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S.I. No. 76 of
2007
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EUROPEAN
COMMUNITIES (CLASSIFICATION, PACKAGING AND LABELLING OF DANGEROUS
PREPARATIONS) (AMENDMENT) REGULATIONS 2007
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Notice of the
making of this Statutory Instrument was published in “Iris Oifigiúil” of 27th February, 2007.
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I, MICHEÁL
MARTIN, Minister for Enterprise, Trade and Employment in exercise of the
powers conferred on me by section 3 of the European Communities Act 1972
(No. 27 of 1972) and for the purpose of giving further effect to Directive
1999/45/EC of the European Parliament and of the Council of 31 May 1999 1
as amended by Commission Directive
2006/8/EC of 23 January 2006 2 hereby
make the following regulations:
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1. (1)
These Regulations may be cited as the European Communities (Classification,
Packaging and Labelling of Dangerous Preparations) (Amendment) Regulations
2007 and come into operation on 1 March 2007.
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(2) The
Principal Regulations and these Regulations may be cited together as the
European Communities (Classification, Packaging and Labelling of Dangerous
Preparations) Regulations 2004 and 2007.
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2. (1) In
these Regulations—
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“Principal Regulations” means the European Communities (Classification,
Packaging and Labelling of Dangerous Preparations) Regulations 2004 ( S.I.
No. 62 of 2004 ).
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(2) A word
or expression that is used in these Regulations and is also used in
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 preparations and Commission
Directive 2006/8/EC of 23 January 2006 amending, for the purposes of their
adaptation to technical progress, Annexes II, III and V to 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
preparations, has, unless the contrary intention appears, the same meaning
in these Regulations as in Directive 1999/45/EC as so amended.
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3. (1)
Schedule 3 to the Principal Regulations is amended—
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(a) in Part B under the
heading Point 6.1 Non-gaseous preparations, Table VI, by substituting the
provisions set out in Schedule A, and
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(b) in Part B under the
heading Point 6.2 Gaseous preparations, Table VI A, by substituting the
provision set out in Schedule B.
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4. (1)
Schedule 4 to the Principal Regulations is amended—
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(a) by deleting in Part
A, section (b)(1), paragraph 1.2—
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“1.2 Preparations should be
classified as dangerous for the environment and assigned the risk phrase R59
if they contain one or more substances classified as dangerous to the
environment and to which is assigned R59 in individual concentrations equal
to or greater than:
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(a) either the
concentration specified in Annex I for the substance or substances under
consideration, or
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(b) the
concentration specified in Part B of this Schedule (Table 5) where the
substance or substances do not appear in Annex I or appear in it without
concentration limits;”,
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(b) by substituting
Tables 1a and 1b set out in Schedule C for Table 1, Part B set out in the
said Schedule 4,
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(c) by substituting
Table 2 set out in Schedule D for Table 2, Part B in the said Schedule 4,
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(d) by substituting
Table 5 set out in Schedule E for Table 5 of point II, Part B of the said
Schedule 4.
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5. Schedule
7 to the Principal Regulations is replaced with the provisions set out in
Schedule F.
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Regulation 3(1)(a)
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Schedule A
“Point 6.1 (of Schedule 3) – Non-gaseous preparations
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Table VI
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Classification of the substance
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Classification of the preparation
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Categories 1 and 2
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Category 3
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Carcinogenic substances of category 1 or 2 with R45 or R49
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Concentration 0.1 %carcinogenicR45, R49 obligatory as appropriate
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Carcinogenic substances of category 3 with R40
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Concentration 1 %carcinogenicR40 obligatory (unless already assigned
R45 (*))
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Mutagenic substances of category 1 or 2 with R46
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Concentration 0.1 % mutagenic R46 obligatory
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Mutagenic substances of category 3 with R68
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Concentration 1 %mutagenic R68 obligatory (unless already assigned
R46)
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Substances “toxic for reproduction” of category 1 or 2 with R60
(fertility)
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Concentration 0.5 %toxic for reproduction (fertility) R60 obligatory
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Substances “toxic for reproduction” of category 3 with R62 (fertility)
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Concentration 5 %toxic for reproduction (fertility)R62 obligatory (unless
already assigned R60)
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Substances “toxic for reproduction” of category 1 or 2 with R61
(development)
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Concentration 0.5 %toxic for reproduction (development)R61 obligatory
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Substances “toxic for reproduction” of category 3 with R63
(development)
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Concentration 5 %toxic for reproduction (development)R63 obligatory (unless
already assigned R61)
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(*) In cases where the preparation is assigned R49 and R40, both R
phrases shall be kept, because R40 does not distinguish between the
exposure routes, whereas R49 is only assigned for the inhalation route.
