Changes from report parliamentary committee draft to plenary report

RemovedEXPLANATORY STATEMENT

AddedRegulation (EC) No 1272/2008

RemovedChemicals are the building blocks of all materials and products we produce and use and are therefore important determinants of their overall safety and sustainability. All European citizens are exposed in their daily life to chemicals, while many also use chemicals at the working environment.

AddedArticle 1 – paragraph 1 – point 27 – point a, Article 53a – paragraph 2: The power to adopt delegated acts referred to in Articles 37(5), 37(7), 37(8), 45(4), 53(1), 53(1a), 53(1b), 53(3) and 53(3a) shall be conferred on the Commission for a period of five years from [OP please insert the date = the date of entry into force of this Regulation].

RemovedThe European Green Deal sets the EU on a course to become a climate neutral, clean and circular economy by 2050. It has also set a goal to step up protection of human health and the environment from hazardous chemicals and to move towards a zero pollution ambition for a toxic-free environment. Towards this end, the Chemicals Strategy for Sustainability is the first step, by defining a 2030 vision and objectives where all chemicals will be produced and used safely and sustainably, so that their negative impacts on health and environment are avoided, while their benefits for the economy and society can be fully exploited.

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RemovedIn this context, the revision of the CLP is an important deliverable of the Chemicals Strategy for Sustainability, which is a key building block of the European Green Deal. Since CLP provides for a horizontal approach to identify and classify the hazards related to chemicals, its revision is a first necessary step for several elements of the further revision of REACH and other sectorial legislation.

AddedArticle 1 – paragraph 1 – point 27 – point b, Article 53a – paragraph 3: The delegations of power referred to in Articles 37(5), 37(7) and 37(8), 45(4), 53(1), 53(1a), 53(1b), 53(3) and 53(3a) may be revoked at any time by the European Parliament or by the Council.

RemovedThe objectives of CLP are to protect human health and the environment from hazardous chemicals and to facilitate the free movement of chemicals in the European market. So far, the Union has overall been successful in creating an efficient single market for chemicals. However, some weaknesses or gaps in the CLP Regulation prevent consumers, companies, and authorities from fully benefiting from protection against the dangers posed by hazardous chemicals.

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RemovedAlthough certain chemicals and articles may pose risks to human health or to the environment, their hazards are not always properly identified and communicated. As it has been identified, the main driver behind this issue are inefficiencies in the procedures for assessing and classifying hazards. In addition, there is also a high number of erroneous or obsolete classifications of substances, as well as diverging classifications for the same substance in the European Chemical Agency’s classification and labelling inventory (‘inventory’), with almost 60% of companies having multiple notified classifications for a single substance.

AddedArticle 1 – paragraph 1 – point 27 – point c, Article 53 – paragraph 6: A delegated act adopted pursuant to Article Articles 37(5), 37(7), 37(8), 45(4), 53(1), 53(1a), 53(1b), 53(3) or 53(3a) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.;

RemovedOne of the novelties of the new legislative proposal is the addition of new hazard classes for chemical substances. This initiative was triggered by scientific evidence supporting the fact that harmful substances and mixtures were not fully addressed via the existing criteria. Therefore, as a part of the CLP proposal, a Commission Delegated Act introduces new hazard classes and scientific and technical criteria for classifying substances and mixtures that have endocrine disrupting (‘ED’), persistent, bioaccumulative and toxic (‘PBT’), very persistent and very bioaccumulative (‘vPvB’), persistent, mobile and toxic (‘PMT’), or very persistent and very mobile (‘vPvM’) properties.

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RemovedThis proposal has as its legal basis in Article 114 of the Treaty on the Functioning of the European Union.

AddedArticle 1 – paragraph 1 – point 29 a (new), Article 54 a (new): (29a) the following article is inserted: / "Article 54a / Review Clause / By ...[insert date four years after the date of entry into force of this Regulation], the Commission shall present a report to the European Parliament and to the Council regarding the identification and examination of substances of renewable botanical origin containing more than one constituent referred to in Article 5.3a. The report shall be accompanied, where appropriate, by a legislative proposal."

RemovedThe Rapporteur generally supports many elements of the Commission proposal. However, there is certain room for further improvement of the proposal, by keeping some current best practices, aligning better with the needs of the European citizens and industry and providing clarifications where needed.

