Commission Regulation (EU) No 487/2013Show full title

ANNEX I U.K.

Annex I to Regulation (EC) No 1272/2008 is amended as follows:

A.

Part 1 is amended as follows:

(1)

The following section 1.3.6 is inserted:

‘1.3.6. Substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes

Substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes which are in the finished state as packaged for consumer use do not require on the label the hazard pictogram GHS05.’

(2)

The following sections 1.5.2.4 and 1.5.2.5 are inserted:

‘1.5.2.4. Labelling of inner packaging where the contents do not exceed 10 ml

1.5.2.4.1. The label elements required by Article 17 may be omitted from the inner packaging where:

(a)

the contents of the inner packaging do not exceed 10 ml;

(b)

the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis; and

(c)

the inner packaging is contained within outer packaging that meets the requirements of Article 17.

1.5.2.4.2. Notwithstanding sections 1.5.1.2 and 1.5.2.4.1, the label on the inner packaging shall contain the product identifier and, where appropriate, the hazard pictograms “GHS01”, “GHS05”, “GHS06” and/or “GHS08”. Where more than two pictograms are assigned, “GHS06” and “GHS08” may take precedence over “GHS01” and “GHS05”.

1.5.2.5. Section 1.5.2.4 shall not apply to substances or mixtures within the scope of Regulation (EC) No 1107/2009 or (EU) No 528/2012.’

B.

Part 2 is amended as follows:

(1)

The second sentence in section 2.1.2.1 is replaced by the following:

‘The test methods are described in Part I of the UN RTDG, Manual of Tests and Criteria.’;

(2)

In point (f) of section 2.1.2.2, the word ‘detonating’ is deleted;

(3)

In section 2.1.2.3 and in the column entitled ‘Criteria’ of Table 2.1.1 the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(4)

In section 2.1.3, the column entitled ‘Unstable Explosive’ of Table 2.1.2, the precautionary statement ‘P281’ is replaced by ‘P280’;

(5)

In the first paragraph and in the footnote to Figure 2.1.1 of section 2.1.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(6)

In the first paragraph of section 2.1.4.2, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(7)

In point (a) of section 2.1.4.3, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(8)

Sections 2.2 to 2.3.4.1 are replaced by the following:

‘2.2. Flammable gases (including chemically unstable gases)

2.2.1. Definitions

2.2.1.1. Flammable gas means a gas or gas mixture having a flammable range with air at 20 °C and a standard pressure of 101,3 kPa.

2.2.1.2. A chemically unstable gas means a flammable gas that is able to react explosively even in the absence of air or oxygen.

2.2.2. Classification criteria

2.2.2.1. A flammable gas shall be classified in this class in accordance with Table 2.2.1:

Table 2.2.1
Criteria for flammable gases
Note: Aerosols shall not be classified as flammable gases; see section 2.3.
Category	Criteria
1	Gases, which at 20 °C and a standard pressure of 101,3 kPa: (a) are ignitable when in a mixture of 13 % or less by volume in air; or (b) have a flammable range with air of at least 12 percentage points regardless of the lower flammable limit.
2	Gases, other than those of Category 1, which, at 20 °C and a standard pressure of 101,3 kPa, have a flammable range while mixed in air.

2.2.2.2. A flammable gas that is also chemically unstable shall additionally be classified in one of the two categories for chemically unstable gases using the methods described in Part III of the UN RTDG, Manual of Tests and Criteria according to the following table:

Table 2.2.2
Criteria for chemically unstable gases
Category	Criteria
A	Flammable gases which are chemically unstable at 20 °C and a standard pressure of 101,3 kPa
B	Flammable gases which are chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa

2.2.3. Hazard Communication

Label elements shall be used for substances and mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.2.3.

Table 2.2.3

Label elements for flammable gases (including chemically unstable gases)

Classification	Flammable gas		Chemically unstable gas
	Category 1	Category 2	Category A	Category B
GHS Pictogram		No pictogram	No additional pictogram	No additional pictogram
Signal Word	Danger	Warning	No additional signal word	No additional signal word
Hazard Statement	H220: Extremely flammable gas	H221: Flammable gas	H230: May react explosively even in the absence of air	H231: May react explosively even in the absence of air at elevated pressure and/or temperature
Precautionary Statement Prevention	P210	P210	P202	P202
Precautionary Statement Response	P377 P381	P377 P381
Precautionary Statement Storage	P403	P403
Precautionary Statement Disposal

The classification procedure is set out in the following decision logic (see Figures 2.2.1 to 2.2.2).

