30.3.2011   

EN

Official Journal of the European Union

L 83/1


COMMISSION REGULATION (EU) No 286/2011

of 10 March 2011

amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 53 thereof,

Whereas:

(1)

Regulation (EC) No 1272/2008 harmonises the provisions and criteria for the classification and labelling of substances, mixtures and certain specific articles within the European Union.

(2)

That Regulation takes into account the Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter referred to as ‘the GHS’) of the United Nations (UN).

(3)

The classification criteria and labelling rules of the GHS are periodically reviewed at UN level. The third revised edition of the GHS was adopted in December 2008 by the United Nations Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals (UNCETDG/GHS). It contains amendments concerning, inter alia, the provisions for the allocation of hazard statements and for the labelling of small packaging, new sub-categories for respiratory and skin sensitisation, the revision of the classification criteria for long-term hazards (chronic toxicity) to the aquatic environment and a new hazard class for substances and mixtures hazardous to the ozone layer. It is therefore necessary to adapt the technical provisions and criteria in the Annexes to Regulation (EC) No 1272/2008 to the third revised edition of the GHS.

(4)

The GHS allows authorities to adopt supplemental labelling provisions to protect individuals already sensitised to a specific chemical that may elicit a response at very low concentration. Requirements should be introduced to add the name of such chemical on the label even if present at very low concentration in a mixture.

(5)

The terminology of different provisions in the Annexes and certain technical criteria should also be amended to facilitate implementation by operators and enforcement authorities, to improve consistency of the legal text and to enhance clarity.

(6)

To ensure that suppliers of substances can adapt to the new classification, labelling and packaging provisions introduced by this Regulation, a transitional period should be foreseen and the application of this Regulation should be deferred. This should allow for the possibility to apply the provisions laid down in this Regulation on a voluntary basis before the transitional period is over.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established pursuant to Article 133 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2),

HAS ADOPTED THIS REGULATION:

Article 1

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

(1)

Article 25(5) is deleted;

(2)

the following new section (e) is inserted in Article 26(1):

‘(e)

if the hazard pictogram “GHS02” or “GHS06” applies, the use of the hazard pictogram “GHS04” shall be optional.’;

(3)

Annex I is amended in accordance with Annex I to this Regulation;

(4)

Annex II is amended in accordance with Annex II to this Regulation;

(5)

Annex III is amended in accordance with Annex III to this Regulation;

(6)

Annex IV is amended in accordance with Annex IV to this Regulation;

(7)

Annex V is amended in accordance with Annex V to this Regulation;

(8)

Annex VI is amended in accordance with Annex VI to this Regulation;

(9)

Annex VII is amended in accordance with Annex VII to this Regulation.

Article 2

Transitional provisions

1.   By way of derogation from the second paragraph of Article 3, substances and mixtures may, before 1 December 2012 and 1 June 2015 respectively, be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.

2.   By way of derogation from the second paragraph of Article 3, substances classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 and placed on the market before 1 December 2012, are not required to be relabelled and repackaged in accordance with this Regulation until 1 December 2014.

3.   By way of derogation from the second paragraph of Article 3, mixtures classified, labelled and packaged in accordance with Directive 1999/45/EC of the European Parliament and of the Council (3) or Regulation (EC) No 1272/2008 and placed on the market before 1 June 2015, are not required to be relabelled and repackaged in accordance with this Regulation until 1 June 2017.

Article 3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply in respect of substances from 1 December 2012 and in respect of mixtures from 1 June 2015.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 March 2011.

For the Commission

The President

José Manuel BARROSO


(1)   OJ L 353, 31.12.2008, p. 1.

(2)   OJ L 396, 30.12.2006, p. 1.

(3)   OJ L 200, 30.7.1999, p. 1.


ANNEX I

A.

Part 1 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:

(1)

in section 1.1.2.2.2, the Note under Table 1.1 is replaced by the following:

‘Note:

Generic cut-off values are in weight percentages except for gaseous mixtures for those hazard classes where the generic cut-off values may be best described in volume percentages.’;

(2)

in section 1.1.3.1, the beginning of the first sentence is replaced by ‘If a tested mixture’;

(3)

sections 1.1.3.2, 1.1.3.3 and 1.1.3.4 are replaced by the following:

‘1.1.3.2.   Batching

The hazard category of a tested production batch of a mixture can be assumed to be substantially equivalent to that of another untested production batch of the same commercial product, when produced by or under the control of the same supplier, unless there is reason to believe there is significant variation such that the hazard classification of the untested batch has changed. If the latter occurs, a new evaluation is necessary.

1.1.3.3.   Concentration of highly hazardous mixtures

In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, if a tested mixture is classified in the highest hazard category or sub-category, and the concentration of the components of the tested mixture that are in that category or sub-category is increased, the resulting untested mixture shall be classified in that category or sub-category without additional testing.

1.1.3.4.   Interpolation within one toxicity category

In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, for three mixtures (A, B and C) with identical components, where mixtures A and B have been tested and are in the same hazard category, and where untested mixture C has the same hazardous components as mixture A and B but has concentrations of those hazardous components intermediate to the concentrations in mixtures A and B, then mixture C is assumed to be in the same hazard category as A and B.’;

(4)

in section 1.1.3.5, the last sentence is replaced by the following:

‘If mixture (i) or (ii) is already classified based on test data, then the other mixture shall be assigned the same hazard category.’;

(5)

sections 1.2, 1.2.1, 1.2.1.1, 1.2.1.2 and 1.2.1.3 are replaced by the following:

‘1.2.   Labelling

1.2.1.   General rules for the application of labels required by Article 31

1.2.1.1.   Hazard pictograms shall be in the shape of a square set at a point.

1.2.1.2.   Hazard pictograms as laid down in Annex V shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible.

1.2.1.3.   Each hazard pictogram shall cover at least one fifteenth of the minimum surface area of the label dedicated to the information required by Article 17. The minimum area of each hazard pictogram shall not be less than 1 cm2.

1.2.1.4.   The dimensions of the label and of each pictogram shall be as follows:

Table 1.3

Minimum dimensions of labels and pictograms

Capacity of the package

Dimensions of the label (in millimetres) for the information required by Article 17

Dimensions of each pictogram (in millimetres)

Not exceeding 3 litres:

If possible, at least 52 × 74

Not smaller than 10 × 10

If possible, at least 16 × 16

Greater than 3 litres but not exceeding 50 litres:

At least 74 × 105

At least 23 × 23

Greater than 50 litres but not exceeding 500 litres:

At least 105 × 148

At least 32 × 32

Greater than 500 litres:

At least 148 × 210

At least 46 × 46’

(6)

the introductory sentence in section 1.5.2.1.3 is replaced by the following:

‘The pictogram, the signal word, the hazard statement, and the precautionary statement linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where:’;

(7)

in section 1.5.2.2, point (b) is replaced by the following:

‘(b)

The classification of the contents of the soluble packaging is exclusively one or more of the hazard categories in 1.5.2.1.1 (b), 1.5.2.1.2 (b) or 1.5.2.1.3 (b); and’.

B.

Part 2 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:

(1)

section 2.1.4.1 is amended as follows:

(a)

the footnote under Figure 2.1.1 is replaced by the following:

‘(*)

See UN Recommendations on the Transport of Dangerous Goods, Model Regulations, 16th rev. ed, sub-section 2.1.2.’;

(b)

Figure 2.1.3 is replaced by the following:

‘Figure 2.1.3

Procedure for assignment to a division in the class of explosives (Class 1 for transport)

Image 1

ARTICLE OR SUBSTANCE PROVISIONALLY ACCEPTED IN THIS CLASS (from 2.1.2)

No

Is the article a candidate for Division 1.6?

Is the substance a candidate for Division 1.5?

No

Package the substance

TEST SERIES 6

Yes

Yes

Is the result a mass explosion?

Yes

TEST SERIES 7

TEST SERIES 5

No

Is it an extremely insensitive article?

No

Is the major hazard that from dangerous projections?

Yes

Yes

Yes

Is it a very insensitive explosive substance with a mass explosion hazard?

No

No

No

Is the major hazard radiant heat and/or violent burning but with no dangerous blast or projection hazard?

Would the hazard hinder fire-fighting in the immediate vicinity?

