Key Benefits:
Minister of State, Minister of Economy, Finance and Industry, Minister of Employment, Labour and Social Cohesion, Minister of Health and Social Welfare, Minister of Agriculture, Food, Fisheries and Rural Affairs, Minister of Ecology and Sustainable Development and Minister Delegate to Industry,
Having regard to Directive 67/548/EEC of 27 June 1967, last amended by Directive 99/33/EC of the European Parliament and the Council of 10 May 1999, concerning the approximation of the legislative, regulatory and administrative provisions relating to the classification, packaging and labelling of hazardous substances;
In view of the Commission ' s directive 2001/59/EC of 6 August 2001 on twenty-eighth adaptation to the technical progress of amended Directive 67/548/EEC referred to above;
Considering the Labour Code, including articles L. 231-2, L. 231-6 and R. 231-52-3;
Considering the public health code, including articles L. 1342-3, L. 5132-2 to L. 5132-5 and R. 5132-46;
Considering the environmental code, including articles L. 521-6, L. 521-9 and L. 522-12;
Considering the rural code, including its article L. 253-1;
Considering Decree No. 2004-725 of 22 July 2004 on chemical substances and preparations and amending the Labour Code and the Public Health Code;
Considering the amended decision of 20 April 1994 on the declaration, classification, packaging and labelling of substances;
Considering the opinion of the National Commission for Hygiene and Safety in Agriculture of 22 May 2003;
In light of the opinion of the Conseil supérieur de la prévention des risques professionnels dated 28 April 2003,
Stop:
In article 3 of the above-mentioned decision of 20 April 1994, paragraphs II to VI shall become paragraphs III to VII and a paragraph II shall be inserted between paragraphs I and III, as follows:
“II. - The nature and procedure for testing the reduced test battery in accordance with Article R. 231-52-3 of the Labour Code and the definition of the relevant exposure situations are specified in Appendix VII A to this Order. »
The foreword to Schedule I to the above-mentioned Order of 20 April 1994 is amended as follows:
The drafting of the paragraph on the submission of entries, point c, is replaced by the following wording:
"(c) Concentration and classification limits required to classify hazardous preparations containing the substance in accordance with the 9 November 2004 Dangerous Preparations Order.
Unless otherwise specified, concentration limits are percentages by weight of the substance calculated from the total weight of the preparation.
When no concentration limits are indicated, the limits to be used to apply the conventional health hazard assessment method are those set out in Appendix II and the limits to be used to apply the conventional method of environmental hazards are those set out in Appendix III of the 9 November 2004 Decision relating to the classification, packaging and labelling of hazardous preparations. »
The second example of note A of the paragraph "explanation of notes on the identification, classification and labelling of substances" is deleted and replaced by the following paragraph:
"Example:
For substance AB - no specific entry in Appendix I:
Group entry of A compounds in Appendix I:
Repr. Cat. 1; R 61
Repr. Cat. 3; R 62
Xn; R 20/22 R 33
N; R 50-53.
Group entry of B compounds in Appendix I:
Carc. Cat. 1; R 45
T; R 23/25
N; R 51-53.
The classification of substance AB is therefore:
Carc. Cat. 1; R 45
Repr. Cat. 1; R 61
Repr. Cat. 3; R 62
T; R 23/25 R 33
N; R 50-53. »
The terms: "of this directive" in the first paragraph of note D of the paragraph "explanation of notes relating to the identification, classification and labelling of substances" are deleted and replaced by the words "of this Order".
The second sentence of note E of the paragraph "explanation of notes on the identification, classification and labelling of substances" is deleted and replaced by the following sentence:
"For these substances, phrases R 20, R 21, R 22, R 23, R 24, R 25, R 26, R 27, R 28, R 39, R 68 (nocif), R 48 and R 65 and all combinations of these risk phrases must be preceded by the term "also. »
In note R of the paragraph "explanation of notes on the identification, classification and labelling of substances", the term "geometric" is inserted after the words "less than two errors".
In note 1 of the paragraph "explanation of the notes on the labelling of preparations", the words "the order of February 21, 1990" are replaced by the words "the order of November 9, 2004".
Note 6 of the paragraph "explanation of the notes on the labelling of preparations" is deleted.
The following information replaces the corresponding indications in Table A of the foreword in Appendix I to the above-mentioned Order of 20 April 1994:
42 Molybdenum;
81 Tl Thallium;
89 Ac Actinium.
In Appendix I of the above-mentioned Order of 20 April 1994, the text beginning with the words "Appendix I..." to the words "Guideline 67/548/EEC" is replaced by the following text:
"Annex I to this Order on the List of Dangerous Substances is Annex I to Directive 67/548/EEC of 27 June 1967, last amended by Directive 99/33/EC of the European Parliament and of the Council of 10 May 1999, concerning the approximation of the regulatory and administrative provisions of the Member States relating to the classification, packaging and labelling of hazardous substances, as set out in the annex to guidelines 93/72/EC of the Commission »
The introductory text of Appendix II to the above-mentioned decision of 20 April 1994 is deleted and replaced by the following text:
"Annex II below, on symbols and indications of danger of substances and dangerous preparations, is Appendix II of Directive 67/548/EEC of 27 June 1967, last amended by Directive 99/33/EC of the European Parliament and of the Council of 10 May 1999, concerning the approximation of the regulatory and administrative legislative provisions of the Member States relating to the classification, packaging and labelling of hazardous substances, as set out in Annex II »
A. - The introductory text of Annex III to the above-mentioned Order of 20 April 1994 is deleted and replaced by the following text:
"Annex III below, on risk phrases (phrases R) of hazardous substances and preparations, is Appendix III of Directive 67/548/EEC of 27 June 1967, last amended by Directive 99/33/EC of the European Parliament and the Council of 10 May 1999, concerning the approximation of the regulatory and administrative legislative provisions of the Member States relating to the classification, packaging and labelling of hazardous substances, as set out in Annex III, »
B. - Schedule III to the Order of 20 April 1994 is amended to read:
- the wording of sentence R 40 is deleted and replaced by the following text: "Presented carcinogenic effect: insufficient evidence. » ;
- the wording of sentence R 45 is deleted and replaced by the following text: "Can cause cancer. » ;
- the wording of sentence R 46 is deleted and replaced by the following text: "Can cause hereditary genetic alterations. » ;
- the wording of sentence R 49 is deleted and replaced by the following text: "Can cause cancer by inhalation. » ;
- R 68: "Possibility of irreversible effects. is added to the list of phrases R;
- the following combined R sentences: R 40/20, R 40/21, R 40/22, R 40/20/21, R 40/21/22, R 40/20/21/22 are deleted.
- the following combined sentences are added:
"R 68/20 Nocif: possibility of irreversible effects by inhalation;
R 68/21 Nocif: possibility of irreversible effects by contact with the skin;
R 68/22 Nocif: possibility of irreversible effects by ingestion;
R 68/20/21 Nocif: possibility of irreversible effects by inhalation and contact with the skin;
R 68/20/22 Nocif: possibility of irreversible effects by inhalation and ingestion;
R 68/21/22 Nocif: possibility of irreversible effects by contact with the skin and by ingestion;
R 68/20/21/22 Nocif: possibility of irreversible effects by inhalation, contact with the skin and ingestion. »
The introductory text of Appendix V to the above-mentioned decision of 20 April 1994 is deleted and replaced by the following text:
"Second, Annex V to this Order is Annex V to Directive 67/548/EEC of 27 June 1967, last amended by Directive 99/33/EC of the European Parliament and the Council of 10 May 1999, concerning the approximation of the regulatory and administrative legislative provisions of the Member States relating to the classification, packaging and labelling of hazardous substances, as set out in the annex to Directives 87/302 of the European Commission of 18 November 1987, 92/ »
Appendix VI to the above-mentioned Order of 20 April 1994 is repealed and replaced by Appendix I to this Order.
A. - The introductory text of Schedule VII A to the above-mentioned Order of 20 April 1994 is deleted and replaced by the following text:
"Appendix VII A to this Order is Appendix VII A to Directive 67/548/EEC of 27 June 1967, last amended by Directive 99/33/EC of the European Parliament and the Council of 10 May 1999, concerning the approximation of the regulatory and administrative legislative provisions of the Member States relating to the classification, packaging and labelling of hazardous substances. »
B. - The text in Appendix II to this Order is inserted before section 0 of Schedule VII A of the above-mentioned Order of 20 April 1994.
C. - The text entitled “7. Reduced testing for synthetic intermediaries whose quantity is greater than or equal to one ton per year. "Appendix III to this Order is inserted at the end of Schedule VII A to the above-mentioned Order of 20 April 1994.
A. - The introductory text of Annex VIII to the above-mentioned Order of 20 April 1994 is deleted and replaced by the following text:
"Appendix VIII to this Order is Appendix VIII to Directive 67/548/EEC of 27 June 1967, last amended by Directive 99/33/EC of the European Parliament and the Council of 10 May 1999, concerning the approximation of the regulatory and administrative legislative provisions of the Member States relating to the classification, packaging and labelling of hazardous substances. »
B. - The text in Appendix IV to this Order is inserted between the title "Level 1" and the subtitle "Physico-chemical Studies" in Appendix VIII to the above-mentioned Order of 20 April 1994.
C. - The text in Appendix V to this Order is inserted between the title "Level 2" and the subtitle "Terological Studies" in Appendix VIII of the above-mentioned Order of 20 April 1994.
The Director of Labour Relations, the Director General of Forest and Rural Affairs, the Director of Pollution and Risk Prevention, the Director General of Health, the Director General of Competition, Consumption and Suppression of Frauds, and the Director General of Industry, Information Technology and Posts are responsible, each with regard to the performance of this Order, which will be published as well as its annexes to the Official Journal of the French Republic.
A N N E X E I
(Annex VI to the amended decision of 20 April 1994)
This annex is annexed to Directive (EEC) No. 67-548, last amended by Directive (EC) No. 2001-59, as set out in the annex to Directive (EC) No. 2001-59, containing twenty-eighth adaptation to the technical progress of Directive (EEC) No. 67-548 (EEC No. L 225 of 21 August 2001).
1. General Introduction
1.1. The classification aims to identify all physico-chemical, toxicological and ecotoxicological properties of substances or preparations, which may constitute a risk in the normal handling or use of these substances or preparations. After identification of each hazardous property, the substance or preparation shall be labelled to indicate the hazard(s) in order to protect the user, the public and the environment.
1.2. This annex lists the general principles governing the classification and labelling of substances and preparations, as referred to in section 4 of Directive 67/548/EEC, in section 4 of Directive 1999/45/EC and in other guidelines for hazardous preparations.
It is intended for any person concerned (manufacturers, importers, national authorities) through the classification and labelling of hazardous substances and preparations.
1.3. The requirements of Directive 67/548/EEC and Directive 1999/45/EC are intended to make available to the public and workers a basic tool containing essential information on hazardous substances and preparations. The label draws the attention of people who handle or use these substances and preparations to the dangers inherent in some of them.
The purpose of the label may also be to provide more complete information on precautionary measures and the terms and conditions of use of products available in different forms.
1.4. The label takes into account all potential hazards that may be related to the normal handling and use of hazardous substances and preparations in the form they are placed on the market, but not necessarily in any different form of final use, for example in the diluted state. The most serious hazards are illustrated by symbols and hazards, as well as those resulting from other hazardous properties, are set out in standard phrases of risk, while sentences indicating precautionary statements specify the precautions that are essential to respect.
In the case of substances, the information is supplemented by the mention of the name of the substance conforming to an internationally recognized chemical nomenclature, preferably the name used in the European inventory of marketed chemicals (EINECS) or in the European list of notified chemical substances (ELINCS), as well as by the mention of the EC number and the name, address and telephone number of the person, established in the Community, responsible for placing the substance on the market.
In the case of preparations, the information is supplemented, pursuant to Article 10, paragraph 2, of Directive 1999/45/EC, by the following:
- trade name or preparation designation;
- chemical name of the substance(s) present in the preparation, and
- name, complete address and telephone number of the person, established in the Community, responsible for placing on the preparation market.
1.5. Section 6 of Directive 67/548/EEC states that manufacturers, distributors and importers of hazardous substances not yet listed in Appendix I but listed in the EINECS are required to conduct a search in order to learn of the relevant accessible data regarding the properties of these substances. Based on this information, they must pack and label these substances provisionally in accordance with the rules set out in articles 22 to 25 of Directive 67/548/EEC and the criteria set out in this annex.
1.6. Data required for classification and labelling.
1.6.1. For substances, classification and labelling data may be obtained as follows:
(a) For substances that require the communication of the information referred to in Annex VII, most of the indications required for classification and labelling will be included in the "basic file". This classification and labelling will be reviewed, if any, when additional information is available (Annex VIII);
(b) For other substances (e.g. those referred to in point 1.5), the classification and labelling data may, where applicable, be obtained from a number of different sources, such as:
- results of previous tests;
- the information required under international regulations on the transport of dangerous substances;
- information from reference work and bibliography, or
- information based on practical experience.
It is also possible to take into account the results of validated structural/activity relationships and expert opinions.
1.6.2. For preparations, the data required for classification and labelling may generally be obtained:
(a) If this is physico-chemical data, by applying the methods referred to in Appendix V. This also applies to preparations under Directive 91/414/EEC, unless other internationally recognized methods are acceptable under the provisions of Annexes II and III of Directive 91/414/EEC (Article 5, paragraph 5, of Directive 1999/45/EC). For gaseous preparations, a calculation method can be used for flammability properties and oxidizing properties (see points 9.1.1.1 and 9.1.1.2). For non-gaseous preparations containing organic peroxides, a calculation method may be used for oxidizing properties (see point 2.2.2.1);
(b) If this is data on health effects:
- by the application of the methods specified in Annex V, unless, in the case of phytopharmaceuticals, other internationally recognized methods are acceptable, in accordance with Annex II and III of Directive 91/414/EEC (Article 6, paragraph 1, point b, of Directive 1999/45/EC);
- and/or the application of a conventional method referred to in Articles 15 to 18 and Annex II, Parts A.1 to A.6 and B.1 to B.5, Directive 1999/45/EC, or
- in the case of risk phrase R 65, by applying the rules set out in 3.2.3;
- however, if it is the assessment of carcinogenic or mutagenic properties or of reproductive toxicity, by the application of a conventional method referred to in sections 15 to 18 and Appendix II, Parts A.7 to A.9 and B.6 of Directive 1999/45/EC;
(c) If this is data on ecotoxicological properties:
(i) With respect to aquatic toxicity only:
- by applying the methods specified in Annex V, subject to the conditions specified in Annex III, Part C, of Directive 1999/45/EC, unless, in the case of phytopharmaceutical products, other internationally recognized methods are acceptable in accordance with the provisions of Annexes II and III of Directive 91/414/EEC (Article 7, paragraph 1, item b, of Directive 1999/45/EC),
- by applying a conventional method referred to in Article 7 and Annex III, Parts A and B, of Directive 1999/45/EC;
(ii) With respect to the assessment of the potential for bioaccumulation (or effective bioaccumulation), the determination of log Po/e (or BCF) or, with respect to the assessment of degradability, the application of a conventional method referred to in Article 7 and Annex III, Parts A and B, of Directive 1999/45/EC;
(iii) With respect to ozone layer hazards, the application of a conventional method referred to in Article 7 and Annex III, Parts A and B, of Directive 1999/45/EC.
Note regarding animal testing:
Testing on animals for experimental data is subject to the requirements of Directive 86/609/EEC on the protection of animals used for experimental purposes.
Note concerning physico-chemical properties:
For organic peroxides and organic peroxides preparations, the data may be obtained by the calculation method described in paragraph 9.5. For gaseous preparations, a calculation method can be used for flammability properties and oxidizing properties (see point 9).
1.7. Application of the criteria of the guide.
The classification shall cover the physico-chemical, toxicological and ecotoxicological properties of substances and preparations.
The classification of substances and preparations shall be carried out in accordance with point 1.6, based on the criteria set out in paragraphs 2 to 5 (substances) and in items 2, 3, 4.2.4 and 5 of this annex. All types of risks must be considered. For example, a classification according to point 3.2.1 does not imply that points 3.2.2 or 3.2.4 are perdeated.
The selection of the symbol(s) and the risk phrase(s) is made on the basis of the classification, so as to ensure that the specific nature of potential hazards identified in the classification will be well mentioned on the label.
Notwithstanding the criteria set out in 2.2.3, 2.2.4 and 2.2.5, substances and preparations in the form of aerosols are subject to the provisions of amended Directive 75/324/EEC and adapted to technical progress.
1.7.1. Definitions.
"Substances" means the chemical elements and their compounds to the natural state or as obtained by any production process, containing any additive necessary to preserve the stability of the product and any deriving impurity of the process, excluding any solvent that may be separated without affecting the stability of the substance or altering its composition.
A substance can be very well defined chemically (e.g. acetone) or a complex mixture of variable composition components (e.g. aromatic distillates). For some complex substances, individual components are sometimes identified.
"preparations" means mixtures or solutions composed of two or more substances.
1.7.2. Application of the criteria of the guide for substances.
The guidance criteria in this Appendix are directly applicable when the data has been obtained from test methods comparable to those used in Appendix V. In other cases, the available data will be evaluated by comparing the test methods used with those listed in Appendix V and with the appropriate classification and labelling rules referred to in this annex.
There may be a doubt about the application of the criteria, particularly where the use of the expert advice is necessary. The manufacturer, distributor or importer must then provisionally classify and label the subject substance based on an assessment of the evidence by a competent person.
Without prejudice to Article 6 of Directive 67/548/EEC, in cases where the above-mentioned procedure has been applied and where there are concerns about possible inconsistencies, the provisional classification may be proposed for its introduction in Appendix I. This proposal shall be submitted to one of the member States and shall be accompanied by all necessary scientific information (see also item 4.1).
A similar procedure may be applied if new information is used to question the accuracy of an existing entry in Appendix I.
1.7.2.1. Classification of substances containing individual impurities, additives or components.
When individual impurities, additives or components of substances have been identified, they must be taken into account if their concentration is greater than or equal to the concentration limits set to:
0.1% for substances classified as highly toxic, toxic, carcinogenic (category 1 or 2), mutagenics (category 1 or 2), toxic to reproduction (category 1 or 2) or hazardous to the environment (affected by the symbol "N", that is, dangerous to the aquatic environment, hazardous to the ozone layer);
1% for substances classified as harmful, corrosive, irritating, sensitivizing, carcinogenic (category 3), mutagenics (category 3), toxic to reproduction (category 3) or hazardous to the environment (not affected by the "N" symbol, that is, harmful to aquatic organisms, may cause long-term adverse effects),
unless lower values are set out in Appendix I.
With the exception of substances specifically listed in Appendix I, the classification shall be carried out in accordance with the provisions of sections 5, 6 and 7 of Directive 1999/45/EC.
In the case of asbestos (650-013-00-6), this general rule is not applicable until a concentration limit is set out in Appendix I. Substances containing asbestos shall be classified and labelled according to the principles set out in section 6 of Directive 67/548/EEC.
1.7.3. Application of the criteria for the preparation guide.
The guidance criteria in this Appendix are directly applicable when the data has been obtained from test methods comparable to those used in Appendix V, except for the criteria in point 4 to which the conventional method applies only. A conventional method is also applicable with respect to the criteria in point 5, except for aquatic toxicity, subject to the conditions set out in Annex III, Part C, of Directive 1999/45/EC. For preparations under Directive 91/414/EEC, classification and labelling data may also be obtained by other internationally recognized methods (see special provisions in item 1.6 of this annex). In other cases, the available data will be evaluated by comparing the test methods used with those listed in Appendix V and with the appropriate classification and labelling rules set out in this annex.
If the health and environmental risks are assessed by applying a conventional method referred to in Articles 6 and 7 and in Annexes II and III to Directive 1999/45/EC, the individual limits of concentration shall be used:
- Annex I to Directive 67/548/EEC;
- either in Annex II, Part B, and/or Annex III, Part B, of Directive 1999/45/EC where the substance(s) are not listed in Annex I to Directive 67/548/EEC or are contained without concentration limits.
In the case of preparations containing gas mixtures, the classification of effects on health and the environment will be determined by the method of calculation, on the basis of the individual concentration limits set out in Annex I to Directive 67/548/EEC or, if these limits are not included, on the basis of the criteria in Annexes II and III to Directive 1999/45/EC.
1.7.3.1. Preparations or substances described in 1.7.2.1 used as components of another preparation.
The labelling of such preparations shall be in accordance with the provisions of Article 10 of Directive 1999/45/EC, in accordance with the principles set out in Articles 3 and 4 of Directive 1999/45/EC. In some cases, the information on the label of the preparation or substance described in point 1.7.2.1 is nevertheless insufficient to allow other manufacturers, wishing to use it as a component of their own preparation(s), to correctly perform the classification and labelling of their preparation(s).
In these cases, the person established in the Community responsible for the marketing of the initial preparation or the initial substance described in paragraph 1.7.2.1., whether the manufacturer, importer or distributor, must provide, upon justified request and as soon as possible, all necessary data on the hazardous substances present to allow a proper classification and labelling of the new preparation. This data is also necessary to enable the person responsible for placing the new preparation on the market to comply with the other requirements of Directive 1999/45/EC.
2. Classification based on physico-chemical properties
2.1. Introduction.
Test methods for explosive properties, oxidizing properties and flammability properties in Appendix V are used to provide a specific meaning to the general definitions given in section 2, paragraph 2, points a to e. The criteria directly follow the test methods specified in Appendix V, to the extent that these are mentioned.
If there is adequate information showing that, in practice, the physico-chemical properties of substances and preparations (with the exception of organic peroxides) differ from those that result from the application of the test methods set out in Appendix V, these substances and preparations shall be classified according to the risk that they may present for persons who manipulate them or for others.
2.2. Classification criteria, choice of symbols and hazard indications and choice of phrases indicating risks.
In the case of preparations, consideration should be given to the criteria referred to in Article 5 of Directive 1999/45/EC.
2.2.1. Explosive substances and preparations.
Substances and preparations will be classified as explosive and characterized by the symbol "E" and the hazard indication "explosive" based on the results of the tests referred to in Appendix V and to the extent that they are explosive in their commercialized form. The inclusion of a sentence indicating risks is mandatory; it will be amended to read:
R 2 Risk of explosion by impact, friction, fire or other sources of ignition:
- substances and preparations, except as specified below.
R 3 Large risk of explosion by shock, friction, fire or other sources of ignition:
- particularly sensitive substances and preparations such as salts of picric acid, tetra pentaérythritol nitrate (penthrite).
2.2.2. oxidizing substances and preparations.
Substances and preparations will be classified as oxidizing and characterized by the "O" symbol and by the "oxidizing" hazard indication based on the results of the tests referred to in Appendix V. The inclusion of a sentence indicating risks is mandatory; it will be based on the test results, taking into account the following:
R 7 May cause a fire:
- organic peroxides that have flammable characteristics, even when they are not in contact with other fuel materials.
R 8 Promotes ignition of fuel materials:
- other oxidizing substances and preparations, including inorganic peroxides, which may ignite or increase the risk of flammability when in contact with fuel materials.
R 9 Can explode in mixture with fuels:
- other substances and preparations, including inorganic peroxides, become explosive when mixed with fuel materials, such as some chlorates.
2.2.2.1. Remarks on peroxides.
For explosive properties, organic peroxide or organic peroxide preparation are classified, in the form in which they are marketed, according to the criteria set out in 2.2.1, on the basis of tests conducted in accordance with the methods described in Appendix V.
For oxidizing properties, the methods in Appendix V cannot apply to organic peroxides.
For substances, organic peroxides that are not already classified as explosive are classified as hazardous on the basis of their structure (e.g., R-O-H; R1-O-R2).
Preparations that are not already classified as explosive will be classified using the calculation method based on the presence of active oxygen, as described in 9.5.
Any organic peroxide or any organic peroxide formulation that is not already classified as explosive is classified as oxidizing if peroxide or its formulation contains:
- more than 5% organic peroxides, or
- more than 0.5% oxygen available from organic peroxides and more than 5% hydrogen peroxide.
2.2.3. Extremely flammable substances and preparations.
Substances and preparations will be classified as extremely flammable and characterized by the symbol "F+" and by the extremely flammable hazard indication based on the results of the tests referred to in Appendix V. The risk phrase will be assigned according to the following criteria:
R 12 Extremely flammable:
- liquid substances and preparations whose flashpoint is less than 0 °C and boiling temperature (or, in the case of a distillation interval, the initial boiling temperature) less than or equal to 35 °C;
- gaseous substances and preparations which, at room temperature and pressure, are flammable to air.
2.2.4. Easily flammable substances and preparations.
Substances and preparations will be classified as easily flammable and characterized by the symbol "F" and the hazard indication "easy flammable" based on the results of the tests referred to in Appendix V. Risk statements will be issued according to the following criteria:
R 11 Easily flammable.
Substances and solid preparations that can easily ignite after a brief contact with an ignition source and continue to burn or consume after removal of this source.
Liquid substances and preparations whose flashpoint is less than 21°C but which are not extremely flammable.
R 15 In contact with water, release extremely flammable gases.
Substances and preparations that, in contact with water or wet air, release extremely flammable gases in dangerous quantities at a minimum of 1 l/kg/h.
R 17 Spontaneously flammable to air.
Substances and preparations that can heat up and eventually ignite in contact with air at room temperature, without energy supply.
2.2.5. Flammable substances and preparations.
Substances and preparations will be classified as flammable according to the results of the tests referred to in Appendix V. The risk phrase will be assigned according to the following criteria:
R 10 Inflammable.
Liquid substances and preparations whose flashpoint is greater than or equal to 21 °C and less than or equal to 55 °C.
However, in practice, it has been shown that preparations with a flashpoint greater than or equal to 21°C and less than or equal to 55°C do not need to be classified flammable if the preparation cannot in any way promote combustion and only if there is no risk to be feared for persons handling these preparations or for others.
2.2.6. Other physico-chemical properties.
Additional phrases indicating risks will be assigned to substances and preparations classified in accordance with 2.2.1 to 2.2.5 above or to items 3, 4 and 5, taking into account the following criteria (based on the experience gained in the development of Appendix I):
A 1 Explosive in dry condition.
Explosive substances and preparations put on the market in solution or wet form, for example nitrocellulose containing more than 12.6% nitrogen.
R 4 Form of highly sensitive explosive metal compounds.
Substances and preparations that may give rise to sensitive explosive metal derivatives, such as picric acid, styphnic acid.
A 5 Danger of explosion under heat action.
Unstable heat substances and preparations, not classified as explosives, e.g. perchloric acid ✱ 50%.
A 6 Danger of explosion in contact or contact with air.
Unstable substances and preparations at room temperature, such as acetylene.
R 7 Can cause a fire.
Reactive substances and preparations, such as fluorine, sodium hydrosulfite.
A 14 Reacts violently to water contact.
Substances and preparations strongly react with water, such as acetyle chloride, alkali metals, titanium tetrachloride.
R 16 Can explode in mixture with oxidizing substances.
Substances and preparations reacting explosively in the presence of oxidizing agents, such as red phosphorus.
R 18 During use, possible formation of flammable/explosive vapour-air mixture.
Preparations not classified as flammable as such, containing flammable air volatile components.
R 19 May form explosive peroxides.
Substances and preparations that may form explosive peroxides during storage, e.g. ethyl ether, 1.4-dioxane.
R 30 Can become easily flammable during use.
Preparations not classified as flammable as such, but may become flammable by loss of non-flammable volatile components.
R 44 Risk of explosion so heated in confined atmosphere.
Applies to substances and preparations that are not in themselves classified as explosive in accordance with 2.2.1, but which may nevertheless present in practice explosive properties when heated in a sufficiently confined atmosphere. Thus, some substances that would be decomposed in an explosive manner if heated in a steel container do not have this characteristic when heated in less resistant containers.
For other additional phrases indicating risks, see item 3.2.8.
3. Classification on toxicological properties
3.1. Introduction.
3.1.1. The classification concerns both the acute effects and the long-term effects of substances and preparations, that these effects arise from a single repeated or prolonged exposure or exposure.
When it can be demonstrated, by epidemiological studies, by scientifically based case studies as specified in this annex or by the statistically verified practical experience, for example, by the assessment of data from poison information centres or concerning occupational diseases, that the toxicological effects on man differ from those observed in the application of the methods referred to in paragraph 1.6 of this annex, the substance However, human testing must be unadvised and cannot be used, as a general rule, to cancel positive data from animal testing.
Directive 86/609/EEC aims to protect animals used for experimental purposes and for other scientific purposes. For several types of toxicity, there are validated in vitro test methods listed in Appendix V of Directive 67/548/EEC; these methods, if any, must be used.
3.1.2. The classification of substances must be based on available experimental data, according to the following criteria that take into account the importance of these effects:
(a) For acute toxicity (lethal and irreversible effects after a single exposure), the criteria of points 3.2.1 to 3.2.3 shall be used;
(b) For subacute, subchronic or chronic toxicity, the criteria of points 3.2.2 to 3.2.4 shall be used;
(c) For corrosive and irritating effects, the criteria of points 3.2.5 and 3.2.6 shall be used;
(d) For sensitivizing effects, the criteria of item 3.2.7 shall be used;
(e) For specific health effects (carcinogenic, mutagenic and toxic effects for reproduction), the criteria in point 4.
3.1.3. For preparations, the classification of health hazards is made:
(a) Based on a conventional method referred to in Article 6 and Appendix II of Directive 1999/45/EC, in the absence of experimental data. In this case, the classification is based on the individual concentration limits of:
- Annex I to Directive 67/548/EEC;
- either Annex II, Part B, of Directive 1999/45/EC where the substance(s) do not appear in Annex I to Directive 67/548/EEC or do not contain a concentration limit;
(b) Or, where experimental data are available, according to the criteria described in 3.2.1, except for carcinogenic, mutagenic and toxic properties for reproduction referred to in 3.1.2(e), to be assessed by a conventional method referred to in Article 6 and Annex II, Parts A.7 to A.9 and B.6 of Directive 1999/45/EC.
Note: without prejudice to the provisions of Directive 91/414/EEC, it is only when the person responsible for the marketing of a preparation can scientifically demonstrate that the toxicological properties of this preparation cannot be properly determined either by applying the method referred to in paragraph 3.1.3(a), or by relying on the available results of tests carried out on animals that the methods referred to in paragraph 3.1.3(b) may be used, provided that this is authorized
Regardless of the method used to assess the danger of a preparation, consideration should be given to all hazardous health effects as defined in Annex II, Part B, of Directive 1999/45/EC.
3.1.4. When classification is to be based on experimental results derived from animal testing, the results must be validated for man, to the extent that these tests reveal, in an appropriate manner, the existence of risks to man.
3.1.5. Acute oral toxicity of the substance or preparation on the market may be determined either by a method to assess the DL50, or by determining the discriminating dose (fixed dose method), or by determining the range of exposure values that may lead to lethality (acute toxicity class method).
3.1.5.1. The discriminating dose is the dose that results in manifest but no mortality and must be one of the four doses specified in Appendix V (5, 50, 500 or 2,000 mg of body weight).
The concept of "Manifest Toxicity" is used to describe toxic effects, after exposure to the tested substance, whose severity is such that exposure to the immediately higher dose would likely lead to death.
The results of the test at a given dose, according to the fixed dose method, may be:
- survival below 100%;
- survival equal to 100%, but manifest toxicity;
- survival equal to 100%, but not manifest toxicity.
The criteria in points 3.2.1, 3.2.2 and 3.2.3 indicate only the final result of the test. It is necessary to use the dose of 2,000 mg/kg primarily to obtain information on the toxic effects of substances with low acute toxicity that are not classified on the basis of acute toxicity.
The fixed dose method requires in some cases to perform the test at higher or lower doses if it has not already been performed at the relevant dose. Reference is made to the Evaluation Table for Test Method B.1 bis of Appendix V.
3.1.5.2. The range of exposure values that may result in lethality is deducted from the absence or observed presence of a substance-related mortality, based on the method of the acute toxicity class. For the first test, a dose is used between three doses of starting time fixed (25, 200 or 2,000 mg per kg of body weight).
The method of the acute toxicity class requires in some cases to perform the test at higher or lower doses, if not already done at the relevant dose. Reference is made to the assessment table for the test method B.1 ter in Appendix V.
3.2. Classification criteria, choice of symbols and hazard indication and choice of phrases indicating risks.
3.2.1. Very toxic substances and preparations.
Substances and preparations will be classified as very toxic and characterised by the "T+" symbol and the "very toxic" hazard indication in accordance with the criteria specified below.
The risk phrases are assigned in accordance with the following criteria:
R 28 Very toxic in case of ingestion.
Acute toxicity:
LD50 oral, rat: 25 mg/kg;
Survival less than 100% to 5 mg/kg oral, rat (fixed dose method), or
High dose mortality 25 mg/kg oral, in rats, by the acute toxicity class method (for interpretation of test results, see also the assessment tables in Appendix 2 of Appendix V test method B.1 ter).
R 27 Very toxic by contact with the skin.
Acute toxicity:
DL50 by skin, rat or rabbit: 50 mg/kg.
R 26 Very toxic by inhalation.
Acute toxicity:
CL50 by inhalation, rat, for aerosols or particles: 0.25 mg/l/4 hours,
CL50 by inhalation, rat, for gases and vapours: 0.5 mg/l/4 hours.
