I, BRIAN COWEN, Minister for Labour, 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 Directive 88/379/EEC of 7 June, 1988,⁽¹⁾ and Commission Directives 89/178/EEC of 22 February, 1989,⁽²⁾ 90/35/EEC of 19 December, 1989,⁽³⁾ 90/492/EEC of 5 September, 1990,⁽⁴⁾ 91/155/EEC of 5 March, 1991⁽⁵⁾ and 91/442/EEC of 23 July, 1991,⁽⁶⁾ hereby make the following Regulations:—

⁽¹⁾O.J. No. L187, 16.7.88 P.14

⁽²⁾O.J. No. L64, 8.3.89 P.18

⁽³⁾O.J. No. L19, 24.1.90 P.14

⁽⁴⁾O.J. No. L275, 5.10.90 P.35

⁽⁵⁾O.J. No. L76, 22.3.91 P.35

⁽⁶⁾O.J. No. L238, 27.8.91 P.25

1 Citation

1. These Regulations may be cited as the European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations, 1992.

2 Commencement

2. These Regulations shall come into operation on the 31st day of December, 1992.

3 Interpretation

3. (1) In these Regulations, unless the context otherwise requires,—

"environment", "placing on the market", "preparations" and "substances" have the same meanings as in article 2.1 of Council Directive 67/548/EEC, as amended;

"carcinogenic", "corrosive", "dangerous for the environment", "explosive", "extremely flammable", "flammable", "harmful", "highly flammable", "irritant", "mutagenic", "oxidising", "teratogenic", "toxic" and "very toxic" have the same meanings as in Article 2.2 of Council Directive 67/548/EEC, as amended;

"Annex 1 to Council Directive 67/548/EEC" means Annex I (inserted by Commission Directive No. 76/907/EEC of 14 July, 1976) to Council Directive 67/548/EEC, as amended or replaced from time to time;

"Annex II to Council Directive 67/548/EEC" (which is set out in Schedule 4 hereto) means Annex II (inserted by Commission Directive No. 83/467/EEC of 29 July, 1983) to Council Directive 67/548/EEC, as amended or replaced from time to time;

"Annex III to Council Directive 67/548/EEC" (which is set out in Schedule 5 hereto) means Annex III (inserted by Commission Directive No. 76/907/EEC of 14 July, 1976) to Council Directive 67/548/EEC, as amended or replaced from time to time;

"Annex IV to Council Directive 67/548/EEC" (which is set out in Schedule 6 hereto) means Annex IV (inserted by Commission Directive No. 76/907/EEC of 14 July, 1976) to Council Directive 67/548/EEC, as amended or replaced from time to time;

"Annex V to Council Directive 67/548/EEC" means Annex V (inserted by Commission Directive No. 84/449/EEC of 25 April, 1984) to Council Directive 67/548/EEC, as amended or replaced from time to time;

"Annex VI to Council Directive 67/548/EEC" means Annex VI (inserted by Council Directive No. 79/831/EEC of 18 September, 1979) to Council Directive 67/548/EEC, as amended or replaced from time to time;

"Annex IX to Council Directive 67/548/EEC" means Annex IX (inserted by Council Directive No. 79/831/EEC of 18 September, 1979) to Council Directive 67/548/EEC, as amended or replaced from time to time;

"Annex I to Council Directive 88/379/EEC" means Annex I to Council Directive 88/379/EEC of 7 June 1988 as amended or replaced from time to time;

"Annex II to Council Directive 88/379/EEC" (which is set out in Schedule 10 hereto) means Annex II to Council Directive 88/379/EEC of 7 June 1988, as amended or replaced from time to time;

"Annex to Commission Directive 91/155/EEC" means the Annex to Commission Directive 91/155/EEC of 5 March, 1991;

"Council Directive 67/548/EEC" means Council Directive 67/548/EEC of 27 June, 1967, as amended or replaced from time to time;

"Council Directive 79/831/EEC" means Council Directive 79/831/EEC of 18 September, 1979;

"Council Directive 88/379/EEC" means Council Directive 88/379/EEC of 7 June, 1988, as amended or replaced from time to time;

"Commission Directive 91/155/EEC" means Commission Directive 91/155/EEC of 5 March, 1991, as amended or replaced from time to time;

"Article 2.1 of Council Directive 67/548/EEC means Article 2.1 of Council Directive 67/548/EEC, as amended by Council Directive 79/831/EEC of 18 September, 1979;

"Article 2.2 of Council Directive 67/548/EEC" means Article 2.2 of Council Directive 67/548/EEC, as amended by Council Directive 79/831/EEC of 18 September, 1979;

"Article 8.2 of Council Directive 67/548/EEC" means Article 8.2 of Council Directive 67/548/EEC as amended by Council Directive 79/831/EEC of 18 September, 1979.

(2) In these Regulations, unless the context otherwise requires,—

"aerosol dispensers" has the same meaning as in the European Communities (Aerosol Dispensers) Regulations, 1977 ( S.I. No. 144 of 1977 );

"Authority" means the National Authority for Occupational Safety and Health;

"child-resistant fastening" means a cap, lid, fastening or other means of fastening a package, which complies with the provisions of Part A of Annex IX to Council Directive 67/548/EEC;

"classified" shall be construed—

( a ) in relation to a substance , as a dangerous substance in accordance with the provisions of Council Directive 67/548/EEC, or

( b ) in relation to a preparation, as a dangerous preparation in accordance with the provisions of Regulation 5

and "classification" shall be construed accordingly;

"dangerous preparation" means a preparation classified in accordance with Regulation 5 and where appropriate, Regulations 7 and 9;

"dangerous substance" shall have the same meaning as in Council Directive 67/548/EEC;

"established in the State" means resident and having a place of business in the State, and "this State" shall be construed accordingly;

"gas preparations" means preparations which are gaseous at a temperature of 0° celsius and a pressure of 1 bar absolute pressure;

"gas substance" means a substance which is gaseous at a temperature of 0° celsius and a pressure of 1 bar absolute pressure;

"indication of danger" means the indication of danger specified in Column 3 of the Table to Schedule 7 and required to be contained on the label or marked on the package of a dangerous preparation in accordance with Regulation 17 (d);

"Inspector" has the same meaning as in the Safety, Health and Welfare at Work Act, 1989 ;

"label" means the label required by Regulation 16 (1)(a) and containing the information required by Regulation 17;

"Minister" means the Minister for Labour;

"other State" means a Member State of the European communities other than this State;

"package" means the packaging, receptacle or container containing a preparation, and "packaging" shall be construed accordingly;

"person responsible for placing a preparation, to which these Regulations apply, on the market" means a person (whether a manufacturer, supplier, distributor, wholesaler or retailer established in the State) who places a preparation to which these Regulations apply on the market;

"risk phrase" means a phrase listed in Schedule 5 being an indication of a particular nature of risk created by a substance or preparation labelled with that phrase;

"safety phrase" means a phrase listed in Schedule 6 being an indication of safety precautions required to be taken when handling or using a substance or preparation labelled with that phrase;

"special labelling" means special information which, when required in accordance with the provisions of Annex II to Council Directive 88/379/EEC and Regulations 17 (g) and 25 and Schedule 10, is contained on the label or marked on the package of a preparation;

"symbol" means any symbol specified in Column 2 of the Table to Schedule 7 which, when required, is contained on the label or marked on the package in accordance with Regulation 17 (d);

"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 to which the provisions of Regulation 15 (3) apply, and which complies with the provisions of Part B of Annex IX to Council Directive 67/548/EEC.

(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.

(4) A word or expression that is used in these Regulations and is also used in Council Directive 88/379/EEC has, unless the contrary intention appears, the same meaning in these Regulations as it has in Council Directive 88/379/EEC.

4 Construction and Application

4. (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 dangerous preparations which are placed on the market, but do not apply to—

( a ) medical or veterinary products as defined by Council Directive 65/65/EEC;

( b ) cosmetic products as defined by Council Directive 76/768/EEC;

( c ) waste within the scope of Council Directive 75/442/EEC and Council Directive 78/319/EEC;

( d ) pesticides within the scope of Council Directive 78/631/EEC;

( e ) munitions and explosives to which Council Directive 88/379/EEC does not apply;

( f ) foodstuffs to which Council Directive 88/379/EEC does not apply;

( g ) animal feeding stuffs to which Council Directive 88/379/EEC does not apply;

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

( i ) preparations in transit which are under customs supervision provided they do not undergo any treatment or processing.

