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EC-1272-2008 appex vi.pdf
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REGULATIONS REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)
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I
(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory)
REGULATIONS
REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 December 2008
on classification, labelling and packaging of substances and mixtures, amending and repealing
Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Commu-
nity, 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
),
Acting in accordance with the procedure laid down in Article 251
of the Treaty (
2
),
Whereas:
(1) This Regulation should ensure a high level of protection of
human health and the environment as well as the free
movement of chemical substances, mixtures and certain
specific articles, while enhancing competitiveness and
innovation.
(2) The efficient functioning of the internal market for
substances, mixtures and those articles can be achieved
only if the requirements applicable to them do not differ
significantly between Member States.
(3) A high level of human health and environmental protection
should be ensured in the approximation of legislation on
the criteria for classification and labelling of substances and
mixtures, with the goal of achieving sustainable develop-
ment.
(4) Trade in substances and mixtures is an issue relating not
only to the internal market, but also to the global market.
Enterprises should therefore benefit from the global
harmonisation of rules for classification and labelling and
from consistency between, on the one hand, the rules for
classification and labelling for supply and use and, on the
other hand, those for transport.
(5) With a view to facilitating worldwide trade while protecting
human health and the environment, harmonised criteria for
classification and labelling have been carefully developed
over a period of 12 years within the United Nations (UN)
structure, resulting in the Globally Harmonised System of
Classification and Labelling of Chemicals (hereinafter
referred to as ‘the GHS’).
(6) This Regulation follows various declarations whereby the
Community confirmed its intention to contribute to the
global harmonisation of criteria for classification and
labelling, not only at UN level, but also through the
incorporation of the internationally agreed GHS criteria
into Community law.
(7) The benefits for enterprises will increase as more countries
in the world adopt the GHS criteria in their legislation. The
Community should be at the forefront of this process to
encourage other countries to follow and with the aim of
providing a competitive advantage to industry in the
Community.
(8) Therefore it is essential to harmonise the provisions and
criteria for the classification and labelling of substances,
mixtures and certain specific articles within the Commu-
nity, taking into account the classif ication criteria and
labelling rules of the GHS, but also by building on the 40
years of experience obtained through implementation of
existing Community chemicals legislation and maintaining
31.12.2008
EN
Official Journal of the European Union L 353/1
(
1
) OJ C 204, 9.8.2008, p. 47.
(
2
) Opinion of the European Parliament of 3 September 2008 (not yet
published in the Official Journal).
the level of protection achieved through the system of
harmonisation of classification and labelling, through
Community hazard classes not yet part of the GHS as well
as through current labelling and packaging rules.
(9) This Regulation should be without prejudice to the full and
complete application of Community competition rules.
(10) The objective of this Regulation should be to determine
which properties of substances and mixtures should lead to
a classification as hazardous, in order for the hazards of
substances and mixtures to be properly identified and
communicated. Such properties should include physical
hazards as well as hazards to human health and to the
environment, including hazards to the ozone layer.
(11) This Regulation should, as a general principle, apply to all
substances and mixtures supplied in the Community, except
where other Community legislation lays down more
specific rules on classification and labelling, such as Council
Directive 76/768/EEC of 27 July 1976 on the approxima-
tion of the laws of the Member States relating to cosmetic
products (
1
), Council Directive 82/471/EEC of 30 June
1982 concerning certain products used in animal nutri-
tion (
2
), Council Directive 88/388/EEC of 22 June 1988 on
the approximation of the laws of the Member States
relating to flavourings for use in foodstuffs and to source
materials for their production (
3
), Council Directive 89/
107/EEC of 21 December 1988 on the approximation of
the laws of the Member States concerning food additives
authorised for use in foodstuffs intended for human
consumption (
4
), Council Directive 90/385/EEC of 20 June
1990 on the approximation of the laws of the Member
States relating to active implantable medical devices (
5
),
Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices (
6
), Directive 98/79/EC of the European Par-
liament and of the Council of 27 October 1998 on in vitro
diagnostic medical devices (
7
), Commission Decision 1999/
217/EC of 23 February 1999 adopting a register of
flavouring substances used in or on foodstuffs drawn up in
application of Regulation (EC) No 2232/96 of the European
Parliament and of the Council (
8
), Directive 2001/82/EC of
the European Parliament and of the Council of 6 November
2001 on the Community code relating to veterinary
medicinal products (
9
), Directive 2001/83/EC of the
European Parliament and of the Council of 6 November
2001 on the Community code relating to medicinal
products for human use (
10
), Regulation (EC) No 178/
2002 of the European Parliament and of the Council of
28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food
Safety Authority and laying down procedures in matters of
food safety (
11
) and Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
2003 on additives for use in animal nutrition (
12
) or except
where substances and mixtures are transported by air, sea,
road, rail or inland waterways.
