Directive 1999/45/EC is amended as follows:
Annex II is amended as follows:
table VI is replaced by the following table:
| a 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.’ | ||
| Classification of the substance | Classification of the preparation | |
|---|---|---|
| Categories 1 and 2 | Category 3 | |
| Carcinogenic substances of category 1 or 2 with R45 or R49 | Concentration ≥ 0,1 % carcinogenic R45, R49 obligatory as appropriate | |
| Carcinogenic substances of category 3 with R40 | Concentration ≥ 1 % carcinogenic R40 obligatory (unless already assigned R45 a) | |
| Mutagenic substances of category 1 or 2 with R46 | Concentration ≥ 0,1 % mutagenic R46 obligatory | |
| Mutagenic substances of category 3 with R68 | Concentration ≥ 1 % mutagenic R68 obligatory (unless already assigned R46) | |
| Substances “toxic for reproduction” of category 1 or 2 with R60 (fertility) | Concentration ≥ 0,5 % toxic for reproduction (fertility) R60 obligatory | |
| Substances “toxic for reproduction” of category 3 with R62 (fertility) | Concentration ≥ 5 % toxic for reproduction (fertility) R62 obligatory (unless already assigned R60) | |
| Substances “toxic for reproduction” of category 1 or 2 with R61 (development) | Concentration ≥ 0,5 % toxic for reproduction (development) R61 obligatory | |
| Substances “toxic for reproduction” of category 3 with R63 (development) | Concentration ≥ 5 % toxic for reproduction (development) R63 obligatory (unless already assigned R61) | |
table VI A is replaced by the following table:
| a 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.’ | ||
| Classification of the substance | Classification of the preparation | |
|---|---|---|
| Categories 1 and 2 | Category 3 | |
| Carcinogenic substances of category 1 or 2 with R45 or R49 | Concentration ≥ 0,1 % carcinogenic R45, R49 obligatory as appropriate | |
| Carcinogenic substances of category 3 with R40 | Concentration ≥ 1 % carcinogenic R40 obligatory (unless already assigned R45 a) | |
| Mutagenic substances of category 1 or 2 with R46 | Concentration ≥ 0,1 % mutagenic R46 obligatory | |
| Mutagenic substances of category 3 with R68 | Concentration ≥ 1 % mutagenic R68 obligatory (unless already assigned R46) | |
| Substances “toxic for reproduction” of category 1 or 2 with R60 (fertility) | Concentration ≥ 0,2 % toxic for reproduction (fertility) R60 obligatory | |
| Substances “toxic for reproduction” of category 3 with R62 (fertility) | Concentration ≥ 1 % toxic for reproduction (fertility) R62 obligatory (unless already assigned R60) | |
| Substances “toxic for reproduction” of category 1 or 2 with R61 (development) | Concentration ≥ 0,2 % toxic for reproduction (development) R61 obligatory | |
| Substances “toxic for reproduction” of category 3 with R63 (development) | Concentration ≥ 1 % toxic for reproduction (development) R63 obligatory (unless already assigned R61) | |
Annex III is amended as follows:
in Part A, point 2 of section (b)(1) (I), is deleted;
in Part B, table 1 is replaced by the following tables:
Acute aquatic toxicity and long-term adverse effects
| Classification of the substance | Classification of the preparation | ||
|---|---|---|---|
| N, R50-53 | N, R51-53 | R52-53 | |
| N, R50-53 | see Table 1b | see Table 1b | see Table 1b |
| N, R51-53 | Cn ≥ 25 % | 2,5 % ≤ Cn < 25 % | |
| R52-53 | Cn ≥ 25 % | ||
Preparations containing a substance classified with N, R50-53, the concentration limits and the resulting classification given in table 1b are applicable.
