Common Position (EC) No 18/2006 of 27 June 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No …/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency
Date: 2006-06-27
Institutions: Council of the European Union
Subjects: approximation of laws, chemical product, dangerous substance, labelling, marketing, packaging, product safety

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COMMON POSITION (EC) No 18/2006

adopted by the Council on 27 June 2006

with a view to adopting Directive 2006/…/EC of the European Parliament and of the Council of …
amending Council Directive 67/548/EEC on the approximation of laws, regulations and administra-
tive provisions relating to the classification, packaging and labelling of dangerous substances in
order to adapt it to Regulation (EC) No …/2006 concerning the Registration, Evaluation, Authori-
sation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency

(2006/C 276 E/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

4) Article 5 shall be amended as follows:

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

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (2),

Whereas:

(1)

In view of
the adoption of Regulation (EC) No …/
2006 (3), Directive 67/548/EEC (4) should be adapted and
its rules on the notification and risk assessment of
chemicals deleted,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 67/548/EEC is hereby amended as follows:

1) in Article 1, paragraph 1, points (a), (b) and (c) shall be

deleted;

2) in Article 2, paragraph 1, points (c), (d), (f) and (g) shall be

deleted;

(a) in paragraph 1, the first subparagraph shall be replaced

by the following:

‘Member States shall take all the necessary measures to
ensure that substances cannot be placed on the market
on their own or in preparations unless they have been
packaged and labelled in accordance with Articles 22
to 25 of this Directive and with the criteria in Annex
VI of this Directive, and, for registered substances, in
accordance with the information obtained through the
application of Articles 12 and 13 of Regulation (EC)
No …/2006, save in the case of preparations where
provisions exist in other Directives.’;

(b) paragraph 2 shall be replaced by the following:

The measures

‘2.
referred to in the first
sub-
the
paragraph of paragraph 1 shall apply until
substance is listed in Annex I or until a decision not to
list it has been taken in accordance with the procedure
laid down in Article 29.’;

5) Articles 7 to 15 shall be deleted;

6) Article 16 shall be deleted;

7) Articles 17 to 20 shall be deleted;

8) Article 27 shall be deleted;

3) Article 3 shall be replaced by the following:

9) Article 32 shall be replaced by the following:

‘Article 3

Testing
substances

and

assessment of

the

properties

of

Tests on substances carried out within the framework of
this Directive shall be conducted according to the require-
ments of Article 13 of Regulation (EC) No …/2006 of the
European Parliament and of the Council of … concerning
the Registration, Evaluation, Authorisation and Restriction
of Chemicals (REACH) and establishing a European Chemi-
cals Agency (*).

‘Article 32

References

References to Annexes VIIA, VIIB, VIIC, VIID and VIII of
this Directive shall be construed as references to the corre-
sponding Annexes VI, VII, VIII, IX, X and XI of Regulation
(EC) No …/2006.’;

10) Annex V shall be deleted;

(*) OJ L …’

11) Annex VI shall be amended as follows:

(1) OJ C 294, 25.11.2005, p. 38.
(2) Opinion of the European Parliament of 17 November 2005 (not yet
published in the Official Journal), Council Common Position of 27
June 2006 and Position of the European Parliament of … (not yet
published in the Official Journal).

(3) OJ L …
(4) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission
Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1). Corrected in OJ
L 216, 16.6.2004, p. 3.

(a) in sections 1.6.2, 1.7.2, 1.7.3, 2.1, 2.2.1, 2.2.2,
2.2.2.1, 2.2.3, 2.2.4, 2.2.5, 3.1.1, 3.1.5.1, 3.1.5.2,
3.2.1, 3.2.2, 3.2.3, 3.2.5, 3.2.6.1, 3.2.6.2, 3.2.7.2,
4.2.3.3, 5.1.3, 9.1.1.1, 9.1.1.2, 9.3 and 9.5 of this
Annex, the words ‘Annex V’ and ‘Annex V to this
Directive’, shall be replaced by the words ‘the Commis-
sion Regulation on test methods as specified in Article
13(2) of Regulation (EC) No …/2006’;

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(b) section 1.6.1, point

(a)

shall be replaced by the

Article 2

following:

‘(a) as regards substances for which the information
specified in Annexes VI, VII and VIII of Regulation
(EC) No …/2006 is required, most of the necessary
data for classification and labelling appear in the
base set. This classification and labelling must be
reviewed, if necessary, when further information is
available (Annexes IX and X of Regulation (EC) No
…/2006);’;

(c) in section 5.1, the second paragraph shall be replaced

by the following:

the base set

‘The criteria set out below follow directly from the test
methods set out in the Commission Regulation on test
methods as specified in Article 13(2) of Regulation (EC)
No …/2006 in so far as they are mentioned. The test
methods required for
referred to in
Annexes VII and VIII of Regulation (EC) No …/2006
are limited and the information derived from them
may be insufficient for an appropriate classification.
Classification may require additional data derived from
Annexes IX or X of Regulation (EC) No …/2006 or
other
classified
substances may be subject to review in the light of
other new data.’;

Furthermore,

equivalent

studies.

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive with effect from … (*). They shall forthwith inform
the Commission thereof.

When Member States adopt these measures, they shall contain
a reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by the
Member States.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

This Directive shall enter into force on the twentieth day
following its publication in the Official Journal of the European
Union.

It shall apply from … (*).

Notwithstanding the second paragraph of this Article, Article 1
point 6 shall apply from … (**).

Article 4

This Directive is addressed to the Member States.

(d) in section 5.2.1.2,

second paragraph,

the second

sentence shall be replaced by the following:

‘Such additional scientific evidence should normally be
based on the studies required by Annex IX of Regu-
lation (EC) No …/200, or studies of equivalent value,
and could include:’;

12) Annexes VIIA, VIIB, VIIC, VIID and VIII shall be deleted.

Done at …

For the European Parliament

The President

…

For the Council

The President

…

(*) 12 months after entry into force of the REACH Regulation.
(**) 14 months after entry into force of the REACH Regulation.

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STATEMENT OF THE COUNCIL'S REASONS (1)

(1) See p. 242 of this Official Journal.