(12) The terms and definitions used in this Regulation should be
consistent with those set out in Regulation (EC) No 1907/
2006 of the European Parliament and of the Council of
18 December 2006 concerning the Registration, Evalua-
tion, Authorisation and Restriction of Chemicals
(REACH) (
13
), with those set out in the rules gover ning
transport and with the definitions specified at UN level in
the GHS, in order to ensure maximum consistency in the
application of chemicals legislation within the Community
in the context of global trade. The hazard classes specified
in the GHS should be set out in this Regulation for the same
reason.
(13) It is especially appropriate to include those hazard classes
defined in the GHS which specifically take account of the
fact that the physical hazards which may be exhibited by
substances and mixtures are to some extent influenced by
the way in which they are released.
(14) The term ‘mixture’ as defined in this Regulation should
have the same meaning as the term ‘preparation’ previously
used in Community legislation.
(15) This Regulation should replace Council Directive 67/548/
EEC of 27 June 1967 on the approximation of the laws,
regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous sub-
stances (
14
) as well as Directive 1999/45/EC of the
European Parliament and of the Council of 31 May 1999
concerning the approximation of the laws, regulations and
administrative provisions of the Member States relating to
the classification, packaging and labelling of dangerous
preparations (
15
). It should maintain the overall current
level of protection of human health and the environment
provided by those Directives. Therefore, some hazard
classes which are covered by those Directives but are not
yet included in the GHS should be maintained in this
Regulation.
(16) Responsibility for the identification of hazards of sub-
stances and mixtures and for deciding on their classification
should mainly lie with manufacturers, importers and
downstream users of those substances or mixtures,
regardless of whether they are subject to the requirements
L 353/2
EN
Official Journal of the European Union 31.12.2008
(
1
) OJ L 262, 27.9.1976, p. 169.
(
2
) OJ L 213, 21.7.1982, p. 8.
(
3
) OJ L 184, 15.7.1988, p. 61.
(
4
) OJ L 40, 11.2.1989, p. 27.
(
5
) OJ L 189, 20.7.1990, p. 17.
(
6
) OJ L 169, 12.7.1993, p. 1.
(
7
) OJ L 331, 7.12.1998, p. 1.
(
8
) OJ L 84, 27.3.1999, p. 1.
(
9
) OJ L 311, 28.11.2001, p. 1.
(
10
) OJ L 311, 28.11.2001, p. 67.
(
11
) OJ L 31, 1.2.2002, p. 1.
(
12
) OJ L 268, 18.10.2003, p. 29.
(
13
) OJ L 396, 30.12.2006, p. 1. Corrected version in OJ L 136,
29.5.2007, p. 3.
(
14
) OJ 196, 16.8.1967, p. 1.
(
15
) OJ L 200, 30.7.1999, p. 1.
of Regulation (EC) No 1907/2006. In fulfilling their
responsibilities for classification, downstream users should
be allowed to use the classification of a substance or
mixture derived in accordance with this Regulation by an
actor in the supply chain, provided that they do not change
the composition of the substance or mixture. Responsibility
for classification of substances not placed on the market
that are subject to registration or notification under
Regulation (EC) No 1907/2006 should mainly lie with
the manufacturers, producers of articles and importers.
However, there should be a possibility to provide for
harmonised classifications of substances for hazard classes
of highest concern and of other substances on a case-by-
case basis which should be applied by all manufacturers,
importers and downstream users of such substances and of
mixtures containing such substances.
(17) Where a decision has been taken to harmonise the
classification of a substance for a specific hazard class or
differentiation within a hazard class by including or revising
an entry for that purpose in Part 3 of Annex VI to this
Regulation, the manufacturer, importer and downstream
user should apply this harmonised classification, and only
self-classify for the remaining, non-harmonised hazard
classes or differentiations within the hazard class.