Yes

Yes

No

No

Are there hazardous effects outside the package?

No

Is the substance or article manufactured with the view of producing a practical explosive or pyrotechnic effect?

Yes

Yes

Yes

Is the product an article excluded by definition? (see 2.1.12 (b))

No

NOT AN EXPLOSIVE

DIVISION 1.6

DIVISION 1.5

DIVISION 1.4 Compatibility group S

DIVISION 1.4 Compatibility groups other than S

DIVISION 1.3

DIVISION 1.2

DIVISION 1.1

(c)

Figure 2.1.4, is replaced by the following:

‘Figure 2.1.4

Procedure for the classification of ammonium nitrate emulsion, suspension or gel (ANE)

Image 2

TEST SERIES 8

TEST 8 (a) Thermal stability test. Is the substance/mixture thermally stable?

No

Classify as unstable explosive

Yes

TEST 8 (b) ANE Large scale gap test Is the substance/mixture too sensitive to shock to be accepted as an oxidising liquid or an oxidising solid?

Yes

Substance/mixture to be considered for classification as an explosive other than as an unstable explosive; If the answer to the question ‘is it a very insensitive explosive substance/mixture with a mass explosion hazard?’ in figure 2.1.3 is ‘no’, the substance/mixture shall be classified in Division 1.1

No

TEST 8 (c) Koenen test Is the substance/mixture too sensitive to the effect of intensive heat under confinement?

Yes

Substance/mixture to be considered for classification as an explosive of Division 1.5, proceed with Test Series 5. If the answer to the question ‘is it a very insensitive explosive substance/mixture with a mass explosion hazard?’ in figure 2.1.3 is ‘yes’, the substance/mixture shall be classified in Division 1.5; if the answer is ‘no’ the substance/mixture shall be classified in Division 1.1

No

ANE substance/mixture shall be classified as a Category 2 oxidising liquid or a Category 2 oxidising solid (sections 2.13 and 2.14)

(2)

in section 2.1.4.2, the Note is replaced by the following:

‘Note:

Neither a series 1 type (a) propagation of detonation test nor a series 2 type (a) test of sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g. For organic substances and mixtures of organic substances with a decomposition energy of 800 J/g or more, tests 1 (a) and 2 (a) need not be performed if the outcome of the ballistic mortar Mk.IIId test (F.1), or the ballistic mortar test (F.2) or the BAM Trauzl test (F.3) with initiation by a standard No 8 detonator (see Appendix 1 to the UN RTDG, Manual of Tests and Criteria) is “no”. In this case, the results of test 1 (a) and 2 (a) are deemed to be “-”.’;

(3)

in section 2.2.2.1, the Note under Table 2.2.1 is replaced by the following:

‘Note:

Aerosols shall not be classified as flammable gases; see section 2.3.’;

(4)

in section 2.3.2.1, the Note is replaced by the following notes:

‘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:

Flammable aerosols do not fall additionally within the scope of sections 2.2 (flammable gases), 2.6 (flammable liquids) or 2.7 (flammable solids).’;

(5)

in section 2.3.2.2, the following Note is inserted at the end of the paragraph:

‘Note:

Aerosols not submitted to the flammability classification procedures in this section shall be classified as flammable aerosols, Category 1.’;

(6)

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” mean pure gases or gas mixtures with an oxidising power greater than 23,5 % as determined by a method specified in ISO 10156 as amended or 10156-2 as amended.’;

(7)

in section 2.5.3, the following Note is inserted under Table 2.5.2:

‘Note:

Pictogram GHS04 is not required for gases under pressure where pictogram GHS02 or pictogram GHS06 appears.’;

(8)

in section 2.6.2.1 the following Note is inserted under Table 2.6.1:

‘Note:

Aerosols shall not be classified as flammable liquids; see section 2.3.’;

(9)

section 2.6.4.2 is amended as follows:

(a)

the first paragraph is replaced by the following:

‘In the case of mixtures (*1) containing known flammable liquids in defined concentrations, although they may contain non-volatile components e.g. polymers, additives, the flash point need not be determined experimentally if the calculated flash point of the mixture, using the method given in 2.6.4.3, is at least 5 °C (*2) greater than the relevant classification criterion (23 °C and 60 °C, respectively) and provided that:

(*1)  To date, the calculation method has been validated for mixtures containing up to 6 volatile components. These components may be flammable liquids like hydrocarbons, ethers, alcohols, esters (except acrylates), and water. It is however not yet validated for mixtures containing halogenated sulphurous, and/or phosphoric compounds as well as reactive acrylates."

(*2)  If the calculated flash point is less than 5 °C greater than the relevant classification criterion, the calculation method may not be used and the flash point should be determined experimentally.’;"

(b)

in point (b), the words ‘of the mixture’ shall be added;

(10)

in section 2.6.4.4, Table 2.6.3, the complete row ‘British Standard Institute, BS 2000 Part 170 as amended (identical to EN ISO 13736)’ is deleted;

(11)

section 2.6.4.5 is replaced by the following:

2.6.4.5   Liquids with a flash point of more than 35 °C and not more than 60 °C need not be classified in Category 3 if negative results have been obtained in the sustained combustibility test L.2, Part III, section 32 of the UN RTDG, Manual of Tests and Criteria.’;

(12)

the following new section 2.6.4.6 is inserted:

2.6.4.6.   Possible test methods for determining the initial boiling point of flammable liquids are listed in Table 2.6.4.

Table 2.6.4

Methods for determining the initial boiling point of flammable liquids

European standards:

EN ISO 3405 as amended

Petroleum products — Determination of distillation characteristics at atmospheric pressure

EN ISO 3924 as amended

Petroleum products — Determination of boiling range distribution — Gas chromatography method

EN ISO 4626 as amended

Volatile organic liquids — Determination of boiling range of organic solvents used as raw materials

Regulation (EC) No 440/2008 (*3)

Method A.2 as described in Part A of the Annex to Regulation (EC) No 440/2008

(13)

in section 2.7.2.3, the Note under Table 2.7.1 is replaced by the following:

‘Note 1:

The test shall be performed on the substance or mixture in its physical form as presented. If, for example, for the purposes of supply or transport, the same chemical is to be presented in a physical form different from that which was tested and which is considered likely to materially alter its performance in a classification test, the substance shall also be tested in the new form.

Note 2:

Aerosols shall not be classified as flammable solids; see section 2.3.’;

(14)

in section 2.8.4.2, Figure 2.8.1, points 7.4, 8.4 and 9.4, the word ‘No’ is replaced by ‘None’;

(15)

section 2.11.1.2 is replaced by the following:

2.11.1.2.   Self-heating of a substance or a mixture is a process where the gradual reaction of that substance or mixture with oxygen (in the air) generates heat. If the rate of heat production exceeds the rate of heat loss, then the temperature of the substance or mixture will rise which, after an induction time, may lead to self-ignition and combustion.’;

(16)

in section 2.15.4.2, Figure 2.15.1, points 7.4, 8.4 and 9.4, the word ‘No’ is replaced by ‘None’.

C.

Part 3 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:

(1)

section 3.1.2.1 is replaced by the following:

3.1.2.1.   Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). Explanatory notes are shown following Table 3.1.1.

Table 3.1.1

Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories

Exposure route

Category 1

Category 2

Category 3

Category 4

Oral (mg/kg bodyweight)

ATE ≤ 5

5 < ATE ≤ 50

50 < ATE ≤ 300

300 < ATE ≤ 2 000

See:

Note (a)

Note (b)

Dermal (mg/kg bodyweight)

ATE ≤ 50

50 < ATE ≤ 200

200 < ATE ≤ 1 000

1 000 < ATE ≤ 2 000

See:

Note (a)

Note (b)

Gases (ppmV (*4))

ATE ≤ 100

100 < ATE ≤ 500

500 < ATE ≤ 2 500

2 500 < ATE ≤ 20 000

see:

Note (a)

Note (b)

Note (c)

Vapours (mg/l)

ATE ≤ 0,5

0,5 < ATE ≤ 2,0

2,0 < ATE ≤ 10,0

10,0 < ATE ≤ 20,0

see:

Note (a)

Note (b)

Note (c)

Note (d)

Dusts and mists (mg/l)

ATE ≤ 0,05

0,05 < ATE ≤ 0,5

0,5 < ATE ≤ 1,0

1,0 < ATE ≤ 5,0

see:

Note (a)

Note (b)

Note (c)

Notes to Table 3.1.1:

(a)

The acute toxicity estimate (ATE) for the classification of a substance is derived using the LD50/LC50 where available.

