1997L0010 — EN — 28.03.1997 — 000.001 — 1
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►B COMMISSION DIRECTIVE 97/10/EC
of 26 February 1997
adapting to technical progress for the 3rd time Annex I to Council Directive 76/769/EEC on the
approximation of the laws, regulations and administrative provisions of the Member Statesrelating to restrictions on the marketing and use of certain dangerous substances and preparations
(CMRs)
(Text with EEA relevance)
(OJ L 68, 8.3.1997, p. 24)
Corrected by:
►C1Corrigendum, OJ L 216, 14.8.1999, p. 25(97/10)
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▼B
COMMISSION DIRECTIVE 97/10/EC
of 26 February 1997
adapting to technical progress for the 3rd time Annex I to Council
Directive 76/769/EEC on the approximation of the laws, regulationsand administrative provisions of the Member States relating torestrictions on the marketing and use of certain dangerous
substances and preparations (CMRs)
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to Council Directive 76/769/EEC of 27 July 1976 on the
approximation of the laws, regulations and administrative provisions ofthe Member States relating to restrictions on the marketing and use ofcertain dangerous substances and preparations(
1), as last amended by
Commission Directive 96/55/EC (2), and in particular Article 2a thereof,
introduced by Council Directive 89/678/EEC (3),
Whereas the Council and the Representatives of the Governments of the
Member States, meeting within the Council, adopted Decision 90/238/Euratom, ECSC, EEC (
4) concerning a 1990 to 1994 action plan in the
context of the ‘Europe against Cancer' programme;
Whereas Directive 94/60/EC (5) of the European Parliament and
Council, amending for the 14th time Directive 76/769/EEC prohibitedwith certain exemptions the placing on the market for use by the generalpublic of substances classified as carcinogenic, mutagenic and toxic toreproduction in categories 1 or 2 (CMRs) by adding such substances toAnnex I of Directive 76/769/EEC;
Whereas Annex I to Directive 76/769/EEC already contained substances
classified CMR to which Directive 94/60/EC did not apply;
Whereas placing on the market for use by the general public of these
CMRs and preparations containing these CMRs should also be prohib-ited with certain exceptions;
Whereas the restrictions laid down by this Directive take into account
the current state of knowledge and techniques regarding safer alterna-tives;
Whereas this Directive does not affect Community legislation laying
down minimum requirements for the protection of workers contained inCouncil Directive 89/391/EEC (
6) and in individual Directives based
thereon, in particular Council Directive 90/394/EEC (7);
Whereas the measures provided for in this Directive are in accordance
with the opinion of the Committee for the adaptation to technicalprogress of the Directives on the removal of technical barriers to tradein dangerous substances and preparations,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex I to Directive 76/769/EEC is hereby adapted to technical
progress as set out in the Annex hereto.
(1) OJ No L 262, 27. 9. 1976, p. 201.
(2) OJ No L 231, 12. 9. 1996, p. 20.
(3) OJ No L 398, 30. 12. 1989, p. 24.
(4) OJ No L 137, 30. 5. 1990, p. 31.
(5) OJ No L 365, 31. 12. 1994, p. 1.
(6) OJ No L 183, 29. 6. 1989, p. 1.
(7) OJ No L 196, 26. 7. 1990, p. 1.
1997L0010 — EN — 28.03.1997 — 000.001 — 3
▼B
Article 2
Member States shall adopt and publish the provisions necessary to
comply with this Directive by 31 December 1997 and shall forthwithinform the Commission thereof. They shall apply these provisions asfrom 30 June 1998.
When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such reference atthe time of their official publication. The procedure for such referenceshall be adopted by Member States.
Article 3
This Directive is addressed to the Member States.
1997L0010 — EN — 28.03.1997 — 000.001 — 4
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ANNEX
Points 29, 30 and 31 of Annex Iare replaced by the following:
‘29. Substances which appear in Annex I to
Directive 67/548/EEC classified as carci-nogen category 1 or carcinogen category 2and labelled at least as “Toxic (T)” withrisk phrase R 45: “May cause cancer” orrisk phrase R49: “May cause cancer byinhalation”, and listed as follows:
Carcinogen category 1: See List 1 in the
Appendix.
Carcinogen category 2: See List 2 in the
Appendix.Without prejudice to the other points of Annex Ito Directive 76/769/EEC:
May not be used in substances and preparations
placed on the market for sale to the generalpublic in individual concentration equal to orgreater than:
— either the concentration specified in Annex I
to Council Directive 67/548/EEC (
1), or
— the concentration specified in point 6, Table
VI, of Annex I to Council Directive 88/379/EEC (
2), where no concentration limit
appears in Annex I to Directive 67/548/EEC.