(18) To ensure that customers receive information on hazards,
suppliers of substances and mixtures should ensure that
they are labelled and packaged in accordance with this
Regulation before placing them on the market, according to
the classification derived. In fulfilling their responsibilities
downstream users should be allowed to use the classifica-
tion of a substance or mixture derived in accordance with
this Regulation by an actor in the supply chain, provided
that they do not change the composition of the substance
or mixture, and distributors should be allowed to use the
classification of a substance or mixture derived in
accordance with this Regulation by an actor in the supply
chain.
(19) To ensure information on hazardous substances is available
when they are included in mixtures containing at least one
substance that is classified as hazardous, supplemental
labelling information should be provided, where applicable.
(20) While a manufacturer, importer or downstream user of any
substance or mixture should not be obliged to generate new
toxicological or eco-toxicological data for the purpose of
classification, he should identify all relevant information
available to him on the hazards of the substance or mixture
and evaluate its quality. The manufacturer, importer or
downstream user should also take into account historical
human data, such as epidemiological studies on exposed
populations, accidental or occupational exposure and effect
data, and clinical studies. That information should be
compared with the criteria for the different hazard classes
and differentiations in order for that manufacturer,
importer or downstream user to arrive at a conclusion as
to whether or not the substance or mixture should be
classified as hazardous.
(21) While the classification of any substance or mixture may be
carried out on the basis of available information, the
available information to be used for the purposes of this
Regulation should preferably have been generated in
accordance with the test methods referred to in Regula-
tion (EC) No 1907/2006, transport provisions or inter-
national principles or procedures for the validation of
information, so as to ensure quality and comparability of
the results and consistency with other requirements at
international or Community level. The same test methods,
provisions, principles and procedures should be followed
where the manufacturer, importer or downstream user
chooses to generate new information.
(22) To facilitate hazard identification for mixtures, manufac-
turers, importers and downstream users should base this
identification on the data for the mixture itself, where
available, except for mixtures with carcinogenic, germ cell
mutagenic or reproductive toxic substances, or where the
biodegradation or bioaccumulation properties in the
hazard class hazardous to the aquatic environment are
evaluated. In those cases, as the hazards of the mixture
cannot be sufficiently assessed in a manner that is based on
the mixture itself, the data for the individual substances of
the mixture should nor mally be used as a basis for the
hazard identification of the mixture.
(23) If sufficient information is available on similar tested
mixtures, including relevant ingredients of the mixtures, it
is possible to determine the hazardous properties of an
untested mixture by applying certain rules known as
‘bridging principles’. Those rules allow characterisation of
the hazards of the mixture without performing tests on it,
but rather by building on the available information on
similar tested mixtures. Where no or inadequate test data
are available for the mixture itself, manufacturers, importers
and downstream users should therefore follow the bridging
principles to ensure adequate comparability of results of the
classification of such mixtures.
(24) Specific industry sectors may establish networks to facilitate
exchange of data and bring together expertise in the
evaluation of information, test data, weight of evidence
determinations and bridging principles. Such networks may
support manufacturers, importers and downstream users
within those industry sectors, and in particular small and
medium-sized enterprises (SMEs) in the fulfilment of their
obligations under this Regulation. Those networks may also
be used to exchange information and best practices with a
view to simplifying fulfilment of the notification obliga-
tions. Suppliers making use of such support should remain
fully responsible for the fulfilment of their classification,
labelling and packaging responsibilities under this Regula-
tion.
31.12.2008
EN
Official Journal of the European Union L 353/3
(25) The protection of animals falling within the scope of
Council Directive 86/609/EEC of 24 November 1986 on
the approximation of laws, regulations and administrative
provisions of the Member States regarding the protection of
animals used for experimental and other scientific
purposes (
1
) is of high priority. Accordingly, where the
manufacturer, importer or downstream user chooses to
generate information for the purposes of this Regulation,
they should first consider means other than testing on
animals within the scope of Directive 86/609/EEC. Tests on
non-human primates should be prohibited for the purposes
of this Regulation.
