22 Amendments of Amalia SARTORI related to 2008/0018(COD)
Amendment 31 #
Proposal for a directive
Recital 16 a (new)
Recital 16 a (new)
(16a) In order to avoid any duplication of evaluation under this Directive and Regulation (EC) No 1907/2006 concerning REACH, CMRs which have previously been evaluated and which have not been prohibited under this Directive should not be made subject to proposals for restriction under Regulation (EC) No 1907/2006 on the grounds of risks to human health and should be not be made subject to authorisation under Regulation (EC) No 1907/2006 on the grounds of risks to human health in accordance with Article 58(2) of that Regulation. Consequently, in order to avoid any duplication, CMRs which have been evaluated for use in toys and which have not been prohibited under Regulation (EC) No 1907/2006 should not be made subject to any restrictions or evaluations under this Directive.
Amendment 36 #
Proposal for a directive
Recital 16 b (new)
Recital 16 b (new)
(16b) It is necessary to apply a harmonised transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of three years after the entry into force of this Directive in all Member States to allow toy manufacturers and economic operators sufficient time to adapt to the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the European Union.
Amendment 38 #
Proposal for a directive
Recital 32
Recital 32
(32) In particular power should be conferred on the Commission in order to adapt the chemical requirements in certain well defined cases and grant exemptions from the prohibition of CMR substances in certain cases as well as to adapt the wording of the specific warnings for certain categories of toys. Since those measures are of general scope and are designed to amend non-essential elements of this Directive and/or to supplement this Directive by the addition of new non- essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 43 #
Proposal for a directive
Article 45 – Paragraph 1
Article 45 – Paragraph 1
1. The Commission may, for the purposes of adapting them to technical and, scientific practicable developments, amend the following: (a) Points 7 and 8 in Part III of Annex II; (b) Annex V. Those measures, designed to amend non- essential elements of this RegulationDirective, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 46(2) and, as appropriate, after the opinion of the relevant Scientific Committee.
Amendment 45 #
Proposal for a directive
Article 45 – Paragraph 2
Article 45 – Paragraph 2
2. The Commission may decide upon the use in toyscontent of substances or preparations classified as carcinogenic, mutagenic or toxic to reproduction, of category 1, 2 and 3, under Annex I to Directive 67/548/EEC in toys. Those measures, designed to amend non- essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 46(2) and, as appropriate, after the opinion of the relevant Scientific Committee.
Amendment 50 #
Proposal for a directive
Article 52
Article 52
Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or at the latest 2 years after this Directive entered into forcefor two years after this Directive enters into force. With regard to Articles 3(1) and 9(1) and part III of Annex II on chemical properties, Member States shall not forbid the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market either before this Directive entered into force or during the three years after its entry into force in all the Member States.
Amendment 59 #
Proposal for a directive
Annex II – part III – paragraph 3
Annex II – part III – paragraph 3
3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys ofoys shall not contain substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR)categories 1 or 2 according to Annex I of Directive 67/548/EEC in individual concentrations equal to or greater than the relevant concentrations established for the classification of preparations containing the substances in accordance with the provisions of Directive 1999/45/EC shall be prohibited, except if the substances are contained in components of toys or micro- structurally distinct parts of toys that are not accessible to any physical contact by childrenr parts of toys that are not accessible by children as defined in standard EN 71.
Amendment 62 #
Proposal for a directive
Annex II – part III – paragraph 4
Annex II – part III – paragraph 4
4. Substances or preparations classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC may be used in toys provided that the following conditions are met:
Amendment 63 #
Proposal for a directive
Annex II – part III – paragraph 4 – subparagraph 4.1
Annex II – part III – paragraph 4 – subparagraph 4.1
4.1 use of the substance has been the relevant Scientific Committee has concluded that the substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC contained in accessible components or parts of toys above the concentration limits in paragraph 3 does not pose an unacceptable risk to human health, in particular in relation to exposure; To that end, manufacturers may, prior to the end of the transition period in Article 52, apply to the Commission for an evaluatedion by the relevant Scientific Committee and found to be safe,of the risk posed by substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC. That application shall be accompanied by relevant information in particular ion view of exposure, and a Decision aexposure. Upon the receipt of an application, the Commission shall without delay mandate the Scientific Committee to provide its opinion. Manufacturers areferred to in Article 45(2) has been taken; allowed to place on the market toys containing the substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC for which a request has been submitted and until a decision is adopted.
Amendment 66 #
Proposal for a directive
Annex II – part III – paragraph 4 – subparagraph 4.2
Annex II – part III – paragraph 4 – subparagraph 4.2
Amendment 70 #
Proposal for a directive
Annex II – part III – paragraph 5
Annex II – part III – paragraph 5
5. Substances or preparations classified as CMRWithout prejudice to the application of the restrictions under the first sentence of paragraph 2, toys shall not contain substances that are classified as carcinogenic, mutagenic or toxic for reproduction category 3 according to Annex I of Directive 67/548/EEC may beif: (i) they have been prohibited for useds in toys if use of the substance has been evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure, and following a Decision as referred to in Article 45(2) and provided that they are not prohibited for uconsumer articles under Regulation (EC) No 1907/2006 (REACH); or (ii) the CMR category 3 substance is contained in components or parts of toys that are accessible by children as defined in standard EN71 and the relevant Scientific Committee has evaluated in accordance with Article 45(2) that the content of the substance in the toy poses ian consumer articles under Regulation (EC) No 1907/2006 (REACH). unacceptable risk to human health, in particular in relation to exposure.
