STATUTORY INSTRUMENTS.

S.I. No. 393 of 2000.

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING, LABELLING AND NOTIFICATION OF DANGEROUS SUBSTANCES) REGULATIONS, 2000.

S.I. No. 393 of 2000.

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING, LABELLING AND NOTIFICATION OF DANGEROUS SUBSTANCES) REGULATIONS, 2000.

ARRANGEMENT OF REGULATIONS.

REGULATION.

S.I. No. 393 of 2000.

EUROPEAN COMMUNITIES (CLASSIFICATION, PACKAGING, LABELLING AND NOTIFICATION OF DANGEROUS SUBSTANCES) REGULATIONS, 2000.

I, Mary Harney, Minister for Enterprise, Trade and Employment, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 ( No. 27 of 1972 ), and for the purpose of giving effect to Council Directives 92/32/EEC of 30 April 1992¹ and 96/56/EC of 3 September, 1996² , Commission Directives 91/155/EEC of 5 March, 1991³ , 92/69/EEC of 31 July, 1992⁴ , 93/21/EEC of 27 April, 1993⁵ , 93/67/EEC of 20 July, 1993⁶ , 93/72/EEC of 1 September, 1993⁷ , 93/101/EC of 11 November, 1993⁸ , 93/105/EC of 25 November, 1993⁹ , 93/112/EC of 10 December, 1993¹⁰ , 94/69/EC of 19 December 1994¹¹ , 96/54/EC of 30 July, 1996¹² , 97/69/EC of 5 December, 1997¹³ , 98/73/EC of 18 September, 1998¹⁴ , 98/98/EC of 15 December, 1998¹⁵ , 2000/32/EC of 19 May, 2000¹⁶ , 2000/21/EC of 25 April 2000¹⁷ , and 2000/33/EEC of 25 April 2000 ¹⁸ hereby make the following Regulations:

1.     Citation

These Regulations may be cited as the European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 2000.

2.     Interpretation

(1)       In these Regulations:

“Annex I” means Annex I to Council Directive 67/548/EEC¹⁹ as lastly amended by Commission Directive 2000/32/EC of 19 May 2000, and any reference in the said Annex to “EEC Number” shall be construed as a reference to “EC Number”;

“Annex II” means Annex II to Council Directive 67/548/EEC as amended by Commission Directive 93/21/EEC of 27 April 1993 and which for convenience of reference is set out in Schedule I;

“Annex III” means Annex III to Council Directive 67/548/EEC as lastly amended by Commission Directive 98/98/EC of 15 December 1998 and which for convenience of reference is set out in Schedule 2;

“Annex IV” means Annex IV to Council Directive 67/548/EEC as lastly amended by Commission Directive 2000/32/EC of 19 May 2000 and which for convenience of reference is set out in Schedule 3;

“Annex V” means Annex V to Council Directive 67/548/EEC as lastly amended by Commission Directives 2000/32/EC of 19 May 2000 and 2000/33/EC of 25 April 2000;

“Annex VI” means Annex VI to Council Directive 67/548/EEC as lastly amended by Commission Directive 98/98/EC of 15 December 1998 and which for convenience of reference is set out in Schedule 4;

“Annex VII.A” means Annex VII.A to Council Directive 67/548/EEC as lastly amended by Commission Directive 93/105/EC of 25 November, 1993 and which for convenience of reference is set out in Schedule 5;

“Annex VII.B” means Annex VII.B to Council Directive 67/548/EEC as lastly amended by Commission Directive 93/105/EC of 25 November, 1993 and which for convenience of reference is set out in Schedule 5;

“Annex VII.C” means Annex VII.C to Council Directive 67/548/EEC as lastly amended by Commission Directive 93/105/EC of 25 November, 1993 and which for convenience of reference is set out in Schedule 5;

“Annex VII.D” means Annex VII.D to Council Directive 67/548/EEC as lastly amended by Commission Directive 93/105/EC of 25 November, 1993 and which for convenience of reference is set out in Schedule 5;

“Annex VIII” means Annex VIII to Council Directive 67/548/EEC as amended by 92/32/EEC of 30 April 1992 and which for convenience of reference is set out in Schedule 5;

“Annex IX” means Annex IX of Council Directive 67/548/EEC as lastly amended by Commission Directive 2000 32 EC of 19 May, 2000 and which for convenience of reference is set out in Schedule 6.

“child-resistant fastening” means the cap, lid, fastening or other means of fastening a package, which complies with the provisions of Part A of Annex IX;

“the competent authority” has the meaning assigned to it by Regulation 5;

“dossier” means a “notification dossier”;

“EINECS” means the European Inventory of Existing Commercial Substances²⁰ containing the definitive list of all substances deemed to be on the market in the European Communities on 18 September, 1981;

“Elincs” means the European List of Notified Chemical Substances²¹ , published from time to time containing the list of substances placed on the market in the European Communities after 18 September, 1981 and which have been the subject of a notification;

“indication of danger” means the indication of danger specified in Column 3 of Schedule 2 and required to be contained on the label or marked on the package of a dangerous substance in accordance with Regulation 19;

“inspector” has the same meaning as in the Safety, Health and Welfare at Work Act, 1989 (No. 7 of 1989) ;

“international rules on the transport of dangerous substances” means any of the following (including amendments made to any of them):

(a)     the European Agreement Concerning the International Carriage of Dangerous Goods by Road done at Geneva on 30 September, 1957,

(b)     the International Regulations Concerning the Carriage of Dangerous Goods by Rail appended to the International Convention Concerning the Carriage of Dangerous Goods by Rail, 1980,

(c)     the International Maritime Dangerous Goods Code published by the International Maritime Organisation;

“label” means the label required by Regulations 19 and 20;

“Minister” means the Minister for Enterprise, Trade and Employment;

“monomer unit” means the reacted form of a monomer in a polymer;

“notification” means the documents, with the requisite information, presented to the competent authority of a Member State;

“notifier” means the person submitting a notification;

“package” means the packaging, receptacle or container containing a substance, and “packaging” shall be construed accordingly;

“person responsible for placing on the market a substance to which these Regulations apply” includes a manufacturer, importer, supplier, distributor, wholesaler or retailer established in the State, who places on the market a substance to which these Regulations apply;

“placing on the market” means the making available to third parties, and importation into the European Communities customs territory shall be deemed to be placing on the market for the purposes of these Regulations;

“polymer” means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant, and consisting of less than a simple weight majority of molecules of the same molecular weight, such molecules being distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units;

“preparations” means mixtures or solutions composed of two or more substances;

“process-orientated research and development” means the further development of a substance in the course of which pilot plant or production trials are used to test the fields of application of the substance;

“risk phrase” means any phrase which is listed in Annex III;

“safety phrase” means any phrase which is listed in Annex IV;

“scientific research and development” means scientific experimentation, analysis or chemical research carried out under controlled conditions and includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development;

“sole representative” means the person established in the European Communities who is so designated by the manufacturer of a substance manufactured outside the European Communities for the purposes of submitting a notification for that substance placed on the market, either on its own or in a preparation;

“substance” means a chemical element and its compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

“symbol” means any symbol specified in Annex II;

“tactile warning of danger” means a method of warning a person who has poor sight or no sight of the dangerous contents of a package referred to in Regulation 18, and which complies with the provisions of Part B of Annex IX;

(2)       For the purposes of these Regulations the following are dangerous -

(a)     explosive substances and preparations, namely, solid, liquid, pasty or gelatinous substances and preparations which may react exothermically without atmospheric oxygen thereby quickly evolving gases, and which, under defined test conditions, detonate, quickly deflagrate or upon heating explode when partially confined;

(b)     oxidising substances and preparations, namely, substances and preparations which give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances;

(c)     extremely flammable substances and preparations, namely, liquid substances and preparations having an extremely low flash-point and a low boiling point and gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure;

(d)     highly flammable substances and preparations, namely:

(i)      substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy,

(ii)     solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition.

(iii)     liquid substances and preparations having a very low flash-point, or

(iv)     substances and preparations which, in contact with water or damp air, evolve highly flammable gases in dangerous quantities;

(e)     flammable substances and preparations, namely, liquid substances and preparations having a low flash-point;

(f)      very toxic substances and preparations, namely, substances and preparations which in very low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;

(g)     toxic substances and preparations, namely, substances and preparations which in low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;

(h)     harmful substances and preparations, namely, substances and preparations which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;

(i)      corrosive substances and preparations, namely, substances and preparations which may, on contact with living tissues, destroy them;

(j)      irritant substances and preparations, namely, non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, may cause inflammation;

(k)     sensitising substances and preparations, namely, substances and preparations which, if they are inhaled or if they penetrate the skin, are capable of eliciting a reaction of hypersensitisation such that on further exposure to the substance or preparation, characteristic adverse effects are produced;

(l)      carcinogenic substances and preparations, namely, substances or preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence;

(m)    mutagenic substances and preparations, namely, substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defects or increase their incidence;

(n)     substances and preparations which are toxic for reproduction, namely, substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny or an impairment of male or female reproductive functions or capacity;

(o)     substances and preparations which are dangerous for the environment, namely, substances and preparations which, were they to enter the environment, would present or may present an immediate or delayed danger for one or more components of the environment.

(3)       (a)     In these Regulations a reference to a Regulation or a Schedule is to a Regulation of, or to a Schedule to, these Regulations, unless it is indicated that reference to some other enactment is intended.

(b)     In these Regulations a reference to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.

(c)     Any requirement in these Regulations in relation to a substance shall apply to a substance to which these Regulations apply, unless otherwise indicated.

(d)     A word or expression that is used in these Regulations and is also used in Council Directive 92/32/EEC has, unless the contrary intention appears, the same meaning in these Regulations as it has in that Directive.

3.     Construction and Application

(1)       The Safety, Health and Welfare at Work Act, 1989 , shall be construed and have effect as if these Regulations were existing enactments within the meaning of that Act and for the time being in force and specified in Part II to the Second Schedule of that Act.

(2)       These Regulations apply to all substances, which are intended to be placed on the market either on their own or in a preparation, unless exempted under Regulation 4.

(3)       The testing and notification requirements of these Regulations apply to substances not listed in the EINECS, which are intended to be placed on the market either on their own or in a preparation.

(4)       The classification requirements of these Regulations apply to all dangerous substances which are intended to be placed on the market.

(5)       The packaging, labelling and safety data sheet requirements of these Regulations apply to substances, classified as dangerous under these Regulations, which are placed on the market.

4.     Exemptions

(1)       These Regulations shall not apply to the following preparations in the finished state, intended for the final user -

(a)     medicinal products for human or veterinary use, as defined in Directive 65/65/EEC²² as lastly amended by Commission Directive 93/39/EEC²³ ,

(b)     cosmetic products, as defined by Directive 76/768/EEC²⁴ as lastly amended by Commission Directive 98/62/EC²⁵ ,

(c)     mixtures of substances which, in the form of waste, are the subject of Directives 75/442/EEC²⁶ as lastly amended by Commission Decision 96/350/EEC²⁷ and 91/689/EEC²⁸ as lastly amended by Council Directive 94/31/EEC²⁹ ,

(d)     foodstuffs,

(e)     animal feeding stuffs,

(f)      pesticides,

(g)     radioactive substances, as defined by Directive 80/836/EEC³⁰ ;

(h)     other substances or preparations for which European Communities notification or approval procedures exist and for which requirements relating to notification or approval are equivalent to those required by these Regulations.

(2)       These Regulations shall not apply to -

(a)     the carriage of dangerous substances by rail, road, inland waterway, sea or air;

(b)     substances in transit which are under customs supervision, provided they do not undergo any treatment or processing.

(3)       The following substances shall be exempt from the notification requirements specified in these Regulations -

(a)     substances which appear on the EINECS inventory,

(b)     additives and substances for exclusive use in animal feeding stuffs and to which Directives 70/524/EEC³¹ and 82/471/EEC³² apply,

(c)     substances used exclusively as additives in foodstuffs, to which Directive 89/107/EEC³³ applies, and substances used exclusively as flavourings in foodstuffs to which Directive 88/388/EEC³⁴ applies.

(d)     active ingredients used exclusively in medicinal products for human or veterinary use, as defined in Directive 65/65/EEC as amended by Commission Directive 93/39/EEC₂

(e)     substances for exclusive use in other product sectors for which European Communities notification or approval procedures exist, as set out in the Annex to Commission Directive 2000/21/EC of 25 April 2000, and for which the requirements for data submission are equivalent to those laid down in these Regulations.

(f)      substances manufactured in the European Communities, which are not included in EINECS or Elincs but are intended solely for export outside the European Communities, provided the manufacturer notifies such substances to the competent authority, and in relation to which such notification includes the following information -

(i)       the identity of the substance in accordance with point 1 of Annex VII.C,

(ii)      the quantity of the substance to be exported,

(ii)      the country of destination of the substance,

(iv)     information on the hazards of the substance, where available,

(v)      the proposed labelling of the substance.

(4)       The following substances shall be considered as having been notified within the meaning of these Regulations:

(a)     polymers, with the exception of those which contain in combined form 2% or more of any substance which is not on EINECS;

(b)     substances placed on the market in quantities of less than 10 kg per year per manufacturer;

(c)     substances placed on the market in quantities not exceeding 100 kg per manufacturer per year, and intended solely for purposes of scientific research and development carried out under controlled conditions, provided the manufacturer or importer maintains written records, containing the identity of the substance labelling data, quantities and a list of customers involved,

(d)     without prejudice to the provisions of paragraph (14)(a), substances placed on the market for the purposes of process-orientated research and development with a limited number of registered customers in quantities which are limited to the purpose of process-orientated research and development

(5)       The packaging and labelling requirements of Regulations 21 to 20 shall not apply to munitions and explosives placed on the market with a view to producing a practical effect by explosion or a pyrotechnic effect.

(6)       For the purpose of these Regulations, labelling requirements shall be deemed to be satisfied -

(a)     in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous substances and the inner package or packages are labelled in accordance with Regulations 19 and 20;

(b)     in the case of a single package if such a package is labelled in accordance with international rules on the transport of dangerous substances and with Regulations 19(1)(a), (b), (d), (e) and (f), and where appropriate, for particular types of packaging such as mobile gas cylinders, in accordance with the specific requirements referred to in Annex VI.