(26) The test methods in Commission Regulation (EC) No 440/
2008 of 30 May 2008 laying down test methods pursuant
to Regulation (EC) No 1907/2006 of the European
Parliament and of the Council on the Registration,
Evaluation, Authorisation and Restriction of Chemicals
(REACH) (
2
) are regularly reviewed and improved with a
view to reducing testing on vertebrate animals and the
number of animals involved. The European Centre for the
Validation of Alternative Methods (ECVAM) of the
Commission's Joint Research Centre plays an important
role in the scientific assessment and validation of alternative
test methods.
(27) The classification and labelling criteria set out in this
Regulation should take the utmost account of promoting
alternative methods for the assessment of hazards of
substances and mixtures and of the obligation to generate
information on intrinsic properties by means other than
tests on animals within the meaning of Directive 86/609/
EEC as laid down in Regulation (EC) No 1907/2006. Future
criteria should not become a barrier to this aim and the
corresponding obligations under that Regulation, and
should under no circumstances lead to the use of animal
tests where alternative tests are adequate for the purposes of
classification and labelling.
(28) For the purposes of classification, data should not be
generated by means of testing on humans. Available,
reliable epidemiological data and experience with regard to
the effects of substances and mixtures on humans (e.g.
occupational data and data from accident databases) should
be taken into account and may be given pr iority over data
derived from animal studies when they demonstrate
hazards not identified from those studies. The results of
animal studies should be weighed against the results of data
from humans and expert judgement should be used to
ensure the best protection of human health when
evaluating both the animal and human data.
(29) New information as regards physical hazards should always
be necessary, except if the data are already available or if a
derogation is provided for in this Regulation.
(30) Testing that is carried out for the sole purpose of this
Regulation should be carried out on the substance or
mixture in the form(s) or physical state(s) in which the
substance or mixture is placed on the market and in which
it can reasonably be expected to be used. It should,
however, be possible to use, for the purpose of this
Regulation, the results of tests that are carried out to
comply with other regulatory requirements, including those
laid down by third countries, even if the tests were not
carried out on the substance or mixture in the form(s) or
physical state(s) in which it is placed on the market and in
which it can reasonably be expected to be used.
(31) If tests are performed, they should comply where
appropriate with the relevant requirements for the protec-
tion of laboratory animals, set out in Directive 86/609/EEC,
and, in the case of ecotoxicological and toxicological tests,
good laboratory practice, set out in Directive 2004/10/EC
of the European Parliament and of the Council of
11 February 2004 on the harmonisation of laws,
regulations and administrative provisions relating to the
application of the principles of good laboratory practice
and the verification of their application for tests on
chemical substances (
3
).
(32) The criteria for classification in different hazard classes and
differentiations should be set out in an annex, which should
also contain additional provisions as to how the criter ia
may be met.
(33) Recognising that the application of the criteria for the
different hazard classes to information is not always
straightforward and simple, manufacturers, importers and
downstream users should apply weight of evidence
determinations involving expert judgement to arrive at
adequate results.
(34) Specific concentration limits for substances should be
assigned to a substance by a manufacturer, importer or
downstream user in accordance with the criteria referred to
in this Regulation, provided the manufacturer, importer or
downstream user is able to justify the limits and informs the
European Chemicals Agency (hereinafter referred to as
‘the Agency’) accordingly. However, specific concentration
limits should not be set for harmonised hazard classes or
differentiations for substances included in the harmonised
classification and labelling tables annexed to this Regula-
tion. Guidance should be provided by the Agency for the
purpose of setting the specific concentration limits. In order
to ensure uniformity, specific concentration limits should
also be included, where appropriate, in cases of harmonised
classifications. Specific concentration limits should take
precedence over any other concentration limit for the
purpose of classification.
(35) Multiplying factors (M-factors) for substances classified as
hazardous to the aquatic environment, acute category 1 or
chronic category 1, should be assigned to a substance by a
manufacturer, importer or downstream user in accordance
with the criteria referred to in this Regulation. Guidance
should be provided by the Agency for the purpose of
setting the M-factors.
L 353/4
EN
Official Journal of the European Union 31.12.2008
(
1
) OJ L 358, 18.12.1986, p. 1.
(
2
) OJ L 142, 31.5.2008, p. 1. (
3
) OJ L 50, 20.2.2004, p. 44.
(36) For reasons of proportionality and workability, generic cut-
off values should be defined, both for identified impurities,
additives and individual constituents of substances and for
substances in mixtures, specifying when information on
these should be taken into account in determining the
hazard classification of substances and mixtures.
