Cosmetic Safety and Compliance in the UK & Europe
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Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 came into force on 1st January 2021 following the end of the Brexit transition period. This Regulation sets out the requirements for businesses placing cosmetic products onto the market in Great Britain.
The European Cosmetic Regulation 1223/2009 was fully implemented in 2013 and sets out the requirements for cosmetic products sold in the European Union (EU).
At Connect Compliance we support clients to meet the requirements of both these Regulations.
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A cosmetic product as defined by the Regulation(s) means ‘any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours’ Article 2.
The Regulation(s) set out the requirements on how cosmetic product safety is to be achieved by ensuring raw materials are fit for their intended purpose, products are made according to Good Manufacturing Practice (GMP) and the final product is assessed by a qualified person to ensure it is safe.
The Regulation(s) define the role of the Responsible Person. The Responsible Person has legal responsibility for products placed onto the UK or EU markets and they must be established within their respective jurisdictions. Their duties include ensuring:
- A Product Information File (PIF) is in place, readily accessible and kept for 10 years after the last batch of the product was placed on the market
- The Product is safety assessed by a qualified person
- Product labels are compliant
- Product claims are substantiated
- Products are notified to the appropriate system prior to being placed on the market. For the UK this is the UK Submit Cosmetic Product Notification (SCPN) service. For Europe this is the European Commission’s database, the Cosmetic Product Notification Portal (CPNP)
- Post market surveillance