(b)

The acute toxicity estimate (ATE) for the classification of a substance in a mixture is derived using:

the LD50/LC50 where available,

the appropriate conversion value from Table 3.1.2 that relates to the results of a range test, or

the appropriate conversion value from Table 3.1.2 that relates to a classification category.

(c)

Generic concentration limits for inhalation toxicity 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.

(d)

For some substances the test atmosphere will not just be a vapour but will consist of a mixture of liquid and vapour phases. For other substances the test atmosphere may consist of a vapour which is near the gaseous phase. In these latter cases, classification shall be based on ppmV as follows: Category 1 (100 ppmV), Category 2 (500 ppmV), Category 3 (2 500 ppmV), Category 4 (20 000 ppmV).

The terms “dust”, “mist” and “vapour” are defined as follows:

dust: solid particles of a substance or mixture suspended in a gas (usually air),

mist: liquid droplets of a substance or mixture suspended in a gas (usually air),

vapour: the gaseous form of a substance or mixture released from its liquid or solid state.

Dust is generally formed by mechanical processes. Mist is generally formed by condensation of supersaturated vapours or by physical shearing of liquids. Dusts and mists generally have sizes ranging from less than 1 to about 100 µm.’;

(2)

section 3.1.3.2 is replaced by the following:

3.1.3.2.   For acute toxicity each route of exposure shall be considered for the classification of mixtures, but only one route of exposure is needed as long as this route is followed (estimated or tested) for all components and there is no relevant evidence to suggest acute toxicity by multiple routes. When there is relevant evidence of toxicity by multiple routes of exposure, classification is to be conducted for all appropriate routes of exposure. All available information shall be considered. The pictogram and signal word used shall reflect the most severe hazard category and all relevant hazard statements shall be used.’;

(3)

in section 3.1.3.3, points (c) and (d) are added:

‘(c)

If the converted acute toxicity point estimates for all components of a mixture are within the same category, then the mixture should be classified in that category.

(d)

When only range data (or acute toxicity hazard category information) are available for components in a mixture, they may be converted to point estimates in accordance with Table 3.1.2 when calculating the classification of the new mixture using the formulas in sections 3.1.3.6.1 and 3.1.3.6.2.3.’;

(4)

section 3.1.3.5.2 is replaced by the following:

3.1.3.5.2.   If a tested mixture is diluted with a diluent that has an equivalent or lower toxicity classification than the least toxic original components, and which is not expected to affect the toxicity of other components, then the new diluted mixture may be classified as equivalent to the original tested mixture. Alternatively, the formula explained in section 3.1.3.6.1 can be applied.’;

(5)

section 3.1.3.6.1, is amended as follows:

(a)

point (c) is replaced by the following:

‘(c)

ignore components if the data available are from a limit dose test (at the upper threshold for Category 4 for the appropriate route of exposure as provided in Table 3.1.1) and do not show acute toxicity.’;

(b)

the first sentence beneath point (c) is replaced by the following:

‘Components that fall within the scope of this section are considered to be components with a known acute toxicity estimate (ATE). See note (b) to Table 3.1.1 and section 3.1.3.3 for appropriate application of available data to the equation below, and section 3.1.3.6.2.3.’;

(6)

in section 3.1.3.6.2.1, point (a), the footnote is replaced by the following:

‘(1)

When mixtures contain components that do not have acute toxicity data for each route of exposure, acute toxicity estimates may be extrapolated from the available data and applied to the appropriate routes (see section 3.1.3.2). However, specific legislation may require testing for a specific route. In those cases, classification shall be performed for that route based upon the legal requirements.’;

(7)

section 3.1.3.6.2.2 is 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 of 1 % or greater, 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: “× percent of the mixture consists of component(s) of unknown toxicity”.’;

(8)

in section 3.1.3.6.2.3, the title of Table 3.1.2 is replaced by the following:

‘Conversion from experimentally obtained acute toxicity range values (or acute toxicity hazard categories) to acute toxicity point estimates for use in the formulas for the classification of mixtures’;

(9)

the following sentence is added to section 3.1.4.1:

‘Without prejudice to Article 27, combined hazard statements may be used in accordance with Annex III.’;

(10)

in Tables 3.1.3, 3.2.5, 3.3.5, 3.4.4 and 3.8.4, the pictogram with the exclamation mark is replaced by the following pictogram:

Image 3
’;

(11)

in section 3.4.1.5 the words ‘at section 3.4.4.’ are replaced by ‘in Annex II, section 2.8.’;

(12)

in section 3.4.1.6 the word ‘and’ is inserted after ‘Respiratory Sensitisation’;

(13)

sections from 3.4.2 to 3.4.2.2.4.1 are replaced by the following:

‘3.4.2.   Classification criteria for substances

3.4.2.1.   Respiratory sensitisers

3.4.2.1.1.   Hazard categories

3.4.2.1.1.1.   Respiratory sensitisers shall be classified in Category 1 where data are not sufficient for sub-categorisation.

3.4.2.1.1.2.   Where data are sufficient a refined evaluation according to 3.4.2.1.1.3 shall allow the allocation of respiratory sensitisers into sub-category 1A, strong sensitisers, or sub-category 1B for other respiratory sensitisers.

3.4.2.1.1.3.   Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for respiratory sensitisers. Substances may be allocated to one of the two sub-categories 1A or 1B using a weight of evidence approach in accordance with the criteria given in Table 3.4.1 and on the basis of reliable and good quality evidence from human cases or epidemiological studies and/or observations from appropriate studies in experimental animals.

3.4.2.1.1.4.   Substances shall be classified as respiratory sensitisers in accordance with the criteria in Table 3.4.1:

Table 3.4.1

Hazard category and sub-categories for respiratory sensitisers

Category

Criteria

Category 1

Substances shall be classified as respiratory sensitisers (Category 1) where data are not sufficient for sub-categorisation in accordance with the following criteria:

(a)

if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity; and/or

(b)

if there are positive results from an appropriate animal test.

Sub-category 1A:

Substances showing a high frequency of occurrence in humans; or a probability of occurrence of a high sensitisation rate in humans based on animal or other tests (*5). Severity of reaction may also be considered.

Sub-category 1B:

Substances showing a low to moderate frequency of occurrence in humans; or a probability of occurrence of a low to moderate sensitisation rate in humans based on animal or other tests (*5). Severity of reaction may also be considered.

3.4.2.1.2.   Human evidence

3.4.2.1.2.1.   Evidence that a substance can lead to specific respiratory hypersensitivity will normally be based on human experience. In this context, hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such as rhinitis/conjunctivitis and alveolitis are also considered. The condition will have the clinical character of an allergic reaction. However, immunological mechanisms do not have to be demonstrated.

3.4.2.1.2.2.   When considering the human evidence, it is necessary for a decision on classification to take into account, in addition to the evidence from the cases:

(a)

the size of the population exposed;

(b)

the extent of exposure.

The use of human data is discussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.

3.4.2.1.2.3.   The evidence referred to above could be:

(a)

clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence which may include:

(i)

in vivo immunological test (e.g. skin prick test);

(ii)

in vitro immunological test (e.g. serological analysis);

(iii)

studies that indicate other specific hypersensitivity reactions where immunological mechanisms of action have not been proven, e.g. repeated low-level irritation, pharmacologically mediated effects;

(iv)

a chemical structure related to substances known to cause respiratory hypersensitivity;

(b)

data from one or more positive bronchial challenge tests with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction.

3.4.2.1.2.4.   Clinical history shall include both medical and occupational history to determine a relationship between exposure to a specific substance and development of respiratory hypersensitivity. Relevant information includes aggravating factors both in the home and workplace, the onset and progress of the disease, family history and medical history of the patient in question. The medical history shall also include a note of other allergic or airway disorders from childhood, and smoking history.

