Activities of João ALBUQUERQUE related to 2022/0432(COD)
Plenary speeches (1)
Classification, labelling and packaging of substances and mixtures (debate)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures
Amendments (51)
Amendment 58 #
Proposal for a regulation
Recital 1
Recital 1
(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, together with requirements in Regulation (EU) No xxx/xxx [reference to adopted act to be inserted] on General Product Safety, Regulation (EU) No 2022/2065, and Regulation (EU) 2019/1020 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 66 #
Proposal for a regulation
Recital 2
Recital 2
(2) From a toxicological point of view, substances withcontaining 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-substances containing more than one constituentsubstances 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-constituentsubstances. substances. Specific provisions could be provided into Annex I on the basis of adequate and reliable scientific argumentation. Such derogations would be needed for cases where using data on constituents and calculation rules would result in a less appropriate classification of a substance with more than one constituent than by using data on the substance itself. This could be the case for example when a substance with more than one constituent contains constituents interacting with each other. Such interactions could have an impact on the hazard of the whole substance, notably when antagonistic effects occur. The scientific criteria to derogate to the mixture rule should be established by the Risk Assessment Committee. This committee should also be consulted for specific cases where appropriate. _________________ 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 86 #
Proposal for a regulation
Recital 3
Recital 3
(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a multi-substance containing more than one constituent substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi- constituent substance should therefore normally be used as the basis for hazard identification of those multi-constituent substances or mixtures. However, in certain cases, data on those multi-substances containing more than one constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substancessubstances containing more than one constituent are used in those cases.
Amendment 91 #
Proposal for a regulation
Recital 10
Recital 10
(10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/143540. Where the new hazard class is additional to an existing hazard class or represents a more severe hazard class or category, or where new supplemental labelling elements are required under Article 25, the deadline to update the labelling information in the case of adaptation of the classification in accordance with the result of a new evaluation should be set at 63months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. In case where a classification is updated to a less severe hazard class or category without triggering classification in an additional hazard class or new supplemental labelling requirements, the deadline for updating the labels should remain at 18 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. It should also be clarified that, in cases of harmonised classification and labelling, the deadlines to update the labelling information should be set at the date of application of the provisions setting out the new or amended classification and labelling of the substance concerned, which is usually 18 months from the date of entry into force of those provisions. The same applies in case of changes triggered by other delegated acts adopted in light of the adaptation to technical and scientific progress, for instance as a result of the implementation of new or amended provisions of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). _________________ 40 Commission Implementing Regulation (EU) 2020/1435 of 9 October 2020 on the duties placed on registrants to update their registrations under Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 331, 12.10.2020, p.24.)
Amendment 105 #
Proposal for a regulation
Recital 18
Recital 18
(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. Where it is scientifically justified and possible, proposals for classification should prioritise groups of substances rather than individual substances.
Amendment 110 #
Proposal for a regulation
Recital 19
Recital 19
(19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. For the same reason, a competent authority that receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. Moreover, to increase the efficiency of the harmonised classification and labelling process, a 6 months deadline should be fixed for the Commission to amend Annex VI after the adoption of an opinion on any proposals submitted to the Agency.
Amendment 113 #
Proposal for a regulation
Recital 24
Recital 24
(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. Moreover, the Agency should be able to remove incomplete, incorrect or obsolete notifications from the inventory after having informed the notifier.
Amendment 116 #
Proposal for a regulation
Recital 29
Recital 29
(29) Regulation (EC) No 1272/2008 regulates advertisement of hazardous substances and mixtures in a general manner and provides that an advertisement for a substance classified as hazardous is to mention the hazard classes or hazard categories concerned, and an advertisement for a mixture classified as hazardous or a mixture containing a classified substance is to mention the types of hazards indicated on the label where such advertisement allows concluding a contract for purchase without first having sight of the label. This obligation should be changed to ensure that the advertisement of hazardous substances and mixtures contains all the information which is most important in terms of safety and protection of human health and the environment. Therefore, the advertisement should contain the hazard pictogram, the signal word, the hazard class and the hazard statements. The hazard category should not be provided, as it is reflected by the hazard statement.
Amendment 122 #
Proposal for a regulation
Recital 35 a (new)
Recital 35 a (new)
(35a) Where the Agency deems it necessary, it should provide further guidance for the application of the provisions associated with the revision of this Regulation.
