This presentation explains the rules and legislation regarding animal testing of cosmetic products in the EU and its development over the last few years.

1. EU REGULATION 1223/2009
© CE.way Regulatory Consultants Ltd

2. LEGISLATION
• EU cosmetic regulation 1223/2009 (replacing
directive 76/768/EC)
• Applicable: July 2013 onwards
© CE.way Regulatory Consultants Ltd

3. COSMETIC PRODUCTS ANIMAL TESTING EU
Animal testing of cosmetic products in the EU is
prohibited!
• The phasing-out of animal testing was already
announced in the Cosmetics Directive 76/768/EEC
• The prohibition applies to all cosmetic products
placed on the EU market – those produced in the EU
and those imported from third countries alike
© CE.way Regulatory Consultants Ltd

4. COSMETIC PRODUCTS ANIMAL TESTING EU
Animal testing phasing-out timeline:
• 11 September 2004: prohibition of the testing of finished
products on animals
• 11 March 2009: prohibition of the testing of ingredients or
combination of ingredients on animals
• 11 March 2009: marketing ban (ban of sales) of cosmetic
products and their ingredients which have been tested on
animals in order to meet the requirements of the EU
cosmetics Directive
 Applied to all but the most complex human health effects
to be tested to demonstrate the safety of cosmetic
products (repeated-dose systemic toxicity, skin
sensitisation, carcinogenicity, reproductive toxicity and
toxicokinetics), for which the deadline was extended to
11 March 2013
© CE.way Regulatory Consultants Ltd

5. COSMETIC PRODUCTS ANIMAL TESTING EU
• 11 March 2013: total marketing
ban, irrespective of the availability of
alternative non-animal tests
© CE.way Regulatory Consultants Ltd
Prohibition of
the testing of
finished
products on
animals
11.9.2004
• Prohibition
of the
testing of
ingedients
on animals
• Marketing
ban for all
human
health
effects
11.3.2009
Total
marketing ban
11.3.2013

6. COSMETIC PRODUCTS ANIMAL TESTING EU
• Data from animal testing that has been
carried out before the respective
implementation dates of the marketing ban
(11 March 2009/11 March 2013) can continue
to be relied on in the safety assessment of
cosmetic products
• Any animal testing has to be included in the
Product Information File
© CE.way Regulatory Consultants Ltd

7. COSMETIC PRODUCTS ANIMAL TESTING EU
• Critical wording 'in order to meet the
requirements of this Regulation' is used in the
Cosmetics Regulation in order to qualify the
scope of the 2013 marketing ban
 Animal testing clearly motivated by compliance
with non-cosmetics related legislative
frameworks should not be considered to have
been carried out 'in order to meet the
requirements of this Regulation‘ and should not
trigger the marketing ban
© CE.way Regulatory Consultants Ltd

8. COSMETIC PRODUCTS ANIMAL TESTING EU
 Testing carried out on ingredients that have been
specifically developed for cosmetic purposes and
are exclusively used in cosmetic products would
always be assumed to be carried out 'in order to
meet the requirements of this Regulation'
• If animal testing was carried out for
compliance with cosmetics requirements in
third countries, this data cannot be relied on
in the EU for the safety assessment of
cosmetics
© CE.way Regulatory Consultants Ltd

9. www.ceway.eu
info@ceway.eu
© CE.way Regulatory Consultants Ltd