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Commission Regulation (EU) 2016/918 of 19 May 2016 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)

C/2016/2882
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14.6.2016   

EN

Official Journal of the European Union

L 156/1


COMMISSION REGULATION (EU) 2016/918

of 19 May 2016

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 (1), and in particular Article 53(1) 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 Union.

(2)

That Regulation takes into account the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) of the United Nations (UN).

(3)

The classification criteria and labelling rules of the GHS are periodically reviewed at UN level. The fifth revised edition of the GHS results from changes adopted in December 2012 by the UN Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals. It contains amendments concerning, inter alia, a new, alternative method for the classification of oxidising solids, changes to the provisions on classification for the hazard classes for skin corrosion/irritation and serious eye damage/eye irritation, and aerosols. Furthermore, it includes changes to several precautionary statements, as well as changes in the order of some precautionary statements, as reflected by a deletion of the entry and a separate insertion at the new location of the entry. It is therefore necessary to adapt the technical provisions and criteria in the Annexes to Regulation (EC) No 1272/2008 to the fifth revised edition of the GHS.

(4)

Following the fourth revision of the GHS, Commission Regulation (EU) No 487/2013 (2) introduced a labelling derogation for substances or mixtures classified as corrosive to metals but not classified for skin corrosion or serious eye damage. Whereas the content of the derogation should remain unchanged, a more precise formulation should be provided for the hazards addressed by the derogation.

(5)

Redundancy in the labelling of mixtures containing isocyanates and certain epoxy constituents should be avoided while maintaining the longstanding and well known specific information about the presence of these particular sensitizing substances. Therefore, the use of the hazard statement EUH208 should not be obligatory where a mixture is already labelled in accordance with the hazard statements EUH204 or EUH205.

(6)

To ensure that suppliers of substances and mixtures have some time to adapt to the new classification and labelling provisions introduced by this Regulation, a transitional period should be provided and the application of this Regulation should be deferred. That 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 by Article 133 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3),

HAS ADOPTED THIS REGULATION:

Article 1

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

(1)

In Article 23, point (f) is replaced by the following:

‘(f)

substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1).’

(2)

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

(3)

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

(4)

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

(5)

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

(6)

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

(7)

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

(8)

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

Article 2

By way of derogation from Article 3, substances and mixtures may, before 1 February 2018, be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.

By way of derogation from Article 3, substances and mixtures classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 and placed on the market before 1 February 2018 shall not be required to be relabelled and repackaged in accordance with this Regulation before 1 February 2020.

Article 3

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

This Regulation shall apply from 1 February 2018.

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

Done at Brussels, 19 May 2016.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 353, 31.12.2008, p. 1.

(2)  Commission Regulation (EU) No 487/2013 of 8 May 2013 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 (OJ L 149, 1.6.2013, p. 1).

(3)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).


ANNEX I

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

A.

Part 1 is amended as follows:

(1)

The title of Section 1.1.3.4 is replaced by the following:

‘1.1.3.4   Interpolation within one hazard category

(2)

Section 1.3.6 is replaced by the following:

‘1.3.6    Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1)

Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1) which are in the finished state and packaged for consumer use do not require on the label the hazard pictogram GHS05.’

B.

Part 2 is amended as follows:

(1)

Section 2.1.3 is replaced by the following:

‘2.1.3    Hazard Communication

Label elements shall be used for substances, mixtures or articles meeting the criteria for classification in this hazard class in accordance with Table 2.1.2.

Table 2.1.2

Label elements for explosives

Classification

Unstable Explosive

Division 1.1

Division 1.2

Division 1.3

Division 1.4

Division 1.5

Division 1.6

GHS Pictograms

Image

Image

Image

Image

Image

 

 

Signal Word

Danger

Danger

Danger

Danger

Warning

Danger

No signal word

Hazard Statement

H200: Unstable Explosive

H201: Explosive; mass explosion hazard

H202: Explosive; severe projection hazard

H203: Explosive; fire, blast or projection hazard

H204: Fire or projection hazard

H205: May mass explode in fire

No hazard statement

Precautionary Statement Prevention

P201

P250

P280

P210

P230

P234

P240

P250

P280

P210

P230

P234

P240

P250

P280

P210

P230

P234

P240

P250

P280

P210

P234

P240

P250

P280

P210

P230

P234

P240

P250

P280

No precautionary statement

Precautionary Statement Response

P370 + P372 + P380 + P373

P370 + P372 + P380 + P373

P370 + P372 + P380 + P373

P370 + P372 + P380 + P373

P370 + P372 + P380 + P373

P370 + P380 + P375

P370 + P372 + P380 + P373

No precautionary statement

Precautionary Statement Storage

P401

P401

P401

P401

P401

P401

No precautionary statement

Precautionary Statement Disposal

P501

P501

P501

P501

P501

P501

No precautionary statement

NOTE 1: Unpackaged explosives or explosives repackaged in packaging other than the original or similar packaging shall include all of the following label elements:

(a)

the pictogram: exploding bomb;

(b)

the signal word “Danger”; and

(c)

the hazard statement: “Explosive; mass explosion hazard”

unless the hazard is shown to correspond to one of the hazard categories in Table 2.1.2, in which case the corresponding symbol, the signal word and/or the hazard statement shall be assigned.

NOTE 2: Substances and mixtures, as supplied, with a positive result in Test Series 2 in Part I, Section 12, of the UN RTDG, Manual of Tests and Criteria, which are exempted from classification as explosives (based on a negative result in Test Series 6 in Part I, Section 16 of the UN RTDG, Manual of Tests and Criteria) still have explosive properties. The user shall be informed of these intrinsic explosive properties because they have to be considered for handling — especially if the substance or mixture is removed from its packaging or is repackaged — and for storage. For this reason, the explosive properties of the substance or mixture shall be communicated in Section 2 (Hazards identification) and Section 9 (Physical and chemical properties) of the Safety Data Sheet and other sections of the Safety Data Sheet, as appropriate.’

(2)

In Section 2.1.4, 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

(3)

In Section 2.2.3, Table 2.2.3 is replaced by the following:

‘Table 2.2.3

Label elements for flammable gases (including chemically unstable gases)

Classification

Flammable gas

Chemically unstable gas

Category 1

Category 2

Category A

Category B

GHS Pictogram

Image

No pictogram

No additional pictogram

No additional pictogram

Signal Word

Danger

Warning

No additional signal word

No additional signal word

Hazard Statement

H220: Extremely flammable gas

H221: Flammable gas

Additional hazard statement H230: May react explosively even in the absence of air

Additional hazard statement H231: May react explosively even in the absence of air at elevated pressure and/or temperature

Precautionary Statement Prevention

P210

P210

P202

P202’

Precautionary Statement Response

P377

P381

P377

P381

 

 

Precautionary Statement Storage

P403

P403

 

 

Precautionary Statement Disposal

 

 

 

 

(4)

Section 2.3.2.1 is replaced by the following:

2.3.2.1.   Aerosols shall be classified in one of the three categories of this hazard class, depending on their flammable properties and their heat of combustion. They shall be considered for classification in Category 1 or 2 if they contain more than 1 % components (by mass) which are classified as flammable according to the following criteria set out in this Part:

Flammable gases (see Section 2.2);

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

Flammable solids (see Section 2.7);

or if their heat of combustion is at least 20 kJ/g.

