Amen­de­menten Hazekamp tot wijziging van Veror­dening (EG) nr. 1272/2008 van het Europees Parlement en de Raad betref­fende de indeling, etiket­tering en verpakking van stoffen en mengsels

Proposal for a regulation on amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures of the Committee on the Environment, Public Health and Food Safety.

Amendment 1
Anja Hazekamp

Proposal for a regulation
Recital 1

Text proposed by the Commission

(1) In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council. While under that Regulation it is assumed that all responsible actors in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore appropriate to require that there is a supplier established in the Union, which ensures that the substance or the mixture in question meets the requirements set out in that Regulation when it is being placed on the market, including via distance sales. This provision would improve compliance with and enforcement of the Regulation (EC) No 12727/2008 and thereby ensure a high level of protection of human health and the environment. In order to prevent situations where consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the Union, it is necessary to specify that the supplier which ensures that the substance or the mixture in question meets the requirements set out in that Regulation acts in course of an industrial or professional activity.

Amendment

(1) In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council. While under that Regulation it is assumed that all responsible actors in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore appropriate to require that there is a supplier established in the Union, which ensures that the substance or the mixture in question meets the requirements set out in that Regulation when it is being placed on the market, including via distance sales. This provision would improve compliance with and enforcement of the Regulation (EC) No 12727/2008 and thereby ensure a high level of protection of human and animal health and the environment. In order to prevent situations where consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the Union, it is necessary to specify that the supplier which ensures that the substance or the mixture in question meets the requirements set out in that Regulation acts in course of an industrial or professional activity.

Amendment 2
Anja Hazekamp

Proposal for a regulation
Recital 2

Text proposed by the Commission

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council³⁹, aimed to limit animal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituent substances.

³⁹ Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

Amendment

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council³⁹ , aimed to phase out, through replacement, reduction and refinement of animal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituent substances.

³⁹ Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

Amendment 3
Anja Hazekamp

Proposal for a regulation
Recital 13

Text proposed by the Commission

(13) In order to adapt the label elements allowed to be provided only in a digital format to technical progress or to the level of digital readiness among all population groups in the Union, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to amend the list of label elements allowed to be provided only in a digital format, taking into account societal needs and a high level of protection of human health and the environment.

Amendment

(13) In order to adapt the label elements allowed to be provided only in a digital format to technical progress or to the level of digital readiness among all population groups in the Union, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to amend the list of label elements allowed to be provided only in a digital format, taking into account societal needs and a high level of protection of human and animal health and the environment.

Amendment 4
Anja Hazekamp

Proposal for a regulation
Recital 18

Text proposed by the Commission

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group.

Amendment

(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and should cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group and can thereby reduce the use of animals.

Amendment 5
Anja Hazekamp

Proposal for a regulation
Recital 24

Text proposed by the Commission

(24) Manufacturers and importers often notify different information for the same substance to be included in the Agency’s inventory for classification and labelling. In some cases, such divergences result from different impurities, physical states or other differentiations and may be justified. In other cases, the divergences are due to differences in data used for classification, or to disagreement between notifiers or registrants in the case of joint submission of data in accordance with Regulation (EC) No 1907/2006, or to obsolete classification entries. As a result, the classification and labelling inventory contains divergent classifications, which makes the inventory less effective as a hazard collection and communication tool and leads to incorrect classifications, ultimately hindering the ability of Regulation (EC) No 1272/2008 to protect human health and the environment. Therefore, the notifiers should be required to provide reasons for divergence from the most severe classification or for introducing a more severe classification per hazard class for the same substance to the Agency. To address divergences between more recent and obsolete classifications, notifiers should be required to update their notifications within 6 months after a decision to change the classification and labelling of a substance has been taken pursuant to a review in Article 15(1) of that Regulation.

Amendment

(24) Manufacturers and importers often notify different information for the same substance to be included in the Agency’s inventory for classification and labelling. In some cases, such divergences result from different impurities, physical states or other differentiations and may be justified. In other cases, the divergences are due to differences in data used for classification, or to disagreement between notifiers or registrants in the case of joint submission of data in accordance with Regulation (EC) No 1907/2006, or to obsolete classification entries. As a result, the classification and labelling inventory contains divergent classifications, which makes the inventory less effective as a hazard collection and communication tool and leads to incorrect classifications, ultimately hindering the ability of Regulation (EC) No 1272/2008 to protect human and animal health and the environment. Therefore, the notifiers should be required to provide reasons for divergence from the most severe classification or for introducing a more severe classification per hazard class for the same substance to the Agency. To address divergences between more recent and obsolete classifications, notifiers should be required to update their notifications within 6 months after a decision to change the classification and labelling of a substance has been taken pursuant to a review in Article 15(1) of that Regulation, and the Agency should be entitled to delete obsolete classifications. Furthermore, divergent classifications should be harmonised within 12 months to the most severe classification per hazard class.

