02008R1272 — EN — 01.01.2020 — 014.002

---

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance) (OJ L 353 31.12.2008, p. 1)

Amended by:

		Official Journal
		No	page	date
►M1	COMMISSION REGULATION (EC) No 790/2009 of 10 August 2009	L 235	1	5.9.2009
►M2	COMMISSION REGULATION (EU) No 286/2011 of 10 March 2011	L 83	1	30.3.2011
M3	COMMISSION REGULATION (EU) No 618/2012 of 10 July 2012	L 179	3	11.7.2012
►M4	COMMISSION REGULATION (EU) No 487/2013 of 8 May 2013	L 149	1	1.6.2013
►M5	COUNCIL REGULATION (EU) No 517/2013 of 13 May 2013	L 158	1	10.6.2013
M6	COMMISSION REGULATION (EU) No 758/2013 of 7 August 2013	L 216	1	10.8.2013
►M7	COMMISSION REGULATION (EU) No 944/2013 of 2 October 2013	L 261	5	3.10.2013
►M8	COMMISSION REGULATION (EU) No 605/2014 of 5 June 2014	L 167	36	6.6.2014
M9	Amended by: COMMISSION REGULATION (EU) 2015/491 of 23 March 2015	L 78	12	24.3.2015
►M10	COMMISSION REGULATION (EU) No 1297/2014 of 5 December 2014	L 350	1	6.12.2014
►M11	COMMISSION REGULATION (EU) 2015/1221 of 24 July 2015	L 197	10	25.7.2015
►M12	COMMISSION REGULATION (EU) 2016/918 of 19 May 2016	L 156	1	14.6.2016
►M13	COMMISSION REGULATION (EU) 2016/1179 of 19 July 2016	L 195	11	20.7.2016
►M14	COMMISSION REGULATION (EU) 2017/542 of 22 March 2017	L 78	1	23.3.2017
►M15	COMMISSION REGULATION (EU) 2017/776 of 4 May 2017	L 116	1	5.5.2017
►M16	COMMISSION REGULATION (EU) 2018/669 of 16 April 2018	L 115	1	4.5.2018
M17	Notice concerning the classification of pitch, coal tar, high temperature as Aquatic Acute 1 and Aquatic Chronic 1 according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council  2018/C 239/03	C 239	3	9.7.2018
►M18	COMMISSION REGULATION (EU) 2018/1480 of 4 October 2018	L 251	1	5.10.2018
►M19	REGULATION (EU) 2019/1243 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019	L 198	241	25.7.2019
►M20	COMMISSION DELEGATED REGULATION (EU) 2020/11 of 29 October 2019	L 6	8	10.1.2020
►M21	COMMISSION DELEGATED REGULATION (EU) 2020/217 of 4 October 2019	L 44	1	18.2.2020

Corrected by:

►C1	Corrigendum, OJ L 016, 20.1.2011, p.  1 (1272/2008)
C2	Corrigendum, OJ L 138, 26.5.2011, p.  66 (286/2011)
►C3	Corrigendum, OJ L 349, 21.12.2016, p.  1 (1272/2008)
►C4	Corrigendum, OJ L 117, 3.5.2019, p.  8 (No 1272/2008)

---

▼B

REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 December 2008

on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

(Text with EEA relevance)

TITLE I

GENERAL ISSUES

Article 1

Purpose and scope

1.  The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:

2.  This Regulation shall not apply to the following:

3.  Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste ( 2 ) is not a substance, mixture or article within the meaning of Article 2 of this Regulation.

4.  Member States may allow for exemptions from this Regulation in specific cases for certain substances or mixtures, where necessary in the interests of defence.

5.  This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user:

6.  Save where Article 33 applies this Regulation shall not apply to the transport of dangerous goods by air, sea, road, rail or inland waterways.

Article 2

Definitions

For the purpose of this Regulation, the following definitions shall apply:

Article 3

Hazardous substances and mixtures and specification of hazard classes

A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.

Where, in Annex I, hazard classes are differentiated on the basis of the route of exposure or the nature of the effects, the substance or mixture shall be classified in accordance with such differentiation.

Article 4

General obligations to classify, label and package

1.  Manufacturers, importers and downstream users shall classify substances or mixtures in accordance with Title II before placing them on the market.

2.  Without prejudice to the requirements of paragraph 1, manufacturers, producers of articles and importers shall classify those substances not placed on the market in accordance with Title II where:

3.  If a substance is subject to harmonised classification and labelling in accordance with Title V through an entry in Part 3 of Annex VI, that substance shall be classified in accordance with that entry, and a classification of that substance in accordance with Title II shall not be performed for the hazard classes or differentiations covered by that entry.

However, where the substance also falls within one or more hazard classes or differentiations not covered by an entry in Part 3 of Annex VI, classification under Title II shall be carried out for those hazard classes or differentiations.

4.  Where a substance or mixture is classified as hazardous, suppliers shall ensure that the substance or mixture is labelled and packaged in accordance with Titles III and IV, before placing it on the market.

5.  In fulfilling their responsibilities under paragraph 4, distributors may use the classification for a substance or mixture derived in accordance with Title II by an actor in the supply chain.

6.  In fulfilling their responsibilities under paragraphs 1 and 4, downstream users may use the classification of a substance or mixture derived in accordance with Title II by an actor in the supply chain, provided that they do not change the composition of the substance or mixture.

7.  A mixture referred to in Part 2 of Annex II that contains any substance classified as hazardous shall not be placed on the market, unless it is labelled in accordance with Title III.

8.  For the purposes of this Regulation, the articles referred to in section 2.1 of Annex I shall be classified, labelled and packaged in accordance with the rules for substances and mixtures before being placed on the market.

9.  Suppliers in a supply chain shall cooperate to meet the requirements for classification, labelling and packaging in this Regulation.

10.  Substances and mixtures shall not be placed on the market unless they comply with this Regulation.

TITLE II

HAZARD CLASSIFICATION

CHAPTER 1

Identification and examination of information

Article 5

Identification and examination of available information on substances

1.  Manufacturers, importers and downstream users of a substance shall identify the relevant available information for the purposes of determining whether the substance entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following:

The information shall relate to the forms or physical states in which the substance is placed on the market and in which it can reasonably be expected to be used.

2.  Manufacturers, importers and downstream users shall examine the information referred to in paragraph 1 to ascertain whether it is adequate, reliable and scientifically valid for the purpose of the evaluation pursuant to Chapter 2 of this Title.

Article 6

Identification and examination of available information on mixtures

1.  Manufacturers, importers and downstream users of a mixture shall identify the relevant available information on the mixture itself or the substances contained in it for the purposes of determining whether the mixture entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following:

The information shall relate to the forms or physical states in which the mixture is placed on the market and, when relevant, in which it can reasonably be expected to be used.

2.  Subject to paragraphs 3 and 4, where the information referred to in paragraph 1 is available for the mixture itself, and the manufacturer, importer or downstream user has ascertained that information to be adequate and reliable and where applicable, scientifically valid, that manufacturer, importer or downstream user shall use that information for the purposes of the evaluation pursuant to Chapter 2 of this Title.

3.  For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’ and ‘reproductive toxicity’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1 and 3.7.3.1 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture.

Further, in cases where the available test data on the mixture itself demonstrate germ cell mutagenic, carcinogenic or toxic to reproduction effects which have not been identified from the information on the individual substances, those data shall also be taken into account.

4.  For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ‘biodegradation and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ hazard class referred to in sections 4.1.2.8 and 4.1.2.9 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture.

5.  Where no or inadequate test data on the mixture itself of the kind referred to in paragraph 1 are available, the manufacturer, importer or downstream user shall use other available information on individual substances and similar tested mixtures which may also be considered relevant for the purposes of determining whether the mixture is hazardous, provided that that manufacturer, importer or downstream user has ascertained that information to be adequate and reliable for the purpose of the evaluation pursuant to Article 9(4).

Article 7

Animal and human testing

1.  Where new tests are carried out for the purposes of this Regulation, tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where no other alternatives, which provide adequate reliability and quality of data, are possible.

2.  Tests on non-human primates shall be prohibited for the purposes of this Regulation.

3.  Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation.

Article 8

Generating new information for substances and mixtures

1.  For the purposes of determining whether a substance or a mixture entails a health or environmental hazard as set out in Annex I to this Regulation, the manufacturer, importer or downstream user may, provided that he has exhausted all other means of generating information including by applying the rules provided for in section 1 of Annex XI to Regulation (EC) No 1907/2006, perform new tests.

2.  For the purposes of determining whether a substance or a mixture entails any of the physical hazards referred to in Part 2 of Annex I, the manufacturer, importer or downstream user shall perform the tests required in that Part, unless there is adequate and reliable information already available.

3.  The tests referred to in paragraph 1 shall be conducted in accordance with one of the following methods:

4.  Where the manufacturer, importer or downstream user carries out new ecotoxicological or toxicological tests and analyses, these shall be carried out in compliance with Article 13(4) of Regulation (EC) No 1907/2006.

5.  Where new tests for physical hazards are carried out for the purposes of this Regulation, they shall be carried out, at the latest from 1 January 2014, in compliance with a relevant recognised quality system or by laboratories complying with a relevant recognised standard.

6.  Tests that are carried out for the purposes of this Regulation shall be carried out on the substance or on the mixture in the form(s) or physical state(s) in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used.

CHAPTER 2

Evaluation of hazard information and decision on classification

Article 9

Evaluation of hazard information for substances and mixtures

1.  Manufacturers, importers and downstream users of a substance or a mixture shall evaluate the information identified in accordance with Chapter 1 of this Title by applying to it the criteria for classification for each hazard class or differentiation in Parts 2 to 5 of Annex I, so as to ascertain the hazards associated with the substance or mixture.

2.  In evaluating available test data for a substance or a mixture which have been obtained from test methods other than those referred to in Article 8(3), manufacturers, importers and downstream users shall compare the test methods employed with those indicated in that Article in order to determine whether the use of those test methods affects the evaluation referred to in paragraph 1 of this Article.

3.  Where the criteria cannot be applied directly to available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006.

4.  Where only the information referred to in Article 6(5) is available, manufacturers, importers and downstream users shall apply the bridging principles referred to in section 1.1.3 and in each section of Parts 3 and 4 of Annex I for the purposes of the evaluation.

However, where that information permits the application neither of the bridging principles nor the principles for using expert judgement and weight of evidence determination as described in Part 1 of Annex I, manufacturers, importers and downstream users shall evaluate the information by applying the other method or methods described in each section of Parts 3 and 4 of Annex I.

5.  When evaluating the available information for the purposes of classification, the manufacturers, importers and downstream users shall consider the forms or physical states in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used.

Article 10

Concentration limits and M-factors for classification of substances and mixtures

1.  Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.

Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when the substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I.

In exceptional circumstances specific concentration limits may be set by the manufacturer, importer or downstream user where he has adequate, reliable and conclusive scientific information that a hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.

2.  M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, shall be established by manufacturers, importers and downstream users.

3.  Notwithstanding paragraph 1, specific concentration limits shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI.

4.  Notwithstanding paragraph 2, M-factors shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an M-factor is given in that Part.

However, where an M-factor is not given in Part 3 of Annex VI for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, an M-factor based on available data for the substance shall be set by the manufacturer, importer or downstream user. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, this M-factor shall be used.

5.  In setting the specific concentration limit or M-factor manufacturers, importers and downstream users shall take into account any specific concentration limits or M-factors for that substance which have been included in the classification and labelling inventory.

6.  Specific concentration limits set in accordance with paragraph 1 shall take precedence over the concentrations in the relevant sections of Part 2 of Annex I or the generic concentration limits for classification in the relevant sections of Parts 3, 4 and 5 of Annex I.

7.  The Agency shall provide further guidance for the application of paragraphs 1 and 2.

Article 11

Cut-off values

1.  Where a substance contains another substance, itself classified as hazardous, whether in the form of an identified impurity, additive or individual constituent, this shall be taken into account for the purposes of classification, if the concentration of the identified impurity, additive or individual constituent is equal to, or greater than, the applicable cut-off value in accordance with paragraph 3.

2.  Where a mixture contains a substance classified as hazardous, whether as a component or in the form of an identified impurity or additive, this information shall be taken into account for the purposes of classification, if the concentration of that substance is equal to or greater than its cut-off value in accordance with paragraph 3.

3.  The cut-off value referred to in paragraphs 1 and 2 shall be determined as set out in section 1.1.2.2 of Annex I.

Article 12

Specific cases requiring further evaluation

Where, as a result of the evaluation carried out pursuant to Article 9, the following properties or effects are identified, manufacturers, importers and downstream users shall take them into account for the purposes of classification:

Article 13

Decision to classify substances and mixtures

If the evaluation undertaken pursuant to Article 9 and Article 12 shows that the hazards associated with the substance or mixture meet the criteria for classification in one or more hazard classes or differentiations in Parts 2 to 5 of Annex I, manufacturers, importers and downstream users shall classify the substance or mixture in relation to the relevant hazard class or classes or differentiations by assigning the following:

Article 14

Specific rules for the classification of mixtures

1.  The classification of a mixture shall not be affected where the evaluation of the information indicates any of the following:

2.  A mixture need not be classified for explosive, oxidising, or flammable properties as referred to in Part 2 of Annex I provided that any of the following requirements are met:

▼M4 —————

▼B

Article 15

Review of classification for substances and mixtures

1.  Manufacturers, importers and downstream users shall take all reasonable steps available to them to make themselves aware of new scientific or technical information that may affect the classification of the substances or mixtures they place on the market. When a manufacturer, importer or downstream user becomes aware of such information which he considers to be adequate and reliable, that manufacturer, importer or downstream user shall without undue delay carry out a new evaluation in accordance with this Chapter.

2.  Where the manufacturer, importer or downstream user introduces a change to a mixture that has been classified as hazardous, that manufacturer, importer or downstream user shall carry out a new evaluation in accordance with this Chapter where the change is either of the following:

3.  A new evaluation in accordance with paragraphs 1 and 2 shall not be required if there is valid scientific justification that this will not result in a change of classification.

4.  Manufacturers, importers and downstream users shall adapt the classification of the substance or the mixture in accordance with the results of the new evaluation except where there are harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI.

5.  For paragraphs 1 to 4 of this Article, when the substance or mixture concerned is within the scope of Directive 91/414/EEC or Directive 98/8/EC, the requirements of those Directives shall also apply.

Article 16

Classification of substances included in the classification and labelling inventory

1.  Manufacturers and importers may classify a substance differently from the classification already included in the classification and labelling inventory, provided they submit the reasons for the classification to the Agency together with the notification in accordance with Article 40.

2.  Paragraph 1 shall not apply if the classification included in the classification and labelling inventory is a harmonised classification included in Part 3 of Annex VI.

TITLE III

HAZARD COMMUNICATION IN THE FORM OF LABELLING

CHAPTER 1

Content of the label

Article 17

General rules

1.  A substance or mixture classified as hazardous and contained in packaging shall bear a label including the following elements:

2.  The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.

Suppliers may use more languages on their labels than those required by the Member States, provided that the same details appear in all languages used.

Article 18

Product identifiers

1.  The label shall include details permitting the identification of the substance or mixture (hereinafter referred to as ‘product identifiers’).

The term used for identification of the substance or mixture shall be the same as that used in the safety data sheet drawn up in accordance with Article 31 of Regulation (EC) No 1907/2006 (hereinafter referred to as ‘safety data sheet’), without prejudice to Article 17(2) of this Regulation.

2.  The product identifier for a substance shall consist of at least the following:

Where the name in the IUPAC nomenclature exceeds 100 characters, one of the other names (usual name, trade name, abbreviation) referred to in section 2.1.2 of Annex VI to Regulation (EC) No 1907/2006 may be used provided that the notification in accordance with Article 40 includes both the name set out in the IUPAC Nomenclature and the other name used.

3.  The product identifier for a mixture shall consist of both of the following:

Where, in the case referred to in (b), that requirement leads to the provision of multiple chemical names, a maximum of four chemical names shall suffice, unless more than four names are needed to reflect the nature and the severity of the hazards.

The chemical names selected shall identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding hazard statements.

Article 19

Hazard pictograms

1.  The label shall include the relevant hazard pictogram(s), intended to convey specific information on the hazard concerned.

2.  Subject to Article 33, hazard pictograms shall fulfil the requirements laid down in section 1.2.1 of Annex I and in Annex V.

3.  The hazard pictogram relevant for each specific classification is set out in the tables indicating the label elements required for each hazard class in Annex I.

Article 20

Signal words

1.  The label shall include the relevant signal word in accordance with the classification of the hazardous substance or mixture.

2.  The signal word relevant for each specific classification is set out in the tables indicating the label elements required for each hazard class in Parts 2 to 5 of Annex I.

3.  Where the signal word ‘Danger’ is used on the label, the signal word ‘Warning’ shall not appear on the label.

Article 21

Hazard statements

1.  The label shall include the relevant hazard statements in accordance with the classification of the hazardous substance or mixture.

2.  The hazard statements relevant for each classification are set out in the tables indicating the label elements required for each hazard class in Parts 2 to 5 of Annex I.

3.  Where a substance is included in Part 3 of Annex VI, the hazard statement relevant for each specific classification covered by the entry in that Part shall be used on the label, together with the hazard statements referred to in paragraph 2 for any other classification not covered by that entry.

4.  The hazard statements shall be worded in accordance with Annex III.

Article 22

Precautionary statements

1.  The label shall include the relevant precautionary statements.

2.  The precautionary statements shall be selected from those set out in the tables in Parts 2 to 5 of Annex I indicating the label elements for each hazard class.

3.  The precautionary statements shall be selected in accordance with the criteria laid down in Part 1 of Annex IV taking into account the hazard statements and the intended or identified use or uses of the substance or the mixture.