NOTE 1: Flammable components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because such components are never used as aerosol contents.

NOTE 2: Aerosols do not fall additionally within the scope of Sections 2.2 (flammable gases), 2.5 (gases under pressure), 2.6 (flammable liquids) and 2.7 (flammable solids). Depending on their contents, aerosols may however fall within the scope of other hazard classes, including their labelling elements.’

(5)

In Section 2.3.2, Figure 2.3.1(a) is replaced by the following:

‘Figure 2.3.1(a) for aerosols

Image

(6)

In Section 2.3.3, the heading of Table 2.3.1 is replaced by the following:

Label elements for aerosols

(7)

In Section 2.5.3, Table 2.5.2 is replaced by the following:

‘Table 2.5.2

Label elements for gases under pressure

Classification

Compressed gas

Liquefied gas

Refrigerated liquefied gas

Dissolved gas

GHS Pictograms

Image

Image

Image

Image

Signal Word

Warning

Warning

Warning

Warning

Hazard Statement

H280: Contains gas under pressure; may explode if heated

H280: Contains gas under pressure; may explode if heated

H281: Contains refrigerated gas; may cause cryogenic burns or injury

H280: Contains gas under pressure; may explode if heated

Precautionary Statement Prevention

 

 

P282

 

Precautionary Statement Response

 

 

P336 + P315

 

Precautionary Statement Storage

P410 + P403

P410 + P403

P403

P410 + P403’

Precautionary Statement Disposal

 

 

 

 

(8)

In Section 2.8.3, Table 2.8.1 is replaced by the following:

‘Table 2.8.1

Label elements for self-reactive substances and mixtures

Classification

Type A

Type B

Type C & D

Type E & F

Type G (1)

GHS Pictograms

Image

Image

Image

Image

There are no label elements allocated to this hazard category

Signal Word

Danger

Danger

Danger

Warning

Hazard Statement

H240: Heating may cause an explosion

H241: Heating may cause a fire or explosion

H242: Heating may cause a fire

H242: Heating may cause a fire

Precautionary Statement Prevention

P210

P234

P235

P240

P280

P210

P234

P235

P240

P280

P210

P234

P235

P240

P280

P210

P234

P235

P240

P280

Precautionary Statement Response

P370 + P372 + P380 + P373

P370 + P380 + P375 [+ P378] (2)

P370 + P378

P370 + P378

 

Precautionary Statement Storage

P403

P411

P420

P403

P411

P420

P403

P411

P420

P403

P411

P420

 

Precautionary Statement Disposal

P501

P501

P501

P501

 

(9)

In Section 2.8.4, Figure 2.8.1 is replaced by the following:

‘Figure 2.8.1

Self-reactive substances and mixtures

Image

(10)

In Section 2.9.3, Table 2.9.2 is replaced by the following:

‘Table 2.9.2

Label elements for pyrophoric liquids

Classification

Category 1

GHS Pictogram

Image

Signal Word

Danger

Hazard Statement

H250: Catches fire spontaneously if exposed to air

Precautionary Statement Prevention

P210

P222

P231 + P232

P233

P280

Precautionary Statement Response

P302 + P334

P370 + P378’

Precautionary Statement Storage

 

Precautionary Statement Disposal

 

(11)

In Section 2.10.3, Table 2.10.2 is replaced by the following:

‘Table 2.10.2

Label elements for pyrophoric solids

Classification

Category 1

GHS Pictogram

Image

Signal Word

Danger

Hazard Statement

H250: Catches fire spontaneously if exposed to air

Precautionary Statement Prevention

P210

P222

P231 + P232

P233

P280

Precautionary Statement Response

P302 + P335 + P334

P370 +P378’

Precautionary Statement Storage

 

Precautionary Statement Disposal

 

(12)

In Section 2.11.3, Table 2.11.2 is replaced by the following:

‘Table 2.11.2

Label elements for self-heating substances and mixtures

Classification

Category 1

Category 2

GHS Pictograms

Image

Image

Signal Word

Danger

Warning

Hazard Statement

H251: Self-heating; may catch fire

H252: Self-heating in large quantities; may catch fire

Precautionary Statement Prevention

P235

P280

P235

P280

Precautionary Statement Response

 

 

Precautionary Statement Storage

P407

P413

P420

P407

P413

P420’

Precautionary Statement Disposal

 

 

(13)

In Section 2.12.3, Table 2.12.2 is replaced by the following:

‘Table 2.12.2

Label elements for substances and mixtures which in contact with water emit flammable gases

Classification

Category 1

Category 2

Category 3

GHS Pictograms

Image

Image

Image

Signal Word

Danger

Danger

Warning

Hazard Statement

H260: In contact with water releases flammable gases which may ignite spontaneously

H261: In contact with water releases flammable gases

H261: In contact with water releases flammable gases

Precautionary Statement Prevention

P223

P231 + P232

P280

P223

P231 + P232

P280

P231 + P232

P280

Precautionary Statement Response

P302 + P335 + P334

P370 + P378

P302 + P335 + P334

P370 + P378

P370 + P378

Precautionary Statement Storage

P402 + P404

P402 + P404

P402 + P404

Precautionary Statement Disposal

P501

P501

P501’

(14)

In Section 2.13.3, Table 2.13.2 is replaced by the following:

‘Table 2.13.2

Label elements for oxidising liquids

Classification

Category 1

Category 2

Category 3

GHS Pictograms

Image

Image

Image

Signal Word

Danger

Danger

Warning

Hazard Statement

H271: May cause fire or explosion; strong oxidiser

H272: May intensify fire; oxidiser

H272: May intensify fire; oxidiser

Precautionary Statement Prevention

P210

P220

P280

P283

P210

P220

P280

P210

P220

P280

Precautionary Statement Response

P306 + P360

P371 + P380 + P375

P370 + P378

P370 + P378

P370 + P378

Precautionary Statement Storage

P420

 

 

Precautionary Statement Disposal

P501

P501

P501’

(15)

In Section 2.14.2.1, the introductory sentence is replaced by the following:

‘An oxidising solid shall be classified in one of the three categories for this class using test O.1 in Part III, sub-section 34.4.1 or test O.3 in Part III, sub-section 34.4 3 of the UN RTDG, Manual of Tests and Criteria in accordance with Table 2.14.1:’

(16)

In Section 2.14.2.1, Table 2.14.1 is replaced by the following:

‘Table 2.14.1

Criteria for oxidising solids

Category

Criteria using test O.1

Criteria using test O.3

1

Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time less than the mean burning time of a 3:2 mixture, (by mass), of potassium bromate and cellulose.

Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning rate greater than the mean burning rate of a 3:1 mixture (by mass) of calcium peroxide and cellulose.

2

Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 2:3 mixture (by mass) of potassium bromate and cellulose and the criteria for Category 1 are not met.

Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning rate equal to or greater than the mean burning rate of a 1:1 mixture (by mass) of calcium peroxide and cellulose and the criteria for Category 1 are not met.

3

Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 3:7 mixture (by mass) of potassium bromate and cellulose and the criteria for Categories 1 and 2 are not met.

Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning rate equal to or greater than the mean burning rate of a 1:2 mixture (by mass) of calcium peroxide and cellulose and the criteria for Categories 1 and 2 are not met.’

(17)

In Section 2.14.2.1, in Note 1 to Table 2.14.1, ‘(BC Code, Annex 3, Test 5)’ is replaced by ‘(IMSBC Code (International Maritime Solid Bulk Cargoes Code, IMO), Appendix 2, Section 5)’.

(18)

In Section 2.14.3, Table 2.14.2 is replaced by the following:

‘Table 2.14.2

Label elements for oxidising solids

 

Category 1

Category 2

Category 3

GHS Pictograms

Image

Image

Image

Signal Word

Danger

Danger

Warning

Hazard Statement

H271: May cause fire or explosion; strong oxidiser

H272: May intensify fire; oxidiser

H272: May intensify fire; oxidiser

Precautionary Statement Prevention

P210

P220

P280

P283

P210

P220

P280

P210

P220

P280

Precautionary Statement Response

P306 + P360

P371 + P380 + P375

P370 + P378

P370 + P378

P370 + P378

Precautionary Statement Storage

P420

 

 

Precautionary Statement Disposal

P501

P501

P501’

(19)

In Section 2.15.3, Table 2.15.1 is replaced by the following:

‘Table 2.15.1

Label elements for organic peroxides

Classification

Type A

Type B

Type C & D

Type E & F

Type G

GHS Pictograms

Image

Image

Image

Image

There are no label elements allocated to this hazard category

Signal Word

Danger

Danger

Danger

Warning

Hazard Statement

H240: Heating may cause an explosion

H241: Heating may cause a fire or explosion

H242: Heating may cause a fire

H242: Heating may cause a fire

Precautionary Statement Prevention

P210

P234

P235

P240

P280

P210

P234

P235

P240

P280

P210

P234

P235

P240

P280

P210

P234

P235

P240

P280

Precautionary Statement Response

P370 + P372 + P380 + P373

P370 + P380 + P375[+ P378] (3)

P370 + P378

P370 + P378

 

Precautionary Statement Storage

P403

P410

P411

P420

P403

P410

P411

P420

P403

P410

P411

P420

P403

P410

P411

P420

 

Precautionary Statement Disposal

P501

P501

P501

P501

 

(20)

In Section 2.15.4, Figure 2.15.1 is replaced by the following:

‘Figure 2.15.1

Organic Peroxides

Image

C.

Part 3 is amended as follows:

(1)

In Section 3.1.2.1, the first sentence is replaced by the following:

‘Substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1.’

(2)

In Section 3.1.2.3.2, the first sentence is replaced by the following:

‘Of particular importance in classifying for inhalation toxicity is the use of well articulated values in the highest hazard categories for dusts and mists.’

(3)

In Section 3.1.3.6.1, point (a) is replaced by the following:

‘include ingredients with a known acute toxicity, which fall into any of the acute hazard categories shown in Table 3.1.1;’

(4)

Chapter 3.2 is replaced by the following:

‘3.2.   Skin corrosion/irritation

3.2.1.    Definitions and general considerations

 

Skin corrosion means the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology shall be considered to evaluate questionable lesions.

 

Skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

3.2.1.2.   In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data and then other sources of information. Classification results directly when the data satisfy the criteria. In some cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of skin corrosion/irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5).

3.2.2.    Classification criteria for substances

Substances shall be allocated to one of the following two categories within this hazard class:

(a)

Category 1 (skin corrosion)

This category is further subdivided in three sub-categories (1A, 1B, 1C). Corrosive substances shall be classified in Category 1 where data is not sufficient for sub-categorisation. When data are sufficient, substances shall be classified in one of the three sub-categories 1A, 1B, or 1C (see Table 3.2.1.)

(b)

Category 2 (skin irritation) (see Table 3.2.2).

3.2.2.1.   Classification based on standard animal test data

3.2.2.1.1.   Skin corrosion

3.2.2.1.1.1.

A substance is corrosive to skin when it produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis in at least one tested animal after exposure for up to 4 hours.

3.2.2.1.1.2.

Corrosive substances shall be classified in Category 1 where data is not sufficient for sub-categorisation.

3.2.2.1.1.3.

When data are sufficient substances shall be classified in one of the three sub-categories 1A, 1B, or 1C in accordance with the criteria in Table 3.2.1.

3.2.2.1.1.4.

Three sub-categories are provided within the corrosion category: sub-category 1A — where corrosive responses are noted following up to 3 minutes exposure and up to 1 hour observation; sub-category 1B — where corrosive responses are described following exposure greater than 3 minutes and up to 1 hour and observations up to 14 days; and sub-category 1C — where corrosive responses occur after exposures greater than 1 hour and up to 4 hours and observations up to 14 days.

Table 3.2.1

Skin corrosion category and sub-categories

Category

Criteria

Category 1 (4)

Destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least one tested animal after exposure ≤ 4 h

Sub-Category 1A

Corrosive responses in at least one animal following exposure ≤ 3 min during an observation period ≤ 1 h

Sub-Category 1B

Corrosive responses in at least one animal following exposure > 3 min and ≤ 1 h and observations ≤ 14 days

Sub-Category 1C

Corrosive responses in at least one animal after exposures > 1 h and ≤ 4 h and observations ≤ 14 days

3.2.2.1.1.5.

The use of human data is discussed in Sections 3.2.1.2 and 3.2.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.

3.2.2.1.2.   Skin irritation

3.2.2.1.2.1.

A substance is irritant to skin when it produces reversible damage to the skin following its application for up to 4 hours. The major criterion for the irritation category is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 and ≤ 4,0.

3.2.2.1.2.2.