(3) Regulations 2 to 4, 14, 16 to 21 and 25 to 29 and Schedule 10 shall also apply to preparations, whether dangerous or not, which are contained in Annex II to Council Directive 88/379/EEC and Schedule 10 and are placed on the market.

(4) These Regulations shall apply without prejudice to and not in substitution for any other enactments or any instruments made under any enactments.

5 Determination of classification

5. (1) For the purpose of these Regulations, a dangerous preparation shall be classified as one or more of the following—

( a ) explosive,

( b ) oxidizing,

( c ) extremely flammable,

( d ) highly flammable,

( e ) flammable,

( f ) very toxic,

( g ) toxic,

( h ) harmful,

( i ) corrosive,

( j ) irritant,

( k ) dangerous for the environment,

( l ) carcinogenic,

( m ) teratogenic,

( n ) mutagenic.

(2) Subject to Regulation 6 (5), the classifications mentioned in subparagraphs (a) to (e) of paragraph (1) shall be—

( a ) within the meaning of the provisions of Council Directive 67/548/EEC and assigned the risk and safety phrases in accordance with those provisions, or

( b ) as assessed in accordance with the provisions of Regulation 6 (2) in the case of gas preparations, provided that the provisions contained in Chapter 9.1.1.1 of Annex VI to Council Directive 67/548/EEC relating to quantities apply.

(3) The classifications of a preparation mentioned in subparagraphs (f) to (j) of paragraph (1) shall be—

( a ) within the meaning of the provisions of Council Directive 67/548/EEC and assigned the risk and safety phrases in accordance with those provisions, or

( b ) as assessed in accordance with the provisions of—

(i) Regulation 7 (2), in the case of preparations which are not gas preparations, and

(ii) Regulation 7 (3) in the case of gas preparations.

(4) The classification mentioned in subparagraph (1) (k) shall be within the meaning of the provisions of Council Directive 67/548/EEC and assigned the risk and safety phrases in accordance with these provisions.

(5) The classifications mentioned in subparagraphs (1), (m) and (n) of paragraph (1) shall be as assessed in accordance with the provisions of—

(i) Part VII of Schedule 2 in the case of preparations which are not gas preparations, and

(ii) Part VII of Schedule 3 in the case of gas preparations.

(6) Notwithstanding any other provision of this Regulation, the provisions of Chapter 9 of Annex VI to Council Directive 67/548/EEC shall apply to the classification or classifications of a preparation in appropriate cases.

6 Classifications

6. (1) Subject to paragraphs (2) to (5), the physio-chemical properties for the determination of the classifications of preparations mentioned in Regulation 5 (2) (a) shall be determined according to the methods specified in Part A of Annex V to Council Directive 67/548/EEC.

(2) In the case of gas preparations manufactured in small quantities and for which it would not be reasonably practicable to comply with the provisions of paragraph (1), the determination of the highly flammable classification may be assessed in accordance with the methods specified in Part I of Schedule 1.

(3) In the case where none of the substances in a preparation is classified as explosive, oxidizing, extremely flammable, highly flammable or flammable and where, on the basis of information available to the manufacturer of the preparation, such preparation is unlikely to be so classified, the provisions of paragraphs (1) and (2) need not be complied with and the preparation shall not be so classified.

(4) Notwithstanding the provisions of paragraph (1), the classification of a preparation in the form of an aerosol as extremely flammable shall be in accordance with the provisions contained in the European Communities (Aerosol Dispensers) Regulations, 1977.

(5) In the case of a gas preparation, the determination of the oxidizing classification shall be assessed in accordance with the method specified in Part II of Schedule 1.

7 Determination of classifications

7. (1) Subject to paragraph (5) and Regulation 9, the properties for the determination of the classifications of a preparation mentioned in Regulation 5 (3) (a) shall be determined according to the methods specified in Part B of Annex V to Council Directive 67/548/EEC.

(2) Subject to paragraph (5) and Regulations 8 and 9 and notwithstanding the provisions of paragraph (1), the classifications of a preparation mentioned in Regulation 5 (3) (b) (i) shall be assessed in accordance with the provisions in Schedule 2 in the case of a preparation which is not a gas preparation.

(3) Subject to paragraph (5) and Regulations 8 and 9, and notwithstanding the provisions of paragraph (1), the classifications of a gas preparation mentioned in Regulation 5 (3) (b) (ii) shall be assessed in accordance with the provisions in Schedule 3.

(4) Where a property of a preparation has not been determined in accordance with the provisions of paragraph (1), the relevant classification of the preparation shall be assessed in accordance with the provisions of paragraph (2) or paragraph (3), as the case may be.

(5) Where a classification of a preparation has been determined in accordance with the provisions of paragraph (1) and has also been assessed in accordance with the provisions of paragraph (2) or (3), the classification shall be that resulting from the provisions of paragraph (1).

8 Potentiation and Antagonism

8. (1) Potentiation or a similar effect shall be taken into consideration in the classification of a preparation whose classification, assessed in accordance with the provisions of Regulations 5 (5), 7 (2), or 7 (3), would be underestimated because of such an effect.

(2) Antagonism or a similar effect shall be taken into consideration in the classification of a preparation whose classification, assessed in accordance with the provisions of Regulations 5 (5), 7 (2) or 7 (3), would be overestimated because of such an effect.

9 Variations in effect

9. Where there is adequate evidence to demonstrate that the effects on man differ from the determination or assessments arising out of Regulations 7 and 5 (5), the preparation shall be classified according to its effects on man.

10 Disregarding impurities, etc.

10. In the assessment and determination of the classifications of preparations in accordance with the provisions of Regulations 5 (5) and 7, no account shall be taken of substances present in the preparation, whether existing as impurities or as additives, if their concentration by weight in the preparation is less than—

( a ) 0.1% for substances classified as very toxic or toxic;

( b ) 1% for substances classified as harmful, corrosive or irritant;

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

11 Changes in concentration

11. (1) Subject to paragraph (2) and Regulation 12, the classification or classifications of a dangerous preparation, whose composition is known and which has been classified in accordance with the provisions of Regulation 7 (1), shall be redetermined in accordance with the provisions of Regulation 5 (5) or Regulation 7 or both whenever there is a change in the concentration or concentrations of the dangerous substance(s) in the preparation.

(2) The requirements of paragraph (1) shall not apply to a dangerous preparation where the change in the concentration of each dangerous substance is such that it is within the permitted variation specified in Column 2 of the Table to this Regulation, corresponding to the initial concentration range specified opposite thereto in Column 1 of that Table.

TABLE

1		2
Initial Concentration Range of dangerous substance		Permitted variation in the initial Concentration of the dangerous substance
	≤ 2.5%	± 15 %
>2.5	≤ 10%	± 10 %
> 10	≤ 25%	± 6 %
> 25	≤ 50%	± 5 %
> 50	≤ 100%	± 2.5%

12 Changes in Composition

12. The classification of a dangerous preparation whose composition is known and which has been classified in accordance with the provisions of Regulation 7 (1) shall, subject to Regulation 5 (5), be redetermined in accordance with the provisions of Regulation 5 (5) or Regulation 7 or both, whenever there is a change in the composition of the preparation involving the substitution or addition of one or more substances in the preparation, whether or not any such substance or substances is or are classified as dangerous.

13 Compliance with Regulations

13. (1) Dangerous preparations to which these Regulations apply shall comply with the provisions of these Regulations.

(2) Without prejudice to paragraph (1), preparations listed in Annex II to council directive 88/379/EEC shall comply with the provisions therein when placed on the market and, in addition in the case of such preparations which are not dangerous, shall also comply with the Regulation mentioned in Regulations 14, 16 to 20 and 25 to 28.

14 Data on Preparation

14. (1) The manufacturer of a preparation to which these Regulations apply or, if he is not within the State, the person responsible for placing such a preparation on the market, shall have available for inspection by an Inspector all the information used in the classification and labelling of the preparation being information obtained from determining the properties of the preparations in accordance with the provisions of Regulations 5 and 7.

(2) The information to be kept available for the purpose of paragraph (1) of this regulation shall be held by the manufacturer, or the person responsible for placing it on the market (as the case may be) for at least 5 years after the last time the preparation has been placed on the market.