4.  The precautionary statements shall be worded in accordance with Part 2 of Annex IV.

Article 23

Derogations from labelling requirements for special cases

The specific provisions on labelling laid down in section 1.3 of Annex I shall apply in respect of the following:

▼M12

▼B

Article 24

Request for use of an alternative chemical name

1.  The manufacturer, importer or downstream user of a substance in a mixture may submit a request to the Agency to use an alternative chemical name which refers to that substance in a mixture either by means of a name that identifies the most important functional chemical groups or by means of an alternative designation, where the substance meets the criteria set out in Part 1 of Annex I and where he can demonstrate that disclosure on the label or in the safety data sheet of the chemical identity of that substance puts the confidential nature of his business, in particular his intellectual property rights, at risk.

2.  Any request referred to in paragraph 1 of this Article shall be made in the format referred to in Article 111 of Regulation (EC) No 1907/2006 and shall be accompanied by a fee.

The level of the fees shall be determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2) of this Regulation.

A reduced fee shall be set for SMEs.

3.  The Agency may require further information from the manufacturer, importer or downstream user making the request if such information is necessary to take a decision. If the Agency raises no objection within six weeks of the request or the receipt of further required information, the use of the requested name shall be deemed to be allowed.

4.  If the Agency does not accept the request, the practical arrangements referred to in Article 118(3) of Regulation (EC) No 1907/2006 shall apply.

5.  The Agency shall inform competent authorities of the outcome of the request in accordance with paragraph 3 or 4 and provide them with the information submitted by the manufacturer, importer or downstream user.

6.  Where new information shows that an alternative chemical name used does not provide sufficient information for necessary health and safety precautions to be taken at the workplace and to ensure that risks from handling the mixture can be controlled, the Agency shall review its decision on the use of that alternative chemical name. The Agency may withdraw its decision or amend it by a decision specifying which alternative chemical name is allowed to be used. If the Agency withdraws or amends its decision, the practical arrangements referred to in Article 118(3) of Regulation (EC) No 1907/2006 shall apply.

7.  Where the use of an alternative chemical name has been allowed, but the classification of the substance in a mixture for which the alternative name is used no longer meets the criteria set out in section 1.4.1 of Annex I, the supplier of that substance in a mixture shall use the product identifier for the substance in accordance with Article 18 on the label and in the safety data sheet, and not the alternative chemical name.

8.  For substances, whether on their own or in a mixture, where a justification in accordance with Article 10(a)(xi) of Regulation (EC) No 1907/2006 regarding information referred to in Article 119(2)(f) or (g) of that Regulation has been accepted as valid by the Agency, the manufacturer, importer or downstream user may use on the label and in the safety data sheet a name that will be made publicly available over the Internet. For those substances in a mixture for which Article 119(2)(f) or (g) of that Regulation no longer applies, the manufacturer, importer or downstream user may submit a request to the Agency to use an alternative chemical name as provided for in paragraph 1 of this Article.

9.  Where the supplier of a mixture, before 1 June 2015, has demonstrated under Article 15 of Directive 1999/45/EC that the disclosure of the chemical identity of a substance in a mixture puts the confidential nature of his business at risk, he can continue to use the agreed alternative name for the purposes of this Regulation.

Article 25

Supplemental information on the label

1.  Statements shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous has the physical properties or health properties referred to in sections 1.1 and 1.2 of Annex II.

The statements shall be worded in accordance with sections 1.1 and 1.2 of Annex II and Part 2 of Annex III.

Where a substance is included in Part 3 of Annex VI, any supplemental hazard statements given therein for the substance shall be included in the supplemental information on the label.

2.  A statement shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of Directive 91/414/EEC.

The statement shall be worded in accordance with Part 4 of Annex II and Part 3 of Annex III to this Regulation.

3.  The supplier may include supplemental information in the section for supplemental information on the label other than that referred to in paragraphs 1 and 2, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1) (a) to (g) and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements.

4.  Statements such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’, ‘ecological’ or any other statements indicating that the substance or mixture is not hazardous or any other statements that are inconsistent with the classification of that substance or mixture shall not appear on the label or packaging of any substance or mixture.

▼M2 —————

▼B

6.  Where a mixture contains any substance classified as hazardous, it shall be labelled in accordance with Part 2 of Annex II.

The statements shall be worded in accordance with Part 3 of Annex III and shall be placed in the supplemental information section of the label.

The label shall also include the product identifier referred to in Article 18 and the name, address and telephone number of the supplier of the mixture.

▼M20

7.  Where under Annex VIII the submitter creates a unique formula identifier, it shall be included in the supplemental information on the label in accordance with the provisions of Section 5 of Part A of that Annex.

▼B

Article 26

Principles of precedence for hazard pictograms

1.  Where the classification of a substance or mixture would result in more than one hazard pictogram on the label, the following rules of precedence shall apply to reduce the number of hazard pictograms required:

▼M2

▼B

2.  Where the classification of a substance or mixture would result in more than one hazard pictogram for the same hazard class the label shall include the hazard pictogram corresponding to the most severe hazard category for each hazard class concerned.

For substances that are included in Part 3 of Annex VI and also subject to classification pursuant to Title II, the label shall include the hazard pictogram corresponding to the most severe hazard category for each relevant hazard class.

Article 27

Principles of precedence for hazard statements

If a substance or mixture is classified within several hazard classes or differentiations of a hazard class, all hazard statements resulting from the classification shall appear on the label, unless there is evident duplication or redundancy.

Article 28

Principles of precedence for precautionary statements

1.  Where the selection of the precautionary statements results in certain precautionary statements being clearly redundant or unnecessary given the specific substance, mixture or packaging, such statements shall be omitted from the label.

2.  Where the substance or mixture is supplied to the general public, one precautionary statement addressing the disposal of that substance or mixture as well as the disposal of packaging shall appear on the label, unless not required under Article 22.

In all other cases, a precautionary statement addressing disposal shall not be required, where it is clear that the disposal of the substance or mixture or the packaging does not present a hazard to human health or the environment.

3.  Not more than six precautionary statements shall appear on the label, unless necessary to reflect the nature and the severity of the hazards.

Article 29

Exemptions from labelling and packaging requirements

1.  Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements of Article 31 for a label in the languages of the Member State in which the substance or mixture is placed on the market, the label elements in accordance with the first subparagraph of Article 17(2) shall be provided in accordance with section 1.5.1 of Annex I.

2.  If the full label information cannot be provided in the way specified in paragraph 1 the label information may be reduced in accordance with section 1.5.2 of Annex I.

3.  When a hazardous substance or mixture referred to in Part 5 of Annex II is supplied to the general public without packaging it shall be accompanied by a copy of the label elements in accordance with Article 17.

4.  For certain mixtures classified as hazardous to the environment, exemptions to certain provisions on environmental labelling or specific provisions in relation to environmental labelling may be determined in accordance with the procedure referred to in Article 53, where it can be demonstrated that there would be a reduction in the environmental impact. Such exemptions or specific provisions are defined in Part 2 of Annex II.

▼M20

4a.  Where under Annex VIII the submitter creates a unique formula identifier, the submitter may, instead of including it in the supplemental information on the label, opt to show it in another way permitted by Section 5 of Part A of that Annex.

▼B

5.  The Commission may request the Agency to prepare and submit to it further draft exemptions from labelling and packaging requirements.

Article 30

Updating information on labels

1.  The supplier shall ensure that the label is updated, without undue delay, following any change to the classification and labelling of that substance or mixture, where the new hazard is more severe or where new supplemental labelling elements are required under Article 25, taking into account the nature of the change as regards the protection of human health and the environment. Suppliers shall cooperate in accordance with Article 4(9) to complete the changes to the labelling without undue delay.

2.  Where labelling changes are required other than those referred to in paragraph 1, the supplier shall ensure that the label is updated within 18 months.

3.  The supplier of a substance or a mixture within the scope of Directives 91/414/EEC or 98/8/EC shall update the label in accordance with those Directives.

CHAPTER 2

Application of labels

Article 31

General rules for the application of labels

1.  Labels shall be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and shall be readable horizontally when the package is set down normally.

2.  The colour and presentation of any label shall be such that the hazard pictogram stands out clearly.

3.  The label elements referred to in Article 17(1) shall be clearly and indelibly marked. They shall stand out clearly from the background and be of such size and spacing as to be easily read.

4.  The shape, colour and the size of a hazard pictogram as well as the dimensions of the label shall be as set out in section 1.2.1 of Annex I.

5.  A label shall not be required when the label elements referred to in Article 17(1) are shown clearly on the packaging itself. In such cases, the requirements of this Chapter applicable to a label shall be applied to the information shown on the packaging.

Article 32

Location of information on the label

1.  The hazard pictograms, signal word, hazard statements and precautionary statements shall be located together on the label.

2.  The supplier may decide the order of the hazard statements on the label. However, subject to paragraph 4, all hazard statements shall be grouped on the label by language.

The supplier may decide the order of the precautionary statements on the label. However, subject to paragraph 4, all precautionary statements shall be grouped on the label by language.

3.  Groups of hazard statements and groups of precautionary statements referred to in paragraph 2 shall be located together on the label by language.

4.  The supplemental information shall be placed in the supplemental information section referred to in Article 25, and shall be located with the other label elements specified in Article 17(1)(a) to (g).

5.  In addition to its use in hazard pictograms, colour may be used on other areas of the label to implement special labelling requirements.

6.  Label elements resulting from the requirements provided for in other Community acts shall be placed in the section for supplemental information on the label referred to in Article 25.

Article 33

Specific rules for labelling of outer packaging, inner packaging and single packaging

1.  Where a package consists of an outer and an inner packaging, together with any intermediate packaging, and the outer packaging meets labelling provisions in accordance with the rules on the transport of dangerous goods, the inner and any intermediate packaging shall be labelled in accordance with this Regulation. The outer packaging may also be labelled in accordance with this Regulation. Where the hazard pictogram(s) required by this Regulation relate to the same hazard as in the rules for the transport of dangerous goods, the hazard pictogram(s) required by this Regulation need not appear on the outer packaging.

2.  Where the outer packaging of a package is not required to meet labelling provisions in accordance with rules on the transport of dangerous goods, both the outer and any inner packaging, including any intermediate packaging, shall be labelled in accordance with this Regulation. However, if the outer packaging permits the inner or intermediate packaging labelling to be clearly seen, the outer packaging need not be labelled.

3.  Single packages that meet the labelling provisions in accordance with the rules on the transport of dangerous goods shall be labelled both in accordance with this Regulation and the rules on the transport of dangerous goods. Where the hazard pictogram(s) required by this Regulation relate to the same hazard as in rules on the transport of dangerous goods, the hazard pictogram(s) required by this Regulation need not appear.

Article 34

Report on communication on safe use of chemicals

1.  By 20 January 2012, the Agency shall carry out a study on the communication of information to the general public on the safe use of substances and mixtures and the potential need for additional information on labels. This study shall be carried out in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice.

2.  Without prejudice to the labelling rules provided for in this Title, the Commission shall, on the basis of the study referred to in paragraph 1, submit a report to the European Parliament and the Council and, if justified, present a legislative proposal to amend this Regulation.

TITLE IV

PACKAGING

Article 35

Packaging

1.  Packaging containing hazardous substances or mixtures shall satisfy the following requirements:

2.  Packaging containing a hazardous substance or a mixture supplied to the general public shall not have either a shape or design likely to attract or arouse the active curiosity of children or to mislead consumers, or have a similar presentation or a design used for foodstuff or animal feeding stuff or medicinal or cosmetic products, which would mislead consumers.

Where the packaging contains a substance or mixture which meets the requirements in section 3.1.1 of Annex II it shall have a child-resistant fastening in accordance with sections 3.1.2, 3.1.3 and 3.1.4.2 of Annex II.

Where the packaging contains a substance or mixture which meets the requirements in section 3.2.1 of Annex II it shall bear a tactile warning of danger in accordance with section 3.2.2 of Annex II.

▼M10

Where a liquid consumer laundry detergent, as defined in Article 2(1a) of Regulation (EC) No 648/2004 of the European Parliament and of the Council ( 3 ), is contained in a soluble packaging for single use, the additional requirements of section 3.3 of Annex II shall apply.

▼B

3.  The packaging of substances and mixtures shall be deemed to satisfy the requirements of paragraph 1(a), (b) and (c) if it complies with the requirements of the rules on the transport of dangerous goods by air, sea, road, rail or inland waterways.

TITLE V

HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES AND THE CLASSIFICATION AND LABELLING INVENTORY

CHAPTER 1

Establishing harmonised classification and labelling of substances

Article 36

Harmonisation of classification and labelling of substances

1.  A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37:

2.  A substance that is an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC shall normally be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37, paragraphs 1, 4, 5 and 6 shall apply.

3.  Where a substance fulfils the criteria for other hazard classes or differentiations than those referred to in paragraph 1 and does not fall under paragraph 2, a harmonised classification and labelling in accordance with Article 37 may also be added to Annex VI on a case-by-case basis, if justification is provided demonstrating the need for such action at Community level.

Article 37

Procedure for harmonisation of classification and labelling of substances

1.  A competent authority may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits or M-factors, or a proposal for a revision thereof.

The proposal shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.

2.  A manufacturer, importer or downstream user of a substance may submit to the Agency a proposal for harmonised classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, provided that there is no entry in Part 3 of Annex VI for such a substance in relation to the hazard class or differentiation covered by that proposal.

The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.

3.  Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of a substance in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2).

4.  The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission.

▼M19

5.  The Commission shall without undue delay adopt delegated acts in accordance with Article 53a, where it finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, to amend Annex VI by inclusion of that substance together with the relevant classification and labelling elements in Table 3.1 of Part 3 of Annex VI and, where appropriate, the specific concentration limits or M-factors.

A corresponding entry shall be included in Table 3.2 of Part 3 of Annex VI subject to the same conditions, until 31 May 2015.

Where, in the case of harmonisation of classification and labelling of substances, imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.

▼B

6.  Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the competent authority in one of the Member States in which the substance is placed on the market.

Article 38

Content of opinions and decisions for harmonised classification and labelling in Part 3 of Annex VI; accessibility of information

1.  Any opinion referred to in Article 37(4) and any decision according to Article 37(5) shall at least specify for each substance:

2.  When making publicly available an opinion or a decision as referred to in Article 37(4) and (5) of this Regulation, Article 118(2) and Article 119 of Regulation (EC) No 1907/2006 shall apply.

CHAPTER 2

Classification and labelling inventory

Article 39

Scope

This Chapter shall apply to:

Article 40

Obligation to notify the Agency

1.  Any manufacturer or importer, or group of manufacturers or importers (hereinafter referred to as ‘the notifier(s)’), who places on the market a substance referred to in Article 39, shall notify to the Agency the following information in order for it to be included in the inventory referred to in Article 42:

The information referred to in (a) to (f) shall not be notified, if it has been submitted to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006, or if it has already been notified by that notifier.

The notifier shall submit this information in the format specified pursuant to Article 111 of Regulation (EC) No 1907/2006.

2.  The information listed in paragraph 1 shall be updated and notified to the Agency by the notifier(s) concerned when, pursuant to the review in Article 15(1), a decision to change the classification and labelling of the substance has been taken.

3.  Substances placed on the market on or after 1 December 2010 shall be notified in accordance with paragraph 1 within one month after their placing on the market.

However, substances placed on the market before 1 December 2010 may be notified in accordance with paragraph 1 before that date.

Article 41

Agreed entries

Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly.

Article 42

The classification and labelling inventory

1.  The Agency shall establish and maintain a classification and labelling inventory in the form of a database.

The information notified pursuant to Article 40(1) shall be included in the inventory, as well as information submitted as part of registrations under Regulation (EC) No 1907/2006.

Information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006 shall be publicly accessible. The Agency shall grant access to the other information on each substance in the inventory to the notifiers and registrants who have submitted information on that substance in accordance with Article 29(1) of Regulation (EC) No 1907/2006. It shall grant access to such information to other parties subject to Article 118 of that Regulation.

2.  The Agency shall update the inventory when it receives updated information in accordance with Article 40(2) or Article 41.

3.  In addition to the information referred to in paragraph 1, the Agency shall, where applicable, include the following information in each entry:

The information referred to in (a) shall be updated where a decision is taken in accordance with Article 37(5).

TITLE VI

COMPETENT AUTHORITIES AND ENFORCEMENT

Article 43

Appointment of competent authorities and enforcement authorities and cooperation between authorities

Member States shall appoint the competent authority or competent authorities responsible for proposals for harmonised classification and labelling and the authorities responsible for the enforcement of the obligations set out in this Regulation.

The competent authorities and the authorities responsible for enforcement shall cooperate with each other in the performance of their tasks under this Regulation and shall give the corresponding authorities of other Member States all necessary and useful support to this end.

Article 44

Helpdesk

Member States shall establish national helpdesks to provide advice to manufacturers, importers, distributors, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation.

Article 45

Appointment of bodies responsible for receiving information relating to emergency health response

1.  Member States shall appoint a body or bodies responsible for receiving information relevant, in particular, for formulating preventative and curative measures, in particular in the event of emergency health response, from importers and downstream users placing mixtures on the market. This information shall include the chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects, including the chemical identity of substances in mixtures for which a request for use of an alternative chemical name has been accepted by the Agency, in accordance with Article 24.

2.  The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:

The information shall not be used for other purposes.

3.  The appointed bodies shall have at their disposal all the information required from the importers and downstream users responsible for marketing to carry out the tasks for which they are responsible.

▼M19

4.  The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Annex VIII to further harmonise the information relating to emergency health response and preventative measures, following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT).

▼B

Article 46

Enforcement and reporting

1.  Member States shall take all necessary measures, including maintaining a system of official controls, to ensure that substances and mixtures are not placed on the market, unless they have been classified, labelled, notified and packaged in accordance with this Regulation.

2.  Member States shall submit a report to the Agency every five years by 1 July on the results of the official controls, and other enforcement measures taken. The first report shall be submitted by 20 January 2012. The Agency shall make those reports available to the Commission, which shall take them into account for its report under Article 117 of Regulation (EC) No 1907/2006.

3.  The Forum referred to in Article 76(1)(f) of Regulation (EC) No 1907/2006 shall undertake the tasks specified in Article 77(4)(a) to (g) of Regulation (EC) No 1907/2006 concerning enforcement of this Regulation.

Article 47

Penalties for non-compliance

Member States shall introduce penalties for non-compliance with this Regulation and shall take all measures necessary to ensure that this Regulation is applied. The penalties must be effective, proportionate and dissuasive. Member States shall notify the Commission of the provisions for penalties by 20 June 2010 and shall notify it without delay of any subsequent amendment affecting them.

TITLE VII

COMMON AND FINAL PROVISIONS

Article 48

Advertisement

1.  Any advertisement for a substance classified as hazardous shall mention the hazard classes or hazard categories concerned.

2.  Any advertisement for a mixture classified as hazardous or covered by Article 25(6) which allows a member of the general public to conclude a contract for purchase without first having sight of the label shall mention the type or types of hazard indicated on the label.

The first subparagraph shall be without prejudice to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts ( 4 ).

Article 49

Obligation to maintain information and requests for information

1.  The supplier shall assemble and keep available all the information used by that supplier for the purposes of classification and labelling under this Regulation for a period of at least 10 years after the substance or the mixture was last supplied by that supplier.

The supplier shall keep this information together with the information required in Article 36 of Regulation (EC) No 1907/2006.

2.  In the event of a supplier ceasing activity, or transferring part or all of his operations to a third party, the party responsible for liquidating the supplier's undertaking or assuming responsibility for the placing on the market of the substance or mixture concerned shall be bound by the obligation in paragraph 1 in place of the supplier.

3.  The competent authority or the enforcement authorities of a Member State in which a supplier is established or the Agency may require the supplier to submit to it any information referred to in the first subparagraph of paragraph 1.

However, where that information is available to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006 or a notification pursuant to Article 40 of this Regulation, the Agency shall use that information and the authority shall address itself to the Agency.

Article 50

Tasks of the Agency

1.  The Agency shall provide the Member States and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with this Regulation.

2.  The Secretariat of the Agency shall:

Article 51

Free movement clause

On grounds relating to the classification, labelling or packaging of substances and mixtures within the meaning of this Regulation, Member States shall not prohibit, restrict or impede the placing on the market of substances or mixtures which comply with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation.

Article 52

Safeguard clause

1.  Where a Member State has justifiable grounds for believing that a substance or a mixture, although satisfying the requirements of this Regulation, constitutes a serious risk to human health or the environment due to reasons of classification, labelling or packaging, it may take appropriate provisional measures. The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving the reasons for its decision.

2.  Within 60 days of receipt of the information from the Member State, the Commission shall in accordance with the regulatory procedure referred to in Article 54(2) either authorise the provisional measure for a time period defined in the decision or require the Member State to revoke the provisional measure.

3.  In the case of an authorisation of a provisional measure related to classification or labelling of a substance as referred to in paragraph 2, the competent authority of the Member State concerned shall in accordance with the procedure laid down in Article 37 submit a proposal to the Agency for harmonised classification and labelling, within three months of the date of the Commission decision.

Article 53

Adaptations to technical and scientific progress

▼M19

1.  The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases.

Where imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.

▼B

2.  Member States and the Commission shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances at the level of the UN.

▼M19

Article 53a

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The power to adopt delegated acts referred to in Article 37(5), Article 45(4) and Article 53(1) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.  The delegation of power referred to in Articles 37(5), Article 45(4) and Article 53(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making ( 5 ).

5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.  A delegated act adopted pursuant to Article 37(5), Article 45(4) and Article 53(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 53b

Urgency procedure

1.  Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.

2.  Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 53a(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.

Article 53c

Separate delegated acts for different delegated powers

The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation.

▼B

Article 54

Committee procedure

1.  The Commission shall be assisted by the Committee instituted by Article 133 of Regulation (EC) No 1907/2006.

2.  Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5 (6) of Decision 1999/468/EC shall be set at three months.

▼M19 —————

▼B

Article 55

Amendments to Directive 67/548/EEC

Directive 67/548/EEC shall be amended as follows:

Article 56

Amendments to Directive 1999/45/EC

Directive 1999/45/EC shall be amended as follows:

Article 57

Amendments to Regulation (EC) No 1907/2006 from the entry into force of this Regulation

Regulation (EC) No 1907/2006 shall be amended as from the entry into force of this Regulation as follows:

Article 58

Amendments to Regulation (EC) No 1907/2006 from 1 December 2010

Regulation (EC) No 1907/2006 shall be amended from 1 December 2010 as follows:

Article 59

Amendments to Regulation (EC) No 1907/2006 from 1 June 2015

Regulation (EC) No 1907/2006 shall be amended from 1 June 2015 as follows:

Article 60

Repeal

Directive 67/548/EEC and Directive 1999/45/EC shall be repealed with effect from 1 June 2015.

Article 61

Transitional provisions

1.  Until 1 December 2010, substances shall be classified, labelled and packaged in accordance with Directive 67/548/EEC.

Until 1 June 2015, mixtures shall be classified, labelled and packaged in accordance with Directive 1999/45/EC.

2.  By way of derogation from the second subparagraph of Article 62 of this Regulation and in addition to the requirements of paragraph 1 of this Article, substances and mixtures may, before 1 December 2010 and 1 June 2015 respectively, be classified, labelled and packaged in accordance with this Regulation. In that case, the provisions on labelling and packaging in Directives 67/548/EEC and 1999/45/EC shall not apply.

3.  From 1 December 2010 until 1 June 2015, substances shall be classified in accordance with both Directive 67/548/EEC and this Regulation. They shall be labelled and packaged in accordance with this Regulation.

4.  By way of derogation from the second subparagraph of Article 62 of this Regulation, substances classified, labelled and packaged in accordance with Directive 67/548/EEC and already placed on the market before 1 December 2010, are not required to be relabelled and repackaged in accordance with this Regulation until 1 December 2012.

By way of derogation from the second subparagraph of Article 62 of this Regulation, mixtures classified, labelled and packaged in accordance with Directive 1999/45/EC and already placed on the market before 1 June 2015 are not required to be relabelled and repackaged in accordance with this Regulation until 1 June 2017.

5.  Where a substance or mixture has been classified in accordance with Directive 67/548/EEC or 1999/45/EC before 1 December 2010 or 1 June 2015 respectively, manufacturers, importers and downstream users may amend the classification of the substance or mixture using the conversion table in Annex VII to this Regulation.

6.  Until 1 December 2011 a Member State may maintain any existing and more stringent classification and labelling of substances entered into Part 3 of Annex VI to this Regulation, provided that these classifications and labelling elements have been notified to the Commission in accordance with the safeguard clause in Directive 67/548/EEC before 20 January 2009 and that the Member State submits a proposal for harmonised classification and labelling containing these classifications and labelling elements to the Agency in accordance with Article 37(1) of this Regulation by 1 June 2009.

It is a precondition that a decision on the proposed classification and labelling by the Commission in accordance with the safeguard clause of Directive 67/548/EEC has not yet been taken before 20 January 2009.

If the proposed harmonised classification and labelling submitted under the first subparagraph is not included or is included in an amended form in Part 3 of Annex VI in accordance with Article 37(5), the exemption in the first subparagraph of this paragraph is no longer valid.

Article 62

Entry into force

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

Titles II, III and IV shall apply in respect of substances from 1 December 2010 and in respect of mixtures from 1 June 2015.

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

---

ANNEX I

CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES

This annex sets out the criteria for classification in hazard classes and in their differentiations and sets out additional provisions on how the criteria may be met.

1.   PART 1: GENERAL PRINCIPLES FOR CLASSIFICATION AND LABELLING

1.0.   Definitions

Gas means a substance which:

Liquid means a substance or mixture which:

Solid means a substance or mixture which does not meet the definitions of liquid or gas.

1.1.   Classification of substances and mixtures

1.1.0.   Cooperation to meet the requirements in this Regulation

Suppliers in a supply chain shall cooperate to meet the requirements for classification, labelling and packaging set out in this Regulation.

Suppliers in an industry sector may cooperate to manage the transitional arrangements in Article 61 for substances and mixtures placed on the market.

Suppliers in an industry sector may cooperate through formation of a network or by other means to share data and expertise when classifying substances and mixtures in accordance with Title II of this Regulation. In these circumstances suppliers in an industry sector shall document fully the basis on which classification decisions are made and shall make available to the competent authorities and, on request, to the relevant enforcement authorities the documentation, together with the data and information on which classifications are based. However, where suppliers in an industry sector cooperate in this way, each supplier shall remain fully responsible for the classification, labelling and packaging of substances and mixtures he places on the market, and for meeting any other requirements of this Regulation.

The network may also be used to exchange information and best practices with a view to simplifying fulfilment of the notification obligations.

1.1.1.   The role and application of expert judgement and weight of evidence determination

1.1.2.   Specific concentration limits, M-factors and generic cut-off values

1.1.2.2.   Cut-off values

▼M2

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.

▼B

1.1.3.   Bridging principles for the classification of mixtures where test data are not available for the complete mixture

Where the mixture itself has not been tested to determine its hazardous properties, but there are sufficient data on similar tested mixtures and individual hazardous ingredient substances to adequately characterise the hazards of the mixture, these data shall be used in accordance with the following bridging rules referred to in Article 9(4) for each individual hazard class in Part 3 and Part 4 of this Annex, subject to any specific provisions for mixtures in each hazard class.

1.1.3.1.   Dilution

►M2  If a tested mixture  ◄ is diluted with a substance (diluent) which has an equivalent or lower hazard category classification than the least hazardous original ingredient substance and which is not expected to affect the hazard classification of other ingredient substances, then one of the following shall be applied:

▼M2

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.

▼M12

1.1.3.4.   Interpolation within one hazard category

▼M2

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.

▼B

1.1.3.5.   Substantially similar mixtures

Given the following:

▼M2

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

▼B

1.1.3.6.   Review of classification where the composition of a mixture has changed

The following variations in initial concentration are defined for the application of Article 15(2)(a):

1.1.3.7.   Aerosols

In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.4, 3.8 and 3.9, an aerosol form of a mixture shall be classified in the same hazard category as the non-aerosolised form of the mixture, provided that the added propellant does not affect the hazardous properties of the mixture upon spraying and scientific evidence is available demonstrating that the aerosolised form is not more hazardous than the nonaerosolised form.

▼M2

1.2.   Labelling

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

1.2.1.1.

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

1.2.1.2.

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

1.2.1.3.

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

1.2.1.4.

The dimensions of the label and of each pictogram shall be as follows: Table 1.3 Minimum dimensions of labels and pictograms Capacity of the package Dimensions of the label (in millimetres) for the information required by Article 17 Dimensions of each pictogram (in millimetres) Not exceeding 3 litres: If possible, at least 52 × 74 Not smaller than 10 × 10 If possible, at least 16 × 16 Greater than 3 litres but not exceeding 50 litres: At least 74 × 105 At least 23 × 23 Greater than 50 litres but not exceeding 500 litres: At least 105 × 148 At least 32 × 32 Greater than 500 litres: At least 148 × 210 At least 46 × 46

▼B

1.3.   Derogations from labelling requirements for special cases

In accordance with Article 23 the following derogations shall apply:

1.3.1.   Transportable gas cylinders

For transportable gas cylinders, one of the following shall be permitted to be used for gas cylinders with a water capacity of less than or equal to 150 litres:

1.3.2.   Gas containers intended for propane, butane or liquefied petroleum gas (LPG)

1.3.3.   Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard

With regard to the application of section 3.10.4, substances or mixtures classified in accordance with the criteria of sections 3.10.2 and 3.10.3 need not be labelled for this hazard when placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

1.3.4.   Metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers

1.3.5.   Explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect

Explosives, as referred to in section 2.1, placed on the market with a view to obtaining an explosive or pyrotechnic effect shall be labelled and packaged in accordance with the requirements for explosives only.

▼M12

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

1.4.   Request for use of an alternative chemical name

1.4.1.   Requests for use of an alternative chemical name under Article 24 may be granted only where

1.4.2.   The choice of the chemical name(s) for mixtures intended for the fragrance or perfume industry

In the case of substances occurring in nature, a chemical name or chemical names of the type ‘essential oil of …’ or ‘extract of …’ may be used instead of the chemical names of the components of that essential oil or extract as referred to in Article 18(3)(b).

1.5.   Exemptions from labelling and packaging requirements

1.5.1.   Exemptions from Article 31 [(Article 29(1))]

1.5.2.   Exemptions from Article 17 [(Article 29(2)]

1.5.2.1.   Labelling of packages where the contents do not exceed 125 ml

1.5.2.2.   Labelling of soluble packaging for single use

The label elements required by Article 17 may be omitted from soluble packaging intended for single use where:

▼M2

▼B

▼M4

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

1.5.2.5.

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

▼B

2.   PART 2: PHYSICAL HAZARDS

2.1.   Explosives

2.1.1.   Definitions

An explosive substance or mixture is a solid or liquid substance or mixture of substances which is in itself capable by chemical reaction of producing gas at such a temperature and pressure and at such a speed as to cause damage to the surroundings. Pyrotechnic substances are included even when they do not evolve gases.

A pyrotechnic substance or mixture is a substance or mixture of substances designed to produce an effect by heat, light, sound, gas or smoke or a combination of these as the result of non-detonative self-sustaining exothermic chemical reactions.

An unstable explosive is an explosive substance or mixture which is thermally unstable and/or too sensitive for normal handling, transport and use.

An explosive article is an article containing one or more explosive substances or mixtures.

A pyrotechnic article is an article containing one or more pyrotechnic substances or mixtures.

An intentional explosive is a substance, mixture or article which is manufactured with a view to producing a practical, explosive or pyrotechnic effect.

2.1.2.   Classification criteria

▼M12

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.

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

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.

▼B

2.1.4.   Additional Classification Considerations

The first step is to ascertain whether the substance or mixture has explosive effects (Test Series 1). The second step is the acceptance procedure (Test Series 2 to 4) and the third step is the assignment to a hazard division (Test Series 5 to 7). The assessment whether a candidate for ‘ammonium nitrate emulsion or suspension or gel, intermediate for blasting explosives (ANE)’ is insensitive enough for inclusion as an oxidising liquid (section 2.13) or an oxidising solid (section 2.14) is answered by Test Series 8 tests.

Explosive substances and mixtures wetted with water or alcohols, or diluted with other substances to suppress their explosive properties, may be treated differently in terms of classification and other hazard classes may apply, according to their physical properties (see also Annex II section 1.1.).

Certain physical hazards (due to explosive properties) are altered by dilution, as is the case for desensitised explosives, by inclusion in a mixture or article, packaging or other factors.

The classification procedure is set out in the following decision logic (see Figures 2.1.1 to 2.1.4).

Figure 2.1.1
Overall scheme of the procedure for classifying a substance, mixture or article in the class of explosives (Class 1 for transport)
►(1) M2  
►(2) M4  

Figure 2.1.2
Procedure for provisional acceptance of a substance, mixture or article in the class of explosives (Class 1 for transport)

▼M12

Figure 2.1.3
Procedure for assignment to a division in the class of explosives (Class 1 for transport)

▼M2

Figure 2.1.4

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

▼B

2.1.4.2.   Screening procedure

Explosive properties are associated with the presence of certain chemical groups in a molecule which can react to produce very rapid increases in temperature or pressure. The screening procedure is aimed at identifying the presence of such reactive groups and the potential for rapid energy release. If the screening procedure identifies the substance or mixture to be a potential explosive, the acceptance procedure (see section 10.3 of the ►M4  UN RTDG ◄ , Manual of Tests and Criteria) has to be performed.

▼M2

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 ‘-’.

▼B

▼M4

2.2.    Flammable gases (including chemically unstable gases)

2.2.1.    Definitions

2.2.2.    Classification criteria

2.2.3.    Hazard Communication

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

▼M12

▼M4

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

Figure 2.2.1

Flammable gases

Figure 2.2.2

Chemically unstable gases

2.2.4.    Additional Classification Considerations

2.3.    Aerosols

2.3.1.    Definitions

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

2.3.2.    Classification criteria

▼M12

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.

▼M4

Note:

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

▼M12

Figure 2.3.1 (a)
For aerosols

▼M4

Figure 2.3.1 (b)
Spray aerosols

Figure 2.3.1 (c)
Foam aerosols

2.3.3.    Hazard Communication

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

2.3.4.    Additional Classification Considerations

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

where:

ΔΗc

=

chemical heat of combustion (kJ/g);

wi %

=

mass fraction of component i in the product;

ΔΗc(i)

=

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

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

▼B

2.4.   Oxidising gases

2.4.1.   Definitions

Oxidising gas means any gas or gas mixture which may, generally by providing oxygen, cause or contribute to the combustion of other material more than air does.

2.4.2.   Classification criteria

▼M4

Note:

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

▼B

2.4.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.4.2.

▼M4

2.4.4.   Additional Classification Considerations

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

▼B

2.5.   Gases under pressure

2.5.1.   Definition

They comprise compressed gases, liquefied gases, dissolved gases and refrigerated liquefied gases.

▼M4

2.5.2.    Classification criteria

▼B

2.5.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.5.2.

▼M12

▼M2

Note:

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

▼B

2.5.4.   Additional Classification Considerations

For this group of gases, the following information is required to be known:

▼M4

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

▼B

2.6.   Flammable liquids

2.6.1.   Definition

Flammable liquid means a liquid having a flash point of not more than 60 oC.

2.6.2.   Classification criteria

▼M2

Note:

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

▼B

2.6.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.6.2.

2.6.4.   Additional Classification Considerations

▼M2

▼M2

▼B

2.7.   Flammable solids

2.7.1.   Definition

Readily combustible solids are powdered, granular, or pasty substances or mixtures which are dangerous if they can be easily ignited by brief contact with an ignition source, such as a burning match, and if the flame spreads rapidly.

2.7.2.   Classification criteria

▼M2

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.

▼B

2.7.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.7.2.