(7)       The packaging of dangerous substances which are not explosive, very toxic or toxic may be unlabelled or may be labelled in such other way as may be approved by the competent authority if they contain such small quantities that there is no reason to fear any danger to persons handling such substances or to other persons.

(8)       The packaging of dangerous substances which are explosive, very toxic or toxic may be labelled in such other way as may be approved by the competent authority if they are too small for labelling in accordance with Regulations 19 and 20 and there is no reason to fear any danger to persons handling such substances or to other persons.

(9)       The labelling required on packages which are either too small or otherwise unsuitable for labelling in accordance with Regulations 19 and 20 may be applied on packages in such other appropriate manner as may be approved by the competent authority.

(10)     A derogation under paragraph (7), (8), or (9) shall not permit the use of symbols, indications of danger, risk phrases or safety phrases different from those required by these Regulations.

(11)     Where dangerous substances do not leave the State, labelling may be permitted by the competent authority which complies with national rules relating to the transport of dangerous substances.

(12)     The competent authority may communicate the contents of notifications received under paragraph (3)(f) to the Commission and the competent authorities of other Member States.

(13)     Records kept under paragraph (4)(c) shall be made available upon request to the competent authority where the manufacture, importation or scientific research and development takes place in the State.

(14)     (a)     Substances referred to in paragraph (4)(d) shall qualify for an exemption for a period of one year provided that the manufacturer or importer communicates their identity, labelling data, quantity, the justification for the quantity and a list of customers and the research and development programme to the competent authorities of each Member State where the manufacture, importation or process-orientated research and development takes place and complies with any conditions imposed by these authorities or the Member States on such research and development, and the conditions imposed by the competent authorities or the Member States may include information not exceeding that provided for in Annex VII.C for quantities less than 500 kg, Annex VII.B for quantities between 500 kg and less than 1 tonne, and Annex VII.A for other quantities.

(b)     The manufacturer or importer shall also give an assurance to the competent authority that the substance or the preparation in which it is incorporated will be handled only by customers' staff in controlled conditions and will not be made available to the general public at any time either on its own or in a preparation.

(c)     Where the competent authority considers that there may exist an unacceptable risk for man and the environment, it may restrict any product, containing a new substance, which was produced during the process-orientated research and development.

(d)     The one-year exemption period referred to in subparagraph (a) may be extended for a further year where the notifier can demonstrate, to the satisfaction of the competent authority that such an extension is justified.

(15)     (a)     A substance referred to in paragraph (4) shall, where the manufacturer may reasonably be expected to be aware of its dangerous properties, be packaged and provisionally labelled by the manufacturer or his representative in accordance with Regulations 21 to 20.

(b)     Where it is not possible to label the substances completely and in accordance with Regulation 19, because the results of all tests provided for in Annex VII.A are not available, the label shall bear, in addition to the label deriving from the tests already carried out, the warning “Caution - substance not yet fully tested”.

(c)     Where a substance referred to in paragraph (4) is labelled as very toxic, toxic, carcinogenic, toxic for reproduction, or mutagenic in accordance with Regulation 19, the manufacturer or importer of such a substance shall submit to the competent authority any appropriate information specified in Annex VII.A, Sections 2.3, 2.4 and 2.5, including, where available, acute toxicity data.

accordance with these Regulations a notifier need only supply items 1 and 2 of the relevant Annex in the case of a substance for which the information was originally submitted at least 10 years previously.

5.     Competent Authority

The competent authority shall be the National Authority for Occupational Safety and Health established by Part III of the Safety, Health and Welfare at Work Act, 1989 .

6.     Placing on the Market

(1)       A person shall not place on the market a substance to which these Regulations apply either on its own or in a preparation unless it has been notified, packaged and labelled, and safety data sheets have been provided in accordance with these Regulations

(2)       The notification referred to in paragraph (1) shall, for substances manufactured in the State, be submitted to the competent authority by the manufacturer concerned.

(3)       The notification referred to in paragraph (1) shall, for substances manufactured outside the European Communities, be submitted to the competent authority, by any person established in the State who is responsible for placing the substance either on its own or in a preparation on the market, or by the person established within the State who is, for the purposes of submitting a notification for a given substance placed on the market, either on its own or in a preparation, designated by the manufacturer as his sole representative.

(4)       Paragraph (1) shall not apply to a substance placed on the market in quantities of less than one tonne per annum for any manufacturer which was notified under the European Communities (Dangerous Substances) (Classification, Packaging, Labelling and Notification) Regulations, 1982 ( S.I. No. 258 of 1982 ); provided that -

(a)     the substance has been notified in the State prior to the commencement of these Regulations, and

(b)     the substance concerned has been manufactured by the same manufacturer of the substance to which the notification referred to in subparagraph (a) relates.

7.     Testing and Assessment

(1)       For the purposes of these Regulations -

(a)     tests on substances shall as a general principle be conducted according to the methods laid down in Annex V,

(b)     the physico-chemical properties of substances shall be determined according to the methods specified in Annex V (A),

(c)     the toxicity of substances shall be determined according to the methods specified in Annex V (B),

(d)     the ecotoxicity of substances shall be determined according to the methods specified in Annex V (C),

(e)     laboratory tests on substances shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 87/18/EE C³⁵ and in Directive 86/609/EEC³⁶ ,

(f)      for substances on the EINECS the adequacy of the data for the purposes of classification and labelling and the need to conduct new tests shall be decided on a case-by-case basis taking into account the need to minimise testing on vertebrate animals.

(2)       (a)     Where more than one notification exists for a substance manufactured by the same manufacturer outside the European Communities, the obligation to carry out supplementary testing required under these Regulations will fall collectively on all notifiers placing that substance on the market;

(b)     For substances referred to in subparagraph (a), if the quantities detailed in Regulation 10(3) are attained, the competent authority shall contact each notifier and inform him of the identity of the other notifiers and shall draw his attention to the provisions of subparagraph (a).

(3)       Where it is necessary in the opinion of the competent authority for the purposes of carrying out the evaluation of the risks which may be caused by a substance in accordance with Directive 93/67/EEC, the competent authority may ask for further information, verification or confirmatory tests concerning the substances or their transformation products of which they have been notified or have received information under these Regulations and may also request information referred to in Annex VIII earlier than provided for in Regulation 10(3).

8.     Classification

(1)       For the purposes of these Regulations a dangerous substance shall be classified as one or more of the following -

(a)     explosive;

(b)     oxidising;

(c)     extremely flammable;

(d)     highly flammable;

(e)     flammable;

(f)      very toxic;

(g)     toxic;

(h)     harmful;

(i)      corrosive;

(j)      irritant;

(k)     sensitising;

(l)      carcinogenic;

(m)    mutagenic;

(n)     toxic for reproduction;

(o)     dangerous for the environment.

(2)       Dangerous substances shall be classified and labelled in accordance with the criteria in Annex VI.

(3)       In classifying a substance account shall be taken of the concentration of any impurity in as far as the latter exceeds the concentration limits specified in Annex I and in Article 3 of Directive 88/379/EEC³⁷ .

9.     Obligation to carry out investigation

Manufacturers, distributors and importers of dangerous substances, which appear in the EINECS but which have not yet been introduced into Annex I, shall carry out an investigation to make themselves aware of the relevant and accessible data existing concerning the properties of such substances, and on the basis of this information shall package and provisionally label these substances in accordance with Regulations 21 to 20.

10.   Full Notification

(1)       Subject to Regulation 4, a notifier intending to place on the European Communities market a substance in quantities of greater than or equal to one tonne per annum per manufacturer shall submit to the competent authority, a notification including -

(a)     a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for man and the environment, and containing all available relevant data for this purpose,

(b)     a declaration concerning the unfavourable effects of the substance in relation to the various foreseeable uses,

(c)     the proposed classification and labelling of the substance in accordance with these Regulations,

(d)     in the case of dangerous substances, a proposal for a safety data sheet in accordance with Regulation 22,

(e)     in the case of a manufacturer located outside the European Communities, a statement if appropriate from the manufacturer to the effect that, for the purpose of submitting a notification for the substance in question, he is designated as the manufacturer's sole representative,

(f)      if so desired by the notifier, a statement requesting on reasoned grounds that as a first notifier of a substance the notification be exempted from the provisions of Regulation 16(2) for a maximum period which shall not in any case exceed one year following the date of notification,

(g)     if so desired by the notifier, a preliminary assessment of the real or potential risk to man and the environment on the basis of the principles adopted in Directive 93/67/EEC.

(2)       A dossier required by paragraph (1) (a) shall contain the information and results of the studies referred to in Annex VII.A, together with a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to them.

(3)       Notwithstanding anything in Regulation 15, a notifier of a substance already notified shall inform the competent authority -

(a)     when the quantity of the substance placed on the market reaches 10 tonnes per year per manufacturer or when the total quantity placed on the market reaches 50 tonnes per manufacturer, and in such case the competent authority may require some or all of the additional tests and studies laid down in Annex VIII, level 1, to be carried out within such period as it determines;

(b)     when the quantity of the substance placed on the market reaches 100 tonnes per year per manufacturer or when the total quantity placed on the market reaches 500 tonnes per manufacturer, and in such case the competent authority shall require the additional tests and studies laid down in Annex VIII, level 1, to be carried out within such period as it determines, unless the notifier can give good reason why a particular test or study is not appropriate or an alternative scientific test or study would be preferable;

(c)     when the quantity of a substance placed on the market reaches 1,000 tonnes per year per manufacturer or when the total quantity placed on the market reaches 5,000 tonnes per manufacturer, and in such case the competent authority shall draw up a programme of tests and studies according to Annex VIII, level 2, to be carried out by the notifier within such period as the competent authority determines.

(4)       When additional tests or studies are carried out either in accordance with the requirements of paragraph (3) or voluntarily, the notifier shall provide the competent authority with the results of such tests or studies.

11.   Reduced Notification

(1)       Subject to Regulation 4, a notifier intending to place on the European Communities market a substance in quantities of less than one tonne per annum per manufacturer shall submit to the competent authority a notification including the information referred to in Regulation 10(1).

(2)       A dossier required by paragraph (1) shall contain the information and results of the studies referred to in Annex VII.B, together with a full and detailed description of the studies conducted and of the methods used or a bibliographical reference to them if the competent authority so requires.

(3)       When the quantities to be placed on the market are below 100kg per year per manufacturer the notifier may, without prejudice to Regulation 7(3), restrict the information in the technical dossier referred to in paragraph (2) to that provided for in Annex VII.C.

(4)       In the case of a notifier who has submitted a reduced notification dossier under paragraph (3), he shall, before the quantity of the substance placed on the market reaches 100 kg per year per manufacturer or before the total quantity placed on the market reaches 500 kg per manufacturer, provide the competent authority with the additional information necessary to complete the technical dossier to the level referred to in paragraph (2).

(5)       In the case of a notifier who has submitted a reduced notification dossier under paragraph (1) he shall, before the quantity of the substance placed on the market reaches 1 tonne per year per manufacturer, or before the total quantity placed on the market reaches 5 tonnes per manufacturer, submit a full notification in accordance with Regulation 10.

(6)       The substances notified under paragraphs (1) and (3) shall, in so far as the notifier may reasonably be expected to be aware of their dangerous properties, be packaged and provisionally labelled in accordance with Regulations 21 to 20.

(7)       Where it is not possible to label substances in accordance with Regulation 19, because all the results of tests provided for in Annex VII.A are not available, the label shall bear, in addition to the label deriving from the tests already carried out, the warning “Caution - substance not yet fully tested”.

12.   Substances notified at least 10 years previously

Where the information specified in Annex VII.A, VII.B, V.II.C or VII.D is required in accordance with these Regulations, a notifier need only supply items 1 and 2 of the relevant Annex in the case of a substance for which the information was originally submitted at least 10 years previously.

13.   Notification of Polymers

In the case of polymers, the provisions concerning the technical dossiers contained in the notifications referred to in Regulations 10(2) and 11(2) shall be construed as if the reference to Annex VII.A and Annex VII.B respectively were a reference to Annex VII.D.

14.   Pre-marketing Notification Period

(1)       (a)     Substances notified under Regulation 10 may, in the absence of any indication to the contrary from the competent authority, be placed on the market no sooner than 60 days after receipt by the competent authority of a dossier in conformity with the requirements of these Regulations.

(b)     Where the competent authority considers that the dossier is not in conformity with these Regulations and advises the notifier accordingly, the substance may be placed on the market no sooner than 60 days after receipt by the competent authority of the information necessary to bring the notification into conformity with these Regulations.

(2)       (a)     Substances notified under Regulation 11(1) or 11(3) may, in the absence of any indication to the contrary from the competent authority, be placed on the market no sooner than 30 days after receipt by the competent authority of a dossier in conformity with the requirements of these Regulations.

(b)     Where the competent authority considers that the dossier is not in conformity with these Regulations and advises the notifier accordingly, the substance may be placed on the market no sooner than 30 days after receipt by the competent authority of the information necessary to bring the notification into conformity with these Regulations.

(c)     Notwithstanding subparagraph (a) where the notifier has received notice from the competent authority of the official number which has been allocated to his notification indicating acceptance of the dossier, the substance may be placed on the market no sooner than 15 days after receipt of the dossier by the competent authority.

15.   Follow-up Information

(1)        Any notifier of a substance already notified in conformity with Regulation 10(1) or Regulation 11(1) shall inform the competent authority in writing of any -

(a)     change in the annual or total quantities placed on the market by him or, by him or others as the case may be where he is the sole representative for a substance manufactured outside the European Communities,

(b)     new knowledge of the effects of the substance on man of which he may reasonably be expected to have become aware,

(c)     new knowledge of the effects of the substance on the environment of which he may reasonably be expected to have become aware,

(d)     new uses for which the substance is placed on the market of which he may reasonably be expected to have become aware,

(e)     change in the composition of the substance as given in section 1.3 of each of Annexes VII.A, VII.B, VII.C and VII.D,

(f)      change in his status as manufacturer or importer.

(2)       An importer of a substance produced by a manufacturer established outside the European Communities who imports the substance under a notification previously submitted by a sole representative shall ensure that the sole representative is provided with up-to-date information concerning the quantities of the substance placed on the market by him.

(3)       Where the sole representative ceases to act in that capacity the importer shall submit the information required under Regulation 15(2) to such other sole representative as may exist or, in his absence, to the competent authority.