15 Packaging

15. (1) A dangerous preparation 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 law;

( b ) the materials constituting the packaging and fastening are not susceptible to adverse attack by the contents or liable to form harmful or 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 fastened without the contents escaping;

( e ) containers, containing dangerous preparations and which are offered or sold to the general public, do not have—

(i) a shape or graphic decoration, or both, likely to attract or arouse the active curiosity of children or to mislead consumers, or

(ii) a presentation or a designation, or both, used for human and animal foodstuffs, medicinal or cosmetic products.

(2) ( a ) (i) Containers containing dangerous preparations which are listed in Part I of Schedule 8 and which are intended to be offered or sold to the general public shall not be placed on the market unless they are fitted with child-resistant fastenings;

(ii) such child-resistant fastenings shall be the only fastenings fitted to such containers.

( b ) the child-resistant fastenings required by subparagraph (a) shall comply with the specifications contained in Part A of Annex IX to Council Directive 67/548/EEC.

(3) ( a ) Containers containing dangerous preparations which are listed in Part II of Schedule 8 and which are intended to be offered or sold to the general public shall carry a tactile warning of danger.

( b ) The warning required by subparagraph (a) shall comply with the specifications contained in Part B of Annex IX to Council Directive 67/548/EEC.

16 Labels

16. (1) Subject to Regulation 29, a preparation to which these Regulations apply shall not be placed on the market unless—

( a ) its packaging is provided with a label, or

(i) the information required to be contained on the label in accordance with the provisions of Regulation 17 is clearly marked on the package containing the preparation, such that it can be read horizontally when the package is set down normally; and

(ii) the area of the surface of the package on which the information is marked in accordance with the preceding provision of this subparagraph complies with the provisions of subparagraph (3) in relation to the dimensions specified in Schedule 4, and

( b ) the colour and presentation of the label or the package containing such a preparation is such that any danger symbol or symbols required in accordance with the provisions of Regulations 17 (d) and 22 and its or their background stand out clearly from the label or package.

(2) Subject to Regulation 29—

( a ) the label shall be firmly affixed to one or more surfaces of the packaging and so affixed such that it can be read horizontally when the package is set down normally; and

( b ) the entire surface of the label shall adhere to the package containing the preparation.

(3) Subject to Regulations 27 and 29—

( a ) the dimensions of the label or the requirements of Regulation 16 (1) (a) (ii) (as the case may be) shall comply with the provisions of Schedule 4; and

( b ) the label or the area referred to in Regulation 16 (1) (a) (ii) (as the case may be) shall only be used to contain the information required by Regulation 17 and, if necessary, any supplementary health or safety information.

17 Information on Packages

17. Subject to Regulations 27 and 29, the following information shall be clearly and indelibly marked on packages containing preparations to which these Regulations apply, or on the labels (as the case may be) in the Irish and English languages or in the English language:

( a ) the trade name or description of the preparation;

( b ) the name, full address and telephone number of the person, established in the European Community, responsible for placing the preparation on the market;

( c ) the name of the substance or substances present in the preparation in accordance with the provisions of Regulations 19, 20 and 21;

( d ) the symbol or symbols if required, together with any corresponding indication of danger in accordance with the provisions of Regulation 22;

( e ) one or more risk phrases, when appropriate, in accordance with the provisions of Regulation 23;

( f ) one or more safety phrases in accordance with the provisions of Regulation 24;

( g ) special labelling, when appropriate, in accordance with Regulation 25;

( h ) the quantity, either by volume or by mass, of the preparation in the package, in the case of preparations intended for sale to the general public; and

( i ) the phrase 'Caution — this preparation contains a substance not yet fully tested' in the case of a preparation containing at least one substance, in a concentration equal to or in excess of 1% in the preparation, which bears the warning 'Caution — substance not yet fully tested' in accordance with Article 8.2 of Council Directive 67/548/EEC.

18 Prohibition of certain phrases etc.

18. The phrase "non toxic", "not harmful" or any other statement that the preparation is not dangerous, shall not be marked on the package or contained on the label of a preparation to which these Regulations apply.

19 Named Substances

19. (1) Subject to Regulations 20, 21 and 29 and to paragraphs (2) and (3), and in accordance with the requirements of Regulation 17 (c), the names of the following substances shall be marked on the package or contained on the label:—

( a ) in the case of a preparation assigned one or more of the risk phrases R39, R40, R42, R43, R42/43, and/or R48, each substance to which is assigned one or more of these risk phrases and which is responsible, in accordance with the provisions of Regulation 5 (3), for the preparation being assigned that risk phrase or those risk phrases;

( b ) in the case of a preparation assigned one or more of the risk phrases R40, R45, R46 and/or R47, each substance to which is assigned one or more of these risk phrases and which is responsible, in accordance with the provisions of Regulation 5 (5) for the preparation being assigned that risk phrase or those risk phrases; and

( c ) subject to paragraph (2) and Regulation 21—

(i) in the case of a preparation classified as very toxic, toxic or harmful, those substances, classified as very toxic, toxic or harmful, present in the preparation in a concentration in the preparation equal to or exceeding the lowest limit;

(ii) in the case of a preparation classified as corrosive, those substances, classified as corrosive, present in the preparation in a concentration equal to or exceeding the lowest limit.

(2) ( a ) Notwithstanding the provisions of subparagraph (1) (c) and subject to subparagraphs (1) (a), (1) (b) and (2) (b), a maximum of 4 names shall be sufficient to satisfy the requirements of paragraph (1) and Regulation 17 (c).

( b ) Subject to Regulations 21 and 29, the names of the substances to be marked on the package or contained in the label in accordance with the provisions of paragraph (1) and Regulation 17 (c) shall identify the substances present in the preparation primarily responsible for the major health hazards which have given rise to the classification of the preparation and the choice of the corresponding phrases referring to the risk or risks involved.

(3) The requirements of Regulation 17 (c) shall not apply to preparations to which the provisions of subparagraphs (a), (b) and (c) or any of them of paragraph (1) do not apply.

(4) ( a ) In paragraph (1), "lowest limit" means that concentration of a substance in a preparation which would, in accordance with the provisions of Schedule 2 or 3 (as the case may be) have the effect of the preparation being classified—

(i) harmful in the case of subparagraph (1) (c) (i), or

(ii) irritant in the case of subparagraph (1) (c) (ii).

( b ) In subparagraph (a) of paragraph (1), reference to a preparation assigned any of the risk phrases R39, R40 or R48 means a reference to that risk phrase incorporated in a combined risk phrase.

20 Chemical Names

20. Subject to Regulations 21 and 29, the name of each substance to be marked on the package or contained on the label in accordance with the requirements of Regulations 17 (c) and 19 shall be one of the designations listed for that substance in Annex I to Council Directive 67/548/EEC if it is contained therein, or an internationally recognised designation if it is not so contained.

21 Exemption on grounds of confidentiality

21. (1) Subject to the subsequent paragraphs of this Regulation and to Regulation 29 and notwithstanding their requirements, the provisions of Regulations 17 (c), 19 and 20 shall not apply, in the case of a dangerous substance present in a preparation where the name of that dangerous substance, marked on the package or contained on the label in accordance with the provisions of the said Regulations 17 (c), 19 and 20, would put at risk the confidential nature of the manufacturer's property, provided that—

( a ) the substance is classified as harmful;

( b ) the substance is not assigned any of the risk phrases referred to in subparagraphs 1 (a) and (b) of Regulation 19;

( c ) the manufacturer has demonstrated that the disclosure of the chemical identity of the substance would put at risk the confidential nature of his property; and

( d ) the manufacturer has marked on the package or on the label a name which identifies the most important functional groups, or an alternative name.

(2) Where a manufacturer has invoked the provisions of paragraph (1) he shall forthwith inform the Authority when the particular dangerous preparation is placed on the market for the first time in the State or elsewhere in the European Community, and shall provide the Authority with the reasons for the alleged reasons for confidentiality, together with all information relevant to the classification and labelling of the dangerous preparation, including—

(i) the name and full address (including telephone number) of the manufacturer and importer, if the preparation is manufactured outside the State,

(ii) the designation or trade name of the preparation, including any different names used in the other States,

(iii) the full composition of the preparation,

(iv) the classification or classifications, in accordance with the provisions of Regulations 5 and 7, of the preparation,

(v) the labelling, in accordance with the provisions of Regulations 17, 19, 20, 21, 22, 23, 24 and 25, of the preparation,

(vi) the precise identification of each substance for which the provisions of this Regulation are invoked and the name identifying its most important functional groups, or an alternative name if one is used,

(vii) the intended use of the preparation, and

(viii) the safety data sheet, in accordance with the provisions of Regulation 30 and Schedule 9, for the preparation.