A single irritation category (Category 2) is presented in Table 3.2.2, using the results of animal testing.

3.2.2.1.2.3.

Reversibility of skin lesions is also considered in evaluating irritant responses. When inflammation persists to the end of the observation period in 2 or more test animals, taking into consideration alopecia (limited area), hyperkeratosis, hyperplasia and scaling, then a material shall be considered to be an irritant.

3.2.2.1.2.4.

Animal irritant responses within a test can be variable, as they are with corrosion. A separate irritant criterion accommodates cases where there is a significant irritant response but less than the mean score criterion for a positive test. For example, a test material might be designated as an irritant if at least 1 of 3 tested animals shows a very elevated mean score throughout the study, including lesions persisting at the end of an observation period of normally 14 days. Other responses could also fulfil this criterion. However, it should be ascertained that the responses are the result of chemical exposure.

Table 3.2.2

Skin irritation category  (1)

Category

Criteria

Irritation (Category 2)

(1)

Mean score of ≥ 2,3 and ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

(2)

Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling reactions; or

(3)

In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above .

3.2.2.1.2.5.

The use of human data is discussed in Sections 3.2.1.2 and 3.2.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.

3.2.2.2   Classification in a tiered approach

3.2.2.2.1.   A tiered approach to the evaluation of initial information shall be considered, where applicable, recognising that not all elements may be relevant.

3.2.2.2.2.   Existing human and animal data including information from single or repeated exposure shall be the first line of evaluation, as they give information directly relevant to effects on the skin.

3.2.2.2.3.   Acute dermal toxicity data may be used for classification. If a substance is highly toxic by the dermal route, a skin corrosion/irritation study is not practicable since the amount of test substance to be applied considerably exceeds the toxic dose and, consequently, results in the death of the animals. When observations are made of skin corrosion/irritation in acute toxicity studies and are observed up through the limit dose, these data may be used for classification, provided that the dilutions used and species tested are equivalent. Solid substances (powders) may become corrosive or irritant when moistened or in contact with moist skin or mucous membranes.

3.2.2.2.4.   In vitro alternatives that have been validated and accepted shall be used to make classification decisions.

3.2.2.2.5.   Likewise, pH extremes like ≤ 2 and ≥ 11,5 may indicate the potential to cause skin effects, especially when associated with significant acid/alkaline reserve (buffering capacity). Generally, such substances are expected to produce significant effects on the skin. In the absence of any other information, a substance is considered as corrosive to skin (Skin Corrosion Category 1) if it has a pH ≤ 2 or a pH ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the substance may not be corrosive despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test.

3.2.2.2.6.   In some cases, sufficient information may be available from structurally related substances to make classification decisions.

3.2.2.2.7.   The tiered approach provides guidance on how to organize existing information on a substance and to make a weight of evidence decision about hazard assessment and hazard classification.

Although information might be gained from the evaluation of single parameters within a tier (see Section 3.2.2.2.1.), consideration shall be given to the totality of existing information and making an overall weight of evidence determination. This is especially true when there is conflict in information available on some parameters.

3.2.3.    Classification criteria for mixtures

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

3.2.3.1.1.   The mixture shall be classified using the criteria for substances, taking into account the tiered approach to evaluate data for this hazard class.

3.2.3.1.2.   When considering testing of the mixture, classifiers are encouraged to use a tiered weight of evidence approach as included in the criteria for classification of substances for skin corrosion and irritation (Sections 3.2.1.2 and 3.2.2.2), to help ensure an accurate classification as well as to avoid unnecessary animal testing. In the absence of any other information, a mixture is considered corrosive to skin (Skin Corrosion Category 1) if it has a pH ≤ 2 or a pH ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the mixture may not be corrosive despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test.

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

3.2.3.2.1.   Where the mixture itself has not been tested to determine its skin corrosion/irritation potential, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in Section 1.1.3.

3.2.3.3.   Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture

3.2.3.3.1.   In order to make use of all available data for purposes of classifying the skin corrosion/irritation hazards of mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:

The “relevant ingredients” of a mixture are those which are present in concentrations ≥ 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases), unless there is a presumption (e.g., in the case of skin corrosive ingredients) that an ingredient present at a concentration < 1 % can still be relevant for classifying the mixture for skin corrosion/irritation.

3.2.3.3.2.   In general, the approach to classification of mixtures as corrosive or irritant to skin when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each skin corrosive or skin irritant ingredient contributes to the overall skin corrosive or skin irritant properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for skin corrosive ingredients when they are present at a concentration below the generic concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as skin irritant. The mixture is classified as corrosive or irritant to skin when the sum of the concentrations of such ingredients exceeds a concentration limit.

3.2.3.3.3.   Table 3.2.3 provides the generic concentration limits to be used to determine if the mixture is considered to be corrosive or irritant to the skin.

3.2.3.3.4.1.   Particular care must be taken when classifying certain types of mixtures containing substances such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in Sections 3.2.3.3.1 and 3.2.3.3.2 may not be applicable given that many such substances are corrosive or irritant to the skin at concentrations < 1 %.

3.2.3.3.4.2.   For mixtures containing strong acids or bases the pH shall be used as a classification criterion (see Section 3.2.3.1.2) since pH is a better indicator of skin corrosion than the concentration limits in Table 3.2.3.

3.2.3.3.4.3.   A mixture containing ingredients that are corrosive or irritant to the skin and that cannot be classified on the basis of the additivity approach (Table 3.2.3), due to chemical characteristics that make this approach unworkable, shall be classified as Skin Corrosion Category 1 if it contains ≥ 1 % of an ingredient classified as Skin Corrosion or as Skin Irritation (Category 2) when it contains ≥ 3 % of an skin irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 3.2.3 does not apply is summarised in Table 3.2.4.

3.2.3.3.5.   On occasion, reliable data may show that the skin corrosion/irritation hazard of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4 in Section 3.2.3.3.6. In these cases the mixture shall be classified according to that data (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazard of an ingredient is not evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4, testing of the mixture shall be considered. In those cases the tiered weight of evidence approach shall be applied, as described in Section 3.2.2.2.

3.2.3.3.6.   If there are data showing that (an) ingredient(s) is/are corrosive or irritant to skin at a concentration of < 1 % (skin corrosive) or < 3 % (skin irritant), the mixture shall be classified accordingly.