2.8.   Self-reactive substances and mixtures

2.8.1.   Definition

2.8.2.   Classification criteria

Such a mixture showing the properties of a self-reactive substance type B to F (see 2.8.2.3) shall be classified as a self-reactive substance.

Where the test is conducted in the package form and the packaging is changed, a further test shall be conducted where it is considered that the change in packaging will affect the outcome of the test.

Where the test is conducted in the package form and the packaging is changed, a further test shall be conducted where it is considered that the change in packaging will affect the outcome of the test.

2.8.2.4.   Criteria for temperature control

Self-reactive substances need to be subjected to temperature control if their SADT is less than or equal to 55 oC. Test methods for determining the SADT as well as the derivation of control and emergency temperatures are given in, Part II, section 28 of the ►M4  UN RTDG ◄ , Manual of Tests and Criteria. The test selected shall be conducted in a manner which is representative, both in size and material, of the package.

2.8.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.8.1.

▼M12

▼B

Type G has no hazard communication elements assigned but shall be considered for properties belonging to other hazard classes.

2.8.4.   Additional Classification Considerations

▼M12

Figure 2.8.1

Self-reactive substances and mixtures

▼B

2.9.   Pyrophoric liquids

2.9.1.   Definition

Pyrophoric liquid means a liquid substance or mixture which, even in small quantities, is liable to ignite within five minutes after coming into contact with air.

2.9.2.   Classification criteria

2.9.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.9.2.

▼M12

▼B

2.9.4.   Additional Classification Considerations

2.10.   Pyrophoric solids

2.10.1.   Definition

Pyrophoric solid means a solid substance or mixture which, even in small quantities, is liable to ignite within five minutes after coming into contact with air.

2.10.2.   Classification criteria

Note

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.

2.10.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.10.2.

▼M12

▼B

2.10.4.   Additional Classification Considerations

2.11.   Self-heating substances and mixtures

2.11.1.   Definition

▼M2

▼B

2.11.2.   Classification criteria

Note

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.

2.11.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.11.2.

▼M12

▼B

2.11.4.   Additional Classification Considerations

Figure 2.11.1.

Self-heating substances and mixtures

2.12.   Substances and mixtures which in contact with water emit flammable gases

2.12.1.   Definition

Substances or mixtures which, in contact with water, emit flammable gases means solid or liquid substances or mixtures which, by interaction with water, are liable to become spontaneously flammable or to give off flammable gases in dangerous quantities.

2.12.2.   Classification criteria

Note:

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 must also be tested in the new form.

2.12.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.12.2.

▼M12

▼B

2.12.4.   Additional Classification Considerations

2.13.   Oxidising liquids

2.13.1.   Definition

Oxidising liquid means a liquid substance or mixture which, while in itself not necessarily combustible, may, generally by yielding oxygen, cause, or contribute to, the combustion of other material.

2.13.2.   Classification criteria

2.13.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.13.2.

▼M12

▼B

2.13.4.   Additional Classification Considerations

2.14.   Oxidising solids

2.14.1.   Definition

Oxidising solid means a solid substance or mixture which, while in itself is not necessarily combustible, may, generally by yielding oxygen, cause, or contribute to, the combustion of other material.

2.14.2.   Classification criteria

▼M12

▼B

Note 1

Some oxidising solids also present explosion hazards under certain conditions (when stored in large quantities). Some types of ammonium nitrate may give rise to an explosion hazard under extreme conditions and the ‘Resistance to detonation test’ ►M12  (IMSBC Code (International Maritime Solid Bulk Cargoes Code, IMO), Appendix 2, Section 5) ◄ can be used to assess this hazard. Appropriate information shall be made in the SDS.

Note 2

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.

2.14.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.14.2.

▼M12

▼B

2.14.4.   Additional Classification Considerations

2.15.   Organic peroxides

2.15.1.   Definition

2.15.2.   Classification criteria

Note

The available oxygen content ( %) of an organic peroxide mixture is given by the formula:

where:

ni

=

number of peroxygen groups per molecule of organic peroxide i;

ci

=

concentration (mass %) of organic peroxide i;

mi

=

molecular mass of organic peroxide i.

2.15.2.3.   Criteria for temperature control

The following organic peroxides need to be subjected to temperature control:

Test methods for determining the SADT as well as the derivation of control and emergency temperatures are given in the ►M4  UN RTDG ◄ , Manual of Tests and Criteria, Part II, section 28. The test selected shall be conducted in a manner which is representative, both in size and material, of the package.

2.15.3.   Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.15.1.

▼M12

▼B

Type G has no hazard communication elements assigned but shall be considered for properties belonging to other hazard classes.

2.15.4.   Additional Classification Considerations

Note: The sum of the individual parts can be more hazardous than the individual components.

▼M12

Figure 2.15.1

Organic Peroxides

▼B

2.16.   Corrosive to metals

2.16.1.   Definition

A substance or a mixture that is corrosive to metals means a substance or a mixture which by chemical action will materially damage, or even destroy, metals.

2.16.2.   Classification criteria

Note

Where an initial test on either steel or aluminium indicates the substance or mixture being tested is corrosive the follow up test on the other metal is not required.

2.16.3.   Hazard Communication

Label elements shall be used for substances and mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.16.2.

▼M4

Note:

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

▼B

2.16.4.   Additional Classification Considerations

3.   PART 3: HEALTH HAZARDS

3.1.   Acute toxicity

3.1.1.   Definitions

3.1.2.   Criteria for classification of substances as acutely toxic

▼M2

Notes to Table 3.1.1:

▼M4

▼M2

▼B

3.1.2.2.   Specific considerations for classification of substances as acutely toxic

3.1.2.3.   Specific considerations for classification of substances as acutely toxic by the inhalation route

3.1.3.   Criteria for classification of mixtures as acutely toxic

▼M2

▼B

▼M2

▼B

Figure 3.1.1

Tiered approach to classification of mixtures for acute toxicity

3.1.3.4.   Classification of mixtures where acute toxicity data are available for the complete mixture

3.1.3.5.   Classification of mixtures where acute toxicity data are available for the complete mixture: bridging principles

▼M2

▼B

3.1.3.6.   Classification of mixtures based on ingredients of the mixture (Additivity formula)

3.1.3.6.1.    Data available for all ingredients

In order to ensure that classification of the mixture is accurate, and that the calculation need only be performed once for all systems, sectors, and categories, the acute toxicity estimate (ATE) of ingredients shall be considered as follows:

▼M2

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

▼B

The ATE of the mixture is determined by calculation from the ATE values for all relevant ingredients according to the following formula for Oral, Dermal or Inhalation Toxicity:

where:

Ci

=

concentration of ingredient i ( % w/w or % v/v)

i

=

the individual ingredient from 1 to n

n

=

the number of ingredients

ATEi

=

Acute Toxicity Estimate of ingredient i.

3.1.3.6.2.    Classification of mixtures when data are not available for all components

This includes evaluation of:

This approach generally requires substantial supplemental technical information, and a highly trained and experienced expert (expert judgement, see section 1.1.1), to reliably estimate acute toxicity. If such information is not available, proceed to paragraph 3.1.3.6.2.3.

▼M4

▼B

Note 1

These values are designed to be used in the calculation of the ATE for classification of a mixture based on its components and do not represent test results.

3.1.4.   Hazard Communication

▼M4

▼B

Note 1

In addition to classification for inhalation toxicity, if data are available that indicates that the mechanism of toxicity is corrosivity, the substance or mixture shall also be labelled as EUH071: ‘corrosive to the respiratory tract’ — see advice at 3.1.2.3.3. In addition to an appropriate acute toxicity pictogram, a corrosivity pictogram (used for skin and eye corrosivity) may be added together with the statement ‘corrosive to the respiratory tract’.

Note 2

In the event that an ingredient without any useable information at all is used in a mixture at a concentration of 1 % or greater, the mixture shall be labelled with the additional statement that ‘x percent of the mixture consists of ingredient(s) of unknown toxicity’ — see advice at 3.1.3.6.2.2.

▼M4

▼M12

3.2.   Skin corrosion/irritation

3.2.1.    Definitions and general considerations

3.2.1.1.

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:

3.2.2.1.    Classification based on standard animal test data

3.2.2.1.1.    Skin corrosion

3.2.2.1.2.    Skin irritation

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 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

3.3.   Serious eye damage/eye irritation

3.3.1.    Definitions and general considerations

3.3.1.1.

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:

3.3.2.1.    Classification based on standard animal test data

3.3.2.1.1.    Serious eye damage (Category 1)

3.3.2.1.2.    Eye irritation (Category 2)

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.

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 () Classification Category 1 Category 2 GHS Pictograms 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     (1)   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).

▼B

3.4.   Respiratory or skin sensitisation

3.4.1.   Definitions and general considerations

▼M2

3.4.2.   Classification criteria for substances

3.4.2.1.   Respiratory sensitisers

3.4.2.1.1.   Hazard categories

3.4.2.1.1.1.

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

3.4.2.1.1.2.

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

3.4.2.1.1.3.

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

3.4.2.1.1.4.

Substances shall be classified as respiratory sensitisers in accordance with the criteria in Table 3.4.1: Table 3.4.1 Hazard category and sub-categories for respiratory sensitisers Category Criteria Category 1 Substances shall be classified as respiratory sensitisers (Category 1) where data are not sufficient for sub-categorisation in accordance with the following criteria: (a)  if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity; and/or (b)  if there are positive results from an appropriate animal test. Sub-category 1A: Substances showing a high frequency of occurrence in humans; or a probability of occurrence of a high sensitisation rate in humans based on animal or other tests (1). Severity of reaction may also be considered. Sub-category 1B: Substances showing a low to moderate frequency of occurrence in humans; or a probability of occurrence of a low to moderate sensitisation rate in humans based on animal or other tests (1). Severity of reaction may also be considered. (1)   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.

3.4.2.1.2.   Human evidence

3.4.2.1.2.1.

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

3.4.2.1.2.2.

When considering the human evidence, it is necessary for a decision on classification to take into account, in addition to the evidence from the cases: (a)  the size of the population exposed; (b)  the extent of exposure. The use of human data is discussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.

3.4.2.1.2.3.

The evidence referred to above could be: (a)  clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence which may include: (i)  in vivo immunological test (e.g. skin prick test); (ii)  in vitro immunological test (e.g. serological analysis); (iii)  studies that indicate other specific hypersensitivity reactions where immunological mechanisms of action have not been proven, e.g. repeated low-level irritation, pharmacologically mediated effects; (iv)  a chemical structure related to substances known to cause respiratory hypersensitivity; (b)  data from one or more positive bronchial challenge tests with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction.

3.4.2.1.2.4.

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

3.4.2.1.2.5.

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

3.4.2.1.3.   Animal studies

3.4.2.1.3.1.

Data from appropriate animal studies ( 12 ) which may be indicative of the potential of a substance to cause sensitisation by inhalation in humans ( 13 ) may include: (a)  measurements of Immunoglobulin E (IgE) and other specific immunological parameters in mice; (b)  specific pulmonary responses in guinea pigs.

3.4.2.2.   Skin sensitisers

3.4.2.2.1.   Hazard categories

3.4.2.2.1.1.

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

3.4.2.2.1.2.

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

3.4.2.2.1.3.

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

3.4.2.2.1.4.

Substances shall be classified as skin sensitisers in accordance with the criteria in Table 3.4.2: Table 3.4.2 Hazard category and sub-categories for skin sensitisers Category Criteria Category 1 Substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub-categorisation in accordance with the following criteria: (a)  if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or (b)  if there are positive results from an appropriate animal test (see specific criteria in section 3.4.2.2.4.1). Sub-category 1A: Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered. Sub-category 1B: Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

3.4.2.2.2.   Human evidence

3.4.2.2.2.1.

Human evidence for sub-category 1A can include: (a)  positive responses at ≤ 500 μg/cm2 (HRIPT, HMT — induction threshold); (b)  diagnostic patch test data where there is a relatively high and substantial incidence of reactions in a defined population in relation to relatively low exposure; (c)  other epidemiological evidence where there is a relatively high and substantial incidence of allergic contact dermatitis in relation to relatively low exposure.

3.4.2.2.2.2.

Human evidence for sub-category 1B can include: (a)  positive responses at > 500 μg/cm2 (HRIPT, HMT — induction threshold); (b)  diagnostic patch test data where there is a relatively low but substantial incidence of reactions in a defined population in relation to relatively high exposure; (c)  other epidemiological evidence where there is a relatively low but substantial incidence of allergic contact dermatitis in relation to relatively high exposure. The use of human data is discussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.

3.4.2.2.3.   Animal studies

3.4.2.2.3.1.

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

3.4.2.2.3.2.

Animal test results for sub-category 1A can include data with values indicated in Table 3.4.3 Table 3.4.3 Animal test results for sub-category 1A Assay Criteria Local lymph node assay EC3 value ≤ 2 % Guinea pig maximisation test ≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose Buehler assay ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose

3.4.2.2.3.3.

Animal test results for sub-category 1B can include data with values indicated in Table 3.4.4 below: Table 3.4.4 Animal test results for sub-category 1B Assay Criteria Local lymph node assay EC3 value > 2 % Guinea pig maximisation test ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose Buehler assay ≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose

3.4.2.2.4.   Specific considerations

3.4.2.2.4.1.

For classification of a substance, evidence should include any or all of the following using a weight of evidence approach: (a)  positive data from patch testing, normally obtained in more than one dermatology clinic; (b)  epidemiological studies showing allergic contact dermatitis caused by the substance. Situations in which a high proportion of those exposed exhibit characteristic symptoms are to be looked at with special concern, even if the number of cases is small; (c)  positive data from appropriate animal studies; (d)  positive data from experimental studies in man (see section 1.3.2.4.7); (e)  well documented episodes of allergic contact dermatitis, normally obtained in more than one dermatology clinic; (f)  severity of reaction may also be considered.

3.4.2.2.4.2.

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

3.4.2.2.4.3.

If none of the abovementioned conditions are met, the substance need not be classified as a skin sensitiser. However, a combination of two or more indicators of skin sensitisation as listed below may alter the decision. This shall be considered on a case-by-case basis. (a)  Isolated episodes of allergic contact dermatitis; (b)  epidemiological studies of limited power, e.g. where chance, bias or confounders have not been ruled out fully with reasonable confidence; (c)  data from animal tests, performed according to existing guidelines, which do not meet the criteria for a positive result described in section 3.4.2.2.3, but which are sufficiently close to the limit to be considered significant; (d)  positive data from non-standard methods; (e)  positive results from close structural analogues.

3.4.2.2.4.4.

Immunological contact urticaria Substances meeting the criteria for classification as respiratory sensitisers may in addition cause immunological contact urticaria. Consideration should be given to classifying these substances also as skin sensitisers. Substances which cause immunological contact urticaria without meeting the criteria for respiratory sensitisers should also be considered for classification as skin sensitisers. There is no recognised animal model available to identify substances which cause immunological contact urticaria. Therefore, classification will normally be based on human evidence which will be similar to that for skin sensitisation.

▼B

3.4.3.   Classification criteria for mixtures

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

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

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

▼M2

▼M2

▼M4

Note 1:

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

▼B

3.4.4.   Hazard communication

▼M2

▼M4

▼B

3.5.   Germ cell mutagenicity

3.5.1.   Definitions and general considerations

3.5.2.   Classification criteria for substances

3.5.2.3.   Specific considerations for classification of substances as germ cell mutagens

▼M12 —————

▼B

3.5.3.   Classification criteria for mixtures

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

▼M4

▼B

Note

The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).

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

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

3.5.4.   Hazard communication

▼M4

▼B

3.5.5.   Additional classification considerations

It is increasingly accepted that the process of chemical-induced tumorigenesis in humans and animals involves genetic changes for example in proto-oncogenes and/or tumour suppresser genes of somatic cells. Therefore, the demonstration of mutagenic properties of substances in somatic and/or germ cells of mammals in vivo may have implications for the potential classification of these substances as carcinogens (see also Carcinogenicity, section 3.6, paragraph 3.6.2.2.6).

3.6.   Carcinogenicity

3.6.1.   Definition

3.6.2.   Classification criteria for substances

3.6.2.2.   Specific considerations for classification of substances as carcinogens

3.6.3.   Classification criteria for mixtures

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

▼M4

▼B

Note

The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).

Note 1

If a Category 2 carcinogen is present in the mixture as an ingredient at a concentration ≥ 0,1  % a SDS shall be available for the mixture upon request.

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

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

3.6.4.   Hazard Communication

▼M4

▼B

3.7.   Reproductive toxicity

3.7.1.   Definitions and general considerations

In this classification system, reproductive toxicity is subdivided under two main headings:

Some reproductive toxic effects cannot be clearly assigned to either impairment of sexual function and fertility or to developmental toxicity. Nonetheless, substances with these effects, or mixtures containing them, shall be classified as reproductive toxicants.

3.7.1.3.   Adverse effects on sexual function and fertility

Any effect of substances that has the potential to interfere with sexual function and fertility. This includes, but is not limited to, alterations to the female and male reproductive system, adverse effects on onset of puberty, gamete production and transport, reproductive cycle normality, sexual behaviour, fertility, parturition, pregnancy outcomes, premature reproductive senescence, or modifications in other functions that are dependent on the integrity of the reproductive systems.

3.7.1.4.   Adverse effects on development of the offspring

Developmental toxicity includes, in its widest sense, any effect which interferes with normal development of the conceptus, either before or after birth, and resulting from exposure of either parent prior to conception, or exposure of the developing offspring during prenatal development, or postnatally, to the time of sexual maturation. However, it is considered that classification under the heading of developmental toxicity is primarily intended to provide a hazard warning for pregnant women, and for men and women of reproductive capacity. Therefore, for pragmatic purposes of classification, developmental toxicity essentially means adverse effects induced during pregnancy, or as a result of parental exposure. These effects can be manifested at any point in the life span of the organism. The major manifestations of developmental toxicity include (1) death of the developing organism, (2) structural abnormality, (3) altered growth, and (4) functional deficiency.

3.7.2.   Classification criteria for substances

3.7.2.1.   Hazard categories

3.7.2.2.   Basis of classification

The classification of a substance is derived from the hazard categories in the following order of precedence: Category 1A, Category 1B, Category 2 and the additional Category for effects on or via lactation. If a substance meets the criteria for classification into both of the main categories (for example Category 1B for effects on sexual function and fertility and also Category 2 for development) then both hazard differentiations shall be communicated by the respective hazard statements. Classification in the additional category for effects on or via lactation will be considered irrespective of a classification into Category 1A, Category 1B or Category 2.

3.7.2.3.   Weight of evidence

3.7.2.4.   Maternal toxicity

Maternal mortality:

an increased incidence of mortality among the treated dams over the controls shall be considered evidence of maternal toxicity if the increase occurs in a dose-related manner and can be attributed to the systemic toxicity of the test material. Maternal mortality greater than 10 % is considered excessive and the data for that dose level shall not normally be considered for further evaluation.

Mating index

(no. animals with seminal plugs or sperm/no. mated × 100) ( 14 )

Fertility index

(no. animals with implants/no. of matings × 100)

Gestation length

(if allowed to deliver)

Body weight and body weight change:

Consideration of the maternal body weight change and/or adjusted (corrected) maternal body weight shall be included in the evaluation of maternal toxicity whenever such data are available. The calculation of an adjusted (corrected) mean maternal body weight change, which is the difference between the initial and terminal body weight minus the gravid uterine weight (or alternatively, the sum of the weights of the foetuses), may indicate whether the effect is maternal or intrauterine. In rabbits, the body weight gain may not be useful indicators of maternal toxicity because of normal fluctuations in body weight during pregnancy.

Food and water consumption (if relevant):

The observation of a significant decrease in the average food or water consumption in treated dams compared to the control group is useful in evaluating maternal toxicity, particularly when the test material is administered in the diet or drinking water. Changes in food or water consumption need to be evaluated in conjunction with maternal body weights when determining if the effects noted are reflective of maternal toxicity or more simply, unpalatability of the test material in feed or water.

Clinical evaluations (including clinical signs, markers, haematology and clinical chemistry studies):

The observation of increased incidence of significant clinical signs of toxicity in treated dams relative to the control group is useful in evaluating maternal toxicity. If this is to be used as the basis for the assessment of maternal toxicity, the types, incidence, degree and duration of clinical signs shall be reported in the study. Clinical signs of maternal intoxication include: coma, prostration, hyperactivity, loss of righting reflex, ataxia, or laboured breathing.

Post-mortem data:

Increased incidence and/or severity of post-mortem findings may be indicative of maternal toxicity. This can include gross or microscopic pathological findings or organ weight data, including absolute organ weight, organ-to-body weight ratio, or organ-to-brain weight ratio. When supported by findings of adverse histopathological effects in the affected organ(s), the observation of a significant change in the average weight of suspected target organ(s) of treated dams, compared to those in the control group, may be considered evidence of maternal toxicity.

3.7.2.5.   Animal and experimental data

3.7.3.   Classification criteria for mixtures

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

▼M4

▼B

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

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

3.7.4.   Hazard Communication

▼M4

▼B

3.8.   Specific target organ toxicity — single exposure

3.8.1.   Definitions and general considerations

See Table 3.8.1.

3.8.2.   Classification criteria for substances

3.8.2.1.   Substances of Category 1 and Category 2

Dose/concentration levels in humans shall not be considered in the classification and any available evidence from animal studies shall be consistent with the Category 2 classification. In other words, if there are also animal data available on the substance that warrant Category 1 classification, the substance shall be classified as Category 1.

3.8.2.1.7.    Effects considered to support classification for Category 1 and 2

3.8.2.1.8.    Effects considered not to support classification for Category 1 and 2

It is recognised that effects may be seen that does not justify classification. Such effects in humans and/or animals include, but are not limited to:

3.8.2.1.9.    Guidance values to assist with classification based on the results obtained from studies conducted in experimental animals for Category 1 and 2

Note

3.8.2.1.10.    Other considerations

3.8.2.2.   Substances of Category 3: Transient target organ effects

3.8.2.2.1.    Criteria for respiratory tract irritation

The criteria for classifying substances as Category 3 for respiratory tract irritation are:

3.8.2.2.2    Criteria for narcotic effects

The criteria for classifying substances as Category 3 for narcotic effects are:

3.8.3.   Classification criteria for mixtures

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

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

3.8.3.4.   Classification of mixtures when data are available for all components or only for some components of the mixture

Note 1

If a Category 2 specific target organ toxicant is present in the mixture as an ingredient at a concentration ≥ 1,0  % a SDS shall be available for the mixture upon request.

3.8.4.   Hazard Communication

▼M4

▼B

3.9.   Specific target organ toxicity — repeated exposure

3.9.1.   Definitions and general considerations

3.9.2.   Classification criteria for substances

Note

Attempts shall be made to determine the primary target organ of toxicity and classify for that purpose, such as hepatotoxicants, neurotoxicants. One shall carefully evaluate the data and, where possible, not include secondary effects (a hepatotoxicant can produce secondary effects in the nervous or gastro-intestinal systems).

Dose/concentration levels in humans shall not be considered in the classification and any available evidence from animal studies shall be consistent with the Category 2 classification. In other words, if there are also animal data available on the substance that warrant Category 1 classification, the substance shall be classified as Category 1.

3.9.2.7.   Effects considered to support classification for specific target organ toxicity following repeated exposure

3.9.2.8.   Effects considered not to support classification for specific target organ toxicity following repeated exposure

3.9.2.9.   Guidance values to assist with classification based on the results obtained from studies conducted in experimental animals

▼M4

▼B

3.9.2.10.   Other considerations

3.9.3.   Classification criteria for mixtures

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

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

3.9.3.4.   Classification of mixtures when data are available for all components or only for some components of the mixture

Note 1

If a Category 2 specific target organ toxicant is present in the mixture as an ingredient at a concentration ≥ 1,0  % a SDS shall be available for the mixture upon request.

3.9.4.   Hazard Communication

3.10.   Aspiration hazard

3.10.1.   Definitions and general considerations

3.10.1.6.   Specific considerations

▼M2

▼B

3.10.1.6.3.    Classification of aerosol/mist products

Aerosol and mist forms of a substance or a mixture (product) are usually dispensed in containers such as self-pressurised containers, trigger and pump sprayers. The key to classifying these products is whether a pool of product is formed in the mouth, which then may be aspirated. If the mist or aerosol from a pressurised container is fine, a pool may not be formed. On the other hand, if a pressurised container dispenses product in a stream, a pool may be formed that may then be aspirated. Usually, the mist produced by trigger and pump sprayers is coarse and therefore, a pool may be formed that then may be aspirated. When the pump mechanism may be removed, and the contents are available to be swallowed then the classification of the substance or mixture shall be considered.

3.10.2.   Classification criteria for substances

Note:

Substances in Category 1 include but are not limited to certain hydrocarbons, turpentine and pine oil.

3.10.3.   Classification criteria for mixtures

3.10.3.1.   Classification when data are available for the complete mixture

A mixture is classified in Category 1 based on reliable and good quality human evidence.

3.10.3.2.   Classification when data are not available for the complete mixture: bridging principles

3.10.3.3.   Classification when data are available for all components or only some components of the mixture

3.10.3.3.1.    Category 1

3.10.4.   Hazard Communication

▼M2

4.   PART 4: ENVIRONMENTAL HAZARDS

4.1.   Hazardous to the aquatic environment

4.1.1.   Definitions and general considerations

4.1.1.1.   Definitions

4.1.1.2.   Basic elements

4.1.1.2.0.

►M12  Hazardous to the aquatic environment is differentiated into: —  short-term (acute) aquatic hazard —  long-term (chronic) aquatic hazard. ◄

4.1.1.2.1.

The basic elements used for classification for aquatic environmental hazards are: —  acute aquatic toxicity, —  chronic aquatic toxicity, —  potential for or actual bioaccumulation, and —  degradation (biotic or abiotic) for organic chemicals.

4.1.1.2.2.

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

4.1.1.3.   Other considerations

4.1.1.3.1.

Classification of substances and mixtures for environmental hazards requires the identification of the hazards they present to the aquatic environment. ►M12  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. ◄

4.1.1.3.2.

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

4.1.2.   Classification criteria for substances

4.1.2.1.

►M12  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. ◄ The lowest of the available toxicity values between and within the different trophic levels (fish, crustacean, algae/aquatic plants) shall normally be used to define the appropriate hazard category(ies). There are circumstances, however, when a weight of evidence approach is appropriate.

4.1.2.2.

►M12  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. ◄

4.1.2.3.

►M12  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). ◄ Figure 4.1.1 ▼M12 Categories for substances long-term (chronic) hazardous to the aquatic environment ▼M2

4.1.2.4.

►M12  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). ◄

4.1.2.5.

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

4.1.2.6.

The criteria for classifying and categorising substances as ‘hazardous to the aquatic environment’ are summarised in Table 4.1.0. ▼M12 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. ▼M2 Note 1: When classifying substances as Acute Category 1 and/or Chronic Category 1 it is necessary at the same time to indicate the appropriate M-factor(s) (see Table 4.1.3). Note 2: Classification shall be based on the ErC50 [= EC50 (growth rate)]. In circumstances where the basis of the EC50 is not specified or no ErC50 is recorded, classification shall be based on the lowest EC50 available. Note 3: When no useful data on degradability are available, either experimentally determined or estimated data, the substance should be regarded as not rapidly degradable. Note 4: ‘No acute toxicity’ is taken to mean that the L(E)C50(s) is/are above the water solubility. Also for poorly soluble substances, (water solubility < 1 mg/l), where there is evidence that the acute test does not provide a true measure of the intrinsic toxicity.

4.1.2.7.

Aquatic toxicity 4.1.2.7.1. Acute aquatic toxicity is normally determined using a fish 96-hour LC50, a crustacea species 48-hour EC50 and/or an algal species 72- or 96-hour EC50. These species cover a range of trophic levels and taxa and are considered as surrogate for all aquatic organisms. Data on other species (e.g. Lemna spp.) shall also be considered if the test methodology is suitable. The aquatic plant growth inhibition tests are normally considered as chronic tests but the EC50s are treated as acute values for classification purposes (see note 2). 4.1.2.7.2. For determining chronic aquatic toxicity for classification purposes data generated according to the standardised test methods referred to in Article 8(3) shall be accepted, as well as results obtained from other validated and internationally accepted test methods. The NOECs or other equivalent ECx (e.g. EC10) shall be used.

4.1.2.8.

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

4.1.2.9.

Rapid degradability of organic substances 4.1.2.9.1. Substances that rapidly degrade can be quickly removed from the environment. While effects of such substances can occur, particularly in the event of a spillage or accident, they are localised and of short duration. In the absence of rapid degradation in the environment a substance in the water has the potential to exert toxicity over a wide temporal and spatial scale. 4.1.2.9.2. One way of demonstrating rapid degradation utilises the biodegradation screening tests designed to determine whether an organic substance is ‘readily biodegradable’. Where such data are not available, a BOD(5 days)/COD ratio ≥ 0,5 is considered as indicative of rapid degradation. Thus, a substance which passes this screening test is considered likely to biodegrade ‘rapidly’ in the aquatic environment, and is thus unlikely to be persistent. However, a fail in the screening test does not necessarily mean that the substance will not degrade rapidly in the environment. Other evidence of rapid degradation in the environment may therefore also be considered and are of particular importance where the substances are inhibitory to microbial activity at the concentration levels used in standard testing. Thus, a further classification criterion is included which allows the use of data to show that the substance did actually degrade biotically or abiotically in the aquatic environment by > 70 % in 28 days. Thus, if degradation is demonstrated under environmentally realistic conditions, then the criterion of ‘rapid degradability’ is met. 4.1.2.9.3. Many degradation data are available in the form of degradation half-lives and these can be used in defining rapid degradation provided that ultimate biodegradation of the substance, i.e. full mineralisation, is achieved. Primary biodegradation does not normally suffice in the assessment of rapid degradability unless it can be demonstrated that the degradation products do not fulfil the criteria for classification as hazardous to the aquatic environment. 4.1.2.9.4. The criteria used reflect the fact that environmental degradation may be biotic or abiotic. Hydrolysis can be considered if the hydrolysis products do not fulfil the criteria for classification as hazardous to the aquatic environment. 4.1.2.9.5. Substances are considered rapidly degradable in the environment if one of the following criteria holds true: (a)  if, in 28-day ready biodegradation studies, at least the following levels of degradation are achieved: (i)  tests based on dissolved organic carbon: 70 %; (ii)  tests based on oxygen depletion or carbon dioxide generation: 60 % of theoretical maximum. These levels of biodegradation must be achieved within 10 days of the start of degradation which point is taken as the time when 10 % of the substance has been degraded, unless the substance is identified as an UVCB or as a complex, multi-constituent substance with structurally similar constituents. In this case, and where there is sufficient justification, the 10-day window condition may be waived and the pass level applied at 28 days; or (b)  if, in those cases where only BOD and COD data are available, when the ratio of BOD5/COD is ≥ 0,5; or (c)  if other convincing scientific evidence is available to demonstrate that the substance can be degraded (biotically and/or abiotically) in the aquatic environment to a level > 70 % within a 28-day period.

4.1.2.10.

Inorganic compounds and metals 4.1.2.10.1. For inorganic compounds and metals, the concept of degradability as applied to organic compounds has limited or no meaning. Rather, such substances may be transformed by normal environmental processes to either increase or decrease the bioavailability of the toxic species. Equally the use of bioaccumulation data shall be treated with care ( 15 ). 4.1.2.10.2. Poorly soluble inorganic compounds and metals may be acutely or chronically toxic in the aquatic environment depending on the intrinsic toxicity of the bioavailable inorganic species and the rate and amount of this species which enter solution. All evidence must be weighed in a classification decision. This would be especially true for metals showing borderline results in the Transformation/Dissolution Protocol.

4.1.3.   Classification criteria for mixtures

4.1.3.1.

The classification system for mixtures covers all classification categories which are used for substances, i.e. categories Acute 1 and Chronic 1 to 4. In order to make use of all available data for purposes of classifying the aquatic environmental hazards of the mixture, the following is applied where appropriate: The ‘relevant components’ of a mixture are those which are classified ‘Acute 1’or ‘Chronic 1’ and present in a concentration of 0,1 % (w/w) or greater, and those which are classified ‘Chronic 2’, ‘Chronic 3’ or ‘Chronic 4’ and present in a concentration of 1 % (w/w) or greater, unless there is a presumption (such as in the case of highly toxic components (see section 4.1.3.5.5.5)) that a component present in a lower concentration can still be relevant for classifying the mixture for aquatic environmental hazards. Generally, for substances classified as ‘Acute 1’ or ‘Chronic 1’ the concentration to be taken into account is (0,1/M) %. (For explanation M-factor see section 4.1.3.5.5.5.)

4.1.3.2.

The approach for classification of aquatic environmental hazards is tiered, and is dependent upon the type of information available for the mixture itself and for its components. Figure 4.1.2 outlines the process to be followed. Elements of the tiered approach include: —  classification based on tested mixtures, —  classification based on bridging principles, —  the use of ‘summation of classified components’ and/or an ‘additivity formula’. ▼M12 Figure 4.1.2 Tiered approach to classification of mixtures for short-term (acute) and long-term (chronic) aquatic environmental hazards ▼M2

4.1.3.3.

Classification of mixtures when toxicity data are available for the complete mixture 4.1.3.3.1. When the mixture as a whole has been tested to determine its aquatic toxicity, this information can be used for classifying the mixture according to the criteria that have been agreed for substances. The classification is normally based on the data for fish, crustacea and algae/plants (see sections 4.1.2.7.1 and 4.1.2.7.2). When adequate acute or chronic toxicity data for the mixture as a whole are lacking, ‘bridging principles’ or ‘summation method’ should be applied (see sections 4.1.3.4 and 4.1.3.5). 4.1.3.3.2. ►M12  The long-term (chronic) hazard classification of mixtures requires additional information on degradability and in certain cases bioaccumulation. ◄ Degradability and bioaccumulation tests for mixtures are not used as they are usually difficult to interpret, and such tests may be meaningful only for single substances. 4.1.3.3.3. Classification for category Acute 1 (a)  When there are adequate acute toxicity test data (LC50 or EC50) available for the mixture as a whole showing L(E)C50 ≤ 1 mg/l: Classify mixture as Acute 1 in accordance with point (a) of Table 4.1.0. (b)  When there are acute toxicity test data (LC50(s) or EC50(s)) available for the mixture as a whole showing L(E)C50(s) > 1 mg/l for normally all trophic levels: ▼M12 No need to classify for short-term (acute) hazard. ▼M2 4.1.3.3.4. Classification for categories Chronic 1, 2 and 3 (a)  When there are adequate chronic toxicity data (ECxx or NOEC) available for the mixture as a whole showing ECx or NOEC of the tested mixture ≤ 1mg/l: (i)  Classify the mixture as Chronic 1, 2 or 3 in accordance with point (b)(ii) of Table 4.1.0 as rapidly degradable if the available information allows the conclusion that all relevant components of the mixture are rapidly degradable; (ii)  Classify the mixture as Chronic 1 or 2 in all other cases in accordance with point (b)(i) of Table 4.1.0 as non-rapidly degradable; (b)  When there are adequate chronic toxicity data (ECx or NOEC) available for the mixture as a whole showing ECx(s) or NOEC(s) of the tested mixture > 1 mg/l for normally all trophic levels: ▼M12 No need to classify for long-term (chronic) hazard in categories Chronic 1, 2 or 3. ▼M2 4.1.3.3.5. Classification for category Chronic 4 If there are nevertheless reasons for concern: Classify the mixture as Chronic 4 (safety net classification) in accordance with Table 4.1.0.

4.1.3.4.

Classification of mixtures when toxicity data are not available for the complete mixture: bridging principles 4.1.3.4.1. Where the mixture itself has not been tested to determine its aquatic environmental hazard, but there are sufficient data on the individual components and similar tested mixtures to adequately characterise the hazards of the mixture, this data shall be used in accordance with the bridging rules set out in section 1.1.3. However, in relation to application of the bridging rule for dilution, sections 4.1.3.4.2 and 4.1.3.4.3 shall be used. 4.1.3.4.2. Dilution: if a mixture is formed by diluting another tested mixture or a substance classified for its aquatic environmental hazard with a diluent which has an equivalent or lower aquatic hazard classification than the least toxic original component and which is not expected to affect the aquatic hazards of other components, then the resulting mixture may be classified as equivalent to the original tested mixture or substance. Alternatively, the method explained in section 4.1.3.5 may be applied. ▼M4 4.1.3.4.3. If a mixture is formed by diluting another tested mixture or substance with water or other totally non-toxic material, the toxicity of the mixture can be calculated from the original mixture or substance. ▼M2

4.1.3.5.

Classification of mixtures when toxicity data are available for some or all components of the mixture 4.1.3.5.1. The classification of a mixture is based on summation of the concentration of its classified components. The percentage of components classified as ‘Acute’ or ‘Chronic’ is fed straight in to the summation method. Details of the summation method are described in section 4.1.3.5.5. 4.1.3.5.2. Mixtures can be made of a combination of both components that are classified (as Acute 1 and/or Chronic 1, 2, 3, 4) and others for which adequate toxicity test data is available. When adequate toxicity data are available for more than one component in the mixture, the combined toxicity of those components is calculated using the following additivity formulas (a) or (b), depending on the nature of the toxicity data: (a)  Based on acute aquatic toxicity: where: Ci = concentration of component i (weight percentage); L(E)C50i = (mg/l) LC50 or EC50 for component i; η = number of components, and i is running from 1 to n; L(E)C50m = L(E) C50 of the part of the mixture with test data. ▼M12 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; ▼M2 (b)  Based on chronic aquatic toxicity: where: Ci = concentration of component i (weight percentage) covering the rapidly degradable components; Cj = concentration of component j (weight percentage) covering the non- rapidly degradable components; NOECi = NOEC (or other recognised measures for chronic toxicity) for component i covering the rapidly degradable components, in mg/l; NOECj = NOEC (or other recognised measures for chronic toxicity) for component j covering the non-rapidly degradable components, in mg/l; n = number of components, and i and j are running from 1 to n; EqNOECm = Equivalent NOEC of the part of the mixture with test data. The equivalent toxicity thus reflects the fact that non-rapidly degrading substances are classified one hazard category level more ‘severe’ than rapidly degrading substances. ▼M12 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. ▼M2 4.1.3.5.3. When applying the additivity formula for part of the mixture, it is preferable to calculate the toxicity of this part of the mixture using for each substance toxicity values that relate to the same taxonomic group (i.e. fish, crustacean, algae or equivalent) and then to use the highest toxicity (lowest value) obtained (i.e. use the most sensitive of the three taxonomic groups). However, when toxicity data for each component are not available in the same taxonomic group, the toxicity value of each component is selected in the same manner that toxicity values are selected for the classification of substances, i.e. the higher toxicity (from the most sensitive test organism) is used. The calculated acute and chronic toxicity is then used to assess whether this part of the mixture shall be classified as Acute 1 and/or Chronic 1, 2 or 3 using the same criteria described for substances. 4.1.3.5.4. If a mixture is classified in more than one way, the method yielding the more conservative result shall be used. 4.1.3.5.5. Summation method 4.1.3.5.5.1.   Rationale 4.1.3.5.5.1.1. In case of the substance classification categories Chronic 1 to Chronic 3, the underlying toxicity criteria differ by a factor of 10 in moving from one category to another. Substances with a classification in a high toxicity band therefore contribute to the classification of a mixture in a lower band. The calculation of these classification categories therefore needs to consider the contribution of any substance classified as Chronic 1, 2 or 3. 4.1.3.5.5.1.2. When a mixture contains components classified as Acute 1 or Chronic 1, attention must be paid to the fact that such components, when their acute toxicity is below 1 mg/l and/or chronic toxicity is below 0,1 mg/l (if non rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration. Active ingredients in pesticides often possess such high aquatic toxicity but also some other substances like organometallic compounds. Under these circumstances the application of the normal generic concentration limits leads to an ‘under-classification’ of the mixture. Therefore, multiplying factors shall be applied to account for highly toxic components, as described in section 4.1.3.5.5.5. 4.1.3.5.5.2.   Classification procedure 4.1.3.5.5.2.1. In general a more severe classification for mixtures overrides a less severe classification, e.g. a classification with Chronic 1 overrides a classification with Chronic 2. As a consequence, in this example, the classification procedure is already completed if the result of the classification is Chronic 1. A more severe classification than Chronic 1 is not possible. Therefore it is not necessary to undergo the further classification procedure. 4.1.3.5.5.3.   Classification for category Acute 1 4.1.3.5.5.3.1. First all components classified as Acute 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is greater than 25 % the whole mixture is classified as Acute 1. 4.1.3.5.5.3.2. ►M12  The classification of mixtures for short-term (acute) hazards based on this summation of classified components is summarised in Table 4.1.1. ◄ Table 4.1.1 ▼M12 Classification of a mixture for short-term (acute) hazards based on summation of classified components ▼M2 Sum of components classified as: Mixture is classified as: Acute 1 × M () ≥ 25 % Acute 1 (1)   For explanation of the M-factor, see 4.1.3.5.5.5. 4.1.3.5.5.4.   Classification for the categories Chronic 1, 2, 3 and 4 4.1.3.5.5.4.1. First all components classified as Chronic 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is equal to or greater than 25 %, the mixture is classified as Chronic 1. If the result of the calculation is a classification of the mixture as Chronic 1, the classification procedure is completed. 4.1.3.5.5.4.2. In cases where the mixture is not classified as Chronic 1, classification of the mixture as Chronic 2 is considered. A mixture is classified as Chronic 2 if 10 times the sum of the concentrations (in %) of all components classified as Chronic 1 multiplied by their corresponding M-factors plus the sum of the concentrations (in %) of all components classified as Chronic 2 is equal to or greater than 25 %. If the result of the calculation is classification of the mixture as Chronic 2, the classification process is completed. 4.1.3.5.5.4.3. In cases where the mixture is not classified either as Chronic 1 or Chronic 2, classification of the mixture as Chronic 3 is considered. A mixture is classified as Chronic 3 if 100 times the sum of the concentrations (in %) of all components classified as Chronic 1 multiplied by their corresponding M-factors plus 10 times the sum of the concentrations (in %) of all components classified with Chronic 2 plus the sum of the concentrations (in %) of all components classified as Chronic 3 is ≥ 25 %. 4.1.3.5.5.4.4. If the mixture is still not classified in Chronic 1, 2 or 3, classification of the mixture as Chronic 4 shall be considered. A mixture is classified as Chronic 4 if the sum of the concentrations (in %) of components classified as Chronic 1, 2, 3 and 4 is equal to or greater than 25 %. 4.1.3.5.5.4.5. ►M12  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. ◄ Table 4.1.2 ▼M12 Classification of a mixture for long-term (chronic) hazards, based on summation of the concentration of classified components ▼M2 Sum of components classified as: Mixture is classified as: Chronic 1 × M () ≥ 25 % Chronic 1 (M × 10 × Chronic 1) + Chronic 2 ≥ 25 % Chronic 2 (M × 100 × Chronic 1) + (10 × Chronic 2) + Chronic 3 ≥ 25 % Chronic 3 Chronic 1 + Chronic 2 + Chronic 3 + Chronic 4 ≥ 25 % Chronic 4 (1)   For explanation of the M-factor, see 4.1.3.5.5.5. 4.1.3.5.5.5.   Mixtures with highly toxic components 4.1.3.5.5.5.1. Acute 1 and Chronic 1 components with toxicities below 1 mg/l and/or chronic toxicities below 0,1 mg/l (if non-rapidly degradable) and 0,01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach. When a mixture contains components classified as Acute or Chronic 1, one of the following shall be applied: —  the tiered approach described in sections 4.1.3.5.5.3 and 4.1.3.5.5.4 using a weighted sum by multiplying the concentrations of Acute 1 and Chronic 1 components by a factor, instead of merely adding up the percentages. This means that the concentration of ‘Acute 1’ in the left column of Table 4.1.1 and the concentration of ‘Chronic 1’ in the left column of Table 4.1.2 are multiplied by the appropriate multiplying factor. The multiplying factors to be applied to these components are defined using the toxicity value, as summarised in Table 4.1.3. Therefore, in order to classify a mixture containing Acute/Chronic 1 components, the classifier needs to be informed of the value of the M-factor in order to apply the summation method, —  the additivity formula (see section 4.1.3.5.2) provided that toxicity data are available for all highly toxic components in the mixture and there is convincing evidence that all other components, including those for which specific acute and/or chronic toxicity data are not available, are of low or no toxicity and do not significantly contribute to the environmental hazard of the mixture. ▼M4 Table 4.1.3 Multiplying factors for highly toxic components of mixtures Acute toxicity M factor Chronic toxicity M factor L(E)C50 value (mg/l)   NOEC value (mg/l) NRD () components RD () components 0,1 < L(E)C50 ≤ 1 1 0,01 < NOEC ≤ 0,1 1 — 0,01 < L(E)C50 ≤ 0,1 10 0,001 < NOEC ≤ 0,01 10 1 0,001 < L(E)C50 ≤ 0,01 100 0,0001 < NOEC ≤ 0,001 100 10 0,0001 < L(E)C50 ≤ 0,001 1 000 0,00001 < NOEC ≤ 0,0001 1 000 100 0,00001 < L(E)C50 ≤ 0,0001 10 000 0,000001 < NOEC ≤ 0,00001 10 000 1 000 (continue in factor 10 intervals) (continue in factor 10 intervals) (1)   Non-rapidly degradable. (2)   Rapidly degradable. ▼M2

4.1.3.6.

Classification of mixtures with components without any useable information 4.1.3.6.1. ►M12  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). ◄ 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: ‘Contains x % of components with unknown hazards to the aquatic environment’.

4.1.4.   Hazard communication

4.1.4.1.

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 4.1.4. ▼M12 Table 4.1.4 Label elements for hazardous to the aquatic environment SHORT-TERM (ACUTE) AQUATIC HAZARD   Acute 1 GHS Pictogram 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 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

▼M2

5.   PART 5: ADDITIONAL HAZARDS

5.1.   Hazardous to the ozone layer

5.1.1.   Definitions and general considerations

5.1.1.1.

Ozone depleting potential (ODP) is an integrative quantity, distinct for each halocarbon source species, that represents the extent of ozone depletion in the stratosphere expected from the halocarbon on a mass-for-mass basis relative to CFC-11. The formal definition of ODP is the ratio of integrated perturbations to total ozone, for a differential mass emission of a particular compound relative to an equal emission of CFC-11. Substance hazardous to the ozone layer means a substance which, on the basis of the available evidence concerning its properties and its predicted or observed environmental fate and behaviour may present a danger to the structure and/or the functioning of the stratospheric ozone layer. This includes substances which are listed in Annex I to Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer ( 16 ).

5.1.2.   Classification criteria for substances

5.1.2.1.

A substance shall be classified as hazardous to the ozone layer (Category 1) if the available evidence concerning its properties and its predicted or observed environmental fate and behaviour indicate that it may present a danger to the structure and/or the functioning of the stratospheric ozone layer.

5.1.3.   Classification criteria for mixtures

5.1.3.1.

Mixtures shall be classified as hazardous to the ozone layer (Category 1) on the basis of the individual concentration of the substance(s) contained therein that are also classified as hazardous to the ozone layer (Category 1), in accordance with Table 5.1. Table 5.1 Generic concentration limits for substances (in a mixture), classified as hazardous to the ozone layer (Category 1), that trigger classification of the mixture as hazardous to the ozone layer (Category 1) Classification of the substance Classification of the mixture Hazardous to the ozone layer (Category 1) C ≥ 0,1 %

5.1.4.   Hazard communication

5.1.4.1.

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 5.2. Table 5.2 Label elements for hazardous to the ozone layer Symbol/pictogram Signal word Warning Hazard statement H420: Harms public health and the environment by destroying ozone in the upper atmosphere Precautionary statements P502

▼B

---

ANNEX II

SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES

This Annex consists of 5 parts:

1.   PART 1: SUPPLEMENTAL HAZARD INFORMATION

The statements set out in sections 1.1 and 1.2 shall be assigned in accordance with Article 25(1) to substances and mixtures classified for physical, health or environmental hazards.

1.1.   Physical properties

1.1.1.   EUH001 — ‘Explosive when dry’

For explosive substances and mixtures as referred to in section 2.1 of Annex I, placed on the market wetted with water or alcohols or diluted with other substances to suppress their explosive properties.

▼M4 —————

▼B

1.1.3.   EUH014 — ‘Reacts violently with water’

For substances and mixtures which react violently with water, such as acetyl chloride, alkali metals, titanium tetrachloride.

1.1.4.   EUH018 — ‘In use, may form flammable/explosive vapour-air mixture’

For substances and mixtures not classified as flammable themselves, which may form flammable/explosive vapour-air mixtures. For substances this might be the case for halogenated hydrocarbons and for mixtures this might be the case due to a volatile flammable component or due to the loss of a volatile non-flammable component.

1.1.5.   EUH019 — ‘May form explosive peroxides’

For substances and mixtures which may form explosive peroxides during storage, such as diethyl ether, 1,4-dioxane.

1.1.6.   EUH044 — ‘Risk of explosion if heated under confinement’

For substances and mixtures not in themselves classified as explosive in accordance with section 2.1 of Annex I, but which may nevertheless display explosive properties in practice if heated under sufficient confinement. In particular, substances which decompose explosively if heated in a steel drum do not show this effect if heated in less-strong containers.

1.2.   Health properties

1.2.1.   EUH029 — ‘Contact with water liberates toxic gas’

For substances and mixtures which in contact with water or damp air, evolve gases classified for acute toxicity in category 1, 2 or 3 in potentially dangerous amounts, such as aluminium phosphide, phosphorus pentasulphide.

1.2.2.   EUH031 — ‘Contact with acids liberates toxic gas’

For substances and mixtures which react with acids to evolve gases classified for acute toxicity in category 3 in dangerous amounts, such as sodium hypochlorite, barium polysulphide.

1.2.3.   EUH032 — ‘Contact with acids liberates very toxic gas’

For substances and mixtures which react with acids to evolve gases classified for acute toxicity in category 1 or 2 in dangerous amounts, such as salts of hydrogen cyanide, sodium azide.

1.2.4.   EUH066 — ‘Repeated exposure may cause skin dryness or cracking’

For substances and mixtures which may cause concern as a result of skin dryness, flaking or cracking but which do not meet the criteria for skin irritancy in section 3.2 of Annex I, based on either:

1.2.5.   EUH070 — ‘Toxic by eye contact’

For substances or mixtures where an eye irritation test has resulted in overt signs of systemic toxicity or mortality among the animals tested, which is likely to be attributed to absorption of the substance or mixture through the mucous membranes of the eye. The statement shall also be applied if there is evidence in humans for systemic toxicity after eye contact.

The statement shall also be applied where a substance or a mixture contains another substance labelled for this effect, if the concentration of this substance is equal to, or greater than 0,1  %, unless otherwise specified in part 3 of Annex VI.

1.2.6.   EUH071 — ‘Corrosive to the respiratory tract’

For substances and mixtures in addition to classification for inhalation toxicity, if data are available that indicate that the mechanism of toxicity is corrosivity, in accordance with section 3.1.2.3.3 and Note 1 of Table 3.1.3 in Annex I.

For substances and mixtures in addition to classification for skin corrosivity, if no acute inhalation test data are available and which may be inhaled.

2.   PART 2: SPECIAL RULES FOR SUPPLEMENTAL LABEL ELEMENTS FOR CERTAIN MIXTURES

The statements set out in sections 2.1 to 2.10 shall be assigned to mixtures in accordance with Article 25(6).

2.1.   Mixtures containing lead

The label on the packaging of paints and varnishes containing lead in quantities exceeding 0,15  % (expressed as weight of metal) of the total weight of the mixture, as determined in accordance with ISO standard 6503, shall bear the following statement:

EUH201 — ‘Contains lead. Should not be used on surfaces liable to be chewed or sucked by children’

In the case of packages the contents of which are less than 125 ml, the statement may be as follows:

EUH201A — ‘Warning! Contains lead’

2.2.   Mixtures containing cyanoacrylates

The label on the immediate packaging of adhesives based on cyanoacrylate shall bear the following statement:

EUH202 — ‘Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of the reach of children’

Appropriate advice on safety shall accompany the package.

2.3.   Cements and cement mixtures

Unless cements or cement mixtures are already classified and labelled as a sensitiser with the hazard statement H317, ‘May cause an allergic skin reaction’, the label on the packaging of cements and cement mixtures that contain, when they are hydrated, more than 0,0002  % soluble chromium (VI) of the total dry weight of the cement shall bear the statement:

EUH203 — ‘Contains chromium (VI). May produce an allergic reaction’

If reducing agents are used, then the packaging of cement or cement-containing mixtures shall include information on the packing date, the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below 0,0002  %.

2.4.   Mixtures containing isocyanates

Unless already identified on the label of the packaging, mixtures containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) shall bear the following statement:

EUH204 — ‘Contains isocyanates. May produce an allergic reaction.’

2.5.   Mixtures containing epoxy constituents with an average molecular weight ≤ 700

Unless already identified on the label of the packaging, mixtures containing epoxy constituents with an average molecular weight ≤ 700 shall bear the following statement:

EUH205 — ‘Contains epoxy constituents. May produce an allergic reaction.’