(3) Where the Authority is of the opinion that the provisions of paragraph (1) do not apply in a particular case, it may serve a notice in writing on the manufacturer stating that it is of that opinion, and thereupon the provisions of paragraph (1) shall cease to apply in the case of that dangerous preparation.

(4) A person who is aggrieved by a notice under paragraph (3) may, within the period of 14 days beginning on the day on which the notice is served on him, appeal to a Judge of the district Court, in the District Court District in which the notice was served, against the notice and in determining the appeal the Judge may, if he is satisfied that it is reasonable to do so, confirm, vary or cancel the notice.

(5) A person who appeals under paragraph (4) shall at the same time notify the Authority of the appeal and the grounds for the appeal and the Authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal.

(6) Where an appeal under paragraph (4) is taken and the notice is not cancelled, the notice shall take effect on the day next following the day on which the notice is confirmed on appeal or the appeal is withdrawn.

(7) The authority may withdraw a notice under paragraph (3) at any time.

(8) For the purpose of the application of the provisions of paragraph (1), the Authority shall notify the Commission of the European Communities and the other Member States of the invocation of the provisions thereof and provide it with the information supplied to the Authority in accordance with the provisions of paragraph (2).

(9) Confidential information brought to the attention of the Authority in the application of the provisions of paragraphs (1) and (2) shall be treated in accordance with the provisions of Article 11.4 of Council Directive 67/548/EEC, as amended by Council Directive 79/831/EEC.

22 Danger Symbols etc.

22. (1) In accordance with the requirements of Regulation 17 (d) and subject to paragraph (2) and to Regulations 27 and 29, at least one danger symbol and its corresponding indication of danger shall be marked on the package of a dangerous preparation or contained in the label in accordance with the provisions of Schedule 7.

(2) Notwithstanding the requirements of paragraph (1), a danger symbol and indication of danger shall not be required to be marked on the package of a dangerous preparation or contained in the label in the case of a dangerous preparation classified only as flammable.

23 Risk Phrases

23. (1) In accordance with the requirements of Regulation 17 (e) and subject to paragraphs (2) and (3), and to Regulation 29, the risk phrase or phrases, assigned to a dangerous preparation in accordance with the provisions of Regulations 5 to 7 and Schedules 1 to 3, shall be marked on the package of the dangerous preparation or contained in the label in accordance with the following provisions:

( a ) the risk phrase or phrases shall be selected from Schedule 5;

( b ) not more than four risk phrases shall be marked, but more may be added if considered appropriate;

( c ) when two or three of the risk phrases assigned can be included in a combined risk phrase in accordance with the provisions of Schedule 5, the combined risk phrase shall be used and, for the purpose of subparagraph (b), shall be counted as one risk phrase;

( d ) the risk phrase or phrases to be marked on the package of the dangerous preparation or contained in the label shall be selected in accordance with the principles contained in Annex I to Council Directive 88/379/EEC and Annex VI to Council Directive 67/548/EEC;

( e ) the risk phrase or phrases to be marked on the package or contained in the label, shall indicate the special risk or risks arising from the use of the dangerous preparation;

( f ) in the case of a dangerous preparation having more than one classification, the risk phrases to be marked on the package or contained on the label shall cover all the principal hazards associated with the dangerous preparation;

( g ) in the case of a dangerous preparation classified only both as harmful and as irritant, risk phrases drawing attention to both its harmful and its irritant characteristics shall be marked on the package or contained on the label.

(2) Notwithstanding the requirements of paragraph (1), the risk phrases R11 and R12 shall not be required to be marked on the package of a dangerous preparation or contained on the label if to do so would involve repeating the provisions of Regulations 17 (d) and 22 (1).

(3) The requirements of paragraph (1) shall not apply to a dangerous preparation, the contents of the package of which do not exceed 125 ml,—

( a ) in the case of a dangerous preparation classified only as highly flammable, flammable, oxidizing, highly flammable and oxidizing, or flammable and oxidizing, or

( b ) in the case of a dangerous preparation classified only as irritant provided it is not assigned one of the risk phrases R42, R43 or R42/43.

24 Safety Phrases

24. (1) In accordance with the requirements of Regulation 17 (f) and subject to paragraphs (2) and (3) and to Regulations 26 and 29, the safety phrase or phrases shall be assigned to a dangerous preparation and marked on its package or contained on the label in accordance with the following provisions—

( a ) the safety phrase or phrases shall be selected from Schedule 6;

( b ) not more than four safety phrases shall be marked, but more may be added if considered appropriate;

( c ) when two or more safety phrases assigned to the dangerous preparation can be combined in a combined safety phrase in accordance with the provisions of Schedule 6, the combined safety phrase shall be used and, for the purposes of subparagraph (b), shall be counted as one safety phrase;

( d ) the safety phrase or phrases to be marked on the package or contained in the label shall be selected in accordance with the principles contained in Annex VI to Council Directive 67/548/EEC.

(2) The requirements of paragraph (1) shall not apply to a dangerous preparation, where it is physically impossible to mark the safety phrases on the package or contain them on the label; but in such a case the package shall be accompanied by a document containing such safety advice as would, but for the size of the package, have been marked on the package or contained in the label.

(3) Notwithstanding its provisions, the requirements of paragraph (1) shall not apply to a dangerous preparation, the contents of the package of which do not exceed 125 ml,—

( a ) in the case of a dangerous preparation classified only as highly flammable, flammable or oxidising or highly flammable and oxidising or flammable and oxidising, or

( b ) in the case of a dangerous preparation classified only as irritant provided it is not assigned one of the risk phrases R42, R43 or R42/43.

25 Special labelling provisions

25. In accordance with the requirements of Regulation 17 (g) and subject to Regulations 27 and 29, the safety phrases and the special labelling phrases contained in Annex II to Council Directive 88/379/EEC and Schedule 10 shall be marked on the package of a preparation or contained in the label in accordance with the provisions contained in Annex II to Council Directive 88/379/EEC and contained in Schedule 10.

26 Outer Packages

26. The requirements of those Regulations in relation to labelling shall be deemed to be satisfied if, in the case of an outer package containing one or more inner packages,—

( a ) the appropriate provisions and requirements of Regulations 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25 are complied with in relation to the inner packages; and

( b ) the outer package is labelled in accordance with—

(i) international rules on the transport of dangerous substances, or

(ii) the Dangerous Substances (Conveyance of Petroleum by Road) Regulations 1979 ( S.I. No. 314 of 1979 ), or the Dangerous Substances (Conveyance of Scheduled Substances by Road) (Trade or Business) Regulations, 1980 ( S.I. No. 235 of 1980 ).

27 Alternative labelling

27. Notwithstanding the provisions of Regulations 16 (3), 17 and 22, the requirements of these Regulations in relation to labelling shall be deemed to be satisfied if—

( a ) in the case of a single package, containing a preparation to which these Regulations apply, the package is labelled in accordance with—

(i) international rules on the transport of dangerous substances, or

( b ) the requirements of Regulation 17 (other than subparagraphs (d), (g), (h) and (i)) and Regulations 18, 19, 20, 21, 23 and 24 are complied with.

28 Definition for purposes of Regulations 26 and 27

28. (1) For the purpose of Regulations 26 and 27, "international rules on the transport of dangerous substances" means—

( 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 Goods by Rail, 1970;

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

( d ) IATA Dangerous Goods Regulations, published by the International Air Transport Association;

as amended.

(2) In any proceedings under these regulations, prima facie evidence of the terms of any of the following, namely the—

( 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 Goods by Rail, 1970,

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

( d ) IATA Dangerous Goods Regulations, published by the International Air Transport Association,

may be given by producing a document purporting to be a copy thereof.

(3) In any proceedings under these Regulations, prima facie evidence of any amendments of the Agreement referred to in subparagraph (a) of paragraph (2) of this Regulation, or the Regulations referred to in subparagraph (b) of paragraph (2) of this Regulation, or the code referred to in subparagraph (c) of paragraph (2) of this regulation, or the Regulations referred to in subparagraph (d) of paragraph (2) of this regulation may be given by the production of a document purporting to be a copy of such amendment.

29 Exemptions

29. (1) Notwithstanding the provisions of Regulations 16 to 25, the Authority may grant, at its discretion and subject to the provisions of Article 9 of Council Directive 88/379/EEC by certificate, subject to any conditions specified in the certificate, exemption from compliance with any or all of the requirements of those provisions where it is satisfied that compliance with these requirements is inappropriate or otherwise unsuitable in any case where the package containing a preparation to which these Regulations apply is too small or otherwise unsuitable for compliance with such a requirement.

(2) In the case of a preparation to which these Regulations apply which has not been classified as explosive, very toxic, or toxic and notwithstanding the provisions of Regulations 16 to 25, the authority may at its discretion and subject to the provisions of Article 9 of Council Directive 88/379/EEC by certificate grant, subject to any conditions specified in the certificate, exemption from any or all of the requirements of those provisions where it is satisfied that compliance with such a requirement is not necessary because of the small quantity contained in the package of the preparation, and because there is no reason to fear any danger to persons handling such a package of the preparation or to other persons from its handling.

(3) In any case of the application of paragraph (1) or (2), the Authority shall forthwith inform the Commission of the European Communities thereof.

(4) An exemption granted by the Authority under paragraph (1) or (2) may be revoked by the Authority at any time.

(5) Notwithstanding the provisions of Regulations 16 to 25, the provisions of Chapter 9 of Annex VI to Council Directive 67/548/EEC shall apply, in relation to any matter contained in any of those Regulations, to a preparation to which the provisions of that Chapter are appropriate.

(6) For the purposes of this Regulation, Article 9 of Council Directive 88/379/EEC shall mean Article 9 of Council Directive 88/379/EEC of 7 June, 1988.

30 Material Safety Data Sheets

30. (1) A person placing a dangerous preparation on the market shall have available, to provide when requested by any person, a safety data sheet giving information on the properties and hazards of the preparation and on safety advice on the handling, storage and use of the preparation.

(2) Without prejudice to the provisions of paragraph (1) and subject to paragraph (10), the person supplying the preparation shall provide the recipient with a safety data sheet referred to in paragraph (1) when that recipient is an industrial user of the preparation.

(3) Without prejudice to the provisions of paragraphs (1) and (2), the safety data sheet referred to in paragraph (1) shall, so far as is reasonably practicable, contain such information as will enable the industrial user to take the necessary measures to ensure, so far as is reasonably practicable, the protection of the health and safety of his employees at his place of work.

(4) Without prejudice to the provisions of paragraphs (1) to (3), a safety data sheet shall be in accordance with the provisions in Schedule 9.

(5) A safety data sheet referred to in paragraph (1) shall, in addition to the other requirements of this Regulation, have the name of the person responsible for providing it stated on it and shall contain the date on which it was published.

(6) The person responsible for providing a safety data sheet under paragraph (1) shall amend it when new information of a significant nature so requires, and the amended safety sheet shall comply with the requirements of paragraph (5).

(7) Whenever a safety data sheet is amended, the amended safety data sheet shall be provided to all persons to whom the previous safety data sheet had been provided in accordance with the provisions of paragraph (1) and to whom the relevant preparations had been supplied within a year prior to the date on which the amended safety data sheet was published.

(8) For the purposes of this Regulation and Schedule 9, a safety data sheet shall be in writing and shall contain such information as is required by this Regulation.

(9) ( a ) Notwithstanding any other provision of this Regulation or Schedule 9, the provisions relating to the contents of a safety data sheet specified in paragraph (6) and Schedule 9 shall not apply in the case of safety data sheets in existence prior to the commencement of these Regulations.

( b ) The provisions of subparagraph (a) shall cease to apply on the 30th day of June, 1993.

(10) The provisions of paragraph (2) shall not apply in the case where the dangerous preparation is offered or sold to the general public provided—

( a ) sufficient information to enable users to take the necessary measures as regards the protection of health and safety, is furnished, and

( b ) A 'Safety Data Sheet' is available when requested, in accordance with the provisions of paragraph (1).

(11) ( a ) For the purpose of this Regulation and Schedule 9, 'industrial user' means the person who (whether as an employer or self-employed person), uses the preparation in work carried on by way of trade or for the purposes of gain.

( b ) For the purposes of this Regulation, "employer" and "self-employed person" have the same meanings as in Section 2 (1) of the Safety, Health and Welfare at Work Act, 1989 .

31 Poison Information Centre

31. (1) The Minister, after consultation with the Minister for Health, may appoint a body (hereinafter referred to as "the poison centre") for the purposes of this Regulation.

(2) The poison centre shall have power to require the person responsible for placing a dangerous preparation to which these Regulations apply on the market to provide it with information relating to the preparation.

(3) The information to be provided in accordance with the provisions of paragraph (2) shall be such as will enable the poison centre to carry out the functions assigned to it in accordance with the provisions of paragraph (4) and shall include the chemical composition of the preparation, including confidential information in accordance with the provisions of Regulation 21.

(4) The poison centre may use the information obtained in accordance with the provisions of paragraph (2) only to provide medical information in the case of exposure or likely exposure of persons to the preparation, especially in emergencies, and such medical information may be provided to formulate preventative and curative measures in relation to exposure of persons to the preparation.

(5) The poison centre shall not divulge to anyone other than the Authority any information deemed to be confidential in accordance with Regulation 21.

(6) The person responsible for placing a preparation to which these Regulations apply on the market shall, when requested to do so by the poison centre, provide the centre with information relating to the preparation in accordance with the provisions of paragraph (3).

32 Restriction on sale

32. (1) Where the Authority is of opinion that a preparation, although satisfying the requirements of Council Directive 88/379/EEC, constitutes a hazard for man or the environment by reason of its classification, packaging or labelling, the Authority may, by notice in writing to the person who placed the preparation on the market, prohibit the sale of that preparation or subject its placing on the market to special conditions.

(2) A person who sells or offers for sale a preparation, the sale of which is prohibited by the Authority by virtue of paragraph (1) shall be guilty of an offence.

(3) Where the authority by virtue of paragraph (1) subjects the sale of any preparation to special conditions, a person who sells or offers for sale such preparation shall be guilty of an offence unless such preparation satisfies such special conditions.

33 Taking and detention of preparations

33. (1) An Inspector may, seize and retain, or seize, remove and retain any preparation which he believes is a preparation 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 preparation which has been seized under this Regulation—

( a ) require things specified in the notice to be done in relation to the preparation before it is released by an Inspector.

( b ) either—

(i) require the disposal of the preparation 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) indicate the Inspector's intention of disposing of the preparation at the expense of the owner,

such disposal to be, in either case, such as will prevent the preparation 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 preparation, the Inspector shall retain control of the preparation 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 the Inspector by whom the notice was given sell, move, dispose of or otherwise interfere with the preparation 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 preparation to which it relates to be disposed of or indicates an intention to dispose of such preparations 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 preparation to which the relevant notice under this Regulation relates is one to which these Regulations apply, and

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

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

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

( b ) Where an order made by the appropriate court under this paragraph requires the preparation to which it relates to be disposed of by an Inspector, the cost of such disposal shall be recoverable by the 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 preparation 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 amount 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 opinion during the hearing of the appeal that the estimated cost 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 cost 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.

34 Offences

34. Any person who contravenes Regulation 13, 14, 15, 16, 17, 18, 19 (1), 20, 21 (2), 22, 23 (1), 24 (1), 25, 30 (1) to (8), 31 (3) and (6), or 33 (3) shall be guilty of an offence.

35 Revocations

35. (1) The European Communities (Paints, etc.) (Classification, Packaging and Labelling) Regulations, 1980 to 1987, are hereby revoked.

(2) The European Communities (Dangerous Preparations) (Solvents) (Classification, Packaging and Labelling) Regulations, 1983 ( S.I. No. 189 of 1983 ), are hereby revoked.

(3) Notwithstanding the provisions of paragraphs (1) and (2), any preparation classified and labelled in accordance with the appropriate provisions of the Regulations mentioned in paragraphs (1) and (2) shall, in the period of one year after the commencement of these Regulations, be deemed to comply with the provisions of these Regulations.

36 Amendments to the Poisons Regulations 1982

36. (1) The provisions of paragraph (4) of Article 19 of the Poisons Regulations, 1982 ( S.I. No. 188 of 1982 ) are hereby revoked.