16.   Re-notification

(1)       In the case of a substance which has already been notified in accordance with Regulation 10(1) or 11(1), the competent authority may agree that the subsequent notifier of that substance may, for the purposes of sections 3, 4 and 5 of each of Annexes VII.A, VII.B and VII.D and sections 3 and 4 of Annex VII.C, refer to the results of the tests and studies forwarded by the first notifier, in so far as the subsequent notifier can provide evidence that the substance renotified is the same as the one previously notified, including the degree of purity and the nature of impurities, but the first notifier shall give his agreement in writing to the references to the results of the tests and studies he has forwarded before such reference can be made.

(2)       Before carrying out testing on vertebrate animals for the purpose of submitting a notification under Regulations 10(1) or 11(1) and notwithstanding paragraph (1), prospective notifiers shall enquire of the competent authority as to -

(a)     whether or not the substance they intend to notify has already been notified;

(b)     the name and address of the first notifier, and

this enquiry shall be supported by evidence that the prospective notifier intends to place the substance on the market and, specify the quantities involved.

(3)       Where a substance has been previously notified and the competent authority is satisfied with the evidence provided under paragraph (2), it shall supply the prospective notifier with the name and address of the first notifier and shall inform the first notifier of the name and address of the prospective notifier except where the first notifier has requested and been granted a temporary exemption from the provisions of this paragraph.

(4)       The first notifier and the prospective notifier shall take all reasonable steps to reach an agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.

(5)       Notifiers of the same substance who have agreed to share information relating to Annex VII.A, VII.B, VII.C or VII.D in accordance with paragraphs (1) and (4) shall take all necessary steps to reach an agreement on the sharing of information derived from testing on vertebrate animals submitted in conformity with Regulation 10(3).

(6)       Where notifiers and prospective notifiers of the same substance cannot reach an agreement on the sharing of data, the competent authority may require notifiers and prospective notifiers to share the data with a view to avoiding duplicative testing on vertebrate animals and may determine the procedure for utilizing information.

17.   Confidentiality of data

(1)       In the case of submissions made under Regulations 10, 11 or 15 the notifier may indicate the information required by these Regulations which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially, and which he wishes to be kept secret from all persons other than the competent authority and the Commission, and shall give full justification in such cases.

(2)       Industrial and commercial secrecy shall not apply to -

(a)     the trade name of the substance,

(b)     the name of the manufacturer and the notifier,

(c)     physico-chemical data concerning the substance in connection with section 3 of each of Annexes VII.A, VII.B, VII.C, and VII.D,

(d)     the possible ways of rendering the substance harmless,

(e)     the summary results of the toxicological and ecotoxicological tests,

(f)      the degree of purity of the substance or the identity of impurities or additives which are known to be dangerous within the meaning of these Regulations, if essential to classification and labelling for the purpose of introducing the substance into Annex I,

(g)     the recommended methods and precautions referred to in Annexes VII.A, VII.B, VII.C, and VII.D, section 2.3, and the emergency measures referred to in Annex VII.A, VII.B, VII.C and VII.D, sections 2.4 and 2.5,

(h)     the information contained in the safety data sheet,

(i)      in the case of substances in Annex I, analytical methods that make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.

(3)       Where the notifier, manufacturer or importer himself subsequently discloses previously confidential information, he shall inform the competent authority accordingly.

(4)       The competent authority, on receipt of information under Regulation 10, 11 or 15 shall decide at its discretion which information is covered by industrial and commercial secrecy in accordance with paragraph (1).

(5)       Confidential information brought to the attention of the competent authority shall be kept secret by it.

(6)       In all cases such confidential information -

(a)     may be brought to the attention only of the Commission and the competent authority of another Member State,

(b)     may, when administrative or legal proceedings involving sanctions are undertaken for the purpose of controlling substances placed on the market, be divulged to persons directly involved in such proceedings,

(c)     may be divulged to persons directly involved in providing medical information in the case of exposure or likely exposure of persons to the substance, especially in emergencies, and such information may only be used to formulate preventative and curative measures in relation to exposure of persons to the substance.

(7)       For a substance appearing in Elincs which is not classified as dangerous for the purpose of these Regulations, its name may be included in the form of its trade name when requested by the competent authority.

(8)       Substances referred to in paragraph (7) may be included in Elincs in the form of their trade name for a maximum of three years unless the competent authority considers that the publication of the chemical name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature itself could reveal information concerning commercial exploitation or manufacture, in which case the name of the substance may be recorded under its trade name alone for as long as the competent authority sees fit.

(9)       Dangerous substances to which these Regulations apply may, at the request of the competent authority, be entered on Elincs in the form of their trade names alone until such time as they are introduced into Annex I.

18.   Packaging

A dangerous substance to which these Regulations apply shall not be placed on the market unless its packaging satisfies the following requirements -

(a)     it is so designed and constructed that its contents cannot escape, except in a case where special safety devices are prescribed by Regulations made by the Minister,

(b)     the materials constituting the packaging and fastening are not susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents,

(c)     the packaging and fastenings are sufficiently strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling,

(d)     containers fitted with replaceable fastening devices can be repeatedly refastened without the contents escaping,

(e)     containers, containing dangerous substances which are offered or sold to the general public, and which are labelled “very toxic”, “toxic” or “corrosive” as defined in these Regulations must have a child resistant fastening and bear a tactile warning of danger,

(f)      containers, containing dangerous substances which are offered or sold to the general public, and which are labelled “harmful”, “extremely flammable” or “highly flammable” as defined in these Regulations must bear a tactile warning of danger.

19.   Labelling

(1)       A dangerous substance to which these Regulations apply shall not be placed on the market unless the labelling on its packaging shows clearly and indelibly the following -

(a)     the name of the substance under one of the designations given in Annex I, or, if the substance is not yet listed in Annex I, a name using an internationally recognised designation for that substance,

(b)     the name and full address, including the telephone number, of the person established in the European Communities who is responsible for placing the substance on the market,

(c)     danger symbols, if required, and an indication of the danger involved in the use of the substance,

(d)     standard phrases (risk phrases) indicating the special risks arising from the dangers involved in using the substance,

(e)     standard phrases (safety phrases) relating to the safe use of the substance,

(f)      the EC number, if allocated,

(g)     for substances listed in Annex I, the words “EC label”, but until 31 December 2000 the words “EEC label” shall be deemed to satisfy this requirement.

(2)       Subject to paragraphs (3) and (5) -

(a)     the design of danger symbols and the wording of the indications of danger shall comply with those laid down in Annex II.

(b)     the danger symbol shall be printed in black on an orange-yellow background; and

(c)     the danger symbols and indications of danger to be used for each substance shall -

(i)      for substances listed in Annex I, be those indicated in that Annex; and

(ii)     for substances not listed in Annex I, be assigned according to the rules laid down in Annex VI.

(3)       When more than one danger symbol is assigned to a substance, the following requirements apply

(a)     the obligation to indicate the symbol T makes the symbols X and C optional, unless Annex I provides otherwise;

(b)     the obligation to indicate the symbol C makes the symbol X optional;

(c)     the obligation to indicate the symbol E makes the symbol F and O optional.

(4)       Subject to paragraph (8) -

(a)     the wording of risk phrases shall comply with that laid down in Annex III,

(b)     the risk phrases to be used for each substance shall -

(i)      be as indicated in Annex I

(ii)     for dangerous substances not yet appearing in Annex I the risk phrases to be used shall be assigned according to the rules laid down in Annex

(5)       The requirement to label with the symbol “Xn”, the indication of danger “Harmful” and the risk phrase R65 “Harmful: may cause lung damage if swallowed” shall not apply to substances which are placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

(6)       Subject to paragraph (8) -

(a)     the wording of safety phrases shall comply with that laid down in Annex IV, and

(b)     the safety phrases to be used for each dangerous substance shall -

(i)      be as indicated in Annex I,

(ii)     for dangerous substances not yet appearing in Annex I, the safety phrase to be used shall be as assigned according to the rules laid down in Annex VI.

(7)       The EC number shall be obtained from the EINECS or from the Elincs.

(8)       An indication of risk phrases and safety phrases need not be given if the package contains 125 millilitres or less of -

(a)   an irritant, highly flammable, flammable or oxidising substance, or

(b)   a harmful substance that is not retailed to the general public.

(9)       Indications such as “non-toxic”, “non-harmful” or any other similar indications shall not appear on the label or packaging of substances to which these Regulations apply.

(10)     The information referred to in paragraph (1) shall be shown on the packaging in the English language or in both the English and Irish languages.

(11)     Subject to Regulation 4 (6) (b), gas cylinders placed on the market and intended for propane, butane or liquefied petroleum gas shall be labelled in accordance with the requirements of these Regulations.

(12)     Information regarding effects on human health is not required on the label of gas containers intended for propane, butane or liquefied petroleum gas if -

(a)     the propane, butane or liquefied petroleum gas is placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope of ISEN 417 1993 as fuel gases which are only released for combustion,

(b)     the information regarding effects on human health is transmitted, in the format required by Regulation 22, to professional or industrial users, distributors, wholesalers, retailers and consumers by the person placing the propane, butane or liquefied petroleum gas on the market, and

(c)     sufficient information regarding effects on human health is transmitted to consumers to enable them to take all necessary measures for health and safety as indicated in Article 1 paragraph 3 of Commission Directive 91/155/EEC of 5 March, 1991, as modified by Commission Directive 93/112/EEC of 10 December, 1993.

(13)     For the purpose of paragraph 12 (a), “ISEN 417 1993” means Irish Standard ISEN 417 1993 of the National Standards Authority of Ireland.

20.   Implementation of labelling

(1)       Where the particulars required by Regulation 19 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that these particulars can be read horizontally when the package is set down normally.

(2)       The dimensions of such a label shall be as follows -

(3)       Each symbol required by Regulation 19 shall cover at least one-tenth of the surface area of the label but not be less than one square centimetre (1 cm²), and the entire surface of the label shall adhere to the package immediately containing the substance.

(4)       A label shall not be required where the particulars are clearly shown on the package itself in accordance with this Regulation.

(5)       The colour and presentation of the label (or, in the case of paragraph (3), of the package) shall be such that the danger symbol and its background stand out clearly from the label or package.

(6)       The information required on a label by Regulation 19 shall stand out clearly from its background and shall be of such size and spacing as to be easily read and shall be in accordance with the provisions of Annex VI.

21.   Advertising

A person shall not publish any advertisement for a substance which belongs to one or more of the categories referred to in Regulation 8(1)(a) to (o) unless mention is made in the advertisement of the category or categories concerned.

22.   Safety Data Sheet

(1)       A person placing a dangerous substance to which these Regulations apply on the market shall prepare a safety data sheet giving information on that substance.

(2)       A safety data sheet shall be amended by the person who provides it when any new information of a significant nature so requires.

(3)       At, or before the first delivery, following the commencement of these Regulations, the manufacturer, importer or distributor of a dangerous substance to which these Regulations apply shall communicate the safety data sheet to any recipient who is a professional or industrial user, distributor, wholesaler or retailer of the substance.

(4)       The safety data sheet referred to in paragraph (3) shall be provided free of charge to the recipient and may be communicated on paper or electronically.

(5)       An amended safety data sheet referred to in paragraph (2) shall be provided forthwith free of charge to all industrial or professional users, distributors, wholesalers and retailers who were supplied with the particular dangerous substance within the 12 months preceding the publication date of the amended safety data sheet.

(6)       Without prejudice to paragraphs (3) and (4), recipients or users of a dangerous substance shall on request be provided with the safety data sheet by the supplier of the substance to them.

(7)       The safety data sheet referred to in paragraph (1) shall contain such information necessary for the protection of man and the environment as the manufacturer, importer or distributor may reasonably be expected to be aware of.

(8)       A safety data sheet referred to in paragraph (1) shall be clearly written in the English language or in both the English and Irish languages.

(9)       (a)     A safety data sheet required to be provided in accordance with this Regulation shall contain information on the dangerous substance under the headings set out in Schedule 7 and shall contain those headings.

(b)     The information required to be contained in the safety data sheet in accordance with subparagraph (a) shall be compiled in accordance with the guidelines laid down in the Annex to Directive 93/112/EC.

(c)     The information required under subparagraph (a) shall include -

(i)       the name of the person responsible for providing the safety data sheet,

(ii)      the date of publication or the date of preparation of the safety data sheet, and

(iii)     for an amended safety data sheet, a notice of revision together with the revision date.

23.   Supply of Substances

A notifier shall supply to the competent authority on request such quantities of a notified substance as the competent authority deems necessary for the carrying out of verification tests.

24.   Restriction on Sale

Where the competent authority is of opinion that a substance, although satisfying the requirements of these Regulations, constitutes a hazard for man or the environment by reason of its classification, packaging or labelling, the competent authority may, by notice in writing to the person who placed the substance on the market, prohibit the sale of that substance or subject its placing on the market to special conditions.

25.   Fees Payable by Notifier

The fee fixed by column 2 of Schedule 8 shall be payable in advance by a notifier to the competent authority in relation to any matter referred to in the corresponding entry in column 1 of that Schedule.

26.   Taking and Detention of Substances

(1)       An inspector may, seize and retain, or seize, remove and retain any substance which he believes is a substance to which these Regulations apply and in relation to which he has reasonable grounds for suspecting that there is or has been a failure to comply with any provision of these Regulations.

(2)       An inspector may, by a notice in writing given to the owner or to the person in apparent charge or control of a substance which has been seized under this Regulation -

(a)     require things specified in the notice to be done in relation to the substance before it is released by an inspector;

(b)     either -

(i)      require the disposal of the substance by the person to whom the notice is given, in a manner specified in the notice and at the expense of the owner, or

(ii)     indictate the inspector's intention of disposing of the substance at the expense of the owner.

such disposal to be, in either case, such as will prevent the substance from being again placed on the market, and, where a notice given under this paragraph requires specified things to be done in relation to a substance, the inspector shall retain control of the substance to which the notice relates until the requirements of the notice have been complied with.

(3)       Where a notice is given under this Regulation, a person shall not, without the consent of an inspector sell, move, dispose of or otherwise interfere with the substance in any way pending compliance with the requirements of the notice.

(4)       Any person who is aggrieved by a notice given under paragraph (2) of this Regulation which either requires the substance to which it relates to be disposed of or indicates an intention to dispose of such substances may, not later than the expiration of the period of seven days beginning on the date of the notice, appeal to the appropriate court against the notice.