Amendment 6
Anja Hazekamp

Proposal for a regulation
Recital 25

Text proposed by the Commission

(25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ duty to come to an agreed notification entry for the same substance, certain information notified to the Agency’s classification and labelling inventory should be made publicly available, free of charge. Without prejudice to the protection of commercial interests, that information should include the identity of the notifiers as, knowing whom to contact, would facilitate the objective of coming to an agreed entry to be included in that classification and labelling inventory. In the case of notifications by a group of manufacturers or importers, it should suffice to make publicly available the identity of the notifier submitting the information on behalf of the other members of the group.

Amendment

(25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ duty to come to an agreed notification entry for the same substance, all information notified to the Agency’s classification and labelling inventory should be made publicly available, free of charge. Without prejudice to the protection of commercial interests, that information should include the identity of the notifiers as, knowing whom to contact, would facilitate the objective of coming to an agreed entry to be included in that classification and labelling inventory. In the case of notifications by a group of manufacturers or importers, it should suffice to make publicly available the identity of the notifier submitting the information on behalf of the other members of the group.

Amendment 7
Anja Hazekamp

Proposal for a regulation
Recital 33

Text proposed by the Commission

(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council⁴⁷ , it is necessary to replace, reduce or refine testing on animals. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative test methods, suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be monitored and systematically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without undue delay.

⁴⁷ Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Amendment

(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council⁴⁷ , it is necessary to replace, reduce or refine testing on animals, with a view to stop using animals for testing as soon as possible. Implementation of Regulation (EC) No 1272/2008 should be based on the promotion, development and use of New Approach Methodologies (NAM), suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be supported, monitored and systematically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without delay.

⁴⁷ Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Amendment 8
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point -1 (new)
Regulation (EC) 1272/2008
Article 1 - paragraph 1

Present text

The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:

Amendment

(-1) Article 1, paragraph 1 is amended as follows:

"The purpose of this Regulation is to ensure a high level of protection of human and animal lives and health, protection of the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:"

Amendment 9
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 5 a (new)
Regulation (EC) 1272/2008
Article 7

Present text

Animal and human testing

1. Where new tests are carried out for the purposes of this Regulation, tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where no other alternatives, which provide adequate reliability and quality of data, are possible.

2. Tests on non-human primates shall be prohibited for the purposes of this Regulation.

3. Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation.

Amendment

(5 a) Article 7 is amended as follows:

"New Approach Methodologies, animal and human testing

1. Where new tests are carried out for the purposes of this Regulation, New Approach methodologies (NAM) shall be used as the norm. Tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where it is demonstrated that no other alternatives, which provide adequate reliability and quality of data, exist.

2. Tests on non-human primates shall be prohibited for the purposes of this Regulation, as well as the use of data derived from tests on non-human primates.

3. Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation.

Amendment 10
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 7 a (new)
Regulation (EC) 1272/2008
Article 17 - paragraph 1 - point (i) NEW

Amendment

(7 a) in Article 17, paragraph 1, the following point (i) is added:

where relevant, the species and number of animals used in tests;

Amendment 11
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 12
Regulation (EC) 1272/2008
Article 30 - paragraph 1

Text proposed by the Commission

1. In case of a change regarding the classification and labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier shall ensure that the label is updated within 6 months after the results of the new evaluation referred to in Article 15(4) were obtained.

Amendment

1. In case of a change regarding the classification and labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier shall ensure that the label is updated within 3 months after the results of the new evaluation referred to in Article 15(4) were obtained.

Amendment 12
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 12
Regulation (EC) 1272/2008
Article 30 - paragraph 2

Text proposed by the Commission

2. Where a change regarding the classification and labelling of a substance or a mixture is required other than that referred to in paragraph 1, the supplier shall ensure that the label is updated within 18 months after the results of the new evaluation referred to in Article 15(4) were obtained.

