REGULATORY BODIES

On the 11th September 2004 The Cosmetic Products (Safety) Regulations 2004 came into force. The Regulations bring together the old cosmetic regulations and their amendment regulations, and implement the Seventh Amendment to the EC Cosmetics Directive. This legislation now forms The Cosmetic Products (Safety) Regulations 2004. The Regulations establish an offence for supplying, offering to supply, agreeing to supply, exposing for supply or possessing to supply cosmetic products which are liable to cause damage to human health when applied under normal or reasonably foreseeable conditions of use. In addition the regulations prohibit a number of substances from use in cosmetic products and also restrict certain substances including preservatives, colouring agents, and UV filters. It is a requirement that the supplier of the cosmetic within Europe keeps aProduct Information Package. This must be readily accessible to the enforcement authorities (e.g. Trading Standards). It must contain the following information: - Product Composition(Typically this would be the INCI name, CAS number and concentration.) Under the FD&C Act, a cosmetic is adulterated if, among other reasons, it bears or contains any poisonous or deleterious substance which may render it injurious under the labeled conditions of use, or under customary or usual conditions of use. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing26 fragrance compounds have been found to be allergens that can produce allergic reactions to individuals sensitive to these compounds. The presence of any of these 26 fragrances above certain threshold limits must be declared in the ingredient list. All sources of these fragrances must be taken into account. Normal ingredient labelling rules apply, with the fragrances listed in the main body of the ingredient list. The threshold limits are as follows:Leave on products 0.001%.Rinse-off products 0.01%3.With a view to strengthening supervision and management of the cosmetics market and aligning with international standards, the Ministry of Health (MOH) has released the Hygiene Standard for Cosmetics (2007 Edition) to be effective from 1 July 2007. The new rule contains a revised list of prohibited and restricted substances. First, an additional 790 substances have been included in the prohibited list based on the EU's Cosmetics Directive, bringing the total number of prohibited substances to 1,286. Second, the substances on the List of hair dye agent Ingredients issued by MOH in 2005 have been added to the restricted list. Third, rules restricting the use of certain ingredients contained in preservatives, sun screen agent, colouring agent and hair dye agent have been removed, added or modified.The Hygien Standard for Cosmetics (2002 Edition) issued and implemented by MOH in 2002 primarily contains a list of prohibited and restricted ingredients, toxicity assessment methods and micro physical/chemical analysis methods. As safety assessment methods and testing technologies for cosmetics have advanced steadily in recent years, the technical standards contained in the 2002 version can no longer meet the market supervision requirements of the EU and US4. The global currents about the safety evaluation methods of special mention is the Seventh Amendment of EU Cosmetics Directive that provides the animal experiments prohibitions (animal testing ban) and also the sales prohibition of the product that is containing the ingredients which is evaluated by using the animal (marketing ban)5. Scientific Committee of Cosmetics and Non-Food Products (SCCNFP) has proposed and told the importance of safety guidelines for the cosmetic products.The system for all ingredients indication on cosmetics' products was introduced in 20016. Among the ingredients in personal care products, the group found known carcinogens, reproductive toxicants, harmful impurities and untested chemicals. Of the 10,500 chemical ingredients used in personal care products, just 11 percent have been safety assessed, the report found - and the assessments were not conducted by government officials, but by a panel funded by manufacturers, the Cosmetic Industry Review board7. SAFETY ASSESSER RESPONSIBILITYThe safety assessor is responsible for determining:Whether or not the ingredients present in the formula meet the requirements of the legislation in respect of the concentration for authorized substances, absence of substances prohibited by the law and, more generally, in respect of all legal requirements.

1. Whether or not particular endpoint(s) have to be considered for a given ingredient.
2. Whether the data available are relevant and sufficient.
3. Whether or not interactions of toxicological relevance and/or modifications to penetration are likely to occur.
4. Whether or not complementary data are needed either on ingredients or on the finished product.

1. Recognized competence and ethics in the field.
2. Access both to the toxicological and to the analytical information pertinent from a safety view point.
3. 
   
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