Table VI

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(*))
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)
(*) 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.
(**) R68 here refers to substances classified as mutagenic. Concentration limits for substances required to be labelled R68 but classified as harmful are given in Table II.

Table VIA

Classification of the substance (gas)	Classification of the gaseous 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(*))
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)
(*) 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.
(**) R68 here refers to substances classified as mutagenic. Concentration limits for substances required to be labelled R68 but classified as harmful are given in Table IIA.

Table 1a

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%
For preparations containing a substance classified with N, R50-53, the concentration limits and the resulting classification given in table 1b are applicable.

Table 1b

Acute aquatic toxicity and long-term adverse effects of substances very toxic to the aquatic environment

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%
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).

Table 2

Acute aquatic toxicity

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%
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).

Table 5

Dangerous for the ozone layer

Classification of the substance	Classification of preparation N, R59
N with R59	Cn ≥ 0.1%

PART IIPARTICULAR PROVISIONS CONCERNING CERTAIN PREPARATIONS

ASPECIAL PROVISIONS FOR DANGEROUS PREPARATIONS

Dangerous preparations to be supplied to the general public1

1

The label on the packaging of dangerous preparations intended to be supplied to the general public must in addition to the relevant safety advice bear the relevant safety phrase S1, S2, S45 or S46 in accordance with the approved classification and labelling guide.

2

When the dangerous preparations referred to in sub-paragraph (1) are classified as very toxic, toxic or corrosive and where it is physically impossible to give the 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.

Dangerous preparations intended for use by spraying2

The label on the packaging containing dangerous preparations intended to be used for spraying shall bear the safety phrase S23 and safety phrase S38 or S51 assigned in accordance with the approved classification and labelling guide.

Dangerous preparations containing a substance affected by the risk phrase R33 (danger of cumulative effects)3

When a dangerous preparation contains at least one substance required to show the risk phrase R33, that phrase must be shown on the label on the packaging of the dangerous preparation when the concentration of that substance is equal to or higher than 1% unless a different value is shown for that substance in the approved supply list.

Dangerous preparations containing a substance affected by the risk phrase R64 (may cause harm to breast-fed babies)4

When a dangerous preparation contains at least one substance required to show the risk phrase R64, that phrase must be shown on the label on the packaging of the dangerous preparation when the concentration of that substance is equal to or higher than 1% unless a different value is shown for that substance in the approved supply list.

BSPECIAL PROVISIONS APPLYING TO ANY PREPARATION

Paints and varnishes containing lead1

1

The label on the packaging of paints and varnishes containing lead in quantities exceeding 0.15% (expressed as weight of lead out of the total weight of the preparation and determined in accordance with ISO Standard 6503/1984) shall bear the following inscription—

• “Contains lead. Should not be used on surfaces that are liable to be chewed or sucked by children.”.

2

In the case of packages containing less than 125 millilitres of the preparations referred to in sub-paragraph (1), the inscription on the label may be—

• “Warning! Contains lead.”.

Cyanoacrylate based adhesives2

1

The label on the immediate packaging of glues based on cyanoacrylates shall bear the following inscriptions—

• “Cyanoacrylate.

• Danger.

• Bonds skin and eyes in seconds.

• Keep out of the reach of children.”

2

Appropriate safety advice shall accompany the package.

Preparations containing isocyanates3

The label on the packaging of preparations containing isocyanates (whether as monomers, oligomers, prepolymers etc. or as mixtures thereof) shall bear the following inscriptions—

• “Contains isocyanates.

• See information supplied by the manufacturer.”.

Certain preparations containing epoxy constituents4

The label on the packaging of preparations containing epoxy constituents with an average molecular weight ≤700 shall bear the following inscriptions—

• “Contains epoxy constituents.

• See information supplied by the manufacturer.”.

Preparations intended to be sold to the general public that contain active chlorine5

The label on the packaging of preparations containing more than 1% of active chlorine which are intended to be sold to the general public shall bear the following inscription—

• “Warning! Do not use together with other products. May release dangerous gases (chlorine).”.

Preparations containing cadmium (alloys) intended to be used for brazing or soldering6

The label on the packaging of preparations containing cadmium (alloys) intended to be used for brazing or soldering shall bear the following inscriptions—

• “Warning! Contains cadmium.

• Dangerous fumes are formed during use.

• See information supplied by the manufacturer.

• Comply with the safety instructions.”.

Preparations containing substances not yet tested completely7

Where a preparation contains at least one substance which, in accordance with regulation 6(7) of the Notification of New Substances Regulations (Northern Ireland) 199416, bears the inscription “Caution – 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 that substance is present in a concentration ≥1%.

Preparations not classified as sensitising but containing at least one sensitising substance8

The label on the packaging of preparations containing at least one substance classified as sensitising and being present in a concentration ≥0.1% or in a concentration greater than or equal to that specified under a specific note for the substance in the approved supply list must bear the inscription—

• “Contains (name of sensitising substance). May produce an allergic reaction.”.

Liquid preparations containing halogenated hydrocarbons9

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.”.

Preparations containing a substance assigned the risk phrase R6710

When a preparation contains one or more substances assigned the risk phrase R67, the label on the packaging of the preparation must bear the following inscription—

• “Vapours may cause drowsiness and dizziness.”,

when the total concentration of such substances present in the preparation is ≥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.

Cement and cement preparations11

1

The label on the packaging of any cement or cement preparation which would contain, when hydrated, more than 0.0002% soluble chromium (VI) of the total dry weight of the cement but for the use of reducing agents shall be marked with information on the packing date, and on the storage conditions and storage period appropriate to maintaining the activity of the reducing agent and to preventing the content of soluble chromium (VI) from exceeding 0.0002% of the total dry weight of the cement, unless it is supplied or used for controlled, closed and totally automated processes in which cement and cement-containing preparations are handled solely by machines and in which there is no possibility of contact with the skin.

2

The label on the packaging of any cement or cement preparation containing more than 0.0002% soluble chromium (VI) of the total dry weight of the cement shall 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.

CSPECIAL PROVISIONS APPLYING TO CERTAIN OTHER PREPARATIONS

Preparations not intended for the general public12

The label on the packaging of a preparation of the type specified in regulation 5(3) must bear the following inscription

Safety data sheet available for professional user on request.