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IN THE COURT OF JUSTICE OF THE EUROPEAN UNION
CASE C-592/14
THE EUROPEAN FEDERATION FOR COSMETIC INGREDIENTS
WRITTEN OBSERVATIONS OF THE UNITED KINGDOM
The United Kingdom is represented by Mr. Luke Barfoot of the European Law
Group, Government Legal Department, acting as Agent, and by Mr. Josh
Holmes, Barrister.
Submitted by:
Luke Barfoot
and
Josh Holmes
Agent for the xxxxxxxxxxxxxx
Barrister
EU Litigation, European Law Group
Government Legal Department
Room 3/02, 1 Horse Guards Road
London, SW1A 2HQ
Service may also be made by fax or email:
Fax: ++44 20 7276 0184
Email:
14 April 2015
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A.
INTRODUCTION
1.
Pursuant to Article 23 of the Protocol on the Statute of the Court of
Justice of the European Union, the United Kingdom
(‘the UK’) submits
these Written Observations to the Court.
2.
The case arises out of a reference for preliminary ruling made by the
High Court of England and Wales
(‘the Referring Court’) on 12
December 2014, regarding the interpretation of Article 18(1)(b) of
Regulation (EC) No. 1223/2009 of the European Parliament and of the
Council of 30 November 2009 on cosmetic products
(‘the
Regulation’).
3.
That provision prohibits the placing on the market within the European
Union
(‘the EU’) of cosmetic products containing ingredients or
combinations of ingredients which, in order to meet the requirements of
the Regulation, have been the subject of animal testing.
4.
The Claimant is a trade association representing manufacturers within
the EU of ingredients for use in cosmetic products. Its members, or
their customers, wishing to market cosmetic products in certain third
countries, including China, must subject the products to tests on
animals in order to demonstrate their safety for human health. It has
brought proceedings before the Referring Court to determine whether
such persons may lawfully place products that have been tested in this
way on the market in the EU, relying upon the data obtained from the
animal testing in order to show that they are safe for the purposes of
the Regulation.
5.
The Referring Court considers that the proper interpretation of Article
18(1)(b) of the Regulation is not free from doubt. It has therefore
decided to stay the national proceedings in order to obtain guidance
from the Court of Justice.
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6.
The Referring Court has referred two questions for preliminary ruling,
which are set out at §24 of the order for reference. In summary, the
Court seeks:
a. To ascertain whether the prohibition in Article 18(1)(b) applies in
the case of cosmetic products containing ingredients, or
combinations of ingredients, which have been tested on animals
outside the EU in order to meet the legislative or regulatory
requirements imposed by third countries on those wishing to
market cosmetic products containing those ingredients in those
countries; and
b. To establish the relevance of various factors in answering that
question, including in particular:
i. whether the data obtained from such testing are used in
order to demonstrate, for the purposes of the safety
assessment required by Article 10 of the Regulation, that
the cosmetic product is safe for human health; and
ii. whether the third country requirements relate to the
safety of cosmetic products.
7.
The United Kingdom sets out below its interpretation of the prohibition
contained in Article 18(1)(b) of the Regulation by reference to those
factors. In summary, the xxxxxxxxxxxxxx submits that:
a.
Point 1: Article 18(1)(b) prohibits the placing on the market in
the EU of a cosmetic product containing ingredients, or
combinations of ingredients, which have been tested on animals
outside the EU in order to satisfy the requirements of a third
country, in circumstances where:
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i. the data obtained from the animal testing are used in
order to demonstrate that the cosmetic product is safe for
human health for the purposes of the Regulation and
ii. the third country requirements are intended to ensure the
safety of cosmetic products.
b.
Point 2: Article 18(1)(b) does not prohibit the placing of such a
product on the market in the EU in circumstances where the
data obtained from the animal testing are not used in order to
demonstrate that the cosmetic product is safe for human health
for the purposes of the Regulation
c.
Point 3: Article 18(1)(b) does not prohibit the placing of such a
product on the market in the EU in circumstances where:
i. the data obtained from the animal testing are used in
order to demonstrate that the cosmetic product is safe for
human health for the purposes of the Regulation; but
ii. the third country requirements are intended to ensure a
purpose other than the safety of the cosmetic product, for
which animal testing remains lawful in the EU.
B.
ANALYSIS
The United Kingdom’s proposed interpretation of Article 18(1)(b) of the
Regulation
Point 1
8.
In the United Kingdom’s submission, the prohibition in Article 18(1)(b)
of the Regulation applies to products containing ingredients, or
combinations of ingredients, which have been tested on animals
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outside the EU in order to satisfy the requirements of a third country, in
circumstances where:
a. the results of such testing are used in order to demonstrate that
the cosmetic product is safe for human health for the purposes
of the Regulation; and
b. the testing is required to be undertaken by the third country
concerned in order to achieve the same purpose as is pursued
by the Regulation, namely ensuring the safety of cosmetic
products.
9.
Such an interpretation accords with the purpose of Article 18(1)(b) as it
emerges from the recitals in the preamble of the Regulation:
a. Recital (38) underlines the need ‘
to pay full regard to the welfare
requirements of animals in the implementation of [EU] policies,
in particular with regard to the internal market’. Recital (42)
likewise identifies the objective of achieving ‘
the highest possible
degree of animal protection’.
b. Recital (39) refers to the requirement under Directive
86/609/EEC that ‘
animal experiments be replaced by alternative
methods, where such methods exist and are scientifically
satisfactory’.
c. Recital (40) records that ‘
the safety of cosmetic products and
their ingredients may be ensured through the use of alternative
methods’ to animal testing, and that ‘
the use of such methods by
the whole cosmetic industry should be promoted and their
adoption at [EU] level ensured, where such methods offer an
equivalent level of protection to consumers’.
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10.
It would be inconsistent with those objectives if the Regulation were
construed as allowing cosmetic manufacturers to rely on data obtained
from animal testing performed in third countries for the same purpose
(of ensuring the safety of cosmetic products) as is pursued by the
Regulation itself.
11.
The proposed interpretation also accords with the view expressed by
the Commission in its communication on the animal testing and
marketing ban and on the state of play in relation to alternative
methods in the field of cosmetics (COM/2013/0135 final), at §3.1.
12.
Such an interpretation would enable manufacturers easily to
circumvent the requirements of Article 18(1)(b) of the Regulation, by
purporting to place a product containing a given ingredient on the
market in a third country where animal testing is required, carrying out
animal tests and using the data resulting from such tests in order to
meet the requirements of the Regulation.
Point 2
13.
However, on its proper construction, Article 18(1)(b) of the Regulation
does not go so far as to preclude the placing on the market of a
product containing ingredients which have been the subject of animal
testing pursuant to the requirements of a third country, but where data
obtained from such testing are not relied upon in order to demonstrate
that the cosmetic product is safe for human health for the purposes of
the Regulation.
14. In that case, it cannot be said that the tests are in any sense being
used ‘
in order to meet the requirements of the Regulation’.
15. It would be disproportionately onerous to require manufacturers to
choose between marketing products containing particular ingredients in
the EU and in third countries where animal testing is required.
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16. Recital (45) in the preamble of the Regulation shows that this was not
the intention of the EU legislature. That recital exhorts the Commission
and the Member States to encourage the recognition by third countries
of alternative methods to animal testing ‘
so as to ensure that the export
of cosmetic products for which such methods have been used is not
hindered and to prevent or avoid third countries requiring the repetition
of such tests using animals’. The recital therefore records the view of
the legislature that unnecessary animal testing in third countries should
be prevented or avoided. It does not indicate any intention that the
effect of such testing should be to block the marketing of the products
in question within the EU.
Point 3
17.
Equally, on its proper construction, Article 18(1)(b) of the Regulation
does not prohibit a manufacturer from placing a product on the market
in the EU which contains ingredients that have been tested on animals
outside the EU in order to meet a third country’s requirements where
the purpose of those requirements is not to ensure the safety of
cosmetic products but to achieve some other objective (e.g. the safety
testing of a medicinal product), for which animal testing remains
permissible within the EU.
18. In such a case, the testing is not undertaken in order to meet the same
underlying purpose as the Regulation – namely to ensure the safety of
cosmetic products – but rather to meet other objectives that are
recognised as legitimate reasons to undertake animal testing within the
EU legal order.
19. Such testing therefore cannot be said to have been undertaken ‘
in
order to meet the requirements of the Regulation’, even where the data
are subsequently used to meet those requirements.
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Arguments as to the construction of Article 18(1)(b) of the Regulation
advanced by the Claimant in the national proceedings
20.
In the national proceedings, the Claimant contends that the Regulation
permits manufacturers to meet the requirements of the Regulation by
reference to data obtained from animal testing undertaken outside the
EU to meet the requirements of a third country, whatever the purpose
underlying those requirements.
21.
The Claimant has advanced three principal arguments in support of
that contention. For the reasons set out below, those arguments are
incorrect.
22.
First, the Claimant cites Articles 11(2)(e) and 20(3) of the Regulation,
which both refer to animal testing in connection with products that are
(lawfully) marketed in the EU, in support of a contextual interpretation
of Article 18(1)(b) of the Regulation as permitting reliance on data
obtained from animal testing.
23.
Those provisions do not support the Claimant’s case: under the
interpretation of the United Kingdom, advanced above, a product may
lawfully be marketed notwithstanding the fact that such animal testing
has been undertaken in a third country. This may occur, for example:
a. where the testing was undertaken for a purpose other than to
ensure the safety of cosmetic products; or
b. where the results of the testing are not relied on to show the
safety of the products for the purposes of the Regulation; or
c. where the testing was undertaken before the deadline for
validation and adoption of alternative methods at EU level.
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24.
Secondly, the Claimant refers to various recitals in the preamble of the
Regulation, which show that the Regulation has as one of its purposes
to achieve a functioning internal market in cosmetics.
25.
However, it is also clear from the recitals that the Regulation was
intended to achieve a high level of human health and respect for the
welfare of animals. The United Kingdom submits that its interpretation
of Article 18(1)(b) of the Regulation best achieves the purposes of the
Regulation, considered together.
26.
Thirdly, the Claimant identifies certain aspects of the legislative history
of (what is now) Article 18(1)(b) of the Regulation, which are said to
support its interpretation. In particular, it says that when the European
Parliament first introduced an amendment providing for the prohibition
now contained in that provision, the amendment referred to ingredients
tested on animals ‘
in order to assess their safety or efficacy’, but the
prohibition as adopted omitted the reference to ‘
safety or efficacy’.
This is said to support a narrow interpretation of ‘
the requirements of
the Regulation’, excluding safety testing originally undertaken to
comply with third country requirements.
27.
However, the deletion of the reference to safety and efficacy could
equally have been made because the legislature thought that the
deleted words were otiose. The legislative history therefore does not
provide any support for the Claimant’s position.
C.
CONCLUSION
28.
For the reasons set out above, the UK respectfully submits that the
Court should answer the questions referred as follows:
‘Article 18(1)(b) of the Regulation prohibits the placing on the
market of cosmetic products containing ingredients or
combinations of ingredients the safety of which is proved, for the
purposes of the Regulation, by means of data obtained from
animal tests carried out in order to satisfy the legislative and