A new Regulation has entered into force that simplifies the process for placing cosmetic products on the EU market.
On 11 January 2010 a new EU Regulation came into force that could result in significant changes for many cosmetics producers. Its purpose is to provide greater legal certainty and to save costs. In the past a cosmetics producer had to comply with different regulatory regimes in each of the 27 EU Member States. Under the old Cosmetics Directive (which will remain in force in parallel with the new Regulation until 2013) a number of important legal differences exist between the different Member States, for example concerning notification and safety assessment requirements for cosmetics. The new Regulation makes it possible to place cosmetics anywhere on the EU market by complying only with the single set of rules.
Until 11 July 2013 two very similar but parallel regimes will apply equally to cosmetics. During this period cosmetics producers can choose either regime to market their products in the European Union. From 11 January 2010, a cosmetics producer has the option to either comply with a single set of rules as set out in the new Regulation – with some exceptions for notification to national authorities, or continue to comply with the old 1976 Cosmetics Directive, whereby individual Member State laws vary slightly. In 2013 this Directive will be fully repealed and the many different national laws of the 27 Member States will be replaced by this single and directly applicable Regulation. Note, however, that in any case the nature, extent and enforcement of sanctions for failing to comply with the applicable rules will remain with the national authorities. Some of the most important changes created by the new Regulation are summarised below.
New Requirement for a “Responsible Person”
The new Regulation contains much clearer lines of responsibility for a cosmetic product. Each cosmetic product placed on the market is linked to a “responsible person”. That is, only cosmetics having a designated responsible person within the European Union can be placed on the EU market. This provision also applies to cosmetics supplied from outside the European Union, such as those either manufactured outside the European Union or supplied via the internet. The main rationale for this requirement is that it is the responsible person who must ensure that each cosmetic product placed on the market complies with the requirements set out in the Regulation.
Distributors and Identification within Supply Chain
The Regulation draws up a list of obligations for distributors of cosmetics, whereas no such list was included in the old Cosmetics Directive. A distributor must verify the labelling information, language requirements and the date of minimum durability of the cosmetic product. The distributor is also required to comply with cosmetics surveillance and corrective measures obligations, e.g., to bring a product into conformity with the Regulation, withdraw it from the market, or implement a product recall.
The Regulation introduces new provisions concerning the traceability of cosmetics throughout the entire supply chain. A competent authority may require a distributor to identify its upstream suppliers/responsible person, or a responsible person to identify downstream distributors. Both are obliged to do so for the three years that follow the batch of the cosmetic product being made available to the distributor.
Pre-Market Cosmetics Safety Assessment
The old Cosmetics Directive required that a safety assessment be done prior to placing the cosmetic product on the market, but it was not clear on the legal prerequisites for conducting a safety assessment. The new Regulation establishes specific requirements for the safety assessment to show that a cosmetic product is safe for human health. This assessment must be accompanied by a safety report included in the product information file for the 10 years that follow the placing on the EU market of the last batch of that product. It must be noted that the obligation to meet these safety assessment and reporting requirements is also applicable to cosmetic products already notified under the old Cosmetics Directive.
Modified Notification Requirements
The Regulation substantially amends the notification requirements for placing a cosmetic product on the EU market. The current notification process has been replaced by a simplified, centralised and electronic system. Instead of submitting information on a cosmetic product to competent authorities and poison control centres in each of the 27 Member States, the Regulation obliges a responsible person (and to some extent distributors) to submit electronically one single notification containing the information specified in the Regulation to the European Commission. The Commission then makes this information available to the relevant Member State authorities and poison control centres. Note, however, that cosmetic producers will only be able to submit centralised notifications from 11 January 2012. The Regulation also implies that producers who have opted to comply with the old Cosmetics Directive can submit their notification to the Commission from the same date.
New Regime for CMR Substances
The use in cosmetic products of substances classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) substances of category 1A or 1B (category 1 and 2 under the old Cosmetics Directive) are not automatically banned. These CMR substances may be used in cosmetic products if certain conditions are satisfied, such as the following:
- They comply with food safety requirements.
- There are no suitable alternative substances available.
- An application is made for a particular use of the product category with a known exposure.
- They have been evaluated by and found safe by the Scientific Committee for Consumer Safety (SCCS).
The Regulation introduces specific notification, safety evaluation and labelling provisions for cosmetics that contain nanomaterials. In addition to the general notification requirements for any cosmetic products, cosmetics containing nanomaterials must be notified to the Commission by electronic means six months prior to being placed on the EU market. If the Commission has concerns about its safety, the Commission must request the SCCS to give its opinion and make that information public. Additional labelling requirements apply to cosmetic products containing nanomaterials.
Labelling and Restrictions on Product Claims
The Regulation introduces the option of printing a minimum durability date on the label using a pictogram. It also requires that the ingredients used in a cosmetic product must appear on its label using common ingredient names. A glossary of common names will be compiled and updated by the Commission, taking into account, for example, the International Nomenclature of Cosmetic Ingredients (INCI). There are also stricter rules on product claims on labels. The labelling and advertising of cosmetics may not be used to imply that the products have characteristics or functions which they do not have.
Enhanced Rules for Non-Compliant Products
The Regulation introduces a clearer procedure for corrective measures, such as the withdrawal or recall of non-compliant products. These provisions apply both to the responsible person and to the distributor(s). The Regulation also contains detailed provisions on administrative cooperation between the Commission and national authorities if non-compliance is not limited to the territory of the EU Member State in which the cosmetic product is marketed.