(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

(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:

(1)

section 2.1.4.1 is amended as follows:

(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) 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) 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:

(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

(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’.

(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

Notes to Table 3.1.1:

(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:

(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:

(6)

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

(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:

‘

(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

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:

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:

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:

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

3.4.2.2.2.   Human evidence

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

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

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

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

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:

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.

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:

(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
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.’;

(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.

—

acute aquatic hazard,

—

long-term aquatic hazard.

—

acute aquatic toxicity,

—

chronic aquatic toxicity,

—

potential for or actual bioaccumulation, and

—

degradation (biotic or abiotic) for organic chemicals.

(a)

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

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.

—

classification based on tested mixtures,

—

classification based on bridging principles,

—

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

(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.

(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:

(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.

(a)

Based on acute aquatic toxicity:

where:

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:

where:

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.

—

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.

(a)

section 2.8 is replaced by the following:

‘2.8.   Mixtures containing at least one sensitising substance

The label on the packaging of mixtures not classified as sensitising but containing at least one substance classified as sensitising and present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I shall bear the statement:

EUH208 — “Contains (name of sensitising substance). May produce an allergic reaction”.

Mixtures classified as sensitising containing other substance(s) classified as sensitising (in addition to the one that leads to the classification of the mixture) and present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I shall bear the name(s) of that/those substance(s) on the label.’;

(b)

in section 2.10, the first indent is replaced by the following:

‘3.2.2.1.

(a)

the introductory sentence is replaced by the following:

‘The hazard statements shall be applied in accordance with Parts 2, 3, 4 and 5 of Annex I.

In selecting the hazard statements in accordance with Articles 21 and 27, suppliers may use the combined hazard statements provided for in this Annex.

In accordance with Article 27 the following principles of precedence for hazard statements may apply to labelling:

In order to indicate the route of administration or exposure the combined hazard statements in Table 1.2 may be used.’;

(b)

in Table 1.1, the footnote to code H200 is deleted;

(c)

Table 1.2 is amended as follows:

(d)

Table 1.3 is amended as follows:

(a)

in the title the words ‘substances and’ are deleted;

(b)

in Code EUH201/201A, first column, all references to ‘201/201A’ are deleted;

(c)

in Code EUH209/209A, first column, all references to ‘209/209A’ are deleted.

(a)

Table 6.2 is amended as follows:

(b)

Table 6.3 is amended as follows:

(c)

Table 6.5 is replaced by the following:

‘Table 6.5

Precautionary statements — Disposal

(a)

in column 1, the pictogram GHS07 is replaced by the following pictogram:

‘GHS07

(b)

in column 2, the words ‘Skin sensitisation, hazard category 1’ are replaced by ‘Skin sensitisation, hazard categories 1, 1A, 1B’;

(a)

Table 1.1 is amended as follows:

(b)

in section 1.1.2.3, the last paragraph is replaced by the following:

‘In case an M-factor has been harmonised for substances classified as hazardous to the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, this M-factor is given in Table 3.1 in the same column as the specific concentration limits. In case an M-factor for Aquatic Acute 1 and an M-factor for Aquatic Chronic 1 have been harmonised, each M-factor shall be listed in the same line as its corresponding differentiation. Where a single M-factor is given in Table 3.1 and the substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, this M-factor shall be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance for acute and long-term aquatic hazards using the summation method. Where no M-factor is given in Table 3.1, M-factor(s) based on available data for the substance shall be set by the manufacturer, importer or downstream user. For the setting and use of M-factors, see section 4.1.3.5.5.5 of Annex I.’;

(c)

in section 1.1.3.1, ‘Note H (Table 3.1)’ and ‘Note H (Table 3.2)’ are deleted;

(d)

section 1.1.4.4 is deleted;

(a)

the first two paragraphs are replaced by the following:

‘Table 3.1: List of harmonised classification and labelling of hazardous substances.

Table 3.2: The list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC.’;

(b)

in Tables 3.1 and 3.2, last column, all the references to Note ‘H’ are deleted;

(c)

in Table 3.1, entries 602-002-00-2, 602-008-00-5, 602-013-00-2 and 602-084-00-X are replaced by the following: