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Classification by the conventional method as carcinogenic

13.—(1) Preparations shall be classified as carcinogenic category 1 or 2 and assigned the symbol “T” and the risk phrase R45 or R49 if they contain one or more substance producing such effects to which is assigned the risk phrase R45 or R49 which denotes carcinogenic substances in category 1 and category 2 in individual concentrations equal to or exceeding—

(a) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits.

(2) Preparations shall be classified as carcinogenic category 3 and assigned the symbol “Xn” and risk phrase R40 if they contain one or more substances producing such effects to which is assigned the risk phrase R40 which denotes carcinogenic substances in category 3 in individual concentrations equal to or exceeding—

(a) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits.

Classification by the conventional method as mutagenic

14.—(1) Preparations shall be classified as mutagenic category 1 or 2 and assigned the symbol “T” and risk phrase R46 if they contain one or more substances producing such effects to which is assigned the risk phrase R46 which denotes mutagenic substances in category 1 and category 2 in individual concentrations equal to or exceeding—

(a) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits.

(2) Preparations shall be classified as mutagenic category 3 and assigned the symbol “Xn” and risk phrase R68 if they contain one or more substances producing such effects to which is assigned the risk phrase R68 which denotes mutagenic substances in category 2 in individual concentrations equal to or exceeding—

(a) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits.

Classification by the conventional method as toxic for reproduction

15.—(1) Preparations shall be classified as toxic for reproduction category 1 or 2 and assigned the symbol “T” and risk phrase R60 (fertility) if they contain one or more substances producing such effects to which is assigned the risk phrase R60 which denotes substances toxic for reproduction of category 1 and category 2 in individual concentrations equal to or exceeding—

(a) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits.

(2) Preparations shall be classified as toxic for reproduction category 3 and assigned the symbol “Xn” and the risk phrase R62 (fertility) if they contain one or more substances producing such effects to which is assigned the risk phrase R62 which denotes substances toxic for reproduction in category 3 in individual concentrations equal to or exceeding—

(a) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits.

(3) Preparations shall be classified as toxic for reproduction category 1 or 2 and assigned the symbol “T” and risk phrase R61 (development) if they contain one or more substances producing such effects to which is assigned the risk phrase R61 which denotes substances toxic for reproduction of category 1 and category 2 in individual concentrations equal to or exceeding—

(a) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits.

(4) Preparations shall be classified as toxic for reproduction category 3 and assigned the symbol “Xn” and the risk phrase R63 (development) if they contain one or more substances producing such effects to which is assigned the risk phrase R63 which denotes substances toxic for reproduction in category 3 in individual concentrations equal to or exceeding—

(a) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table VI or Table VIA) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits.

Classification of preparations for environmental hazards

16.—(1) The environmental hazards of a preparation shall be assessed by one or more of the following methods—

(a) by the conventional method described in paragraphs 18 and 19 using concentration limits; or

(b) by the criteria referred to in the approved classification and labelling guide in relation to the preparation for an appropriate classification and label.

(2) Where the environmental hazards have been established by both methods, the results of the method referred to in sub-paragraph (1)(b) shall be used for classifying the preparation.

(3) Subject to sub-paragraph (4), for preparations of a known composition, with the exception of plant protection products, classified in accordance with the method set out in sub-paragraph (1)(b), a new assessment of the environmental hazards shall be performed either by the method set out in sub-paragraph (1)(a) or (1)(b) whenever—

(a) changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer which exceed the permitted variations set out in the following table—

(b) changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the definitions in Schedule 1, are introduced by the manufacturer.

(4) The revised assessment required by paragraph (3) shall not be required where there is a valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Use of concentration limits in classification for environmental effects

17.—(1) In accordance with paragraph 16(1)(a), the environmental hazards shall be assessed by the conventional method described in paragraphs 18 and 19 using concentration limits.

(2) Where the substances concerned are dangerous substances and are listed as dangerous substances in Table 3.2 of part 3 of Annex VI of the CLP Regulation and are assigned concentration limits necessary for the application of the method of assessment described below, these concentration limits shall be used.

(3) Where the substances concerned are dangerous substances and do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation as dangerous substances or appear there without the concentration limits necessary for the application of the method of evaluation described below, the concentration limits shall be assigned in accordance with Part III of this Schedule.

Conventional method for the evaluation of hazards to the aquatic environment

18.—(1) The following preparations shall be classified as dangerous for the environment and assigned the symbol “N”, the indication of danger “dangerous for the environment” and the risk phrases R50 and R53 (R50-R53)—

(a) preparations containing one or more substances classified as dangerous for the environment and to which is assigned risk phrases R50-R53 in individual concentrations equal to or greater than—

(i) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 1) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits;

(b) preparations containing more than one substance classified as dangerous for the environment and to which is assigned risk phrases R50-R53 in lower individual concentrations than the limits specified under paragraph (a) if—

   

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• where—

• P_{N. R 50-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R50-53 in the preparation,

• L_{N. R 50-53} is the limit R50-53 for each substance dangerous for the environment to which is assigned the risk phrases R50-53 expressed as a percentage by weight.

(2) The following preparations shall be classified as dangerous for the environment and assigned the symbol “N”, the indication of danger “dangerous for the environment” and risk phrases R51 and R53 (R51-R53) unless the preparation is already classified according to sub-paragraph (1)—

(a) preparations containing one or more substances classified as dangerous for the environment and to which is assigned risk phrases R50-R53 or R51-R53 in individual concentrations equal to or greater than—

(i) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 1) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits;

(b) preparations containing more than one substance classified as dangerous for the environment and to which is assigned risk phrases R50-R53 or R51-R53 in lower individual concentrations than the limits specified under paragraph (a) if—

   

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• where—

• P_{N. R 50-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R50-53 in the preparation,

• P_{N. R 51-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R51-53 in the preparation,

• L_{N. R 51-53} is the respective limit R51-53 for each substance dangerous for the environment to which is assigned the risk phrases R50-53 or R51-53 expressed as a percentage by weight.