(37) To ensure adequate classification of mixtures, available
information on synergistic and antagonistic effects should
be taken into account for the classification of mixtures.
(38) Manufacturers, importers and downstream users should re-
evaluate the classifications of substances or mixtures they
place on the market if they become aware of new adequate
and reliable scientific or technical information that may
affect those classifications or if they change the composi-
tion of their mixtures, to ensure that the classification is
based on up-to-date information, unless there is sufficient
evidence that the classification would not change. Suppliers
should update the labels accordingly.
(39) Substances and mixtures classified as hazardous should be
labelled and packaged according to their classification, so as
to ensure appropriate protection and to provide essential
information to their recipients, by drawing their attention
to the hazards of the substance or mixture.
(40) The two instruments foreseen by this Regulation to be used
to communicate the hazards of substances and mixtures are
labels and the safety data sheets provided for in Regula-
tion (EC) No 1907/2006. Of these two, the label is the only
tool for communication to consumers, but it may also serve
to draw the attention of workers to the more comprehen-
sive information on substances or mixtures provided in
safety data sheets. Since the provisions on safety data sheets
are included in Regulation (EC) No 1907/2006 which uses
the safety data sheet as the main communication tool
within the supply chain of substances, it is appropriate not
to duplicate the same provisions in this Regulation.
(41) To ensure proper and comprehensive information provision
to consumers on the hazards and safe use of chemicals and
mixtures, the use and dissemination of Internet sites and
free-phone numbers should be promoted, particularly in
connection with information provision on specific types of
packaging.
(42) Workers and consumers worldwide would benefit from a
globally harmonised hazard communication tool in the
form of labelling. Therefore, the elements to be included in
labels should be specified in accordance with the hazard
pictograms, signal words, hazard statements and precau-
tionary statements which form the core information of the
GHS. Other information included in labels should be
limited to a minimum and should not call into question the
main elements.
(43) It is essential that the substances and mixtures placed on the
market are well identified. However, the Agency should
allow enterprises, upon their request and where necessary,
to describe the chemical identity of certain substances in a
way that does not put the confidential nature of their
businesses at risk. Where the Agency refuses such a request,
an appeal should be allowed in accordance with this
Regulation. The appeal should have a suspensive effect, so
that the confidential information with regard to which the
request has been made, should not appear on the label
while the appeal is pending.
(44) The International Union of Pure and Applied Chemistry
(IUPAC) is a long-standing global authority on chemical
nomenclature and terminology. Identification of substances
by their IUPAC name is widespread practice worldwide and
provides the standard basis for identifying substances in an
international and multilingual context. It is therefore
appropriate to use these names for the purposes of this
Regulation.
(45) The Chemical Abstracts Ser vice (CAS) provides a system
whereby substances are added to the CAS Registry and are
assigned a unique CAS Registry Number. Those CAS
numbers are used in reference works, databases, and
regulatory compliance documents throughout the world to
identify substances without the ambiguity of chemical
nomenclature. It is therefore appropriate to use the CAS
numbers for the purposes of this Regulation.
(46) To limit the information on the label to the most essential
information, principles of precedence should determine the
most appropriate label elements for cases in which
substances or mixtures possess several hazardous proper-
ties.
(47) Council Directive 91/414/EEC of 15 July 1991 concerning
the placing of plant protection products on the market (
1
)
and Directive 98/8/EC of the European Parliament and of
the Council of 16 Febr uary 1998 concerning the placing of
biocidal products on the market (
2
) should remain fully
applicable to any product within their scope.
(48) Statements such as ‘non-toxic’, ‘non-harmful’, ‘non-pollut-
ing’, ‘ecological’ or other statements indicating that the
substance or mixture is not hazardous or any other
statements that are inconsistent with its classification
should not appear on the label or packaging of any
substance or mixture.
(49) In general, substances and mixtures, especially those
supplied to the general public, should be supplied in
packaging together with the necessary labelling informa-
tion. The supply of appropriate information between
professionals, including for unpackaged substances and
31.12.2008
EN
Official Journal of the European Union L 353/5
(
1
) OJ L 230, 19.8.1991, p. 1.
(
2
) OJ L 123, 24.4.1998, p. 1.
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