EU Responsible Person (EU RP) for Cosmetics
Are you looking to expand your cosmetics business and sell into the EU market? Under EU cosmetic regulation, cosmetic manufactures are required to have an EU Responsible Person. Let’s breakdown what that means.
Contents
What is an EU Responsible Person (EU RP)?
EU Law on Responsible Person
Key Roles of the EU Responsible Person
Who can be an EU Responsible Person?
Our EU Responsible Person Service
As the name suggests, the EU Responsible Person (EU RP) is a contact with an EU address that is responsible for the compliance of a product on the EU market. All cosmetics on the EU market should have an EU RP.
The EU cosmetic regulation (EC) No 1223/2009 Article 4 Paragraph 1 states:
Only cosmetic products for which legal or natural person is designated is designated within the Community as ‘responsible person’ shall be placed on the market
Article 4 Paragraph 2 clarifies the key role of the EU RP:
For each cosmetic product placed on the market, the respon sible person shall ensure compliance with the relevant obligations set out in this Regulation
The EU Responsible Person key role is to ensure that all cosmetic products assigned to them comply with the EU cosmetic regulation before they are placed on the EU market. Also, they are responsible for the ongoing compliance activities throughout the product’s lifecycle e.g. changes to labelling and formulation as a result of updates to the regulation.
The EU Responsible Person is required to maintain a properly compiled Product Information File (PIF) as per the requirements. The PIF contains vital documentation such as the cosmetic safety assessment, declarations, mock up of labelling, test reports and substantiation of product claims (if applicable), among other things.
Labelling rules apply to cosmetics in the EU. It is incumbent upon the Responsible Person to ensure that all cosmetic products within their remit are labeled accurately and in compliance with the EU cosmetic regulation.
The EU Responsible Person must submit notifications via the Cosmetic Products Notification Portal (CPNP) in the EU or the UK Submit Cosmetic Product Notifications (SCPN) system in the UK for all cosmetic products intended for placement on the market.
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
1. Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the follow ing information to the Commission:
(a) the category of cosmetic product and its name or names, enabling its specific identification;
(b) the name and address of the responsible person where the product information file is made readily accessible;
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
(c) the country of origin in the case of import;
(d) the Member State in which the cosmetic product is to be placed on the market;
(e) the contact details of a physical person to contact in the case of necessity;
Extract from the EU Directive
In the event of any undesirable or serious undesirable effects associated with a cosmetic product, the EU Responsible Person must communicate such occurrences to the competent authorities with minimal delay and take swift action, including a product recall or withdrawal from the market.
The Responsible Person is required to make themselves available and cooperate fully with all EU competent authorities should they enquire about a product in their remit.
If the manufacturer or brand is based in the EU, then their address can be used for EU RP purposes. For non-EU based cosmetic businesses there are other options including third-party services (read on).
In some cases, the importer or distributor may choose to take on the EU RP services provided they have the experience and, of course, an EU address.
For cosmetic businesses that do not have an EU base can opt to go with a
We offer EU Responsible Person services for cosmetic manufacturers and brands that require an EU-base.
We are trusted by our clients as a reliable EU Responsible Person to act accordingly in line with the regulations.
With years of RP experience, working with businesses large and small, rest assured you are in safe hands.
Our advisors are available to help you through the Responsible Person process.
Contact us today to learn about our EU Responsible Person services.
We are a London-based regulatory affairs consultancy providing services to the e-cigarette, cosmetic, biocide, pharmaceutical and medical device industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and analytical testing services.