Cosmetics regulations have changed for any such product on the market in the UK and EU. Since July 2013 these products now need to comply with the Cosmetics Products Regulation (EC) 1223/2009 and the main purpose of this legislation is to ensure the safety of the products that we put on our skin.
The main requirements of Regulation (EC) 1223/2009 are as follows:
• Products must be safe for human health when used under normal or reasonably foreseeable conditions of use; taking account in particular of the following:
o Presentation and appearance of the product
o Instructions for use and disposal
o Any other indication or information provided by the responsible person
• There are certain substances that are either prohibited or restricted for use in cosmetic formulations (refer to Regulation 1223/2009 – Annex II and III)
• Certain ingredients classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR Substances) are banned in cosmetics
• There are restrictions on animal testing of products and ingredients
• Particular information must be kept and updated by the “Responsible Person” (see definition below)
• “Responsible Persons” and “Distributors” have specific legal obligations
• Cosmetics are subject to specific labeling requirements
What is a Cosmetic Product?
This 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
“Placing on the Market”
This means the first time that the product is supplied or made available for distribution, consumption or use on the European Community market in the course of a commercial activity (Note: this includes any items supplied free of charge)
Who is a Manufacturer?
“Manufacturer” means a natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that product under his name or trademark
Who is a Distributor?
'Distributor' means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes the product available in the EU
This is the person or business within the European Union (EU) who places a the product on the market, which may be any one of the following persons:
o The Manufacturer (if based within the EU)
o Representative of the manufacturer appointed under written mandate
o The importer of the product in to the EU
o Representative appointed under written mandate by the importer in to EU
o A distributor who modifies a product already on the market or by applying their own name or trade mark to the goods (Ie own branding)
Product Safety Report
Before placing a cosmetic product on the market, the responsible person must ensure that it has undergone a safety assessment and that a relevant product safety report is produced. A safety assessment must be completed by a suitably qualified person; Ie a doctor, registered pharmacist, chartered chemist or chartered biologist. The name, address and qualifications of the safety assessor must be specified in the safety report.
A Product Safety Report should contain the following:
Part A: Cosmetic product safety information
1. Quantitative and qualitative composition of the product
2. Physical / chemical characteristics and stability of the product
3. Microbiological quality
4. Impurities, traces, information about the packaging material
5. Normal and reasonably foreseeable use
6. Exposure to the product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects and serious undesirable effects
10. Information on the product
1. Assessment conclusion
2. Labeled warnings and instructions of use
4. Assessor's credentials and approval of part B
The Responsible Person and the safety assessor should work closely together to ensure that the safety of the product is properly assessed, documented and kept up-to-date to ensure the product is “safe”.