Amendment 112 #
Proposal for a directive
Recital 16 a (new)
Recital 16 a (new)
Amendment 117 #
Proposal for a directive
Recital 16 b (new)
Recital 16 b (new)
(16b) It is necessary to apply a harmonized transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of three years after the entry into force of this Directive in all Member States to provide toy manufacturers and economic operators with sufficient time to adapt to the new technical requirements on chemicals, and to ensure consistent application of this Directive throughout the EU.
Amendment 135 #
Proposal for a directive
Recital 32
Recital 32
(32) In particular power should be conferred on the Commission in order to adapt the chemical requirements in certain well defined cases and grant exemptions from the prohibition of CMR substances in certain cases as well as to adapt the wording of the specific warnings for certain categories of toys. Since those measures are of general scope and are designed to amend non-essential elements of this Directive and/or to supplement this Directive by the addition of, inter alia by supplementing it with new non- essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 221 #
Proposal for a directive
Article 45 - paragraph 1
Article 45 - paragraph 1
1. The Commission may, for the purposes of adapting them to technical and, scientific practical developments, amend the following: (a) Points 7 and 8 in Part III of Annex II; (b) Annex V. Those measures, designed to amend non- essential elements of this RegulationDirective, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 46(2) and, as appropriate, after the opinion of the relevant Scientific Committee.
Amendment 231 #
Proposal for a directive
Article 45 - paragraph 2
Article 45 - paragraph 2
2. The Commission may decide upon the use in toyscontent of substances or preparations classified as carcinogenic, mutagenic or toxic to reproduction, of category 1, 2 and 3, under Annex I to Directive 67/548/EEC in toys. Those measures, designed to amend non- essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 46(2) and, as appropriate, after the opinion of the relevant Scientific Committee.
Amendment 243 #
Proposal for a directive
Article 52
Article 52
Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or at the latest 2 years after this Directive entered into forceduring a period of 2 years after this Directive enters into force. With regard to Article 3(1), Article 9(1) and point III of Annex II, Member States shall not prohibit the placing on the market of toys in accordance with Directive 88/378/EEC which were placed on the market before this Directive entered into force or for three additional years after this Directive enters into force in all the Member States.
Amendment 306 #
Proposal for a directive
Annex II – Part III – point 3
Annex II – Part III – point 3
3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys ofoys shall not contain substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR)categories 1 or 2 according to Annex I of Directive 67/548/EEC in individual concentrations equal to or greater than the relevant concentrations established for the classification of preparations containing the substances in accordance with the provisions of Directive 1999/45/EC shall be prohibited, except if the substances are contained in components of toys or micro- structurally distinct parts of toys that are not accessible to any physical contact by childrenr parts of toys that are not accessible by children as defined in standard EN 71.
Amendment 309 #
Proposal for a directive
Annex II – Part III – point 4
Annex II – Part III – point 4
4. Substances or preparations classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC may be used in toys provided that the following two conditions are met: 4.1 use of the substance has been evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure, and a Decision as referred to in Article 45(2) has been taken; 4.2The relevant Scientific Committee has evaluated that the substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC contained in accessible components or parts of toys above the concentration limits in point 3 does not pose an unacceptable risk to human health, in particular in view of exposure. To that end, manufacturers may submit requests to the Commission prior to the end of the transition period in Article 52 for an evaluation by the relevant Scientific Committee of the risk posed by substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC. That request shall be accompanied by relevant information in particular on exposure. Upon the receipt of a re no suitable substances available, as documented in an analysis of alternatives, 4.3 tquest, the Commission shall without delay mandate the Scientific Committee to provide its opinion. Manufactures are allowed to place toys on the market containing the substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC for which a request has been submitted and until a decision is adopted. A decision to amend Annex IIa listing the CMR 1 and 2 substances concerned by this Article shall be taken in accordance with Article 45(2). 4.2 They arhave not already been prohibited for uses in consumer articles under Regulation (EC) No 1907/2006 (REACH). The Commission shall mandate the relevant Scientific Committee to re- evaluate those substances or preparationslisted in Annex IIa as soon as safety concerns arise and at the latest every 5 years from the date that a decision in accordance with Article 45(2) was taken.
Amendment 327 #
Proposal for a directive
Annex II – Part III – point 5
Annex II – Part III – point 5
5. Substances or preparations classified as CMR cWithout prejudice to the application of the restrictions under the first sentence of point 2, toys shall not contain substances that are classified as carcinogenic, mutagenic or toxic for reproduction Category 3 according to Annex I of Directive 67/548/EEC may beif: (i) they have been prohibited for useds in toys if use of the substance has been evaluated by the relevant Scientific Committee and found to be safeconsumer articles under Regulation (EC) No 1907/2006 (REACH); or (ii) the CMR 3 substance is contained in components or parts of toys that are accessible by children as defined in standard EN71 and the relevant Scientific Committee has evaluated that the content of the substance in the toy poses an unacceptable risk to human health, in particular in view of exposure, and following a D. A decision asto referred to in Article 45(2) and provided that they are not prohibited for uses in consumer articles under Regulation (EC) No 1907/2006 (REACHvise Annex IIb listing the CMR 3 substances prohibited by this provision shall be taken according with Article 45(2).
Amendment 353 #
Proposal for a directive
Annex II a - title (new)
Annex II a - title (new)
Annex IIa List of CMR 1 and 2 substances exempt from the prohibition of Annex II point III (3)
Amendment 359 #
Proposal for a directive
Annex II b -title (new)
Annex II b -title (new)
Annex IIb List of prohibited CMR 3 substances