The Cosmetic Safety Regulations
The main EU directive currently affecting the manufacture, labelling and supply of cosmetics and personal care products is 76/768EEC(4). It applies to all the countries of the EU as well as Switzerland and Norway. These regulations apply even to single-person companies making or importing just one product, all the way up to large multinationals. In the UK the directive is enacted as the Cosmetic Product (safety) Regulations 2008, and is enforced by Trading Standards. Cosmetic claims are also policed by the Advertising Standards Agency. Having an EU directive means that the rules on ingredient restrictions and product labelling are more or less the same across all EEA countries, reducing the barriers to trade. It also means that a cosmetic health assessment produced in one EU country is valid for sale in another, as long as local language requirements are adhered to.
This link gives a useful summary of the cosmetic safety regulations, from Cheshire East Trading Standards. There are 4 main aspects of the regulations that need to be followed, namely correct labelling, having an up-to-date Product Information File available for inspection, having a valid safety assessment for each product, and notification to the authorities. In other EU countries, but not the UK, there is also a requirement to inform the national poison centres with details of the products being sold.
Definition of cosmetics
The regulations also define what is a cosmetic. Products such as candles and room sprays, oils to go on the pillow, insect repellents and dog shampoos are not cosmetics and don't actually require cosmetic safety assessments, though other regulations may well apply. However, it is good practice for insect repellents that may contact the human body to be assessed as though they were cosmetics. Products that claim improvement in medical conditions such as psoriasis or relief from pain could well be considered as medicines and the borderline products department of the MHRA should be consulted to check product status and confirm appropriate wording.
Definition of "Responsible Person"
The regulations define a so-called "responsible person", who must have an address in the EU and is responsible for holding all the documentation on the product, including the safety assessment in a PIF (Product Information File). They are either the company that manufactures the cosmetic, has it manufactured, or they are the local office or agent for a manufacturer based outside the EU. If there is no local agent for a non-EU manufacturer, then the first company importing the product into the EU is the "responsible person".
The EU have issued a new cosmetics regulation EC 1223/2009 (sometimes called the "Recast" Directive), most parts of which come into force during 2013. In it, the legal responsibilities of the Responsible Person are extended and more clearly defined compared to the current regulation 76/768EEC.
Labelling of cosmetic products
The Cosmetic Safety Regulations also define the correct labelling that must be used with cosmetic products. This is quite a technical excercise, especially since some suppliers don't always use correct INCI labelling on their ingredients, and the calculation for labelling of allergens can be difficult. EF Chemical Consulting offer a labelling service, specifying everything that must be written to comply with the regulations, including correct ingredients listing and any necessary warnings. The information is supplied on a WORD document but we don't actually print the labels.
Please call us on 01244-351644 (UK) or email edmund@efchemicalconsulting.co.uk to find out more about our cosmetic safety assessment and labelling services, or to discuss pricing.