Cosmetics and personal care products are regulated by the US FDA and Health Canada. While there is no formal approval process by either agency, cosmetic products sold in North America must follow the regulations carefully and meet all the legal requirements to be sold in either country.

Since 2013, the Cosmetic Products Regulation (EC) No. 1223/2009 has established standards ensuring that all cosmetic products placed on the European Economic Area (EEA) market are safe for human health. Under the Regulation, ‘Cosmetic product’ 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.

Cosmetic products may include liquids, creams, emulsions, lotions, lacquers, gels, oils, pastes, powders, salts, and foams in the following categories; Hair and Scalp Products, Nail and Cuticle Products, Oral Hygiene Products, and Skin Products.

The Cosmetics Regulation applies to the EEA – the 27 EU Member States, plus Iceland, Liechtenstein and Norway – and imposes significant obligations on companies placing cosmetics on the EEA market.

Cosmetics companies are required to have a designated legal or natural ‘Responsible Person’ (RP) within the EEA if they wish to place products on the EEA market. This person is charged with ensuring compliance of products with all the requirements of the Cosmetics Regulation. CSI offers a RP service to companies seeking to delegate this key role to a trusted third party.

CSI prepares a Product Information File (PIF) for each cosmetic product in our client’s portfolio. The PIF must contain a description of the cosmetic product, a detailed Cosmetic Product Safety Report (CPSR), a description of the method of manufacturing, proof of effect(s) claimed for the product, and data on any animal testing. A PIF for each cosmetic product must be retained (and made available to Member State Competent Authorities on request by the RP.

The two-part CPSR is composed of Part A, which includes hazard and exposure information, and Part B, which contains a safety assessment of the product. This assessment must be performed by suitably qualified safety professionals. All of CSI’s Cosmetic Safety Assessors meet the strict qualifications requirements stated in the Regulation.

Information on cosmetic products placed on the EEA market must be provided through notification via the Cosmetic Products Notification Portal (CPNP). CSI notifies cosmetic products on behalf of our clients.

Cosmetic products may include liquids, creams, emulsions, lotions, lacquers, gels, oils, pastes, powders, salts, and foams in the following categories; Hair and Scalp Products, Nail and Cuticle Products, Oral Hygiene Products, and Skin Products.

The Cosmetics Regulation applies to the EEA – the 27 EU Member States, plus Iceland, Liechtenstein and Norway – and imposes significant obligations on companies placing cosmetics on the EEA market.

Cosmetics companies are required to have a designated legal or natural ‘Responsible Person’ (RP) within the EEA if they wish to place products on the EEA market. This person is charged with ensuring compliance of products with all the requirements of the Cosmetics Regulation. CSI offers a RP service to companies seeking to delegate this key role to a trusted third party.

Although the UK left the EU on 31^st January 2020, the Cosmetic Products Regulation (EC) No. 1223/2009 was transposed into UK law almost unchanged, so the provisions of the Regulation apply in full in the UK.

CSI prepares a Product Information File (PIF) for each cosmetic product in our client’s portfolio. The PIF must contain a description of the cosmetic product, a detailed Cosmetic Product Safety Report (CPSR), a description of the method of manufacturing, proof of effect(s) claimed for the product, and data on any animal testing. A PIF for each cosmetic product must be retained (and made available to Member State Competent Authorities on request by the RP.

The two-part CPSR is composed of Part A, which includes hazard and exposure information, and Part B, which contains a safety assessment of the product. This assessment must be performed by suitably qualified safety professionals. All of CSI’s Cosmetic Safety Assessors meet the strict qualifications requirements stated in the Regulation.

Information on cosmetic products placed on the EEA market must be provided through notification via the Cosmetic Products Notification Portal (CPNP). CSI notifies cosmetic products on behalf of our clients.

CSI provides a UK Responsible Person (UK RP) service for companies wishing to place products on the UK market, and submits the required product notifications on the UK Office for Product Safety and Standards (OPSS) database.   

Cosmetics and personal care products are regulated by the China State Food and Drug Administration (SFDA).  Under this agency, CSI provides regulatory consulting support for food, drug, cosmetics, food additives, and dietary supplements. In Taiwan, cosmetics and personal care products are regulated by the Taiwan Department of Health.