3.4.2.1.2.5.   The results of positive bronchial challenge tests are considered to provide sufficient evidence for classification on their own. It is however recognised that in practice many of the examinations listed above will already have been carried out.

3.4.2.1.3.   Animal studies

3.4.2.1.3.1.   Data from appropriate animal studies (*6) which may be indicative of the potential of a substance to cause sensitisation by inhalation in humans (*7) may include:

(a)

measurements of Immunoglobulin E (IgE) and other specific immunological parameters in mice;

(b)

specific pulmonary responses in guinea pigs.

3.4.2.2.   Skin sensitisers

3.4.2.2.1.   Hazard categories

3.4.2.2.1.1.   Skin sensitisers shall be classified in Category 1 where data are not sufficient for sub-categorisation.

3.4.2.2.1.2.   Where data are sufficient a refined evaluation according to section 3.4.2.2.1.3 allows the allocation of skin sensitisers into sub-category 1A, strong sensitisers, or sub-category 1B for other skin sensitisers.

3.4.2.2.1.3.   Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for skin sensitisers as described in section 3.4.2.2.2. Substances may be allocated to one of the two sub-categories 1A or 1B using a weight of evidence approach in accordance with the criteria given in Table 3.4.2 and on the basis of reliable and good quality evidence from human cases or epidemiological studies and/or observations from appropriate studies in experimental animals according to the guidance values provided in sections 3.4.2.2.2.1 and 3.4.2.2.3.2 for sub-category 1A and in sections 3.4.2.2.2.2 and 3.4.2.2.3.3 for sub-category 1B.

3.4.2.2.1.4.   Substances shall be classified as skin sensitisers in accordance with the criteria in Table 3.4.2:

Table 3.4.2

Hazard category and sub-categories for skin sensitisers

Category

Criteria

Category 1

Substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub-categorisation in accordance with the following criteria:

(a)

if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b)

if there are positive results from an appropriate animal test (see specific criteria in section 3.4.2.2.4.1).

Sub-category 1A:

Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Sub-category 1B:

Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

3.4.2.2.2.   Human evidence

3.4.2.2.2.1.   Human evidence for sub-category 1A can include:

(a)

positive responses at ≤ 500 µg/cm2 (HRIPT, HMT — induction threshold);

(b)

diagnostic patch test data where there is a relatively high and substantial incidence of reactions in a defined population in relation to relatively low exposure;

(c)

other epidemiological evidence where there is a relatively high and substantial incidence of allergic contact dermatitis in relation to relatively low exposure.

3.4.2.2.2.2.   Human evidence for sub-category 1B can include:

(a)

positive responses at > 500 µg/cm2 (HRIPT, HMT — induction threshold);

(b)

diagnostic patch test data where there is a relatively low but substantial incidence of reactions in a defined population in relation to relatively high exposure;

(c)

other epidemiological evidence where there is a relatively low but substantial incidence of allergic contact dermatitis in relation to relatively high exposure.

The use of human data is discussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.

3.4.2.2.3.   Animal studies

3.4.2.2.3.1.   For Category 1, when an adjuvant type test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive. For a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive. For Category 1, a stimulation index of three or more is considered a positive response in the local lymph node assay. Test methods for skin sensitisation are described in the OECD Guideline 406 (the Guinea Pig Maximisation test and the Buehler guinea pig test) and Guideline 429 (Local Lymph Node Assay). Other methods may be used provided that they are well-validated and scientific justification is given. For example, the mouse ear swelling test (MEST) could be a reliable screening test to detect moderate to strong sensitisers, and could be used as a first stage in the assessment of skin sensitisation potential.

3.4.2.2.3.2.   Animal test results for sub-category 1A can include data with values indicated in Table 3.4.3

Table 3.4.3

Animal test results for sub-category 1A

Assay

Criteria

Local lymph node assay

EC3 value ≤ 2 %

Guinea pig maximisation test

≥ 30 % responding at ≤ 0,1 % intradermal induction dose or

≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose

Buehler assay

≥ 15 % responding at ≤ 0,2 % topical induction dose or

≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose

3.4.2.2.3.3.   Animal test results for sub-category 1B can include data with values indicated in Table 3.4.4 below:

Table 3.4.4

Animal test results for sub-category 1B

Assay

Criteria

Local lymph node assay

EC3 value > 2 %

Guinea pig maximisation test

≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or

≥ 30 % responding at > 1 % intradermal induction dose

Buehler assay

≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or

≥ 15 % responding at > 20 % topical induction dose

3.4.2.2.4.   Specific considerations

3.4.2.2.4.1.   For classification of a substance, evidence should include any or all of the following using a weight of evidence approach:

(a)

positive data from patch testing, normally obtained in more than one dermatology clinic;

(b)

epidemiological studies showing allergic contact dermatitis caused by the substance. Situations in which a high proportion of those exposed exhibit characteristic symptoms are to be looked at with special concern, even if the number of cases is small;

(c)

positive data from appropriate animal studies;

(d)

positive data from experimental studies in man (see section 1.3.2.4.7);

(e)

well documented episodes of allergic contact dermatitis, normally obtained in more than one dermatology clinic;

(f)

severity of reaction may also be considered.

3.4.2.2.4.2.   Evidence from animal studies is usually much more reliable than evidence from human exposure. However, in cases where evidence is available from both sources, and there is conflict between the results, the quality and reliability of the evidence from both sources must be assessed in order to resolve the question of classification on a case-by-case basis. Normally, human data are not generated in controlled experiments with volunteers for the purpose of hazard classification but rather as part of risk assessment to confirm lack of effects seen in animal tests. Consequently, positive human data on skin sensitisation are usually derived from case-control or other, less defined studies. Evaluation of human data must therefore be carried out with caution as the frequency of cases reflect, in addition to the inherent properties of the substances, factors such as the exposure situation, bioavailability, individual predisposition and preventive measures taken. Negative human data should not normally be used to negate positive results from animal studies. For both animal and human data, consideration should be given to the impact of vehicle.

3.4.2.2.4.3.   If none of the abovementioned conditions are met, the substance need not be classified as a skin sensitiser. However, a combination of two or more indicators of skin sensitisation as listed below may alter the decision. This shall be considered on a case-by-case basis.

(a)

Isolated episodes of allergic contact dermatitis;

(b)

epidemiological studies of limited power, e.g. where chance, bias or confounders have not been ruled out fully with reasonable confidence;

(c)

data from animal tests, performed according to existing guidelines, which do not meet the criteria for a positive result described in section 3.4.2.2.3, but which are sufficiently close to the limit to be considered significant;

(d)

positive data from non-standard methods;

(e)

positive results from close structural analogues.

3.4.2.2.4.4.   Immunological contact urticaria

Substances meeting the criteria for classification as respiratory sensitisers may in addition cause immunological contact urticaria. Consideration should be given to classifying these substances also as skin sensitisers. Substances which cause immunological contact urticaria without meeting the criteria for respiratory sensitisers should also be considered for classification as skin sensitisers.

There is no recognised animal model available to identify substances which cause immunological contact urticaria. Therefore, classification will normally be based on human evidence which will be similar to that for skin sensitisation.

(*6)  At present, recognised and validated animal models for the testing of respiratory hypersensitivity are not available. Under certain circumstances, data from animal studies may provide valuable information in a weight of evidence assessment."

(*7)  The mechanisms by which substances induce symptoms of asthma are not yet fully known. For preventative measures, these substances are considered respiratory sensitisers. However, if on the basis of the evidence, it can be demonstrated that these substances induce symptoms of asthma by irritation only in people with bronchial hyper reactivity, they should not be considered as respiratory sensitisers.’;"

(14)

in section 3.4.3.3.1 the reference to ‘Table 3.4.3’ is replaced by ‘Table 3.4.5’;

(15)

section 3.4.3.3.2 is amended as follows:

(a)

the reference to ‘Table 3.4.1’ is replaced by ‘Table 3.4.5’;

(b)

the reference to ‘Table 3.4.3’ is replaced by ‘Table 3.4.6’;

(c)

Table 3.4.3 and Notes 1, 2 and 3 are replaced by the following:

‘Table 3.4.5

Generic concentration limits of components of a mixture classified as either respiratory sensitisers or skin sensitisers that trigger classification of the mixture

Component classified as:

Generic concentration limits triggering classification of a mixture as:

Respiratory sensitiser

Category 1

Skin sensitiser

Category 1

Solid/liquid

Gas

All physical states

Respiratory sensitiser

Category 1

≥ 1,0 %

≥ 0,2 %

 

Respiratory sensitiser

Sub-category 1A

≥ 0,1 %

≥ 0,1 %

 

Respiratory sensitiser

Sub-category 1B

≥ 1,0 %

≥ 0,2 %

 

Skin sensitiser

Category 1

 

 

≥ 1,0 %

Skin sensitiser

Sub-category 1A

 

 

≥ 0,1 %

Skin sensitiser

Sub-category 1B

 

 

≥ 1,0 %’

(d)

a new Table 3.4.6 is inserted after the new Table 3.4.5:

‘Table 3.4.6

Concentration limits for elicitation of components of a mixture

Component classified as:

Concentration limits for elicitation

Respiratory sensitiser

Category 1

Skin sensitiser

Category 1

Solid/liquid

Gas

All physical states

Respiratory sensitiser

Category 1

≥ 0,1 % (Note 1)

≥ 0,1 % (Note 1)

 

Respiratory sensitiser

Sub-category 1A

≥ 0,01 % (Note 1)

≥ 0,01 % (Note 1)

 

Respiratory sensitiser

Sub-category 1B

≥ 0,1 % (Note 1)

≥ 0,1 % (Note 1)

 

Skin sensitiser

Category 1

 

 

≥ 0,1 % (Note 1)

Skin sensitiser

Sub-category 1A

 

 

≥ 0,01 % (Note 1)

Skin sensitiser

Sub-category 1B

 

 

≥ 0,1 % (Note 1)

Note 1:

This concentration limit for elicitation is used for the application of the special labelling requirements of Annex II section 2.8 to protect already sensitised individuals. A SDS is required for the mixture containing a component 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.’;

(16)

section 3.4.4.1 is replaced by the following:

3.4.4.1.   Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.4.7.

Table 3.4.7

Respiratory or skin sensitisation label elements

Classification

Respiratory sensitisation

Skin sensitisation

Category 1 and sub-categories 1A and 1B

Category 1 and sub-categories 1A and 1B

GHS pictograms

Image 4

Image 5

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

P285

P261

P272

P280

Precautionary statement response

P304 + P341

P342 + P311

P302 + P352

P333 + P313

P321

P363

Precautionary statement storage

 

 

Precautionary statement disposal

P501

P501’

(17)

in section 3.8.3.4.5, the following sentence is added at the end:

‘Respiratory tract irritation and narcotic effects are to be evaluated separately in accordance with the criteria given in section 3.8.2.2. When conducting classifications for these hazards, the contribution of each component should be considered additive, unless there is evidence that the effects are not additive.’;

(18)

in section 3.9.1.2, the words ‘or mixture’ are added after the word ‘substance’;

(19)

the following section 3.10.1.6.2a. is inserted:

3.10.1.6.2a   Although the definition of aspiration in section 3.10.1.2 includes the entry of solids into the respiratory system, classification according to point (b) in Table 3.10.1 for Category 1 is intended to apply to liquid substances and mixtures only.’;

D.

Part 4 of Annex I to Regulation (EC) No 1272/2008 is replaced by the following text:

‘4.   PART 4: ENVIRONMENTAL HAZARDS

4.1.   Hazardous to the aquatic environment

4.1.1.   Definitions and general considerations

4.1.1.1.   Definitions

(a)

“acute aquatic toxicity” means the intrinsic property of a substance to be injurious to an aquatic organism in a short-term aquatic exposure to that substance.

(b)

“acute (short-term) hazard” means for classification purposes the hazard of a substance or mixture caused by its acute toxicity to an organism during short-term aquatic exposure to that substance or mixture.

(c)

“availability of a substance” means the extent to which this substance becomes a soluble or disaggregate species. For metal availability, the extent to which the metal ion portion of a metal (M°) compound can disaggregate from the rest of the compound (molecule).

(d)

“bioavailability” or “biological availability” means the extent to which a substance is taken up by an organism, and distributed to an area within the organism. It is dependent upon physico-chemical properties of the substance, anatomy and physiology of the organism, pharmacokinetics, and route of exposure. Availability is not a prerequisite for bioavailability.

(e)

“bioaccumulation” means the net result of uptake, transformation and elimination of a substance in an organism due to all routes of exposure (i.e. air, water, sediment/soil and food).

(f)

“bioconcentration” means the net result of uptake, transformation and elimination of a substance in an organism due to waterborne exposure.

(g)

“chronic aquatic toxicity” means the intrinsic property of a substance to cause adverse effects to aquatic organisms during aquatic exposures which are determined in relation to the life-cycle of the organism.

(h)

“degradation” means the decomposition of organic molecules to smaller molecules and eventually to carbon dioxide, water and salts.

(i)

“ECx” means the effect concentration associated with x% response.

(j)

“long-term hazard” means for classification purposes the hazard of a substance or mixture caused by its chronic toxicity following long-term exposure in the aquatic environment.

(k)

“no observed effect concentration (NOEC)” means the test concentration immediately below the lowest tested concentration with statistically significant adverse effect. The NOEC has no statistically significant adverse effect compared to the control.

4.1.1.2.   Basic elements

4.1.1.2.0.   Hazardous to the aquatic environment is differentiated into:

acute aquatic hazard,

long-term aquatic hazard.

4.1.1.2.1.   The basic elements used for classification for aquatic environmental hazards are:

acute aquatic toxicity,

chronic aquatic toxicity,

potential for or actual bioaccumulation, and

degradation (biotic or abiotic) for organic chemicals.

4.1.1.2.2.   Preferably data shall be derived using the standardised test methods referred to in Article 8(3). In practice data from other standardised test methods such as national methods shall also be used where they are considered as equivalent. Where valid data are available from non-standard testing and from non-testing methods, these shall be considered in classification provided they fulfil the requirements specified in section 1 of Annex XI to Regulation (EC) No 1907/2006. In general, both freshwater and marine species toxicity data are considered suitable for use in classification provided the test methods used are equivalent. Where such data are not available classification shall be based on the best available data. See also Part 1 of Annex I to Regulation (EC) No 1272/2008.

4.1.1.3.   Other considerations

4.1.1.3.1.   Classification of substances and mixtures for environmental hazards requires the identification of the hazards they present to the aquatic environment. The aquatic environment is considered in terms of the aquatic organisms that live in the water, and the aquatic ecosystem of which they are part. The basis, therefore, of the identification of acute (short-term) and long-term hazards is the aquatic toxicity of the substance or mixture, although this shall be modified by taking account of further information on the degradation and bioaccumulation behaviour, if appropriate.

4.1.1.3.2.   While the classification system applies to all substances and mixtures, it is recognised that for special cases (e.g. metals) the European Chemicals Agency has issued guidance.

4.1.2.   Classification criteria for substances

4.1.2.1.   The system for classification recognises that the intrinsic hazard to aquatic organisms is represented by both the acute and long-term hazard of a substance. For the long-term hazard, separate hazard categories are defined representing a gradation in the level of hazard identified. The lowest of the available toxicity values between and within the different trophic levels (fish, crustacean, algae/aquatic plants) shall normally be used to define the appropriate hazard category(ies). There are circumstances, however, when a weight of evidence approach is appropriate.

4.1.2.2.   The core classification system for substances consists of one acute hazard classification category and three long-term hazard classification categories. The acute and the long-term hazard classification categories are applied independently.

The criteria for classification of a substance in category Acute 1 are defined on the basis of acute aquatic toxicity data only (EC50 or LC50). The criteria for classification of a substance into the categories Chronic 1 to 3 follow a tiered approach where the first step is to see if available information on chronic toxicity merits long-term hazard classification. In absence of adequate chronic toxicity data, the subsequent step is to combine two types of information, i.e. acute aquatic toxicity data and environmental fate data (degradability and bioaccumulation data) (see figure 4.1.1).

Figure 4.1.1

Categories for substances long-term hazardous to the aquatic environment

Image 6

Are there adequate chronic toxicity data available for all three trophic levels?

