In the Spotlight
Upcoming Changes to Cosmetic Regulations in the EU in 2013
Published: January 5, 2013
Under the EU Cosmetics Directive (76/768/EEC), as of March 11, 2013, cosmetics that contain ingredients tested on animals will be banned from sale in the European Union. As of July 11, 2013, Cosmetics Regulation (EC) No 1223/2009 will replace the Cosmetics Directive. The new Regulation will maintain the animal testing bans established under the Cosmetics Directive, while harmonizing cosmetics regulations across the 27 EU member countries. The EU legislation that bans animal testing of cosmetic ingredients is providing many challenges to the cosmetics industry, but ultimately could stimulate greater effort towards the international harmonization of cosmetics regulations.
The current European Union (EU) Cosmetics Directive (76/768/EEC), along with its 7th Amendment that outlines specific testing and marketing bans related to using animals in the safety evaluation of cosmetics, will be replaced by Cosmetics Regulation (EC) No 1223/2009 in 2013.
The new Cosmetics Regulation entered into force on Jan. 11, 2010, but many of its provisions are being enacted on different deadlines. Enactment of the new Regulation will be complete on July 11, 2013, and the prior Cosmetics Directive will be repealed. Unlike a directive, an EU regulation represents a common code of law enforceable in all member states, so the new Regulation will “simplify rules and procedures related to the marketing of cosmetic products” throughout the EU.
Like the Cosmetics Directive that will be replaced, the purpose of the new Cosmetics Regulation is the protection of consumer’s health “by monitoring the composition and labelling of products [and providing] for the assessment of product safety and the prohibition of animal testing.”
Animal Testing Bans
The elements of the outgoing Cosmetics Directive and the incoming Cosmetics Regulation related to the use of animal testing for cosmetics products in the EU can be summarized as follows.
The 1976 EU Cosmetics Directive, including the 7th Amendment of the Cosmetics Directive adopted in 2003, imposed the following animal testing bans:
- Testing Ban since September 11, 2004: ban on using animals to test finished cosmetics products within the EU
- Testing ban since March 11, 2009: ban on using animals to test cosmetic ingredients or combinations of ingredients within the EU
- Marketing ban since March 11, 2009: ban on marketing of cosmetic products in the EU whose ingredients had been tested on animals (with no geographic limitations) for all human health effect endpoints with the exceptions of repeated-dose toxicity, reproductive toxicity, and toxicokinetics
- Marketing ban as of March 11, 2013: ban on marketing of cosmetic products in the EU whose ingredients had been tested on animals (with no geographic limitations) for all human health effect endpoints, irrespective of the availability of alternative non-animal tests
The provisions of the 2009 EU Cosmetics Regulation that will be implemented as of July 11, 2013 will continue the previously established bans on animal testing for cosmetics as follows:
Animal testing must be replaced by alternative methods.
The Regulation prohibits the performance of animal testing in the European Union for:
- finished products
- ingredients or combinations of ingredients
The Regulation also prohibits the placing on the European Union market of:
- products where the final formulation has been the subject of animal testing
- products containing ingredients or combinations of ingredients which have been the subject of animal testing
A derogation from the ban relating to placing products on the market shall be granted until 11 March 2013 in order to test repeated-dose toxicity, the effects of certain substances on reproduction, and to study toxicokinetics.
In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.
Thus, the ban on animal testing defined in the 7th Amendment of the Cosmetics Directive will remain unchanged under the new Cosmetics Regulation. Furthermore, Dr. Tonio Borg, who was appointed EU Commissioner for Health and Consumer Policy on November 30, 2012, has testified that he plans to implement the Cosmetics Regulation with its current animal testing bans.
Animal Test Ban Issues
Availability of Alternative Test
The ban on the testing of cosmetics and cosmetic ingredients in animals means that alternative test methods (in vitro assays and/or in silico modeling), rather than the traditional animal tests, will need to be used to estimate the safety of cosmetic products (i.e., for the hazard assessment). “However, only data from validated methods are accepted for assessment of cosmetic ingredients and products in Europe.” Validated animal alternative test methods are those that have been endorsed as valid following an established assessment procedure by the European Union Reference Laboratory on Alternatives to Animal Testing (EURL ECVAM), or other international validation authorities such as the Organization for Economic Cooperation and Development (OECD) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).
