accepted according to EU Cosmetic Regulation.

Manufacturers of cosmetic products with Responsible Person based in the UK wishing to continue supply in the EU will have to designate EU based Responsible Person. In practice, it means two Responsible Persons will be needed for companies wishing to supply their cosmetic products both in the EU and the UK.

Please get in touch via info@moleculeregulatoryservices.co.uk for further information on Responsible Person or other regulatory topics like CPSR (Cosmetic Product Safety Report).

Watch this space for upcoming blog posts exploring further aspects of cosmetic regulations and how to make and sell your cosmetics in a safe and compliant way. We will make it simple!

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