Commission Directive 2001/60/EC of 7 August 2001 adapting to technical progress Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (Text with EEA relevance)
Date: 2001-08-07
Institutions: European Commission
Subjects: approximation of laws, classification, dangerous substance, labelling, packaging

22.8.2001

EN

Official Journal of the European Communities

L 226/5

COMMISSION DIRECTIVE 2001/60/EC

of 7 August 2001

adapting to technical progress Directive 1999/45/EC of the European Parliament and of the Council
concerning the approximation of the laws, regulations and administrative provisions of the
Member States relating to the classification, packaging and labelling of dangerous preparations

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Directive 1999/45/EC of the European Parlia-
ment and of the Council of 31 May 1999 concerning the
the laws, regulations and administrative
approximation of
provisions of the Member States relating to the classification,
packaging and labelling of dangerous preparations (1), and in
particular Article 20 thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

for

Commission Directive 98/98/EC (2) adapting to technical
the 25th time Council Directive 67/
progress
548/EEC (3), as last amended by Directive 2000/33/
EC (4), provides for new criteria and a new R phrase
(R67)
for vapours which may cause drowsiness and
dizziness. The provisions set out in Annex V to Directive
1999/45/EC should therefore be supplemented.

Commission Directive 2001/59/EC (5)
introduces new
wording for R phrase R40 when it is assigned to carci-
nogens of category 3. Consequently, the old wording of
R phrase R40 will now be referred to as R68 and will
continue to be used for mutagens of category 3 and for
certain substances with non-lethal irreversible effects. It
is therefore necessary to amend the references to R40 in
Annex II to Directive 1999/45/EC.

Directive 2001/59/EC introduces into Annex VI
to
Directive 67/548/EEC clearer advice on the classification
of substances and preparations for corrosive effects. It is
therefore necessary to supplement Annex II to Directive
1999/45/EC accordingly.

It is known that cement preparations containing chro-
mium (VI) may cause allergic reactions
in certain
circumstances. It is therefore desirable to require such
preparations to display a warning label by supple-
menting Annex V to Directive 1999/45/EC.

The measures provided for in this Directive are in
accordance with the opinion of the Committee for the
adaptation to technical progress of the Directives on the

(1) OJ L 200, 30.7.1999, p. 1.
(2) OJ L 355, 30.12.1998, p. 1.
(3) OJ 196, 16.8.1967, p. 1.
(4) OJ L 136, 8.6.2000, p. 90.
(5) OJ L 225, 21.8.2001, p. 1.

removal of
technical barriers to trade in dangerous
substances and preparations established under Article 20
of Directive 1999/45/EC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 1999/45/EC is amended as follows:

1. In Annex II, Part A:

— in paragraph 3.3, the term ‘R40’ is replaced by ‘R68’,

— in paragraph 8.2, the term ‘R40’ is replaced by ‘R68’

each time it occurs.

2. In Annex II, Part B:

— in paragraph 2.1 (including Table II), the term ‘R40’ is

replaced by ‘R68’ each time it occurs,

— in paragraph 2.2 (including Table II A), the term ‘R40’ is

replaced by ‘R68’ each time it occurs,

— in paragraph 6.1, the term ‘R40’ is replaced by ‘R68’ the
in relation to mutagenic

second time it occurs (i.e.
category 3),

— in Table VI, the term ‘R40’ is replaced by ‘R68’ in the
fourth row, columns 1 and 3 (i.e. in relation with muta-
genic category 3),

— in paragraph 6.2, the term ‘R40’ is replaced by ‘R68’ the
in relation to mutagenic

second time it occurs (i.e.
category 3),

— in Table VI A, the term ‘R40’ is replaced by ‘R68’ in the
fourth row, columns 1 and 3 (i.e. in relation with muta-
genic category 3).

3. In Annex II, Part B, Tables IV and IV A are supplemented

with the following note:

‘NB: Simple application of

the conventional method to
preparations containing substances classified as corro-
sive or irritant may result in under-classification or
relevant
over-classification of
factors (e.g. pH of the preparation) are not taken into
account. Therefore,
in classifying for corrosivity,
consider the advice given in paragraph 3.2.5 of Annex
VI to Directive 67/548/EEC and in the second and
third indents of Article 6(3), of this Directive.’

the hazard,

if other

L 226/6

EN

Official Journal of the European Communities

22.8.2001

Article 2

Annex V(B) to Directive 1999/45/EC is supplemented by the
addition of new paragraphs 11 and 12 as in Annex I to this
Directive.

3. When Member States adopt those provisions, they shall
contain a reference to this Directive or be accompanied by
such a reference on the occasion of their official publication.
Member States shall determine how such reference is to be
made.

Article 3

Article 4

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 30 July 2002 at the latest. They shall forthwith
inform the Commission thereof.

2. Member States shall apply the laws, regulations and
administrative provisions referred to in paragraph 1:

(a) to preparations not within the scope of Council Directive
91/414/EEC (1) on the placing of plant protection products
on the market, or European Parliament and Council
Directive 98/8/EC (2) on the placing of biocidal products on
the market as from 30 July 2002;

(b) and to preparations within the scope of Directive 91/
414/EEC or Directive 98/8/EC as from 30 July 2004.

This Directive shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Communities.

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 7 August 2001.

For the Commission

Erkki LIIKANEN

Member of the Commission

ANNEX

The following paragraphs 11 and 12 are added to Annex V(B) to Directive 1999/45/EC:

‘11. Preparations containing a substance assigned phrase R67: vapours may cause drowsiness and dizziness

When a preparation contains one or more substances assigned the phrase R67, the label of the preparation must
carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the total concentration of
these substances present in the preparation is equal to or higher than 15 %, unless:

— the preparation is already classified with phrases R20, R23, R26, R68/20, R39/23 or R39/26,

— or the preparation is in a package not exceeding 125 ml.

12. Cements and cement preparations

The packaging of cements and cement preparations containing more than 0,0002 % soluble chromium (VI) of
the total dry weight of the cement must bear the inscription:

“Contains chromium (VI). May produce an allergic reaction”

unless the preparation is already classified and labelled as a sensitiser with phrase R43.’

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 123, 24.4.1998, p. 1.