2.6.   Mixtures sold to the general public which contain active chlorine

The label on the packaging of mixtures containing more than 1 % of active chlorine shall bear the following statement:

EUH206 — ‘Warning! Do not use together with other products. May release dangerous gases (chlorine)’

2.7.   Mixtures containing cadmium (alloys) and intended to be used for brazing or soldering

The label on the packaging of the above mentioned mixtures shall bear the following statement:

EUH207 — ‘Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions’

▼M2

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.

▼M12

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.

▼B

2.9.   Liquid mixtures containing halogenated hydrocarbons

For liquid mixtures which show no flashpoint or a flashpoint higher than 60 oC but not more than 93 oC and contain a halogenated hydrocarbon and more than 5 % highly flammable or flammable substances, the label on the packaging shall bear one of the following statements, depending on whether the substances referred to above are highly flammable or flammable:

EUH209 — ‘Can become highly flammable in use’ or

EUH209A — ‘Can become flammable in use’

2.10.   Mixtures not intended for the general public

For mixtures not classified as hazardous but which contain:

▼M2

▼B

the label on the packaging shall bear the statement:

EUH210 — ‘Safety data sheet available on request’.

2.11   Aerosols

Note that aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 in the Annex to Directive 75/324/EEC.

3.   PART 3: SPECIAL RULES ON PACKAGING

3.1.   Provisions relating to child-resistant fastenings

3.1.1.   Packaging to be fitted with child-resistant fastenings

3.1.2   Reclosable packages

Child-resistant fastenings used on reclosable packages shall comply with EN ISO standard 8317 as amended relating to ‘Child-resistant packages — Requirements and methods of testing for reclosable packages’ adopted by the European Committee for standardisation (CEN) and the International Standard Organisation (ISO).

3.1.3   Non-reclosable packages

Child-resistant fastenings used on non-reclosable packages shall comply with CEN standard EN 862 as amended relating to ‘Packaging — Child-resistant packaging — Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products’ adopted by the European Committee for Standardisation (CEN).

3.1.4   Notes

3.1.4.2.   Specific cases

If it seems obvious that packaging is sufficiently safe for children because they cannot get access to the contents without the help of a tool, the test referred to in section 3.1.2 or 3.1.3 does not need to be performed.

In all other cases and when there are sufficient grounds for doubting the security of the closure for a child, the national authority may ask the person responsible for putting the product on the market to give it a certificate from a certifying laboratory, referred to in section 3.1.4.1, stating that either:

▼M4

3.2    Tactile Warnings

3.2.1.    Packaging to be fitted with a tactile warning

3.2.2.    Provisions relating to tactile warning

The technical specifications for tactile warning devices shall conform to EN ISO standard 11683 as amended ‘Packaging — Tactile warnings of danger — Requirements’.

▼M10

3.3    Liquid consumer laundry detergents in soluble packaging for single use

Where a liquid consumer laundry detergent in dosages for single use is contained in a soluble packaging, the following additional provisions shall apply:

▼B

4.   PART 4: SPECIAL RULE FOR LABELLING OF PLANT PROTECTION PRODUCTS

Without prejudice to the information required in accordance with Article 16 of Directive 91/414/EEC and Annex V of that Directive, the labelling for plant protection products subject to Directive 91/414/EEC shall also include the following wording:

EUH401 — ‘To avoid risks to human health and the environment, comply with the instructions for use’

5.   PART 5: LIST OF HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES

---

ANNEX III

LIST OF HAZARD STATEMENTS, SUPPLEMENTAL HAZARD INFORMATION AND SUPPLEMENTAL LABEL ELEMENTS

1.   Part 1: hazard statements

▼M2

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:

▼M12

▼M2

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

▼B

▼M4

▼B

▼M4

▼B

▼M12

▼B

▼M12

▼B

▼M2

▼M12

▼M2

▼M12

▼M2

▼B

▼M2

▼B

2.   Part 2: supplemental hazard information

▼M4 —————

▼B

▼M2 —————

▼B

3.   Part 3: supplemental label elements/information on certain ►M2  ————— ◄ mixtures

---

ANNEX IV

LIST OF PRECAUTIONARY STATEMENTS

▼M4

In selecting the precautionary statements in accordance with Articles 22 and 28(3), suppliers may combine the Precautionary Statements in the table below, having regard to clarity and comprehensibility of the precautionary advice.

Where square brackets […] appear around some text in a precautionary statement in column (2), this indicates that the text in square brackets is not appropriate in every case and should be used only in certain circumstances. In these cases, conditions for use explaining when the text should be used are given in column (5).

▼M12

When a forward slash or diagonal mark [/] appears in a precautionary statement text in column (2), this indicates that a choice has to be made between the phrases they separate in accordance with the indications provided in column (5).

▼M4

When three full stops […] appear in a precautionary statement text in column (2), details on the information to be provided are indicated in column (5).

▼M12

Where the text in column 5 indicates that a precautionary statement may be omitted if another precautionary statement is given on the label, this information may be used in selecting precautionary statements in accordance with Articles 22 and 28.

▼B

1.   Part 1: Criteria for the selection of precautionary statements

▼M2

▼B

2.   Part 2: precautionary statements

The precautionary statements shall be taken from this part of Annex IV and selected in accordance with Part 1.

▼M4

▼B

▼M12

▼M12 —————

▼B

▼M4

▼B

▼M12

▼B

▼M12

▼B

▼M12

▼M4

▼M12

▼M4

▼B

▼M12

▼B

▼M4 —————

▼M12

▼M4

▼M4 —————

▼M12

▼M12 —————

▼B

▼M4 —————

▼B

▼M4 —————

▼M4

▼M12

▼B

▼M4 —————

▼B

▼M12

▼B

▼M4

▼M4 —————

▼B

▼M4 —————

▼B

▼M4

▼M12

▼B

▼M4

▼B

▼M4

▼B

▼M12

▼B

▼M12 —————

▼B

▼M4

▼B

▼M12

▼B

▼M4

▼M12

▼M12 —————

▼M12

▼M4 —————

▼M4

▼M12 —————

▼M4

▼M4 —————

▼M12 —————

▼B

▼M4

▼B

▼M4 —————

▼B

▼M12

▼M12 —————

▼B

▼M4

▼M4

▼B

▼M4

▼M12

▼M12 —————

▼B

▼M12

▼B

▼M12

▼B

▼M12

▼M12 —————

▼B

▼M12 —————

▼B

▼M12

▼B

---

ANNEX V

HAZARD PICTOGRAMS

INTRODUCTION

▼M2

The hazard pictograms for each hazard class, differentiation of a hazard class and hazard category shall satisfy the provisions of this Annex and Annex I, section 1.2 and conform in terms of symbols and general format, to the specimens shown.

▼B

1.   PART 1: PHYSICAL HAZARDS

1.1.   Symbol: exploding bomb

1.2.   Symbol: flame

1.3.   Symbol: flame over circle

1.4.   Symbol: gas cylinder

1.5.   Symbol: corrosion

1.6.   A pictogram is not required for the following physical hazard classes and hazard categories:

Section 2.1: Explosives of Division 1.5

Section 2.1: Explosives of Division 1.6

Section 2.2: Flammable gases, hazard Category 2

▼M4

Section 2.3: Aerosols, hazard Category 3

▼B

Section 2.8: Self-reactive substances and mixtures, Type G

Section 2.15: Organic peroxides, Type G

2.   PART 2: HEALTH HAZARDS

2.1.   Symbol: skull and crossbones

▼M12

2.2.   Symbol: corrosion

▼B

2.3.   Symbol: exclamation mark

2.4.   Symbol: health hazard

2.5.   A pictogram is not required for the following health hazard categories:

Section 3.7: Reproductive toxicity, Effects on or via lactation, additional hazard category

3.   PART 3: ENVIRONMENTAL HAZARDS

▼M4

3.1.   Symbol: environment

A pictogram is not required for the following environmental hazard classes and hazard categories:

Section 4.1: Hazardous to the aquatic environment — Long-term hazard categories: Chronic 3, Chronic 4.

▼M2

4.   PART 4: ADDITIONAL HAZARDS

4.1.   Symbol: exclamation mark

▼B

---

ANNEX VI

Harmonised classification and labelling for certain hazardous substances

▼M15

Part 1 of this Annex provides an introduction to the list of harmonised classification and labelling, including information listed for each entry and related classifications and hazard statements in Table 3.

Part 2 of this Annex lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling of substances at Union level.

Part 3 of this Annex lists hazardous substances for which harmonised classification and labelling have been established at Union level. In Table 3 the classification and labelling are based on the criteria in Annex I to this Regulation.

▼B

1.   PART 1: INTRODUCTION TO THE LIST OF HARMONISED CLASSIFICATIONS AND LABELLING

1.1.   Information listed for each entry

1.1.1.   Numbering of entries and identification of a substance

1.1.1.1.   Index numbers

Entries in Part 3 are listed according to the atomic number of the element most characteristic of the properties of the substance. Organic substances, because of their variety, have been placed in classes. The Index number for each substance is in the form of a digit sequence of the type ABC-RST-VW-Y. ABC corresponds to the atomic number of the most characteristic element or the most characteristic organic group in the molecule. RST is the consecutive number of the substance in the series ABC. VW denotes the form in which the substance is produced or placed on the market. Y is the check-digit calculated in accordance with the 10-digit ISBN method. This number is indicated in the column entitled ‘Index No’.

1.1.1.2.   EC numbers

The EC number, i.e. EINECS, ELINCS or NLP, is the official number of the substance within the European Union. The EINECS number can be obtained from the European Inventory of Existing Commercial Chemical Substance (EINECS) ( 17 ). The ELINCS number can be obtained from the European List of Notified Substances (as amended) (EUR 22543 EN, Office for Official Publications of the European Communities, 2006, ISSN 1018-5593). The NLP number can be obtained from the list of ‘No-longer-polymers’ (as amended) (Document, Office for Official Publications of the European Communities, 1997, ISBN 92-827-8995-0). The EC number is a seven-digit system of the type XXX-XXX-X which starts at 200-001-8 (EINECS), at 400-010-9 (ELINCS) and at 500-001-0 (NLP). This number is indicated in the column entitled ‘EC No’.

1.1.1.3.   CAS number

The Chemical Abstracts Service (CAS) number is also included to assist identification of the entry. It should be noted that the EINECS number includes both anhydrous and hydrated forms of a substance, and there are frequently different CAS numbers for anhydrous and hydrated forms. The CAS number included is for the anhydrous form only, and therefore the CAS number shown does not always describe the entry as accurately as the EINECS number. This number is indicated in the column entitled ‘CAS No’.

1.1.1.4.    ►M18  Chemical name ◄

Wherever possible, hazardous substances are designated by their IUPAC names. Substances listed in EINECS, ELINCS or the list of ‘No-longer-polymers’ are designated using the names in these lists. Other names, such as usual or common names, are included in some cases. Whenever possible, plant protection products and biocides are designated by their ISO names.

Impurities, additives and minor components are normally not mentioned unless they contribute significantly to the classification of the substance.

Some substances are described with a specific percentage of purity. Substances containing a higher content of active material (e.g. organic peroxide) than this percentage are not included in the entry in Part 3 and may have other hazardous properties (e.g. explosive) and should be classified and labelled accordingly.

Where specific concentration limits are shown, these apply to the substance or substances shown in the entry. In particular, in the case of entries which are mixtures of substances or substances described with a specific percentage of purity, the limits apply to the substance as described in Part 3 and not the pure substance.

Without prejudice to Article 17(2), for substances appearing in Part 3, the name of the substance to be used on the label shall be one of the designations given there. For certain substances, additional information has been added in square brackets in order to help identify the substance. This additional information need not be included on the label.

Certain entries contain a reference to impurities; in these cases the name of the substance is followed by the text: ‘(containing ≥ xx % impurity)’. The reference in brackets is then to be considered as a part of the name, and must be included on the label.

1.1.1.5.   Entries for groups of substances

A number of group entries are included in Part 3. In these cases, the classification and labelling requirements will apply to all substances covered by the description.

In some cases, there are classification and labelling requirements for specific substances that would be covered by the group entry. In such cases a specific entry is included in Part 3 for the substance and the group entry will be annotated with the phrase ‘except those specified elsewhere in this Annex’.

In some cases, individual substances may be covered by more than one group entry. In these cases, the classification of the substance reflects the classification for each of the two group entries. In cases where different classifications for the same hazard are given, the most severe classification shall be applied.

Entries in Part 3 for salts (under any denomination) cover both anhydrous and hydrous forms, unless specified otherwise.

EC or CAS numbers are not usually included for entries which comprise more than four individual substances.

▼M15

1.1.2.   Information related to the classification and labelling of each entry in Table 3

▼B

1.1.2.1.   Classification codes

1.1.2.1.1.    Hazard class and category codes

The classification for each entry is based on the criteria set out in Annex I, in accordance with Article 13(a) and is presented in the form of a code representing the hazard class and the category or categories/divisions/types within this hazard class.

The Hazard class and category codes used for each of the hazard categories/divisions/types included in a class are shown in Table 1.1.

1.1.2.1.2.    Hazard statement codes

▼M4

The hazard statements assigned in accordance with Article 13(b) are indicated in accordance with Annex III. In addition, for certain hazard statements, letters are added to the 3-digit hazard statement code for further differentiations. The following additional codes are used:

▼B

1.1.2.2.   Labelling codes

In the labelling column, the following elements are listed:

▼M15

1.1.2.3.   Specific concentration limits, M-factors and Acute Toxicity Estimates (ATE)

Specific concentration limits (SCL), where different from the generic concentration limits given in Annex I for a certain category, are given in a separate column together with the classification concerned using the same codes as under 1.1.2.1.1. Also harmonised ATEs are listed in the same column of table 3. The SCLs and harmonised ATEs must be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance. When applying an ATE, the additivity formula as described in 3.1.3.6 of Annex I shall be used. Where no specific concentration limits are given in this Annex for a certain category, the generic concentration limits given in Annex I must be applied for the classification of substances containing impurities, additives or individual constituents or for mixtures. If harmonised ATE values are missing for acute toxicity the correct value has to be established by using the available data.

Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the mixture.

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, that M-factor is given in Table 3 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 and the substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, that 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, 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.

▼B

1.1.3.   Notes assigned to an entry

The note(s) assigned to an entry are listed in the column entitled ‘Notes’. The meaning of the notes is as follows:

1.1.3.1.   Notes relating to the identification, classification and labelling of substances

Note A:

Without prejudice to Article 17(2), the name of the substance must appear on the label in the form of one of the designations given in Part 3.

In Part 3, use is sometimes made of a general description such as ‘... compounds’ or ‘... salts’. In this case, the supplier is required to state on the label the correct name, due account being taken of section 1.1.1.4.

Note B:

Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and, therefore, these solutions require different classification and labelling since the hazards vary at different concentrations.

In Part 3 entries with Note B have a general designation of the following type: ‘nitric acid … %’.

In this case the supplier must state the percentage concentration of the solution on the label. Unless otherwise stated, it is assumed that the percentage concentration is calculated on a weight/weight basis.

Note C:

Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.

In this case the supplier must state on the label whether the substance is a specific isomer or a mixture of isomers.

Note D:

Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3.

However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the supplier must state on the label the name of the substance followed by the words ‘non-stabilised’.

▼M15 —————

▼B

Note F:

This substance may contain a stabiliser. If the stabiliser changes the hazardous properties of the substance, as indicated by the classification in Part 3, classification and labelling should be provided in accordance with the rules for classification and labelling of hazardous mixtures.

Note G:

This substance may be marketed in an explosive form in which case it must be evaluated using the appropriate test methods. The classification and labelling provided shall reflect the explosive properties.

▼M2 —————

▼B

Note J:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1  % w/w benzene (EINECS No 200-753-7). This note applies only to certain complex coal- and oil-derived substances in Part 3.

▼M15

Note K:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 should apply. This note applies only to certain complex oil-derived substances in Part 3.

▼B

Note L:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346 ‘Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method’, Institute of Petroleum, London. This note applies only to certain complex oil-derived substances in Part 3.

Note M:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005  % w/w benzo[a]-pyrene (EINECS No 200-028-5). This note applies only to certain complex coal-derived substances in Part 3.

Note N:

The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen. This note applies only to certain complex oil-derived substances in Part 3.

▼M15

Note P:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7).

When the substance is not classified as a carcinogen at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply.

This note applies only to certain complex oil-derived substances in Part 3.

▼B

Note Q:

The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions:

Note R:

The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter less two standard geometric errors greater than 6 μm.

▼M15

Note S:

This substance may not require a label according to Article 17 (see Section 1.3 of Annex I) (Table 3).

▼B

Note T:

This substance may be marketed in a form which does not have the physical hazards as indicated by the classification in the entry in Part 3. If the results of the relevant method or methods in accordance with Part 2 of Annex I of this Regulation show that the specific form of substance marketed does not exhibit this physical property or these physical hazards, the substance shall be classified in accordance with the result or results of this test or these tests. Relevant information, including reference to the relevant test method(s) shall be included in the safety data sheet.

▼M15

Note U (Table 3):

▼M12

When put on the market gases have to be classified as ‘Gases under pressure’, in one of the groups compressed gas, liquefied gas, refrigerated liquefied gas or dissolved gas. The group depends on the physical state in which the gas is packaged and therefore has to be assigned case by case. The following codes are assigned:

Aerosols shall not be classified as gases under pressure (See Annex I, Part 2, Section 2.3.2.1, Note 2).

▼B

1.1.3.2.   Notes relating to the classification and labelling of mixtures

▼M15

Note 1:

The concentration stated or, in the absence of such concentrations, the generic concentrations set out in this Regulation are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture.

▼B

Note 2:

The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the mixture.

Note 3:

The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the mixture.

Note 5:

The concentration limits for gaseous mixtures are expressed as volume per volume percentage.

Note 7:

Alloys containing nickel are classified for skin sensitisation when the release rate of 0,5  μg Ni/cm2/week, as measured by the European Standard reference test method EN 1811, is exceeded.

▼M15

Note 8:

The classification as a carcinogen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0,1 %.

Note 9:

The classification as a mutagen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 1 %.

