Changes from report parliamentary committee draft to plenary report

AddedArticle 1 – paragraph 1 – point 21, Article 42 – paragraph 1 – subparagraph 3 – introductory part: The following information shall be made publicly available free of charge online in a user-friendly format:

RemovedThe legal text should clarify that aligning on diverging classifications should only be required when practically achievable, without having to acquire new data or studies (this would imply costs and such costs would change the Commission’s Impact Assessment). Further guidance on when that requirement is applicable and how that requirement should be fulfilled in practice would need to be developed by ECHA.

Regulation (EC) No 1272/2008

Change 45

RemovedArticle 1 – paragraph 1 – point 22 – point c, Article 45 – paragraph 2 – point b: (b) where requested by a Member State, the Commission or the Agency, to undertake a statistical analysis to identify where improved risk management measures may be needed. The Agency shall be provided with the adequate resources to support this work, under a separate budgetary line. The ‘ECHA Founding Regulation’ shall take account of these needs.

AddedArticle 1 – paragraph 1 – point 21, Article 42 – paragraph 1 – subparagraph 3 – point a: (a) information referred to in Article 40(1), point (a);

RemovedMember States may appoint ECHA as the body responsible for receiving information relating to emergency health response and preventative measures. ECHA therefore should be granted sufficient resources, under a separate budget to carry out these tasks. This should be clearly reflected in the envisaged standalone ECHA Founding Regulation.

Regulation (EC) No 1272/2008

Change 46

RemovedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 1: 1. Any advertisement for the sale to the general public of a substance classified as hazardous shall request the user to “always read and follow product label information”, indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.

AddedArticle 1 – paragraph 1 – point 21 a (new), Article 42 – paragraph 3 a (new): (21a) In the Article 42, the following paragraph 3a is added: / "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."

RemovedThe advertisement requirements currently proposed would carry disproportionate burdens, without improving human health and environmental protection. Hazardous substances offered to industrial and professional users must be accompanied by Safety Data Sheets. More specific requirements on advertisement should therefore only be directed to the general public.

Regulation (EC) No 1272/2008

Change 47

RemovedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 2: 2. Any advertisement for the sale to the general public of a mixture classified as hazardous or covered by Article 25(6) shall request the user to “always read and follow product label information”.

AddedArticle 1 – paragraph 1 – point 21 b (new), Article – 43 (new): (21b) The following Article -43 is inserted: / 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 or mixture, or of substances or mixtures, showing that hazardous properties of a substance or mixture or of substances or mixtures 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, adding 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 shown that the substance 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 shown a wide dispersive use of and/or consumer exposu…

RemovedFor the general public, 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. It will also be more straightforward to implement in the context of advertisements, which would otherwise always need to be updated following changes in labels. This is particularly important as “any advertisement” will cover a broad range of advertising materials, including company websites, TV commercials, internet videos, customer presentations, brochures, weekly supermarket circulars and other materials, including updated in case of label changes. Such advertisements are often not made specifically for jurisdictions where CLP is the applicable legislation on hazard communication. Incorporating CLP label elements into a global promotional video will be confusing to non-EU viewers.

Regulation (EC) No 1272/2008

Change 48

RemovedArticle 1 – paragraph 1 – point 24, Article 48a – paragraph 1: Suppliers placing substances or mixtures on the market through distance sales to the general public shall clearly indicate the label elements referred to in Article 17.

AddedArticle 1 – paragraph 1 – point 21 c (new), Article – 43 a (new): (21c) The following Article -43a is added: / Article -43a / Access to justice / 1. Any natural or legal person which has submitted a substantiated concern in accordance with Article -43a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant competent authority under this Regulation. / 2. Member States shall ensure access to administrative or judicial procedures to review their decisions, acts and omissions, in accordance with national law or practice. Decisions, acts and omissions by the Commission shall be subject to review in accordance with Regulation EU (No) 1367/2006. / 3. The procedures referred to in paragraph 2 shall be fair, equitable, timely and not prohibitively expensive while providing adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

RemovedHazardous substances offered to industrial and professional users must be accompanied by Safety Data Sheets. Including a copy of the CLP label in B2B ordering systems will therefore not improve human health and environmental protection. In such cases, the label would often be visible to a procurement agent who has no relation to the way the purchased hazardous substances and mixtures are used by the employees of the purchasing company. The proposed amendment therefore targets the new requirements to distance sales to the general public.

Regulation (EC) No 1272/2008

Change 49

RemovedArticle 1 – paragraph 1 – point 25 – point b, Article 50 – paragraph 3: 3. Where the Agency acts as an appointed body in accordance with Article 45(1a), it shall put in place the tools necessary to provide access to the information to the relevant appointed body or bodies of the appointing Member State to fulfil their tasks with regard to emergency health response and preventative measures. The Agency shall be provided with the adequate resources to support this work, under a separate budgetary line. The ‘ECHA Founding Regulation’ shall take account of these needs.

AddedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 1: 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. Any advertisement for a substance for sale to the general public shall in addition indicate “always read and follow the information on the product label.

RemovedArticle 50 as foreseen provides for the possibility to designate the Agency as the appointed body to receive relevant information for emergency health responses under Article 45. It further tasks the Agency with ensuring the availability of appropriate tools to share information with national appointed authorities so they fulfil their other obligations under Article 45. Therefore, ECHA should be granted adequate resources to carry out these tasks, on a separate budgetary basis.

Regulation (EC) No 1272/2008

Change 50

RemovedArticle 1 – paragraph 1 – point 25 a (new), Article 53 – paragraph 1: (25a) In Article 53, paragraph 1, is replaced by the following: / ‘1. The Commission may adjust and adapt Articles 6(5), 11(3), 12, 14, 18(3)(b), 23, 25 to 29 and 35(2) second and third subparagraph and Annexes I to VII to technical and scientific progress, including opportunities to promote the inclusion of harmonised criteria based on available non-animal approaches, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases, and subject to the provisions of Article 1.1(b)(iv). Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4).’;

AddedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 2: 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. Any advertisement for sale of mixtures to the general public shall, in addition, indicate “always read and follow the information on the product label.

Removed(https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R1272&from=EN)

RemovedAccording to the Rapporteur, this amendment is necessary to ensure that the Commission’s powers to introduce delegated acts are guided by the provisions of Article 1, as amended, to ensure alignment with the Union’s goal of fully replacing animal testing.

Regulation (EC) No 1272/2008

Change 51

RemovedArticle 1 – paragraph 1 – point 29, Article 54 – paragraph 1: 1. The Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011*. The committee shall be provided with the adequate resources to support this work, under a separate budgetary line. This shall be clearly reflected in the ‘ECHA Founding Regulation’.

AddedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 2a (new): 2a. The use of environmental claims, as defined in Article 2, point (o), of Directive 2005/29/EC, is prohibited.

RemovedArticle 54 makes reference to the work of the RAC. In order to carry out future tasks, the committee should be provided with adequate resources. These resources shall be provided under a separate budgetary line. This should be clearly reflected in the envisaged standalone ECHA Founding Regulation.

Regulation (EC) No 1272/2008

Change 52

RemovedArticle 1 – paragraph 1 – point 30, Article 61 – paragraph 7: 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].

AddedArticle 1 – paragraph 1 – point 25 – point -a (new), Article 50 – paragraph 2 – point a: (-a) in Article 50, paragraph 2, point a is amended as following: / "(a) provide industry with up to date technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by this Regulation;"

RemovedDifferentiated dates for substances and mixtures should be introduced in this paragraph, as in paragraph 2 of article 2, allowing 18 months for substances and 24 months for mixtures. This is consistent with the CLP Regulation, and the delegated act for hazard classes.

Regulation (EC) No 1272/2008

Change 53

RemovedArticle 1 – paragraph 1 – point 30 a (new), Article 61 – paragraph 7 a (new): (30a) in Article 61, the paragraph 7a 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 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 24 months [VC1] 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 …

AddedArticle 1 – paragraph 1 – point 25 – point a, Article 50 – paragraph 2 – point b: (b) provide competent authorities with up to date technical and scientific guidance and tools on the operation and implementation of this Regulation and provide support to the helpdesks established by Member States under Article 44.

RemovedDifferentiated dates for substances and mixtures should be introduced in this paragraph, as in 2 of article 2, allowing 18 months for substances and 24 months for mixtures. This is consistent with the CLP Regulation, and the delegated act for hazard classes.

RemovedArticle 2 – paragraph 2 – introductory part: 2. The following provisions shall apply to substances 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]:

RemovedCurrently there is the same application date for substances and mixtures, which makes it very challenging if not impossible for suppliers of mixtures to comply. Given the significance of these changes in the CLP OLP text (first substance, then mixtures), a differentiated timeline should be provided as foreseen in when CLP was first introduced, and as it is also in line with the delegated act on the new hazard classes. A reasonable timeline for application of these provisions would be 18 months for substances and 24 months for mixtures.

RemovedArticle 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) Annex I, points (2), (3), (7), (9) and (10); / (c) Annex II; / (d) Annex III, points (1)(c), (2), (3) and (4).

RemovedCurrently there is the same application date for substances and mixtures, which makes it very challenging if not impossible for suppliers of mixtures to comply. Given the significance of these changes in the CLP OLP text (first substance, then mixtures), a differentiated timeline should be provided as foreseen in when CLP was first introduced, and as it is also in line with the delegated act on the new hazard classes. A reasonable timeline for application of these provisions would be 18 months for substances and 24 months for mixtures.