(5)       (a)     Where an appeal is made to the appropriate court under paragraph (4) the court, if it is satisfied that -

(i)       the substance to which the relevant notice under this Regulation relates is one to which these Regulations apply, and

(ii)      if such substance were released, it might be placed on the market, and

(iii)     there has been a failure to comply with the provisions of these Regulations -

may order that the substance be disposed of in the manner specified in the notice, or in such other manner as may be specified by the court which, in the opinion of the court, will prevent the substance from being placed on the market.

(b)     Where an order made by a court under this paragraph requires the substance to which it relates to be disposed of by an inspector, the cost of such disposal shall be recoverable by the competent authority as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the product at the time of its seizure under this Regulation.

(6)       A notice under this Regulation shall not come into force unless -

(a)     where an appeal is taken against the notice, the appeal is withdrawn;

(b)     in any other case, the period within which such an appeal may be taken has expired.

(7)       In this Regulation ‘appropriate court’ means in relation to an appeal made under this Regulation against a notice given under paragraph (2) -

(a)     in case the estimated value of the substance and cost of complying with the order to which the appeal relates does not exceed £5,000, the District Court for the district in which the goods were seized;

(b)     in case the estimated amounts aforesaid does not exceed £30,000, the Judge of the Circuit Court for the circuit in which the goods were seized;

(c)     in any other case, the High Court.

(8)       (a)     If, in relation to an appeal under this Regulation to the District Court, that court becomes of the opinion during the hearing of the appeal that the estimated amounts aforesaid will exceed £5,000, it may, if it so thinks fit, transfer the appeal to the Circuit Court or the High Court, whichever it considers appropriate having regard to the estimated amounts aforesaid.

(b)     If, in relation to an appeal under this regulation to the Circuit Court, that court becomes of opinion during the hearing of the appeal that the estimated amounts aforesaid will exceed £30,000, it may, if it so thinks fit, by order transfer the appeal to the High Court.

27.   Offences

(1)       A person shall be guilty of an offence if the person -

(a)     contravenes Regulation 6, 9, 10, 11, 15, 16 (2), 21, 22, 23 or 26 (3),

(b)     places on the market a substance to which these Regulations apply and which has not been tested and classified in accordance with these Regulations,

(c)     places on the market a substance referred to in Regulation 14 (1) or (2) before the expiry of the relevant period specified in that Regulation,

(d)     fails to comply with a requirement imposed on that person under Regulation 16 (6), or

(e)     contravenes a prohibition, or fails to comply with a condition, imposed on that person under Regulation 24.

(2)       Where an offence under these Regulations has been committed by a body corporate and is proved to have been so committed with the consent, or connivance of, or to be attributable to any neglect on the part of any director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if he or she were guilty of the first mentioned offence.

(3)       A person guilty of an offence under these regulations shall be liable on summary conviction to a fine not exceeding £1,500 or imprisonment for a term not exceeding 6 months or both.

28.   Revocations

The following are hereby revoked:-

(a)     The European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 1994 ( S.I. No. 77 of 1994 ),

(b)     The European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) Regulations, 1998 ( S.I. No. 317 of 1998 ),

(c)     The European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) (No. 2) Regulations, 1998 ( S.I. No. 513 of 1998 ) and

(d)     The European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) Regulations, 1999 ( S.I. No. 363 of 1999 ).

SCHEDULE 1

ANNEX II

SYMBOLS AND INDICATIONS OF DANGER FOR DANGEROUS SUBSTANCES AND PREPARATIONS

SCHEDULE 2

ANNEX III

NATURE OF SPECIAL RISKS ATTRIBUTED TO DANGEROUS SUBSTANCES AND PREPARATIONS

R1

Explosive when dry

R2

Risk of explosion by shock, fire or other sources of ignition

R3

Extreme risk of explosion by shock, friction, fire or other sources of ignition

R4

Forms very sensitive explosive metallic compounds

R5

Heating may cause an explosion

R6

Explosive with or without contact with air

R7

May cause fire

R8

Contact with combustible material may cause fire

R9

Explosive when mixed with combustible materials

R10

Flammable

R11

Highly flammable

R12

Extremely flammable

R14

Reacts violently with water

R15

Contact with water liberates highly flammable gases

R16

Explosive when mixed with oxidizing substances

R17

Spontaneously flammable in air

R18

In use, may form flammable/explosive vapour-air mixture

R19

May form explosive peroxides

R20

Harmful by inhalation

R21

Harmful in contact with skin

R22

Harmful if swallowed

R23

Toxic by inhalation

R24

Toxic in contact with skin

R25

Toxic if swallowed

R26

Very toxic by inhalation

R27

Very toxic in contact with skin

R28

Very toxic if swallowed

R29

Contact with water liberates toxic gas

R30

Can become highly flammable in use

R31

Contact with acids liberates toxic gas

R32

Contact with acids liberates very toxic gas

R33

Danger of cumulative effects

R34

Causes burns

R35

Causes severe burns

R36

Irritating to eyes

R37

Irritating to respiratory system

R38

Irritating to skin.

R39

Danger of very serious irreversible effects

R40

Possible risk of irreversible effects

R41

Risk of serious damage to eyes

R42

May cause sensitisation by inhalation

R43

May cause sensitisation by skin contact

R44

Risk of explosion if heated under confinement

R45

May cause cancer

R46

May cause heritable genetic damage

R48

Danger of serious damage to health by prolonged exposure

R49

May cause cancer by inhalation

R50

Very toxic to aquatic organisms

R51

Toxic to aquatic organisms

R52

Harmful to aquatic organisms

R53

May cause long-term adverse effects in the aquatic environment

R54

Toxic to flora

R55

Toxic to fauna

R56

Toxic to soil organisms

R57

Toxic to bees

R58

May cause long-term adverse effects in the environment

R59

Dangerous for the ozone layer

R60

May impair fertility

R61

May cause harm to the unborn child

R62

Possible risk of impaired fertility

R63

Possible risk of harm to the unborn child

R64

May cause harm to breastfed babies

R65

Harmful: May cause lung damage if swallowed

R66

Repeated exposure may cause skin dryness or cracking

R67

Vapours may cause drowsiness and dizziness

COMBINATION OF R-PHRASES

R14/15

Reacts violently with water, liberating highly flammable gases

R15/29

Contact with water liberates toxic, highly flammable gas

R20/21

Harmful by inhalation and in contact with skin

R20/22

Harmful by inhalation and if swallowed

R20/21/22

Harmful by inhalation, in contact with skin and if swallowed

R21/22

Harmful in contact with skin and if swallowed

R23/24

Toxic by inhalation and in contact with skin

R23/25

Toxic by inhalation and if swallowed

R23/24/25

Toxic by inhalation, in contact with skin and if swallowed

R24/25

Toxic in contact with skin and if swallowed

R26/27

Very toxic by inhalation and in contact with skin

R26/28

Very toxic by inhalation and if swallowed

R26/27/28

Very toxic by inhalation and in contact with skin and if swallowed

R27/28

Very toxic in contact with skin and if swallowed

R36/37

Irritating to eyes and respiratory system

R36/38

Irritating to eyes and skin

R36/37/38

Irritating to eyes, respiratory system and skin

R37/38

Irritating to respiratory system and skin

R39/23

Toxic: danger of very serious irreversible effects through inhalation

R39/24

Toxic: danger of very serious irreversible effects in contact with skin

R39/25

Toxic: danger of very serious irreversible effects if swallowed

R39/23/24

Toxic: danger of very serious irreversible effects through inhalation and in contact with skin

R39/23/25

Toxic: danger of very serious irreversible effects through inhalation and if swallowed

R39/24/25

Toxic: danger of very serious irreversible effects in contact with skin and if swallowed

R39/23/24/25

Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed

R39/26

Very toxic: danger of very serious irreversible effects through inhalation

R39/27

Very toxic: danger of very serious irreversible effects in contact with skin

R39/28

Very toxic: danger of very serious irreversible effects if swallowed

R39/26/27

Very toxic: danger of very serious irreversible effects through inhalation and in contact with skin

R39/26/28

Very toxic: danger of very serious irreversible effects through inhalation and if swallowed

R39/27/28

Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed

R39/26/27/28

Very toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed

R40/20

Harmful: possible risk of irreversible effects through inhalation

R40/21

Harmful: possible risk of irreversible effects in contact with skin

R40/22

Harmful: possible risk of irreversible effects if swallowed

R40/20/21

Harmful: possible risk of irreversible effects through inhalation and in contact with skin

R40/20/22

Harmful: possible risk of irreversible effects through inhalation and if swallowed

R40/21/22

Harmful: possible risk of irreversible effects in contact with skin and if swallowed

R40/20/21/22

Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed

R42/43

May cause sensitisation by inhalation and skin contact

R48/20

Harmful: danger of serious damage to health by prolonged exposure through inhalation

R48/21

Harmful: danger of serious damage to health by prolonged exposure in contact with skin

R48/22

Harmful: danger of serious damage to health by prolonged exposure if swallowed

R48/20/21

Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin

R48/20/22

Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed

R48/21/22

Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed

R48/20/21/22

Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed

R48/23

Toxic: danger of serious damage to health by prolonged exposure through inhalation

R48/24

Toxic: danger of serious damage to health by prolonged exposure in contact with skin

R48/25

Toxic: danger of serious damage to health by prolonged exposure if swallowed

R48/23/24

Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin

R48/23/25

Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed

R48/24/25

Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed

R48/23/24/25

Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed

R50/53

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment

R51/53

Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment

R52/53

Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment

SCHEDULE 3

ANNEX IV

SAFETY ADVICE CONCERNING DANGEROUS SUBSTANCES AND PREPARATIONS

S 1

Keep locked up.

S 2

Keep out of the reach of children.

S 3

Keep in a cool place.

S 4

Keep away from living quarters.

S 5

Keep contents under … (appropriate liquid to be specified by the manufacturer).

S 6

Keep under … (inert gas to be specified by the manufacturer).

S 7

Keep container tightly closed.

S 8

Keep container dry.

S 9

Keep container in a well-ventilated place.

S 12

Do not keep the container sealed.

S 13

Keep away from food, drink and animal feeding stuffs.

S 14

Keep away from … (incompatible materials to be indicated by the manufacturer).

S 15

Keep away from heat.

S 16

Keep away from sources of ignition - No smoking.

S 17

Keep away from combustible material.

S 18

Handle and open container with care.

S 20

When using do not eat or drink.

S 21

When using do not smoke.

S 22

Do not breathe dust.

S 23

Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).

S 24

Avoid contact with skin.

S 25

Avoid contact with eyes.

S 26

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

S 27

Take off immediately all contaminated clothing.

S 28

After contact with skin, wash immediately with plenty of … (to be specified by the manufacturer).

S 29

Do not empty into drains.

S 30

Never add water to this product.

S 33

Take precautionary measures against static discharges.

S 35

This material and its container must be disposed of in a safe way.

S 36

Wear suitable protective clothing.

S 37

Wear suitable gloves.

S 38

In case of insufficient ventilation, wear suitable respiratory equipment.

S 39

Wear eye/face protection.

S 40

To clean the floor and all objects contaminated by this material, use … (to be specified by the manufacturer).

S 41

In case of fire and/or explosion do not breathe fumes.

S 42

During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer).

S 43

In case of fire, use … (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add - ‘Never use water’).

S 45

In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).

S 46

If swallowed, seek medical advice immediately and show this container or label.

S 47

Keep at temperature not exceeding … °C (to be specified by the manufacturer).

S 48

Keep wetted with … (appropriate material to be specified by the manufacturer).

S 49

Keep only in the original container.

S 50

Do not mix with … (to be specified by the manufacturer).

S 51

Use only in well-ventilated areas.

S 52

Not recommended for interior use on large surface areas.

S 53

Avoid exposure - obtain special instructions before use.

S 56

Dispose of this material and its container at hazardous or special waste collection point.

S 57

Use appropriate containment to avoid environmental contamination.

S 59

Refer to manufacturer/supplier for information on recovery/recycling.

S 60

This material and its container must be disposed of as hazardous waste.

S 61

Avoid release to the environment. Refer to special instructions/Safety data sheets.

S 62

If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label.

S 63

In case of accident by inhalation: remove casualty to fresh air and keep at rest.

S 64

If swallowed, rinse mouth with water (only if the person is conscious).

Combination of S-phrases

S 1/2

Keep locked up and out of reach of children.

S 3/7

Keep container tightly closed in a cool place.

S 3/9/14

Keep in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).

S 3/9/14/49

Keep only in the original container in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).

S 3/9/49

Keep only in the original container in a cool, well-ventilated place.

S 3/14

Keep in a cool place away from … (incompatible materials to be indicated by the manufacturer).

S 7/8

Keep container tightly closed and dry.

S 7/9

Keep container tightly closed and in a well-ventilated place.

S 7/47

Keep container tightly closed and at a temperature not exceeding … °C (to be specified by the manufacturer).

S 20/21

When using do not eat, drink or smoke.

S 24/25

Avoid contact with skin and eyes.

S 27/28

After contact with skin, take off immediately all contaminated clothing and wash immediately with plenty of... (to be specified by the manufacturer).

S 29/35

Do not empty into drains; dispose of this material and its container in a safe way.

S 29/56

Do not empty into drains, dispose of this material and its container to hazardous or special waste collection point.

S 36/37

Wear suitable protective clothing and gloves.

S 36/37/39

Wear suitable protective clothing, gloves and eye/face protection.

S 36/39

Wear suitable protective clothing and eye/face protection.

S 37/39

Wear suitable gloves and eye/face protection.

S 47/49

Keep only in the original container at a temperature not exceeding … °C (to be specified by the manufacturer).

SCHEDULE 4

ANNEX VI

CLASSIFICATION AND LABELLING REQUIREMENTS FOR DANGEROUS SUBSTANCES AND PREPARATIONS

CONTENTS

1.                  GENERAL INTRODUCTION

1.1                The object of classification is to identify all the toxicological, physico-chemical and ecotoxicological properties of substances and toxicological and physiochemical properties of preparations which may constitute a risk during normal handling or use. Having identified any hazardous properties the substance or preparation must then be labelled to indicate the hazard(s) in order to protect the user, the general public and the environment.

1.2                This Annex sets out the general principles governing the classification and labelling of substances and preparations referred to in Article 4 of Directive 67/548/EEC³⁸ and in Article 3 of Directive 88/379/EEC and other relevant Directives on dangerous preparations.

