Activities of Carl SCHLYTER related to 2007/0121(COD)
Plenary speeches (2)
Classification, labelling and packaging of substances and mixtures - Classification, labelling and packaging of substances and mixtures (amendment of Directives 76/768/EEC, 88/378/EEC, 1999/13/EC, 2000/53/EC, 2002/96/EC and 2004/42/EC) - Classification, labelling and packaging of substances and mixtures (amendment of Regulation (EC) No 648/2004) (debate)
Classification, labelling and packaging of substances and mixtures - Classification, labelling and packaging of substances and mixtures (amendment of Directives 76/768/EEC, 88/378/EEC, 1999/13/EC, 2000/53/EC, 2002/96/EC and 2004/42/EC) - Classification, labelling and packaging of substances and mixtures (amendment of Regulation (EC) No 648/2004) (debate)
Amendments (30)
Amendment 45 #
Proposal for a regulation – amending act
Recital 8
Recital 8
(8) Therefore it is essential to harmonise the provisions for the classification and labelling of substances and mixtures within the Community, taking into full account the classification criteria and labelling rules of the GHS, but also by building on the 40 years of experience obtained through implementation of existing Community chemicals legislation and maintaining the level of protection achieved through the system of harmonisation of classification and labelling, through Community hazard classes not yet part of the GHS as well as through current labelling and packaging rules.
Amendment 50 #
Proposal for a regulation – amending act
Recital 24 a (new)
Recital 24 a (new)
(24a) When conducting or overseeing validation studies to assess non-animal tests, or methods that reduce the number of animals used or the suffering experienced by test animals, account should be taken of the need to classify and label substances according to this Regulation and legislation implementing the GHS.
Amendment 51 #
Proposal for a regulation – amending act
Recital 24 b (new)
Recital 24 b (new)
(24b) In the event that non-animal tests, or animal tests that have been refined to reduce the number of animals used or the suffering experienced by test animals, generate data that are not directly compatible with certain classification and labelling criteria under this Regulation, but in all respects satisfy the requirements of scientific validation for the purpose of protection of human health and the environment, this Regulation should be adapted, where there is adequate scientific justification, to ensure that classification and labelling criteria do not become a barrier to use of such test methods.
Amendment 57 #
Proposal for a regulation – amending act
Recital 37
Recital 37
(37) It is essential that the substances and mixtures placed on the market be well identified,; however, the Agency should allow enterprises, where necessary, to describe the chemical identity of certain substances in a way that does not put the confidential nature of their businesses at risk.
Amendment 67 #
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 73 #
Proposal for a regulation – amending act
Article 7 - paragraph 2 a (new)
Article 7 - paragraph 2 a (new)
2a. Validation studies to assess non- animal tests, or methods that reduce the number of animals used or the suffering experienced by test animals, shall be designed to ensure that new test methods take account of the requirements contained in this Regulation and similar legislation implementing the Globally Harmonised System of Classification and Labelling of Chemicals in other jurisdictions so that classification and labelling requirements do not become a barrier to the replacement, reduction and refinement of animal testing.
Amendment 74 #
Proposal for a regulation – amending act
Article 7 - paragraph 2 b (new)
Article 7 - paragraph 2 b (new)
2b. Where there is sufficient scientific justification, and in order to minimise animal testing, the Commission shall adapt this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 54(3) to ensure that classification and labelling requirements do not become a barrier to the use of test methods that replace, reduce or refine animal testing.
Amendment 82 #
Proposal for a regulation – amending act
Article 14 - paragraph 1
Article 14 - paragraph 1
1. The classification of a mixture shall not be affected where the evaluation of the information indicates any of the following: (a) that the substances in the mixture react slowly with atmospheric gases, in particular oxygen, carbon dioxide, water vapour, to form different substances; (b) that the substances in the mixture react very slowly with other substances in the mixture to form different substances; (c) that the substances in the mixture may self-polymerize to form oligomers or polymers.
Amendment 86 #
Proposal for a regulation – amending act
Article 17 - paragraph 1 - points (d) to (h)
Article 17 - paragraph 1 - points (d) to (h)
(d) where appropriate, hazard pictograms in accordance with Article 19; (e) where appropriate, signal words in accordance with Article 20; (f) where appropriate, hazard statements in accordance with Article 21; (g) where appropriate, precautionary statements in accordance with Article 22; (h) where appropriate, a section for supplemental information in accordance with Article 27.
Amendment 91 #
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 93 #
Proposal for a regulation – amending act
Article 21 - paragraph 1
Article 21 - paragraph 1
1. The label shall include the relevant hazard statements describing the nature of the hazards of a hazardous substance or mixture, including, where appropriatlicable, the degree of hazard.
Amendment 95 #
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 99 #
Proposal for a regulation – amending act
Article 26 - paragraph 1 a (new)
Article 26 - paragraph 1 a (new)
1a. Paragraph 1 shall not apply to substances that have been identified as meeting the criteria referred to in Article 57 of Regulation (EC) No 1907/2006.
Amendment 104 #
Proposal for a regulation – amending act
Article 30 - paragraph 2 - subparagraph 1
Article 30 - paragraph 2 - subparagraph 1
2. Where the substance or mixture is sold to the general public, one precautionary statement addressing the disposal of that substance or mixture shall appear on the label, where appropriate.