Amendment

2. Where a change regarding the classification and labelling of a substance or a mixture is required other than that referred to in paragraph 1, the supplier shall ensure that the label is updated within 12 months after the results of the new evaluation referred to in Article 15(4) were obtained.

Amendment 13
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 18 - point a
Regulation (EC) 1272/2008
Article 37 - paragraph 1

Text proposed by the Commission

The Commission may ask the Agency or the European Food Safety Authority established in accordance with Article 1(2) of Regulation (EC) No 178/2002* to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency.

Amendment

The Commission may ask the Agency or the European Food Safety Authority established in accordance with Article 1(2) of Regulation (EC) No 178/2002* to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency. The Agency and the Authority may, on their own initiative, provide scientific advice to the Commission and Member States on substances where a harmonised classification could be necessary to protect human and animal health and the environment.

Amendment 14
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 18 - point c
Regulation (EC) 1272/2008
Article 37 - paragraph 2a - subparagraph 1

Text proposed by the Commission

Within one week from receipt of the notification, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance(s), the status of the proposal and the name of the submitter. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in Article 37(4) and (5).

Amendment

Within one week from receipt of the notification, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance(s), the status of the proposal and the name of the submitter, as well as scientific data, studies and other information supporting the proposal. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in Article 37(4) and (5).

Amendment 15
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 20 a (new)
Regulation (EC) 1272/2008
Article 41

Present text

Agreed entries

Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly.

Amendment

(20 a) Article 41 is amended as follows:

Agreed entries

Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly. If after 6 months no agreement has been reached, the most severe hazard classification will apply for all concerned entries, and the Agency will change them accordingly.

Amendment 16
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 21
Regulation (EC) 1272/2008
Article 42 - paragraph 1 - subparagraph 3 - point (a)

Text proposed by the Commission

(a) information referred to in Article 40(1), point (a), except where a notifier duly justifies why such publication is potentially harmful for its commercial interests or the commercial interests of any other concerned party;

Amendment

(a) information referred to in Article 40(1), point (a);

Amendment 17
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 21 a (new)

Present text

The Agency shall update the inventory when it receives updated information in accordance with Article 40(2) or Article 41.

Amendment

(21 a) Article 42, paragraph 2 is amended as follows:

"The Agency shall update the inventory when it receives updated information in accordance with Article 40(2) or Article 41.

The Agency shall delete entries which it considers obsolete.

Amendment 18
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 22 a (new)
Regulation (EC) 1272/2008
Article 46a (new)

Amendment

(22 a) The following article is inserted:

Article 46 a

Access to justice

1. Any natural or legal person having sufficient interest shall have access to a court or other independent and impartial public body competent to review the procedural and substantive legality of the decisions, plans, permits, acts or failure to act of the competent authority under this Regulation. Any non-governmental organisation promoting environmental protection, the protection of human or animal health or animal welfare, and meeting any requirements under national law shall be deemed to have sufficient interest.

2. Access to a court or other independent and impartial public body pursuant to paragraph 1 shall be fair, equitable, timely and not prohibitively expensive and provide adequate and effective remedies, including injunctive relief where appropriate. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

Amendment 19
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 23
Regulation (EC) 1272/2008
Article 48 - paragraph 1

Text proposed by the Commission

1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.

Amendment

1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements. The use of environmental claims as defined in Article 2, point (o), of Directive 2005/29/EC is prohibited;

Amendment 20
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 23
Regulation (EC) 1272/2008
Article 48 - paragraph 2

Text proposed by the Commission

2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictogram, the signal word, the hazard class and the hazard statements.

Amendment

2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictogram, the signal word, the hazard class and the hazard statements. The use of environmental claims as defined in Article 2, point (o), of Directive 2005/29/EC is prohibited;

Amendment 21
Anja Hazekamp

Proposal for a regulation
Article 1 - paragraph 1 - point 26 - point c
Regulation (EC) 1272/2008
Article 52 - paragraph 3

Text proposed by the Commission

3. The Commission shall regularly evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures.

Amendment

3. The Commission shall promote and at least every two years evaluate the development of New Approach Methodologies, including those referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures.

No later than six months after new harmonised criteria based on available NAM are included in UN GHS, the Commission shall adopt Delegated Acts in accordance with Article 53a to update Annex I of this Regulation.