On July 11, 2013, the new European Union (EU) cosmetics Regulation (EC 1223/2009) will fully replace the existing cosmetics Directive (76/768/EEC) that has applied since July 27, 1976. Unlike the previous EU cosmetics Directive, the self-executing Regulation unifies the cosmetics requirements of the European Economic Area (EEA) into a single law and eliminates ambiguities that may occur among EU member states during the enforcement process. The new Regulation, which applies to all EU cosmetics companies, is intended to ensure that consumers’ health is protected and that they are well informed by monitoring the composition and labeling of cosmetic products.
The Regulation is focused on simplifying procedures, streamlining terminology, and strengthening certain elements of the regulatory framework for cosmetics. The main changes it introduces include:
- creating a new, electronic, centralized system that will replace the current national competent authority notification process
- clarifying the format and content of the product information file (PIF) to be used in conducting a product safety assessment; particularly, the PIF must include data to support any claims made about a product
- narrowing the “exceptional cases” when substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMRs) can be used
- requiring the presence of nanomaterials in cosmetic ingredients be clearly indicated by the word “nano” in brackets
- requiring cosmetics companies to designate a legal or natural person within the EU—known as a “responsible person”—whose role will be to ensure certain safety requirements for each cosmetics product introduced on the market
The Regulation also continues the previously established ban on animal testing, which came into full force through the Cosmetics Directive on March 11, 2013. Although the inclusion of the ban has been applauded by many consumers and animal welfare groups, it has also raised some concerns in the cosmetics industry about the potential negative impact on innovation due to the inability to fully test new ingredients as well as potential conflicts arising from the testing requirements imposed by other regulations. The European Commission has posted an impact assessment [PDF] online that discusses the various effects of the ban.
Notable milestone reached by the Regulation en route to becoming applicable, exclusively, to cosmetics placed on the EU market include: prohibiting use of CMR 1A/1B/2 substances in cosmetics, although certain CMR 2 substances may be exempted by the EU Scientific Committee of Consumer Safety (SCCS) after assessment; submission of all cosmetics through the new centralized notification system; commencing the notification process for nanomaterials already on the market. All cosmetics are expected to be fully compliant with the new Regulation by July 11, 2013.