AddedRegulation (EC) No 1272/2008

RemovedThe grouping process shall be scientifically robust, coherent and transparent for all stakeholders. The Rapporteur considers there is a need to develop clear, transparent criteria for the grouping of chemical substances, and guidance to apply such criteria with a high degree of scientific rigour and robustness, which is necessary for legal clarity and certainty. In this regard, the development of a guidance document for the grouping process is also essential to ensure consistency with ongoing processes under REACH. In this context, it has to be taken into consideration the Chemicals Strategy for Sustainability objective to move towards ‘one substance, one assessment’ approach by improving efficiency, effectiveness, coherence and transparency of the delivery of safety assessments of chemicals across all relevant legislation. This approach aims to a simpler and more transparent process and reduce additional bureaucratic burdens.

AddedArticle 1 – paragraph 1 – point 30, Article 61 – paragraph 7: Substances which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 18 months after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].

RemovedGrouping based merely on structural similarity may lead to inadequate classification. Therefore, it has to be complemented by an assessment of the hazard properties of the various substances of the group to identify similarities and differences within the group. The assessment of hazard profiles should be carried out in a Weight of Evidence manner in order to give priority to actual robust experimental data.

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RemovedRegarding the evaluation of hazard information for substances and mixtures, it should be reflected in the proposal that where more comprehensive and more refined data is available for the assessment of substances, these data should be used in the hazard classification process to avoid false results. In addition, the Rapporteur supports that the interested parties that have relevant data should be able to provide the relevant information for the proposal of harmonized classification on one substance or on a group of substances at all stages of the process.

AddedArticle 1 – paragraph 1 – point 30 – point a (new), Article 61 – paragraph 7 a (new): a) In Article 61, the following paragraph is added: / "7a. Mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third subparagraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first subparagraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 24 months ] after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date =the first day of the month following 48 months after th…

RemovedThe new CLP proposal seeks to introduce a new definition for multi-constituent substances for clarifying classification rules for substances that contain impurities, additives or individual constituents above certain concentration limit. However, this new definition may create confusion as it is at odds with how multi-constituent substances have been identified under REACH. For that reason, the Rapporteur supports that the classification rules can be clarified without introducing a new definition for multi-constituent substances.

AddedArticle 2 – paragraph 2 – introductory part: 2. The following provisions shall apply to substances and mixtures from [OP: please insert the date = the first day of the month following 18 months after the date of entry into force of this Regulation]:

RemovedThe Rapporteur believes that the legislation should consider, inter alia, the specificities of essential oils, including their character as substances with variable composition and concentration for their classification. Taking into consideration the lack of data particularly, when it comes to the essential oils a derogation is needed. By this derogation will also avoid additional bureucratic burdens, support the local jobs, traditional productions and regional economies of various Member States.

AddedArticle 2 – paragraph 2 a (new): 2a. The following provisions shall apply to mixtures from [OP: please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation]: (a) Article 1, points (1), (4), (5), (6), (7), (10), (11), (12), (15), (16), (20), (21), (23) and (24); (b) points (2), (3), (7), (9) and (10) of Annex I; (c) Annex II; (d) points (1)(c), (2), (3) and (4) of Annex III.

RemovedConcerning the reference to animal testing, the Rapporteur considers that the Commission has to ensure, prior to introducing new hazard classes or classification criteria, that such classes or criteria can be fully satisfied with existing data and are aligned with the EU’s goal of fully replacing animal testing. This goal should be reflected in the proposal to translate aspiration into action and accountability.

AddedArticle 2 – paragraph 3 – introductory part: 3. By way of derogation from Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub-paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII to Regulation (EC) No 1272/2008 as applicable on [OP: please insert the date = the day before the date of entry into force of this Regulation], substances may until … [OP: please insert the date = 18months after the date of entry into force of this Regulation] and mixtures may until … [OP: please insert the date = the last day of the month following 35 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by the following provisions of this Regulation:

RemovedChemicals’ labelling information should be made available before placing on the market, regardless of the means of sale. The new CLP Regulation proposal requires labels to be updated in case a new hazard class or a more severe classification needs to be assigned to a substance or a mixture, or when new supplemental information on the label is required. The Rapporteur considers that 18 months should be the timeline for all label updates, in particular for complex value chains that involve several mixture formulators downstream. This timeline is consistent with current practices, which have proven adequate to allow re-design, re-printing of labels and re-labelling of packages.