The hazard assessment for cosmetic ingredients will continue to require data on a base set of toxicological endpoints. The cosmetic industry is concerned about the current lack of validated alternative test methods for some of these endpoints. To address the lack of alternative methods for the testing of cosmetic products, the European Commission along with the EU cosmetics industry initiated the Safety Evaluation Ultimately Replacing Animal Testing (SEURAT) program, which is based on the long-term goal of replacing animals in safety testing. The first 5-year phase, SEURAT-1, began in 2011 with the goal of replacing animal methods for repeated dose systemic toxicity testing.
Implementation of Regulation (EC) No 1223/2009 also includes new conditions on the use of nanomaterial ingredients in cosmetic products, which will be enacted as of January 11, 2013. The Regulation includes a definition for nanomaterials as well as the following regulatory changes: 1) that industries will have to submit notification of all cosmetic products containing nanomaterials six months before placing them on the market, and 2) that nanomaterial ingredients will now be identified on the product label (ingredient name followed by “nano” in brackets). The Scientific Committee on Consumer Safety (SCCS) was enlisted to develop guidance on the safety assessment of nanomaterials in cosmetics, which was published in June 2012. This guidance document explains components of the Regulation related to the definition of a nanomaterial, and requirements for notification, labeling, and safety assessment of cosmetic products that contain nanomaterial ingredients. The SCCS guidance also provides considerations for testing nanomaterials, especially regarding the EU animal testing ban.
The cosmetics industry has expressed concern over various issues related to the EU animal test bans. Among these are concerns about the negative impact on innovation due to the inability to fully test new ingredients, and potential conflict due to the need to test an ingredient to meet the testing requirements of other regulations (such as a chemical used in other product types). “The European Federation for Cosmetic Ingredients (EFfCI) developed an approach for its members and their customers regarding how to address (i.e, tackle and interpret) these bans,” which is stated as follows:
EFfCI interprets the legal provisions in such a way that the practical application of the test results is linked to the objective of the test at the time it was initiated. Therefore, EFfCI contends that the ban only applies to tests that were performed specifically for the purpose of meeting the requirements of the EU regulatory frameworks for cosmetics.
The EFfCI position, however, is not a legally binding interpretation of the animal testing ban, so “manufacturers and importers of cosmetic products remain individually accountable for compliance with the law.” In fact, decisions from earlier legal cases (action brought by EffCI; action brought by French Republic) supported the ban on animal testing.
Need for Regulatory Harmonization
Cosmetic manufacturers and other industry stakeholders within the EU and globally are continually working to keep up to date and comply with the various national and regional regulations. One complication with cosmetic products is the national/regional differences in the types of products that are considered to be cosmetics. For example, cosmetics with certain “medicinal” effects (e.g., sunscreens, anti-cavity toothpaste, and anti-perspirants) are marketed as cosmetics within the EU, but are regulated as over-the-counter (OTC) drugs by the US Food and Drug Administration (FDA). On the other hand, some regions such as the Association of Southeast Asian Countries (ASEAN) have adopted the EU definition for cosmetic products.
The proceedings from the 2009 EU-Japan Centre for Industrial Cooperation seminar explain additional areas where regulatory frameworks for cosmetic products still need to be harmonized, and it proposed the International Cooperation on Cosmetic Regulation (ICCR) (a forum of Canada, EU, Japan, and US members) as a means to facilitate harmonization on these issues. Until full international harmonization, cosmetic manufacturers have to comply with the regulations in the country in which a product will be marketed.
While it is possible additional amendments will be added to the Cosmetics Regulation or derogations issued with respect to the upcoming deadlines, the above comprises our current understanding of the issues and changes in 2013 one can expect regarding the animal testing bans on cosmetic products marketed in the EU.