Figure 2.2.1

Flammable gases

Figure 2.2.2

Chemically unstable gases

2.2.4. Additional Classification Considerations

2.2.4.1. Flammability shall be determined by tests or, for mixtures where there are sufficient data available, by calculation in accordance with the methods adopted by ISO (see ISO 10156 as amended, Gases and gas mixtures — Determination of fire potential and oxidising ability for the selection of cylinder valve outlet). Where insufficient data are available to use these methods, test method EN 1839 as amended (Determination of explosion limits of gases and vapours) may be used.

2.2.4.2. Chemical instability shall be determined in accordance with the method described in Part III of the UN RTDG, Manual of Tests and Criteria. If the calculations in accordance with ISO 10156 as amended show that a gas mixture is not flammable it is not necessary to carry out the tests for determining chemical instability for classification purposes.

2.3. Aerosols

2.3.1. Definitions

Aerosols, this means aerosol dispensers, are any non-refillable receptacles made of metal, glass or plastics and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state or in a gaseous state.

2.3.2. Classification criteria

2.3.2.1. Aerosols shall be considered for classification as flammable in accordance with section 2.3.2.2 if they contain any component which is classified as flammable according to the following criteria set out in this Part:

• Liquids with a flash point ≤ 93 °C, which includes Flammable Liquids according to section 2.6;

• Flammable gases (see section 2.2);

• Flammable solids (see section 2.7).

Note 1:

Flammable components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because such components are never used as aerosol contents.

Note 2:

Aerosols do not fall additionally within the scope of sections 2.2 (flammable gases), 2.5 (gases under pressure), 2.6 (flammable liquids) and 2.7 (flammable solids). Depending on their contents, aerosols may however fall within the scope of other hazard classes, including their labelling elements.

2.3.2.2. An aerosol shall be classified in one of the three categories for this Class on the basis of its components, of its chemical heat of combustion and, if applicable, of the results of the foam test (for foam aerosols) and of the ignition distance test and enclosed space test (for spray aerosols) in accordance with Figures 2.3.1(a) to 2.3.1(c) of this Annex and subsections 31.4, 31.5 and 31.6 of Part III of the UN RTDG, Manual of Tests and Criteria. Aerosols which do not meet the criteria for inclusion in Category 1 or Category 2 shall be classified in Category 3.

Note:

Aerosols containing more than 1 % flammable components or with a heat of combustion of at least 20 kJ/g, which are not submitted to the flammability classification procedures in this section shall be classified as aerosols, Category 1.

Figure 2.3.1 (a)

Aerosols

Figure 2.3.1 (b)

Spray aerosols

Figure 2.3.1 (c)

Foam aerosols

2.3.3. Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.3.1.

Table 2.3.1

Label elements for flammable and non-flammable aerosols

Classification	Category 1	Category 2	Category 3
GHS Pictograms			No pictogram
Signal Word	Danger	Warning	Warning
Hazard Statement	H222: Extremely flammable aerosol H229: Pressurised container: May burst if heated	H223: Flammable aerosol H229: Pressurised container: May burst if heated	H229: Pressurised container: May burst if heated
Precautionary Statement Prevention	P210 P211 P251	P210 P211 P251	P210 P251
Precautionary Statement Response
Precautionary Statement Storage	P410 + P412	P410 + P412	P410 + P412
Precautionary Statement Disposal

2.3.4. Additional Classification Considerations

2.3.4.1. The chemical heat of combustion (ΔΗ_c), in kilojoules per gram (kJ/g), is the product of the theoretical heat of combustion (ΔΗ_comb), and a combustion efficiency, usually less than 1,0 (a typical combustion efficiency is 0,95 or 95 %).

For a composite aerosol formulation, the chemical heat of combustion is the summation of the weighted heats of combustion for the individual components, as follows:

where:

ΔΗ_c

=

chemical heat of combustion (kJ/g);

w_i %

=

mass fraction of component i in the product;

ΔΗ_c(i)

=

specific heat of combustion (kJ/g)of component i in the product.

