Cosmetics [EU]

Cosmetics.

EU legislation on cosmetics dates back almost 50 years.  Cosmetic products are substances intended to be placed in contact with various external parts of the human body or with teeth and the mucus membrane of  the oral cavity, with a view  exclusively or mainly to cleansing, perfuming, change in their appearance or correcting body odours and/or protecting them or keeping them in good condition.

Products are listed in the annexe to the directive in illustrative fashion.  They must not be harmful to health when they are applied under normal or foreseeable conditions of use.

States must take necessary measures to ensure that only cosmetic products that conform with the directive are placed on the market.  Conforming products may not be refused, prohibited or restricted.

If a state notes that a product, although complying with the directive represents a hazard to health, it may provisionally prohibit it from marketing subject to the conditions.  It must then inform the states and the Commission, giving reasons for the decision.  The Commission must consult states and deliver an opinion without delay.

The directive provides lists of ingredients which may not be included in cosmetic products and lists of substances which can only be included under certain conditions.  There are lists of colourings, preservatives and UV filters which are permitted.

Packaging for cosmetics must contain legible and visible and indelible labelling containing name and trade address of the manufacturer or importer or marketer, contents at the time of packaging by weight and volume.

Products with a minimum durability of less than 30 months must specify the date, best before.  Products with a minimum durability of more than 30 months must state the period after opening for which the product can be used without harm.  Particular precautions for use must be specified.  Batch number or product reference must be labelled to permit identification.  Product function must be specified.The information must be in the national language or official language of the state.

Labels must contain lists of ingredients in descending order preceded by the word ‘ingredients’.  Perfume and aromatic compositions must be referred to by the word ‘perfume’ or ‘aroma’ other than where they contain an allergic substance which may cause an allergic reaction in sensitive users.  Lists of ingredients may be required to be labelled in accordance with common ingredients naming conventions.

Manufacturers, their agents or persons to  whose order cosmetic products are manufactured and persons  responsible for placing imported cosmetics on to the EU market must keep certain product and safety information at the disposal of the competent authorities.  States must check the safety of products and take necessary measures to ensure that manufacturers not importers place products in the market which do not comply with the directive.  They must take steps to ensure that cosmetic products do not exhibit characteristics which they do not possess.

Manufacturers or the above parties must notify the authority of the place of manufacture of the product or the place where first imported.

The directive bans animal testing for cosmetic  products.  This ban covers testing finished cosmetic products and ingredients on animals and marketing finished cosmetic products which have been tested on animals or which contain ingredients which have been tested.  The ban commenced in 2004.  Transitional measures applied for five years.

A marketing ban applies progressively as alternative methods are validated under EU legislation.  Certain products tested for human health effects enjoyed a 10 year deadline to 2013.

From July 2013 year regulation replaces the cosmetic directives which have dated back to 1976.  The definition of cosmetic products is much the same as above.  Provided products comply with the regulation, they must be allowed free movement in the internal market.

A responsible person established in the EU is to be designated for each  product placed on the market.  That person must ensure compliance with the rules and provisions of the regulation.  This includes in particular, requirements in relation to human health, safety and consumer information.  The person must maintain product information while accessible to public authorities.

In order to ensure # persons responsible must identify distributors whom they supply products for a period of three years following the date on which the batch has been delivered.

In the case of product noncompliance, the responsible persons will take measures to render it compliant, withdraw it from the market and recall it.  Where these steps are not taken, the competent authorities may take the necessary corrective measures.

The Annexes to the directive provide a list of prohibited substances and restricted substances.  The regulation prohibits the use of substances recognised as carcinogenic, mutagenic and toxic for reproduction other than in exceptional circumstances.  It provides very high level of protection of human health where nanomaterials are used in cosmetic products.

Product labelling requirements require containers and packages to bear written information in indelible, easily legible and visible lettering.  This includes particulars as set out above.  They must be included in the language of the member of the state where they are made available.

The above prohibition on animal testing is reaffirmed.  The commission is assisted by a standing committee on cosmetic products.

Consumer information

Product labelling contributes to consumer protection. Containers or packaging must bear written information in indelible, easily legible and visible lettering.This information concerns:

• the name or registered name and the address of the responsible person;
• the country of origin for imported products;
• the weight or volume of the content at the time of packaging;
• a use-by date for products kept in appropriate conditions;
• precautions for use, including for cosmetics for professional use;
• the batch number of manufacture or the reference for identifying the cosmetic product;
• the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing.

The language of the information shall be determined by the Member State where the product is made available to the end user.

Animal testing

Animal testing must be replaced by alternative methods. The Regulation prohibits the performance of animal testing in the European Union for:

• finished products,
• ingredients or combinations of ingredients.

The Regulation also prohibits the placing on the European Union market of:

• products where the final formulation has been the subject of animal testing;
• products containing ingredients or combinations of ingredients which have been the subject of animal testing.

A derogation from the ban relating to placing products on the market shall be granted until 11 March 2013 in order to test repeated-dose toxicity, the effects of certain substances on reproduction and to study toxicokinetics

In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.