(3) The following preparations shall be classified as dangerous for the environment and assigned the risk phrases R52 and R53 (R52-R53) unless the preparation is already classified according to sub-paragraph (1) or (2)—

(a) preparations containing one or more substances classified as dangerous for the environment and to which is assigned risk phrases R50-R53 or R51-R53 or R52-R53 in individual concentrations equal to or greater than—

(i) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 1) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits;

(b) preparations containing more than one substance classified as dangerous for the environment and to which is assigned risk phrases R50-R53 or R51-R53 or R52-R53 in lower individual concentrations than the limits specified under paragraph (a) if—

   

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• where—

• P_{N. R 50-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R50-53 in the preparation,

• P_{N. R 51-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R51-53 in the preparation,

• P_{R 52-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R52-53 in the preparation,

• L_{R 52-53} is the respective limit R52-53 for each substance dangerous for the environment to which is assigned the risk phrases R50-53, R51-53 or R52-53 expressed as a percentage by weight.

(4) The following preparations shall be classified as dangerous for the environment and assigned the symbol “N”, the indication of danger “dangerous for the environment” and the risk phrase R50 unless the preparation is already classified according to sub-paragraph (1)—

(a) preparations containing one or more substances classified as dangerous for the environment and assigned risk phrase R50 individual concentrations equal to or greater than—

(i) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 2) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits;

(b) preparations containing more than one substance classified as dangerous for the environment and to which is assigned risk phrase R50 in lower individual concentrations than the limits specified under paragraph (a) if—

   

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• where—

• P_{N. R 50} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrase R50 in the preparation,

• L_{N. R 50} is the limit R50 for each substance dangerous for the environment to which is assigned risk phrase R50 expressed as a percentage by weight.

  (c)

  preparations containing one or more substances classified as dangerous for the environment and to which is assigned risk phrase R50 not meeting the criteria under paragraph (a) or (b) and containing one or more substances classified as dangerous for the environment and to which is assigned risk phrases R50-R53 if—

   

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• where—

• P_{N. R 50} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrase R50 in the preparation,

• P_{N. R 50-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R50-53 in the preparation,

• L_{N. R 50} is the respective limit R50 for each substance dangerous for the environment to which is assigned risk phrases R50 or R50-53 expressed as a percentage by weight.

(5) The following preparations shall be classified as dangerous for the environment and assigned the risk phrase R52 unless the preparation is already classified according to sub-paragraph (1), (2), (3) or (4)—

(a) preparations containing one or more substances classified as dangerous for the environment and to which is assigned risk phrase R52 in individual concentrations equal to or greater than—

(i) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 3) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits;

(b) preparations containing more than one substance classified as dangerous for the environment and to which is assigned risk phrase R52 in lower individual concentrations than the limits specified under paragraph (a) if—

   

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• where—

• P_{R 52} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrase R52 in the preparation,

• L_{R 52} is the limit R52 for each substance dangerous for the environment to which is assigned risk phrase R52 expressed as a percentage by weight.

(6) The following preparations shall be classified as dangerous for the environment and assigned the risk phrase R53 unless the preparation is already classified according to sub-paragraph (1), (2) or (3)—

(a) preparations containing one or more substances classified as dangerous for the environment and assigned risk phrase R53 in individual concentrations equal to or greater than—

(i) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 4) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits;

(b) preparations containing more than one substance classified as dangerous for the environment and to which is assigned risk phrase R53 in lower individual concentrations than the limits specified under paragraph (a) if—

   

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• where—

• P_{R 53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrase R53 in the preparation,

• L_{R 53} is the limit R53 for each substance dangerous for the environment to which is assigned risk phrase R53 expressed as a percentage by weight.

  (c)

  preparations containing one or more substances classified as dangerous for the environment and to which is assigned risk phrase R53 not meeting the criteria under paragraph (b) and containing one or more substances classified as dangerous for the environment and to which is assigned risk phrases R50-R53, R51-R53 or R52-R53 if—

   

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• where—

• P_{R 53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrase R53 in the preparation,

• P_{N. R 50-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R50-53 in the preparation,

• P_{N. R 51-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R51-53 in the preparation,

• P_{R 52-53} is the percentage by weight of each substance dangerous for the environment to which is assigned risk phrases R52-53 in the preparation,

• L_{R 53} is the respective limit R53 for each substance dangerous for the environment to which is assigned risk phrases R53, R50-53, R51-53 or R52-53 expressed as a percentage by weight.

Conventional method for the evaluation of hazards to the ozone layer

19.  Preparations containing one or more substances classified as dangerous for the environment and to which is assigned the symbol “N” and the risk phrase R59 in individual concentrations equal to or greater than—

(i) either the concentration specified in Table 3.2 of part 3 of Annex VI of the CLP Regulation for the substance or substances under consideration, or

(ii) the concentration specified in Part III of this Schedule (Table 5) where the substance or substances do not appear in Table 3.2 of part 3 of Annex VI of the CLP Regulation or appear in it without concentration limits,

shall be classified as dangerous for the environment and assigned the symbol “N”, the indication of danger “dangerous for the environment” and the risk phrase R59.