Table 3.2.3

Generic concentration limits of ingredients classified as skin corrosion (Category 1, 1A, 1B or 1C)/skin irritation (Category 2) that trigger classification of the mixture as skin corrosion/skin irritation where the additivity approach applies

Sum of ingredients classified as:

Concentration triggering classification of a mixture as:

 

Skin corrosion

Skin irritation

 

Category 1 (see note below)

Category 2

Skin corrosion Sub-Category 1A, 1B, 1C or Category 1

≥ 5 %

≥ 1 % but < 5 %

Skin irritation Category 2

 

≥ 10 %

(10 × Skin corrosion Sub-Category 1A, 1B, 1C or Category 1) + Skin irritation Category 2

 

≥ 10 %

Note:

The sum of all ingredients of a mixture classified as Skin Corrosion Sub-Category 1A, 1B, or 1C respectively, shall each be ≥ 5 % in order to classify the mixture as either Skin Corrosion Sub-Category 1A, 1B or 1C. If the sum of the ingredients classified as Skin Corrosion Sub-Category 1A is < 5 % but the sum of ingredients classified as Skin Corrosion Sub-Category 1A + 1B is ≥ 5 %, the mixture shall be classified as Skin Corrosion Sub-Category 1B. Similarly, if the sum of ingredients classified as Skin Corrosion Sub-Category 1A + 1B ingredients is < 5 % but the sum of ingredients classified as Sub-Category 1A + 1B + 1C is ≥ 5 % the mixture shall be classified as Skin Corrosion Sub-Category 1C. Where at least one relevant ingredient in a mixture is classified as Category 1 without sub-categorisation, the mixture shall be classified as Category 1 without sub-categorisation if the sum of all ingredients corrosive to skin is ≥ 5 %.

Table 3.2.4

Generic concentration limits of ingredients that trigger classification of the mixture as skin corrosion/skin irritation, where the additivity approach does not apply

Ingredient:

Concentration:

Mixture classified as:

Acid with pH ≤ 2

≥ 1 %

Skin corrosion Category 1

Base with pH ≥ 11,5

≥ 1 %

Skin corrosion Category 1

Other skin corrosive (Sub-Categories 1A, 1B, 1C or Category 1) ingredients

≥ 1 %

Skin corrosion Category 1

Other skin irritant (Category 2) ingredients, including acids and bases

≥ 3 %

Skin irritation Category 2

3.2.4.    Hazard Communication

3.2.4.1.   Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.2.5.

Table 3.2.5

Label elements for skin corrosion/irritation

Classification

Sub-Categories 1A/1B/1C and Category 1

Category 2

GHS Pictograms

Image

Image

Signal Word

Danger

Warning

Hazard Statement

H314: Causes severe skin burns and eye damage

H315: Causes skin irritation

Precautionary Statement Prevention

P260

P264

P280

P264

P280

Precautionary Statement Response

P301 + P330 + P331

P303 + P361 + P353

P363

P304 + P340

P310

P321

P305 + P351 + P338

P302 + P352

P321

P332 + P313

P362 + P364

Precautionary Statement Storage

P405

 

Precautionary Statement Disposal

P501’

 

(5)

Chapter 3.3 is replaced by the following:

‘3.3.   Serious eye damage/eye irritation

3.3.1.    Definitions and general considerations

 

Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.

 

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

3.3.1.2.   In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data, and then other sources of information. Classification results directly when the data satisfy the criteria. In other cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of serious eye damage/eye irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Section 1.1.1.3).

3.3.2.    Classification criteria for substances

Substances are allocated to one of the categories within this hazard class, Category 1 (serious eye damage) or Category 2 (eye irritation), as follows:

(a)

Category 1 (serious eye damage):

substances that have the potential to seriously damage the eyes (see Table 3.3.1).

(b)

Category 2 (eye irritation):

substances that have the potential to induce reversible eye irritation (see Table 3.3.2).

3.3.2.1.   Classification based on standard animal test data

3.3.2.1.1.   Serious eye damage (Category 1)

3.3.2.1.1.1.

A single hazard category (Category 1) is adopted for substances that have the potential to seriously damage the eyes. This hazard category includes as criteria the observations listed in Table 3.3.1. These observations include animals with grade 4 cornea lesions and other severe reactions (e.g. destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. Hazard classification as Category 1 also contains substances fulfilling the criteria of corneal opacity ≥ 3 or iritis > 1,5 observed in at least 2 of 3 tested animals, because severe lesions like these usually do not reverse within a 21-day observation period.

3.3.2.1.1.2.

The use of human data is discussed in Section 3.3.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.

Table 3.3.1

Serious eye damage  (2)

Category

Criteria

Category 1

A substance that produces:

(a)

in at least one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or

(b)

in at least 2 of 3 tested animals, a positive response of:

(i)

corneal opacity ≥ 3; and/or

(ii)

iritis > 1,5;

calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material.

3.3.2.1.2.   Eye irritation (Category 2)

3.3.2.1.2.1.

Substances that have the potential to induce reversible eye irritation shall be classified in Category 2 (eye irritation).

3.3.2.1.2.2.

For those substances where there is pronounced variability among animal responses, this information shall be taken into account in determining the classification.

3.3.2.1.2.3.

The use of human data is addressed in Sections 3.3.2.2, and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.

Table 3.3.2

Eye irritation  (3)

Category

Criteria

Category 2

Substances that produce in at least 2 of 3 tested animals a positive response of:

(a)

corneal opacity ≥ 1; and/or

(b)

iritis ≥ 1; and/or

(c)

conjunctival redness ≥ 2; and/or

(d)

conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material, and which fully reverses within an observation period of normally 21 days.

3.3.2.2.   Classification in a tiered approach

3.3.2.2.1.   A tiered approach to the evaluation of initial information shall be considered where applicable, recognizing that not all elements may be relevant.

3.3.2.2.2.   Existing human and animal data shall be the first line of evaluation as they give information directly relevant to effects on the eye. Possible skin corrosion has to be evaluated prior to consideration of any testing for serious eye damage/eye irritation in order to avoid testing for local effects on eyes with skin corrosive substances. Skin corrosive substances shall be considered as leading to serious eye damage (Category 1) as well, while skin irritant substances may be considered as leading to eye irritation (Category 2).

3.3.2.2.3.   In vitro alternatives that have been validated and accepted shall be used to make classification decisions.

3.3.2.2.4.   Likewise, pH extremes like ≤ 2 and ≥ 11,5, may indicate serious eye damage, especially when associated with significant acid/alkaline reserve (buffering capacity). Generally such substances are expected to produce significant effects on the eyes. In the absence of any other information, a substance is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the substance may not cause serious eye damage despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test.

3.3.2.2.5.   In some cases sufficient information may be available from structurally related substances to make classification decisions.

3.3.2.2.6.   The tiered approach provides guidance on how to organize existing information and to make a weight-of-evidence decision about hazard assessment and hazard classification. Animal testing with corrosive substances shall be avoided whenever possible. Although information might be gained from the evaluation of single parameters within a tier (see 3.3.2.1.1) consideration shall be given to the totality of existing information and making an overall weight of evidence determination. This is especially true when there is conflict in information available on some parameters.

3.3.3.    Classification criteria for mixtures

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

3.3.3.1.1.   The mixture shall be classified using the criteria for substances, and taking into account the tiered approach to evaluate data for this hazard class.

3.3.3.1.2.   When considering testing of the mixture classifiers are encouraged to use a tiered weight of evidence approach as included in the criteria for classification of substances for skin corrosion and serious eye damage/eye irritation to help ensure an accurate classification, as well as to avoid unnecessary animal testing. In the absence of any other information, a mixture is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or ≥ 11,5. However, if consideration of acid/alkali reserve suggests the mixture may not cause serious eye damage despite the low or high pH value, this needs to be confirmed by other data, preferably data from an appropriate validated in vitro test.

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

3.3.3.2.1.   Where the mixture itself has not been tested to determine its skin corrosivity or potential to cause serious eye damage/eye irritation, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in Section 1.1.3.

3.3.3.3.   Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture

3.3.3.3.1.   In order to make use of all available data for purposes of classifying the serious eye damage/eye irritation properties of the mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:

The “relevant ingredients” of a mixture are those which are present in concentrations ≥ 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases), unless there is a presumption (e.g. in the case of skin corrosive ingredients) that an ingredient present at a concentration < 1 % can still be relevant for classifying the mixture for serious eye damage/eye irritation.

3.3.3.3.2.   In general, the approach to classification of mixtures as seriously damaging to the eye/eye irritant when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each skin corrosive or serious eye damaging/eye irritant ingredient contributes to the overall serious eye damage/eye irritation properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for skin corrosive and serious eye damaging ingredients when they are present at a concentration below the generic concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as eye irritant. The mixture is classified as seriously damaging to the eye or eye irritant when the sum of the concentrations of such ingredients exceeds a concentration limit.

3.3.3.3.3.   Table 3.3.3 provides the generic concentration limits to be used to determine if the mixture shall be classified as seriously damaging to the eye or as eye irritant.

3.3.3.3.4.1.   Particular care must be taken when classifying certain types of mixtures containing substances such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in Sections 3.3.3.3.1 and 3.3.3.3.2 might not work given that many such substances are seriously damaging to the eye/eye irritant at concentrations < 1 %.

3.3.3.3.4.2.   For mixtures containing strong acids or bases the pH shall be used as classification criterion (see Section 3.3.3.1.2) since pH will be a better indicator of serious eye damage (subject to consideration of acid/alkali reserve) than the generic concentration limits in Table 3.3.3.

3.3.3.3.4.3.   A mixture containing skin corrosive or serious eye damaging/eye irritating ingredients that cannot be classified based on the additivity approach (Table 3.3.3) due to chemical characteristics that make this approach unworkable, shall be classified as Serious Eye Damage (Category 1) if it contains ≥ 1 % of a skin corrosive or serious eye damaging ingredient and as Eye Irritation (Category 2) when it contains ≥ 3 % of an eye irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 3.3.3 does not apply is summarised in Table 3.3.4.

3.3.3.3.5.   On occasion, reliable data may show that the effects of serious eye damage/eye irritation of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4 in Section 3.3.3.3.6. In these cases the mixture shall be classified according to those data (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazards or the effects of serious eye damage/eye irritation of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4, testing of the mixture shall be considered. In those cases, the tiered weight of evidence approach shall be applied.

3.3.3.3.6.   If there are data showing that (an) ingredient(s) may be corrosive to the skin or seriously damaging to the eye/eye irritating at a concentration of < 1 % (corrosive to the skin or seriously damaging to the eye) or < 3 % (eye irritant), the mixture shall be classified accordingly.

Table 3.3.3

Generic concentration limits of ingredients classified as skin corrosion (Category 1, 1A, 1B or 1C) and/or serious eye damage (Category 1) or eye irritation (Category 2) that trigger classification of the mixture as serious eye damage/eye irritation where the additivity approach applies

Sum of ingredients classified as:

Concentration triggering classification of a mixture as:

Serious eye damage

Eye irritation

Category 1

Category 2

Skin corrosion Sub-Category 1A, 1B, 1C or Category 1 + Serious eye damage (Category 1) (4)

≥ 3 %

≥ 1 % but < 3 %

Eye irritation ( Category 2)

 

≥ 10 %

10 × (Skin corrosion Sub-Category 1A, 1B, 1C or Skin corrosion Category 1 + Serious eye damage (Category 1)) + Eye irritation (Category 2)

 

≥ 10 %


Table 3.3.4

Generic concentration limits of ingredients that trigger classification of the mixture as serious eye damage (Category 1) or eye irritation (Category 2), where the additivity approach does not apply

Ingredient

Concentration

Mixture classified as:

Acid with pH ≤ 2

≥ 1 %

Serious eye damage (Category 1)

Base with pH ≥ 11,5

≥ 1 %

Serious eye damage (Category 1)

Other ingredient classified as skin corrosion (Sub-Category 1A, 1B, 1C or Category 1) or serious eye damage (Category 1)

≥ 1 %

Serious eye damage (Category 1)

Other ingredient classified as eye irritation (Category 2)

≥ 3 %

Eye irritation (Category 2)

3.3.4.    Hazard Communication

3.3.4.1.   Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.3.5.

Table 3.3.5

Label elements for serious eye damage/eye irritation  (5)

Classification

Category 1

Category 2

GHS Pictograms

Image

Image

Signal Word

Danger

Warning

Hazard Statement

H318: Causes serious eye damage

H319: Causes serious eye irritation

Precautionary Statement Prevention

P280

P264

P280

Precautionary Statement Response

P305 + P351 + P338

P310

P305 + P351 + P338

P337 + P313

Precautionary Statement Storage

 

 

Precautionary Statement Disposal

 

 

(6)

In Section 3.5.2.3.5, the second indent is deleted.

D.

Part 4 is amended as follows:

(1)

Section 4.1.1.1 is amended as follows:

(a)

In point (b), the term ‘acute (short-term) hazard’ is replaced by the term ‘short-term (acute) hazard’.

(b)

In point (j), the term ‘long-term hazard’ is replaced by the term ‘long-term (chronic) hazard’.

(2)

Section 4.1.1.2.0 is replaced by the following:

‘Hazardous to the aquatic environment is differentiated into:

short-term (acute) aquatic hazard

long-term (chronic) aquatic hazard.’

(3)

In Section 4.1.1.3.1, the second and third sentences are replaced by the following:

‘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 short-term (acute) and long-term (chronic) 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)

In Section 4.1.2.1, the first and second sentences are replaced by the following:

‘The system for classification recognises that the intrinsic hazard to aquatic organisms is represented by both the acute and chronic toxicity of a substance. For the long-term (chronic) hazard, separate hazard categories are defined representing a gradation in the level of hazard identified.’