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RemovedOne of the objectives of the CLP proposal is to create more flexibility for the use of fold-out labels. To ensure consistency and clarity for economic operators and Member State competent authorities, the Rapporteur has added a corresponding reference to fold-out labels in the relevant articles of the proposal. The Rapporteur would also like to enhance the mandatory use of digital labelling that will be based on the technological progress and taking into account societal needs and a high level of protection of human health and the environment.

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RemovedTo achieve the objectives of consumer protection and protection of human health and of the environment, the CLP Regulation introduces a requirement that suppliers have to ensure that substances or mixtures, including those sold online via distance sales, meet the requirements of CLP, in particular on classification, labelling and packaging. To ensure that the advertisement requirements, when are directed to the general public, secure the human health and environmental protection, the Rapporteur proposes that in the online offers and advertisements a request to “always read and follow product label information” is considered a more effective way to draw attention to the hazards and precautionary information on the label.

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RemovedMoreover, the procedure for harmonisation of classification and labelling of substances has to elaborate better the submission of a proposal for harmonised classification of a substance with constituents and take into consideration that the substance(s) subject to regulatory actions must be clearly and individually identified. This is needed for legal certainty and enforcement purposes.

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RemovedFurthermore, due to the new challenges of the CLP revision, the Rapporteur strongly supports that ECHA should be granted sufficient resources to properly navigate the added workload to the introduction of new hazard classes, as well as the production of clear and robust guidance to support the evaluation of mixtures. These resources have to be provided by a separate budgetary line and have to be clearly reflected in the envisaged standalone ECHA Founding Regulation.

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AddedAnnex I – paragraph 1 – point 3 a (new), Annex I – Part 1 – Section 1.2.1.5 a (new)): (3a) In Annex I, part I, the following section is added: / Section 1.2.1.5.a For multilingual labels, the languages shall be ordered in a logical way, e.g. alphabetically.

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AddedAnnex I – paragraph 1 – point 9, Annex I – Part 1 – Section 1.5.2.4.1. – point b – point iv a (new): (iva) Serious eye damage category 1/eye irritation, category 2;

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AddedAnnex I – paragraph 1 – point -1 (new), Annex I – Part 1 – Section 1.5.2.4.1. – point b – point v a (new): (va) Skin sensitisation, category 1 (sub-categories 1A and 1B);

AddedRegulation (EC) No 1272/2008

AddedAnnex II – paragraph 1 – point -1 a(new), Annex II – Part 3 – Section 3.1.1.1: -1a in Part 3 of Annex II to Regulation (EC) No 1272/2008, point 3.1.1.1. is amended as following: / "3.1.1.1. 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."

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AddedAnnex II – paragraph -1 a (new), Annex II – Part 3 – section 3.2.1: (-1a) In Part 3 of Annex II, section 3.2.1. is replaced by the following: / "3.2.1. Packaging to be fitted with a tactile warning / Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion/skin irritation, serious eye damage/eye irritation, endocrine disruption for human health category 2, endocrine disruption for the environment category 2, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity 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. "

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AddedAnnex II – paragraph 1 – point 1, Annex II – Part 3 – Section 3.4 – point b: (b) a label is firmly affixed on a visible place of the refill station and fulfils the requirements of Article 31;

AddedRegulation (EC) No 1272/2008

AddedAnnex II – paragraph 1 – point 1, Annex II – Part 3 – Section 3.4 – point b a (new): (ba) a label 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 the labels correspond to;

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AddedAnnex II – paragraph 1 – point 1, Annex II – Part 3 – Section 3.4. – point k – point iv a (new): (iva) Serious eye damage category 1/eye irritation, category 2;

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AddedAnnex II – paragraph 1 – point 1, Annex II – Part 3 – Section 3.4. – point k – point v a (new): (va) Skin sensitisation, category 1 (sub-categories 1A and 1B);

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AddedAnnex III – paragraph 1 a (new), Annex VI: Annex VI is amended as follows: / "ANNEX VI / — Justification for the proposed grouping of substances to harmonized classification and labelling. / Where a harmonised classification and labelling proposal is made for a group of substances, the dossier shall include a scientific justification. / — Justification for other effects at Community level / For effects other 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 that there is a need for action demonstrated at Union level shall be provided. This will not apply for an active substance within the meaning of Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012."