The chemical heats of combustion can be found in the literature, calculated or determined by tests (see ASTM D 240 as amended — Standard Test Methods for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter, EN/ISO 13943 as amended, 86.l to 86.3 — Fire safety — Vocabulary, and NFPA 30B as amended — Code for the Manufacture and Storage of Aerosol Products).’;

(9)

In section 2.4.2.1, the Note under Table 2.4.1 is replaced by the following:

‘Note:

“Gases which cause or contribute to the combustion of other material more than air does” means pure gases or gas mixtures with an oxidising power greater than 23,5 % as determined by a method specified in ISO 10156 as amended.’;

(10)

Section 2.4.4 is replaced by the following:

‘2.4.4. Additional Classification Considerations

To classify an oxidising gas, tests or calculation methods as described in ISO 10156 as amended, “Gases and gas mixtures — Determination of fire potential and oxidising ability for the selection of cylinder valve outlet” shall be performed.’;

(11)

In section 2.5.1.1, the first paragraph is replaced by the following:

‘Gases under pressure are gases which are contained in a receptacle at a pressure of 200 kPa (gauge) or more at 20 °C, or which are liquefied or liquefied and refrigerated.’;

(12)

Section 2.5.2 is replaced by the following:

‘2.5.2. Classification criteria

2.5.2.1. Gases under pressure shall be classified, according to their physical state when packaged, in one of four groups in accordance with Table 2.5.1:

Table 2.5.1
Criteria for gases under pressure
Note: Aerosols shall not be classified as gases under pressure. See section 2.3.’;
Group	Criteria
Compressed gas	A gas which when packaged under pressure is entirely gaseous at – 50 °C; including all gases with a critical temperature ≤ – 50 °C.
Liquefied gas	A gas which, when packaged under pressure, is partially liquid at temperatures above – 50 °C. A distinction is made between: (i) high pressure liquefied gas: a gas with a critical temperature between – 50 °C and + 65 °C; and (ii) low pressure liquefied gas: a gas with a critical temperature above + 65 °C.
Refrigerated liquefied gas	A gas which when packaged is made partially liquid because of its low temperature.
Dissolved gas	A gas which when packaged under pressure is dissolved in a liquid phase solvent.

(13)

In section 2.5.4, the second paragraph is replaced by the following:

‘Data can be found in the literature, calculated or determined by testing. Most pure gases are already classified in the UN RTDG, Model Regulations.’;

(14)

In sections 2.7.2.1 and 2.7.2.3, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(15)

The footnote relating to point (e) of section 2.8.2.1 is replaced by the following:

‘(1) See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.’;

(16)

In section 2.8.2.4, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(17)

In section 2.8.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(18)

In points (a) and (b) of 2.8.4.2, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(19)

In the introductory sentence of sections 2.9.2.1, 2.10.2.1, 2.11.2.1, 2.11.2.2, 2.12.2.1 and 2.13.2.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(20)

In section 2.13.4.4, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(21)

In the introductory sentence of section 2.14.2.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(22)

The footnote relating to point (g) of section 2.15.2.2 is replaced by the following:

‘(1) See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.’;

(23)

Section 2.15.2.3 is amended as follows:

(i)

the footnote relating to point (b) is replaced by the following: ‘(1) As determined by test series E as prescribed in UN RTDG, Manual of Tests and Criteria, Part II.’;

(ii)

in the second paragraph, the words ‘UN Recommendation on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(24)

In section 2.15.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(25)

In the introductory sentence of section 2.16.2.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(26)

In section 2.16.3, the following Note is inserted under Table 2.16.2:

‘Note:

Where a substance or mixture is classified as corrosive to metals but not corrosive to skin and/or eyes, the labelling provisions set out in section 1.3.6 shall be used.’;

(27)

In the introductory sentence of section 2.16.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’.

C.

Part 3 is amended as follows:

(1)

In section 3.1.2.1, Note (c) under Table 3.1.1 is replaced by the following:

‘(c)

The ranges of the acute toxicity estimates (ATE) for inhalation toxicity used in the Table are based on 4-hour testing exposures. Conversion of existing inhalation toxicity data which have been generated using a 1-hour exposure can be carried out by dividing by a factor of 2 for gases and vapours and 4 for dusts and mists.’;

(2)

Sections 3.1.3.6.2.2 and 3.1.3.6.2.3 are replaced by the following:

‘3.1.3.6.2.2. In the event that a component without any useable information for classification is used in a mixture at a concentration ≥ 1 %, it is concluded that the mixture cannot be attributed a definitive acute toxicity estimate. In this situation the mixture shall be classified based on the known components only, with the additional statement on the label and in the SDS that “x per cent of the mixture consists of component(s) of unknown acute toxicity”, taking into account the provisions set out in section 3.1.4.2.

3.1.3.6.2.3. If the total concentration of the relevant ingredient(s) with unknown acute toxicity is ≤ 10 % then the formula presented in section 3.1.3.6.1 shall be used. If the total concentration of the relevant ingredient(s) with unknown toxicity is > 10 %, the formula presented in section 3.1.3.6.1 shall be corrected to adjust for the percentage of the unknown ingredient(s) as follows:

’;

(3)

In section 3.1.4.1, Table 3.1.3 is replaced by the following:

‘Table 3.1.3

Acute toxicity label elements

Classification	Category 1	Category 2	Category 3	Category 4
GHS Pictograms
Signal Word	Danger	Danger	Danger	Warning
Hazard Statement: Oral	H300: Fatal if swallowed	H300: Fatal if swallowed	H301: Toxic if swallowed	H302: Harmful if swallowed
— Dermal	H310:Fatal in contact with skin	H310:Fatal in contact with skin	H311: Toxic in contact with skin	H312: Harmful in contact with skin
— Inhalation (see Note 1)	H330:Fatal if inhaled	H330: Fatal if inhaled	H331: Toxic if inhaled	H332: Harmful if inhaled
Precautionary Statement Prevention (oral)	P264 P270	P264 P270	P264 P270	P264 P270
Precautionary Statement Response (oral)	P301 + P310 P321 P330	P301 + P310 P321 P330	P301 + P310 P321 P330	P301 + P312 P330
Precautionary Statement Storage (oral)	P405	P405	P405
Precautionary Statement Disposal (oral)	P501	P501	P501	P501
Precautionary Statement Prevention (dermal)	P262 P264 P270 P280	P262 P264 P270 P280	P280	P280
Precautionary Statement Response (dermal)	P302 + P352 P310 P321 P361 + P364	P302 + P352 P310 P321 P361 + P364	P302 + P352 P312 P321 P361 + P364	P302 + P352 P312 P321 P362 + P364
Precautionary Statement Storage (dermal)	P405	P405	P405
Precautionary Statement Disposal (dermal)	P501	P501	P501	P501
Precautionary Statement Prevention (inhalation)	P260 P271 P284	P260 P271 P284	P261 P271	P261 P271
Precautionary Statement Response (inhalation)	P304 + P340 P310 P320	P304 + P340 P310 P320	P304 + P340 P311 P321	P304 + P340 P312
Precautionary Statement Storage (inhalation)	P403 + P233 P405	P403 + P233 P405	P403 + P233 P405
Precautionary Statement Disposal (inhalation)	P501	P501	P501’

(4)

The following section 3.1.4.2 is inserted:

‘3.1.4.2. The acute toxicity hazard statements differentiate the hazard based on the route of exposure. Communication of acute toxicity classification should also reflect this differentiation. If a substance or mixture is classified for more than one route of exposure then all relevant classifications should be communicated on the safety data sheet as specified in Annex II to Regulation (EC) No 1907/2006 and the relevant hazard communication elements included on the label as prescribed in section 3.1.3.2. If the statement “x % of the mixture consists of ingredient(s) of unknown acute toxicity” is communicated, as prescribed in section 3.1.3.6.2.2, then, in the information provided in the safety data sheet, it can also be differentiated based on the route of exposure. For example, “x % of the mixture consists of ingredient(s) of unknown acute oral toxicity” and “x % of the mixture consists of ingredient(s) of unknown acute dermal toxicity”.’;

(5)

Section 3.2.3.3.5 is replaced by the following:

‘3.2.3.3.5. On occasion, reliable data may show that the skin corrosion/irritation hazard of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4 in section 3.2.3.3.6. In these cases the mixture shall be classified according to that data (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazard of an ingredient is not evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4, testing of the mixture shall be considered. In those cases the tiered weight of evidence strategy shall be applied, as set out in section 3.2.2.5.’;

(6)

In section 3.2.4, Table 3.2.5 is replaced by the following:

‘Table 3.2.5

Label elements for skin corrosion/irritation

Classification	Category 1 A/1 B/1 C	Category 2
GHS Pictograms
Signal Word	Danger	Warning
Hazard Statement	H314: Causes severe skin burns and eye damage	H315: Causes skin irritation
Precautionary Statement Prevention	P260 P264 P280	P264 P280
Precautionary Statement Response	P301 + P330 + P331 P303 + P361 + P353 P363 P304 + P340 P310 P321 P305 + P351 + P338	P302 + P352 P321 P332 + P313 P362 + P364
Precautionary Statement Storage	P405
Precautionary Statement Disposal	P501’

