The EU Legislation
The EU Cosmetics Directive (76/768/EEC) protects consumers and makes sure that all cosmetic products on the European market are safe. It requires cosmetics to cause no damage to human health when applied under normal or reasonably foreseeable conditions of use.
For cosmetics manufacturers, safety is the guiding principle in everything they do across their operations, their research and development and their innovation. They check each product’s formulation, how it might be used in all reasonably foreseeable conditions, its packaging and labelling (including any warning or instructions for use) and its disposal.
The Cosmetics Directive’s principles of in-market controls confer on manufacturers, distributors and importers - or the persons responsible for placing the cosmetics products on the market - the main obligation to ensure that their products meet safety requirements. Compliance with the regulations is controlled by the national or regional competent authorities in the EU member states. The cosmetics industry welcomes this responsibility and supports fully the Directive’s safety objectives.
Banned and restricted substances
The Cosmetics Directive’s second and third annexes list substances that must not be used owing to their toxicity, and substances that can be used only in specified circumstances.
Approved substances
The fourth, sixth and seventh annexes are positive lists of the only substances approved for use in cosmetics as colouring agents, preservatives and UV filters.
The Scientific Committee for Consumer Products (SCCP) evaluates substances that are, or could be used in cosmetics. It is the scientific advisory body to the European Commission and no substance can be regulated without its opinion.
Safety assessment
The Cosmetics Directive requires the persons responsible for placing cosmetic products on the market, to have a safety assessment carried out and ensure the results are available for inspection.
Cosmetic products for children under three and cosmetic products intended exclusively for use in external intimate hygiene must undergo a specific safety assessment that takes account of their special needs, for example, their higher skin surface area to body weight ratio.
The person who carries out the safety assessment must have adequate qualifications and relevant experience and hold a recognised diploma in pharmacy, toxicology, dermatology, medicine or a similar discipline.
Information to consumers
The Cosmetics 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 (PAO), when appropriate, 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 INCI nomenclature and certain substances specified in Annex III of the Cosmetics Directive
In-market surveillance
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 country carries out in-market control inspections. These bodies have powers to analyse samples for compliance with requirements for labelling, ingredients and microbiological quality.
Testing must be carried out in accordance with official European methods in properly equipped analytical laboratories.
The Cosmetics Directive specifies mandatory product information such as manufacturer’s details, product content, durability, precautions for use and ingredients. These must be accessible to the inspecting body.
Inspectors can carry out product controls for different reasons:
- Random controls for general compliance of cosmetic products (labelling, composition, claims etc)
- Controls on specific cosmetic product categories where there is a general public interest, for example, sunscreens
- Controls on a product following a recurrent complaint
- Controls for product compliance following new regulation, use of a newly regulated substance, or to assess labelling of new warnings
Free circulation of goods
The Cosmetics Directive aims to ensure the free circulation of cosmetic products throughout the EU. Member States must transpose the Directive and all amendments into their national law and they may not introduce any additional requirements.
Collaboration between the European Commission (EC), the National Competent Authorities and the dynamic cosmetics industry continues to ensure that competitiveness and innovation can be combined with the highest possible level of consumer protection and sustainability.
The EU Regulation on Cosmetics Products aims to ensure uniformity in the implementation of rules governing the cosmetics industry across all EU Member States.
The process to simplify the Cosmetics Directive involved a complete recast of the text and its 55 amendments. At more than 30 years old, the Directive has been amended frequently since its first entry into law in 1976.
A simpler route to market
Present legal uncertainties and inconsistencies disappears with the Regulation’s introduction because it is directly applicable in all Member States.
The regulation clarifies requirements for product safety assessments and simplifies notification rules for cosmetics.
Safety remains the crucial objective
Safety is already the cornerstone of EU cosmetics legislation. The current Cosmetics Directive requires cosmetics products to cause no damage to human health when applied under normal or reasonably foreseeable conditions of use.
The EU Regulation strengthens in-market control leading to improved consumer confidence. It sharpens the focus on manufacturer responsibility for the safety of cosmetics placed on the market, a move welcomed by the industry.
Safety assessment
The Cosmetics Regulation includes clearer requirements for manufacturers to conduct a safety assessment and produce a product safety report prior to placing a cosmetics product on the market. These requirements are set out in Annex I.
The new text, recast from the current Cosmetics Directive, clarifies what information needs to be included in the safety assessment as evidence that the cosmetic product being placed on the market is safe.
The Regulation strengthens the system of administrative cooperation between EU Member States’ authorities which is already in place. This is designed to coordinate product assessment and the supporting information and rules for product withdrawal.
In-market control
As with the Cosmetics Directive, the new text is based on in-market controls. These are strengthened in the Regulation (in particular in view of increasing imports from third countries).
The new Regulation defines what it means by a “responsible person” for relevant legal obligations which include responsibilities for products supplied to consumers from outside the EU, for example, via the internet.
Manufacturers have an obligation to report serious, undesirable effects to the authorities as part of an early detection mechanism. A single notification portal will provide product information to authorities in all EU countries.
CMR substances
In the former Cosmetics Directive, CMR 1 and 2 substances are automatically banned unless the Scientific Committee finds them safe for use in cosmetics. This can lead to absurd situations where food use is permitted but cosmetic use is banned. This is now addressed in the recast.
Facilitating the management of cosmetics legislation
The new Regulation includes a glossary of ingredient names. This is easier to update than the inventory of ingredients in the Cosmetics Directive and it does not require translation into EU national languages.
Summing up its reasons for bringing forward its proposed Regulation, the European Commission said in its explanatory memorandum: “Community action is necessary to avoid a fragmentation of the market and to ensure a high and equal level of protection of the European consumer.”
Web links
European Commission / Directorate General Enterprise and Industry / Cosmetics