(2) The provisions of Articles 7, 10, 11 and 12 of the Poisons Regulations, 1982 ( S.I. No. 188 of 1982 ), shall not apply to any poison (within the meaning of the Poisons Regulations, 1982 ( S.I. No. 188 of 1982 )) where—

( a ) (i) it is a preparation to which these Regulations apply; or

(ii) it is a substance to which the European Communities (Dangerous Substances) (Classification, Packaging and Labelling) Regulations, 1979 ( S.I. No. 383 of 1979 ), as amended in cases where the amendments add or vary substances, apply; or

(iii) it is a substance to which the European Communities (Dangerous Substances) (Classification, Packaging, Labelling and Notification) Regulations, 1982 ( S.I. No. 258 of 1982 ), as amended in cases where the amendments add or vary substances apply: and

( b ) its packaging and labelling are in accordance with the provisions of the appropriate Regulations referred to in subparagraph (a).

SCHEDULE 1

Conventional Method of Assessment of Classification of Certain Gas Preparations due to Physio-Chemical Properties.

PART 1 — FLAMMABILITY

1. In the case of gas preparations produced to order in small amounts where it would not be reasonably practicable to comply with the provisions of Regulation 6(1), the flammability may, in accordance with the provisions of Regulation 6 (2), be assessed in accordance with the provisions of this Schedule.

2. Subject to paragraph 1, a gas preparation shall be classified as highly flammable and assigned the risk phrase R12 or R13, as appropriate, if it contains at least one gas substance, classified as highly flammable, and satisfies the provisions of subparagraph 9.1.1.1. of Chapter 9 of Annex VI to Council Directive 67/548/EEC.

PART II — OXIDIZING

1. A gas preparation shall be classified as oxidizing if it contains at least one gas substance, classified as oxidizing, in accordance with the provisions of subparagraph 9.1.1.2 of Chapter 9 of Annex VI to Council Directive 67/548/EEC.

2. A gas preparation classified as oxidizing in accordance with the provisions of paragraph 1 shall be assigned the risk phrase R8 in accordance with the provisions of subparagraph 9.1.1.2 of Chapter 9 of Annex VI to Council Directive 67/548/EEC.

SCHEDULE 2

Conventional Method of Assessment of Classification of Preparations, which are not gas preparations, due to health effects.

PART 1 — GENERAL

1. The methods by which a preparation is classified in accordance with the provisions of Regulations 5 (3) (b) (i) and 7 (2) shall be in accordance with the provisions of this Schedule.

2. A preparation classified in accordance with this Schedule shall have the risk phrases assigned to it in accordance with the provisions of this Schedule.

3. For the purposes of this Schedule, a reference to a substance contained in a preparation shall include a reference to a preparation which is a constituent of the first-mentioned preparation.

4. In the case of a preparation being assigned the risk phrase R42/43 in accordance with the provisions of both paragraph 5 of Part IV and paragraph 6 of Part VI, it shall be classified as harmful unless otherwise classified as very toxic or toxic.

5. For the purposes of this Schedule—

( a ) carcinogenic categories 1, 2 and 3, mutagenic categories 1, 2 and 3, and teratogenic categories 1 and 2 shall have the same meanings as in Chapter 4 of Annex VI to Council Directive 67/548/EEC.

( b ) a reference to a substance assigned a risk phrase shall mean—

(i) in the case of a substance which is a substance within the meaning of Regulation 3, the risk phrase assigned to it in accordance with the provisions of Council Directive 67/548/EEC;

(ii) in the case of a preparation (forming a constituent of another preparation), the risk phrase assigned to it in accordance with these Regulations.

( c ) a reference to a preparation assigned a risk phrase, being a preparation which is being assessed in accordance with this Schedule, shall mean the risk phrase assigned to it in accordance with the provisions of this Schedule.

6. For the purpose of this Schedule—

( a ) "appropriate limit" means the lowest concentration specified for a substance in Annex I to Council Directive 67/548/EEC which, if present in a preparation in a concentration equal to or exceeding this limit, would itself have the effect of that preparation being classified as—

(i) very toxic in accordance with the provisions of paragraph 1 of Part II, or

(ii) very toxic in accordance with the provisions of paragraph 2 of Part II, or

(iii) toxic in accordance with the provisions of paragraph 1 of Part III, or

(iv) toxic in accordance with the provisions of paragraph 2 of Part III, or

(v) toxic in accordance with the provisions of paragraph 3 of Part III, or

(vi) harmful in accordance with the provisions of paragraph 1 of Part IV, or

(vii) harmful in accordance with the provisions of paragraph 2 of Part IV, or

(viii) harmful in accordance with the provisions of paragraph 3 of Part IV, or

(ix) harmful in accordance with the provisions of paragraph 5 of Part IV, or

(x) corrosive in accordance with the provisions of paragraph 1 of Part V, or

(xi) corrosive in accordance with the provisions of paragraph 2 of Part V, or

(xii) irritant in accordance with the provisions of paragraph 1 of Part VI, or

(xiii) irritant in accordance with the provisions of paragraph 2 of Part VI, or

(xiv) irritant in accordance with the provisions of paragraph 3 of Part VI due to—

—the risk phrase R41 having been assigned to the substance or (as the case may be)

—one of the risk phrases R36, R36/37/38 having been assigned to the substance, or

(xv) irritant in accordance with the provisions of paragraph 4 of Part VI, or

(xvi) irritant in accordance with the provisions of paragraph 6 of Part VI, or

(xvii) carcinogenic in accordance with the provisions of paragraph 1 of Part VII, or

(xviii) suspect for humans, owing to its possible carcinogenic effects, in accordance with the provisions of paragraph 2 of Part VII, or

(xix) mutagenic in accordance with the provisions of paragraph 4 of Part VII, or

(xx) suspect for humans, owing to its possible mutagenic effects, in accordance with the provisions of paragraph 5 of Part VII,

(xxi) teratogenic in accordance with the provisions of paragraph 7 of Part VII, or

(xxii) having specific effects on health not further defined in accordance with the provisions of paragraph 9 of Part VII.

7. For the purposes of this Schedule, a reference to a Part is a reference to that Part of this Schedule unless it is indicated that reference to some other provision is intended.

8. For the purposes of this Schedule, a reference to a substance or a preparation assigned one or more of the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28, R36, R37 or R38 shall include a reference to a combination risk phrase (other than a combination risk phrase incorporating R39, R40 or R48) which has two or more of those risk phrases incorporated into it.

9. For the purposes of this Schedule, a reference to a substance or a preparation assigned any of the risk phrases R39, R40 (other than when assigned due to the substance's or preparation's possible carcinogenic or mutagenic effects) or R48 shall mean a reference to that risk phrase incorporated in a combined risk phrase.

10. For the purposes of this Schedule, a reference to concentration is a reference to a concentration expressed on a mass/mass basis.

PART II — VERY TOXIC CLASSIFICATION

1. (1) Subject to paragraph 3, a preparation shall be classified as being very toxic if—

( a ) it contains at least one very toxic substance, assigned one or more of the risk phrases R26, R27 or R28, in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 7% or

( b ) it contains more than one very toxic substance (as mentioned in subparagraph (a)), the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a), and the sum of their quotients satisfies the following equation—

/images/si393y92p0039.gif

where

(i) Σ means the sum of,

(ii) P_T+ is the concentration in the preparation of each very toxic substance, and

(iii) L_T+ is

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 7%.

(2) ( a ) In the case of its being classified very toxic in accordance with the provisions of subparagraphs (a) or (b) of subparagraph (1), the preparation shall be assigned the risk phrase which shall be appropriate to the substance or substances most responsible for the very toxic classification of the preparation.

( b ) For the purposes of subparagraph (a), the reference to the risk phrase shall include a combination risk phrase.

2. (1) A preparation shall be classified as being very toxic if it contains at least one very toxic substance assigned the risk phrase R39 in a concentration equal to or exceeding—

( a ) in the case of a substance which is contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 10%.

(2) In the case of its being classified very toxic in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R39 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.1 of Annex VI to Council Directive 67/548/EEC.

3. The provisions of paragraph 1 shall apply only in the case of a substance assigned a risk phrase mentioned in paragraph 1 when that risk phrase does not form part of a combined risk phrase with risk phrase R39.