▼M15

1.2.   Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC

1.2.1.   Minimum classification

For certain hazard classes, including acute toxicity and STOT repeated exposure, the classification according to the criteria in Directive 67/548/EEC does not correspond directly to the classification in a hazard class and category under this Regulation. In these cases the classification in this Annex shall be considered as a minimum classification. This classification shall be applied if none of the following conditions are fulfilled:

Minimum classification for a category is indicated by the reference * in the column ‘Classification’ in Table 3.

The reference * can also be found in the column ‘Specific Conc. Limits and M-factors and Acute Toxicity Estimates (ATE)’ where it indicates that the entry concerned had specific concentration limits under Directive 67/548/EEC for acute toxicity. These concentration limits cannot be ‘translated’ into concentration limits under this Regulation, especially when a minimum classification is given. However, when the reference * is shown, the classification for acute toxicity for this entry may be of special concern.

1.2.2.   Route of exposure cannot be excluded

For certain hazard classes, e.g. STOT, the route of exposure should be indicated in the hazard statement only if it is conclusively proven that no other route of exposure can cause the hazard in accordance to the criteria in Annex I. Under Directive 67/548/EEC the route of exposure was indicated for classifications with R48 when there was data justifying the classification for this route of exposure. The classification under 67/548/EEC indicating the route of exposure has been translated into the corresponding class and category according to this Regulation, but with a general hazard statement not specifying the route of exposure as the necessary information is not available.

These hazard statements are indicated by the reference ** in Table 3.

1.2.3.   Hazard statements for reproductive toxicity

Hazard statements H360 and H361 indicate a general concern for effects on fertility and/or development: ‘May damage/Suspected of damaging fertility or the unborn child’. According to the criteria, the general hazard statement can be replaced by the hazard statement indicating the specific effect of concern in accordance with Section 1.1.2.1.2. When the other differentiation is not mentioned, this is due to evidence proving no such effect, inconclusive data or no data and the obligations in Article 4(3) shall apply for that differentiation.

In order not to lose information from the harmonised classifications for fertility and developmental effects under Directive 67/548/EEC, the classifications have been translated only for those effects classified under that Directive.

These hazard statements are indicated by the reference *** in Table 3.

1.2.4.   Correct classification for physical hazards could not be established

For some entries the correct classification for physical hazards could not be established because sufficient data are not available for the application of the classification criteria in this Regulation. The entry might be assigned to a different (also higher) category or even another hazard class than indicated. The correct classification shall be confirmed by testing.

The entries with physical hazards that need to be confirmed by testing are indicated by the reference **** in Table 3.

▼B

2.   PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING

This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling.

The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier.

For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier.

A dossier for harmonised classification and labelling shall contain the following:

▼M15

3.   PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLE

▼M13 —————

▼B

---

ANNEX VII

Translation table from classification under Directive 67/548/EEC to classification under this Regulation

This Annex includes a table to assist translation of a classification made for a substance or a mixture under Directive 67/548/EEC or Directive 1999/45/EC, respectively, into the corresponding classification under this Regulation. Whenever data for the substance or mixture are available, an evaluation and classification shall be done in accordance with Articles 9 to13 of this Regulation.

1.   Translation table

The codes used are introduced in Table 1.1 and section 1.1.2.2 of Annex VI.

▼M14

---

ANNEX VIII

Harmonised information relating to emergency health response and preventative measures

PART A

GENERAL REQUIREMENTS

1.    Application

▼M20

1.1.	Importers and downstream users placing on the market mixtures for consumer use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.

▼M14

1.2.	Importers and downstream users placing on the market mixtures for professional use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.

1.3.	Importers and downstream users placing on the market mixtures for industrial use within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2024.

1.4.

Importers and downstream users having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability mentioned in Sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025.

1.5.	By way of derogation from Section 1.4, if one of the changes described in Section 4.1 of Part B of this Annex occurs before 1 January 2025, importers and downstream users shall comply with this Annex before placing that mixture, as changed, on the market.

2.    Purpose, definitions and scope

2.1.

This Annex sets out the requirements that importers and downstream users placing mixtures on the market, hereinafter ‘submitters’, shall fulfil in respect of the submission of information so that appointed bodies shall have at their disposal the information to carry out the tasks for which they are responsible under Article 45.

2.2.

This Annex shall not apply to mixtures for scientific research and development and to mixtures for product and process oriented research and development as defined in Article 3(22) of Regulation (EC) No 1907/2006. This Annex shall not apply to mixtures classified only for one or more of the following hazards: (1)  gases under pressure; (2)  explosives (unstable explosives and Divisions 1.1 to 1.6)

▼M20

2.3.

In the case of mixtures placed on the market for industrial use only, submitters may opt for a limited submission, as an alternative to general submission requirements, in accordance with Section 3.1.1 of Part B, provided that a rapid access to additional detailed product information is available in accordance with Section 1.3 of that Part.

▼M14

2.4.

For the purposes of this Annex the following definitions shall apply: (1)  ‘Mixture for consumer use’ means a mixture intended to be used by consumers; (2)  ‘Mixture for professional use’ means a mixture intended to be used by professional users but not at industrial sites; (3)  ‘Mixture for industrial use’ means a mixture intended to be used at industrial sites only. Where mixtures have more than one use, the requirements for all relevant categories of use shall be met.

3.    Submission requirements

3.1.

Before placing mixtures on the market, submitters shall provide information relating to mixtures classified as hazardous on the basis of their health or physical effects to the bodies appointed under Article 45(1) (hereinafter ‘appointed bodies’), in the Member State or Member States where the mixture is placed on the market. The submission shall contain the information laid down in Part B. It shall be submitted by electronic means in an XML format provided by the Agency and made available free of charge.

3.2.

Where following receipt of a submission under Section 3.1 an appointed body makes a reasoned request to the submitter that additional information or clarification is necessary for that appointed body to carry out the tasks for which it is responsible under Article 45, the submitter shall provide the necessary information or clarification requested without undue delay.

3.3.	The submission shall be in the official language(s) of the Member State(s) where the mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.

3.4.	The intended use of the mixture shall be described in accordance with a harmonised product categorisation system provided by the Agency.

3.5.	A submission update shall be made without undue delay when the conditions laid down in Section 4.1 of Part B are met.

4.    Group submission

▼M20

4.1.	A single submission, hereinafter ‘group submission’, may be provided for more than one mixture where all the mixtures in a group have the same classification for health and physical hazards.

▼M14

4.2.	A group submission shall only be permitted when all mixtures in the group contain the same components (as identified in Section 3.2 of Part B), and for each of the components, the reported concentration range is the same for all mixtures (as provided in Section 3.4 of Part B).

▼M20

4.3.	By way of derogation from Section 4.2, a group submission shall also be allowed where the difference in the composition between different mixtures in the group only concerns perfumes, provided that the total concentration of the differing perfumes contained in each mixture does not exceed 5 %.

▼M14

4.4.	In the case of a group submission, the information required in Part B shall be provided for each of the mixtures contained in the group where applicable.

5.    Unique formula identifier (UFI)

5.1.

The submitter shall create a unique formula identifier, hereinafter UFI, by electronic means made available by the Agency. The UFI is a unique alphanumeric code that unambiguously links the submitted information on the composition of a mixture or a group of mixtures to a specific mixture or group of mixtures. The assignment of a UFI is free of charge. A new UFI shall be created when a change in the composition of the mixture or group of mixtures fulfils one or more of the conditions foreseen in points (a), (b) and (c) of the fourth indent of Section 4.1 of Part B. ▼M20 By way of derogation from the second subparagraph, a new UFI shall not be required for mixtures in a group submission containing perfumes provided that the change in the composition only concerns those perfumes or the addition of new perfumes.

5.2.

Instead of including the UFI in the supplemental information on the label, the submitter may opt to print or affix it on the inner packaging located with the other label elements. Where the inner packaging is either in such a shape or so small that it is impossible to affix the UFI on it, the submitter may print or affix the UFI located with the other label elements on an outer packaging. In the case of mixtures which are not packaged, the UFI shall be indicated in the Safety Data Sheet or be included in the copy of the label elements referred to in Article 29(3), as applicable. The UFI shall be preceded by the acronym ‘UFI’ in capital letters followed by a colon (‘UFI:’) and it shall be clearly visible, legible and indelibly marked.

5.3.	By way of derogation from the first subparagraph of Section 5.2, in the case of mixtures supplied for use at industrial sites, the UFI may alternatively be indicated in the Safety Data Sheet.

▼M14

6.    Formats and technical support for submission of information

6.1.	The Agency shall specify, maintain and update the UFI generator, the XML formats for submissions and a harmonised product categorisation system and make them available free of charge on its website.

6.2.	The Agency shall provide technical and scientific guidance, technical support and tools facilitating the submission of information.

PART B

INFORMATION CONTAINED IN A SUBMISSION

1.    Identification of the mixture and of the submitter

1.1.    Product identifier of the mixture

The product identifier shall be provided in accordance with Article 18(3)(a).

▼M20

The complete trade name(s) of the mixture shall be provided, including, where relevant, brand name(s), name of the product and variant names as they appear on the label, without abbreviations and enabling its specific identification.

▼M14

In addition, the UFI(s) shall be included in the submission.

▼M20

1.2.    Details of the submitter and contact point

The name, full address, telephone number and email address of the submitter shall be provided and, if different, the name, full address, telephone number and email address of the point of contact to be used for obtaining further information relevant for emergency health response purposes.

1.3.    Name, telephone number and email address for rapid access to additional product information

In the case of a limited submission as laid down in Section 2.3 of Part A, a name, a telephone number and an email address shall be provided at which rapid access to detailed additional product information relevant for emergency health response purposes is available in the language provided in Section 3.3 of Part A. The telephone number shall be accessible 24 hours per day, 7 days per week.

▼M14

2.    Hazards identification and additional information

This section sets out the information requirements related to the health and physical hazards of the mixture and the appropriate warning information associated with those hazards, as well as the additional information to be included in a submission.

2.1.    Classification of the mixture

The classification of the mixture for health and physical hazards (hazard class and category) shall be provided in accordance with the classification rules in Annex I.

2.2.    Label elements

The following label elements required in accordance with Article 17 shall be provided, if applicable:

2.3.    Toxicological information

The submission shall include the information on the toxicological effects of the mixture or its components that is required in Section 11 of the Safety Data Sheet of the mixture, in accordance with Annex II to Regulation (EC) No 1907/2006.

2.4.    Additional information

The following additional information shall be provided:

▼M20

▼M14

3.    Information on mixture components

3.1.    General requirements

The chemical identity and the concentrations of the components contained in the mixture shall be indicated in the submission in accordance with Sections 3.2, 3.3 and 3.4.

Components which are not present in a mixture shall not be notified.

▼M20

By way of derogation from the second subparagraph, in a group submission, perfume components in mixtures shall be present in at least one of the mixtures.

For group submissions where the perfumes vary between the mixtures contained in the group, a list shall be provided of the mixtures and the perfumes they contain, including their classification.

3.1.1.   Requirements for mixtures for industrial use

In the case of a limited submission as laid down in Section 2.3 of Part A, the information to be submitted on the composition of a mixture for industrial use may be limited to the information contained in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006, provided that additional information on the composition is available on request for rapid access in accordance with Section 1.3.

▼M14

3.2.    ►M20  Identification of mixture components  ◄

▼M20

A mixture component is either a substance or a mixture in mixture.

▼M14

3.2.1.   Substances

The product identifier for the substances identified according to Section 3.3 shall be provided in accordance with Article 18(2). However, an INCI name, a colour index name or another international chemical name may be used, provided the chemical name is well-known and unambiguously defines the substance identity. The chemical name of substances for which an alternative chemical name has been allowed in accordance with Article 24 shall be provided as well.

3.2.2.   Mixture in mixture

When a mixture is used in the composition of a second mixture placed on the market, the first mixture is referred to as a mixture in mixture (hereinafter MIM).

▼M20

Information on the substances contained in a MIM shall be provided in accordance with the criteria of Section 3.2.1, unless the submitter does not have access to information on the full composition of the MIM. In the latter case, the MIM shall be identified by means of its product identifier in accordance with Article 18(3)(a), together with its concentration and UFI, if available and if the appointed body has received the information on the MIM in a prior submission. In absence of a UFI or if the appointed body has not received the information on the MIM in a prior submission, the MIM shall be identified by means of its product identifier in accordance with Article 18(3)(a), together with its concentration and the compositional information contained in the Safety Data Sheet of the MIM and any other known components, as well as the name, email address and telephone number of the MIM supplier.

3.2.3.   Generic product identifiers

By way of derogation from Sections 3.2.1 and 3.2.2, the generic product identifiers ‘perfumes’ or ‘colouring agents’ may be used for mixture components used exclusively to add perfume or colour, where the following conditions are met:

3.3.    Mixture components subject to submission requirements

The following mixture components shall be indicated:

3.4.    Concentration and concentration ranges of the mixture components

Submitters shall provide the information laid down in Sections 3.4.1 and 3.4.2 with regard to the concentration of the mixture components, identified in accordance with Section 3.3.

▼M14

3.4.1.   Hazardous components of major concern for emergency health response and preventative measures

When mixture components are classified in accordance with this Regulation for at least one of the hazard categories listed below, their concentration in a mixture shall be expressed as exact percentages, in descending order by mass or volume:

As an alternative to providing concentrations as exact percentages, a range of percentages may be submitted in accordance with Table 1.

▼M20

3.4.2.   Other hazardous components and components not classified as hazardous

The concentration of the hazardous components in a mixture that are not classified for any of the hazard categories listed in Section 3.4.1 and of the identified components not classified as hazardous shall be expressed, in accordance with Table 2, as ranges of percentages in descending order by mass or volume. As an alternative, exact percentages may be provided.

By way of derogation from the first subparagraph, for perfume components that are not classified or only classified for skin sensitisation Category 1, 1A or 1B or aspiration toxicity, submitters shall not be required to provide information on their concentration, provided that their total concentration does not exceed 5 %.

3.5.    Classification of mixture components

The classification of mixture components for health and physical hazards (hazard classes, hazard categories and hazard statements) shall be provided. This includes the classification for at least all substances referred to in Point 3.2.1 of Annex II to Regulation (EC) No 1907/2006 on requirements for the compilation of Safety Data Sheets. In the case of a MIM identified by means of its product identifier and its UFI in accordance with Section 3.2.2 of Part B, only the classification for health and physical hazards of the MIM shall be provided.

▼M14

4.    Submission update

4.1.

Where one of the following changes applies to a mixture in an individual or group submission, submitters shall provide a submission update before placing that mixture, as changed, on the market: —  when the mixture product identifier (including the UFI) has changed, —  when the mixture classification for health or physical hazards has changed, —  when relevant new toxicological information that is required in Section 11 of the Safety Data Sheet becomes available on the hazardous properties of the mixture or its components, —  if a change in the composition of the mixture fulfils one of the following conditions: (a)  addition, substitution, or deletion of one or more components in the mixture that shall be indicated in accordance with Section 3.3; (b)  change in the concentration of a component in the mixture beyond the concentration range provided in the original submission; (c)  the exact concentration of a component was provided in accordance with Sections 3.4.1 or 3.4.2, and a change occurs to that concentration beyond the limits identified in Table 3. Table 3 ▼M20 Variations of the concentration of components requiring a submission update ▼M14 Exact concentration of the component contained in the mixture (%) Variations (±) of the initial component concentration requiring a submission update > 25 - ≤ 100 5 % > 10 - ≤ 25 10 % > 2,5 - ≤ 10 20 % ≤ 2,5 30 % ▼M20 When the perfumes in a group submission change, the list of mixtures and the perfumes they contain as required in Section 3.1 shall be updated. ▼M14

4.2.	Content of the submission update The submission update shall comprise a revised version of the previous submission containing the new information available as described in Section 4.1.

PART C

SUBMISSION FORMAT

1.1.    Submission format

The submission of information to appointed bodies in accordance with Article 45 shall be in a format to be provided by the Agency. The submission format shall address the following elements:

▼M20

1.2.    Identification of the mixture and of the submitter

Product identifier

Contact details of the submitter and, where applicable, contact point

Contact details for rapid access to additional product information (24 hours/7 days). Only for limited submission.

▼M14

1.3.    Classification of the mixture, label elements and toxicology

Classification of the mixture and label elements

Toxicological information

▼M20

Additional information on the mixture

▼M14

1.4.    Product identifiers of the mixture components

Product identifiers of the mixture components (substances and mixtures in mixtures where applicable)

Concentration and concentration ranges of the mixture components

Classification of mixture components (substances and MIM)

List according to Part B, Section 3.1, fourth paragraph (where applicable)

---

( ) OJ L 159, 29.6.1996, p. 1.

( ) OJ L 114, 27.4.2006, p. 9.

( 1 ) Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1).

( 1 ) OJ L 144, 4.6.1997, p. 19.

( 2 ) OJ L 123, 12.5.2016, p. 1.

( *1 ) OJ L 353, 31.12.2008, p. 1’;

( *2 ) OJ L 353, 31.12.2008, p. 1’;

( *3 ) OJ L 353, 31.12.2008, p. 1’;

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

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

( 4 ) See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.

See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.

 ◄

( 4 ) See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.

See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.

 ◄

( 4 )  ►M4  As determined by test series E as prescribed in UN RTDG, Manual of Tests and Criteria, Part II. ◄

( 4 )  ►M2  When mixtures contain components that do not have acute toxicity data for each route of exposure, acute toxicity estimates may be extrapolated from the available data and applied to the appropriate routes (see section 3.1.3.2). However, specific legislation may require testing for a specific route. In those cases, classification shall be performed for that route based upon the legal requirements. ◄

( 5 ) 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.

( 6 ) 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.

( 6 ) It is recognised that the Mating index and the Fertility index can also be affected by the male.

( 7 ) Specific guidance has been issued by the European Chemicals Agency on how these data for such substances may be used in meeting the requirements of the classification criteria.

( 8 ) OJ L 286, 31.10.2009, p. 1.

( 8 ) OJ C 146A, 15.6.1990.