8 Amendments of Lena EK related to 2007/0121(COD)
Amendment 66 #
Proposal for a regulation – amending act
Article 3 - paragraph 2 - point (b)
Article 3 - paragraph 2 - point (b)
(b) hazard classes 3.1 other than category 5, 3.2 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
Amendment 90 #
Proposal for a regulation – amending act
Article 19 - paragraph 3
Article 19 - paragraph 3
3. The hazard pictogram relevant for each specific classification is set out in the tables indicating the label elements required for each hazard class in parts 2, 3 and 4 of Annex I.
Amendment 94 #
Proposal for a regulation – amending act
Article 23
Article 23
Where a substance or mixture is classified in accordance with part 5 of Annex I the following shall apply: (a) a hazard pictogram shall not be included on the label, (b) the signal words, hazard statements and precautionary statlabelling elements shall be placed in the supplemental information section as referred to in Article 27.
Amendment 145 #
Proposal for a regulation – amending act
Annex I - part 3.1. - paragraph 3.1.2.1. and table 3.1.1. - rows 1 and 2
Annex I - part 3.1. - paragraph 3.1.2.1. and table 3.1.1. - rows 1 and 2
3.1.2.1. Substances can be allocated to one of fourive toxicity categories based on acute toxicity by the oral, route and to one of four toxicity categories based on acute toxicity by the dermal or inhalation route according to the numeric criteria shown in Table 3.1.1 below. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). Explanatory notes are shown following Table 3.1.1. Table 3.1.1. Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories Exposure Category 1 Category 2 Category 3 Category 4 Route Oral (mg/kg Category 5 Route Oral (mg/kg 2000 < ATE < bodyweight) 5 < ATE < 50 < ATE < 300 < ATE < 5000 ATE < 5 50 5 300 3200 2000 See Note (a) 0 See Note (a) See Note (ca) Notes to Table 3.1.1: (ca) Criteria for Category 5 are intended to enable the identification of substances which are of relatively low acute toxicity hazard but which under certain circumstances may present a danger to vulnerable populations. These substances are anticipated to have an oral LD50 in the range of 2000-5000 mg/kg bodyweight. The specific criteria for Category 5 are: (i) The substance is classified in this Category if reliable evidence is already available that indicates the LD50 to be in the range of Category 5 values or other animal studies or toxic effects in humans indicate a concern for human health of an acute nature. (ii) The substance is classified in this Category, through extrapolation, estimation or measurement of data, if assignment to a more hazardous category is not warranted, and: - reliable information is available indicating significant toxic effects in humans; or - any mortality is observed when tested up to Category 4 values by the oral, inhalation or dermal routes; or - where expert judgement confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhoea, piloerection or an ungroomed appearance; or - where expert judgement confirms reliable information indicating the potential for significant acute effects from other animal studies. Recognising the need to protect animal welfare, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such a test would be of direct relevance for the protection of human health.
Amendment 147 #
Proposal for a regulation – amending act
Annex I - part 3.1. - paragraph 3.1.2.2.1a (new)
Annex I - part 3.1. - paragraph 3.1.2.2.1a (new)
3.1.2.2.1a. Category 5 is for chemicals which are of relatively low acute toxicity but which, under certain circumstances, may pose a hazard to vulnerable populations. Criteria for identifying substances in Category 5 are provided in addition to the table. These substances are anticipated to have an oral LD50 value in the range 2000 - 5000 mg/kg bodyweight. In light of animal welfare considerations, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such testing would be of direct relevance for the protection of human health.
Amendment 149 #
Proposal for a regulation – amending act
Annex I - part 3.1. - paragraph 3.1.3.6.2.3 - table 3.1.2. - row 2
Annex I - part 3.1. - paragraph 3.1.3.6.2.3 - table 3.1.2. - row 2
Table 3.1.2. Conversion from experimentally obtained acute toxicity range values (or acute toxicity hazard categories) to acute toxicity point estimates for classification for the respective routes of exposure Converted Acute Classification Category or experimentally Exposure routes Toxicity point estimate obtained acute toxicity range estimate (see Note 1) 0 < Category 1 ≤ 5 0.5 Oral 5 < Category 2 ≤ 50 5 (mg/kg bodyweight)Oral 50 < Category 3 ≤ 300 100 (mg/kg bodyweight) 300 < Category 4 ≤ 2000 500 2000 < Category 5 ≤ 5000 (see Note 1a) 2500 Note 1: These values are designed to be used in the calculation of the ATE for classification of a mixture based on its components and do not represent test results. Note 1a: Category 5 is for mixtures which are of relatively low acute toxicity but which under certain circumstances may pose a hazard to vulnerable populations. These mixtures are anticipated to have an oral LD50 value in the range of 2000-5000 mg/kg bodyweight. In light of animal welfare considerations, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such testing would be of direct relevance for the protection of human health.
Amendment 151 #
Proposal for a regulation – amending act
Annex I - paragraph 3.1.4.1. and table 3.1.3. - rows 1 to 4 and 8
Annex I - paragraph 3.1.4.1. and table 3.1.3. - rows 1 to 4 and 8
3.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.1.3. Specific considerations for labelling of substances and mixtures classified in Category 5 are given in Note 2a to the table. Table 3.1.3. Acute toxicity label elements Classification Category 1 Category 2 Category 3 Category 34 Category 45 No GHS Pictograms pictogram Signal word Danger Danger Danger Warning Warning Hazard H300:3: H300: H300: H301: H302: Hazard statement: May be Fatal if Fatal if Toxic if Harmful if Oral harmful if swallowed swallowed swallowed swallowed swallowed Precautionary P301 + P310 P301 + P310P301 + P310 P301 + P310 P301 + P310 P301 + P3102 statement P321 P321 P321 P301 + P312 P321 P321 P32130 response (oral) P330 P330 P330 P330 P330 P330 P330 (oral) Note 2a: The label elements for Category 5 in Table 3.1.3 shall be used for substances and mixtures available to the general public. Regarding substances and mixtures in Category 5 which are intended for professional users only, the supplier shall provide the information on classification to downstream users and distributors by means of the safety data sheet.
Amendment 154 #
Proposal for a regulation – amending act
Annex I - paragraph 5.1a (new)
Annex I - paragraph 5.1a (new)