PART III — TOXIC CLASSIFICATION

1. (1) Subject to Part II and to paragraph 4, a preparation shall be classified as being toxic if—

( a ) it contains at least one very toxic substance, assigned one or more of the risk phrases R26, R27 or R28, in a concentration—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in annex I to Council Directive 67/548/EEC or is therein but does not have the limit range specified, equal to or exceeding 1% but less than 7%; or

( b ) it contains at least one toxic substance, assigned one or more of the risk phrases R23, R24 or R25, in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 25%; or

( c ) It contains more than one substance classified as very toxic or toxic (as mentioned in subparagraphs (a) and ( b )), the concentration in the preparation of each of which does not satisfy the provisions of subparagraphs (a) or (b), and the sum of their quotients satisfies the following equation—

/images/si393y92p0041.gif

where—

(i) Σ means the sum of,

(ii) P_T+ is the concentration in the preparation of each very toxic substance, and

(iii) P_T is the concentration in the preparation of each toxic substance, and

(iv) L_T is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a very toxic substance which is not contained in Annex 1 to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%, or

(C) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 25%.

2. ( a ) In the case of its being classified toxic in accordance with the provisions of subparagraphs (a), (b) or (c) of subparagraph (1), the preparation shall, subject to subparagraph (3), be assigned the risk phrase which shall be appropriate to the substance or substances most responsible for the toxic classification of the preparation.

( b ) For the purposes of subparagraph (a), the reference to the risk phrase shall include a combination risk phrase.

(3) In the case of a risk phrase, in accordance with the provisions of subparagraph (2), being assigned to a preparation due to the presence in it of a very toxic substance, that risk phrase shall be appropriate to that substance, but as if that substance were classified as a toxic substance.

2. (1) A preparation shall be classified as being toxic if it contains at least one substance classified as very toxic or toxic and assigned the risk phrase R39 in a concentration—

( a ) in the case of a very toxic substance contained in Annex 1 to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

( b ) in the case of a toxic substance contained in Annex I to Council Directive 67/548/EEC, equal to or exceeding the appropriate limit specified therein for that substance, if it is so specified; or

( c ) in the case of a very toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit range specified, equal to or exceeding 1% but less than 10%; or

( d ) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 10%.

(2) In the case of its being classified toxic in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R39 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.2 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Part II and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a very toxic preparation which would be classified as toxic in accordance with the provisions of subparagraph (1).

3. (1) A preparation shall be classified as being toxic if it contains at least one toxic substance assigned the risk phrase R48 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 10%

(2) In the case of its being classified toxic in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R48 in a combined ask phrase to indicate route of administration or exposure in accordance with Chapter 3.2.2 of annex VI to Council Directive 67/548/EEC.

4. The provisions of paragraph 1 shall apply only in the case of a substance assigned a risk phrase mentioned in paragraph 1 where that risk phrase does not form part of a combined risk phrase with risk phrases R39 and R48.

PART IV

HARMFUL CLASSIFICATION

1. (1) Subject to Parts II and III and to paragraph 4, a preparation shall be classified as harmful if—

( a ) it contains at least one very toxic substance, assigned one or more of the risk phrases R26, R27, R28 or at least one toxic substance, assigned one or more of the risk phrases R23, R24 or R25 in a concentration—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified,—

(A) equal to or exceeding 0.1% but less than 1% in the case of a very toxic substance, or

(B) equal to or exceeding 3% but less than 25% in the case of a toxic substance; or

( b ) it contains at least one harmful substance assigned one or more of the risk phrases R20, R21 or R22 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 25%; or

( c ) it contains more than one substance classified as very toxic, toxic or harmful (as mentioned in subparagraphs (a) and (b)), the concentration in the preparation of each of which does not satisfy the provisions of subparagraphs (a) or (b), and the sum of their quotients satisfies the following equation—

/images/si393y92p0043.gif

where—

(i) Σ means the sum of,

(ii) P_T+ is the concentration in the preparation of each very toxic substance,

(iii) P_T is the concentration in the preparation of each toxic substance,

(iv) P_Xn is the concentration in the preparation of each substance, and

(v) L_Xn is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a very toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.1%, or

(C) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 3%, or

(D) in the case of a harmful substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 25%.

(2) ( a ) In the case of its being classified harmful in accordance with the provisions of subparagraphs (a), (b) or (c) of subparagraph (1), the preparation shall, subject to paragraph (3), be assigned the risk phrase which shall be appropriate to the substance or which shall be appropriate to the substance or substances most responsible for the harmful classification of the preparation.

( b ) For the purposes of subparagraph (a), the reference to the risk phrase shall include a combination risk phrase.

(3) In the case of a risk phrase being, in accordance with the provisions of subparagraph (2), assigned to a preparation due to the presence in it of a very toxic or toxic substance, the risk phrase shall be that appropriate to that substance but as if that substance were classified as a harmful substance.

2. (1) A preparation shall be classified as harmful if it contains at least one substance classified as very toxic or toxic and assigned the risk phrase R39 or harmful and assigned the risk phrase R40 (owing to non-lethal irreversible effects after a single dose, but not including carcinogenic, mutagenic or teratogenic effects) in a concentration—

( a ) in the case of a very toxic or toxic substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

( b ) in the case of a harmful substance contained in Annex I to Council Directive 67/548/EEC, equal to or exceeding the appropriate limit specified therein for that substance, if it is so specified; or

( c ) in the case of a very toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 0.1% but less than 1%;

( d ) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 1% but less than 10%; or

( e ) in the case of a harmful substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 10%.

(2) In the case of its being classified harmful in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R40 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.3 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Parts II and III and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a very toxic or toxic preparation which would be classified as harmful in accordance with the provisions of subparagraph (1).

3. (1) A preparation shall be classified as harmful if it contains at least one substance, classified as toxic or harmful and assigned the risk phrase R48, in a concentration—

( a ) in the case of a toxic substance contained in Annex I to Council directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

( c ) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit range specified, equal to or exceeding 1% but less than 10%; or

( d ) in the case of a harmful substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 10%

(2) In the case of its being classified harmful in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R48 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.3 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Parts II and III and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a preparation, classified as very toxic or toxic, which would be classified as harmful in accordance with the provisions of subparagraph (1).

4. The provisions of paragraph 1 shall apply only in the case of a substance assigned a risk phrase mentioned in paragraph 1 when that risk phrase does not form part of a combined risk phrase with risk phrases R39, R40 or R48.

5. Subject to the provisions of paragraph 6 a preparation shall be classified as harmful (unless otherwise classified as very toxic or toxic) if it contains at least one substance, assigned one of the risk phrases R42 or R42/43 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit specified therein for that substance, if it is so specified; or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.

6. ( a ) In the case of a preparation being classified very toxic or toxic in accordance with the provisions of Part II or Part III and satisfying the provisions of paragraph 5, the preparation shall be classified very toxic or toxic as appropriate.

( b ) Notwithstanding the provisions of subparagraph (a) a preparation shall be assigned the risk phrase R42 or R42/43 (as appropriate) if it satisfies the provisions of paragraph 5.

PART V

CORROSIVE CLASSIFICATION

1. A preparation shall be classified as corrosive and shall be assigned the risk phrase R35 if—

( a ) it contains at least one corrosive substance, assigned the risk phrase R35 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 10%; or

( b ) it contains more than one corrosive substance assigned the risk phrase R35, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a), and the sum of their quotients satisfies the following equation—

/images/si393y92p0046a.gif

where—

(i) Σ means the sum of,

(ii) P_{C, R35} is the concentration in the preparation of each corrosive substance assigned the risk phrase R35, and—

(iii) L_{C, R35} is

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 10%.

2. Subject to paragraph 1, a preparation shall be classified as corrosive and assigned the risk phrase R34 if—

( a ) it contains at least one corrosive substance assigned the risk phrase R35 or R34 in a concentration—

(i) in the case of a substance assigned the risk phrase R35 and contained in Annex I to Council Directive 67/548/EEC within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance assigned the risk phrase R34 and contained in Annex I to Council Directive 67/548/EEC, equal to or exceeding the appropriate limit specified therein for that substance, if it is so specified; or

(iii) in the case of a substance assigned the risk phrase R35 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified, equal to or exceeding 5% but less than 10%; or

(iv) in the case of a substance assigned the risk phrase R34 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, equal to or exceeding 10%; or

( b ) it contains more than one corrosive substance assigned the risk phrase R35 or R34, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (1), and the sum of their quotients satisfy the following equation—

/images/si393y92p0046b.gif

where—

(i) Σ means the sum of,

(ii) P_{C, R35} is the concentration in the preparation of each corrosive substance assigned the risk phrase R35,

(iii) P_{C, R34} is the concentration in the preparation of each corrosive substance assigned the risk phrase R34,

(iv) L_{C, R34} is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance assigned the risk phrase R35 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%, or

(C) in the case of a substance assigned the risk phrase R34 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 10%.

