Background to Cosmetic Product Legislation
The manufacture of cosmetics in the EU is covered by the EC Cosmetics Directive (76/768/EEC). The Cosmetics Directive is implemented in each member state via national legislation which, in the UK, this is the Cosmetic Products (Safety) Regulations.
The main purpose of the Cosmetics Directive is human safety. The laws covers both those products that are intended to be retailed and those given away free (as this is considered to be a commercial enterprise). Ignorance of the law is no excuse and no defense; and the penalties for non-compliance can be severe with heavy fines and even periods of imprisonment options open to the courts.
The main purpose of the Cosmetics Directive is human safety. Each cosmetic product must have a safety assessment performed on it before putting the product on the market for sale. One further specific safety assessment which must be undertaken is for products intended for use on children under the age of three and for products exclusively used for external intimate hygiene.
Is my product a cosmetic product?
Before embarking on a product safety assessment you might first want to confirm that your product is actually a 'cosmetic product' as this is key to whether your product falls under the Cosmetic Products (Safety) Regulations or another set of regulations:
A Cosmetic Product is defined as:
"any substance or preparation intended to be placed in contact with the various 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 and/or correcting body odours and/or protecting them or keeping them in good condition."
Mumbo jumbo right! Possibly. I guess the easiest way of thinking about whether a product is a cosmetic or not is to think about what the product is to be used for. In most cases it will be obvious. If not, seek further guidance.
Who can undertake a Safety Assessment?
The safety assessment must be undertaken by a qualified professional. The UK regulations state that a safety assessor assessing the product must be one of the following:
1. a pharmacist
2. a medical practitioner
3. a Chartered Biologist
4. a Chartered Chemist.
No other person is authorised to carry out or take responsibility for safety assessments of cosmetic products. It is fine for the assessor to be in another country just as long as they follow the UK guidelines.
What is a Product Information File?
Each product should have a Product Information File (PIF). The PIF will contain the results/details of the Product Safety Assessment, but will also contain other qualitative information such as the ingredients list for the product, specifications of raw materials and finished products and the purity and microbiological controls, details of methods of manufacture in accordance with good manufacturing practice, the name and address of the person responsible for safety assessment.
Product labelling requirements:
Each product should be marked with:
For products containing essential oils there is a requirement to also list the naturally occuring allergens in the ingredients listing where the % inclusion level of the allergen exceeds the threshholds for a 'leave on product' (0.001%) or a 'rinse off product' (0.01%).
The following is a list of 26 allergens found in cosmetics. Only 16 ot these are actually found in essential oils:
For information of which of these 16 naturally occurring allergens is present in the most common essential oils then refer to the following document:
The following links may be a useful resource to you: