2003/829/EC: Commission Decision of 25 November 2003 concerning national provisions on the use of azodyes notified by Germany under Article 95(4) of the EC Treaty (Text with EEA relevance) (notified under document number C(2003) 4356)
Date: 2003-11-25
Institutions: European Commission
Subjects: Germany, dangerous substance, derogation from EU law, dyestuff, marketing restriction

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COMMISSION DECISION

of 25 November 2003

concerning national provisions on the use of azodyes notified by Germany under Article 95(4) of
the EC Treaty

(notified under document number C(2003) 4356)

(Only the German text is authentic)

(Text with EEA relevance)

(2003/829/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

1.2. Directive 2002/61/EC

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95(6) thereof,

Whereas:

(1)

(2)

(3)

I. FACTS

By letter of the Permanent Representation of the Federal
Republic of Germany to the European Union of 21 May
2003,
the German Government, referring to Article
95(4) of the EC Treaty, notified to the Commission its
national provisions on the use of azodyes that it deems
necessary to maintain after the adoption of Directive
2002/61/EC of
the
Council of 19 July 2002 amending for the nineteenth
time Council Directive 76/769/EEC relating to restric-
tions on the marketing and use of certain dangerous
substances and preparations (azocolourants) (1).

the European Parliament and of

1. Community legislation

1.1. Article 95(4) and (6) of the EC Treaty

Article 95(4) of the EC Treaty provides that ‘If, after the
adoption by the Council or by the Commission of a
harmonisation measure, a Member State deems it neces-
sary to maintain national provisions on grounds of
major needs referred to in Article 30, or relating to the
protection of the environment or the working environ-
ment, it shall notify the Commission of these provisions
as well as the grounds for maintaining them.’

According to Article 95(6), the Commission shall, within
six months of the notification, approve or reject the
national provisions
verified
whether or not they are a means of arbitrary discrimina-
tion or a disguised restriction on trade between Member
States and whether or not
they shall constitute an
obstacle to the functioning of the internal market.

involved after having

(4)

(5)

(6)

(7)

Council Directive 76/769/EEC of 27 July 1976 on the
approximation of the laws, regulations and administra-
tive provisions of the Member States relating to restric-
tions on the marketing and use of certain dangerous
substances and preparations (2), as last amended by
Directive 2003/53/EC of the European Parliament and of
the Council (3), establishes rules restricting the marketing
and use of certain dangerous substances and prepara-
tions. According to Article 1(1), the Directive applies to
the dangerous substances and preparations listed in
Annex I.

take all
Article 2 provides that Member States shall
necessary measures
the dangerous
to ensure
substances and preparations listed in Annex I may only
be placed on the market or used subject to the condi-
tions specified therein.

that

Directive 76/769/EEC has been amended on several
inter alia, to add new dangerous substances
occasions,
and preparations to Annex I thereto, thereby introducing
the restrictions on their marketing or use that are neces-
sary to protect human health or the environment. In
certain cases,
also placed on the
marketing or use of products treated with or containing
those substances and preparations.

restrictions

are

Adopted on the legal basis of Article 95 of the EC
Treaty, Directive 2002/61/EC of the European Parlia-
ment and of the Council has inserted in Annex I to
Directive 76/769/EEC a new point 43 concerning azoco-
lourants, laying down rules on the marketing and use of
these substances.

(1) OJ L 243, 11.9.2002, p. 15.

(2) OJ L 262, 27.9.1976, p. 201.
(3) OJ L 178, 17.7.2003, p. 24.

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(8)

Recitals 2 to 4 of the Directive recall the background of
the Directive, stating that ‘Textile and leather articles
containing certain azodyes have the capacity to release
certain arylamines, which may pose cancer risks’ (1), that
‘Limitations already adopted or planned by certain
Member States on the use of azodyed textile and leather
articles concern the completion and functioning of the
internal market. It is therefore necessary to approximate
the laws of the Member States in this field and, conse-
quently, to amend Annex I to Council Directive 76/769/
EEC’ (2) and that ‘The Scientific Committee on Toxicity,
Ecotoxicity and the Environment (SCTEE), after being
consulted by the Commission, has confirmed that cancer
risks posed by textile and leather goods coloured by
certain azodyes, give cause for concern’ (3).

(9)

Consequently, as stated in recital 5, ‘In order to protect
human health, the use of dangerous azodyes and the
placing on the market of some articles coloured with
such dyes should be prohibited’.

(10) According to point 43.1, azodyes which, by reductive
cleavage of one or more azo groups, may release one or
more of the aromatic amines listed in the Appendix (4),
in detectable concentrations, i.e. above 30 ppm in the
finished articles or in the dyed parts thereof, according
to the testing method established in accordance with
Article 2a of this Directive, may not be used in textile
and leather articles which may come into direct and
prolonged contact with the human skin or oral cavity,
such as:

— clothing, bedding,

towels, hairpieces, wigs, hats,

nappies and other sanitary items, sleeping-bags,

— footwear,

gloves, wristwatch

straps, handbags,
purses/wallets, briefcases, chair covers, purses worn
round the neck,

— textile or leather toys and toys which include textile

or leather garments,

— yarn and fabric intended for use by the final

consumer (5).

(11)

‘Furthermore,

Point 43.2 states that
the textile and
leather articles referred to in point 1 above may not be
placed on the market unless they conform to the
requirements set out in that point’, while providing for a
time-limited exemption for
textile articles made of
recycled fibres previously dyed with azodyes.

(1) See recital 2 of Directive 2002/61/EC.
(2) See recital 3 of Directive 2002/61/EC.
(3) See recital 4 of Directive 2002/61/EC.
(4) Directive 2002/61/EC introduced in the Appendix to Directive 76/
769/EEC, under ‘Point 43 — Azocolourants’ a list of 22 aromatic
amines.

(5) Point 43.1 provides for a non-exhaustive list of articles.

(12)

In addition, point 43.3 provides that not later than 11
September 2005, the Commission shall, in the light of
new scientific knowledge,
review the provisions on
azocolourants, in accordance with recital 9 stating that
‘In the light of new scientific knowledge, the provisions
on certain azocolourants should be reviewed, in particu-
lar with regard to the need to include other materials
not covered by this Directive, as well as other aromatic
amines. Special attention should be paid to possible risks
to children’.

(13) Article 3(1) of the Directive provides that Member States
shall adopt and publish, not later than 11 September
2003, the laws, regulations and administrative provisions
necessary to comply with this Directive, they shall forth-
with inform the Commission thereof and shall apply
these provisions from 11 September 2003.

(14)

(15)

2. National provisions notified

The national provisions notified by the Federal Govern-
ment of Germany were introduced by the second ordi-
amending the Consumer Goods Ordinance
nance
[Bedarfsgegenständeverordnung] of 15 July 1994. The
ban of the use of harmful azodyes in eight groups of
articles, which are in prolonged contact with the body,
was introduced to protect the consumer against health
risks, given the fact that these dyes can break down into
substances which are potentially carcinogenic.

that

‘The

Subsection 3 of the Consumer Goods Ordinance headed
‘Prohibited substances’
commercial
states
manufacture or treatment of the materials and articles
in Annex 1 may not employ substances
set out
mentioned therein’. Annex 1 deals with the substances
which may not be used in the manufacture or processing
of certain articles. Point 7 of Annex 1 lists among the
prohibited substances ‘Azodyes which can form one of
the following amines (6) by breaking down into one or
more azo groups, with the exception of pigments in
which none of
the amines specified below can be
detected using the methods in accordance with the
procedure given in Annex 10(7)’. These azodyes may
not be employed in the manufacture or treatment of the
following categories of products, listed in Annex 1:

1. Clothing, materials for the manufacture of clothing;

2. Bed linen, blankets, pillows, sleeping bags;

(6) Point 7 of Annex 1 includes thereafter a list of 20 amines.

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3. Hand towels, beach mats, air mattresses;

4. Masks, hair-pieces, wigs, artificial eyelashes;

5. Articles of jewellery which are worn on the skin,

armbands;

6. Money bags, rucksacks;

7. Crawling mats, covers for seats and loungers for

infants and small children;

(21)

8. Nappies, sanitary towels, panty liners, tampons.

(16)

(17)

(18)

II. PROCEDURE

By letter of 21 May 2003, the German Permanent Repre-
sentation to the European Union informed the Commis-
sion that,
in accordance with Article 95(4) of the EC
Treaty, the Federal Republic of Germany intended to
maintain its national provisions regarding the use of
azodyes which deviate from those provided for in Direc-
tive 2002/61/EC amending Directive
76/769/EEC
regarding the marketing and use of azocolourants. The
Commission received the letter on 26 May 2003.

By letter of 12 June 2003, the Commission informed the
German Government that it had received the notification
under Article 95(4) of the EC Treaty and that the six-
month period for its examination under Article 95(6)
started on 27 May 2003, the day following the day on
which the notification was received.

By letter of 1 August 2003, the Commission informed
the other Member States of the notification received
from the Federal Republic of Germany. The Commission
also published a notice regarding the notification in the
in order to
Official
inform other interested parties of the national provisions
that Germany intended to maintain as well as the
grounds invoked to that effect.

the European Union (1)

Journal of

III. LEGAL ASSESSMENT

1. Consideration of admissibility

(19) Article 95(4) concerns cases in which the national provi-
sions are notified in relation to a Community harmoni-
sation measure where these provisions were adopted and
entered into force before the adoption of the latter and
the maintenance of which would be incompatible with
it.

(20)

The German notification received by the Commission on
26 May 2003 is intended to obtain approval for the
maintenance of national provisions derogating from
those of Directive 2002/61/EC, which constitutes a
the laws,
measure concerning the approximation of

(1) OJ C 185, 5.8.2003, p. 3.

regulations and administrative provisions of the Member
States, aiming at the establishment and operation of the
Internal Market, adopted on the basis of Article 95 of
the EC Treaty.
these national provisions
were adopted and entered into force in 1994, therefore
before the adoption of that Directive.

In addition,

The need for harmonisation in the field of azocolourants
arose from the cancer risks posed by textile and leather
goods coloured by certain azodyes, giving cause for
concern, as confirmed by the SCTEE in its opinion of 18
January 1999, and from the national legislations banning
certain carcinogenic azocolourants introduced or noti-
fied by several Member States. Therefore, Directive
2002/61/EC introduced restrictions on the use of azoco-
lourants by banning
in articles
containing dangerous substances that have clearly been
shown, on the basis of sufficient data, to pose risks, i.e.
articles made of textiles or leather.

certain azodyes

(22) According to a well-established case law, a Community
measure has to be interpreted in the light of the objec-
tives pursued. Directive 2002/61/EC is based on Article
95(1) of the Treaty, which is the legal basis for the adop-
tion of harmonisation measures having as their object
the establishing and functioning of the internal market.
It is clear from recital 3 of that Directive that its main
objective is to remove the obstacles to the completion
and the functioning of the internal market resulting from
the limitations already adopted or planned by certain
Member States on the use of certain azocolourants.

(23)

The Commission therefore considers
that Directive
2002/61/EC has to be interpreted as having introduced a
harmonisation of all the current uses of azodyes, thus
preventing Member States from introducing or main-
taining national restrictions on the use of azodyes going
further than those laid down in that Directive.

(24) When comparing the provisions of Directive 2002/61/
EC and the national measures notified by Germany, it
emerges that the national ban on the use of azodyes
considered as harmful to health in certain articles, differs
from the requirements of Directive 2002/61/EC. The
German provisions (Subsection 3 together with Annex
1(7)) ban the use of azodyes in eight groups of articles
without limiting these to textile and leather as required
by Directive 2002/61/EC.

(25)

Furthermore Article 95(4) requires that the notification
of the national provisions be accompanied by a descrip-
tion of the grounds relating to one or more of the major
needs referred to in Article 30 or to the protection of
the environment or the working environment.

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(26) As required by Article 95(4) of the EC Treaty, Germany
notified the Commission of the exact wording of the
provisions going beyond those set out
in Directive
2002/61/EC,
including with the application a short
explanation of the reasons relating to the protection of
consumer health which, in its opinion, justify the main-
tenance of those provisions.

requesting Member State which seeks to maintain them.
Given the procedural framework established by Article
95 of the EC Treaty, including in particular a strict dead-
line for a decision to be adopted,
the Commission
normally has to limit itself to examining the relevance of
the elements which are submitted by the requesting
Member State, without having to seek itself possible
reasons of justifications.

(27)

In the light of the foregoing, the Commission considers
that the application submitted by Germany with a view
to obtaining authorisation to maintain its national provi-
sions on azodyes is admissible under Article 95(4) of the
EC Treaty.

2. Assessment of merits

(28)

(29)

In accordance with Article 95(4) and (6), first subpara-
graph, of the EC Treaty, the Commission must ascertain
that all the conditions enabling a Member State to main-
tain its national provisions derogating from a Com-
munity harmonisation measure provided for in that
Article are fulfilled. In particular, the national provisions
have to be justified by the major needs referred to in
Article 30 of the Treaty or relating to the protection of
the environment or the working environment, must not
be a means of arbitrary discrimination or a disguised
restriction on trade between Member States and must
not constitute an obstacle to the functioning of
the
internal market.

It should be pointed out that the Court's case law is
consistent in requiring that the conditions for granting a
derogation from the fundamental rules of Community
law must be interpreted restrictively. As the provision in
question creates an exception to the principles of
uniform application of Community law and the unity of
the market, Article 95(4) of the EC Treaty must, as with
all measures relating to derogations, be interpreted in
such a way that its scope is not extended beyond the
cases expressly foreseen. As Article 95 is precisely the
expression of such a derogation, it must be interpreted
strictly and only be applied under strict conditions with
regard to the justification required.

2.1. The burden of proof

(31)

(32)

It is up to the notifying Member State to provide enough
grounds, facts and scientific evidence so that it can be
given authorisation to make a derogation (1). It is thus in
the Member State's interest to attach to the notification
any substantive or legal elements which could support
the application (2). Failure to include in the notification
to maintain or
such
elements shall lead the Commission to consider the noti-
fication not founded.

introduce national provisions

In their letter of notification, the German authorities
invoke the objective of safeguarding consumer health.
The Commission therefore must check whether
the
national provisions are commensurate with the aim, i.e.
necessary and proportionate to the objective pursued,
given that the harmonisation measure already adopted,
i.e. Directive 2002/61/EC, has itself taken as its basis a
high level of protection in accordance with Article 95(3)
and pursues this objective in a proportionate way.

2.2. Justification on grounds of major needs referred to in
Article 30 or relating to the protection of the environ-
ment or the working environment

2.2.1. G e r ma n p osi t i on

(33)

The Federal Government intends to retain the national
ban on certain azodyes for the eight groups of articles
which come into direct and prolonged contact with the
body,
in so far as these do not consist of textile or
leather thereby going beyond the restrictions contained
in Directive 2002/61/EC which is limited to articles
made of textile and leather.

(30)

the EC Treaty,

It has to be noted that, in the light of the time frame
the
established by Article 95(6) of
Commission, when examining whether
the national
measures notified under Article 95(4) are justified, has to
take as a basis ‘the grounds’ put forward by the notifying
Member State. This means that, according to the provi-
sions of the EC Treaty, the responsibility of proving that
justified lies with the
are
the national measures

(34)

To justify the maintenance of their national provisions,
the German authorities have submitted an explanatory
statement which provides the following justifications.

(1) See, in relation to Article 30 of the EC Treaty, the European Court
Justice judgment of 23 September 2003 in case C-192/01,

of
Commission v. Kingdom of Denmark, paragraph 46.

(2) See the ‘Communication from the Commission concerning Article
95 (paragraphs 4, 5 and 6) of the Treaty establishing the European
in particular its
Community’ (COM(2002)760 final, 23.12.2002),
paragraph 13.

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(35)

that

‘the ban on
The German authorities point out
azodyes which are harmful to health in certain articles
which have prolonged contact with the body, enacted in
the Federal Republic of Germany in 1994, was for the
protection of consumer health’. The German authorities
state that ‘even at this point in time it was known that
certain azodyes could break down into carcinogenic
amines’. They consider that
‘consequently, any direct
contact with the body with these azodyes should be
prevented, regardless of the material of which the article,
with which the consumer comes into prolonged contact,
is made’.

(36)

The Federal Government takes the view that the danger
to health from azodyes, which can break down into
harmful amines, applies regardless of whether the dyed
objects are produced from textiles,
leather or another
material.

(41)

concern. The SCTEE considered that the report commis-
sioned by the Commission adequately reviewed the
situation regarding the risk of cancer for consumers as a
result of the use of fabrics dyed with azo compounds
and that its conclusions were in general acceptable. The
Committee supported the report's recommendation that
use of azodyes should be restricted without distin-
guishing between the 14 amines classified by the EU as
category I or II carcinogens and the eight amines classi-
fied by the MAK Commission, and considered that the
restriction should not be subject to prior development of
validated analytical methodology.

Therefore, in line with these recommendations, Directive
2002/61/EC has banned the use of dangerous azocolour-
ants and the placing on the market of textiles and leather
articles coloured with such substances that have clearly
been shown, on the basis of sufficient data, to pose risks.
Therefore Germany cannot rely on the SCTEE opinion
of 1999 for restricting the use of azodyes in materials
other than textiles and leather.

(37) As

scientific data, Germany simply mentions
two
opinions of the SCTEE (Scientific Committee for Toxi-
city, Ecotoxicity and the Environment): the opinion on
‘Risk of cancer caused by textiles and leather goods
coloured with azodyes’ of 18 January 1999 and the
opinion on the Report (final draft) on ‘Assessment of the
risks to human health posed by azocolourants in toys,
writing inks and paper products, and analysis of the
advantages and drawbacks of
restrictions on their
marketing and use’ of 12 June 2001.

(38)

In the following, the statements and positions of the
German authorities will be evaluated in the light of the
criteria established by Article 95(4). In particular the two
opinions of the SCTEE on which Germany bases its
request will be analysed.

2.2.2. T h e S CT E E op i ni on of 1999

(39)

The Commission would like to recall that the effects of
azodyes have been assessed both in the study commis-
sioned by the Commission and in the opinion of the
SCTEE of 1999 during the preparation of Directive
2002/61/EC.

(40) On 18 January 1999, the Scientific Committee on Toxi-
city, Ecotoxicity and the Environment (SCTEE) delivered
its opinion (1), concluding that the cancer risks associated
with the use of
for
concern (2). The Committee confirmed that azodyes
which on cleavage form any of the carcinogenic amines
classified as carcinogenic category 1 or 2, and in addi-
tion 8 amines on the German MAK list, were of special

certain azodyes give

cause

(1) Opinion on Risk of cancer caused by textiles and leather goods
coloured with azodyes expressed at the seventh SCTEE plenary
meeting, Brussels, 18 January 1999.

(2) The concern from the point of view of carcinogenic risks arises
from the potential of azodyes to undergo in vivo reductive cleavage
to aromatic amines, including the 22 amines classified by the EU or
the MAK Commission as proven or suspected human carcinogens.

2.2.3. T h e S CT E E op i ni on of 2001

(42)

The SCTEE, in its opinion of June 2001 (3) stated that
even if some products made of other materials dyed with
azodyes could be possible sources of exposure to
there is a serious lack of quantitative data.
azodyes,
Germany therefore cannot rely on this opinion for justi-
fying its restriction of azodyes in materials other than
textiles and leather.

(43)

This second SCTEE opinion was known before Directive
2002/61/EC was adopted.

(44)

To extend the scope of the ban to other materials, which
have not clearly been shown by sufficient data to pose
risks, would therefore not be justified.

2.2.4. F u r th e r con si de r a t i ons

(45)

In this context, the Commission would also like to stress
that even if a Member State may base an application to
maintain its already existing national provisions on an
assessment of the risk to public health different from
that accepted by the Community legislature when it
adopted the harmonisation measure from which the
national provisions derogate,
falls to the applicant
Member State to prove the necessity and proportionality
of the national provisions in question.

it

(3) Opinion on: Report (final draft) on ‘Assessment of the risks to
human health posed by azocolourants in toys, writing inks and
paper products, and analysis of the advantages and drawbacks of
restrictions on their marketing and use’. Opinion expressed at the
24th SCTEE plenary meeting, Brussels, 12 June 2001.

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(46)

The German authorities have not provided any element
to demonstrate the existence of a known risk to human
health going beyond the risk already identified by the
Community legislature, nor have they demonstrated that
the national measures concerned do not go beyond what
is necessary to attain the objective foreseen (1).

is very limited.

(47) As demonstrated above, the material and data submitted
by the German authorities in support to their request for
application of Article 95(4)
In their
explanatory statement, the German authorities justify the
maintenance of their national provisions on the ground
of consumer protection. However, no further informa-
tion or data is provided to substantiate their arguments.
They have not submitted any scientific data on the risks
which would demonstrate the inadequacy of the Com-
munity harmonisation measure, nor any evaluation of
the risks for health — such as an estimation of the
consumer exposure — enabling them to justify the
maintenance of their national provision. They have not
even provided any information on the use of such
azodyes in the manufacture of products with materials
other than textile and leather.

(51)

(52)

tion on trade between Member States and whether or
not they shall constitute an obstacle to the functioning
of the internal market.

It should be recalled that an application under Article
95(4) of the EC Treaty must be assessed in the light of
the conditions laid down in both that paragraph and
paragraph 6 of that Article. If any one of those condi-
the application must be rejected
tions is not met,
without there being a need to examine the others.

Since the request made by Germany does not fulfil the
basic conditions set out in Article 95(4) (see Part III,
section 2.2, of this Decision), the Commission is not
obliged to verify whether or not the notified national
provisions are a means of arbitrary discrimination or a
disguised restriction on trade between Member States,
and whether or not they constitute an obstacle to the
functioning of the internal market.

IV. CONCLUSION

(48)

Concerning the remaining arguments put forward by the
German authorities, the Commission would like to recall
that a ban on products constitutes a restriction to trade
in the internal market and thus a serious impediment to
the fundamental objective of
the free circulation of
goods. Any restriction of that kind would therefore have
to be based on very solid grounds, and the examination
of
the German application has shown that no such
grounds have been presented.

(53)

In light of the elements which it had available to assess
the merits of
forward for the
the justifications put
national measures notified, and in light of the considera-
tions set out above, the Commission considers that the
request of Germany for maintaining national provisions
derogating from Directive 2002/61/EC amending Direc-
tive 76/769/EEC with regard to the marketing and use
of certain azodyes, submitted on 21 May 2003:

(49) Overall it can be seen that the documentation and argu-
ments submitted by the German authorities in support
of their request for a derogation under Article 95(4) do
not allow to conclude that the national measures are
justified by a major need referred to in Article 30 of the
EC Treaty. Consequently, the request from Germany for
maintaining its national measures does not fulfil all the
conditions set out in Article 95(4) of the EC Treaty.

— is admissible,

— does not fulfil all the conditions set out in Article
95(4) of the EC Treaty, as Germany did not justify
the maintenance of its national provisions by the
major need to protect consumer health.

(54)

The Commission therefore has grounds to consider that
the national provisions notified cannot be approved in
accordance with Article 95(6) of the EC Treaty,

2.3. Absence of any arbitrary discrimination, any disguised
trade between Member States or any

restriction of
obstacle to the functioning of the internal market

HAS ADOPTED THIS DECISION:

(50)

Pursuant to Article 95(6) of the EC Treaty, the Commis-
sion shall approve or reject
the national provisions
involved after having verified whether or not they are a
means of arbitrary discrimination or a disguised restric-

(1) See the European Court of Justice judgment of 20 March 2003 in

case C-3/00, paragraphs 63 and 64.

Article 1

The national provisions on restriction on the use and
marketing of azodyes notified by the Federal Republic of
the EC Treaty are
to Article 95(4) of
Germany pursuant
rejected.

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This Decision is addressed to the Federal Republic of Germany.

Article 2

Done at Brussels, 25 November 2003.

For the Commission

Erkki LIIKANEN

Member of the Commission