Amendment 123 #
Proposal for a regulation
Recital 35 b (new)
Recital 35 b (new)
(35b) The revision of this regulation expands the tasks and remit of the Agency. In order to provide adequate expertise, support, and thorough scientific evaluations, a sustainable funding for the Agency should be ensured under the framework of the upcoming ECHA Founding Regulation.
Amendment 135 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EC) No 1272/2008
Article 2 – paragraph 7a
Article 2 – paragraph 7a
Amendment 142 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b a (new)
Article 1 – paragraph 1 – point 2 – point b a (new)
Regulation (EC) 1272/2008
Article 2 – paragraph 1 – point 38 a (new)
Article 2 – paragraph 1 – point 38 a (new)
(ba) In Article 2, the following point 38 a is added: '38a. refill’ means an operation by which a consumer or a professional user fills its own container, which fulfils the packaging function, with a hazardous substance or mixture offered by a supplier in the context of a commercial transaction;'
Amendment 143 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b b (new)
Article 1 – paragraph 1 – point 2 – point b b (new)
Regulation (EC) 1272/2008
Article 2 – paragraph 1 – point 38 b (new)
Article 2 – paragraph 1 – point 38 b (new)
(bb) In Article 2, the following point 38 b is added: '38b. refill station’ means a place where a supplier offers to consumers or professional users hazardous substances or mixtures that can be purchased through refill;'
Amendment 154 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
A multi-constituent substance containing at leastmore than one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision.
Amendment 155 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
For the evaluation of multi-substances containing more than one constituent substances pursuant to Chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1. and 4.2.3.1. of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.
Amendment 160 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 3
Article 5 – paragraph 3 – subparagraph 3
Relevant available information on the multi-substance containing more than one constituent substance itself shall be taken into account where one of the following conditions are met:
Amendment 161 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 3 – point b a (new)
Article 5 – paragraph 3 – subparagraph 3 – point b a (new)
(ba) the information conforms to the derogation criteria established in Annex I in accordance with paragraph 4.
Amendment 163 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 4
Article 5 – paragraph 3 – subparagraph 4
Relevant available information on the multi-constituent substancesubstance containing more than one constituent itself showing absence of certainthe properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance.
Amendment 167 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4 Regulation (EC) No 1272/2008
Article 1 – paragraph 1 – point 4 Regulation (EC) No 1272/2008
For the evaluation of multi-substances containing more than one constituent substances pursuant to Chapter 2 of this Title in relation to the ‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance.
Amendment 172 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 6
Article 5 – paragraph 3 – subparagraph 6
Relevant available information on the multi-substance containing more than one constituent substance itself shall be taken into account where one of the following conditions are met:
Amendment 174 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 6 – point a
Article 5 – paragraph 3 – subparagraph 6 – point a
(a) the information demonstrates biodegradation, persistence, mobility and bioaccumulation properties., or lack of biodegradation
Amendment 175 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 6 – point b a (new)
Article 5 – paragraph 3 – subparagraph 6 – point b a (new)
(ba) the information conforms to the derogation criteria established in Annex I in accordance with paragraph 4.
Amendment 178 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 1272/2008
Article 5 – paragraph 3 – subparagraph 7
Article 5 – paragraph 3 – subparagraph 7
Relevant available information on the multi-constituent substancesubstance containing more than one constituent itself showing absence of certainthe properties referred to in (a) or less severe properties shall not override the relevant available information on the constituents in the substance.
Amendment 180 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 1272/2008
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
In Article 5, the following paragraph 3a is added: 'The Commission is empowered to adopt delegated acts in accordance with the procedure referred to in Article 53 in order to amend Annex I to lay down derogation criteria referred to in paragraph 3, subparagraphs 3(ba) and 5(ba) on the basis of the opinion of the Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006. The opinion of the Committee for Risk Assessment shall be based on reliable and updated scientific information, particularly when it demonstrates the occurrence of antagonistic effects among constituents impacting the hazard of the substance.'
Amendment 190 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 1272/2008
Article 6 – paragraph 3
Article 6 – paragraph 3
For the evaluation of mixtures pursuant to chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1 and 4.2.3.1 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself .
Amendment 193 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 1272/2008
Article 6 – paragraph 4
Article 6 – paragraph 4
4. For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ‘biodegradation, persistency, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’, ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself ; However, where the available test data on the mixture itself demonstrates persistent, mobile, or bioaccumulation properties which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, that data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.
Amendment 209 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)
Article 1 – paragraph 1 – point 7 a (new)
Regulation (EC) 1272/2008
Article 18 – paragraph 3 – point b
Article 18 – paragraph 3 – point b
(7a) In Article 18, paragraph 3, point (b) is replaced by the following: "‘(b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, endocrine disruption for human health, endocrine disruption for the environment, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard. , persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM) properties.’;" Or. en (Regulation 1272/2008)
Amendment 214 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) 1272/2008
Article 25 – paragraph 2 and 3
Article 25 – paragraph 2 and 3
In article 25, paragraph 2 and 3 are replaced by the following: "2. A statement shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of Directive 91/414/EECRegulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 .The statement shall be worded in accordance with Part 4 of Annex II and Part 3 of Annex III to this Regulation. 3. The supplier may include supplemental information in the section for supplemental information on the label other than that referred to in paragraphs 1, 2 and 27, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1) (a) to (g) and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements. " Or. en (Regulation 1272/2008)
Amendment 220 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Regulation (EC) No 1272/2008
Article 30 – paragraph 1
Article 30 – paragraph 1
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 63 months after the results of the new evaluation referred to in Article 15(4) were obtained.
Amendment 229 #
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 1272/2008
Article 32 – paragraph 6
Article 32 – paragraph 6
(14) in Article 32, paragraph 6 is deleted; and replaced by the following; ´6. Where the label elements referred to in Article 17(1) is provided by means of a fold-out label, the front page shall contain at least the information provided in accordance with Article 17(1)(e) in all languages of the label along with a reference to the additional information provided on the inside page(s).'
Amendment 233 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Regulation (EC) No 1272/2008
Article 34a – paragraph 2a (new)
Article 34a – paragraph 2a (new)
2a. In Article 34a, the following paragraph 2a is added: 'The Commission shall document in full transparency the decision process to determine what information is not instrumental for the safety of the user or the protection of the environment.'
Amendment 239 #
Proposal for a regulation
Article 1 – paragraph 1 – point 16
Article 1 – paragraph 1 – point 16
Regulation (EC) No 1272/2008
Article 35 – paragraph 2a
Article 35 – paragraph 2a
2a. Hazardous substances or mixtures may be supplied to consumers and professional users via refill stations only if, in addition to the requirements set out in Titles III and IV, the conditions laid down in section 3.4 of Annex II are fulfilled. This paragraph shall not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3).;
Amendment 247 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a
Article 1 – paragraph 1 – point 18 – point a
Regulation (EC) No 1272/2008
Article 37 – paragraph 1 – subparagraph 3 a (new)
Article 37 – paragraph 1 – subparagraph 3 a (new)
In Article 37, the following subparagraph 3a is added: 'Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling should prioritise groups of rather than individual substances.'
Amendment 250 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point e
Article 1 – paragraph 1 – point 18 – point e
Regulation (EC) 1272/2008
Article 37 – paragraph 5
Article 37 – paragraph 5
The Commission shall adopt without undue delayin 6 months after the adoption of an opinion by the Committee for Risk Assessment of the Agency in accordance with paragraph 4, delegated acts in accordance with Article 53a to amend Annex VI by inclusion of substances together with the relevant classification and labelling elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.
Amendment 254 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point e
Article 1 – paragraph 1 – point 18 – point e
Regulation (EC) No 1272/2008
Article 37 – paragraph 6
Article 37 – paragraph 6
6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of substances in Part 3 of Annex VI shall submit a proposal in accordance with paragraph 2, second subparagraph, to the competent authority in one of the Member States in which the substances are placed on the market.; Any proposal referred to in the first subparagraph shall be accompanied by a fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2) of this Regulation.
Amendment 255 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point f
Article 1 – paragraph 1 – point 18 – point f
Regulation (EC) 1272/2008
Article 37 – paragraph 7
Article 37 – paragraph 7
The Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation by inclusion of substances as endocrine disruptor category 1 for human health properties, endocrine disruptor category 1 for environment properties, as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative, as persistent, mobile and toxic or as very persistent, very mobile, together with relevant classification and labelling elements where, on … [OP: please insert the date = the date of entry into force of Commission Delegated Regulation (EU) …i.e. delegated act on the new hazard classes - reference to be added once adopted], those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.