(5)

Section 4.1.2.2 is replaced by the following:

‘The core classification system for substances consists of one short-term (acute) hazard classification category and three long-term (chronic) hazard classification categories. The short-term (acute) and long-term (chronic) classification categories are applied independently.’

(6)

Section 4.1.2.3 is replaced by the following:

‘The criteria for classification of a substance in Acute 1 are defined on the basis of acute aquatic toxicity data only (EC50 or LC 50). The criteria for classification of a substance into Chronic 1 to 3 follow a tiered approach where the first step is to see if available information on chronic toxicity merits long-term (chronic) 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).’

(7)

The title of Figure 4.1.1 is replaced by:

Categories for substances long-term (chronic) hazardous to the aquatic environment’.

(8)

Section 4.1.2.4. is replaced by the following:

‘The system also introduces a “safety net” classification (referred to as 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 Table 4.1.0).’

(9)

Table 4.1.0 is replaced by the following:

‘Table 4.1.0

Classification categories for substances hazardous to the aquatic environment

(a)   

Short-term (acute) 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 (chronic) 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)

≤ 1 mg/l and/or

Chronic NOEC or ECx (for crustacea)

≤ 1 mg/l and/or

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

≤ 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)

≤ 0,1 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 3:

Chronic NOEC or ECx (for fish)

≤ 1 mg/l and/or

Chronic NOEC or ECx (for crustacea)

≤ 1 mg/l and/or

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

≤ 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.’

(10)

In Section 4.1.3.2, Figure 4.1.2 is replaced by the following:

‘Figure 4.1.2

Tiered approach to classification of mixtures for short-term (acute) and long-term (chronic) aquatic environmental hazards

Image

(11)

In Section 4.1.3.3.2, the first sentence is replaced by the following:

‘The long-term (chronic) hazard classification of mixtures requires additional information on degradability and in certain cases bioaccumulation.’

(12)

In Section 4.1.3.3.3, ‘No need to classify for acute hazard’ is replaced by the following:

‘No need to classify for short-term (acute) hazard.’

(13)

In Section 4.1.3.3.4, ‘No need to classify for long-term hazard in categories Chronic 1, 2 or 3’ is replaced by the following:

‘No need to classify for long-term (chronic) hazard in categories Chronic 1, 2 or 3.’

(14)

In Section 4.1.3.5.2, point (a), the last sentence is replaced by the following:

‘The calculated toxicity may be used to assign that portion of the mixture a short-term (acute) hazard category which is then subsequently used in applying the summation method.’

(15)

In Section 4.1.3.5.2, point (b), the last sentence is replaced by the following:

‘The calculated equivalent toxicity may be used to assign that portion of the mixture a long-term (chronic) 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.’

(16)

Section 4.1.3.5.5.3.2 is replaced by the following:

‘The classification of mixtures for short-term (acute) hazards based on this summation of classified components is summarised in Table 4.1.1.’

(17)

In Section 4.1.3.5.5.3.2 the title of Table 4.1.1 is replaced by the following:

‘Classification of a mixture for short-term (acute) hazards based on summation of classified components’.

(18)

Section 4.1.3.5.5.4.5 is replaced by the following:

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

(19)

The title of Table 4.1.2 is replaced by the following:

‘Classification of a mixture for long-term (chronic) hazards, based on summation of the concentration of classified components’.

(20)

In Section 4.1.3.6.1, the first sentence is replaced by the following:

‘In the event that no useable information on short-term (acute) and/or long-term (chronic) aquatic hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed to one or more definitive hazard category(ies).’

(21)

In Section 4.1.4, Table 4.1.4 is replaced by the following:

‘Table 4.1.4

Label elements for hazardous to the aquatic environment

SHORT-TERM (ACUTE) AQUATIC HAZARD

 

Acute 1

GHS Pictogram

Image

Signal Word

Warning

Hazard Statement

H400: Very toxic to aquatic life

Precautionary Statement Prevention

P273

Precautionary Statement Response

P391

Precautionary Statement Storage

 

Precautionary Statement Disposal

P501


LONG-TERM (CHRONIC) AQUATIC HAZARD

 

Chronic 1

Chronic 2

Chronic 3

Chronic 4

GHS Pictograms

Image

Image

No pictogram is used

No pictogram is used

Signal Word

Warning

No signal word is used

No signal word is used

No signal word is used

Hazard Statement

H410: Very toxic to aquatic life with long lasting effects

H411: Toxic to aquatic life with long lasting effects

H412: Harmful to aquatic life with long lasting effects

H413: May cause long lasting harmful effects to aquatic life

Precautionary Statement Prevention

P273

P273

P273

P273

Precautionary Statement Response

P391

P391

 

 

Precautionary Statement Storage

 

 

 

 

Precautionary Statement Disposal

P501

P501

P501

P501’


(1)  Type G has no hazard communication elements assigned but should be considered for properties belonging to other hazard classes.

(2)  See the introduction to Annex IV for details on the use of square brackets.’

(3)  See the introduction to Annex IV for details on the use of square brackets.’

(4)  See the conditions for the use of Category 1 in paragraph (a) of Section 3.2.2.

(1)  Grading criteria are understood as described in Regulation (EC) No 440/2008.

(2)  Grading criteria are understood as described in Regulation (EC) No 440/2008.

(3)  Grading criteria are understood as described in Regulation (EC) No 440/2008.

(4)  If an ingredient is classified as both Skin Corrosion Sub-Category 1A, 1B, 1C or Category 1 and Serious Eye Damage (Category 1), its concentration is considered only once in the calculation.

(5)  Where a chemical is classified as skin corrosion Sub-Category 1A, 1B, 1C or Category 1, labelling for serious eye damage/eye irritation can be omitted as this information is already included in the hazard statement for skin corrosion Category 1 (H314).’


ANNEX II

In Annex II to Regulation (EC) No 1272/2008, in Part 2, Section 2.8 a new last paragraph is added:

‘Where a mixture is labelled in accordance with Section 2.4 or 2.5, the statement EUH208 may be omitted from the label for the substance concerned.’


ANNEX III

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

(1)

Point (b) is replaced by the following:

‘(b)

if the statement H314 “Causes severe skin burns and eye damage” is assigned, the statement H318 “Causes serious eye damage” may be omitted.’

(2)

The entry concerning code H314 in Table 1.2 is replaced by the following:

‘H314

Language

3.2 —

Skin corrosion/irritation, Hazard Category 1, Sub-Categories 1A, 1B, 1C

 

BG

Причинява тежки изгаряния на кожата и сериозно увреждане на очите.