It is addressed to all those concerned (manufacturers, importers, national authorities) with methods of classifying and labelling dangerous substances and preparations.

1.3                The requirements of Directive 67/548/EEC and of Directive 88/379/EEC are intended to provide a primary means by which the general public and persons at work are given essential information about dangerous substances and preparations. The label draws the attention of persons handling or using substances and preparations to the inherent danger of certain such materials.

The label may also serve to draw attention to more comprehensive product information on safety and use available in other forms.

1.4                The label takes account of all potential hazards which are likely to be faced in the normal handling and use of dangerous substances and preparations when in the form in which they are placed on the market, but not necessarily in any different form in which they may finally be used, e.g. diluted. The most severe hazards are highlighted by symbols, such hazards and those arising from other dangerous properties are specified in standard risk phrases, and safety phrases give advice on necessary precautions.

In the case of substances, the information is completed by the name of the substance under an internationally recognised chemical nomenclature, the preferred name being the one used in the European Inventory of Existing Commercial Chemical Substances (EINECS), the European List of Notified Chemical Substances (ELINCS), the EC number and the name, address and telephone number of the person established in the Community who is responsible for placing the substance on the market.

In the case of preparations, the information is completed by the indication of the designation or the trade name of the preparation, the indication of the chemical name of the substances present in the preparation in accordance with Article 7(1)(c) of Directive 88/379/EEC and the indication of the name, address and telephone number of the person established in the Community who is responsible for placing the preparation on the market.

1.5                Article 6 of Directive 67/54/EEC³⁹ requires that manufacturers, distributors and importers of dangerous substances which appear in the EINECS but which have not yet been introduced into Annex I shall be obliged to carry out an investigation to make themselves aware of the relevant and accessible data which exist concerning the properties of such substances. On the basis of this information, they shall package and provisionally label these substances according to the rules laid down in Articles 22 to 25 ⁴⁰ and the criteria in this Annex.

1.6                For substances the data required for classification and labelling may be obtained:

(a)   as regards substances for which the information specified in Annex VII is required, which for convenience of reference is set out in Schedule 5, most of the necessary data for classification and labelling appear in the ‘base set’. This classification and labelling must be reviewed, if necessary, when further information is available (Annex VIII);

(b)   as regards other substances (e.g. those referred to in section 1.5 above), the data required for classification and labelling may, if necessary, be obtained from a number of different sources, for example the results of previous tests, information required by international rules on the transport of dangerous substances, information taken from reference works and the literature or information derived from practical experience. The results of validated structure-activity relationships and expert judgement may also be taken into account where appropriate.

For preparations, the data required for classification and labelling may be obtained:

(a)   if it concerns physico-chemical data, by the application of the methods specified in Annex V. For gaseous preparations a calculation method may be used for flammable and oxidising properties (see Chapter 9 of this Schedule).

(b)   if it concerns data on health effects:

- by the application of the methods specified in Annex V and/or by the application of the conventional method referred to in Article 3(5)(a) to (i) of Directive 88/379/EEC, or, in the case of R65, by the application of the rules under 3.2.3,

- however, if it concerns the evaluation of the carcinogenic, mutagenic and reproductive properties, by the application of the conventional method referred to in Article 3(5)(j) to (q) of Directive 88/379/EEC

Note concerning the performance of animal tests

The performance of animal tests to establish experimental data is subject to the provisions of Directive 86/609/EEC regarding the protection of animals used for experimental purposes.

1.7                Application of the guide criteria

Classification must cover the toxicological and physico-chemical and ecotoxicological properties of substances and preparations.

Classification of substances and preparations is made on the basis of the criteria in Chapters 2 to 4 and additionally for substances Chapter 5 of this Annex. All types of hazard must be considered. For instance, classification under 3.2.1 does not imply that the sections such as 3.2.2 or 3.2.4 can be ignored.

The choice of symbol (s) and risk phrase (s) is made on the basis of the classification in order to ensure that the specific nature of the potential dangers identified in classification is expressed on the label.

Notwithstanding the criteria given under 2.2.3, 2.2.4 and 2.2.5, substances and preparations in the form of aerosols shall be subject to the flammability criteria set out in 1.8 and 2.2 (c) of the Annex to Directive 75/324/EEC.

1.7.1.             Definitions

‘Substances’ means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product, and any impurity deriving from the production process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

A substance may be chemically very well defined (e.g. acetone) or a complex mixture of constituents of variable composition (e.g. aromatic distillates). For certain complex substances, some individual constituents have been identified.

‘Preparations’ means mixtures or solutions composed of two or more substances.

1.7.2             Application of the guide criteria for substances

The guidance criteria set out in this Schedule are directly applicable when the data in question have been obtained from test methods comparable with those described in Annex V. In other cases, the available data must be evaluated by comparing the test methods employed with those indicated in Annex V and the rules specified in this Schedule for determining the appropriate classification and labelling.

In some cases there may be doubt over the application of the relevant criteria, especially where these require the use of expert judgement. In such cases the manufacturer, distributor or importer should provisionally classify and label the substance on the basis of an assessment of the evidence by a competent person.

Without prejudice to Article 6, where the above procedure has been followed and there is concern over possible inconsistencies then a proposal may be submitted for the entry of the provisional classification into Annex I. The proposal should be made to one of the Member States and should be accompanied by appropriate scientific data (see also section 4.1).

A similar procedure may be followed when information is identified which gives cause for concern over the accuracy of an existing entry in Annex I.

1.7.2.1         Classification of substances containing impurities, additives or individual constituents

Where impurities, additives or individual constituents of substances have been identified, they shall be taken into account if their concentration is greater than or equal to the limits specified

-          0.1 % for substances classified as very toxic, toxic, carcinogenic (category 1 or 2), mutagenic (category 1 or 2) or toxic to reproduction (category 1 or 2)

-          1% for substances classified as harmful, corrosive, irritant sensitising, carcinogenic (category 3), mutagenic (category 3), or toxic to reproduction (category 3) 9

unless lower values have been specified in Annex I to Directive 67/548/EEC.

With the exception of substances listed specifically in Annex I, classification for physico-chemical properties and for health hazards should be carried out according to the requirements of Articles 3 and labelled according the requirements of Article 7 of Council Directive 88/379/EEC.

Classification for physico-chemical properties is carried out according to the criteria in Chapter 2, and for effects dangerous for the environment is carried out according to the criteria in Chapter 5 of this Schedule.

In the case of asbestos (650-013-00-6) this general rule does not apply until a concentration limit has been fixed in Annex I. Substances in which asbestos is present must be classified and labelled according to the principles laid down in Article 6 of Directive 67/548/EEC.

1.7.3.             Application of the guide criteria for preparations

The guidance criteria set out in this Annex are directly applicable when the data in question have been obtained from test methods comparable with those described in Annex V with the exception of the criteria of Chapter 4 for which only the conventional method is applicable. In other cases, the available data must be evaluated by comparing the test methods employed with those indicated in Annex V and the rules specified in this Schedule for determining the appropriate classification and labelling.

If the health hazards are assessed by applying the conventional method referred to in Articles 3(5) of Directive 88/379/EEC, the individual concentration limits to be used are those set out either:

-   in Annex I to Directive 67/548/EEC, or

-   in Annex I to Directive 88/379/EEC where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

In the case of preparations containing mixtures of gases, classification with respect to health effects will be established by the calculation method on the basis of the individual concentration limits from Annex I to Directive 67/548/EEC or, when these limits are not in Annex I on the basis of the criteria of Annex I to Directive 88/379/EEC, as amended by Directive 90/492/EEC.

1.7.3.1          Preparations or substances described in Section 1.7.2.1 used as constituents of another preparation

The labelling of such preparations must be in conformity with the provisions of Article 7 according to the conditions foreseen in Article 3 of Directive 88/379/EEC. However, in certain cases, the information on the label of the preparation or substance described in Section 1.7.2.1 is insufficient to enable other manufacturers who wish to use it as a constituent of their own preparation(s) to carry out the classification and labelling of their preparation(s) correctly.

In these cases, the person established within the Community responsible for placing the original preparation or substance described in Section 1.7.2.1 on the market, whether it be the manufacturer, the importer or the distributor shall supply upon justified request and as soon as possible all necessary data concerning the dangerous substances present to enable correct 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 other requirements of Directive 88/379/EEC.

2                    CLASSIFICATION ON THE BASIS OF PHYSICO-CHEMICAL PROPERTIES

2.1.                Introduction

The test methods relating to explosive, oxidizing and flammable properties included in Annex V of Directive 67/548/EEC serve to give specific meaning to the general definitions given in Articles 2(a) to (e) ⁴¹ Criteria follow directly from the test methods in Annex V as far as they are mentioned.

If adequate information is available to demonstrate in practice that the physico-chemical properties of substances and preparations (apart from organic peroxides) are different from those revealed by the test methods given in Annex V, then such substances and preparations should be classified according to the hazard they present, if any, to those handling the substances and preparations or to other persons.

2.2                Criteria for classification, choice of symbols, indication of danger and choice of risk phrases

In the case of preparations, the criteria referred to in Article 3 (2) of Directive 88/379/EEC need to be taken into consideration.

2.2.1              Explosive

Substances and preparations shall be classified as explosive and assigned the symbol ‘E’ and the indication of danger ‘explosive’ in accordance with the results of the tests given in Annex V and in so far as the substances and preparations are explosive as placed on the market. One risk phrase is obligatory, it is to be specified on the basis of the following:

R2       Risk of explosion by shock, friction, fire or other sources of ignition

-        substances and preparations except those set out below.

R3       Extreme risk of explosion by shock, friction, fire or other source of ignition

-        substances and preparations which are particularly sensitive such as picric acid salts or PETN.

2.2.2              Oxidizing

Substances and preparations shall be classified as oxidizing and assigned the symbol ‘O’ and the indication of danger ‘oxidizing’ in accordance with the results of the tests given in Annex V. One risk phrase is obligatory, it is to be specified on the basis of the test results but subject to the following:

R7       May cause fire

-        organic peroxides which have flammable properties even when not in contact with other combustible material.

R8       Contact with combustible material may cause fire

-       other oxidizing substances and preparations, including inorganic peroxides, which may cause fire or enhance the risk of fire when in contact with combustible material.

R9       Explosive when mixed with combustible material

-      other substances and preparations, including inorganic peroxides, which become explosive when mixed with combustible materials, e.g. certain chlorates.

2.2.2.1          Remarks concerning peroxides

For the explosive properties, an organic peroxide or preparation thereof in the form in which it is placed on the market is classified according to the criteria in section 2.2.1 on the basis of tests carried out in accordance with the methods given in Annex V.

For the oxidising properties the existing methods in Annex V cannot be applied to organic peroxides.

For substances, organic peroxides not already classified as explosive are classified as dangerous on the basis of their structure (e.g. R-O-O-H; R₁-O-O-R₂).

Preparations not already classified as explosive shall be classified using the calculation method based on the percentage of active oxygen shown in Section 9.5.

Any organic peroxide or preparation thereof not already classified as explosive is classified as oxidising, if the peroxide or its formulation contains:

-      more than 5% of organic peroxides or,

-      more than 0.5% available oxygen from the organic peroxides, and more than 5 % hydrogen peroxide.

2.2.3             Extremely flammable

Substances and preparations shall be classified as extremely flammable and assigned the symbol ‘F+’ and the indication of danger ‘extremely flammable’ in accordance with the results of the tests given in Annex V. The risk phrase shall be assigned in accordance with the following criteria:

R12       Extremely flammable

-     Liquid substances and preparations which have a flash point lower than 0 °C and a boiling point (or in case of a boiling range the initial boiling point) lower than or equal to 35 °C.

-     Gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure.

2.2.4.             Highly flammable

Substances and preparations shall be classified as highly flammable and assigned the symbol ‘F’ and the indication of danger ‘highly flammable’ in accordance with the results of the tests given in Annex V. Risk phrases shall be assigned in accordance with the following criteria:

R11       Highly flammable

-     Solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition.

-     Liquid substances and preparations having a flash point below 21°C but which are not extremely flammable.

R15        Contact with water liberates extremely flammable gases

-     Substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities, at a minimum rate of one litre per kilogram per hour.

R17       Spontaneously flammable in air

-     Substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any input of energy.

2.2.5.             Flammable

Substances and preparations shall be classified as flammable in accordance with the results of the tests given in Annex V. The risk phrase shall be assigned in accordance with the criteria mentioned below.

R10       Flammable

-     Liquid substances and preparations having a flash point equal to or greater than 21 °C, and less than or equal to 55 °C.

However, in practice it has been shown that a preparation having a flash point equal to or greater than 21 °C and less than or equal to 55 °C need not be classified as flammable if the preparation could not in any way support combustion and only so long as there is no reason to fear risks to those handling these preparations or to other persons.

2.2.6.            Other physico-chemical properties

Additional risk phrases shall be assigned to substances and preparations which have been classified by virtue of Sections 2.2.1 to 2.2.5 above or by Chapters 3, 4 and 5 below, in accordance with the following criteria (based on experience obtained during compilation of Annex I):

R1       Explosive when dry

For explosive substances and preparations put on the market in solution or in a wetted form; e.g. nitrocellulose with more than 12.6% nitrogen.

R4       Forms very sensitive explosive metallic compounds

For substances and preparations which may form sensitive explosive metallic derivatives, e.g. picric acid, styphnic acid.

R5       Heating may cause an explosion

For thermally unstable substances and preparations not classified as explosive, e.g. perchloric acid > 50 %.

R6       Explosive with or without contact with air

For substances and preparations which are unstable at ambient temperatures, e.g. acetylene.

R7       May cause fire

For reactive substances and preparations : e.g. fluorine, sodium hydrosulphite.

R14     Reacts violently with water

For substances and preparations which react violently with water, e.g. acetyl chloride, alkali metals, titanium tetrachloride.

R16     Explosive when mixed with oxidizing substances

For substances and preparations which react explosively with an oxidizing agent, e.g. red phosphorus.

R18     In use, may form flammable/explosive vapour-air mixture

For preparations not in themselves classified as flammable, which contain volatile components which are flammable in air.

R19     May form explosive peroxides

For substances and preparations which may form explosive peroxides during storage, e.g. diethyl ether, 1,4-dioxan.

R30     Can become highly flammable in use

For preparations not in themselves classified as flammable, which may become flammable due to the loss of non-flammable volatile components.