PART VI

IRRITANT CLASSIFICATION

1. Subject to Part V, a preparation shall be classified as irritant and assigned the risk phrase R38 if—

( a ) it contains at least one corrosive substance, assigned the risk phrase R34 or R35 in a concentration—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified,—

(A) equal to or exceeding 1% but less than 5% in the case of a substance assigned the risk phrase R35, or

(B) equal to or exceeding 5% but less than 10% in the case of a substance assigned the risk phrase R34; or

( b ) it contains at least one irritant substance assigned the risk phrase R38, in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 20%; or

( c ) it contains more than one substance classified as irritant (assigned the risk phrase R38) or corrosive, the concentration in the preparation of each of which does not satisfy the provisions of subparagraphs (a) or (b), and the sum of their quotients satisfies the following equation—

/images/si393y92p0047.gif

where—

(i) Σ means the sum of,

(ii) P_{C, R35} is the concentration in the preparation of each corrosive substance assigned the risk phrase R35,

(iii) P_{C, R34} is the concentration in the preparation of each corrosive substance assigned the risk phrase R34,

(iv) P_{Xi, R38} is the concentration in the preparation of each irritant substance assigned the risk phrase R38, and

(v) L_{Xi, R38} is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a corrosive substance assigned the risk phrase R35, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 1%, or

(C) in the case of a corrosive substance assigned the risk phrase R34, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%, or

(D) in the case of an irritant substance, assigned the risk phrase R38, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 20%.

2. Subject to Part V, a preparation shall be classified as irritant and shall be assigned the risk phrase R37 if—

( a ) it contains at least one irritant substance assigned the risk phrase R37 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit specified, 20%; or

( b ) it contains more than one irritant substance assigned the risk phrase R37, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a), and the sum of their quotients satisfies the following equation—

/images/si393y92p0048.gif

where—

(i) Σ means the sum of,

(ii) P_{Xi, R37} is the concentration in the preparation of each irritant substance assigned the risk phrase R37,

(iii) L_{Xi, R37} is:

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 20%.

3. Subject to Part V, a preparation shall be classified as irritant and shall be assigned the risk phrase R36 if—

( a ) it contains at least one irritant substance assigned the risk phrase R36 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit specified, 20%; or

( b ) it contains at least one irritant substance assigned the risk phrase R41 in a concentration in the preparation—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) equal to or exceeding 5% but less than 10% in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit range specified; or

( c ) it contains more than one substance classified as irritant and assigned the risk phrases R36 or R41, the concentration in the preparation of each of which does not satisfy the provisions of subparagraphs (a) or (b), and the sum of their quotients satisfies the following equation—

/images/si393y92p0049.gif

where—

(i) Σ means the sum of,

(ii) P_{Xi, R41} is the concentration in the preparation of each irritant substance assigned the risk phrase R36,

(iii) P_{Xi, R36} is the concentration in the preparation of each irritant substance assigned the risk phrase R36, and

(iv) L_{Xi, R36} is:

(A) in the case of an irritant substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of an irritant substance assigned the risk phrase R41, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%, or

(C) in the case of an irritant substance, assigned the risk phrase R36, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 20%.

4. Subject to the provisions of Part V, a preparation shall be classified as irritant and assigned the risk phrase R41 if—

( a ) it contains at least one irritant substance assigned the risk phrase R41 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained there in but does not have the limit specified, 10%; or

( b ) it contains more than one irritant substance assigned the risk phrase R41, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a), and the sum of their quotients satisfies the equation—

/images/si393y92p0050.gif

where—

(i) Σ means the sum of,

(ii) P_{Xi, R41} is the concentration in the preparation of each irritant substance assigned the risk phrase R41, and—

(iii) L_{Xi, R41} is

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

5. Subject to the provisions of paragraph 6, a preparation shall be classified as irritant and assigned the risk phrase R43 if it contains at least one substance, assigned the risk phrase R43, in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit specified, 1%.

6. ( a ) In the case of a preparation being classified corrosive in accordance with the provision of Part V, the preparation shall be classified as corrosive.

( b ) Notwithstanding the provisions of subparagraph (a), a preparation shall be assigned the risk phrase R43 if it satisfies the provisions of paragraph 5.

PART VII

CARCINOGENIC/MUTAGENIC/TERATOGENIC

1. A preparation shall be classified as carcinogenic and assigned the risk phrase R45 if it contains at least one substance assigned the risk phrase R45 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.1%

2. A preparation shall be classified as suspect for humans owing to its possible carcinogenic effects and shall be assigned the risk phrase R40 if it contains at least one substance assigned the risk phrase R40 (due to the suspicion for humans owing to the possible carcinogenic effects of the substance), in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.

3. (1) A preparation classified as carcinogenic in accordance with the provisions of paragraph 1 shall be assigned the 'toxic' symbol and 'toxic' indication of danger unless the preparation is otherwise classified as very toxic.

(2) A preparation classified as suspect for humans owing to its possible carcinogenic effects in accordance with provisions of paragraph 2 shall be assigned the 'harmful' symbol and 'harmful' indication of danger unless the preparation is otherwise classified as very toxic or toxic.

4. A preparation shall be classified as mutagenic and assigned the risk phrase R46 if it contains at least one substance, assigned the risk phrase R46 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.1%.

5. A preparation shall be classified as suspect for humans owing to its possible mutagenic effects and shall be assigned the risk phrase R40 if it contains at least one substance, classified as mutagenic category 3 and assigned the risk phrase R40 (due to the suspicion for humans owing to the possible mutagenic effects of the substance), in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.

6. (1) A preparation classified as mutagenic, in accordance with the provisions of paragraph 4, shall be—

( a ) assigned the 'toxic' symbol and 'toxic' indication of danger in the case of a preparation classified as mutagenic due to the presence in it of a substance classified as mutagenic category I, unless the preparation is otherwise classified as very toxic; or

( b ) assigned the 'harmful' symbol and 'harmful' indication of danger in the case of a preparation classified as mutagenic due to the presence in it of a substance classified as mutagenic category 2, unless the preparation is otherwise classified as very toxic or toxic.

(2) A preparation classified as suspect for humans owing to its possible mutagenic effects in accordance with the provisions of paragraph 5 shall be assigned the 'harmful' symbol and 'harmful' indication of danger unless the preparation is otherwise classified as very toxic or toxic.

7. (1) A preparation shall be classified as teratogenic and assigned the risk phrase R47 if it contains at least one substance classified as teratogenic category I and assigned the risk phrase R47 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.5%.

(2) A preparation classified as teratogenic in accordance with the provisions of subparagraph (1) shall be assigned the 'toxic' symbol and 'toxic' indication of danger unless the preparation is otherwise classified as very toxic.

8. (1) A preparation shall be classified as teratogenic and assigned the risk phrase R47 if it contains at least one substance classified as teratogenic category 2 and assigned the risk phrase R47 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 5%.

(2) A preparation classified as teratogenic, in accordance with the provisions of subparagraph (1) shall be assigned the 'harmful' symbol and 'harmful' indication of danger unless the preparation is otherwise classified as very toxic or toxic.

SCHEDULE 3

Conventional Method of Assessment of Classification of Gas Preparations, due to Health effects.

PART I — GENERAL

1. The methods by which a preparation is classified in accordance with the provisions of Regulations 5 (3) (b) (ii) and 7 (3) shall be in accordance with the provisions of this Schedule.

2. A preparation classified in accordance with this Schedule shall have the risk phrases assigned to it in accordance with the provisions of this Schedule.

3. For the purposes of this Schedule, a reference to a substance contained in a preparation shall include a reference to a preparation which is a constituent of the first-mentioned preparation.

5. For the purposes of this Schedule—

( a ) carcinogenic categories 1, 2 and 3, mutagenic categories 1, 2 and 3, and teratogenic categories I and 2 shall have the same meanings as in Chapter 4 of Annex VI to Council Directive 67/548/EEC;

( b ) a reference to a substance assigned a risk phrase shall mean—

(i) in the case of a substance which is a substance within the meaning of Regulation 3, the risk phrase assigned to it in accordance with the provisions of Council Directive 67/548/EEC;

(ii) in the case of a preparation (forming a constituent of another preparation), the risk phrase assigned to it in accordance with these Regulations.

( c ) A reference to a preparation assigned a risk phrase, which preparation is being assessed in accordance with this Schedule, shall mean that risk phrase assigned to it in accordance with the provisions of this Schedule.