Regulatory Consulting Support for Cosmetics in EEA/USA/Canada
From 11 July 2013 the Cosmetics Regulation (EC) No. 1223/2009 applied in full, replacing the Cosmetics Directive (76/768/EEC) and aiming to simplify procedures, streamline terminology and strengthen elements of the regulatory framework for cosmetics and personal care products, with a view to ensuring a high level of protection 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 European Economic Area (EEA) – the 28 EU Member States, plus Iceland, Liechtenstein and Norway – and imposes significant obligations on companies placing cosmetics on the EEA market. CSI’s consultancy and safety assessment capabilities now extend to the cosmetics sector in which we offer our clients a comprehensive regulatory service.
Cosmetics companies are required to have a designated legal or natural ‘Responsible Person’ 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, and CSI can offer a Responsible Person (RP) service to companies seeking to delegate this key role to a trusted third party.
CSI can prepare 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 maintained and made available to Member State Competent Authorities on request by the Responsible Person (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 which must be performed by suitably qualified safety assessors. All of CSI’s Cosmetic Safety Assessors are university graduates whose extensive post-graduation experience is professionally recognised by the award of Chartered Biologist, Chartered Chemist and/or Chartered Scientist status.
Information on cosmetic products placed on the EEA market must be provided through Notification via the Cosmetic Products Notification Portal (CPNP), and CSI can notify cosmetic products on behalf of our clients.
We can also provide general regulatory support and advice on all aspects of compliance with the Cosmetics Regulation, including data requirements and testing strategies, nanomaterials, labeling and product claims.
Cosmetics and personal care products are regulated by the US Food and Drug Administration (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.
CSI provides extensive regulatory support and advice to bring products to market. In addition to the regulatory aspects, CSI can provide support and recommendations for testing, safety and labeling. We can work with your product development teams and R&D staff to improve speed to market and compliance with all applicable regulations.
If you would like further information about CSI’s services in the Cosmetics sector, please Contact Us.