 

ES

Provoca quemaduras graves en la piel y lesiones oculares graves.

 

CS

Způsobuje těžké poleptání kůže a poškození očí.

 

DA

Forårsager svære ætsninger af huden og øjenskader.

 

DE

Verursacht schwere Verätzungen der Haut und schwere Augenschäden.

 

ET

Põhjustab rasket nahasöövitust ja silmakahjustusi.

 

EL

Προκαλεί σοβαρά δερματικά εγκαύματα και οφθαλμικές βλάβες.

 

EN

Causes severe skin burns and eye damage.

 

FR

Provoque des brûlures de la peau et de graves lésions des yeux.

 

GA

Ina chúis le dónna tromchúiseacha craicinn agus le damáiste don tsúil.

 

HR

Uzrokuje teške opekline kože i ozljede oka.

 

IT

Provoca gravi ustioni cutanee e gravi lesioni oculari.

 

LV

Izraisa smagus ādas apdegumus un acu bojājumus.

 

LT

Smarkiai nudegina odą ir pažeidžia akis.

 

HU

Súlyos égési sérülést és szemkárosodást okoz.

 

MT

Jagħmel ħruq serju lill-ġilda u ħsara lill-għajnejn.

 

NL

Veroorzaakt ernstige brandwonden en oogletsel.

 

PL

Powoduje poważne oparzenia skóry oraz uszkodzenia oczu .

 

PT

Provoca queimaduras na pele e lesões oculares graves.

 

RO

Provoacă arsuri grave ale pielii şi lezarea ochilor.

 

SK

Spôsobuje vážne poleptanie kože a poškodenie očí.

 

SL

Povzroča hude opekline kože in poškodbe oči.

 

FI

Voimakkaasti ihoa syövyttävää ja silmiä vaurioittavaa.

 

SV

Orsakar allvarliga frätskador på hud och ögon.’

(3)

The entry concerning H318 in Table 1.2 is replaced by the following:

‘H318

Language

3.3 —

Serious eye damage/eye irritation, Hazard Category 1

 

BG

Предизвиква сериозно увреждане на очите.

 

ES

Provoca lesiones oculares graves.

 

CS

Způsobuje vážné poškození očí.

 

DA

Forårsager alvorlig øjenskade.

 

DE

Verursacht schwere Augenschäden.

 

ET

Põhjustab raskeid silmakahjustusi.

 

EL

Προκαλεί σοβαρή οφθαλμική βλάβη.

 

EN

Causes serious eye damage.

 

FR

Provoque de graves lésions des yeux.

 

GA

Ina chúis le damáiste tromchúiseach don tsúil.

 

HR

Uzrokuje teške ozljede oka.

 

IT

Provoca gravi lesioni oculari.

 

LV

Izraisa nopietnus acu bojājumus.

 

LT

Smarkiai pažeidžia akis.

 

HU

Súlyos szemkárosodást okoz.

 

MT

Jagħmel ħsara serja lill-għajnejn.

 

NL

Veroorzaakt ernstig oogletsel.

 

PL

Powoduje poważne uszkodzenie oczu.

 

PT

Provoca lesões oculares graves.

 

RO

Provoacă leziuni oculare grave.

 

SK

Spôsobuje vážne poškodenie očí.

 

SL

Povzroča hude poškodbe oči.

 

FI

Vaurioittaa vakavasti silmiä.

 

SV

Orsakar allvarliga ögonskador.’

(4)

The entry concerning H311 + H331 in Table 1.2 is replaced by the following:

‘H311 + H331

Language

3.1 —

Acute toxicity (dermal) and acute toxicity (inhalation), hazard category 3

 

BG

Токсичен при контакт с кожата или при вдишване

 

ES

Tóxico en contacto con la piel o si se inhala

 

CS

Toxický při styku s kůží a při vdechování

 

DA

Giftig ved hudkontakt eller indånding

 

DE

Giftig bei Hautkontakt oder Einatmen

 

ET

Nahale sattumisel või sissehingamisel mürgine

 

EL

Τοξικό σε επαφή με το δέρμα ή σε περίπτωση εισπνοής

 

EN

Toxic in contact with skin or if inhaled

 

FR

Toxique par contact cutané ou par inhalation

 

GA

Ábhar tocsaineach má theagmhaíonn leis an gcraiceann nó má ionanálaítear é

 

HR

Otrovno u dodiru s kožom ili ako se udiše

 

IT

Tossico a contatto con la pelle o se inalato

 

LV

Toksisks saskarē ar ādu vai ja iekļūst elpceļos

 

LT

Toksiška susilietus su oda arba įkvėpus

 

HU

Bőrrel érintkezve vagy belélegezve mérgező

 

MT

Tossika jekk tmiss mal-ġilda jew tittieħeb bin- nifs

 

NL

Giftig bij contact met de huid en bij inademing

 

PL

Działa toksycznie w kontakcie ze skórą lub w następstwie wdychania

 

PT

Tóxico em contacto com a pele ou por inalação

 

RO

Toxic în contact cu pielea sau prin inhalare

 

SK

Toxický pri styku s kožou alebo pri vdýchnutí

 

SL

Strupeno v stiku s kožo ali pri vdihavanju

 

FI

Myrkyllistä joutuessaan iholle tai hengitettynä

 

SV

Giftigt vid hudkontakt eller förtäring’

(5)

The entry concerning H302 + H312 in Table 1.2 is replaced by the following:

‘H302 + H312

Language

3.1 —

Acute toxicity (oral) and acute toxicity (dermal), hazard category 4

 

BG

Вреден при поглъщане или при контакт с кожата

 

ES

Nocivo en caso de ingestión o en contacto con la piel

 

CS

Zdraví škodlivý při požití a při styku s kůží

 

DA

Farlig ved indtagelse eller hudkontakt

 

DE

Gesundheitsschädlich bei Verschlucken oder Hautkontakt

 

ET

Allaneelamisel või nahale sattumisel kahjulik

 

EL

Επιβλαβές σε περίπτωση κατάποσης ή σε επαφή με το δέρμα

 

EN

Harmful if swallowed or in contact with skin

 

FR

Nocif en cas d'ingestion ou de contact cutané

 

GA

Ábhar dochrach má shlogtar é nó má theagmhaíonn leis an gcraiceann

 

HR

Štetno ako se proguta ili u dodiru s kožom

 

IT

Nocivo se ingerito o a contatto con la pelle

 

LV

Kaitīgs, ja norīts vai saskaras ar ādu

 

LT

Kenksminga prarijus arba susilietus su oda

 

HU

Lenyelve vagy bőrrel érintkezve ártalmas

 

MT

Tagħmel ħsara jekk tinbela' jew jekk tmiss mal- ġilda

 

NL

Schadelijk bij