(7)

Section 3.3.3.3.5 is replaced by the following:

‘3.3.3.3.5. On occasion, reliable data may show that the reversible/irreversible eye effects of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4 in section 3.3.3.3.6. In these cases the mixture shall be classified according to those data. On other occasions, when it is expected that the skin corrosion/irritation hazards or the reversible/irreversible eye effects of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4, testing of the mixture shall be considered. In those cases, the tiered weight of evidence strategy shall be applied.’;

(8)

In section 3.4.3.3.2, Note 1 under Table 3.4.6 is replaced by the following:

‘Note 1:

This concentration limit for elicitation is used for the application of the special labelling requirements of section 2.8 of Annex II to protect already sensitised individuals. A SDS is required for the mixture containing a component at or above this concentration. For sensitising substances with specific concentration limit lower than 0,1 %, the concentration limit for elicitation should be set at one tenth of the specific concentration limit.’;

(9)

In section 3.4.4, Table 3.4.7 is replaced by the following:

‘Table 3.4.7

Respiratory or skin sensitisation label elements

Classification	Respiratory sensitisation	Skin sensitisation
	Category 1 and subcategories 1A and 1B	Category 1 and subcategories 1A and 1B
GHS Pictograms
Signal Word	Danger	Warning
Hazard Statement	H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled	H317: May cause an allergic skin reaction
Precautionary Statement Prevention	P261 P284	P261 P272 P280
Precautionary Statement Response	P304 + P340 P342 + P311	P302 + P352 P333 + P313 P321 P362 + P364
Precautionary Statement Storage
Precautionary Statement Disposal	P501	P501’

(10)

In section 3.5.3.1.1, Table 3.5.2 is replaced by the following:

‘Table 3.5.2

Generic concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger classification of the mixture

Ingredient classified as:	Concentration limits triggering classification of a mixture as:
	Category 1 mutagen		Category 2 mutagen
	Category 1A	Category 1B
Category 1A mutagen	≥ 0,1 %	—	—
Category 1B mutagen	—	≥ 0,1 %	—
Category 2 mutagen	—	—	≥ 1,0 %’

(11)

In section 3.5.4.1, Table 3.5.3 is replaced by the following:

‘Table 3.5.3

Label elements of germ cell mutagenicity

Classification	Category 1(Category 1A, 1B)	Category 2
GHS Pictograms
Signal Word	Danger	Warning
Hazard Statement	H340: May cause genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)	H341: Suspected of causing genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
Precautionary Statement Prevention	P201 P202 P280	P201 P202 P280
Precautionary Statement Response	P308 + P313	P308 + P313
Precautionary Statement Storage	P405	P405
Precautionary Statement Disposal	P501	P501’

(12)

In section 3.6.3.1.1, Table 3.6.2 is replaced by the following:

‘Table 3.6.2

Generic concentration limits of ingredients of a mixture classified as carcinogen that trigger classification of the mixture

Ingredient classified as:	Generic concentration limits triggering classification of a mixture as:
	Category 1 carcinogen		Category 2 carcinogen
	Category 1A	Category 1B
Category 1A carcinogen	≥ 0,1 %	—	—
Category 1B carcinogen	—	≥ 0,1 %	—
Category 2 carcinogen	—	—	≥ 1,0 % [Note 1]’

(13)

In section 3.6.4.1, Table 3.6.3 is replaced by the following:

‘Table 3.6.3

Label elements for carcinogenicity

Classification	Category 1(Category 1A, 1B)	Category 2
GHS Pictograms
Signal Word	Danger	Warning
Hazard Statement	H350: May cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)	H351: Suspected of causing cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)
Precautionary Statement Prevention	P201 P202 P280	P201 P202 P280
Precautionary Statement Response	P308 + P313	P308 + P313
Precautionary Statement Storage	P405	P405
Precautionary Statement Disposal	P501	P501’

(14)

In section 3.7.3.1.2, Table 3.7.2 and the Notes are replaced by the following:

‘Table 3.7.2

Generic concentration limits of ingredients of a mixture classified as reproduction toxicants or for effects on or via lactation that trigger classification of the mixture