Amendment 105 #
Proposal for a regulation – amending act
Article 31 - paragraph 1
Article 31 - paragraph 1
Amendment 111 #
Proposal for a regulation – amending act
Article 31 - paragraph 2 - point (a)
Article 31 - paragraph 2 - point (a)
(a) where the packaging is either too small or otherwise unsuitable for affixing the label, the conditions for applying the label elements onto a separate sheet that accompanies the packaging;
Amendment 112 #
Proposal for a regulation – amending act
Article 31 - paragraph 2 - point (b)
Article 31 - paragraph 2 - point (b)
Amendment 115 #
Proposal for a regulation – amending act
Article 32
Article 32
Packaging destined for the general public on which it is physically impossible to apply a label in accordance with Article 34, shall be exempted from the obligation to bear a label, provided that such packaging is accompanied by precise and clear instructions for use, including, where appropriate, instructions for its disposal, and provided that it contains substances or mixtures classified in accordance with the following hazard classes and categories in Annex I: (a) Section 3.1, acute toxicity category 1, 2 or 3; (b) Section 3.2, skin corrosion category 1; (c) Section 3.8, specific target organ toxicity (STOT) – single exposure category 1; (d) Section 3.9, specific target organ toxicity (STOT) – repeated exposure category 1a separate datasheet with the labelling information and precise and clear instructions for use, including, where relevant, instructions for its disposal.
Amendment 128 #
Proposal for a regulation – amending act
Article 41 - paragraph 1 - point (c a) (new)
Article 41 - paragraph 1 - point (c a) (new)
(ca) where the classification is different from the classification already included in the classification and labelling inventory, the reasons for it;
Amendment 130 #
Proposal for a regulation – amending act
Article 43 - paragraph 3 – introductory part
Article 43 - paragraph 3 – introductory part
3. In addition to the information referred to in paragraph 1, the Agency shall, where appropriatlicable, include the following information in each entry:
Amendment 135 #
Proposal for a regulation – amending act
Article 49 - paragraph 1 - subparagraph 1
Article 49 - paragraph 1 - subparagraph 1
1. Any supplier of a substance or mixture shall assemble and keep available all the information required for the purposes of classification and labelling under this Regulation for a period of at least 130 years after he last supplied the substance or the mixture.
Amendment 138 #
Proposal for a regulation – amending act
Article 53
Article 53
The Commission may adjust and adapt Articles 12, 14, 23, 27 to 320 and 37 (2) second and third subparagraph and Annexes I to VII to technical progress. Those measures, designed to amend non- essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54 (3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 54 (4).
Amendment 139 #
Proposal for a regulation – amending act
Article 53 - paragraph 1 a (new)
Article 53 - paragraph 1 a (new)
The Commission shall adapt Annexes I to VII, where relevant, to incorporate the hazard class persistence, bioaccumulation and toxicity, the hazard class very persistent and very bioaccumulative, and acute toxicity hazard category 5 by ...*. Those measures, designed to amend non- essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54 (3). * Twelve months after entry into force of this Regulation.
Amendment 141 #
Proposal for a regulation – amending act
Article 58
Article 58
1. Until 1 December 2010, substances shall be classified, labelled and packaged in accordance with Directive 67/548/EEC. Until 1 JuneDecember 20153, mixtures shall be classified, labelled and packaged in accordance with Directive 1999/45/EC. 2. By way of derogation from Article 60 and from paragraph 1 of this Article, the substances and mixtures classified in accordance with paragraph 1 may, as regards the period before 1 December 2010 and 1 JuneDecember 20153 respectively, be classified and labelled in accordance with this Regulation. In that case, the provisions on labelling in Directives 67/548/EEC and 1999/45/EC shall not apply. 3. From 1 December 2010 until 1 JuneDecember 20153, substances shall be classified in accordance with both Directive 67/548/EEC and this Regulation. They shall be labelled and packaged in accordance with this Regulation. 4. Substances and mixtures that have been classified and placed on the market before 1 December 2010 and 1 JuneDecember 20153 respectively shall not be required to be labelled and packaged in accordance with this Regulation.
Amendment 143 #
Proposal for a regulation – amending act
Article 60 - paragraph 2
Article 60 - paragraph 2
Titles II, III and IV shall apply in respect of substances from 1 December 2010 and in respect of mixtures from 1 June 2015 December 2013. Or. en (Linked to the amendment by the same author to Article 58)
Amendment 146 #
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 Table 3.1.1 below. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). Explanatory notes are 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 Category 5 Route Oral (mg/kg 2000 < ATE < bodyweight) 5 < ATE < 50 < ATE < 300 < ATE < 5000 ATE < 5 50 5 300 300 2000 See Note (a) 2000 See Note (a) See Note (ca) Note: (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 148 #
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 150 #
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 5 < Category 2 ≤ 50 5 Oral 5 50 < Category 23 ≤ 5300 100 5 (mg/kg bodyweight) 5 300 < Category 34 ≤ 32000 1500 32000 < Category 45 ≤ 25000 (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 152 #
Proposal for a regulation – amending act
Annex I - paragraph 3.1.4.1. - table 3.1.3. - rows 1 to 4 and 8
Annex I - paragraph 3.1.4.1. - table 3.1.3. - rows 1 to 4 and 8
Table 3.1.3. Acute toxicity label elements Category 5 Classification Category 1 Category 2 Category 3 Category 4 GHS Pictograms (see Note 2a) No GHS Pictograms pictogram Signal word Danger Danger Danger Warning Hazard H300:Warning Warning H303: H300: H300: H301: H302: Hazard statement: Fatal if May be Fatal if Fatal if Toxic if Harmful if Oral harmful if swallowed swallowed swallowed swallowed swallowed Precautionary P301 + P310 P301 + P310 P301 + P310 statement P301 + P312 statement P321 P321 P321 P321 response P312 P330 response (oral) P330 P330 P330 (oral) P330 P330 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 155 #
Proposal for a regulation – amending act
Annex I - paragraph 5.1a (new)
Annex I - paragraph 5.1a (new)