Without prejudice to the implementation of other
Community provisions relating to the classi-fication, packaging and labelling of dangeroussubstances and preparations, the packaging ofsuch substances and preparations must be markedlegibly and indelibly as follows:
“Restricted to professional users. Attention —
Avoid exposure — obtain special instructionsbefore use”.
By way of derogation, this provision shall not
apply to:
(a) medicinal or veterinary products as defined
by Council Directive 65/65/EEC (
3);
(b) cosmetic products as defined by Council
Directive 76/768/EEC (4);
(c)►C1— motor fuels which are covered by
Council Directive 85/210/EEC (5),
— mineral oil products intended for
use as fuel in mobile or fixedcombustion plants,
— fuels sold in closed systems (e.g.
liquid gas bottles); ◄
(d) artists’ paints covered by Council Directive
88/379/EEC (
6).
30. Substances which appear in Annex I to
Directive 67/548/EEC classified as mutagencategory 1 or mutagen category 2 andlabelled with risk phrase R46: “May causeheritable genetic damage”, and listed asfollows:
Mutagen category 1: See List 3 in the
Appendix.
Mutagen category: See List 4 in the
Appendix.Without prejudice to the other points of Annex Ito Directive 76/769/EEC
May not be used in substances and preparations
placed on the market for sale to the generalpublic in individual concentration equal to orgreater than:
— either the concentration specified in Annex I
to Directive 67/548/EEC, or
— the concentration specified in point 6, Table
VI, of Annex I to Directive 88/379/EECwhere no concentration limit appears inAnnex I to Directive 67/548/EEC.
Without prejudice to the implementation of other
Community provisions relating to the classi-fication, packaging and labelling of dangeroussubstances and preparations, the packaging ofsuch substances and preparations must be markedlegibly and indelibly as follows:
“Restricted to professional users. Attention —
Avoid exposure — obtain special instructionsbefore use”.
By way of derogation, this provision shall not
apply to:
(a) medicinal or veterinary products as defined
by Directive 65/65/EEC;
(b) cosmetic products as defined by Directive
76/768/EEC;
(c)►
C1— motor fuels which are covered by
1997L0010 — EN — 28.03.1997 — 000.001 — 5
▼B
Council Directive 85/210/EEC (5),
— mineral oil products intended for
use as fuel in mobile or fixedcombustion plants,
— fuels sold in closed systems (e.g.
liquid gas bottles); ◄
(d) artists’ paints covered by Directive 88/
379/EEC.
31. Substances which appear in Annex I to
Directive 67/548/EEC classified as toxic toreproduction category 1 or toxic to repro-duction category 2 and labelled with riskphrase R60: “May impair fertility” and/orR61: “May cause harm to the unborn child”,and listed as follows:
Toxic to reproduction category 1: See List
5in the Appendix.
Toxic to reproduction category 2: See List
6 in the Appendix.Without prejudice to the other points of Annex Ito Directive 76/769/EEC
May not be used in substances and preparations
placed on the market for sale to the generalpublic in individual concentration equal to orgreater than:
— either the concentration specified in Annex I
to Directive 67/548/EEC, or
— the concentration specified in point 6, Table
VI, of Annex I to Directive 88/379/EECwhere no concentration limit appears inAnnex I to Directive 67/548/EEC.
Without prejudice to the implementation of other
Community provisions relating to the classi-fication, packaging and labelling of dangeroussubstances and preparations, the packaging ofsuch substances and preparations must be markedlegibly and indelibly as follows:
“Restricted to professional users. Attention —
Avoid exposure — obtain special instructionsbefore use”.
By way of derogation, this provision shall not
apply to:
(a) medicinal or veterinary products as defined
by Directive 65/65/EEC;
(b) cosmetic products as defined by Directive
76/768/EEC;
(c)►
C1— motor fuels which are covered by
Council Directive 85/210/EEC (5),
— mineral oil products intended for
use as fuel in mobile or fixedcombustion plants,
— fuels sold in closed systems (e.g.
liquid gas bottles); ◄
(d) artists’ paints covered by Directive 88/
379/EEC.
(1) OJ No 196, 16. 8. 1967, p. 1/67.
(2) OJ No L 187, 16. 7. 1988, p. 14.
(3) OJ No L 22, 9. 2. 1965, p. 369/65.
(4) OJ No L 262, 27. 9. 1976, p. 169.
(5) OJ No L 96, 3. 4. 1985, p. 25.
(6) OJ No 187, 16. 7. 1988, p. 14.'