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”
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Regulation 3(1)(b)
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Schedule B
“Point 6.2 (of Schedule 3) – Gaseous preparations
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Table VI A
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Classification of the substance
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Classification of the preparation
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Categories 1 and 2
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Category 3
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Carcinogenic substances of category 1 or 2 with R45 or R49
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Concentration 0.1 %carcinogenicR45, R49 obligatory as appropriate
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Carcinogenic substances of category 3 with R40
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Concentration 1 %carcinogenicR40 obligatory (unless already assigned
R45 (*))
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Mutagenic substances of category 1 or 2 with R46
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Concentration 0.1 %mutagenicR46 obligatory
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Mutagenic substances of category 3 with R68
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Concentration 1 %mutagenicR68 obligatory (unless already assigned
R46)
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Substances “toxic for reproduction” of category 1 or 2 with R60
(fertility)
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Concentration 0.2 %toxic for reproduction (fertility)R60 obligatory
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Substances “toxic for reproduction” of category 3 with R62 (fertility)
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Concentration 1 %toxic for reproduction (fertility)R62 obligatory (unless
already assigned R60)
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Substances “toxic for reproduction” of category 1 or 2 with R61
(development)
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Concentration 0.2 %toxic for reproduction (development)R61 obligatory
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Substances “toxic for reproduction” of category 3 with R63
(development)
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Concentration 1 %toxic for reproduction (development)R63 obligatory (unless
already assigned R61)
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(*) In cases where the preparation is assigned R49 and R40, both R
phrases shall be kept, because R40 does not distinguish between the
exposure routes, whereas R49 is only assigned for the inhalation route.
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”
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Regulation 4(1)(b)
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Schedule C
“ PART B (of Schedule 4) – Concentration limits to be used for the
evaluation of environmental hazards
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1. For the aquatic
environment
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Table 1a
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Acute aquatic toxicity and long-term adverse effects
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Classification of the substance
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Classification of the preparation
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N, R50-53
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N, R51-53
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R52-53
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N, R50-53
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see Table 1b
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see Table 1b
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see Table 1b
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N, R51-53
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Cn 25 %
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2.5 % Cn < 25 %
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R52-53
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Cn 25 %
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Preparations containing a substance classified with N, R50-53, the
concentration limits and the resulting classification given in Table 1b are
applicable.
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Table 1b
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Acute aquatic toxicity and long-term adverse effects of substances
very toxic to the aquatic environment
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LC50 or EC50 value (“L(E)C50”) of substance classified as N, R50-53
(mg/l)
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Classification of the preparation
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N, R50-53
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N, R51-53
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R52-53
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0.1 < L(E)C50 1
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Cn 25 %
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2.5 % Cn < 25 %
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0.25 % Cn < 2.5%
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0.01 < L(E)C50 0.1
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Cn 2.5 %
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0.25 % Cn < 2.5 %
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0.025 % Cn < 0.25 %
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0.001 < L(E)C50 0.01
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Cn 0.25 %
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0.025 % Cn < 0.25 %
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0.0025 % Cn < 0.025 %
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0.0001 < L(E)C50 0.001
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Cn 0.025 %
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0.0025 % Cn < 0.025 %
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0.00025 % Cn < 0.0025 %
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0.00001 < L(E)C50 0.0001
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Cn 0.0025 %
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0.00025 % Cn < 0.0025 %
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0.000025 % Cn < 0.00025 %
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For preparations containing substances with a lower LC50 or EC50 value
than 0.00001 mg/l, the corresponding concentration limits are calculated
accordingly (in factor 10 intervals).
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”
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Regulation 4(1)(c)
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Schedule D
“ PART B (of Schedule 4) – Concentration limits to be used for the
evaluation of environmental hazards
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I. For the aquatic
environment
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Table 2
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Acute aquatic toxicity
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LC50 or EC50 value (“L(E)C50”) of substance classified either as N, R50
or as N, R50-53 (mg/l)
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Classification of the preparation N, R50
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0.1 < L(E)C50 1
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Cn 25 %
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0.01 < L(E)C50 0.1
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Cn 2.5 %
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0.001 < L(E)C50 0.01
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Cn 0.25 %
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0.0001 < L(E)C50 0.001
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Cn 0.025 %
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0.00001 < L(E)C50 0.0001
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Cn 0.0025 %
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For preparations containing substances with a lower LC50 or EC50 value
than 0.00001 mg/l, the corresponding concentration limits are calculated
accordingly (in factor 10 intervals).