A 39 Danger of very serious irreversible effects.
Very clear evidence that irreversible damage, different from the effects cited in point 4, can be caused by a single exposure by an adequate path, usually within the range of the above values.
To indicate the mode of administration/exposure, one of the following combined phrases will be used:
R 39/26, R 39/27, R 39/28, R 39/26/27, R 39/26/28, R 39/27/28, R 39/26/27/28.
3.2.2. Toxic substances and preparations.
Substances and preparations will be classified as toxic and characterized by the "T" symbol and the "toxic" indication in accordance with the criteria specified below. The risk phrases are assigned in accordance with the following criteria:
R 25 Toxic in case of ingestion.
Acute toxicity:
oral DL50, rat: 25 < DL50 200 mg/kg;
Oral discriminating dose, rat, 5 mg/kg: 100% survival, but manifest toxicity, or
High mortality from 25 mg/kg and up to 200 mg/kg orally, in rats, by the acute toxicity class method (for interpretation of test results, see assessment tables in Appendix 2 of Appendix V's B.1 ter test method).
R 24 Toxic by contact with the skin.
Acute toxicity:
DL50 by skin, rat or rabbit: 50 < DL50 400 mg/kg.
R 23 Toxic by inhalation.
Acute toxicity:
CL50 by inhalation, rat, for aerosols or particles: 0.25 < CL50 1 mg/l/4 hours;
CL50 by inhalation, rat, for gases and vapours: 0.5 < CL50 2 mg/l/4 hours.
A 39 Danger of very serious irreversible effects.
Very clear evidence that irreversible damage, different from the effects cited in point 4, can be caused by a single exposure by an adequate path, usually within the range of the above values.
To indicate the mode of administration/exposure, one of the following combined phrases will be used: R 39/23, R 39/24, R 39/25, R 39/23/24, R 39/23/25, R 39/24/25, R 39/23/24/25.
R 48 Risk of serious health effects in the event of prolonged exposure.
Serious lesions (functional rubles or morphological changes that are toxicologically important) may result from repeated or prolonged exposure, by adequate means.
Substances and preparations will be classified at least as toxic when these effects are observed at significantly lower doses (i.e. ten times) than those set for sentence R 48 at 3.2.3.
To indicate the mode of administration/exposure, one of the following combined phrases will be used: R 48/23, R 48/24, R 48/25, R 48/23/25, R 48/24/25, R 48/23/24/25.
3.2.3. Noxious substances and preparations.
Substances and preparations will be classified as harmful and characterized by the symbol "Xn" and the hazard indication "nocif" in accordance with the criteria set out below. The risk phrases will be assigned in accordance with the following criteria:
R 22 Nocif in case of ingestion.
Acute toxicity:
oral DL50, rat: 200 < DL50 2,000 mg/kg;
Oral discriminating dose, rat, 50 mg/kg: 100% survival, but manifest toxicity;
Survival less than 100% to 500 mg/kg oral, rat (fixed dose method).
Refer to the assessment table for the B1 bis test method in Appendix V, or high mortality from 200 mg/kg and up to 2,000 mg/kg, orally, in the rat, by the acute toxicity class method (for the interpretation of the test results, see the evaluation tables in Appendix 2 of the B1 ter test method in Appendix V).
R 21 Nocif by contact with the skin.
Acute toxicity:
DL50 by skin, rat or rabbit: 400 < DL50 2,000 mg/kg.
R 20 Nocif by inhalation.
Acute toxicity:
CL50 by inhalation, rat, for aerosols or particles: 1 < CL50 5 mg/l/4 hours;
CL50 by inhalation, rat, for gases or vapours: 2 < CL50 20 mg/l/4 hours.
R 65 Nocif: may cause an ingestion of the lungs.
Liquid substances and preparations that pose a danger to man in the event of aspiration due to their low viscosity:
(a) For substances and preparations containing aliphatic, alicyclic and aromatic hydrocarbons in a total concentration greater than or equal to 10% and having:
A flow time of less than 30 seconds in an ISO cut of 3 mm, in accordance with ISO 2431 (April 1996/July 1999) for "paintings and varnishes - determination of flow time by means of flow cuts";
Either a cinematic viscosity less than 7 x 10-6 m2/s at 40 °C, measured by a calibrated viscometer in glass in accordance with ISO 3104 (ISO 3104, 1994 edition) concerning "oil products - opaque and transparent liquids - determination of the cinematic viscosity and calculation of the dynamic viscosity" or ISO 3105 (ISO 3105, 1994 edition)
Either a cinematic viscosity less than 7 x 10-6 m2/s than 40 °C, deducted from measurements by rotary viscometer in accordance with ISO 3219 (ISO 3219, 1993 edition) concerning "plastics - polymers/resins with liquid state, emulsion or dispersion - viscosity determination by means of a rotary viscometer with a target speed gradient".
It should be noted that substances and preparations meeting these criteria do not need to be classified if their average superficial voltage is greater than 33 mN/m at 25 °C, measured by Nouy tensiometer, or according to the test methods specified in Annex V, Part A.5;
(b) For substances and preparations, based on practical experience in humans.
R 68 Possibility of irreversible effects.
Very clear evidence that irreversible damage, different from the effects cited in point 4, can be caused by a single exposure by an adequate path, usually within the range of the above values.
To indicate the mode of administration/exposure, one of the following combined phrases will be used:
R 68/20, R 68/21, R 68/22, R 68/20/21, R 68/20/22, R 68/21/22, R 68/20/21/22.
R 48 Risk of serious health effects in the event of prolonged exposure.
Serious lesions (functional rubles or morphological modifications with toxicological significance) may result from repeated or prolonged exposure by an adequate pathway.
Substances and preparations will be classified at least as harmful when these effects are observed at doses of:
- oral, rat: 50 mg/kg (body weight)/day;
- skin, rat or rabbit: 100 mg/kg (body weight)/day;
- by inhalation, rat: 0.25 mg/l, 6 hours/day.
These indicative values may apply directly when severe lesions have been found in a subchronic toxicity study (90 days). For the interpretation of the results of a subacute toxicity study (28 days), these numbers must be multiplied by approximately 3. If a chronic toxicity study (2 years) is available, it should be considered on a case-by-case basis. If the results of studies of different durations are available, the results of the longest study should normally be retained.
To indicate the mode of administration/exposure, one of the following combined phrases will be used: R 48/20, R 48/21, R 48/22, R 48/20/21, R 48/21/22, R 48/20/21/22.
3.2.3.1. Comments on volatile substances.
For some high saturating vapour concentration substances, some elements may indicate effects of concern. Such substances may not be classified according to the health effects criteria set out in this guide (item 3.2.3) or not covered by the provisions of item 3.2.8.
However, where adequate evidence exists that these substances may pose a risk associated with normal handling and use, the classification in Appendix I may be necessary, on a case-by-case basis.
3.2.4. Comments on the use of sentence R 48.
The use of this risk sentence refers to the specific range of biological effects in the terms described below. For the purposes of this risk sentence, it should be considered that serious health injuries include death, obvious functional disorders or significant morphological changes from a toxicological perspective. This is particularly important when these changes are irreversible. It is also necessary to consider not only the serious changes specific to a single organ or biological system, but also the generalized changes that are less severe in several organs or the serious changes in the general health.
To determine the evidence of these types of effects, reference should be made to the following guidelines:
1. Evidence that sentence R 48 should be applied:
(a) Deaths related to the substance;
(b) (i) major functional changes in the central or peripheral nervous system, including sight, hearing and smell, determined by clinical observations or other appropriate methods (e.g. electrophysiological);
(ii) major functional changes of another organ (e.g. lungs);
(c) Any significant changes in the parameters of clinical biochemistry, hematology or urine analysis that reveal a serious malfunction of an organ. Hematological disorders are considered particularly important if it appears that they are due to the decrease in the production of blood cells by bone marrow;
(d) Serious damage to an organ, observed under a microscope after autopsy:
(i) extended or severe necrosis, fibrosis or granuloma formation in vital organs with regenerative capacity (e.g. liver);
(ii) severe morphological changes that are potentially reversible but which clearly indicate a pronounced organic dysfunction (e.g. severe liver fat filtration, severe acute kidney tubular necrosis, ulcerative gastritis), or
(iii) evidence of significant cell mortality in vital organs unable to regenerate (e.g. fibrosis of myocardial or retrograde degeneration of a nerve) or in stem cell populations (e.g. flat or bone marrow hypoplasia).
The evidence mentioned above will be most of the time obtained by experiments on animals. When considering data from practical experience, particular attention must be paid to exposure levels.
2. Evidence that sentence R 48 should not be applied:
The use of this risk sentence is limited to "serious health injury in the event of prolonged exposure". Number of effects related to substances could be observed both on man and animal, but without justification for the use of sentence R 48. These effects are important when trying to determine an effective dose for a chemical. Examples of well-established amendments that would normally not justify a classification with sentence R 48, without taking into account their meaning, include:
(a) Clinical observations or changes in the increase in body weight, consumption of food or water that may have some toxicological significance but do not indicate, as such, "serious injury";
(b) slight changes in the parameters of clinical biochemistry, hematology or urine analysis that are of doubtful or minimal toxicological importance;
(c) Organ weight changes without proof of organic dysfunction;
(d) Adaptive reactions (e.g. macrophages in the lungs, liver hypertrophy and enzyme induction, hyperplastic reactions to irritating substances); the local effects on the skin produced by a repeated skin application of a substance, which would normally be better characterized by the phrase R 38 "irritating to the skin"; or
(e) When a specific mechanism of toxicity of the animal species has been demonstrated (e.g. by specific metabolic pathways).
3.2.5. Corrosive substances and preparations.
The substance or preparation shall be classified as corrosive and characterized by the symbol "C" and by the indication of "corrosive" danger, in accordance with the following criteria:
A substance or preparation is considered to be corrosive if, when applied to the healthy and intact skin of an animal, it produces tissue destruction over the entire depth of the skin, in an animal at least, during the skin irritation test referred to in Appendix V or when applying an equivalent test method;
Classification can be based on validated in vitro test results such as those listed in Appendix V (B.40. Skin corrosion: transcutaneous electric resistance test on rat skin and human skin model test;
A substance or preparation shall also be considered as corrosive when the result of the test can be predicted, for example in cases of highly acidic or alkaline reactions, indicated by a pH less than or equal to 2 or greater than or equal to 11.5. However, where the classification is based on an extreme pH value, it is also possible to consider the acid or alkaline reserve (1). If the acid or alkaline reserve suggests that the substance or preparation may not be corrosive, it is necessary to continue the tests to confirm the hypothesis, preferably by conducting a validated in vitro test. The acid or alkaline reserve argument alone is not sufficient to justify the decision not to classify a substance or preparation as "corrosive".
The risk phrases are assigned in accordance with the following criteria:
R 35 Causes serious burns:
- if, during an application on the healthy and intact skin of an animal, tissue destruction appears on the entire depth of the skin after a exposure time not exceeding three minutes or if such result is predictable.
R 34: Burns:
- if, in an application on the healthy and intact skin of an animal, tissue destruction appears on the entire depth of the skin after an exposure time not exceeding four hours or if such result is predictable;
- organic hydroperoxides, unless there is evidence to the contrary.
Remarks:
When the classification is based on the results of a validated in vitro test, it is necessary to use the phrase R 35 or R 34 depending on the ability of the test to distinguish the corresponding effects.
If the classification is based solely on the determination of an extreme pH value, the phrase R 35.
3.2.6. irritating substances and preparations.
Non-corrosive substances and preparations will be classified as irritating, characterized by the symbol "Xi" and the hazard indication "irritating" in accordance with the criteria mentioned below.
3.2.6.1. Inflammation of the skin.
The following risk sentence is assigned in accordance with the criteria given:
R 38 Irritant for skin:
- substances and preparations that cause significant inflammation of the skin, present for at least 24 hours after an exposure period not exceeding four hours, determined in the rabbit in accordance with the skin irritation test method described in Appendix V.
Skin inflammation is important if:
(a) The average score, for all test animals, for erythema and skeleton formation or edema formation is greater than or equal to 2, or
(b) If the test referred to in Appendix V was performed on 3 animals, when the formation of erythema and skeleton or the formation of edema equal to or equal to 2 for each animal, at least 2 animals.
In both cases, all scores obtained at each reading of an effect (24, 48 and 72 hours) should be used to calculate the respective average values.
Inflammation of the skin is also important if it persists on at least 2 animals at the end of the observation period. Special effects should be taken into account, for example, hyperplasia, desquamation, discoloration, cracks, streaks and alopecia.
Useful data can also be obtained from non-acute animal exposure studies (see comments on R 48, point 2, d). Effects are considered important if they are comparable to those described above:
- substances and preparations that cause significant inflammation of the skin in an instant, prolonged or repeated contact, based on practical observations in humans;
- organic peroxides, unless there is evidence to the contrary.
Paresthesia:
Human paresthesia caused by skin contact with pyrethroid pesticides is not considered an irritating effect to classify Xi; R 38. However, S 24 should be applied to substances that are likely to cause this effect.
3.2.6.2. Eye damage.
The following risk phrases are also assigned in accordance with the criteria given:
R 36 Irritant for the eyes:
- substances and preparations that, in the event of application on the animal's eye, cause significant eye damage that occur within 72 hours of instillation and persist for at least 24 hours.
Eye injuries are considered important if the average of the test scores in Appendix V has one of the following values:
- corneal opacity greater than or equal to 2 but less than 3;
- lesion of the iris greater than or equal to 1, less than or equal to 1.5;
- redness of the conjunctive greater than or equal to 2.5;
- Economic edema (chemosis) greater than or equal to 2,
or if the test referred to in Schedule V has been performed on 3 animals, where lesions on at least 2 animals are equivalent to one of the above values, except for the lesion of the iris where the value must be greater than or equal to 1 but less than 2 and the redness of the conjunctive where the value must be greater than or equal to 2.5.
In both cases, all scores obtained at each reading of an effect (24, 48 and 72 hours) should be used to calculate the respective average values:
- substances and preparations that cause significant eye damage, based on practical observations in man;
- organic peroxides, unless there is evidence to the contrary.
R 41 Risk of severe eye damage:
- substances and preparations that, in the event of application on the animal's eye, cause serious eye damage that occur within 72 hours of instillation and persist for at least 24 hours.
Eye lesions must be considered severe if the average of the eye irritation test scores in Appendix V has one of the following values:
- corneal opacity greater than or equal to 3;
- Iris lesion greater than 1.5.
The same is true if the test was performed on 3 animals, when these lesions on at least 2 animals are equivalent to one of the following values:
- corneal opacity greater than or equal to 3;
- Iris lesion equal to 2.
In both cases, all scores obtained at each reading of an effect (24, 48 and 72 hours) should be used to calculate the respective average values.
Eye injuries are also severe when they persist at the end of the observation period.
Eye lesions are also severe if the substance or preparation causes irreversible coloration of the eyes:
- substances and preparations that cause severe eye damage, based on practical observations in humans.
Note:
When a substance or preparation is classified as corrosive with R 34 or R 35, the risk of serious eye damage is considered implicit and R 41 is not mentioned on the label.
3.2.6.3. Irritation of the respiratory system.
The following risk sentence will be assigned in accordance with the following criteria:
R 37 Respiratory Irritant:
Substances and preparations that cause severe irritation of the respiratory system, on the basis of:
- observations in man;
- positive results obtained during appropriate tests on the animal.
Comments on the use of sentence R 37:
It is appropriate, by interpreting the observations in man, to distinguish between the effects resulting in classification with sentence R 48 (see point 3.2.4) and the effects resulting in classification with sentence R 37. Conditions normally leading to classification with R 37 are reversible and generally limited to upper respiratory tracts.
Positive results obtained during appropriate tests in the animal may include data obtained in a general toxicity test, including histopathological data concerning the respiratory system. Data obtained from the measurement of experimental bradypnea can also be used to assess respiratory irritation.
3.2.7. Awareness.
3.2.7.1. Inhalation awareness.
Substances and preparations will be classified as sensitivizing and characterized by the symbol "Xn", the hazard indication "nocif" and the risk phrase R 42, in accordance with the criteria mentioned below:
R 42 May cause inhalation awareness:
- if it is established that the substance or preparation concerned may cause a specific respiratory hypersensitivity in man;
- if appropriate animal testing has yielded positive results, or
- if the substance isocyanate, unless there is evidence that this specific isocyanate does not cause respiratory hypersensitivity.
Comments on the use of sentence R 42:
Evidence of effects in man:
Evidence that the substance or preparation may cause specific respiratory hypersensitivity will in principle be based on human experience. In this context, asthma is considered an expression of hypersensitivity, but other reactions of hypersensitivity such as rhinitis and alveolite are also taken into consideration. Observed manifestations should have the clinical character of an allergic reaction. However, it is not necessary to demonstrate the immunological character of the mechanisms.
When evidence comes from human exposure data, it is necessary to take into account, in addition to the evidence provided by the cases examined, the following elements:
- importance of the population exposed;
- scope of the exhibition.
The above-mentioned evidence may be:
Appropriate clinical history and respiratory functional tests related to exposure to the substance, confirmed by other evidence, such as:
- a chemical structure related to substances known to cause respiratory hypersensitivity;
- an immunological test in vivo (e.g. prick skin test);
- an immunological test in vitro (e.g. serologic analysis);
- studies highlighting other specific but not immunological mechanisms, for example, repeated slight irritation, effects related to pharmacological action, or
- positive results obtained during bronchial provocative tests carried out with the substance and performed according to recognized guidelines for the determination of a specific hypersensitivity reaction.
Clinical backgrounds must include both medical and professional backgrounds to determine the relationship between exposure to a particular substance or preparation and the development of respiratory hypersensitivity. The information to be taken into account includes the aggravation factors, both in the home and in the workplace, the onset and evolution of the disease, the family and medical history of the patient. Medical history should also include mentioning other allergic or respiratory disorders that have occurred since childhood as well as a history of smoking.
Positive results of bronchial provocative tests are considered to provide sufficient evidence to result in classification. However, it is recognized that in practice many of the above reviews have already been conducted.
Substances that cause asthma symptoms by irritation only in subjects with bronchial hyperreactivity should not be classified with sentence R 42.
Animal studies:
Experimental data that may indicate for a substance or preparation an inhaling potential in man may include:
- measurements of IgE (e.g. on the mouse), or
- specific lung reactions in the guinea pig.
3.2.7.2. Sensitization by skin contact.
Substances and preparations will be classified as sensitivizing and characterized by the symbol "Xi", the hazard indication "irritating" and the risk phrase R 43, in accordance with the criteria mentioned below:
R 43 May raise awareness by contact with the skin:
- if the experience shows that the substance or preparation can cause skin contact awareness in a significant number of people, or
- if appropriate animal testing results.
Comments regarding the use of sentence R 43:
Evidence of effects in man:
The following evidence (common experience) is sufficient to classify a substance or preparation with sentence R 43:
- positive results of appropriate epicutaneous tests (patch tests) obtained in principle in more than one dermatological clinic, or
- epidemiological studies showing the occurrence of allergic contact dermatitis caused by the substance or preparation. The circumstances in which a high proportion of people exposed manifest characteristic symptoms must be studied with particular attention, even if the cases are few, or
- positive data obtained during experimental studies in humans (see also point 3.1.1).
The following elements are sufficient to classify a substance with sentence R 43 when supported by additional evidence:
- isolated episodes of allergic contact dermite, or
- epidemiological studies for which elements related to chance, bias or confusion were not excluded with a reasonable degree of certainty.
Additional evidence to support the above elements may include:
- data obtained during animal testing conducted according to recognized guidelines, giving results that do not meet the criteria set out in the animal studies point, but close enough to the limits to be considered significant, or
- data obtained by unstandardized methods, or
- appropriate structural-activity relationships.
Animal studies:
Positive results of appropriate tests in the animal are:
- in the case of the adjuvant type test method for skin sensitization described in Appendix V or in the case of other adjuvant type test methods, a response of at least 30% of animals is considered positive;
- for any other test method, a response of at least 15% of animals is considered positive.
3.2.7.3. Immunological contact emergency.
Some substances or preparations that meet the criteria for sentence R 42 may also cause immunological contact urticaria. In this case, information on contact urticaries should be introduced using appropriate S sentences (usually S 24 and S 36/37) and should be included in the security data sheet.
For substances or preparations that produce signs of immunological contact urticaria, but which do not meet the criteria for sentence R 42, a classification with sentence R 43.
There is no animal model recognized to identify substances causing immunological contact urticaria. The classification should therefore rely on evidence of effects in humans, similar to those related to skin awareness (R 43).
3.2.8. Other toxicological properties.
Additional risk phrases will be assigned to substances and preparations classified in accordance with items 2.2.1 to 3.2.7 or items 4 and 5, according to the following criteria (based on experience gained in the development of Appendix I):
R 29 In contact with water, releases toxic gases:
Substances and preparations that, in contact with water or wet air, release very toxic/toxic gases in potentially dangerous quantities; For example, aluminum phosphure, phosphorus pentasulphide.
R 31 In contact with an acid, releases a toxic gas:
Substances and preparations that react with acids by removing toxic gases in dangerous quantities; For example, sodium hypochlorite, baryum polysulphide. With respect to substances used by the public, it would be better to use the phrase S 50: "Do not mix with... (to be specified by the manufacturer)".
R 32 In contact with an acid, releases a very toxic gas:
Substances and preparations that react with acids by removing very toxic gases in dangerous quantities; For example, salts of cyanhydric acid, sodium nitrogen. With respect to substances used by the public, it would be better to use the phrase S 50: "Do not mix with... (to be specified by the manufacturer)".
R 33 Danger of cumulative effects:
Substances and preparations that may accumulate in the human body and may thus cause some concern, but this accumulation is such that it justifies the use of sentence R 48.
For comments on the use of this sentence R, see point 4.2.3.3 for substances and Annex V, Part A.3, of Directive 1999/45/EC for preparations.
R 64 Potential risk for breast-fed babies:
Substances and preparations that, absorbed by women, may disrupt breastfeeding or may be present (including metabolites) in breast milk in sufficient quantities to be of concern to the health of a breastfed child.
For comments on the use of this sentence R, see point 4.2.3.3 for substances and Annex V, Part A.4, of Directive 1999/45/EC for preparations.
R 66 Repeated exposure may cause skin to dry or torn:
Substances and preparations that may have a cause for concern, due to a drying, desquamation or sludge, but do not meet the criteria for R 38, on the following basis:
- a practical observation following normal handling and use;
- or relevant evidence regarding the intended effects on the skin.
See also points 1.6 and 1.7.
R 67 Steam inhalation can cause sleepiness and vertigo:
Volatile substances and preparations containing substances that, by inhalation, may cause symptoms characterized by depression of the central nervous system and which are not already classified according to their acute toxicity in the event of inhalation (R 20, R 23, R 26, R 68/20, R 39/23 or R 39/26).
The following evidence is usable:
(a) Animal studies showing symptoms of central nervous system depression, such as narcotic effects, lethargy, lack of coordination (including loss of recovery reflex) and ataxia:
- at concentrations not exceeding 20 mg/l for a 4-hour exposure time, or
- if the ratio between the concentration causing the effect at 4 o'clock and the saturating vapour concentration at 20° C is 1/10;
(b) Practical experience on humans (e.g., narcosis, sleepiness, reduced vigilance, loss of reflexes, lack of coordination, vertigo), on the basis of duly circumstantial reports, under conditions of exposure comparable to those resulting in the aforementioned effects on animals.
See also points 1.6 and 1.7.
For additional risk phrases, see 2.2.6.
4. Classification on the basis
specific health effects
4.1. Introduction.
4.1.1. This chapter describes the classification procedure for substances that may result in the effects described below.
For preparations, see point 4.2.4.
4.1.2. If a manufacturer, distributor or importer has information indicating that a substance should be classified and labelled in accordance with the criteria set out in 4.2.1, 4.2.2 or 4.2.3, the substance must be labelled provisionally in accordance with these criteria, based on the assessment of the evidence by a competent person.
4.1.3. The manufacturer, distributor or importer must submit to a Member State in which a substance is marketed as soon as possible, a document summarizing all information relevant to that substance. Useful information in this context includes, in particular, all published or unpublished data necessary for the appropriate classification of the substance in question, based on its intrinsic properties in accordance with the categories defined in Article 2, paragraph 2, and in accordance with the criteria set out in this annex. The summary that is submitted must include a bibliography containing all relevant references and may include any interesting unpublished information.
4.1.4. In addition, a manufacturer, distributor or importer with new information relevant to the classification and labelling of a substance in accordance with the criteria set out in 4.2.1, 4.2.2 or 4.2.3 shall provide such information to a Member State where the substance is marketed.
4.1.5. In order to achieve as soon as possible a uniform classification in the Community by the procedure provided for in Article 28 of Directive 67/548/EEC, the Member States with information justifying the classification of a substance in one of these categories, whether or not that information has been provided by the manufacturer, must send such information to the Commission as soon as possible, along with proposals for classification and labelling.
The Commission will send to other Member States the proposed classification and labelling it has received. Any Member State may request the Commission to provide the information it has received.
Any Member State which, for specific reasons, considers inappropriate the classification and labelling suggested with respect to the carcinogenic, mutagenic or toxic effects for reproduction, shall inform the Commission.
4.2. Classification criteria, hazard indication and risk phrase choice.
4.2.1. Carcinogenic substances.
With respect to classification and labelling and in view of the current state of knowledge, these substances are divided into three categories.
Category 1:
Substances that are known to be carcinogenic to man. There are sufficient elements available to establish a causal relationship between human exposure to such substances and the occurrence of cancer.
Category 2:
Substances to be assimilated to carcinogenic substances for humans. There is sufficient evidence to justify a strong presumption that human exposure to such substances can cause cancer. This presumption is usually based on:
- appropriate long-term studies on the animal;
- other appropriate information.
Category 3:
Substances of concern to humans because of possible carcinogenic effects, but for which available information does not allow a satisfactory assessment. There is information from adequate animal studies, but it is insufficient to classify the substance in category 2.
4.2.1.1. The symbols and phrases indicating the particular risks below apply.
Categories 1 and 2:
Substances classified as carcinogens in categories 1 and 2 are characterized by the symbol "T" and the risk phrase:
R 45 Can cause cancer.
However, for substances and preparations that pose a carcinogenic risk only by inhalation, e.g. dust, vapour, smoke (e.g. exposure by other channels, for example by ingestion or contact with the skin, with no carcinogenic risk), the symbol "T" should be used and the sentence indicating the following particular risks:
R 49 May cause inhalation cancer.
Category 3:
Substances classified as Category 3 carcinogens are characterized by the Xn symbol and the risk phrase:
R 40 Suspected carcinogenic effect - insufficient evidence.
4.2.1.2. Comments on carcinogenic categorization.
The classification of a substance in category 1 is based on epidemiological data; classification in categories 2 or 3 is mainly based on experimental results on animals.
For classification as a Category 2 carcinogenic substance, either positive results for two animal species, or undisputable positive elements for one species, supported by secondary elements such as genotoxicity data, metabolic or biochemical studies, induction of benign tumours, structural relationships with other known carcinogenic substances or daemic data
Category 3 actually includes two subcategories:
(a) Substances sufficiently studied, but for which there are no sufficient tumoriogenic effects to result in classification in category 2. In addition, additional experiences would not be likely to provide other relevant information for the classification;
(b) Substances not sufficiently investigated. The available data are inadequate but are of concern to man. This classification is provisional; additional experiences are needed before making the final decision.
In order to distinguish between categories 2 and 3, the following arguments are considered relevant which reduce the significant nature of the experimental induction of a tumor with respect to a possible exposure of man. These arguments, especially associated, would in most cases result in a classification in category 3, even if tumours were induced in animals:
- carcinogenic effects only at very high doses exceeding the "maximum tolerated dose". The maximum tolerated dose is characterized by toxic effects, which, even if they do not change the lifetime, are accompanied by physical changes such as a 10% delay in weight gain;
- appearance of tumours, especially at high doses, only in particular organs of certain species known for their propensity to the formation of a large number of spontaneous tumours;
- appearance of tumours, only at the application site, in highly sensitive test systems (e.g. intraperitoneal or subcutaneous application of certain locally active compounds), if this particular target is not applicable to man;
- absence of genotoxicity during short-term tests in vivo and in vitro;
- existence of a secondary mechanism of action that appears only from a certain threshold (e.g. hormone effects on target organs or on physiological control mechanisms, chronic stimulation of cell proliferation);
- existence of a specific mechanism of the species for tumor formation (e.g. by specific metabolic pathways), not applicable to man.
In order to distinguish between a classification in category 3 and no classification, the arguments precluding a human concern are considered to be relevant:
- a substance should not be classified in any of the categories if the experimental tumor training mechanism is clearly identified, with elements clearly indicating that this process cannot be extrapolated to man;
- if the only available data on the tumors relate to liver tumors on certain mouse strains, without further indication, the substance may not be classified in any of the above categories;
- special attention should be given to cases where the only available data on tumors concern the appearance of neoplasms on sites and strains where it is well known that they appear spontaneously with a high incidence.
4.2.2. mutagenic substances.
4.2.2.1. With respect to classification and labelling and in view of the current state of knowledge, these substances are divided into three categories.
Category 1:
Substances that are known to be mutagenic to man.
There are sufficient elements to establish a cause-to-effect relationship between human exposure to such substances and hereditary genetic defects.
Category 2:
Substances to be assimilated to mutagenic substances for humans.
There is sufficient evidence to justify a strong presumption that human exposure to such substances can lead to hereditary genetic defects. This presumption is generally based on:
- appropriate animal studies;
- other appropriate information.
Category 3:
Substances of concern to humans due to possible mutagenic effects.
Appropriate mutagenicity studies have provided elements, but they are insufficient to classify these substances in category 2.
4.2.2.2. The symbols and phrases indicating the particular risks below apply.
Categories 1 and 2:
Substances classified as Category 1 or 2 mutagenics are characterized by the symbol "T" and the risk phrase:
R 46 May cause hereditary genetic alterations.
Category 3:
Substances classified as Category 3 mutagenics are characterized by the Xn symbol and the risk phrase:
R 68 Possibility of irreversible effects.
4.2.2.3. Comments on categorization of mutagenic substances.
Definition of terms:
A mutation is a permanent change in the number or structure of genetic material in an organism that results in a change in the phenotypic characteristics of the organism. The alterations may involve a single gene, a set of genes or an entire chromosome. The effects of single genes can result from effects on only one of the DNA bases (deoxyribonucleic acid) (point switches) or profound changes, including deletions, within the gene. Effects on whole chromosomes can result in structural or digital changes. A mutation of the germ cells in sex-reproduction organisms can be transmitted to the offspring. A mutagenic is an agent that increases the occurrence of mutations.
It should be noted that substances are classified as mutagenic by referring specifically to hereditary genetic defects. However, the type of results leading to a classification of chemicals in category 3, "induction of genetically important events in somatic cells" is generally also considered an alert for a possible carcinogenic activity.
The development of methods for testing mutagenicity is in constant development. For many new tests, there are no standardized protocols or evaluation criteria. To assess mutagenicity data, the quality of the test performance and the validation rate of the test method must be considered.
Category 1:
To classify a substance in category 1, the identification of mutations in humans, from epidemiological studies on human mutation, will be necessary. Examples of such substances are unknown to date. It is recognized that it is difficult to obtain reliable data from studies on the incidence of mutations in human populations or possible increases in their frequencies.
Category 2:
To classify a substance in category 2, positive results from studies must be held showing:
(a) mutagenic effects; or
(b) Other significant cell interactions for mutagenicity in the germ cells of in vivo mammals; or
(c) mutagenic effects in somatic cells of in vivo mammals, accompanied by irrefutable elements indicating that the substance, or a significant metabolite, reaches germ cells.
For classification in category 2, the following methods are currently considered appropriate:
2 (a) In vivo mutagenicity tests on germ cells:
- a specific locus mutation test;
- heereditary translocation test;
- test of dominant lethal mutation.
These tests really demonstrate the existence of an impairment of the progeny or a failure to develop the embryo.
2 (b) In vivo tests showing relevant interaction with germ cells (usually DNA):
- tests of chromosomal abnormalities, such as detected by cytogenetic analysis, including anauploidy caused by poor chromosomal segregation;
- tests of exchanges of sister chromatides;
- unscheduled DNA synthesis testing;
- binding (covalent) test of the mutagenic to the DNA of the germ cell;
- testing other types of DNA defects.
These tests provide more or less indirect evidence. Their positive results should normally be supported by positive results from in vivo tests of mutagenicity on somatic cells, in mammals or in humans (see category 3, preferably methods such as those of point 3, a).
2 (c) In vivo tests showing mutagenic effects in the somatic cells of mammals (see point 3(a), in combination with toxicokinetic methods or other methodologies that can demonstrate that the compound or a significant metabolite reaches the germ cells.
For methods 2 b and 2 c, positive results of tests with intermediate host (host-mediated) or demonstration of irrefutable effects during in vitro tests may be considered additional evidence.
Category 3:
To classify a substance in category 3, positive results must be obtained from tests showing:
(a) mutagenic effects or;
(b) Another cell interaction in relation to mutagenicity in the somatic cells of in vivo mammals. The latter must normally be supported by positive results from mutagenicity tests carried out in vitro.
As regards effects in somatic cells in vivo, the following methods are currently considered appropriate:
3 (a) In vivo tests of mutagenicity on somatic cells:
- tests of the micro nucleus on bone marrow cell or metaphases analysis;
- analysis of peripheral lymphocyte metaphases;
- colorful stain test on the mouse coat (spot-test).
3 (b) In vivo tests of interaction with somatic cell DNA:
- trial of exchanges of sister chromatides in somatic cells;
- unscheduled DNA synthesis test in somatic cells;
- liaison test (covalent) of the mutagenic to the DNA of the somatic cell;
- test of DNA defects, for example by alkaline evasion, in somatic cells.
Substances showing positive results only in one or more in vitro mutagenicity tests should not normally be classified. However, their complementary study by in vivo tests is highly recommended. In exceptional cases, a classification should be considered in category 3, for example for a substance that presents responses in several in vitro tests, for which no relevant information is available in vivo and that has a similarity to known mutagenic/cannerogenic substances.
4.2.3. Toxic substances for reproduction.
4.2.3.1. For classification and labelling, and given the current state of knowledge, these substances are divided into three categories.
Category 1:
Substances known to alter fertility in the human species:
There are sufficient elements to establish the existence of a cause-effect relationship between human exposure to the substance and a deterioration of fertility.
Substances known to cause toxic effects on human development:
There are sufficient elements to establish the existence of a cause-effect relationship between human exposure to the substance and subsequent toxic effects on the development of the offspring.
Category 2:
Substances to be assimilated to substances affecting fertility in the human species.
There is sufficient evidence to justify a strong presumption that human exposure to such substances may affect fertility. This presumption is based on:
- the clear indication, in animal studies, of a deterioration of fertility occurring either in the absence of toxic effects or at levels of doses close to toxic doses, but which is not a non-specific effect secondary to toxic effects;
- other relevant information.
Substances to be assimilated to substances causing toxic effects on development in the human species:
There is sufficient evidence to justify a strong presumption that human exposure to such substances can lead to toxic effects on development. This presumption is usually based on:
- the net evidence, in appropriate animal studies, of observed effects either in the absence of marked maternal toxicity signs or at dose levels close to toxic doses, but which are not a non-specific effect secondary to toxic effects;
- other relevant information.
Category 3:
Substances of concern for fertility in the human species generally on the basis of:
- results of appropriate animal studies that provide sufficient elements to cause a high suspicion of a deterioration of the fertility occurring either in the absence of toxic effects, or at dose levels close to toxic doses, but which is not a non-specific secondary effect to toxic effects, however, these evidence is insufficient to classify the substance in Category 2;
- other relevant information.
Substances of concern to humans due to possible toxic effects on development:
This presumption is generally based on:
- the results of appropriate animal studies, which provide sufficient evidence to cause high suspicion of developmental toxicity either in the absence of marked maternal toxicity signs or at dose levels close to toxic doses, but which is not a non-specific secondary effect to toxic effects, however, evidence being insufficient to classify the substance in Category 2;
- other appropriate information.
4.2.3.2. The symbols and phrases indicating the particular risks below apply.
Category 1:
For substances that affect fertility in the human species:
Substances classified as toxic for Class 1 reproduction are characterized by the symbol "T" and the risk phrase:
R 60 Can alter fertility.
For substances that cause toxic effects on development in the human species: substances classified as toxic for breeding of category 1 are characterized by the symbol "T" and the risk phrase:
R 61 Risk during pregnancy of harmful effects to the child.
Category 2:
For substances to be assimilated to substances affecting fertility in the human species:
Substances classified as toxic for Class 2 reproduction are characterized by the symbol "T" and the risk phrase:
R 60 Can alter fertility.
For substances to be assimilated to substances that cause toxic effects on development in the human species:
Substances classified as toxic for Class 2 reproduction are characterized by the symbol "T" and the risk phrase:
R 61 Risk during pregnancy of harmful effects to the child.
Category 3:
For substances of concern for fertility in the human species:
Substances classified as toxic for Class 3 reproduction are characterized by the Xn symbol and the risk phrase:
R 62 Potential risk of fertility reduction.
For substances of concern to humans with regard to possible toxic effects on development:
Substances classified as toxic for Class 3 reproduction are characterized by the Xn symbol and the risk phrase:
R 63 Potential risk during pregnancy of adverse effects for the child.
4.2.3.3. Comments on categorization of toxic substances for reproduction.
The reproductive toxicity includes the alteration of functions or reproductive capacity in men or women and the induction of non-herited adverse effects on the offspring. It can be classified under two main headings:
1. Effects on male or female fertility;
2. Development toxicity.
1° Effects on male or female fertility: this category includes the adverse effects on libido, sexual behavior, different aspects of spermatogenesis or oocyteogenesis or on hormone activity or physiological response that would disrupt the ability to fertilize, fertilization itself or the development of fertilized egg to and including implantation.
2° Toxicity for development: it is considered in its broadest sense, including any effect disturbing normal development, both before and after birth. It encompasses both the effects that are induced or manifest before birth and those that manifest after birth. This includes embryotoxic/foetotoxic effects such as reduction of body weight, retardation of growth and development, toxicity to organs, death, abortion, structural anomalies (teratogenic effects), functional anomalies, perinatal or postnatal abnormalities, and alteration of mental or physical development after birth, up to and including normal pubertal development.
The classification of chemicals as toxic to reproduction is intended to be used for chemicals that have intrinsic or specific properties to produce such toxic effects. It is not necessary to classify chemicals as toxic to reproduction if these effects occur only as a non-specific secondary consequence of other toxic effects. The most worrisome chemicals are those that are toxic to reproduction at levels of exposure that do not give other signs of toxicity.
The classification of a substance in Class 1 for effects on fertility and/or development toxicity is based on epidemiological data. The classification in categories 2 or 3 is mainly based on animal data. In vitro studies or studies of avenged eggs are considered to be "additional evidence" and could only exceptionally authorize a classification in the absence of in vivo data.
Like most other types of toxic effect, it is likely that substances with reproductive toxicity will have a threshold under which adverse effects would not be demonstrated. Even where net effects have been shown in animal studies, human extrapolation may be uncertain as a result of administered doses, for example, when effects have been shown only at high doses, toxicokinetics are significantly different or the pathway is inadequate.
For these or other similar reasons, classification in category 3, or even absence of classification, may be justified.
Appendix V to Directive 67/548/EEC provides a limit test for low toxicity substances. If a dose of at least 1000 mg/kg oral does not produce any signs of reproductive toxicity, studies at other doses may be considered unnecessary. If there is data from studies at doses above the above-mentioned limit dose, this data must be taken into account with other relevant information. In normal circumstances, the effects found only at doses greater than the limit dose do not necessarily result in a classification as toxic to reproduction.
Effects on fertility:
For the classification of a substance in category 2 due to a deterioration of fertility, there must normally be manifest evidence on an animal species, accompanied by additional evidence on the mechanism or site of action, or on the existence of a chemical analogy with other known "antifertility" agents, or other information in a man who concludes that effects would be likely to be observed in a person. Where studies exist on a single species, without other appropriate complementary evidence, classification in Class 3 may then be appropriate.
Since the deterioration of fertility may occur in a non-specific and secondary manner to a severe general toxicity or in severe inanition, classification in Class 2 must only be performed when it is proven that there is a certain degree of toxicity specificity for the reproductive system. If it has been demonstrated in animal studies that the alteration of fertility was due to failure of mating, classification in category 2 normally requires the identification of the mechanism of action to determine whether an adverse effect such as an alteration of the hormonal production scheme is likely to occur in the human species.
Development toxicity:
For classification in category 2, there must be clear evidence of adverse effects in studies correctly conducted on one or more species. Since the adverse effects of pregnancy or post-natal periods may be a secondary consequence of maternal toxicity, reduced absorption of food or water, maternal stress, lack of maternal care, specific dietary deficits, poor livestock conditions, intercurrent infections, etc., it is important that the effects observed occur in properly conducted studies and in maternal doses not associated with toxicity. The route of exposure is also important. In particular, the intraperitoneal injection of irritating substance can cause local lesions of the uterus and its content, and the results of such studies must be interpreted with caution and normally do not lead to classification alone.
Classification in Class 3 is based on criteria similar to those in Class 2, but can be used when the experimental protocol presents defects that make the conclusions less convincing, or when it is impossible to exclude that the effects may be due to non-specific factors such as general toxicity.
In general, classification in category 3 or non-classification is decided on an ad hoc basis, where the only recorded effects are reduced changes in the incidence of spontaneous defects, the proportions of current variations observed in skeleton examinations or reduced differences in postnatal development appreciation.
Effects during lactation:
Toxic substances for reproduction are also of concern due to their effects on lactation; They should also be labelled with sentence R 64 (see criteria in paragraph 3.2.8).
With respect to classification, the toxic effects on the progeny resulting only from exposure via breast milk or the toxic effects resulting from the direct exposure of children will not be considered to be "toxic for reproduction", unless these effects result in alteration of the development of the offspring.
Substances not classified as toxic for reproduction, but of concern because of their toxicity once transmitted to the infant during the breastfeeding period, must be labelled with sentence R 64 (see criteria in item 3.2.8). This R sentence may also be appropriate for substances that affect the quantity or quality of milk.
The phrase R 64 should normally be assigned on the basis of:
(a) Toxicokinetic studies that indicate the likely presence in the milk of the substance at potentially toxic levels, and/or
(b) Based on studies of one or two generations in the animal, which indicate the presence of adverse effects on the offspring due to the passage into the milk, and/or
(c) On the basis of evidence in man indicating a risk to infants during the breastfeeding period.
Substances that are known to accumulate in the body and could then be released into milk during lactation can be labelled with R 33 and R 64.
4.2.4. Preparation classification procedure for specific health effects.
If a preparation contains one or more substances classified according to the detailed criteria above, it shall be classified in accordance with the criteria set out in Appendix II, Parts A.7 to A.9 and Part B.6, of Directive 1999/45/EC (the concentration limits are either in Appendix I to Directive 67/548/EC or in Annex II, Part B.6, of Directive 1999/45/EC where the substance(s) considered to be
5. Classification on the basis
effects on the environment
5.1. Introduction.
The classification of environmentally hazardous substances and preparations is primarily intended to warn the user of the risks that these substances and preparations pose to ecosystems. While the current criteria refer largely to aquatic ecosystems, it is recognized that some substances and preparations can simultaneously or alternatively affect other ecosystems whose elements can range from microflora and soil microfauna to primates.
The following criteria are directly derived from the test methods listed in Appendix V to the extent they are listed. The test methods required for the "basic file", cited in Appendix VII, are limited and the information derived from it may be insufficient to establish an appropriate classification. Classification may require additional data from Level 1 (Appendix VIII) or other equivalent studies. In addition, classified substances can be reviewed in the light of new data.
With respect to classification and labelling, and in view of the current state of knowledge, these substances and preparations are divided into two groups, depending on their acute and/or long-term effects in aquatic systems, or based on their acute and/or long-term effects in non-aquatic systems.
5.1.1. The classification of substances is generally based on the experimental data on acute toxicity for aquatic systems, degradation and log Po/e (or BCF if available).
5.1.2. The classification of preparations is normally based on the results obtained by a conventional method referred to in Article 7 and Annex III, Parts A and B, of Directive 1999/45/EC. In this case, the classification is based on the individual concentration limits:
- Annex I to Directive 67/548/EEC, or
- in Annex III, Part B, of Directive 1999/45/EC where the substance(s) are not listed in Annex I to Directive 67/548/EEC or are contained without concentration limits.
5.1.3. As a general rule, the classification of a preparation is based on the application of a conventional method.
However, for the determination of acute toxicity for aquatic systems, in some cases it may be useful to conduct tests on the preparation. The results of these tests can only be used to modify the classification with respect to acute toxicity for aquatic systems, which would have been obtained by applying a conventional method. If the market starter chooses to use such tests, it is necessary to ensure that the quality criteria of the test methods referred to in Part C of Schedule V to Directive 67/548/EEC have been met. The tests shall also be carried out on the three groups of species, in accordance with the criteria set out in this annex (algae, daphnies and fish), unless, after testing one of the species, the preparation was classified as the highest risk category for acute toxicity for aquatic systems, or if test results were already available before the entry into force of Directive 1999/45EC.
5.2. Classification criteria, hazard indication and risk phrase choice.
The classification criteria for substances referred to in 5.2.1 shall apply to preparations only if tested in accordance with the provisions of 5.1.3.
5.2.1. Aquatic environment.
5.2.1.1. Substances will be classified as environmentally hazardous and will be assigned the symbol "N", the appropriate hazard indication and risk phrases based on the following criteria:
R 50 Very toxic to aquatic organisms, and
R 53 May cause long-term adverse effects on the aquatic environment:
Acute toxicity:
96 h CL50 (fish) 1 mg/l;
or 48 h CE50 (daphnia) 1 mg/l;
or 72 h IC50 (algae) 1 mg/l,
and:
- the substance does not deteriorate easily, or
- log Po/e (logarithmic expression of the octanol/water partition coefficient) 3.0 (except if the BCF determines experimentally 100) (BCF = bioconcentration factor).
R 50 Very toxic to aquatic organisms:
Acute toxicity:
96 h CL50 (fish) 1 mg/l;
or 48 h CE50 (daphnia) 1 mg/l;
or 72 h CI50 (algae) 1 mg/l.
R 51 Toxic to aquatic organisms, and
R 53 May cause long-term adverse effects on the aquatic environment:
Acute toxicity:
96 h CL50 (fish) 1 mg/l < CL50 10 mg/l;
or 48 h CE50 (daphnia) 1 mg/l < CE50 10 mg/l;
or 72 h CI50 (algae) 1 mg/l < CI50 10 mg/l,
and
- the substance does not deteriorate easily, or
- log Po/e 3.0 (except if the BCF determines experimentally 100).
5.2.1.2. Substances will be classified as environmentally hazardous and will be assigned risk sentences based on the following criteria:
R 52 Nocif for aquatic organisms, and
R 53 May cause long-term adverse effects on the aquatic environment:
Acute toxicity:
96 h CL50 (fish) 10 mg/l < CL50 100 mg/l;
or 48 h CE50 (daphnia) 10 mg/l < CE50 100 mg/l;
or 72 h CI50 (algae) 10 mg/l < CI50 100 mg/l,
and
the substance does not deteriorate easily.
This criterion applies except where there is additional scientific evidence regarding degradation and/or toxicity, sufficient to provide adequate evidence that neither the substance or the products of its degradation will constitute a long-term and/or delayed potential danger to the aquatic environment. These additional scientific evidence should normally be based on the required studies at level 1 (annex VIII) or on equivalent studies and may include:
(i) An established potential for rapid degradation in the aquatic environment;
(ii) A lack of chronic toxic effects at a concentration of 1.0 mg/l, e.g. a non-observed-effect concentration greater than 1.0 mg/l determined in a prolonged study of fish or daphnia toxicity.
R 52 Nocif for aquatic organisms.
Substances that do not fall within the criteria set out above in this chapter, but which, on the basis of available elements for their toxicity, may nevertheless pose a danger to the structure and/or operation of aquatic ecosystems.
R 53 May cause long-term adverse effects for the aquatic environment.
Substances that do not fall within the criteria set out above in this chapter, but which, on the basis of available elements regarding their persistence, their potential for accumulation, as well as their expected or observed behaviour in the environment, may nevertheless pose a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems.
For example, substances that are not soluble in water, i.e., whose solubility is less than 1 mg/l, will be subject to this criterion if:
(a) They do not degrade easily; and
(b) Log Po/e 3.0 (except if the BCF is determined experimentally 100).
This criterion applies to substances except where there is additional scientific evidence regarding degradation and/or toxicity, sufficient to provide adequate assurance that neither the substance nor the products of its degradation will constitute a long-term potential hazard and/or differ for the aquatic environment.
These additional scientific evidence should normally be based on the required studies at level 1 (annex VIII) or on equivalent studies and may include:
(i) An established potential for rapid degradation in the aquatic environment;
(ii) A lack of chronic toxic effects at the solubility limit, e.g. a non-observed concentration greater than a solubility limit determined during a prolonged study of fish toxicity or daphnia.
5.2.1.3. Comments on the determination of CI50 for algae and degradability:
When one can demonstrate, in the case of highly coloured substances, that algae growth is inhibited only by a reduction in light intensity, the 72 h CI50 for algae shall not serve as a basis for classification.
Substances are considered to be degrading easily if the following criteria are checked:
(a) If, during 28-day biodegradation studies, the following degradation levels are met:
- during tests based on dissolved organic carbon: 70%;
- in tests based on oxygen depletion or carbon dioxide production: 60% of theoretical maximums.
These levels of biodegradation must be reached 10 days after the beginning of the degradation, which is taken as when 10% of the substance deteriorated, or
(b) In cases where DCO and DBO5 data are available only, where the DBO5/DCO ratio is greater than or equal to 0.5, or
(c) If other compelling scientific evidence is available to demonstrate that the substance may degrade (biotically and/or abiotically) in the aquatic environment up to a level greater than 70% over a period of 28 days.
5.2.2. Non-aquatic environment.
5.2.2.1. Substances and preparations will be classified as environmentally hazardous and will be assigned the symbol "N", the appropriate hazard indication and the corresponding risk phrases as follows:
R 54 Toxic for flora.
R 55 Toxic for wildlife.
R 56 Toxic to soil organisms.
R 57 Toxic for bees.
R 58 May cause long-term adverse environmental effects.
Substances and preparations that, on the basis of available elements regarding their properties, persistence, potential for accumulation and their intended or observed behaviour in the environment, may present an immediate or long-term danger and/or differ for the structure and/or operation of natural ecosystems other than those referred to in 5.2.1 above. Detailed criteria will be developed later.
5.2.2.2. Substances and preparations will be classified as environmentally hazardous and will be assigned the symbol "N", the appropriate hazard indication, if any, and the corresponding risk phrases, taking into account the following criteria:
R 59 Dangerous for the ozone layer.
Substances that, on the basis of available elements regarding their properties and their fate and their expected or observed behaviour in the environment, could pose a danger to the structure and/or operation of the stratospheric ozone layer. This category includes substances listed in Annex I to Regulation (EC) No. 2037/2000 of the European Parliament and the Council on Substances that Deplete the Ozone Layer and its subsequent amendments.
Preparations are classified on the basis of a conventional method referred to in Article 7 and Annex III, Parts A and B, of Directive 1999/45/EC.
6. Choice of precautionary statements
6.1. Introduction.
Caution advice (phrases S) is assigned to hazardous substances and preparations in accordance with the general criteria below. In addition, for some preparations, precautionary statements in Appendix V to Directive 1999/45/EC are mandatory.
Whenever the manufacturer is mentioned in point 6, it refers to the person responsible for placing the substance or preparation on the market.
6.2. Caution advice on substances and preparations.
S 1 Keep under key:
Applicability:
Very toxic, toxic and corrosive substances and preparations.
Criteria for use:
Required for the substances and preparations mentioned above if sold to the public.
S 2 Keep out of reach of children:
Applicability:
All hazardous substances and preparations.
Criteria for use:
Mandatory for all hazardous substances and preparations sold to the public, except those only classified as environmentally hazardous.
S 3 Store in a cool place:
Applicability:
Organic peroxides,
Other hazardous substances and preparations whose boiling point is less than or equal to 40 °C.
Criteria for use:
Obligatory for organic peroxides unless the phrase S 47 is used;
Recommended for other hazardous substances and preparations whose boiling point is less than or equal to 40 °C.
S 4 Keep away from any residential area:
Applicability:
Very toxic and toxic substances and preparations.
Criteria for use:
Normally limited to very toxic and toxic substances and preparations when it is desirable to complete sentence S 13 (where there is, for example, a risk of inhalation and these substances or preparations must be stored away from any dwelling place). This advice is not intended to exclude the proper use of these substances or preparations in residential premises.
S 5 Keep under... (Approx. to be specified by the manufacturer):
Applicability:
spontaneously flammable substances and solid preparations.
Criteria for use:
Normally limited to special cases such as sodium, potassium or white phosphorus.
S 6 Keep under... (Inert gas to be specified by the manufacturer):
Applicability:
Hazardous substances and preparations that must be kept in an inert atmosphere.
Criteria for use:
Normally limited to special cases such as some organometallic compounds.
S 7 Keep the container closed:
Applicability:
Organic peroxides;
Substances and preparations that may result in highly toxic, toxic, harmful or extremely flammable releases of gases;
Substances and preparations that, in contact with humidity, give rise to extremely flammable gas releases;
Solids easily flammable.
Criteria for use:
Obligatory for organic peroxides;
Recommended for other areas of application above.
S 8 Keep the container safe from moisture:
Applicability:
Substances and preparations that can react violently with water;
Substances and preparations that, in contact with water, result in extremely flammable gas releases;
Substances and preparations that, in contact with water, result in very toxic or toxic gas releases.
Criteria for use:
Normally limited to the above-mentioned areas of application when it is necessary to strengthen the warnings given by phrases R 14 and R 15, in particular, and R 29.
S 9 Keep the container in a well ventilated place:
Applicability:
Volatile substances and preparations that may result in releases of highly toxic, toxic or harmful vapours;
Extremely flammable or easily flammable liquids and extremely flammable gases.
Criteria for use:
Recommended for volatile substances and preparations that may result in releases of highly toxic, toxic or harmful vapours;
Recommended for extremely flammable or easily flammable liquids or extremely flammable gases.
S 12 Do not close the container hermetically:
Applicability:
Substances and preparations that may cause the vessel to be exploded by vapour or gas release.
Criteria for use:
Normally limited to the aforementioned special cases.
S 13 Keep away from food and beverages, including those for animals:
Applicability:
Very toxic, toxic and harmful substances and preparations;
Criteria for use:
Recommended when such substances or preparations are likely to be used by the public.
S 14 Keep away from... (materials incompatible with the manufacturer).
Applicability:
Organic peroxides.
Criteria for use:
Obligatory for organic peroxides and normally limited to organic peroxides. However, it may be useful in some exceptional cases when incompatibility is likely to result in a particular risk.
S 15 Keep away from heat:
Applicability:
Substances and preparations that may decompose or react spontaneously as a result of heat.
Criteria for use:
Normally limited to special cases, such as monomers, but not assigned if R 2, R 3 and/or R 5 are already used.
S 16 Keep away from any flame or source of sparks - do not smoke:
Applicability:
Extremely flammable or easily flammable liquids and extremely flammable gases;
Criteria for use:
Recommended for specified substances and preparations, but not assigned if R 2, R 3 and/or R 5 are already used.
S 17 Keep away from fuels:
Applicability:
Substances and preparations that may constitute explosive or spontaneously flammable mixtures with combustible materials.
Criteria for use:
Use in special cases (e.g. to insist on phrases R 8 and R 9).
S 18 Handling and opening the receptacle with caution:
Applicability:
Substances and preparations that may cause overpressure in the receptacle;
Substances and preparations that may result in the formation of explosive peroxides.
Criteria for use:
Normally limited to the above cases where there is a risk of eye damage and/or where these substances and preparations are likely to be used by the public.
S 20 Do not eat and not drink during use:
Applicability:
Very toxic, toxic and corrosive substances and preparations.
Criteria for use:
Normally limited to special cases (e.g. arsenic and arsenic compounds, fluoroacstates), especially when these products are likely to be used by the public.
S 21 Do not smoke during use:
Applicability:
Substances and preparations whose combustion releases toxic products.
Criteria for use:
Normally limited to special cases (e.g. halogenated compounds).
S 22 Do not breathe dust:
Applicability:
All hazardous solid substances and preparations for health.
Criteria for use:
Mandatory for the substances and preparations referred to in the sentence R 42;
Recommended for the above-mentioned substances and preparations sold as inhalable dust and for which health hazards resulting from inhalation are not known.
S 23 Do not breathe gases/fumes/vapors/aerosols (term[s] appropriate to be indicated by the manufacturer):
Applicability:
All substances and preparations, liquid or gaseous, hazardous to health.
Criteria for use:
Mandatory for the substances and preparations referred to in the sentence R 42;
Required for substances and preparations intended to be used by spraying. S38 or S51 should also be assigned;
Recommended when it is necessary to draw the user's attention to the risks of inhalation not mentioned in the risk phrases that must be attributed to these substances.
S 24 Avoid contact with the skin:
Applicability:
All hazardous substances and preparations for health.
Criteria for use:
Obligatory for substances and preparations to which sentence R 43 was assigned, unless sentence S36 was also assigned;
Recommended when it is necessary to draw the user's attention to the risks of contact with the skin, not mentioned in the risk phrases that must be attributed to these substances (e.g. paresthesia). However, this may be used to highlight such phrases.
S 25 Avoid contact with the eyes:
Applicability:
All hazardous substances and preparations for health.
Criteria for use:
Recommended when it is necessary to draw the user's attention to the risks associated with eye contact, not mentioned in the risk phrases that must be attributed. This mention may, however, be used to highlight such sentences;
Recommended for substances to which phrases R 34, R 35, R 36 or R 41 are assigned and that are likely to be used by the public.
S 26 In case of eye contact, wash immediately and abundantly with water and consult a specialist:
Applicability:
Corrosive or irritating substances and preparations.
Criteria for use:
Obligatory for corrosive substances and preparations, as well as for substances and preparations to which the risk phrase R 41 was assigned;
Recommended for irritating substances and preparations to which the risk phrase R. 36 was assigned.
S 27 Immediately remove any unclean or swollen garments:
Applicability:
Very toxic, toxic or corrosive substances and preparations.
Criteria for use:
Obligatory for very toxic substances and preparations to which the phrase R 27 was assigned and which are likely to be used by the public;
Recommended for highly toxic substances and preparations to which the phrase R 27 was assigned, and which are used in the industry. However, this precautionary statement should not be used if the sentence S 36 was assigned;
Recommended for toxic substances and preparations to which the phrase R 24 was assigned, as well as for corrosive substances and preparations that are likely to be used by the public.
S 28 After contacting the skin, wash immediately and abundantly with... (products appropriate to indicate by the manufacturer):
Applicability:
Very toxic, toxic or corrosive substances and preparations.
Criteria for use:
Obligatory for very toxic substances and preparations;
Recommended for other substances and preparations referred to above, especially when water is not the most indicated rinsing liquid;
Recommended for corrosive substances and preparations that are likely to be used by the public.
S 29 Do not throw the residues into the sewer:
Applicability:
Extremely or easily flammable liquids without water;
Very toxic and toxic substances and preparations;
Hazardous substances and preparations for the environment.
Criteria for use:
Obligatory for substances and preparations hazardous to the environment and bearing the symbol "N" that are likely to be used by the public, unless it is intended to be used;
Recommended for other substances and preparations mentioned above that are likely to be used by the public, unless it is intended to be used.
S 30 Never pour water into this product:
Applicability:
Substances and preparations reacting violently with water.
Criteria for use:
Normally limited to special cases (sulphuric acid, for example); may be used, if any, to provide the clearest possible information, either to emphasize the phrase R 14 or as an alternative to that same sentence R 14.
S 33 Avoid the accumulation of electrostatic charges:
Applicability:
Extremely or easily flammable substances and preparations.
Criteria for use:
Recommended for substances and preparations used by the industry that do not absorb moisture; is practically never used for substances and preparations marketed to the public.
S 35 Do not get rid of this product and its container except by taking all precautions of use:
Applicability:
All hazardous substances and preparations.
Criteria for use:
Recommended for substances and preparations where special instructions are necessary for their correct disposal.
S 36 Carrying an appropriate protective garment:
Applicability:
Organic peroxides;
Very toxic, toxic or harmful substances and preparations;
Corrosive substances and preparations.
Criteria for use:
Obligatory for very toxic and corrosive substances and preparations;
Obligatory for substances and preparations to which R 21 or R 24 was assigned;
Mandatory for carcinogenic, mutagenic and toxic substances for the reproduction of Class 3, unless the effects occur only in the case of inhalation of the substance or preparation;
Obligatory for organic peroxides;
Recommended for toxic substances and preparations when DL 50 by skin is unknown, but the substance or preparation is likely to be toxic by contact with the skin;
Recommended for substances and preparations used in the industry that are likely to be harmful to health in the event of prolonged exposure.
S 37 Bring appropriate gloves:
Applicability:
Very toxic, toxic, harmful or corrosive substances and preparations;
Organic peroxides;
irritating substances and preparations for the skin, or causing skin contact awareness.
Criteria for use:
Obligatory for very toxic and corrosive substances and preparations;
Mandatory for substances and preparations to which the phrase R 21, R 24 or R 43 was assigned;
Mandatory for carcinogenic, mutagenic and toxic substances for the reproduction of Class 3, unless the effects occur only in the case of inhalation of the substance or preparation;
Obligatory for organic peroxides;
Recommended for toxic substances and preparations when DL 50 by skin is unknown, but the substance or preparation is likely to be harmful by contact with the skin;
Recommended for irritating substances and preparations for the skin.
S 38 In the event of insufficient ventilation, carry an appropriate breathing apparatus:
Applicability:
Very toxic or toxic substances and preparations.
Criteria for use:
Normally limited to special cases where very toxic or toxic substances and preparations are used in industry or agriculture.
S 39 Carrying an eye/face protection device:
Applicability:
Organic peroxides;
Corrosive substances and preparations including irritants that may cause serious eye damage;
Very toxic or toxic substances and preparations.
Criteria for use:
Obligatory for substances and preparations to which the phrase R 34, R 35 or R 41 was assigned;
Obligatory for organic peroxides;
Recommended when it is necessary to draw the user's attention to the risks associated with eye contact, not mentioned in the risk phrases that must be assigned;
Normally limited to exceptional cases where very toxic and toxic substances and preparations are used, when there may be splashes and these substances and preparations are likely to be easily absorbed by the skin.
S 40 To clean the soil or objects welded by this product, use... (to be specified by the manufacturer):
Applicability:
All hazardous substances and preparations.
Criteria for use:
Normally limited to hazardous substances and preparations for which water is not considered to be an adequate cleaning agent (when it is necessary to use absorption by pulverulent material, solvent dissolution, etc.) and in case it is important, for sanitary reasons or for safety reasons, to include a warning on the label.
S 41 In case of fire and/or explosion, do not breathe smoke:
Applicability:
Hazardous substances and preparations resulting in the combustion of very toxic or toxic gases.
Criteria for use:
Normally limited to special cases.
S 42 During fumigations/pulverizations, carry an appropriate respiratory system (the appropriate term[s] to be indicated by the manufacturer):
Applicability:
Substances and preparations for this use, but may compromise the health and safety of the user if precautionary measures are not taken.
Criteria for use:
Normally limited to special cases.
S 43 In case of fire, use... (extinguishing means to be specified by the manufacturer; if water increases risks, add: " Never use water":
Applicability:
Extremely flammable, easily flammable and flammable substances and preparations.
Criteria for use:
Obligatory for substances and preparations that, in contact with water or wet air, result in extremely flammable gas discharges;
Recommended for extremely flammable, easily flammable and flammable substances and preparations, especially when they do not mix with water.
S 45 In the event of an accident or malaise, consult a doctor immediately (if possible show the label):
Applicability:
Very toxic substances and preparations;
Toxic and corrosive substances and preparations;
Substances and preparations for inhalation awareness.
Criteria for use:
Mandatory for the substances and preparations mentioned above.
S 46 In case of ingestion, consult a doctor immediately and show him the packaging or label:
Applicability:
All hazardous substances and preparations other than those that are very toxic, toxic, corrosive or dangerous to the environment.
Criteria for use:
Obligatory for all the above-mentioned hazardous substances and preparations that may be used by the public, unless ingestion of these products, especially by children, can be considered inoffensive.
S 47 Store at a temperature not exceeding... °C (to be specified by the manufacturer):
Applicability:
Substances and preparations become unstable at a certain temperature.
Criteria for use:
Normally limited to special cases (some organic peroxides, for example).
S 48 Wet hold with... (mean appropriate to specify by manufacturer):
Applicability:
Substances and preparations that can become very sensitive to sparks, friction or shock if left to dry.
Criteria for use:
Normally limited to special cases, such as nitrocelluloses.
S 49 Store only in the original container:
Applicability:
Substances and preparations sensitive to catalytic decomposition.
Criteria for use:
Substances and preparations sensitive to catalytic decomposition (e.g. some organic peroxides).
S 50 Do not mix with... (to be specified by the manufacturer):
Applicability:
Substances and preparations that can react with the specified product and result in very toxic or toxic gas releases;
Organic peroxides.
Criteria for use:
Recommended for the above-mentioned substances and preparations that may be used by the public, where this is preferable to R 31 or R 32;
Obligatory with certain peroxides that may result in violent reactions in the presence of accelerators or promoters.
S 51 Use only in well-disaggregated areas:
Applicability:
Substances and preparations that may or should result in vapours, dust, aerosols, smoke, fog etc. that pose risks by inhalation or the risks of fire or explosion.
Criteria for use:
Recommended when S38 is not indicated. The use of this reference is therefore important when such substances and preparations are likely to be used by the public.
S 52 Do not use on large surfaces in inhabited premises:
Applicability:
Very toxic, toxic and harmful volatile substances and preparations containing them.
Criteria for use:
Recommended when health can be affected by prolonged exposure to these substances and preparations as a result of their volatilization from large areas treated in homes or other places where people meet.
S 53 Avoid exposure - obtain special instructions before use:
Applicability:
Carcinogenic, mutagenic and/or toxic substances and preparations for reproduction.
Criteria for use:
Mandatory for the substances and preparations assigned to at least one of the following R phrases: R 45, R 46, R 49, R 60 or R 61.
S 56 Remove this product and its container from a hazardous or special waste collection centre:
Applicability:
All hazardous substances and preparations.
Criteria for use:
Recommended for all hazardous substances and preparations that may be used by the public and for which special disposal is required.
S 57 Use an appropriate receptacle to avoid contamination of the ambient environment:
Applicability:
Substances and preparations attributed to the symbol "N".
Criteria for use:
Normally limited to substances and preparations that are not likely to be used by the public.
S 59 Consult the manufacturer/supplier for recovery/recycling information:
Applicability:
All hazardous substances and preparations.
Criteria for use:
Obligatory for hazardous substances and preparations for the ozone layer;
Recommended for other substances and preparations for which recovery/recycling is recommended.
S 60 Eliminate the product and its container as a dangerous waste:
Applicability:
All hazardous substances and preparations.
Criteria for use:
Recommended for substances and preparations not likely to be used by the public, where S 35 was not assigned.
S 61 Avoid release to the environment. See special instructions/security data sheet:
Applicability:
Hazardous substances and preparations for the environment.
Criteria for use:
Normally used for substances and preparations to which the symbol "N" was assigned;
Recommended for all substances and preparations classified as hazardous to the environment not covered above.
S 62 In case of ingestion, do not make vomit. Consult a doctor immediately and show him the packaging or label:
Applicability:
Substances and preparations classified as harmful with sentence R 65 in accordance with the criteria set out in 3.2.3;
Not applicable to substances and preparations placed on the market in the form of aerosols or in containers with a sealed spray device (see points 8 and 9).
Criteria for use:
Obligatory for the substances and preparations mentioned above if they are sold to the public or likely to be used by the public, unless the sentences S 45 or S 46 are mandatory;
Recommended for the above-mentioned substances and preparations used in the industry, unless sentences S 45 or S 46 are mandatory.
S 63 In the event of an inhalation accident, carry the victim out of the contaminated area and keep her at rest:
Applicability:
Very toxic and toxic substances and preparations (gas, vapours, particles, volatile liquids);
Substances and preparations for respiratory awareness.
Criteria for use:
Obligatory for substances and preparations to which phrases R 26, R 23 or R 42 were assigned and that are likely to be used by the public in conditions where there would be a risk of inhalation.
S 64 In case of ingestion, rinse the mouth with water (only if the person is aware):
Applicability:
Corrosive or irritating substances and preparations.
Criteria for use:
Recommended for the above substances and preparations that may be used by the public, and if the above treatment is adapted.
7. Labelling
7.1. After determining the classification of a substance or preparation, the appropriate label shall be established using the requirements of Article 23 of Directive 67/548/EEC, for substances, and the provisions of Article 10 of Directive 1999/45/EC, for preparations. This point explains the method of identification of the label and in particular provides guidance on how to select risk phrases and precautionary statements.
The label bears the following indications:
(a) For preparations, trade name or designation;
(b) For substances, the name of the substance, and for preparations, the names of substances present in the preparation, in accordance with the rules set out in Article 10, paragraph 2.3, of Directive 1999/45/EC;
(c) The name, complete address and telephone number of the person responsible for placing the substance or preparation on the market, whether the manufacturer, importer or distributor;
(d) The symbol(s) and hazard indication(s);
(e) The phrases indicating specific risks (phrases R);
(f) The phrases indicating precautionary statements (phrases S);
(g) For substances, the EC number accompanied, in the case of substances listed in Appendix I, the reference "EC labelling";
(h) For preparations offered or sold to the public, the nominal quantity of the content, unless otherwise specified on the packaging.
Note:
For some preparations, additional labelling requirements are specified in section 10, paragraph 1.2, and Appendix V to Directive 1999/45/EC and section 20 of Directive 98/8/EC.
7.1.1. Final choice of risk phrases and precautionary statements.
Although the final choice of the most appropriate R and S phrases is governed, first of all, by the need to provide all necessary information, it is also necessary to take into account the clarity and impact of the label. For clarity, the necessary information should be expressed in a minimum number of sentences.
In the case of irritating substances, easily flammable, flammable and oxidizing, it is not necessary to recall the phrases R and S if the contents of the packaging do not exceed 125 ml. The same applies to substances that are not sold in detail to the public.
In the case of preparations, if the contents of the packaging do not exceed 125 ml:
- for preparations classified as easily flammable, oxidizing, irritating, with the exception of those assigned in sentence R 41, or dangerous to the environment and affected by the symbol "N", it is not necessary to indicate the phrases R or phrases S;
- for preparations classified as flammable or dangerous to the environment and not affected by the symbol "N", it is necessary to indicate the phrases R, but not the phrases S.
7.1.2. Without prejudice to the provisions of Article 16, paragraph 4, of Directive 91/414/EC and the provisions of Directive 98/8/EC, indications such as "non-toxic", "non-polluting", "environmental" or any other indication to demonstrate the non-hazardous character of a substance or preparation, or likely to result in a sub-estimate of the hazards of that substance or preparation, shall not appear on the label
7.2. Chemical name(s) to be included on the label.
7.2.1. For substances listed in Appendix I, the label must bear the name of the substances under one of the names listed in Appendix I.
For substances not included in Annex I, the name is given using an internationally recognized chemical nomenclature, as defined in 1.4.
7.2.2. For preparations, the choice of names to be included on the label is governed by the rules set out in Article 10, paragraph 2.3, of Directive 1999/45/EC.
Note:
Subject to the provisions of Annex V, item B.9, of Directive 1999/45/EC:
The name of the sensitivizing substance shall be selected in accordance with the provisions of paragraph 7.2.1. of this annex.
In the case of concentrated preparations for the perfume industry:
- the person responsible for their marketing can simply identify the sensitivizing substance that they consider to be primarily responsible for the risk of awareness.
In the case of a natural substance, the chemical name may be of the type "essential oil of...", "extract from...", rather than the name of the constituents of this essential oil or extract.
7.3. Choice of danger symbols.
The drawing of hazard symbols and the wording of hazard indications shall be in accordance with those in Appendix II. The symbol is printed in black on orange yellow background.
7.3.1. For substances listed in Appendix I, hazard symbols and indications are those listed in the Appendix.
7.3.2. For hazardous substances that are not yet included in Annex I and for preparations, symbols and hazard indications are assigned according to the rules set out in this Annex.
When more than one hazard symbol is assigned to a substance or preparation:
- the obligation to affix the symbol "E" makes optional the symbols "F", "F +" and "O";
- the obligation to attach the symbol "T+" or "T" makes optional the symbols "Xn", "Xi" and "C";
- the obligation to affix the symbol "C" makes optional the symbols "Xn" and "Xi";
- the attribution of the symbol "Xn" makes the symbol "Xi" optional.
7.4. Choice of phrases R.
The wording of phrases R must be consistent with the wording set out in Appendix III.
The combined R phrases in Appendix III should be used, if applicable.
7.4.1. For substances listed in Appendix I, the phrases R are those listed in the Appendix.
7.4.2. For substances not listed in Appendix I, R sentences are assigned according to the following criteria and priorities:
(a) In the case of health hazards:
(i) R phrases corresponding to the hazard category illustrated by a symbol must appear on the label;
(ii) R sentences corresponding to other hazard categories that are not illustrated by a symbol in accordance with Article 23 of Directive 67/548/EEC;
(b) In the case of hazards deriving physico-chemical properties:
R phrases corresponding to the hazard category illustrated by a symbol must appear on the label;
(c) In the case of environmental hazards:
The R phrase(s) corresponding to the category "hazardous for the environment" must be on the label.
7.4.3. For preparations, R phrases will be selected in accordance with the following criteria and priorities:
(a) In the case of health hazards:
(i) R phrases that correspond to the hazard category illustrated by a symbol. In some cases, R sentences must be adapted in accordance with the tables in Appendix II, Part B, of Directive 1999/45/EC. More specifically, phrases R of the constituent(s) that justify the classification of the preparation in a hazard category must appear on the label;
(ii) R sentences that correspond to the other hazard categories assigned to the constituents, but are not illustrated by a symbol in accordance with Article 10, paragrahe 2.4, of Directive 1999/45/EC;
(b) In the case of hazards deriving physico-chemical properties:
The criteria described in paragraph 7.4.3. (a) above are applicable, except for "extremely flammable" or "easy flammable" risk phrases that are not to be indicated when they constitute a repetition of the formulation of the hazard indication, represented by a symbol;
(c) In the case of environmental hazards:
(i) The R phrase(s) corresponding to the category "hazardous for the environment" must be on the label;
(ii) If the R 50 risk sentence was assigned in addition to a combined R 51/53 or R 52/53 or R 53 alone, the combined risk phrase R 50/53 should be used.
As a general rule, as far as preparations are concerned, a maximum of six R sentences will be sufficient to describe the risk; for this purpose, the combined sentences identified in Appendix III are considered to be single sentences.
However, when the preparation belongs simultaneously to several hazard categories, these standard phrases must cover all the main risks presented by the preparation. In some cases, more than six R sentences may be required.
7.5. Caution advice.
The wording of phrases S must be consistent with that set out in Appendix IV.
The combined S phrases in Appendix IV should be used, if applicable.
7.5.1. For substances listed in Appendix I, sentences S are those listed in the Appendix.
When no S sentence is indicated, the manufacturer/importer may add any appropriate S sentence(s). For substances not listed in Annex I and for preparations, the manufacturer shall add S sentences according to the criteria set out in Chapter 6 of this Annex.
7.5.2. Selection of precautionary statements.
The final choice of precautionary statements (phrases S) must take into account the risk phrases (phrases R) indicated on the label and the intended use of the substance or preparation:
- in general, a maximum of six S sentences will suffice to formulate the most appropriate precautionary statement; for this purpose, the combined sentences identified in Appendix IV are considered to be single sentences;
- in the case of sentences S concerning disposal, a sentence S must be used, unless it is clear that the removal of the product and its receptacle does not pose any danger to human health or the environment. In particular, safe disposal advice is important for substances and preparations sold to the public;
- some R phrases become superfluous if you make a wise choice of S sentences and vice versa; S phrases giving advice clearly in relation to R phrases will be reproduced on the label only if it is to specifically focus on a specific warning;
- in the choice of phrases S, special attention will be given to the expected conditions of use of certain substances and preparations, such as spraying or other aerosol effects. The sentences must be selected according to the intended use;
- precautionary advice S 1, S 2 and S 45 are mandatory for all highly toxic, toxic and corrosive substances and preparations sold to the public;
- precautionary advice S 2 and S 46 are mandatory for all other hazardous substances and preparations (except those classified only as environmentally hazardous) and sold to the public.
If the phrases selected in strict compliance with the criteria set out in paragraph 6.2 are redundant or ambiguous or if, obviously, they are not necessary in the case of particular product/package packages, some sentences may be deleted.
7.6. Number CE.
If a substance listed on the label is included in the European inventory of existing commercial substances (EINECS) or in the European list of notified substances (ELINCS), the substance's EINECS or ELINCS numbers must be on the label. This provision does not apply to preparations.
7.7. Label dimensions for preparations.
The dimensions of the label are as follows:
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Each symbol must occupy at least one tenth of the surface of the label and have a surface area of at least 1 cm2. The label must be firmly attached to one or more faces of the packaging that are directly in contact with the preparation.
The information to be displayed on the label must clearly detach itself from the bottom, be of sufficient size and have sufficient spacing to be easily readable.
8. Special cases: substances
8.1. Transportable gas cylinders.
For transportable gas cylinders, it is considered that the labelling requirements are met when they comply with Article 23 or Article 24, paragraph 6, point b, of Directive 67/548/EEC.
However, by derogation from Article 24, paragraphs 1 and 2, of Directive 67/548/EEC, for gas cylinders with a water capacity of less than or equal to 150 litres, one of the following alternatives may be used:
- the format and dimensions of the label may meet the requirements of ISO 7225 (1994 edition) for "gas cylinders - risk labels";
- the information referred to in Article 23, paragraph 2, may be provided on a durable disc or label, firmly attached to the bottle.
8.2. Gas containers for propane, butane or liquefied petroleum gas (LPG).
These substances are classified in Appendix I. Although their classification is in accordance with Article 2, they do not pose a danger to human health when placed on the market, as fuel gases released solely for combustion, in closed refillable cylinders or in non-refillable cartridges covered by EN 417 (EN 417, September 1992 edition) construction, control and marking »).
These bottles and cartridges must be labelled with the appropriate symbol and R and S sentences for flammability. Information on human health effects is not required on the label. However, such information that should have appeared on the label will be transmitted to the professional user by the person responsible for placing the substance on the market, in the form provided for in section 27 of the directive. With respect to consumers, they will be provided with sufficient information to enable them to take all necessary measures for health and safety, as provided for in Article 1(3) of Directive 91/155/EEC, as amended by Directive 93/112/EEC.
8.3. Massive metals.
These substances are classified in Appendix I or must be classified in accordance with section 6 of Directive 67/548/EEC. Although classified in accordance with section 2, some of these substances do not present, in their commercial form, a danger to human health in the event of inhalation, ingestion or contact with the skin or the aquatic environment. These substances do not require a label under section 23 of Directive 67/548/EEC. However, all information that should have been on the label must be communicated to the user by the person responsible for placing on the metal market in a form provided for in section 27.
8.4. Substances classified with sentence R 65.
For substances classified as harmful because of the danger in the case of aspiration, it is not necessary to label them "nocif" with the phrase R 65 if placed on the market in the form of aerosols or in containers with a sealed spray device.
9. Special cases: preparations
9.1. Gas preparations (gas mixtures).
For gas preparations, consider:
- the evaluation of physico-chemical properties;
- assessment of health hazards;
- risk assessment for the environment.
9.1.1. Evaluation of physico-chemical properties.
9.1.1.1. Inflammability.
The flammability properties of these preparations are determined in accordance with Article 5 of Directive 1999/45/EC in accordance with the methods specified in Annex V of Directive 67/548/EEC.
These preparations will be classified according to the results of the tests performed and according to the criteria of Appendix V and the classification guide.
However, by derogation, if these gaseous preparations are produced on order in small quantities, the flammability of these gaseous mixtures can be assessed through the following calculation method:
The expression of the gas mixture:
A1F1 +... + AiFi +... AnFn + B1I1 +... + BiIi +...
where:
Ai and Bi are the molar fractions;
Fi is a flammable gas;
Ii is an inert gas;
n is the number of flammable gases;
p is the number of inert gases;
can be processed in a form in which all Ii (inert gas) are expressed by a nitrogen equivalent, using a Ki coefficient, and in which the equivalent content of flammable gas A'i expresses itself as follows:
A'i = Ai x (100/(Ai + KiBi))
Using the value of the maximum flammable gas content which, in a mixture containing nitrogen, gives a composition that is not flammable to air (Tci), one can obtain the following expression:
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The gas mixture is flammable when the value of the aforementioned expression is greater than 1. The preparation is classified extremely flammable and the sentence R 12 is assigned.
Equivalence coefficients (Ki).
The values of the Ki equivalence coefficients between inert gases and nitrogen as well as the values of the maximum flammable gas content (Tci) are shown in tables 1 and 2 of ISO 10156, edition of 15 December 1990 (new 1996 edition), relative to "gas and gas mixtures - determination of the flammability and oxidation potential for the choice of valve outlet connections".
Maximum flammable gas content (Tci).
The value of the maximum flammable gas content (Tci) is shown in table 2 of ISO 10156, edition of 15 December 1990 (new 1996 edition), relating to "gas and gas mixtures - determination of the flammability and oxidation potential for the choice of valve outlet connections".
When the Tci value of a flammable gas is not included in the above standard, the lower explosive limit (LIE) will be used. If there is no LIE value, the Tci value will be set to 1% by volume.
Remarks:
- the above expression may be used to allow appropriate labelling of gaseous preparations; However, it should not be considered a method replacing experimentation in the determination of technical safety parameters;
- in addition, this expression provides no information on whether or not to safely prepare a mixture containing oxidizing gases. These are not considered in the assessment of flammability;
- the above expression will only yield reliable results if flammable gases do not influence each other from the point of view of their flammability. This should be taken into account, for example with halogen hydrocarbons.
9.1.1.2. Combining properties.
Annex V to Directive 67/548/EEC does not contain a method for determining the oxidizing properties of gas mixtures, the properties of gas mixtures must be assessed using the following estimation method.
The principle of this method is to compare the potential oxidizing gases in a mixture with the potential oxidizing oxygen in the air. The concentrations of the gas in the mixture are expressed as a percentage in volume.
The gas mixture is considered as oxidizing or more oxidizing than the air if the following condition is checked:
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where:
xi is the concentration of i gas in percentage volume,
Ci is the oxygen equivalence coefficient.
In this case, the preparation is classified as oxidizing and is assigned the sentence R 8.
Equivalence coefficient between oxidizing gases and oxygen.
The coefficients used in the calculation to determine the oxidizing power of certain gases in a mixture compared to the oxidizing power of oxygen in the air, resumed in paragraph 5.2 of ISO 10156 (new 1996 edition) on "gas and gas mixtures - determination of the flammability and oxidation potential for the choice of valve outlet connections", are as follows:
O2 1
N2O 0.6
Where there is no value of the coefficient (Ci) for a gaseous substance in the cited standard, a value of 40 is assigned to that coefficient.
9.1.2. Labelling.
For transportable gas receptacles, it is considered that the labelling requirements are in conformity with the provisions of Article 11, paragraph 6, point b, of Directive 1999/45/EC.
However, by derogation from Article 11, paragraphs 1 and 2, of Directive 1999/45/EC, for gas receptacles with a water capacity of less than or equal to 150 litres, the format and dimensions of the label may meet the requirements of ISO 7225 (1994 edition) for "gas cylinders. - Risk labels." In this case, the label may mention the generic name or the industrial or commercial name of the preparation provided that the name of the hazardous substances entering its composition are clearly and indelible on the body of the gas container.
The information referred to in Article 10 of Directive 1999/45/EC may be provided on a durable disc or label, firmly attached to the receptacle.
9.2. Gas containers for preparations containing nauseabond propane, butane or liquefied petroleum gas (LPG).
Propane, butane and liquefied petroleum gas are listed in Appendix I. Although preparations containing these substances are classified in accordance with articles 5, 6 and 7 of Directive 1999/45/EC, they do not pose a danger to human health when placed on the market, as fuel gases released solely for combustion, in closed cylinders refillable or in closed cylinders construction, control and marking »).
These bottles and cartridges must be labelled with the appropriate symbol and R and S sentences for flammability. Information on human health effects is not required on the label. However, such information that should have appeared on the label will be transmitted to the professional user by the person responsible for placing the substance on the market in the form provided for in Article 14 of Directive 1999/45/EC. With respect to consumers, they will be provided with sufficient information to enable them to take all necessary measures for health and safety, as provided for in Article 1(3) of Directive 91/155/EEC.
9.3. Alloys, preparations containing polymers and preparations containing elastomers.
These preparations will be classified in accordance with the requirements of sections 5, 6 and 7 of Directive 1999/45/EC and labelled in accordance with the requirements of section 10 of Directive 1999/45/EC.
Although classified in accordance with articles 6 and 7 of Directive 1999/45/EC, some of these preparations do not, in their commercial form, pose a danger to human health in the event of inhalation, ingestion or contact with the skin or a danger to the aquatic environment. Such preparations do not require labelling under section 10 or Annex V, item B.9, of Directive 1999/45/EC. However, all information that should have been on the label must be communicated to the professional user by means of an information system in the form provided for in Article 14 of Directive 1999/45/EC.
9.4. Preparations classified with sentence R 65.
For formulations classified as harmful due to the danger in the case of aspiration, it is not necessary to label them "nocif" with the phrase R 65 if placed on the market in the form of aerosols or in containers with a sealed spray device.
9.5. Organic peroxides.
Organic peroxides combine the properties of a oxidizing substance and a fuel substance into a single molecule: when an organic peroxide breaks down, the oxidizing part of the molecule reacts exothermicly with the fuel part (oxidable). For oxidizing properties, the methods used in Appendix V cannot be applied to organic peroxides.
The following calculation method, based on the presence of active oxygen, should be used.
The oxygen content (%) of an organic peroxide preparation is obtained by the formula:
You can see the table in the OJ
n° 268 of 18/11/2004 text number 16
where:
n = number of peroxide groups per molecule of organic peroxide i;
c = concentration (mass in %) of organic peroxide i;
mi = molecular mass of organic peroxide i.
9.6. Additional labelling requirements for certain preparations.
For some preparations, additional labelling requirements are set out in section 10, paragraph 1.2, and in Appendix V to Directive 1999/45/EC and section 20 of Directive 98/8/EC.
A N N E X E I
A N N E X E I I
7. Reduced testing for synthetic intermediaries whose quantity is greater than or equal to one ton per year.
7.1. Definitions.
Without prejudice to other Community Legislation, the following definitions apply for this Appendix:
"Intermediate synthesis", a chemical that is produced, consumed or used only for chemical treatment in order to be transformed into another or other chemical substances;
"Emission", the release of a substance in case, for example, of a system opening. The main objective must therefore be to ensure a maximum level of protection for workers and the minimalization of emissions in the environment by rigorous containment of the process;
"Exhibition" refers to what happens after the release of the substance, whether it has been emitted into the environment in the broad sense or whether it is likely to be inhaled by a worker or come into contact with his skin. If emissions are foreseeable, rigorous exposure control must be performed by appropriate techniques, keeping in mind the need to adopt the precautionary principle that the physico-chemical, toxicological and ecotoxicological properties that have not been tested must be considered hazardous;
"Integrated aspiration ventilation system", a closed aspiration ventilation system used in combination with locking systems, enclosures, envelopes, containers, etc., to confine chemical agents into the internal part of the closed functional unit. The process openings must be as small as possible. The extraction power and ventilation systems must be designed so that there is a sufficient depression in the extraction unit so that all gases, vapours and/or all the dust generated are perfectly captured and carried away. Discharged hazardous substances must not be able to refluen in the work area. In this type of configuration, hazardous substances cannot spread from the closed functional unit to the work area;
"Very effective aspiration ventilation system", an open or semi-open aspiration ventilation system, dimensioned in such a way that chemical agents remain in the capture area. This means that the presence of chemical agents in the atmosphere of the workplace can practically be excluded;
"Effective aspiration ventilation system", an open or semi-open aspiration ventilation system, dimensioned in such a way that chemical agents remain in the capture area; in other words, the presence of chemical agents in the atmosphere of the workplace may be excluded to a large extent or the respect of the limit value is attested;
"Another aspiration ventilation system", an open or semi-open aspiration ventilation system, dimensioned in such a way that the presence of chemical agents in the workplace atmosphere cannot be excluded;
"Terms of use resulting in low emissions", for example:
- the lost packaging, which consists of entrusting the hazardous substance in an appropriate packaging and introducing it into a reactor with that packaging, without opening it;
- the change of consistency, i.e. the use of the substance in the form of paste or granules rather than in the form of powder, for example;
- the batch master, which consists of surrounding the dangerous substance of a plastic matrix that prevents direct contact with this substance. The matrix is not a dangerous substance. The abrasion of the plastic matrix and thus the release of the dangerous substance is however possible;
« Conditions of use without emissions », for example, a batch master without abrasion (the plastic matrix is so resistant to abrasion that no dangerous substance can escape);
"Technically watertight", the quality of a sub-unit in which no leakage is detectable during testing, testing or sealing checks, for example, by means of foaming agents or detection devices for leakage points set up for this specific purpose. The systems, subsystems and functional elements are technically waterproof if the leak flow is less than 0.00001 mbar.l.s-1.
7.2. Application for reduced test battery.
For synthetic intermediaries, the notifier may apply to the body referred to in the third paragraph of Article L. 231-7 of the Labour Code to grant him permission to perform a reduced battery of tests (EB). BER represents the basic level of information intended to provide a preliminary risk assessment for any synthetic intermediate chemical on the market. However, if necessary, additional tests may be requested, based on the results of the risk assessment.
7.3. Conditions for applying a reduced test battery.
The notifier shall demonstrate, to the satisfaction of the approved body referred to in the third paragraph of Article L. 231-7 of the Labour Code, that the following conditions are met:
(a) The substance is produced, consumed or used only for chemical treatment. The monomers are excluded. After treatment, the substance is transformed into chemically different molecules, which are not polymers;
(b) The substance is limited to up to two use sites. For example, it can be manufactured by a company then transported to one or two others to be treated. It should be noted that if, subsequently, it is envisaged to use the substance in more than two sites, the conditions for achieving an BER are no longer satisfied and the file must be reviewed accordingly;
(c) The supply of the company that uses synthetic intermediaries for further processing must be made directly by the notifier and not by an intermediate supplier;
(d) The substance must be confined rigorously by technical means throughout its life cycle. The latter includes the production, transport, purification, cleaning and maintenance, sampling, analysis, loading and unloading of tanks/dispositives, waste purification/dispositure and storage.
In general, an adequate process corresponds to an installation of which all functional elements such as filling openings, draining devices, etc., are closed-type devices whose sealing is guaranteed or closed-type devices equipped with an integrated aspiration ventilation system;
(e) If there is a risk of exposure, there is a need to implement prevention procedures and techniques to minimize the resulting emissions and exposure;
(f) During maintenance and cleaning work, special procedures, such as those that allow to be purged and washed, must be applied before anyone opens or enters the system;
(g) Transport operations shall be carried out in accordance with the provisions of modified Council Directive 94/55/EC;
(h) In the event of an accident and waste production as a result of maintenance, cleaning or purification procedures, environmental exposure may occur. In each case, prevention procedures and techniques are used to minimize the resulting emissions and exposures;
(i) A management system must be established to identify the roles of each individual in the organization;
(j) The packaging of the substance is labelled in accordance with Annex VI to this Order and also bears the following wording: "Warning. - Substance not yet tested completely » ;
(k) The notifier must implement a responsible product management system and must ensure that users (up to 2) comply with the conditions listed above.
7.4. Technical file to be supplied for a reduced test battery.
A notifier requesting BER for a given substance must provide the following technical file to the competent authority for all production and use sites:
(a) A statement that the notifier and each user accept the conditions listed in paragraph 3;
(b) A description of the technical measures by which rigorous containment of the substance is performed (1), including filling, sampling, transfer and cleaning procedures. It is not necessary to provide details regarding the integrity of each joint or the effectiveness of the integrated aspiration ventilation system. Nevertheless, regardless of the means used to achieve rigorous process containment, it is important that information be available, if necessary, to verify the veracity of statements in the event of control;
(c) If the criteria for the assessment of closed systems during the handling phase of chemical agents (see item 5) are not met, the notifier shall submit data for the evaluation of the exposure based on representative measured data and/or calculations using reliable models, in order to allow the competent authority to decide on the request for BER;
(d) A detailed description of the processes used at all production and use sites. In particular, it should be noted whether wastes of production and/or treatment are released into wastewater, whether liquid or solid waste is incinerated, and how the cleaning and maintenance of all equipment is done;
(e) A detailed assessment of the potential for human and environmental emissions and exposure throughout the life cycle of the substance, detailing the various chemical reactions that occur during the process and the treatment of residues.
Where emissions are likely to result in exposure, the means by which they are controlled must be described in sufficient detail to allow the approved organization provided for in R. 231-52 of the Labour Code to decide to accept the declaration or to calculate an emission rate in accordance with the Community Technical Guide;
(f) Changes that may have an impact on human or environmental exposure, for example, any changes to the functional elements of the facility, the existence of a new user or site, must be notified in advance;
(g) The information required for BER is as follows:
The information requested in Annex VII.B, plus the following tests, referred to in this Annex:
- vapour pressure (3.4);
- explosive properties (3.11);
- auto-inflammation temperature (3.12);
- oxidizing properties (3.13);
- granulometry (3.15);
Acute toxicity for daphnia (5.1.2).
The notifier must also include any other relevant information so that the competent authority can make an informed decision and that appropriate control measures are put in place by the user on the synthesis intermediary processing site. For example, if additional toxicological and/or physico-chemical information and/or information on the behaviour of the substance in the environment are available, they must also be transmitted. In addition, the notifier must review available information on toxicity and ecotoxicity for substances with a close structural relationship with the notified substance. If relevant information is available, including for carcinogenesis, chronic toxicity or reproductive toxicity, a summary of this information should be provided;
(h) Identities of notifier, manufacturer and user (or users).
7.5. Criteria for evaluating closed systems when handling chemical agents.
7.5.1. Use.
An evaluation index is used to assess the facility. The evaluation index classifies the handling of the substance and the exposure potential associated with the corresponding process. The notifier examines the installation or unit of the facility to determine the evaluation index. Each functional element must be evaluated.
The systems are considered closed if the evaluation of all available functional elements corresponds to an assessment index of 0.5 and if the only functional elements used are closed type, with a guaranteed seal and/or an integrated aspiration ventilation system. In addition, direct contact with the skin should be excluded.
In the list of examples, the functional elements that meet these criteria have a index of 0.5, indicated in bold.
Functional elements of a partially open type equipped with a very effective suction ventilation system (also with an assessment index of 0.5, but indicated in normal characters) are not considered closed within the defined criteria.
When functional elements are assigned an assessment index equal to 1, this means that compliance with the limit value is not always ensured on a permanent basis. These functional elements are:
1. Closed-type elements whose sealing is not ensured;
1. Partly open-type elements equipped with an effective aspiration ventilation system.
For the functional elements to which 2 or 4 evaluation indices are assigned, compliance with limit values is not always ensured. These functional elements are:
2. Partly open type elements, designed to operate with a single aspiration ventilation system;
2. The open elements equipped with a simple aspiration ventilation system;
4. Open or partially open elements;
4. The elements with natural ventilation device.
The list of examples in Table 1 facilitates the classification of functional elements. The functional elements that are not included in the document may be classified by analogy. The installation or installation unit is then classified from the value of the functional element having received the highest rating index.
7.5.2. Check.
To apply this criterion, the parameters defined for the processes should be met and the checks indicated in the list of examples (e.g., inspection and maintenance).
7.6. Application of reduced test battery.
If, pursuant to paragraph IV of Article R. 231-52-3 of the Labour Code, the approved body provided for in the third paragraph of Article L. 231-7 of the Labour Code accepts the notifier's request to submit only one BER, the technical record referred to in paragraph I of Article R. 231-52-3 shall contain the information obtained in the context of the tests and/or studies defined in paragraph 7.4. For quantities less than one ton per year, the usual test provisions in Annexes VII.B/VII.C apply.
TABLE 1
You can see the table in the OJ
n° 268 of 18/11/2004 text number 16
A N N E X E I V
When, in accordance with the provisions of Annex VII A relating to synthetic intermediaries, the approved organism provided for in the third paragraph of Article L. 231-7 of the Labour Code authorized that a chemical be subject to a reduced test battery, the requirements of this section shall be reduced as follows:
- if the quantity of substance placed on the market reaches 10 tonnes per year per manufacturer or if the total quantity placed on the market reaches 50 tonnes per manufacturer; in this case, the approved body provided for in the third paragraph of Article L. 231-7 of the Labour Code requires the completion of all tests and studies referred to in items 3 to 6 of Annex VII A (except those already completed); In addition, the conduct of Level 1 tests and studies on aquatic organisms may be required;
- if the quantity of substance placed on the market reaches 100 tonnes per year per manufacturer or if the total quantity placed on the market reaches 500 tonnes per manufacturer; in this case, the approved body provided for in I of R. 231-52 of the Labour Code requires the completion of the tests and studies of Level 1 relating to reproductive toxicity. The approved body referred to in the third paragraph of Article L. 231-7 of the Labour Code may decide that the substance having been classified as a synthesis intermediate that may be subject to a reduced test battery, one or more of the tests and studies, with the exception of those concerning reproductive toxicity, are not appropriate.
A N N E X E V
When, in accordance with the provisions of Annex VII A relating to synthetic intermediaries, the approved organism provided for in the third paragraph of Article L. 231-7 of the Labour Code authorized that a chemical be subject to a reduced battery of tests and that the quantity of substance being marketed to 1,000 tonnes per year and by manufacturer or that the total amount being marketed to 5,000 tonnes per manufacturer, the complementary studies at the level should not be reported at the level The approved body provided for in the third paragraph of Article L. 231-7 of the Labour Code, however, should consider further tests and may request additional tests, including those mentioned at levels 1 and 2 of this annex.
Done in Paris, November 9, 2004.
Minister of Employment, Labour
and social cohesion,
For the Minister and by delegation:
The Director of Labour Relations,
J.-D. Combrexelle
Minister of State, Minister of Economy,
finance and industry,
For the Minister and by delegation:
The Director General of Competition,
consumption
and the suppression of fraud,
G. Cerutti
Minister of Health
and Social Welfare
For the Minister and by delegation:
By preventing
Director General of Health:
The chief of duty,
Y. Coquin
Minister of Agriculture, Food,
and Rural Affairs,
For the Minister and by delegation:
Director General
and Rural Affairs,
A. Moulinier
Minister of Ecology
and Sustainable Development
For the Minister and by delegation:
The Director of Prevention
pollution and risk,
T. Found
Minister Delegate to Industry,
For the Minister and by delegation:
The Director General of Industry,
Information Technology
and posts,
J.-P. Falque-Pierrotin