R44     Risk of explosion if heated under confinement

For substances and preparations not in themselves classified as explosive in accordance with Section 2.2.1 above but which may nevertheless display explosive properties in practice if heated under sufficient confinement. For example, certain substances which would decompose explosively if heated in a steel drum do not show this effect if heated in less-strong containers.

For other additional risk phrases see Section 3.2.7.

3.                   CLASSIFICATION ON THE BASIS OF TOXICOLOGICAL PROPERTIES

3.1.                Introduction

3.1.1.            Classification is concerned with both the acute and long-term effects of substances and preparations, whether resulting from a single instance of exposure or repeated or prolonged exposure.

If adequate evidence is available to demonstrate in practice that the toxic effect of substances and preparations on man is, or is likely to be, different from that suggested by the experimental results obtained in animal tests or by the application of the conventional method referred to in Article 3 (5) of Directive 88/379/EEC then such substances and preparations should be classified according to their toxicity in man. However, tests on man should be discouraged and should not normally be used to negate positive animal data.

3.1.2.            The classification of substances must be made on the basis of the experimental data available in accordance with the following criteria which take into account the magnitude of these effects:

(a)      for acute toxicity (lethal and irreversible effects after a single exposure), the criteria under Sections 3.2.1 to 3.2.3 are to be used,

(b)      for subacute, subchronic or chronic toxicity the criteria under Sections 3.2.2 to 3.2.4 are to be used.

(c)      for corrosive and irritant effects the criteria under Sections 3.2.5 and 3.2.6 are to be used,

(d)      for sensitising effects the criteria under Sections 3.2.7 are to be used,

(e)      for specific effects on health (carcinogenicity, mutagenicity and reproductive toxicity, the criteria in Chapter 4 are to be used.

3.1.3.             For preparations, the classification relating to dangerous for health is carried out:

(a)     on the basis of the conventional method referred to in Article 3 (5) of Directive 88/379/EEC in the absence of experimental data. In this case, the classification is based on the individual concentration limits:

-    either taken from Annex I to Directive 67/548/EEC,

-    or from Annex I of Directive 88/379/EEC where the substance or substances do not appear in Annex I of Directive 67/548/EEC or appear in it without concentration limits.

(b)     or when experimental data are available, according to the criteria described under Sections 3.1.2 excluding the carcinogenic, mutagenic and toxic to reproduction properties referred to under 3.1.2 (e) which must be evaluated by the conventional method referred to in Article 3 (5) (j) to (q) of Directive 88/379/EEC.

Whichever method is used for the evaluation of the danger of a preparation, all the dangerous effects on health as defined in Annex I of Directive 88/379/EEC must be taken into consideration.

3.1.4.            When the classification is to be established from experimental results obtained in animal tests the results should have validity for man in that the tests reflect, in an appropriate way, the risks to man.

3.1.5.            The acute oral toxicity of substances or preparations placed on the market may be established either by a method permitting assessment of the LD50 value, or by determining the discriminating dose (the fixed dose procedure).

The discriminating dose is the dose which causes evident toxicity but not mortality and must be one of the four dosage levels specified in Annex V (5, 50, 500 or 2 000 mg per kg body weight).

The concept ‘evident toxicity’ is used to designate toxic effects, after exposure to the substance tested, which are so severe that exposure to the next highest fixed dose would probably lead to mortality.

The results of testing at a particular dose following the fixed dose method may be either:

- less than 100% survival,

- 100% survival, but evident toxicity,

- 100% survival, but no evident toxicity.

The test method requires in some cases testing at higher or lower doses, if not already tested at the relevant dose level. Refer also to the evaluation table in test method B.1 bis of Annex V.

In the criteria in sections 3.2.1, 3.2.2 and 3.2.3 only the final test result is shown. The 2 000 mg/kg dose should be used primarily to obtain information on the toxic effects of substances which are of low acute toxicity and which are not classified on the basis of acute toxicity.

3.2.               Criteria for classification, choice of symbols, indication of danger, choice of risk phrases

3.2.1.            Very toxic

Substances and preparations shall be classified as very toxic, and assigned the symbol ‘T +’ and indication of danger ‘very toxic’ in accordance with the criteria specified below.

Risk phrases shall be assigned in accordance with the following criteria:

R28       Very toxic if swallowed

Acute toxicity results:

-    LD50 oral, rat ≤ 25 mg/kg,

-    less than 100% survival at 5 mg/kg oral, rat by the fixed dose procedure.

R27       Very toxic in contact with skin

Acute toxicity results:

-    LD50 dermal, rat or rabbit: ≤ 50 mg/kg.

R26       Very toxic by inhalation

Acute toxicity results:

-    LC50 inhalation, rat, for aerosols or particulates: ≤ 0.25 mg/litre/4hr.

-    LC50 inhalation, rat, for gases and vapours: ≤ 0.5 mg/litre/4hr.

R39       Danger of very serious irreversible effects

-  Strong evidence that irreversible damage other than the effects referred to in Chapter 4 is likely to be caused by a single exposure by an appropriate route, generally in the above mentioned dose range.

In order to indicate the route of administration/exposure one of the following combinations shall be used: R39/26, R39/27, R39/28, R39/26/27, R39/26/28, R39/27/28, R39/26/27/28.

3.2.2.            Toxic

Substances and preparations shall be classified as toxic and assigned the symbol ‘T’ and the indication of danger ‘toxic’ in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria.

R25       Toxic if swallowed

Acute toxicity results:

-    LD50 oral, rat: 25 < LD50 ≤ 200 mg/kg,

-    Discriminating dose, oral, rat, 5 mg/kg: 100% survival but evident toxicity,

R24       Toxic in contact with skin

Acute toxicity results:

-    LD50 dermal, rat or rabbit: 50 < LD50 ≤ 400 mg/kg.

R23       Toxic by inhalation

Acute toxicity results:

-    LC50 inhalation, rat, for aerosols or particulates: 0,25 < LC50 ≤ 1 mg/litre/4hr

-    LC50 inhalation, rat, for gases and vapours: 0,5 < LC50 ≤ 2 mg/litre/4hr.

R39       Danger of very serious irreversible effects

-    strong evidence that irreversible damage other than the effects referred to in section 4 is likely to be caused by a single exposure by an appropriate route, generally in the abovementioned dose range.

In order to indicate the route of administration/exposure one of the following combinations shall be used: R39/23, R39/24, R39/25, R39/23/24, R39/23/25, R39/24/25, R39/23/24/25.

R48       Danger of serious damage to health by prolonged exposure

-    serious damage (clear functional disturbance or morphological change which have toxicological significance) is likely to be caused by repeated or prolonged exposure by an appropriate route.

Substances and preparations are classified at least as Toxic when these effects are observed at levels of one order of magnitude lower (i.e. 10- fold) than those set out for R48 in Section 3.2.3.

In order to indicate the route of administration/exposure one of the following combinations shall be used: R48/23, R48/24, R48/25, R48/23/24, R48/23/25, R48/24/25, R48/23/24/25.

3.2.3.            Harmful

Substances and preparations shall be classified as harmful and assigned the symbol ‘Xn’ and the indication of danger ‘harmful’ in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria:

R22       Harmful if swallowed

Acute toxicity results:

-    LD₅₀ per oral, rat: 200 < LD₅₀ ≤ 2000 mg/kg,

-    discriminating dose, oral, rat, 50 mg/kg: 100% survival but evident toxicity,

-    less than 100% survival at 500 mg/kg, rat oral by the fixed dose procedure. Refer to the evaluation table in the test method B1 (a) of Annex V.

R21       Harmful in contact with skin

Acute toxicity results:

-    LD₅₀ dermal, rat or rabbit: 400 < LD₅₀ ≤ 2 000 mg/kg

R20       Harmful by inhalation

Acute toxicity results:

-    LC₅₀ inhalation, rat, for aerosols or particulates: 1 < LC₅₀ ≤ 5 mg/litre/4hr,

-    LC₅₀ inhalation, rat, for gases or vapours: 2 < LC₅₀ ≤ 20 mg/litre/4hr.

R65       Harmful: may cause lung damage if swallowed

Liquid substances and preparations presenting an aspiration hazard in humans because of their low viscosity:

(a) For substances and preparations containing aliphatic, alicyclic and aromatic hydrocarbons in a total concentration equal to or greater than 10% and having either

-      a flow time of less than 30 sec. in a 3 mm ISO cup according to ISO 2431, or

-      a kinematic viscosity measured by a calibrated glass capillary viscometer in accordance with ISO 3104/3105 of less than 7 x 10^-6 m²/sec at 40° C

-      a kinematic viscosity derived from measurements of rotational viscometry in accordance with ISO 3219 of less than 7 x 10^-6 m²/sec at 40° C

Note that substances and preparations meeting these criteria need not be classified if they have a mean surface tension greater than 33mN/m at 25° C as measured by the du Nouy tensiometer or by the test methods shown in Annex V Part A.5.

(b) For substances and preparations, based on practical experience in humans.

R40       Possible risk of irreversible effects

-   strong evidence that irreversible damage other than the effects referred to in Chapter 4 is likely to be caused by a single exposure by an appropriate route, generally in the above-mentioned dose range.

In order to indicate route of administration/exposure one of the following combinations shall be used: R40/20, R40/21, R40/22, R40/20/21, R40/20/22, R40/21/22, R40/20/21/22.

R48       Danger of serious damage to health by prolonged exposure

-   serious damage (clear functional disturbance or morphological change which has toxicological significance) is likely to be caused by repeated or prolonged exposure by an appropriate route.

Substances and preparations are classified at least as harmful when these effects are observed at levels of the order of:

- oral, rat ≤ 50 mg/kg (bodyweight)/day,

- dermal, rat or rabbit ≤ 100 mg/kg (bodyweight)/day,

- inhalation, rat ≤ 0,25 mg/1, 6h/day.

These guide values can apply directly when severe lesions have been observed in a subchronic (90 days) toxicity test. When interpreting the results of a sub-acute (28 days) toxicity test these figures should be increased approximately three fold. If a chronic (two years) toxicity test is available it should be evaluated on a case-by-case basis. If results of studies of more than one duration are available, then those from the study of the longest duration should normally be used.

In order to indicate route of administration/exposure one of the following combinations shall be used: R48/20, R48/21, R48/22, R48/20/21, R48/20/22, R48/21/22, R48/20/21/22.

3.2.3.1         Comments regarding volatile substances

For certain substances with a high saturated vapour concentration evidence may be available to indicate effects that give cause for concern. Such substances may not be classified under the criteria for health effects in this guide (3.2.3) or not covered by section 3.2.8. However, where there is appropriate evidence that such substances may present a risk in normal handling and use then classification on a case-by-case basis in Annex I may be necessary.

3.2.4            Comments regarding the use of R48

Use of this risk phrase refers to the specific range of biological effects within the terms described below. For application of this risk phrase serious damage to health is to be considered to include death, clear functional disturbance or morphological changes which are toxicologically significant. It is particularly important when these changes are irreversible. It is also important to consider not only specific severe changes in a single organ or biological system but also generalized changes of a less severe nature involving several organs, or severe changes in general health status.

When assessing whether there is evidence for these types of effects reference should be made to the following guidelines:

1.  Evidence indicating that R48 should be applied:

(a) substance-related deaths

(b) (i) major functional changes in the central or peripheral nervous systems, including sight, hearing and the sense of smell, assessed by clinical observations or other appropriate methods (e.g. electrophysiology)

(ii) major functional changes in other organ systems (for example the lung).

(c) Any consistent changes in clinical biochemistry, haematology or urinalysis parameters which indicate severe organ dysfunction. Haematological disturbances are considered to be particularly important if the evidence suggests that they are due to decreased bone marrow production of blood cells;

(d) severe organ damage noted on microscopic examination following autopsy;

(i) widespread 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 are clear evidence of marked organ dysfunction (e.g. severe fatty change in the liver, severe acute tubular nephrosis in the kidney, ulcerative gastritis).

(iii) evidence of appreciable cell death in vital organs incapable of regeneration (e.g. fibrosis of the myocardium or dying back of a nerve) or in stem cell populations (e.g. aplasia or hypoplasia of the bone marrow).

The above evidence will most usually be obtained from animal experiments. When considering data derived from practical experience special attention should be given to exposure levels.

2. Evidence indicating that R48 should not be applied.

The use of this risk phrase is restricted to ‘serious damage to health by prolonged exposure’. A number of substance-related effects may be observed in both humans and animals that would not justify the use of R48. These effects are relevant when attempting to determine a no-effect level for a chemical substance. Examples of well documented changes which would not normally justify classification with R48, irrespective of their statistical significance, include:

(a) clinical observations or changes in bodyweight gain, food consumption or water intake, which may have some toxicological importance but which do not, by themselves, indicate ‘serious damage’;

(b) small changes in clinical biochemistry, haematology or urinalysis parameters which are of doubtful or minimal toxicological importance;

(c) changes in organ weights with no evidence of organ dysfunction;

(d) adaptative responses (e.g. macrophage migration in the lung, liver hypertrophy and enzyme induction, hyperplastic responses to irritants). Local effects on the skin produced by repeated dermal application of a substance which are more appropriately classified with R38 ‘irritating to skin’;

(e) where a species-specific mechanism of toxicity (e.g. specific metabolic pathways) has been demonstrated.

3.2.5.           Corrosive

A substance or a preparation is considered to be corrosive if, when it is applied to healthy intact animal skin, it produces full thickness destruction of skin tissue on at least one animal during the test for skin irritation cited in Annex V or during an equivalent method or if the results can be predicted, for example from strongly acid or alkaline reactions (demonstrated pH of 2 or less or 11,5 or greater. Alkaline or acidic reserve should also be taken into account).

Classification can be based on the results of validated in vitro tests.

The substance or preparation shall be classified as corrosive and assigned the symbol ‘C’ and the indication of danger ‘corrosive’. Risk phrases shall be assigned in accordance with the following criteria:

R35       Causes severe burns

-   if, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a result of up to three minutes exposure, or if this result can be predicted.

R34       Causes burns

-   if, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a result of up to four hours exposure, or if this result can be predicted.

-   organic hydroperoxides, except where evidence to the contrary is available.

3.2.6.            Irritant

Substances and preparations shall be classified as irritant and assigned the symbol ‘Xi’ and the indication of danger ‘irritant’ in accordance with the criteria given below.

