The ban on animal testing under the Cosmetics Regulation | Fieldfisher
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The ban on animal testing under the Cosmetics Regulation



Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (the "Cosmetics Regulation").

EU Regulatory Bulletin contents

  • Nano & regulatory framework
  • Animal testing & Cosmetics
  • Honey bees


Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (the "Cosmetics Regulation"), which will repeal and replace Council Directive 76/768/EEC (the "Cosmetics Directive") from 11 July 2013, takes over the prohibition of the testing of cosmetic products and ingredients used in cosmetic products on animals in the European Union (the "Testing Ban") from the previous Cosmetics Directive.  In addition, it takes over the ban on the placing on the European Union ("EU") market of cosmetic products and ingredients contained in cosmetic products that have been tested on animals regardless of the origin of the tests (the "Marketing Ban"). 

Concerns have been expressed about the European Commission's intention to implement the Marketing Ban even before alternative, non-animal testing methods have become available, without taking into account the scientific reality and consumer needs. 

Timeline for the implementation of the Testing Ban

The Testing Ban on finished cosmetic products has applied since 11 September 2004, and the Testing Ban on ingredients (including individual ingredients and combinations of ingredients) has applied since 11 March 2009. 

The Testing Ban applies irrespective of whether or not alternative methods are available.
Timeline for the implementation of the Marketing Ban

Apart from tests relating to the most complex human health effects, such as repeated-dose toxicity, reproductive toxicity and toxicokinetics (the so-called "2013 endpoints"), the Marketing Ban has applied since 11 March 2009.  In the absence of alternative test methods, results of animal tests performed outside of the EU before 11 March 2009 can still be used in order to prove the safety of the cosmetic products marketed in the EU.  There is a similar cut-off point for the 2013 endpoints: 11 March 2013 (unless alternative methods become available before that date).

The Commission is obliged to study the availability of alternative non-animal testing methods.  As part of its obligation, the Commission produces yearly reports to the Parliament and Council to present the progress being made.  If, at the latest two years prior to the March 2013 deadline, a report concludes that alternative tests will not be developed and validated before the deadline, the Commission should put forward a legislative proposal.

In September 2011, the Commission's Report concluded that validated alternative methods would not be available for the 2013 endpoints and full replacement would not be possible.  Nevertheless, the Commission has indicated that it will not postpone the March 2013 deadline: speaking before the Members of the European Parliament in November 2012, Tonio Borg, the Commissioner for Health and Consumer Policy, stated that full implementation was desirable in part to accelerate the development of alternative methods.

Interpretation of the Testing and Marketing Bans

The wording of the animal testing prohibition has created uncertainty as to whether the ban covers all animal testing or only testing performed for purposes of the EU Cosmetics Directive.

On 22 August 2012, the ex-Health and Consumer Policy Commissioner John Dalli, in response to questions from Members of the European Parliament, clarified the Commission's position on the matter: ingredients used in cosmetic products, which also fall within the scope of legislation other than the Cosmetics Regulation, ought to comply with the latter, even if it involves animal testing. 
It is noted that neither EU nor national courts have addressed the issue, apart from the EU Advocate-General's opinion in favour of the Broad Interpretation in Case C-244/03, which is not legally binding.

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