Yes

Classify according to the criteria given in Table 4.1.0(b) (i) or 4.1.0(b)(ii) depending on information on rapid degradation

No

Are there adequate chronic toxicity data available for one or two trophic levels?

Yes

Assess both:

(a) according to the criteria given in Table 4.1.0(b)(i) or 4.1.0(b)(ii) (depending on information on rapid degradation), and

(b) (if for the other trophic level(s) adequate acute toxicity data are available) according to the criteria given in Table 4.1.0(b) (iii),

and classify according to the most stringent outcome

No

Are there adequate acute toxicity data available?

Yes

Classify according to the criteria given in Table 4.1.0(b) (iii)

4.1.2.4.   The system also introduces a “safety net” classification (referred to as category Chronic 4) for use when the data available do not allow classification under the formal criteria for acute 1 or chronic 1 to 3 but there are nevertheless some grounds for concern (see example in Table 4.1.0).

4.1.2.5.   Substances with acute toxicities below 1 mg/l or chronic toxicities below 0,1 mg/l (if non-rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute as components of a mixture to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach (see note 1 of Table 4.1.0 and section 4.1.3.5.5).

4.1.2.6.   The criteria for classifying and categorising substances as “hazardous to the aquatic environment” are summarised in Table 4.1.0.

Table 4.1.0

Classification categories for hazardous to the aquatic environment

(a)   

Acute (short-term) aquatic hazard

Category Acute 1: (Note 1)

96 hr LC50 (for fish)

≤ 1 mg/l and/or

48 hr EC50 (for crustacea)

≤ 1 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquatic plants)

≤ 1 mg/l. (Note 2)

(b)   

Long-term aquatic hazard

(i)   

Non-rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available

Category Chronic 1: (Note 1)

Chronic NOEC or ECx (for fish)

≤ 0,1 mg/l and/or

Chronic NOEC or ECx (for crustacea)

≤ 0,1 mg/l and/or

Chronic NOEC or ECx (for algae or other aquatic plants)

≤0,1 mg/l.

Category Chronic 2:

Chronic NOEC or ECx (for fish)

> 0,1 to ≤ 1 mg/l and/or

Chronic NOEC or ECx (for crustacea)

> 0,1 to ≤ 1 mg/l and/or

Chronic NOEC or ECx (for algae or other aquatic plants)

> 0,1 to ≤ 1 mg/l.

(ii)   

Rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available

Category Chronic 1: (Note 1)

Chronic NOEC or ECx (for fish)

≤ 0,01 mg/l and/or

Chronic NOEC or ECx (for crustacea)

≤ 0,01 mg/l and/or

Chronic NOEC or ECx (for algae or other aquatic plants)

≤ 0,01 mg/l.

Category Chronic 2:

Chronic NOEC or ECx (for fish)

> 0,01 to ≤ 0,1 mg/l and/or

Chronic NOEC or ECx (for crustacea)

> 0,01 to ≤ 0,1 mg/l and/or

Chronic NOEC or ECx (for algae or other aquatic plants)

> 0,01 to ≤ 0,1 mg/l.

Category Chronic 3:

Chronic NOEC or ECx (for fish)

> 0,1 to ≤ 1 mg/l and/or

Chronic NOEC or ECx (for crustacea)

> 0,1 to ≤ 1 mg/l and/or

Chronic NOEC or ECx (for algae or other aquatic plants)

> 0,1 to ≤ 1 mg/l.

(iii)   

Substances for which adequate chronic toxicity data are not available

Category Chronic 1: (Note 1)

96 hr LC50 (for fish)

≤ 1 mg/l and/or

48 hr EC50 (for crustacea)

≤ 1 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquatic plants)

≤ 1 mg/l. (Note 2)

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow≥ 4). (Note 3).

Category Chronic 2:

96 hr LC50 (for fish)

> 1 to ≤10 mg/l and/or

48 hr EC50 (for crustacea)

> 1 to ≤10 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquatic plants)

> 1 to ≤10 mg/l (Note 2)

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow≥ 4). (Note 3).

Category Chronic 3:

96 hr LC50 (for fish)

> 10 to ≤ 100 mg/l and/or

48 hr EC50 (for crustacea)

> 10 to ≤ 100 mg/l and/or

72 or 96 hr ErC50 (for algae or other aquatic plants)

> 10 to ≤ 100 mg/l. (Note 2)

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow≥ 4). (Note 3).

“Safety net” classification

Category Chronic 4

Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in section 4.1.2.9.5.

Note 1:

When classifying substances as Acute Category 1 and/or Chronic Category 1 it is necessary at the same time to indicate the appropriate M-factor(s) (see Table 4.1.3).

Note 2:

Classification shall be based on the ErC50 [= EC50 (growth rate)]. In circumstances where the basis of the EC50 is not specified or no ErC50 is recorded, classification shall be based on the lowest EC50 available.

Note 3:

When no useful data on degradability are available, either experimentally determined or estimated data, the substance should be regarded as not rapidly degradable.

Note 4:

“No acute toxicity” is taken to mean that the L(E)C50(s) is/are above the water solubility. Also for poorly soluble substances, (water solubility < 1 mg/l), where there is evidence that the acute test does not provide a true measure of the intrinsic toxicity.

4.1.2.7.   Aquatic toxicity

4.1.2.7.1.   Acute aquatic toxicity is normally determined using a fish 96-hour LC50, a crustacea species 48-hour EC50 and/or an algal species 72- or 96-hour EC50. These species cover a range of trophic levels and taxa and are considered as surrogate for all aquatic organisms. Data on other species (e.g. Lemna spp.) shall also be considered if the test methodology is suitable. The aquatic plant growth inhibition tests are normally considered as chronic tests but the EC50s are treated as acute values for classification purposes (see note 2).

4.1.2.7.2.   For determining chronic aquatic toxicity for classification purposes data generated according to the standardised test methods referred to in Article 8(3) shall be accepted, as well as results obtained from other validated and internationally accepted test methods. The NOECs or other equivalent ECx (e.g. EC10) shall be used.

4.1.2.8.   Bioaccumulation

4.1.2.8.1.   Bioaccumulation of substances within aquatic organisms can give rise to toxic effects over longer time scales even when actual water concentrations are low. For organic substances the potential for bioaccumulation shall normally be determined by using the octanol/water partition coefficient, usually reported as a log Kow. The relationship between the log Kow of an organic substance and its bioconcentration as measured by the bioconcentration factor (BCF) in fish has considerable scientific literature support. Using a cut-off value of log Kow ≥ 4 is intended to identify only those substances with a real potential to bioconcentrate. While this represents a potential to bioaccumulate, an experimentally determined BCF provides a better measure and shall be used in preference if available. A BCF in fish of ≥ 500 is indicative of the potential to bioconcentrate for classification purposes. Some relationships can be observed between chronic toxicity and bioaccumulation potential, as toxicity is related to the body burden.

4.1.2.9.   Rapid degradability of organic substances

4.1.2.9.1.   Substances that rapidly degrade can be quickly removed from the environment. While effects of such substances can occur, particularly in the event of a spillage or accident, they are localised and of short duration. In the absence of rapid degradation in the environment a substance in the water has the potential to exert toxicity over a wide temporal and spatial scale.

4.1.2.9.2.   One way of demonstrating rapid degradation utilises the biodegradation screening tests designed to determine whether an organic substance is “readily biodegradable”. Where such data are not available, a BOD(5 days)/COD ratio ≥ 0,5 is considered as indicative of rapid degradation. Thus, a substance which passes this screening test is considered likely to biodegrade “rapidly” in the aquatic environment, and is thus unlikely to be persistent. However, a fail in the screening test does not necessarily mean that the substance will not degrade rapidly in the environment. Other evidence of rapid degradation in the environment may therefore also be considered and are of particular importance where the substances are inhibitory to microbial activity at the concentration levels used in standard testing. Thus, a further classification criterion is included which allows the use of data to show that the substance did actually degrade biotically or abiotically in the aquatic environment by > 70 % in 28 days. Thus, if degradation is demonstrated under environmentally realistic conditions, then the criterion of “rapid degradability” is met.