Note: The concentration limits in Table 3.7.2 apply to solids and liquids (w/w units) as well as gases (v/v units).
Note 1: If a Category 1 or Category 2 reproductive toxicant or a substance classified for effects on or via lactation is present in the mixture as an ingredient at a concentration at or above 0,1 %, a SDS shall be available for the mixture upon request.’;
Ingredient classified as:	Generic concentration limits triggering classification of a mixture as:
	Category 1 reproductive toxicant		Category 2 reproductive toxicant	Additional category for effects on or via lactation
	Category 1A	Category 1B
Category 1A reproductive toxicant	≥ 0,3 % [Note 1]
Category 1B reproductive toxicant		≥ 0,3 % [Note 1]
Category 2 reproductive toxicant			≥ 3,0 % [Note 1]
Additional category for effects on or via lactation				≥ 0,3 % [Note 1]

(15)

In section 3.7.4.1, Table 3.7.3 is replaced by the following:

‘Table 3.7.3

Label elements for reproductive toxicity

Classification	Category 1(Category 1A, 1B)	Category 2	Additional category for effects on or via lactation
GHS Pictograms			No pictogram
Signal Word	Danger	Warning	No signal word
Hazard Statement	H360: May damage fertility or the unborn child (state specific effect if known)(state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)	H361: Suspected of damaging fertility or the unborn child (state specific effect if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)	H362: May cause harm to breast-fed children.
Precautionary Statement Prevention	P201 P202 P280	P201 P202 P280	P201 P260 P263 P264 P270
Precautionary Statement Response	P308 + P313	P308 + P313	P308 + P313
Precautionary Statement Storage	P405	P405
Precautionary Statement Disposal	P501	P501’

(16)

In section 3.8.4.1, Table 3.8.4 is replaced by the following:

‘Table 3.8.4

Label elements for specific target organ toxicity after single exposure

Classification	Category 1	Category 2	Category 3
GHS Pictograms
Signal Word	Danger	Warning	Warning
Hazard Statement	H370: Causes damage to organs (or state all organs affected, if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)	H371: May cause damage to organs (or state all organs affected, if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)	H335: May cause respiratory irritation; or H336: May cause drowsiness or dizziness
Precautionary Statement Prevention	P260 P264 P270	P260 P264 P270	P261 P271
Precautionary Statement Response	P308 + P311 P321	P308 + P311	P304 + P340 P312
Precautionary Statement Storage	P405	P405	P403 + P233 P405
Precautionary Statement Disposal	P501	P501	P501’

(17)

Section 3.9.2.9.9 is replaced by the following:

‘3.9.2.9.9. Thus it is feasible that a specific profile of toxicity occurs in repeat-dose animal studies at a dose/concentration below the guidance value, such as < 100 mg/kg bw/day by the oral route, however the nature of the effect, such as nephrotoxicity seen only in male rats of a particular strain known to be susceptible to this effect may result in the decision not to classify. Conversely, a specific profile of toxicity may be seen in animal studies occurring at or above a guidance value, such as ≥ 100 mg/kg bw/day by the oral route, and in addition there is supplementary information from other sources, such as other long-term administration studies, or human case experience, which supports a conclusion that, in view of the weight of evidence, classification is the prudent action to take.’;

(18)

Section 4.1.3.4.3 is replaced by the following:

‘4.1.3.4.3. If a mixture is formed by diluting another tested mixture or substance with water or other totally non-toxic material, the toxicity of the mixture can be calculated from the original mixture or substance.’;

(19)

In section 4.1.3.5.5.5.1, Table 4.1.3 is replaced by the following:

‘Table 4.1.3

Multiplying factors for highly toxic components of mixtures

a Non-rapidly degradable.
b Rapidly degradable.’
Acute toxicity	M factor	Chronic toxicity	M factor
L(E)C50 value (mg/l)		NOEC value (mg/l)	NRDa components	RDb components
0,1 < L(E)C50 ≤ 1	1	0,01 < NOEC ≤ 0,1	1	—
0,01 < L(E)C50 ≤ 0,1	10	0,001 < NOEC ≤ 0,01	10	1
0,001 < L(E)C50 ≤ 0,01	100	0,0001 < NOEC ≤ 0,001	100	10
0,0001 < L(E)C50 ≤ 0,001	1 000	0,00001 < NOEC ≤ 0,0001	1 000	100
0,00001 < L(E)C50 ≤ 0,0001	10 000	0,000001 < NOEC ≤ 0,00001	10 000	1 000
(continue in factor 10 intervals)		(continue in factor 10 intervals)