3.2.6.1          Inflammation of the skin

The following risk phrase shall be assigned in accordance with the criteria given:

R38       Irritating to skin

-    Substances and preparations which cause significant inflammation of the skin which persists for at least 24 hours after an exposure period of up to four hours determined on the rabbit according to the cutaneous irritation test method cited in Annex V.

Inflammation of the skin is significant if:

(a) the mean value of the scores for either erythema and eschar formation or oedema formation, calculated over all the animals tested, is 2 or more,

(b) or, in the case where the Annex V test has been completed using three animals, either erythema and eschar formation or oedema formation equivalent to a mean value of 2 or more calculated for each animal separately has been observed in two or more animals.

In both cases all scores at each of the reading times (24, 48 and 72 hr) for an effect should be used in calculating respective mean values.

Inflammation of the skin is also significant if it persists in at least two animals at the end of the observation time. Particular effects e.g. hyperplasia, scaling, discoloration, fissures, scabs and alopecia should be taken into account.

Relevant data may also be available from non-acute animal studies (see comments on R48, section 2.d). These are considered significant if the effects seen are comparable to those described above.

-     Substances and preparations which cause significant inflammation of the skin, based on practical observations in humans on immediate, prolonged or repeated contact.

-     Organic peroxides, except where evidence to the contrary is available.

Paresthesia:

Paresthesia caused in humans by skin contact with pyrethroid pesticides is not regarded as an irritant effect justifying classification as Xi; R38. The S-phrase S24 should however be applied for substances seen to cause this effect.

3.2.6.2.         Ocular lesions

The following risk phrases shall also be assigned in accordance with the criteria given:

R36       Irritating to eyes

-  Substances and preparations which, when applied to the eye of the animal, cause significant ocular lesions which occur within 72 hours after exposure and which persist for at least 24 hours.

Ocular lesions are significant if the means scores of the eye irritation test cited in Annex V have any of the following values:

-    cornea opacity equal to or greater than 2 but less than 3,

-    iris lesion equal to or greater than 1 but not greater than 1,5,

-    redness of the conjunctivae equal to or greater than 2,5,

-    oedema of the conjunctivae (chemosis) equal to or greater than 2,

or, in the case where the Annex V test has been completed using three animals if the lesions, on two or more animals, are equivalent to any of the above values except that for iris lesion the value should be equal to or greater than 1 but less than 2 and for redness of the conjunctivae the value should be equal to or greater than 2,5.

In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be used in calculating the respective mean values.

- Substances or preparations which cause significant ocular lesions, based on practical experience in humans.

- Organic peroxides except where evidence to the contrary is available.

R41       Risk of serious damage to eyes

- Substances and preparations which, when applied to the eye of the animal cause severe ocular lesions which occur within 72 hours after exposure and which persist for at least 24 hours.

Ocular lesions are severe if the means of the scores of the eye irritation test in Annex V have any of the values:

- cornea opacity equal to or greater than 3,

- iris lesion greater than 1,5.

The same shall be the case where the test has been completed using three animals if these lesions, on two or more animals, have any of the values:

- cornea opacity equal to or greater than 3,

- iris lesion equal to 2.

In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be used in calculating the respective mean values.

Ocular lesions are also severe when they are still present at the end of the observation time.

Ocular lesions are also severe if the substance or preparation causes irreversible colouration of the eyes.

- Substances and preparations which cause severe ocular lesions, based on practical experience in humans.

Note:

When a substance or preparation is classified as corrosive and assigned R34 or R35, the risk of severe damage to eyes is considered implicit and R41 is not included in the label. However, in the case of preparations, when calculating the sum of quotients by the formulae in 3.5(f)(ii) and 3.5(h)(ii) of Directive 88/379/EEC substances classified as corrosive shall be considered as if R41 had been assigned.

3.2.6.3.         Respiratory system irritation

The following risk phrase shall be assigned in accordance with the criteria given:

R37      Irritating to respiratory system

- Substances and preparations which cause serious irritation to the respiratory system based on:

-     practical observation in humans.

-     Positive results from appropriate animal tests

Comments regarding the use of R37

In interpreting practical observations in humans, care should be taken to distinguish between effects which lead to classification with R48 (see section 3.2.4) from those leading to classification with R37. Conditions normally leading to classification with R37 are reversible and usually limited to the upper airways.

Positive results from appropriate animal tests may include data obtained in a general toxicity test, including histopathological data from the respiratory system. Data from the measurement of experimental bradypnea may also be used to assess airway irritation.

3.2.7             Sensitisation

3.2.7.1         Sensitisation by inhalation

Substances and preparations shall be classified as sensitising and assigned the symbol Xn, the indication of danger ‘Harmful’ and the risk phrase R42 in accordance with the criteria given below.

R42       May cause sensitisation by inhalation

-    If there is evidence that the substance or preparation can induce specific respiratory hypersensitivity

-    where there are positive results from appropriate animal tests

-    If the substance is an isocyanate, unless there is evidence that the substance does not cause respiratory hypersensitivity

Comments regarding the use of R42

Human evidence

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

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

- the size of the population exposed

- the extent of exposure

The evidence referred to above could be

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

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

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

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

-      studies that may indicate other specific, but non-immunological mechanisms of action, e.g. repeated low level irritation, pharmacologically mediated effects

-      data from a positive bronchial challenge test with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction

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

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

Substances that elicit symptoms of asthma by irritation only in people with bronchial hyper reactivity should not be assigned R42.

Animal Studies

Data from tests which may be indicative of the potential of a substance to cause sensitisation by inhalation in humans may include:

-     lgE measurements (e.g. in mice)

-     Specific pulmonary responses in guinea pigs

3.2.7.2.         Sensitisation by skin contact

Substances and preparations shall be classified as and sensitising and assigned the symbol ‘Xi’, the indication of danger ‘Irritant’ and the risk phrase R43 in accordance with the criteria given below:

R43       May cause sensitisation by skin contact

-    If practical experience shows the substance or preparation to be capable of inducing a sensitisation by skin contact in a substantial number of persons,

-    where there are positive results from an appropriate animal test

Comments regarding the use of R43

Human evidence

The following evidence (practical experience) is sufficient to classify a substance or preparation with R43:

-    Positive data from appropriate patch testing, normally in more than one dermatological clinic, or

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

-    Positive data from experimental studies in man (see also 3.1.1)

The following is sufficient to classify a substance with R43 when there is supportive evidence:

-    Isolated episodes of allergic contact dermatitis, or

-    Epidemiological studies where chance, bias or confounders have not been ruled out fully with reasonable confidence.

Supportive evidence may include:

-    data from animal tests performed according to existing guidelines, with a result that does not meet the criteria given in the section on animal studies but is sufficiently close to the limit to be considered significant, or

-    data from non-standard methods, or

-    appropriate structure-activity relationships.

Animal studies

Positive results from appropriate animal tests are:

in the case of the adjuvant type test method for skin sensitisation detailed in Annex V or in the case of other adjuvant-type test methods, a response of at least 30% of the animals is considered as positive. For any other test method a response of at least 15% of the animals is considered positive.

3.2.7.3.        Immunological contact urticaria

Some substances which meet the criteria for R42 may in addition cause immunological contact urticaria. In these cases, information concerning contact urticaria should be included by the use of appropriate S-phrases, usually S24 and S36/37, and in the Safety Data Sheet.

For substances or preparations, which produce signs of immunological contact urticaria which do not fulfil the criteria for R42, consideration should be given to classification with R43.

There is no recognised animal model available to identify substances which cause immunological contact urticaria. Therefore, classification will normally be based on human evidence which will be similar to that for skin sensitisation (R43).

3.2.7.4.        Note that if the symbol ‘Xn’ and the indication of danger ‘Harmful’ are assigned, the symbol ‘Xi’ and indication of danger ‘Irritant’ are optional

3.2.8.           Other toxicological properties

Additional risk phrases shall be assigned in accordance with the following criteria (based on experience obtained during compilation of Annex I) to substances and preparations classified by virtue of 2.2.1 to 3.2.7 above and/or chapters 4 and 5:

R29       Contact with water liberates toxic gas

For substances and preparations which in contact with water or damp air, evolve very toxic/toxic gases in potentially dangerous amounts, e.g. aluminium phosphide, phosphorus pentasulphide.

R31       Contact with acids liberates toxic gas

For substances and preparations which react with acids to evolve toxic gases in dangerous amounts, e.g. sodium hypochlorite, barium polysulphide. For substances used by members of the general public, the use of S50 (do not mix with … (to be specified by the manufacturer)) would be more suitable.

R32       Contact with acids liberates very toxic gas

For substances and preparations which react with acids to evolve very toxic gases in dangerous amounts: e.g. salts of hydrogen cyanide, sodium azide. For substances used by members of the general public, the use of S50 (do not mix with … (to be specified by the manufacturer)) would be more suitable.

R33       Danger of cumulative effects

For substances and preparations when accumulation in the human body is likely and may cause some concern which, however, is not sufficient to justify the use of R48.

R64       May cause harm to breastfed babies

For substances and preparations which are absorbed by women and may interfere with lactation or which may be present (including metabolites) in breast milk in amounts sufficient to cause concern for the health of a breastfed child.

For comments on the use of this R-phrase (and in some cases R33) see Section 4.2.3.3.

R66       Repeated exposure may cause skin dryness or cracking.

For substances and preparations which may cause concern as a result of skin dryness, flaking or cracking but which do not meet the criteria for R38:

based on either:

-    practical observation after normal handling and use, or

-    relevant evidence concerning their predicted effects on the skin.

See also paragraphs 1.6 and 1.7.

R67       Vapours may cause drowsiness and dizziness

For volatile substances and preparations containing such substances which cause clear symptoms of central nervous system depression by inhalation and which are not already classified with respect to acute inhalation toxicity (R20, R23, R26, R40/20, R39/23 or R39/26).

The following evidence may be used:

(a)  Data from animal studies showing clear signs of CNS depression such as narcotic effects, lethargy, lack of co-ordination (including loss of righting reflex) and ataxia either:

-           at concentrations/exposure times not exceeding 20 mg/1/4h or,

-           for which the ratio of the effect concentration at ≤ 4 h to the saturated vapour concentration (SVC) at 20°C is ≤ 1/10.

b)  Practical experience in humans (e.g. narcosis, drowsiness, reduced alertness, loss of reflexes, lack of co-ordination, vertigo) from well documented reports under comparable exposure conditions to the effects specified above for animals.

See also paragraphs 1.6 and 1.7.

For other supplementary risk phrases see Section 2.2.6.

4.                  CLASSIFICATION ON THE BASIS OF SPECIFIC EFFECTS ON HUMAN HEALTH

4.1.                Introduction

4.1.1.            This Section sets out the procedure for the classification of substances which may have the effects mentioned below.

4.1.2.            If a manufacturer, distributor or importer has information available which indicates that a substance should be classified and labelled in accordance with the criteria given in Section 4.2.1, 4.2.2 or 4.2.3, he shall provisionally label the substance in accordance with these criteria, on the basis of the assessment of the evidence by a competent person.

4.1.3.            The manufacturer, distributor or importer shall submit as soon as possible a document summarising all relevant information to one Member State in which the substance is placed on the market. This summary document should include a bibliography containing all relevant references, including any relevant unpublished data.

4.1.4.            Furthermore, a manufacturer, distributor or importer who has new data which are relevant to the classification and labelling of a substance in accordance with the criteria given in Section 4.2.1., 4.2.2. or 4.2.3., shall submit this data as soon as possible to one Member State in which the substance is placed on the market.

4.1.5.            In order to obtain as quickly as possible a harmonized classification for the Community by the procedure defined in Article 28 of Directive 67/548/EEC, Member States which have relevant information available justifying the classification of a substance in one of these categories, whether submitted by the manufacturer or not, should forward such information together with suggestions for classification and labelling, to the Commission as soon as possible.

The Commission will forward to the other Member States the classification and labelling proposal that it receives. Any Member State may ask the Commission for the information it has received.

Any Member State which has good reason to believe that the suggested classification and labelling is inappropriate as far as the carcinogenic, mutagenic or reproductive toxicity effects are concerned shall notify the Commission thereof.

4.2.                Criteria for classification, indication of danger, choice of risk phrases

4.2.1.            Carcinogenic substances

For the purpose of classification and labelling, and having regard to the current state of knowledge, such substances are divided into three categories:

Category 1

Substances known to be carcinogenic to man. There is sufficient evidence to establish a causal association between human exposure to a substance and the development of cancer.

Category 2

Substances which should be regarded as if they are carcinogenic to man. There is sufficient evidence to provide a strong presumption that human exposure to a substance may result in the development of cancer, generally on the basis of:

-     appropriate long-term animal studies,

-     other relevant information.

Category 3

Substances which cause concern for man owing to possible carcinogenic effects but in respect of which the available information is not adequate for making a satisfactory assessment. There is some evidence from appropriate animal studies, but this is insufficient to place the substance in Category 2.

4.2.1.1.             The following symbols and specific risk phrases apply:

Categories 1 and 2:

T; R45 May cause cancer

However for substances and preparations which present a carcinogenic risk only when inhaled, for example, as dust, vapour or fumes, (other routes of exposure e.g. by swallowing or in contact with skin do not present any carcinogenic risk), the following symbol and specific risk phrase should be used:

T; R49 May cause cancer by inhalation

Category 3:

Xn;        R40 Possible risk of irreversible effects

4.2.1.2.              Comments regarding the categorisation of carcinogenic substances

The placing of a substance into Category 1 is done on the basis of epidemiological data; placing into Categories 2 and 3 is based primarily on animal experiments.

For classification as a Category 2 carcinogen either positive results in two animal species should be available or clear positive evidence in one species, together with supporting evidence such as genotoxicity data, metabolic or biochemical studies, induction of benign tumours, structural relationship with other known carcinogens, or data from epidemiological studies suggesting an association.

Category 3 actually comprises 2 sub-categories:

(a) substances which are well investigated but for which the evidence of a tumour-inducing effect is insufficient for classification in Category 2. Additional experiments would not be expected to yield further relevant information with respect to classification;

(b) substances which are insufficiently investigated. The available data are inadequate, but they raise concern for man. This classification is provisional; further experiments are necessary before a final decision can be made.