4.1.2.9.3.   Many degradation data are available in the form of degradation half-lives and these can be used in defining rapid degradation provided that ultimate biodegradation of the substance, i.e. full mineralisation, is achieved. Primary biodegradation does not normally suffice in the assessment of rapid degradability unless it can be demonstrated that the degradation products do not fulfil the criteria for classification as hazardous to the aquatic environment.

4.1.2.9.4.   The criteria used reflect the fact that environmental degradation may be biotic or abiotic. Hydrolysis can be considered if the hydrolysis products do not fulfil the criteria for classification as hazardous to the aquatic environment.

4.1.2.9.5.   Substances are considered rapidly degradable in the environment if one of the following criteria holds true:

(a)

if, in 28-day ready biodegradation studies, at least the following levels of degradation are achieved:

(i)

tests based on dissolved organic carbon: 70 %;

(ii)

tests based on oxygen depletion or carbon dioxide generation: 60 % of theoretical maximum.

These levels of biodegradation must be achieved within 10 days of the start of degradation which point is taken as the time when 10 % of the substance has been degraded, unless the substance is identified as an UVCB or as a complex, multi-constituent substance with structurally similar constituents. In this case, and where there is sufficient justification, the 10-day window condition may be waived and the pass level applied at 28 days; or

(b)

if, in those cases where only BOD and COD data are available, when the ratio of BOD5/COD is ≥ 0,5; or

(c)

if other convincing scientific evidence is available to demonstrate that the substance can be degraded (biotically and/or abiotically) in the aquatic environment to a level > 70 % within a 28-day period.

4.1.2.10.   Inorganic compounds and metals

4.1.2.10.1.   For inorganic compounds and metals, the concept of degradability as applied to organic compounds has limited or no meaning. Rather, such substances may be transformed by normal environmental processes to either increase or decrease the bioavailability of the toxic species. Equally the use of bioaccumulation data shall be treated with care (*8).

4.1.2.10.2.   Poorly soluble inorganic compounds and metals may be acutely or chronically toxic in the aquatic environment depending on the intrinsic toxicity of the bioavailable inorganic species and the rate and amount of this species which enter solution. All evidence must be weighed in a classification decision. This would be especially true for metals showing borderline results in the Transformation/Dissolution Protocol.

4.1.3.   Classification criteria for mixtures

4.1.3.1.   The classification system for mixtures covers all classification categories which are used for substances, i.e. categories Acute 1 and Chronic 1 to 4. In order to make use of all available data for purposes of classifying the aquatic environmental hazards of the mixture, the following is applied where appropriate:

The “relevant components” of a mixture are those which are classified “Acute 1”or “Chronic 1” and present in a concentration of 0,1 % (w/w) or greater, and those which are classified “Chronic 2”, “Chronic 3” or “Chronic 4” and present in a concentration of 1 % (w/w) or greater, unless there is a presumption (such as in the case of highly toxic components (see section 4.1.3.5.5.5)) that a component present in a lower concentration can still be relevant for classifying the mixture for aquatic environmental hazards. Generally, for substances classified as “Acute 1” or “Chronic 1” the concentration to be taken into account is (0,1/M) %. (For explanation M-factor see section 4.1.3.5.5.5.)

The approach for classification of aquatic environmental hazards is tiered, and is dependent upon the type of information available for the mixture itself and for its components. Figure 4.1.2 outlines the process to be followed.

Elements of the tiered approach include:

classification based on tested mixtures,

classification based on bridging principles,

the use of “summation of classified components” and/or an “additivity formula”.

Figure 4.1.2

Tiered approach to classification of mixtures for acute and long-term aquatic environmental hazards

Image 7

Aquatic toxicity test data available on the mixture as a whole

No

Yes

CLASSIFY

for acute/long-term aquatic hazard (see 4.1.3.3)

Sufficient data available on similar mixtures to estimate hazards

Yes

Apply bridging principles (see 4.1.3.4.)

CLASSIFY

for acute/long-term aquatic hazard

No

Either aquatic toxicity or classification data available for all relevant components

Yes

Apply summation method (see 4.1.3.5.5) using:

• Percentage of all components classified as ‘Chronic’

• Percentage of components classified as ‘Acute’

• Percentage of components with acute or chronic toxicity data: apply additivity formulas (see 4.1.3.5.2) and convert the derived L(E)C50 or EqNOECm to the appropriate ‘Acute’ or ‘Chronic’ category

CLASSIFY

for acute/long-term aquatic hazard

No

Use available hazard data of known components

Apply summation method and/or additivity formula (see 4.1.3.5) and apply 4.1.3.6

CLASSIFY

for acute/long-term aquatic hazard

4.1.3.3.   Classification of mixtures when toxicity data are available for the complete mixture

4.1.3.3.1.   When the mixture as a whole has been tested to determine its aquatic toxicity, this information can be used for classifying the mixture according to the criteria that have been agreed for substances. The classification is normally based on the data for fish, crustacea and algae/plants (see sections 4.1.2.7.1 and 4.1.2.7.2). When adequate acute or chronic toxicity data for the mixture as a whole are lacking, “bridging principles” or “summation method” should be applied (see sections 4.1.3.4 and 4.1.3.5).

4.1.3.3.2.   The long-term hazard classification of mixtures requires additional information on degradability and in certain cases bioaccumulation. Degradability and bioaccumulation tests for mixtures are not used as they are usually difficult to interpret, and such tests may be meaningful only for single substances.

4.1.3.3.3.   Classification for category Acute 1

(a)

When there are adequate acute toxicity test data (LC50 or EC50) available for the mixture as a whole showing L(E)C50 ≤ 1 mg/l:

Classify mixture as Acute 1 in accordance with point (a) of Table 4.1.0.

(b)

When there are acute toxicity test data (LC50(s) or EC50(s)) available for the mixture as a whole showing L(E)C50(s) > 1 mg/l for normally all trophic levels:

No need to classify for acute hazard.

4.1.3.3.4.   Classification for categories Chronic 1, 2 and 3

(a)

When there are adequate chronic toxicity data (ECxx or NOEC) available for the mixture as a whole showing ECx or NOEC of the tested mixture ≤ 1mg/l:

(i)

Classify the mixture as Chronic 1, 2 or 3 in accordance with point (b)(ii) of Table 4.1.0 as rapidly degradable if the available information allows the conclusion that all relevant components of the mixture are rapidly degradable;

(ii)

Classify the mixture as Chronic 1 or 2 in all other cases in accordance with point (b)(i) of Table 4.1.0 as non-rapidly degradable;

(b)

When there are adequate chronic toxicity data (ECx or NOEC) available for the mixture as a whole showing ECx(s) or NOEC(s) of the tested mixture > 1 mg/l for normally all trophic levels:

No need to classify for long-term hazard in categories Chronic 1, 2 or 3.

4.1.3.3.5.   Classification for category Chronic 4

If there are nevertheless reasons for concern:

Classify the mixture as Chronic 4 (safety net classification) in accordance with Table 4.1.0.

4.1.3.4.   Classification of mixtures when toxicity data are not available for the complete mixture: bridging principles

4.1.3.4.1.   Where the mixture itself has not been tested to determine its aquatic environmental hazard, but there are sufficient data on the individual components and similar tested mixtures to adequately characterise the hazards of the mixture, this data shall be used in accordance with the bridging rules set out in section 1.1.3. However, in relation to application of the bridging rule for dilution, sections 4.1.3.4.2 and 4.1.3.4.3 shall be used.

4.1.3.4.2.   Dilution: if a mixture is formed by diluting another tested mixture or a substance classified for its aquatic environmental hazard with a diluent which has an equivalent or lower aquatic hazard classification than the least toxic original component and which is not expected to affect the aquatic hazards of other components, then the resulting mixture may be classified as equivalent to the original tested mixture or substance. Alternatively, the method explained in section 4.1.3.5 may be applied.

4.1.3.4.3.   If a mixture is formed by diluting another classified 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.

4.1.3.5.   Classification of mixtures when toxicity data are available for some or all components of the mixture

4.1.3.5.1.   The classification of a mixture is based on summation of the concentration of its classified components. The percentage of components classified as “Acute” or “Chronic” is fed straight in to the summation method. Details of the summation method are described in section 4.1.3.5.5.