Amendment 259 #
Proposal for a regulation
Article 1 – paragraph 1 – point 20 a (new) Regulation (EC) 1272/2008
Article 1 – paragraph 1 – point 20 a (new) Regulation (EC) 1272/2008
(20a) The Article 41 is replaced by the following: "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. In case where notifiers and registrants cannot come to an agreed entry because of divergences about the level of scientific evidence supporting a classification and labelling of the same substance, the most protective classification shall prevail.'" Or. en (32008R1272)
Amendment 266 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EC) 1272/2008
Article 42 – paragraph 3 a (new)
Article 42 – paragraph 3 a (new)
In Article 42, the following paragraph 3a is inserted: 3a. Where the Agency considers that an entry is incomplete, incorrect or obsolete it shall delete the corresponding entry from the inventory after having informed the notifier .
Amendment 268 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21 a (new)
Article 1 – paragraph 1 – point 21 a (new)
(21a) The following Article -43 is added: Article -43 – Right to request action from competent authorities and the Commission 1. Any natural or legal person, individually or in association, shall be entitled to submit substantiated evidence to competent authorities as referred to in Article 43 or the Commission, such as peer reviewed studies, human biomonitoring data, or environmental monitoring data, on the hazardous properties of a substance(s) or mixture(s) showing that hazardous properties of a substance(s) or mixture(s) may not have been sufficiently considered in the classification or labelling process. 2. The competent authorities or the Commission shall diligently and impartially assess the information submitted in accordance with paragraph 1, integrating the evidence submitted to all other available evidence using a weight of evidence approach. 3. Where the evidence submitted shows non-compliance with one or several of the requirements on the classification, labelling and packaging of substances and mixtures, enforcement measures shall be initiated in accordance with Article 47. 4. Where the assessment has showed that the substance(s) meets the criteria for classification in any of the hazard classes referred to in Article 36(1), the competent authority or the Commission shall initiate a process of harmonised classification and labelling. Where the assessment has showed a wide dispersive use of and/or consumer exposure to the substance or mixture concerned, the competent authority or the Commission shall initiate a risk management process under Article 59, Article 69, or Article 68(2) of Regulation (EU) No 1907/2006. Where the assessment has showed a lack of information on the risk to health or the environment posed by a hazardous substance or mixture, the competent authority or the Commission shall require companies or any other relevant actor to provide more information, with a view to take risk management measures under Titles VI, VII or VIII of Regulation (EU) 1907/2006, where necessary. 5. Where the evidence submitted should have been included in the registration dossier submitted under Regulation (EU) No 1907/2006 but was omitted by the registrant, enforcement measure should be initiated under Article 126 of Regulation (EU) No 1907/2006 against registrants which registration is non- compliant. 6. The competent authority or the Commission, shall, within 6 months, inform the natural or legal persons referred to in paragraph 1, of its opinion on the evidence and concerns so submitted, and of any steps it plans to take to address these concerns, providing the reasons for both the opinion reached and the steps proposed. 7. Competent authorities and the Commission shall publish an annual report on the requests received and their treatment.
Amendment 270 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21 b (new)
Article 1 – paragraph 1 – point 21 b (new)
Regulation (EC) 1272/2008
Article –43 a (new)
Article –43 a (new)
Amendment 281 #
Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point -a (new)
Article 1 – paragraph 1 – point 26 – point -a (new)
Regulation (EC) 1272/2008
Article 53 – paragraph 1– subparagraph 1 a (new)
Article 53 – paragraph 1– subparagraph 1 a (new)
(-a) In Article 53, paragraph 1, the following subparagraph 1a is added: 'The Commission shall, no later than 2025, adopt delegated acts in accordance with Article 53a to propose the development of hazard criteria for immunotoxicity and neurotoxicity;'
Amendment 287 #
Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point c
Article 1 – paragraph 1 – point 26 – point c
Regulation (EC) No 1272/2008
Article 53 – paragraph 3
Article 53 – paragraph 3
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. Where validated alternative test methods are not available for the endpoint in discussion, the expert judgement of competent authorities on the type of data necessary to decide on the classification of substances and mixtures shall prevail.
