Safety
Safety is the overriding objective
Consumer safety is the overriding objective for the manufacture and sale of cosmetics in Europe. It is the priority as manufacturers develop ever more innovative products to meet consumers’ constantly growing expectations.
Innovation drives the cosmetics industry. It allows manufacturers to develop new, safe products for the billions of people who use them every day, throughout their lives.
To meet safety objectives, companies fulfil specific duties before placing a product on the market. These include safety assessment, providing product information and complying with ingredient and labelling rules.
These duties are contained in the Cosmetics Directive to ensure that all cosmetic products on the European market are safe under normal or reasonably foreseeable conditions of use.
The responsibilities of placing a product on the market
Each finished cosmetic product is an individual and unique combination of ingredients. The Cosmetics Directive requires that every new product must be assessed for safety to human health before it is launched on the European market.
The company or person placing a cosmetics product on the market for the first time is responsible for arranging a safety assessment. This must be carried out by a scientist qualified in a relevant discipline with a diploma defined under Article 1 of Directive 89/48/EEC on the recognition of higher education diplomas.
The result of the safety assessment must be available for inspection by the competent authorities in EU Member States.
The Cosmetics Directive requires safety assessments to take account of product ingredients, chemical structure and level of exposure. The safety assessment must pay particular attention to where the product will be applied (eyes, mouth, scalp etc) and which population group is expected to use it.
Cosmetic products for children under three years old and products intended for use in external intimate hygiene must undergo specific safety assessments that take account of special needs.
Product information
Article 7a of the Cosmetics Directive requires any company or person responsible for placing cosmetics on the market in Europe to keep detailed information about all their products.
This information must be available to national inspection authorities at the address printed on the product’s label — inspectors have to be able to track a product on sale in shops to the company or individual responsible for placing it on the market.
The product safety assessment is one of the pieces of information that must be available, along with contact details for the person responsible for completing the assessment.
Other information includes the manufacturing method, physico-chemical and microbiological specifications, and proof of the effect claimed for the product.
The public has a right to access some product information:
- The composition of the product, and where appropriate, the amount of any substance classified as hazardous in Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances
- Data on undesirable effects on human health resulting from use of the cosmetics product
Labelling and ingredients
The Cosmetics Directive lays down comprehensive requirements for the composition and labelling of cosmetics products.It requires cosmetics to be safe, places restrictions on certain ingredients, specifies the information that must be available for inspection by the competent authorities, and details some information to be marked on packaging.
Article 6.1 of the Directive sets out labelling requirements in order to provide consumers with access to the information they need.
Labelling requirements include:
- Manufacturer, importer or distributor’s name and address
- Nominal content by weight or volume
- Date of minimum durability, or period after opening for products lasting more than 30 months
- Precautions to be observed in use
- Goods identification reference, for example a batch number/manufacturing code
- The function of the product (unless it is clear from the presentation)
- Ingredients in the International Nomenclature for Cosmetics Ingredients (INCI) along with descriptions of certain substances specified in the Directive
- Ingredients are displayed in a uniform way on all cosmetic product labels throughout the EU according to the INCI
Allergy sufferers are able to identify whether an allergen that affects them is present in a product.
Ingredients safety
The Cosmetics Directive ensures that cosmetic products contain only safe ingredients. Technical annexes in the Directive provide positive and negative lists governing the use of certain substances in cosmetics.
The negative lists specify banned substances and substances subject to specific provisions or restrictions. The positive lists specify the only substances approved for use in cosmetics as colouring agents, preservatives and UV filters.
These regulated substances are evaluated by the Scientific Committee for Consumer Products (SCCP), the advisory body to the European Commission. No substance can be included in the Directive’s annexes without the SCCP’s opinion.
Manufacturers are free to include other, unregulated ingredients in their products provided they pass the strict safety assessment required by the Directive. Cosmetic product labels must display a list of all ingredients used in their formulation.
Ingredients labelling
Ingredients used to formulate cosmetics on sale in Europe are classified under the International Nomenclature for Cosmetics Ingredients (INCI). All manufactures follow this system. This guarantees that ingredients are described in the same way on all product labels in all 27 EU Member States.
The Inci list is updated regularly and currently contains more than 6000 ingredient names.
The nomenclature of regulated ingredients specified in Article 5 of the Directive (substances subject to conditions and restrictions, colouring agents, preservatives and UV filters) can also be used on labels.
The Directive states: “…the ingredients used in cosmetic products must be stated on the containers and packaging of cosmetic products, or on the packaging only, under their common nomenclature referred to in Article 7(2) or, failing this, under one of the nomenclatures set out in Article 5(a)(2)”.
Product durability
Cosmetics products with a long life of more than 30 months must display an open jar symbol indicating how many months or years the product will last once it has been opened. For example:
Responsibilities of national competent authorities
The Cosmetics Directive requires the national governments of EU Member States to have surveillance systems that monitor compliance with all requirements.
An official body in each EU Member State, designated the competent authority, is responsible for carrying out in-market control of product safety. These bodies have powers to inspect product information and analyse samples to check they comply with requirements for labelling, ingredients and microbiological quality.
Web links
European Commission / Entreprise and Industry / E & I online magazine