Acute aquatic toxicity and long-term adverse effects of substances very toxic to the aquatic environment
| 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).’ | |||
| LC50 or EC50 value (“L(E)C50”) of substance classified as N, R50-53 (mg/l) | Classification of the preparation | ||
|---|---|---|---|
| N, R50-53 | N, R51-53 | R52-53 | |
| 0,1 < L(E)C50 ≤ 1 | Cn ≥ 25 % | 2,5 % ≤ Cn < 25 % | 0,25 % ≤ Cn < 2,5 % |
| 0,01 < L(E)C50 ≤ 0,1 | Cn ≥ 2,5 % | 0,25 % ≤ Cn < 2,5 % | 0,025 % ≤ Cn < 0,25 % |
| 0,001 < L(E)C50 ≤ 0,01 | Cn ≥ 0,25 % | 0,025 % ≤ Cn < 0,25 % | 0,0025 % ≤ Cn < 0,025 % |
| 0,0001 < L(E)C50 ≤ 0,001 | Cn ≥ 0,025 % | 0,0025 % ≤ Cn < 0,025 % | 0,00025 % ≤ Cn < 0,0025 % |
| 0,00001 < L(E)C50 ≤ 0,0001 | Cn ≥ 0,0025 % | 0,00025 % ≤ Cn < 0,0025 % | 0,000025 % ≤ Cn < 0,00025 % |
in part B, table 2 is replaced by the following table:
Acute aquatic toxicity
| 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).’ | |
| LC50 or EC50 value (“L(E)C50”) of substance classified either as N, R50 or as N, R50-53 (mg/l) | Classification of the preparation N, R50 |
|---|---|
| 0,1 < L(E)C50 ≤ 1 | Cn ≥ 25 % |
| 0,01 < L(E)C50 ≤ 0,1 | Cn ≥ 2,5 % |
| 0,001 < L(E)C50 ≤ 0,01 | Cn ≥ 0,25 % |
| 0,0001 < L(E)C50 ≤ 0,001 | Cn ≥ 0,025 % |
| 0,00001 < L(E)C50 ≤ 0,0001 | Cn ≥ 0,0025 % |
in part B, table 5 of point II, is replaced by the following table:
Dangerous for the ozone layer
| Classification of the substance | Classification of the preparation N, R59 |
|---|---|
| N with R59 | Cn ≥ 0,1 %’ |
Annex V is replaced by the following:
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.
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.
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.
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:
“Contains lead. Should not be used on surfaces liable to be chewed or sucked by children”.
In the case of packages the contents of which are less than 125 millilitres, the particulars may be as follows:
“Warning! Contains lead”.
The label on the immediate packaging of adhesives based on cyanoacrylate must bear the following inscriptions:
‘Cyanoacrylate
Danger
Bonds skin and eyes in seconds
Keep out of the reach of children’.
Appropriate advice on safety must accompany the package.
The label on the packaging of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) must bear the following inscriptions:
‘Contains isocyanates.
See information supplied by the manufacturer’.
The label on the packaging of preparations containing epoxy constituents with an average molecular weight ≤ 700 must bear the following inscriptions:
‘Contains epoxy constituents.
See information supplied by the manufacturer’.
The label on the packaging of preparations containing more than 1 % of active chlorine must bear the following particular inscriptions:
“Warning! Do not use together with other products. May release dangerous gases (chlorine)”.
The label on the packaging of the above mentioned preparations must bear the following inscription printed in clearly legible and indelible characters:
‘Warning! Contains cadmium.
Dangerous fumes are formed during use.
See information supplied by the manufacturer.
Comply with the safety instructions’.
Without prejudice to the provisions of this Directive, 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/EC.
Where a preparation contains at least one substance which, in accordance with Article 13.3 of Directive 67/548/EEC, bears the inscription “[X1Caution — substance not yet fully tested]”, 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 %.
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:
“Contains (name of sensitising substance). May produce an allergic reaction”.
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:
“Can become highly flammable in use” or “Can become flammable in use”.
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:
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.
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:
“Contains chromium (VI). May produce an allergic reaction”
unless the preparation is already classified and labelled as a sensitiser with phrase R43.
The label on the packaging of preparations referred to in Article 14.2.1(b) must bear the following inscription:
“Safety data sheet available for professional user on request”.’
Editorial Information
X1 Substituted by Corrigendum to 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 dangerous preparations (Official Journal of the European Union L 19 of 24 January 2006).