Amendment 304 #
Proposal for a regulation
Annex I – paragraph 1 – point 3
Annex I – paragraph 1 – point 3
Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5. – point a a (new)
Annex I – Part 1 – Section 1.2.1.5. – point a a (new)
(aa) there is a significant contrast between the print and the background;
Amendment 305 #
Proposal for a regulation
Annex I – paragraph 1 – point 3
Annex I – paragraph 1 – point 3
Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5. – point d a (new)
Annex I – Part 1 – Section 1.2.1.5. – point d a (new)
(da) the label elements provided in accordance with Articles 18, 20 and 21 shall be emphasised through a typeset that clearly distinguishes it from the rest of the text for example by means of the colour or style.
Amendment 312 #
Proposal for a regulation
Annex II – paragraph 1 – point -1 (new)
Annex II – paragraph 1 – point -1 (new)
Regulation (EC) No 1272/2008
Annex II – part 3 – section 3.1.1.1
Annex II – part 3 – section 3.1.1.1
(-1) In in Part 3 of Annex II, section 3.1.1.1 is replaced by the following: ‘Packaging of whatever capacity containing a substance or mixture supplied to the general public and classified for acute toxicity, categories 1 to 3, STOT — single exposure category 1, STOT — repeated exposure category 1, or skin corrosion category 1, or serious eye damage category 1 shall be fitted with child- resistant fastenings.’
Amendment 314 #
Proposal for a regulation
Annex II – paragraph 1 – point -1 a (new)
Annex II – paragraph 1 – point -1 a (new)
Regulation (EC) No 1272/2008
Annex II – part 3 – section 3.2.1.1
Annex II – part 3 – section 3.2.1.1
(-1a) In in Part 3 of Annex II, section 3.2.1.1 is replaced by the following: ‘Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion/skin irritation, serious eye damage/eye irritation, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, respiratory sensitisendocrine disruption for human health category 2, endocrine disruption for the environment category 2, respiratory or skin sensitization, STOT categories 1 or 2, aspiration hazard, flammable gases, flammable liquids categories 1 or 2, or flammable solids, the packaging of whatever capacity, shall be fitted with a tactile warning of danger.’
Amendment 316 #
Proposal for a regulation
Annex II – paragraph 1 – point 1
Annex II – paragraph 1 – point 1
Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point b
Annex II – Part 3 – Section 3.4 – point b
(b) a label is firmly affixed on a visible place of the refill station and with a font size that is easily legible and without serifsfulfils the requirements in Article 31;
Amendment 317 #
Proposal for a regulation
Annex II – paragraph 1 – point 1
Annex II – paragraph 1 – point 1
Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point b a (new)
Annex II – Part 3 – Section 3.4 – point b a (new)
(ba) a label that fulfils the requirements in Article 31 is available at the refill station, free-of-charge for consumers in a self-adhesive sticker form to be affixed on the container used by the consumer. Where refill stations provide several substances or mixtures, labels should easily and clearly identify which substance or mixture provided at the refill station they correspond to.
Amendment 321 #
Proposal for a regulation
Annex II – paragraph 1 – point 1
Annex II – paragraph 1 – point 1
Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point iv a (new)
Annex II – Part 3 – Section 3.4 – point iv a (new)
(iva) Serious eye damage/irritation category 1;
Amendment 323 #
Proposal for a regulation
Annex II – paragraph 1 – point 1
Annex II – paragraph 1 – point 1
Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point v a (new)
Annex II – Part 3 – Section 3.4 – point v a (new)
(va) Skin sensitisation category 1 (sub- categories 1A, 1B);
Amendment 326 #
Proposal for a regulation
Annex II a (new)
Annex II a (new)
Regulation (EC) No 1272/2008
Annex VI – Part 2
Annex VI – Part 2
In Annex VI, part 2 is replaced by the following: ‘PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling. The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier. A dossier for harmonised classification and labelling shall contain the following: — Proposal The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed. — Justification for the proposed harmonised classification and labelling A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006. — Justification for other effects at Community level For other effects than carcinogenity, mutagenicity, reprotoxicity, endocrine disruption for human health and the environment, persistent bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM), and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC.Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012.’