Regulation (EC) No 1223/2009, the new European regulatory framework for cosmetics of the European Parliament and of the European Council, was published in the Official Journal of the European Union on Dec. 22, 2009. The new legal framework is a recast of Council Directive 76/768/EEC, the Cosmetics Directive. Regulation (EC) No 1223/2009 entered into force 20 days after its publication in the journal on Jan. 11, 2010, while the majority of the Regulation (EC) No 1223/2009 ’s provisions will be enacted on July 11, 2013. On the same date, the Cosmetics Directive 76/768/EEC will be repealed.
Different deadlines will apply for the enforcement of two provisions of Regulation (EC) No 1223/2009. The provisions for the use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), i.e., Category 2 according to Regulation (EC) No 1272/2008 (CLP), will apply on Dec. 1, 2010. In addition, the notification provisions for nanomaterials will apply on Jan. 11, 2013. During transitional periods, cosmetic products already in compliance Regulation (EC) No 1223/2009 may be placed on the market. Notifications that are performed according to Article 13 of the regulation will be compliant on Jan. 11, 2012, and Regulation (EC) No 1223/2009 applies in the countries of the European Economic Area (EEA), including the 27 EU Member States, Iceland, Liechtenstein and Norway.
The EU Council considers recasting to be a legal technique, which comprises the conversion of the provisions of a directive into a regulation while making substantive amendments to all the provisions of the earlier act, which it replaces and repeals. The background for the recast of the cosmetic framework was to simplify rules and procedures related to the marketing of cosmetic products--a need resulting from different implementations of the directive in the 27 EU member states. According to the EU treaties, a directive must be translated into national legislation and with that translation, member states can include additional requirements; for example, a member state can set higher standards for substances of interest. As such, the directive had created 27 national legal frameworks and 3,500 pages of legal text.
Contrary to a directive, a regulation is immediately enforceable in all EU member states; therefore, Regulation (EC) No 1223/2009 represents a common European code of law. In line with this principal will be a change in notification provisions to harmonize them in a central digital platform to replace all existing national notification procedures.
Another key goal for the recast is to ensure a higher level of consumer protection. In relation to this requirement, major measures will include the enhanced coordination of market surveillance activities, reinforcement of responsibilities along the supply chain, and clearer provisions for the content and format of product safety assessments and product information files (PIF).
For example, all information on cosmetic products obtained from the notification procedures will be electronically forwarded to the national competent authorities, which will use it for market surveillance and consumer information. The information also will be provided to poison centers or similar bodies, where it will be used to inform the public of appropriate medical treatments in case of adverse reactions. And as noted, the responsibilities of the actors in the supply chain will be clearly defined and assigned to a responsible person, which is a new role created with the regulation.
While the Cosmetics Directive had already required safety assessments of finished products and their documentation in information files, no specification on the details of the assessments were given. In response, a guidance document was published by the Scientific Committee on Consumer Safety (SCCS), formerly the Scientific Committee on Consumer Products (SCCP), which reflects the position of the EU and influences the provisions of the new regulation; however, this guidance document had no legal status.
As a background, the SCCP is one of several scientific committees that provide the European Commission (EC) with scientific advice when preparing policies and proposals. In 2009, the SCCP was replaced with the SCCS. SCCS members are appointed by the EC and are responsible for the ongoing assessment of cosmetic ingredients. The group's resulting opinions often lead to amendments of the directive’s annexes for the purpose of adaptations to technical progress.
As positive, negative and restricted lists for cosmetic ingredients are resumed for the new regulation with only minor changes, the SCCS’s assessments will affect the Regulation (EC) No 1223/2009’s annexes in the future. Various clarification and evaluation requests in the text of Regulation (EC) No 1223/2009 regarding safety over the use of nanomaterials or CMR substances, etc., will be directed to the SCCS.
With the deadline of July 11, 2013, the Regulation (EC) No 1223/2009’s provisions for product safety assessments and PIFs will apply according to Article 10, Article 11 and Annex I. Compliance with these requirements is seen as a major challenge with the new regulation. Therefore, it is highly recommended to begin preparations at an early stage.
Considering that toxicity studies are requested for the safety assessments, it is important to note the provisions of the animal testing ban according to the 7th Amendment to the Cosmetics Directive and the respective deadlines specified on Oct. 1, 2004, which have been fully resumed for Regulation (EC) No 1223/2009.
Summary of Key Deadlines
Jan. 11, 2010: Enaction of the new regulations
July 11, 2013: Effective date for the majority of the regulation's provisions
Dec.1, 2010: Effective date for provisions on prohibition of CMR substances
Jan. 11, 2013: Effective date for notification provisions on nanomaterials