For a distinction between Categories 2 and 3 the arguments listed below are relevant which reduce the significance of experimental tumour induction in view of possible human exposure. These arguments, especially in combination, would lead in most cases to classification in Category 3, even though tumours have been induced in animals:

-    carcinogenic effects only at very high dose levels exceeding the ‘maximal tolerated dose’. The maximal tolerated dose is characterized by toxic effects which, although not yet reducing lifespan, go along with physical changes such as about 10 % retardation in weight gain:

-    appearance of tumours, especially at high dose levels, only in particular organs of certain species known to be susceptible to a high spontaneous tumour formation;

-    appearance of tumours, only at the site of application, in very sensitive test systems (e.g. i.p. or s.c. application of certain locally active compounds), if the particular target is not relevant to man;

-    lack of genotoxicity in short-term tests in vivo and in vitro,

-    existence of a secondary mechanism of action with the implication of a practical threshold above a certain dose level (e.g., hormonal effects on target organs or on mechanisms of physiological regulation, chronic stimulation of cell proliferation),

-    existence of a species - specific mechanism of tumour formation (e.g. by specific metabolic pathways) irrelevant for man.

For a distinction between Category 3 and no classification arguments are relevant which exclude a concern for man:

-    a substance should not be classified in any of the categories if the mechanism of experimental tumour formation is clearly identified, with good evidence that this process cannot be extrapolated to man;

-    if the only available tumour data are liver tumours in certain sensitive strains of mice, without any other supplementary evidence, the substance may not be classified in any of the categories;

-    particular attention should be paid to cases where the only available tumour data are the occurrence of neoplasms at sites and in strains where they are well known to occur spontaneously with a high incidence.

4.2.2.            Mutagenic substances

4.2.2.1         For the purposes of classification and labelling, and having regard to the current state of knowledge, such substances are divided into three categories:

Category 1

Substances known to be mutagenic to man.

There is sufficient evidence to establish a causal association between human exposure to a substance and heritable genetic damage.

Category 2

Substances which should be regarded as if they are mutagenic to man.

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in the development of heritable genetic damage, generally on the basis of:

-      appropriate animal studies,

-      other relevant information.

Category 3

Substances which cause concern for man owing to possible mutagenic effects. There is evidence from appropriate mutagenicity studies, but this is insufficient to place the substance in Category 2.

4.2.2.2.        The following symbols and specific risk phrases apply:

Category 1:

T; R46   May cause heritable genetic damage

Category 2:

T;   R46 May cause heritable genetic damage

Category 3:

Xn; R40Possible risk of irreversible effects

4.2.2.3.        Comments regarding the categorisation of mutagenic substances

Definition of terms:

A mutation is a permanent change in the amount or structure of the genetic material in an organism, resulting in a change of the phenotypic characteristics of the organism. The alterations may involve a single gene, a block of genes, or a whole chromosome. Effects involving single genes may be a consequence of effects on single DNA bases (point mutations) or of large changes, including deletions, within the gene. Effects on whole chromosomes may involve structural or numerical changes. A mutation in the germ cells in sexually reproducing organisms may be transmitted to the offspring. A mutagen is an agent that gives rise to an enhanced occurrence of mutations.

It should be noted that substances are classified as mutagens with specific reference to inherited genetic damage. However, the type of results leading to classification of chemicals in Category 3: ‘induction of genetically relevant events in somatic cells’, is generally also regarded as an alert for possible carcinogenic activity.

Method development for mutagenicity testing is an ongoing process. For many new tests no standardized protocols and evaluation criteria are presently available. For the evaluation of mutagenicity data the quality of the test performance and the degree of validation of the test method have to be considered.

Category 1

To place a substance in Category 1, positive evidence from human mutation epidemiology studies will be needed. Examples of such substances are not known to date. It is recognized that it is extremely difficult to obtain reliable information from studies on the incidence of mutations in human populations, or on possible increases in their frequencies.

Category 2

To place a substance in Category 2, positive results are needed from assays showing (a) mutagenic effects, or (b) other cellular interactions relevant to mutagenicity, in germ cells of mammals in vivo, or (c) mutagenic effects in somatic cells of mammals in vivo in combination with clear evidence that the substance or a relevant metabolite reaches the germ cells.

With respect to placement in Category 2, at present the following methods are appropriate:

2 (a) in vivo germ cell mutagenicity assays:

-      specific locus mutation test,

-      heritable translocation test,

-      dominant lethal mutation test.

These assays actually demonstrate the appearance of affected progeny or a defect in the developing embryo.

2 (b.) in vivo assays showing relevant interaction with germ cells (usually DNA):

-      assays for chromosomal abnormalities, as detected by cytogenetic analysis, including aneuploidy, caused by malsegregation of chromosomes,

-      test for sister chromatid exchanges (SCEs),

-      test for unscheduled DNA synthesis (UDS),

-      assay of (covalent) binding of mutagen to germ cell DNA,

-      assaying other kinds of DNA damage.

These assays provide evidence of a more or less indirect nature. Positive results in these assays would normally be supported by positive results from in vivo somatic cell mutagenicity assays, in mammals or in man (see under Category 3, preferably methods as under 3 (a)).

2 (c.)         in vivo assays showing mutagenic effects in somatic cells of mammals (see under 3 (a)), in combination with toxicokinetic methods, or other methodologies capable of demonstrating that the compound or a relevant metabolite reaches the germ cells.

For 2 (b) and 2 (c), positive results from host-mediated assays or the demonstration of unequivocal effects in in vitro assays can be considered as supporting evidence.

Category 3

To place a substance in Category 3, positive results are needed in assays showing (a) mutagenic effects or (b) other cellular interaction relevant to mutagenicity, in somatic cells in mammals in vivo. The latter especially would normally be supported by positive results from in vitro mutagenicity assays.

For effects in somatic cells in vivo at present the following methods are appropriate:

3 (a) in vivo somatic cell mutagenicity assays:

- bone marrow micronucleus test or metaphase analysis,

- metaphase analysis of peripheral lymphocytes,

- mouse coat colour spot test.

3 (b) in vivo somatic cell DNA interaction assays:

- test for SCEs in somatic cells,

- test for UDS in somatic cells,

- assay for the (covalent) binding of mutagen to somatic cell DNA,

- assay for DNA damage, e.g. by alkaline elution, in somatic cells.

Substances showing positive results only in one or more in vitro mutagenicity assays should normally not be classified. Their further investigation using in vivo assays, however, is strongly indicated. In exceptional cases, e.g. for a substance showing pronounced responses in several in vitro assays, for which no relevant in vivo data are available, and which shows resemblance to known mutagens/carcinogens, classification in Category 3 could be considered.

4.2.3.            Substances toxic to reproduction

4.2.3.1.           For the purposes of classification and labelling and having regard to the present state of knowledge, such substances are divided into 3 categories:

Category 1:

Substances known to impair fertility in humans

There is sufficient evidence to establish a causal relationship between human exposure to the substance and impaired fertility.

Substances known to cause developmental toxicity in humans

There is sufficient evidence to establish a causal relationship between human exposure to the substance and subsequent developmental toxic effects in the progeny.

Category 2

Substances which should be regarded as if they impair fertility in humans:

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in impaired fertility on the basis of:

-                clear evidence in animal studies of impaired fertility in the absence of toxic effects, or, evidence of impaired fertility occurring at around the same dose levels as other toxic effects but which is not a secondary non-specific consequence of the other toxic effects,

-                other relevant information.

Substances which should be regarded as if they cause developmental toxicity to humans:

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in developmental toxicity, generally on the basis of:

-                Clear results in appropriate animal studies where effects have been observed in the absence of signs of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the other toxic effects,

-                Other relevant information.

Category 3

Substances which cause concern for human fertility

Generally on the basis of:

-                Results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of impaired fertility in the absence of toxic effects, or evidence of impaired fertility occurring at around the same dose levels as other toxic effects, but which is not a secondary non-specific consequence of the other toxic effects, but where the evidence is insufficient to place the substance in Category 2.

-                other relevant information.

Substances which cause concern for humans owing to possible developmental toxic effects

Generally on the basis of:

-                Results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of developmental toxicity in the absence of signs of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the other toxic effects, but where the evidence is insufficient to place the substance in Category 2,

-                Other relevant information.

4.2.3.2.              The following symbols and specific risk phrases apply:

Category 1:

For substances that impair fertility in humans:

T; R60: May impair fertility

For substances that cause developmental toxicity:

T; R61: May cause harm to the unborn child

Category 2:

For substances that should be regarded as if they impair fertility in humans:

T; R60: May impair fertility

For substances that should be regarded as if they cause developmental toxicity in humans:

T; R61: May cause harm to the unborn child.

Category 3:

For substances which cause concern for human fertility:

Xn; R62: Possible risk of impaired fertility

For substances which cause concern for humans owing to possible developmental toxic effects:

Xn; R63: Possible risk of harm to the unborn child.

4.2.3.3.            Comments regarding the categorization of substances toxic to reproduction

Reproductive toxicity includes impairment of male and female reproductive functions or capacity and the induction of non-inheritable harmful effects on the progeny. This may be classified under two main headings of 1). Effects on male or female fertility; 2). Developmental toxicity.

1)    Effects on male or female fertility, includes adverse effects on libido, sexual behaviour, any aspect of spermatogenesis or oogenesis, or on hormonal activity or physiological response which would interfere with the capacity to fertilise, fertilisation itself or the development of the fertilised ovum up to and including implantation.

2)    Developmental toxicity, is taken in its widest sense to include any effect interfering with normal development, both before and after birth. It includes effects induced or manifested prenatally as well as those manifested postnatally. This includes embrytoxic/fetotoxic effects such as reduced body weight, growth and developmental retardation, organ toxicity, death, abortion, structural defects (teratogenic effects), functional defects, peri-postnatal defects, and impaired postnatal mental or physical development up to and including normal pubertal development.

Classification of chemicals as toxic to reproduction is intended to be used for chemicals which have an intrinsic or specific property to produce such toxic effects. Chemicals should not be classified as toxic to reproduction where such effects are solely produced as a non-specific secondary consequence of other toxic effects. Chemicals of most concern are those which are toxic to reproduction at exposure levels which do not produce other signs of toxicity.

The placing of a compound in Category 1 for effects on Fertility and/or Developmental toxicity is done on the basis of epidemiological data. Placing into Categories 2 or 3 is done primarily on the basis of animal data. Data from in vitro studies, or studies on avian eggs, are regarded as ‘supportive evidence’ and would only exceptionally lead to classification in the absence of in vivo data.

In common with most other types of toxic effect, substances demonstrating reproductive toxicity will be expected to have a threshold below which adverse effects would not be demonstrated. Even when clear effects have been demonstrated in animal studies the relevance for humans may be doubtful because of the doses administered, for example, where effects have been demonstrated only at high doses, or where marked toxicokinetic differences exist, or the route of administration is inappropriate. For these or similar reasons it may be that classification in Category 3, or even no classification, will be warranted.

Annex V to the Directive specifies a limit test in the case of substances of low toxicity. If a dose level of at least 1000 mg/kg orally produces no evidence of effects toxic to reproduction, studies at other dose levels may not be considered necessary. If data are available from studies carried out with doses higher than the above limit dose, this data must be evaluated together with other relevant data. Under normal circumstances it is considered that effects seen only at doses in excess of the limit dose would not necessarily lead to classification as ‘Toxic to reproduction’.

EFFECTS ON FERTILITY

For the classification of a substance into Category 2 for impaired fertility, there should normally be clear evidence in one animal species, with supporting evidence on mechanism of action or site of action, or chemical relationship to other known anti-fertility agents or other information from humans which would lead to the conclusion that effects would be likely to be seen in humans. Where there are studies in only one species without other relevant supporting evidence then classification in Category 3 may be appropriate.

Since impaired fertility may occur as a non-specific accompaniment to severe generalized toxicity or where there is severe inanition, classification into Category 2 should only be made where there is evidence that there is some degree of specificity of toxicity for the reproductive system. If it was demonstrated that impaired fertility in animal studies was due to failure to mate, then for classification into Category 2, it would normally be necessary to have evidence on the mechanism of action in order to interpret whether any adverse effect such as alteration in pattern of hormonal release would be likely to occur in humans.

DEVELOPMENTAL TOXICITY

For classification into Category 2 there should be clear evidence of adverse effects in well conducted studies in one or more species. Since adverse effects in pregnancy or postnatally may result as a secondary consequence of maternal toxicity, reduced food or water intake, maternal stress, lack of maternal care, specific dietary deficiencies, poor animal husbandry, intercurrent infections, and so on, it is important that the effects observed should occur in well conducted studies and at dose levels which are not associated with marked maternal toxicity. The route of exposure is also important. In particular, the injection of irritant material intraperitoneally may result in local damage to the uterus and its contents, and the results of such studies must be interpreted with caution and on their own would not normally lead to classification.

Classification into Category 3 is based on similar criteria as for Category 2 but may be used where the experimental design has deficiencies which make the conclusions less convincing, or where the possibility that the effects may have been due to non-specific influences such as generalised toxicity cannot be excluded.

In general, classification in Category 3 or no category would be assigned on an ad hoc basis where the only effects recorded are small changes in the incidences of spontaneous defects, small changes in the proportions of common variants such as are observed in skeletal examinations, or small differences in postnatal developmental assessments.

Effects during lactation

Substances which are classified as toxic to reproduction and which also cause concern due to their effects on lactation should in addition be labelled with R64 (see criteria in Section 3.2.8.).

For the purpose of classification, toxic effects on offspring resulting only from exposure via the breast milk, or toxic effects resulting from direct exposure of children will not be regarded as ‘Toxic to reproduction’, unless such effects result in impaired development of the offspring.

Substances which are not classified as toxic to reproduction but which cause concern due to toxicity when transferred to the baby during the period of lactation should be labelled with R64 (see criteria in Section 3.2.8.). This R-phrase may also be appropriate for substances which affect the quantity or quality of the milk.

R64 would normally be assigned on the basis of:

(a)   toxicokinetic studies that would indicate the likelihood that the substance would be present in potentially toxic levels in breast milk; and/or

(b)   on the basis of results of one or two generation studies in animals which indicate the presence of adverse effects on the offspring due to transfer in the milk; and/or

(c)   on the basis of evidence in humans indicating a risk to babies during the lactational period.

Substances which are known to accumulate in the body and which subsequently may be released into milk during lactation may be labelled with R33 and R64.

4.2.4.              Procedure for the classification of preparations concerning specific effects on health