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”
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Regulation 4(1)(d)
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Schedule E
“PART B (of Schedule 4) – Concentration limits to be used for the evaluation
of environmental hazards
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II. For the non-aquatic environment
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Table 5
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Dangerous for the ozone layer
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Classification of the substance
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Classification of the preparation N, R59
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N with R59
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Cn 0.1 %
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”
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Regulation 5
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Schedule F
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“SCHEDULE 7
SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS
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A. For preparations
classified as dangerous as defined under Regulation 3(2)
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1. Preparations sold
to the general public
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1.1. The label on the
packaging containing such preparations, in addition to the specific safety
advice, must bear the relevant safety advice S1, S2, S45 or S46 in
accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.
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1.2. When such preparations
are classified as very toxic (T+), toxic (T) or corrosive (C) and where it
is physically impossible to give such information on the package itself,
packages containing such preparations must be accompanied by precise and
easily understandable instructions for use including, where appropriate,
instructions for the destruction of the empty package.
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2. Preparations
intended for use by spraying
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The label on the packaging containing such preparations must compulsorily
bear the safety advice S23 accompanied by safety advice S38 or S51 assigned
to it in accordance with the criteria laid down in Annex VI to Directive
67/548/EEC.
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3. Preparations
containing a substance assigned phrase R33: Danger of cumulative effects
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When a preparation contains at least one substance assigned the phrase
R33, the label on the packaging of the preparation must carry the wording of
this phrase as set out in Annex III to Directive 67/548/EEC, when the
concentration of this substance present in the preparation is equal to or
higher than 1 %, unless different values are set in Annex I to Directive
67/548/EEC.
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4. Preparations
containing a substance assigned phrase R64: May cause harm to breastfed
babies
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When a preparation contains at least one substance assigned phrase R64,
the label on the packaging of the preparation must carry the wording of this
phrase as set out in Annex III to Directive 67/548/EEC, when the
concentration of this substance present in the preparation is equal to or
higher than 1 %, unless different values are set in Annex I to Directive
67/548/EEC.
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B. For preparations irrespective of their classification as
defined under Regulation 3(3)
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1. Preparations
containing lead
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1.1. Paint and
varnishes
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The label on the packaging of paints and varnishes containing lead in
quantities exceeding 0.15 % (expressed as weight of metal) of the total
weight of the preparation, as determined in accordance with ISO standard
6503/1984, must show the following particulars:
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“Contains lead. Should not be used on surfaces liable to be chewed or
sucked by children”.
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In the case of packages the contents of which are less than 125
millilitres, the particulars may be as follows:
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“Warning! Contains lead”.
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2. Preparations
containing cyanoacrylates
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2.1. Adhesives
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The label on the immediate packaging of adhesives based on cyanoacrylate must bear the following inscriptions:
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“Cyanoacrylate
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Danger
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Bonds skin and eyes in seconds
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Keep out of the reach of children”.
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Appropriate advice on safety must accompany the package.
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3. Preparations
containing isocyanates
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The label on the packaging of preparations containing isocyanates
(as monomers, oligomers, prepolymers,
etc., or as mixtures thereof) must bear the following inscriptions:
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“Contains isocyanates.
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See information supplied by the manufacturer”.
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4. Preparations
containing epoxy constituents with an average molecular weight 700
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The label on the packaging of preparations containing epoxy constituents
with an average molecular weight 700 must bear the following inscriptions:
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“Contains epoxy constituents.
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See information supplied by the manufacturer”.
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5. Preparations sold
to the general public which contain active chlorine
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The label on the packaging of preparations containing more than 1 % of
active chlorine must bear the following particular inscriptions:
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“Warning! Do not use together with other products. May release dangerous
gases (chlorine)”.
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6. Preparations
containing cadmium (alloys) and intended to be used for brazing or soldering
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The label on the packaging of the above mentioned preparations must bear
the following inscription printed in clearly legible and indelible
characters:
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“Warning! Contains cadmium.
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Dangerous fumes are formed during use.
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See information supplied by the manufacturer.
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Comply with the safety instructions”.
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7. Preparations
available as aerosols
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Without prejudice to the provisions of the European Communities
(Classification, Packaging and Labelling of Dangerous Preparations)
Regulations 2004 and 2007, preparations available as aerosols are also
subject to the labelling provisions in accordance with points 2.2 and 2.3 of
the Annex to Directive 75/324/EEC as last amended by Directive 94/1/EEC.
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8. Preparations
containing substances not yet tested completely
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Where a preparation contains at least one substance which, in accordance
with Article 13.3 of Directive 67/548/EEC, bears the inscription “Caution —
substance not yet tested completely”, the label on the packaging of the
preparation must bear the inscription “Warning — this preparation contains a
substance not yet tested completely” if this substance is present in a
concentration 1 %.