4.1.3.5.2.   Mixtures can be made of a combination of both components that are classified (as Acute 1 and/or Chronic 1, 2, 3, 4) and others for which adequate toxicity test data is available. When adequate toxicity data are available for more than one component in the mixture, the combined toxicity of those components is calculated using the following additivity formulas (a) or (b), depending on the nature of the toxicity data:

(a)

Based on acute aquatic toxicity:

Formula

where:

Ci

=

concentration of component i (weight percentage);

L(E)C50i

=

(mg/l) LC50 or EC50 for component i;

η

=

number of components, and i is running from 1 to n;

L(E)C50m

=

L(E) C50 of the part of the mixture with test data.

The calculated toxicity may be used to assign that portion of the mixture an acute hazard category which is then subsequently used in applying the summation method;

(b)

Based on chronic aquatic toxicity:

Formula

where:

Ci

=

concentration of component i (weight percentage) covering the rapidly degradable components;

Cj

=

concentration of component j (weight percentage) covering the non- rapidly degradable components;

NOECi

=

NOEC (or other recognised measures for chronic toxicity) for component i covering the rapidly degradable components, in mg/l;

NOECj

=

NOEC (or other recognised measures for chronic toxicity) for component j covering the non-rapidly degradable components, in mg/l;

n

=

number of components, and i and j are running from 1 to n;

EqNOECm

=

Equivalent NOEC of the part of the mixture with test data.

The equivalent toxicity thus reflects the fact that non-rapidly degrading substances are classified one hazard category level more “severe” than rapidly degrading substances.

The calculated equivalent toxicity may be used to assign that portion of the mixture a long-term hazard category, in accordance with the criteria for rapidly degradable substances (point (b)(ii) of Table 4.1.0), which is then subsequently used in applying the summation method.

4.1.3.5.3.   When applying the additivity formula for part of the mixture, it is preferable to calculate the toxicity of this part of the mixture using for each substance toxicity values that relate to the same taxonomic group (i.e. fish, crustacean, algae or equivalent) and then to use the highest toxicity (lowest value) obtained (i.e. use the most sensitive of the three taxonomic groups). However, when toxicity data for each component are not available in the same taxonomic group, the toxicity value of each component is selected in the same manner that toxicity values are selected for the classification of substances, i.e. the higher toxicity (from the most sensitive test organism) is used. The calculated acute and chronic toxicity is then used to assess whether this part of the mixture shall be classified as Acute 1 and/or Chronic 1, 2 or 3 using the same criteria described for substances.

4.1.3.5.4.   If a mixture is classified in more than one way, the method yielding the more conservative result shall be used.

4.1.3.5.5.   Summation method

4.1.3.5.5.1.   Rationale

4.1.3.5.5.1.1.   In case of the substance classification categories Chronic 1 to Chronic 3, the underlying toxicity criteria differ by a factor of 10 in moving from one category to another. Substances with a classification in a high toxicity band therefore contribute to the classification of a mixture in a lower band. The calculation of these classification categories therefore needs to consider the contribution of any substance classified as Chronic 1, 2 or 3.

4.1.3.5.5.1.2.   When a mixture contains components classified as Acute 1 or Chronic 1, attention must be paid to the fact that such components, when their acute toxicity is below 1 mg/l and/or chronic toxicity is below 0,1 mg/l (if non rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration. Active ingredients in pesticides often possess such high aquatic toxicity but also some other substances like organometallic compounds. Under these circumstances the application of the normal generic concentration limits leads to an “under-classification” of the mixture. Therefore, multiplying factors shall be applied to account for highly toxic components, as described in section 4.1.3.5.5.5.

4.1.3.5.5.2.   Classification procedure

4.1.3.5.5.2.1.   In general a more severe classification for mixtures overrides a less severe classification, e.g. a classification with Chronic 1 overrides a classification with Chronic 2. As a consequence, in this example, the classification procedure is already completed if the result of the classification is Chronic 1. A more severe classification than Chronic 1 is not possible. Therefore it is not necessary to undergo the further classification procedure.

4.1.3.5.5.3.   Classification for category Acute 1

4.1.3.5.5.3.1.   First all components classified as Acute 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is greater than 25 % the whole mixture is classified as Acute 1.

4.1.3.5.5.3.2.   The classification of mixtures for acute hazards based on this summation of classified components is summarised in Table 4.1.1.

Table 4.1.1

Classification of a mixture for acute hazards, based on summation of classified components

Sum of components classified as:

Mixture is classified as:

Acute 1 × M (1) ≥ 25 %

Acute 1

4.1.3.5.5.4.   Classification for the categories Chronic 1, 2, 3 and 4

4.1.3.5.5.4.1.   First all components classified as Chronic 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is equal to or greater than 25 %, the mixture is classified as Chronic 1. If the result of the calculation is a classification of the mixture as Chronic 1, the classification procedure is completed.

4.1.3.5.5.4.2.   In cases where the mixture is not classified as Chronic 1, classification of the mixture as Chronic 2 is considered. A mixture is classified as Chronic 2 if 10 times the sum of the concentrations (in %) of all components classified as Chronic 1 multiplied by their corresponding M-factors plus the sum of the concentrations (in %) of all components classified as Chronic 2 is equal to or greater than 25 %. If the result of the calculation is classification of the mixture as Chronic 2, the classification process is completed.

4.1.3.5.5.4.3.   In cases where the mixture is not classified either as Chronic 1 or Chronic 2, classification of the mixture as Chronic 3 is considered. A mixture is classified as Chronic 3 if 100 times the sum of the concentrations (in %) of all components classified as Chronic 1 multiplied by their corresponding M-factors plus 10 times the sum of the concentrations (in %) of all components classified with Chronic 2 plus the sum of the concentrations (in %) of all components classified as Chronic 3 is ≥ 25 %.

4.1.3.5.5.4.4.   If the mixture is still not classified in Chronic 1, 2 or 3, classification of the mixture as Chronic 4 shall be considered. A mixture is classified as Chronic 4 if the sum of the concentrations (in %) of components classified as Chronic 1, 2, 3 and 4 is equal to or greater than 25 %.

4.1.3.5.5.4.5.   The classification of mixtures for long-term hazards, based on this summation of the concentrations of classified components, is summarised in Table 4.1.2.

Table 4.1.2

Classification of a mixture for long-term hazards, based on summation of the concentrations of classified components

Sum of components classified as:

Mixture is classified as:

Chronic 1 × M (2) ≥ 25 %

Chronic 1

(M × 10 × Chronic 1) + Chronic 2 ≥ 25 %

Chronic 2

(M × 100 × Chronic 1) + (10 × Chronic 2) + Chronic 3 ≥ 25 %

Chronic 3

Chronic 1 + Chronic 2 + Chronic 3 + Chronic 4 ≥ 25 %

Chronic 4

4.1.3.5.5.5.   Mixtures with highly toxic components

4.1.3.5.5.5.1.   Acute 1 and Chronic 1 components with toxicities below 1 mg/l and/or chronic toxicities below 0,1 mg/l (if non-rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach. When a mixture contains components classified as Acute or Chronic 1, one of the following shall be applied:

the tiered approach described in sections 4.1.3.5.5.3 and 4.1.3.5.5.4 using a weighted sum by multiplying the concentrations of Acute 1 and Chronic 1 components by a factor, instead of merely adding up the percentages. This means that the concentration of “Acute 1” in the left column of Table 4.1.1 and the concentration of “Chronic 1” in the left column of Table 4.1.2 are multiplied by the appropriate multiplying factor. The multiplying factors to be applied to these components are defined using the toxicity value, as summarised in Table 4.1.3. Therefore, in order to classify a mixture containing Acute/Chronic 1 components, the classifier needs to be informed of the value of the M-factor in order to apply the summation method,

the additivity formula (see section 4.1.3.5.2) provided that toxicity data are available for all highly toxic components in the mixture and there is convincing evidence that all other components, including those for which specific acute and/or chronic toxicity data are not available, are of low or no toxicity and do not significantly contribute to the environmental hazard of the mixture.

Table 4.1.3

Multiplying factors for highly toxic components of mixtures

Acute toxicity

M factor

Chronic toxicity

M factor

L(E)C50 value mg/l

 

NOEC value mg/l

NRD (3) components

RD (4) 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