RemovedArticle 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 = the last day of the month following 17 months 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:

RemovedDifferentiated dates for substances and mixtures should be introduced in this paragraph, as in paragraph 2 of Article 2, allowing 18 months for substances and 36 months for mixtures. This is consistent with the CLP Regulation, and the delegated act for hazard classes

Regulation (EC) No 1272/2008

Change 54

AddedArticle 1 – paragraph 1 – point 25 – point b a (new), Article 50 – paragraph 3 a (new) and 3 b (new): (ba) the following paragraphs are added: / “3a. The Agency shall be provided with adequate resources to support its work. / 3b. In order to provide adequate expertise, support, and thorough scientific evaluations, appropriate and stable funding for the Agency shall be ensured.”

Regulation (EC) No 1272/2008

Change 55

AddedArticle 1 – paragraph 1 – point 26 – point -a (new), Article 53 – paragraph 1: (-a) In Article 53, paragraph 1 is replaced by the following: / "1. The Commission may adjust and adapt Articles 6(5), 11(3), 12, 14, 18(3)(b), 23, 25 to 29 and 35(2) second and third subparagraph and Annexes I to VII to technical and scientific progress, including the promotion of alternative methods for assessment of hazards of substances and mixtures, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4)."

Regulation (EC) No 1272/2008

Change 56

AddedArticle 1 – paragraph 1 – point 26 – point a, Article 53 – paragraph 1a: 1a. The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend section 1.6. of Annex I in order to adapt the label elements referred to in Article 34a(2) to technical progress or to the level of digital readiness among all population groups in the Union. When adopting those delegated acts, the Commission shall ensure a high level of protection of human health and the environment and take into account societal needs. The Commission shall make sure that information which is critical to protect human health and the environment shall be easily accessible on the label;

Regulation (EC) No 1272/2008

Change 57

AddedArticle 1 – paragraph 1 – point 26 – point a, Article 53 – paragraph 1b – point d: (d) take into account the level of digital readiness among all population groups in the Union, as well as the readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals;

Regulation (EC) No 1272/2008

Change 58

RemovedAnnex I – paragraph 1 – point 3, Annex I - part I – point 3: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

AddedArticle 1 – paragraph 1 – point 26 – point b, Article 53 – paragraph 2: 2. The Commission or the Member States acting in the interest of the Union shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances as well the development of criteria for immunotoxic and neurotoxic substances as well as alternative test methods, including new approach methods and in particular non-animal methods at the level of the UN to address existing and emerging hazard classes.;

RemovedThe new rules for formatting labels are too stringent and too specific, particularly those prescribing a minimum font size and spacing requirements. A slight increase in font size would increase legibility, but the proposed increase is unnecessary and impractical: it would make current label sizes unusable for the majority of products and would reduce the number of languages that can be placed on one label and thus, considerably limit flexibility. In addition, companies would need new or updated software’s to manage those requirements. Therefore, we suggest to reach a common ground by maintaining the minimum font size (while increasing it/per category) and eliminating the part 1.2.1.5, as specific formatting rules should be kept in the guidance document. This approach has been underlined also by ECHA Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 Version 4.2 March 2021, according to which: ”Readability is determined by the combination of font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.”. Overly prescriptive additional requirements regarding font size, distance between two lines and background colour are not justified and severely limit the flexibility of suppliers. It is sufficient if the label or fold-out label is easily readable and clearly stand out from the background. In fact, the additional requirements would hinder the free movement of products in the Single Market, which in turn would entail an adjustment of logistics.

Regulation (EC) No 1272/2008

Change 59

RemovedAnnex II a (new), Annex VI: ANNEX IIa / 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 group(s) of substances, the dossier shall include scientific justification (based on assessment of available data on physico-chemical, ecotoxicological and toxicological properties as specified in REACH Annex XI (1.5)) using a weight of evidence approach, for the grouping of substances and for applying a similar classification. / — Justification for other effects at Community level / For other effects than carcinogenity, mutagenicity, reprotoxicity 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.’.

AddedArticle 1 – paragraph 1 – point 26 – point c, Article 53 – paragraph 3: 3. The Commission shall promote and 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, including new approach methods and in particular non-animal test methods, at least every three years, and adopt delegated acts in accordance with Article 53a, to update Annex I to this Regulation to reflect such technical progress, if relevant. The Commission shall adopt a delegated act in accordance with Article 53a to update Annex I to this Regulation no more than twelve months after non-animal data are included in harmonised criteria for classification and labelling at the level of the UN.