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9. Preparations not
classified as sensitising but containing at least one sensitising substance
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The label on the packaging of preparations containing at least one
substance classified as sensitising and being present in a concentration
equal to or greater than 0.1 % or in a concentration equal to or greater
than that specified under a specific note for the substance in Annex I to
Directive 67/548/EEC must bear the inscription:
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“Contains (name of sensitising substance). May produce an allergic
reaction”.
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10. Liquid
preparations containing halogenated hydrocarbons
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For liquid preparations which show no flashpoint or a flashpoint higher
than 55 °C and contain a halogenated hydrocarbon and more than 5 % flammable
or highly flammable substances, the label on the packaging must bear the
following inscription as appropriate:
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“Can become highly flammable in use” or “Can become flammable in use”.
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11. Preparations
containing a substance assigned phrase R67: vapours may cause drowsiness and
dizziness
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When a preparation contains one or more substances assigned the phrase
R67, the label on the packaging 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:
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- the preparation is already classified with phrases R20, R23, R26,
R68/20, R39/23 or R39/26, or
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- the preparation is in a package not exceeding 125 ml.
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12. Cements and
cement preparations
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The label on 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:
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“Contains chromium (VI). May produce an allergic reaction”
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unless the preparation is already classified and labelled as a sensitiser with phrase R43.
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C.
For preparations not classified within the meaning of Regulation 3(2) but
containing at least one dangerous substance
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1. Preparations not
intended for the general public
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The label on the packaging of preparations referred to in Regulation
18(1)(b) of the Principal Regulations must bear the following
inscription:
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“Safety data sheet available for professional user on request”.
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”
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GIVEN under my Official Seal
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26 February 2007
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MICHEÁL MARTIN
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Minister for Enterprise, Trade and Employment
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EXPLANATORY NOTE
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(This note is not part of
the Instrument and does not purport to be a legal interpretation).
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These Regulations amend
Schedules 3, 4 and 7 to the European Communities (Classification, Packaging
and Labelling of Dangerous Preparations) Regulations, 2004 ( S.I. No. 62 of
2004 ).
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These Regulations transpose
Commission Directive 2006/8/EC of 23 January 2006 which amends Annexes II,
III and V to Directive 1999/45/EC of the European Parliament and of the
Council of 31 May 1999 on the approximation of the laws, regulations and
administrative provisions of the Member States relating to the
classification, packaging and labelling of dangerous preparations. Directive
1999/45/EC is transposed into Irish law by the 2004 Regulations ( S.I. No 62
of 2004 ) [The Principal Regulations].
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The aim of these Regulations
is to protect human health and the environment from the harmful effects of
dangerous preparations. The Regulations require each manufacturer, importer
or distributor of a dangerous preparation to classify and label it according
to its inherent hazards and to provide safety data sheets.
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The Regulations introduce a
number of amendments to the Principal Regulations as follows:
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(i)
The classification of preparations containing Carcinogens, Mutagens and Reprotoxins (CMRs) is amended
so that, where previously a preparation would have to be classified and
labelled with both Category 1 or 2 and Category 3 R-phrases, they will now
only be classified and labelled with the highest relevant category. This is
to prevent conflicting messages on labels for users.
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(ii) The classification of
preparations containing substances classified as very toxic to the aquatic
environment is amended, to resolve differences in the way that substances
with specific concentration limits in Annex I to Directive 67/548/EEC on the
approximation of the laws, regulations and administrative provisions
relating to the classification, packaging and labelling of dangerous
substances are classified compared to self-classified substances.
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(iii) Changes are introduced
to classifications for preparations containing substances dangerous to the
ozone layer in that the symbol “N” is now required for substances classified
as “R59 (Dangerous for the ozone layer)”.
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(iv) The terminology in
Schedule 7 to the Principal Regulations regarding “Special Provisions
Concerning the Labelling of Certain Preparations” is replaced to make it
more consistent and accurate.
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Schedules A and B to these
Regulations amend Schedule 3 to the European Communities (Classification,
Packaging and Labelling of Dangerous Preparations) Regulations 2004 ( S.I.
No. 62 of 2004 ); Schedules C, D and E to these Regulations amend Schedule 4
to the 2004 Regulations and Schedule F to these Regulations sets out a
replacement Schedule 7 to the 2004 Regulations.
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These Regulations come into
operation on 1 March 2007.
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1 O.J. No. L200,
30.7.1999, p.1
2 O.J. No. L19,
24.1.2006, p.12
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