A new European Union cosmetics regulation, already in effect, more broadly defines what a cosmetic is and changes the EU’s approach to cosmetics safety, holding that a cosmetic product must be safe for human health.
The regulation also places new responsibilities on manufacturers, importers and distributors by creating a system of “responsible persons” who must oversee compliance with the new law. And in another shift, when questions arise over the safety of a cosmetic product, the burden of proof has moved from the government authorities to the responsible person.
Here are nine significant points about the new Cosmetics Regulation that may affect those who manufacture, distribute or import cosmetics for the EU market.
1. The European Commission, not member states, may define a “cosmetic”
The now outdated EU Cosmetics Directive set out an exemplary list of products that were deemed cosmetics. The new Cosmetics Regulation uses such an exemplary list only in its recitals. To define cosmetic products, it instead refers to the European Commission, which now is empowered to, for instance, issue a guidance note. This change has the potential to broaden and even undermine the previous definition of cosmetics, especially with regard to innovative products. Therefore, producers should keep an eye on upcoming regulatory actions by the European Commission around the definition of “cosmetics.”
2. New responsibilities for manufacturers, importers and distributors: “responsible persons” and their duties
The new directive creates a system of "responsible persons" similar to those existing under the Waste Electrical and Electronic Equipment Directive and other EU product regulations. The "responsible person" has the duty of ensuring compliance with relevant obligations of the Cosmetics Regulation. Products may only be placed on the European market if a "responsible person" (private or legal) has been designated. In general, EU resident manufacturers as well as importers are "responsible persons." The same is true for distributors who distribute cosmetic products under their own name.
Notably, these "responsible persons" are allowed to mandate their responsibilities to third parties. (The mandate is only valid if accepted by the third party, of course.) Please note that non-EU resident manufacturers who make their products in the EU also have the duty to designate a third party as the "responsible person."
In addition to duties which existed under the old Cosmetics Directive's national implementations, the Cosmetics Regulation assigns new duties to manufacturers. The manufacturer is required to:
make a product information file accessible to the competent public authorities
ensure product traceability by keeping records on the supply chain
take measures to ensure a product is compliant
withdraw a product from the market or recall it to the manufacturing company in case of non-compliance.
3. Safety assessment requirements, shift in burden of proof
The Cosmetic Regulation now provides that a cosmetic product must be safe for human health. This intensifies the impact of another aspect of the Regulation. In Germany, for instance, under the former rules, in order to ban a product, the authorities had to prove it posed a specific danger to human health. Now, the burden of proof shifts from the public authorities to the "responsible person." In order to establish proof of compliance with safety requirements, the responsible person has to ensure that a product has undergone a detailed safety assessment procedure, as specified in the Cosmetics Regulation.
We strongly recommend that responsible persons strive to meet the detailed requirements of the safety assessment procedure.
The Cosmetics Regulation also establishes limitations on the use of certain substances in cosmetic products; these substances are listed in the Regulation. These lists, however, were not intended to be comprehensive. With regard to customer protection, only the most important substances have been listed. Because a substance is absent from the list does not mean it is approved for use or regarded by the authorities as safe. The responsibility for ensuring the safety of every single product lies with the responsible person.
4. Product information file requirement
The responsible person is required to store a product information file that contains certain detailed information, including the product safety assessment report, and to keep it accessible for authorities in electronic or other easily accessible form at his or her business address.
Cosmetic products imported from outside the European Union must carry a label which names the country of origin.
Manufacturers and importers may also use a new symbol introduced in The Cosmetics Regulation that shows the product’s date of minimum durability. This symbol allows cross border distribution of cosmetic products without the need to translate the declaration "best before" into all relevant languages. Using this symbol is not mandatory; the traditional "best before" may still be used.
6. Common criteria for advertisement claims
Under the Cosmetics Regulation, the European Commission shall define certain common criteria for claims that may be used in cosmetics advertisements. If by July 2016, the Commission finds infringements against these common criteria, it shall take the necessary measures to ensure compliance. However, the common criteria have yet to be issued. Any actions on this matter should be attentively observed.
The Cosmetics Regulation now requires that product claims shall not be used to imply that these products have characteristics or functions which they actually do not have. Therefore, it should be indicated to costumers in the advertisement where claimed functions are disputed or not scientifically verified.
7. Imports must comply too
Please note that importing cosmetic products into the European market without compliance with these regulations is illegal. The Cosmetics Regulation allows member states to create sanctions against those who violate this law.
8. Unfair trade practices
In addition, competitors may allege that noncompliant manufacturers and importers are engaging in unfair trade practices to force their products from the market.
9. A useful reminder: it’s a regulation, not a directive – ensure you are compliant now
A European Union directive (like the former EU cosmetics law) requires eventual implementation by European Union member states on a national level, but a European Union regulation becomes immediately enforceable as law in all member states, simultaneously. The new Cosmetics Regulation, thus, is already in effect, replacing the old Cosmetics Directive.
Manufacturers and producers should therefore check that they are compliant with the new Cosmetics Regulation, especially with its safety assessment and product information file requirements.