EU Regulation Update: Tackling the Animal Testing Ban

May 10, 2010 | Contact Author | By: Annelie Struessman, PhD, CONUSBAT
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Title: EU Regulation Update: Tackling the Animal Testing Ban
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With the 7th Amendment to the EU Cosmetics Directive1 in 2003, the implementation of marketing bans and animal testing bans at certain defined deadlines was introduced. The testing ban on finished cosmetic products has applied since Sept. 11, 2004, and the testing ban on ingredients or combinations of ingredients has applied since March 11, 2009. Also since March 2009, the marketing ban has been in effect in the EU prohibiting finished cosmetic products and ingredients included in cosmetic products that have been tested on animals. Exempted from the marketing ban for now are the end points of repeated dose toxicity, reproductive toxicity and toxicokinetics; for these specific health effects, the deadline is March 11, 2013. To all implementation deadlines, the provisions become effective irrespective of the availability of non-animal test alternatives. The new Cosmetics Regulation (EC) No. 1223/20092 in force as of January 2010 fully assumed (adopted) the animal testing provisions in its Chapter V.

Manufacturers and importers of cosmetic products in the EU are faced with several issues caused by these bans. There is no legal clarity toward the interpretation of the provisions, while previous challenges for a hearing were denied by the European Court of Justice.3 Opportunities for innovation are severely restricted for ingredient suppliers and product formulators and both must cooperate closely to ensure agreement on policies and interpretation. Additionally, since cosmetic ingredients are chemicals, the testing ban potentially conflicts with other European legislation that imposes animal testing on chemicals in general.

As previous discussions between the EU Commission and the industry led to no further clarity, 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. The position was developed using the legal expertise of Kristian Fischer, professor of law at Mannheim University, and was published in 2009 on the Federation’s Web site.4 The EFfCI position is not a legally binding interpretation of the animal testing ban; only a decision from the European Court of Justice is. However, the paper provides pragmatic guidance while recognizing that manufacturers and importers of cosmetic products remain individually accountable for compliance with the law.

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.

EFfCI’s further general considerations read:

  • Performance of animal testing in the EU for cosmetic purposes is not allowed after March 11, 2009;
  • The marketing ban does not apply to data generated before March 2009;
  • The testing ban does not apply to tests assessing environmental aspects;
  • When a validated non-animal test method is available, this test must be used;
  • The performance of animal testing for EU cosmetic purposes outside of the EU does not fall under the testing ban; however, cosmetics ingredients tested as such do fall under the EU marketing ban;
  • Cosmetic ingredients tested outside of the EU for reproductive toxicity, repeated dose toxicity and toxicokinetics do not fall under the EU marketing ban until March 11, 2013.

With these considerations, seven frequently asked questions4 are raised in the position paper that further clarify how to deal with the marketing and testing bans. For example, question five: I must test my substance used exclusively in cosmetics in order to comply with the EU REACH regulation. Can I perform the animal tests in the EU? The answer given is: Yes, because the testing is not performed to meet the requirements of the EU Cosmetics legislation. With each of these answers, however, EFfCI alerts companies that they should be aware that certain enforcement authorities may have a different view.

In spite of this practical guidance the conflict remains that if testing is needed, the legislation requires use of non-animal methods. Even if these alternatives are not available, animal methods are not permitted. The unavailability of validated alternative protocols was acknowledged by the EU Commission’s Scientific Committee on Consumer Safety (SCCS1294/105 memorandum from December 2009. Furthermore, while the SCCS considers “(Q)SAR and other in silico alternatives as valuable tools for screening purposes,” they also conclude that “currently these fail to deliver the required level of knowledge for a full quantitative risk assessment.” Therefore, while the existing animal testing toolbox was removed, the new toolbox for assessment of ingredient safety using non-animal methods is not yet available.

References
1. Directive 2003/15/EC, 7th Amendment to Council Directive 76/768/EEC (Cosmetics Directive), available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:066:0026:0035:en:PDF or http://ec.europa.eu/enterprise/sectors/cosmetics/documents/directive/  (accessed May 10, 2010)
2. EU Regulatory Update January 2010: Recast of the Cosmetics Directive Published, available at R www.cosmeticsandtoiletries.com/regulatory/region/europe/81240592.html (accessed May 7, 2010)
3. The European Federation for Cosmetic Ingredients (EFfCI) Web site, available at www.effci.org/index.php?id=2 (accessed May 7, 2010)
4. EFfCI Opinion on the Animal testing and Marketing Bans, available at www.effci.org/assets/files/EFFCI_PS/Amendment.pdf (accessed May 7, 2010)
5. SCCS: Memorandum on Alternative Test Methods, December 2009, available at http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_001.pdf (accessed May 7, 2010)