BETA

Activities of Pietro FIOCCHI related to 2022/0432(COD)

Plenary speeches (1)

2023/10/03
Dossiers: 2022/0432(COD)

Shadow reports (1)

2023/09/21
Committee: ENVI
Dossiers: 2022/0432(COD)
Documents: PDF(302 KB) DOC(131 KB)
Authors: [{'name': 'Maria SPYRAKI', 'mepid': 125064}]

Amendments (44)

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Recital 2

(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).deleted

2023/05/16
Committee: ENVI

Proposal for a regulation
Recital 2

(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. I~~and 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-~~substances with more than one 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~~the substance with more than one constituents is not available~~, multi- constituent~~ and where relevant data on individual constituents is available, these 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-constituentsubstances. _________________ 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)substances.

2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
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-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-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 substances are used in those cases.deleted

2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Recital 7 a (new)

(7a) Disposable electronic cigarettes and single use cartridges may contain a nicotine-containing mixture classified as having acute oral and/or acute dermal toxicity properties. However, the mixtures contained in these products cannot directly be ingested or touched. Therefore, it is appropriate to provide for labelling exemptions for these products, unless the mixtures contained are classified as having acute inhalation toxicity and/or respiratory sensitisation properties. This is without prejudice to specific EU and national legislation on the marketability of the mixtures contained.

2023/05/16
Committee: ENVI

Proposal for a regulation
Recital 11

(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size~~, whilst it does not provide for a minimum font size of labels that would ensure readability~~. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels~~, while readability of labels should be ensured by laying down minimum font size and formatting requirements~~.

2023/05/16
Committee: ENVI

Proposal for a regulation
Recital 11

(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size~~, whilst it does not provide for a minimum font size of labels that would ensure readability~~. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while readability of labels should be ensured by ~~lay~~adding ~~down minimum font size and formatting requirements~~more examples of label in the Guidance on Labelling and Packaging.

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) 1272/2008
Article 2 – point 7a

7a. ‘~~multi-constituent~~ substance’ means a substance that contains more than one constituent. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 2, point 7a)

2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3

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2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3

A ~~multi-constituent~~ substance containing at least 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. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 2

For the evaluation of ~~multi-constituent~~these substances pursuant to Chapter 2 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~~ and ‘hazardous to the aquatic environment’ 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.~~1 of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, 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.~~ , impurities and additives in the substance. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art, 5 - paragraph 3 (new))

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 5

For the evaluation of ~~multi-constituent~~these substances pursuant to Chapter 2 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~~3 and 4.4~~.2.3.2~~ of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, 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.~~ , impurities or additives in the substance (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 5 - paragraph 3 (new))

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3 a (new)

In Article 5, the following paragraph 3a is added: '3a. Paragraph 3 shall not apply to UVCB substances of biological origin.'

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 6

Regulation (EC) 1272/2008
Article 9 – paragraph 3

3. Where the criteria referred to in paragraph 1 cannot be applied directly to all available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (in Article 9, paragraphs 3 and 4 are replaced by the following:)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)

Regulation (EC) 1272/2008
Article 10 a (new)

(7a) The following Article 10 a is added: The proposed classification of a substance or mixture shall be accompanied by a socio-economic impact assessment. The assessment shall evaluate potential social and economic impacts associated with the proposed classification. This report is to be conducted by the party submitting the classification proposal and by the industry whose substance is subject to classification. The socio-economic impact assessment shall include, but not be limited to, the following: a) Economic implications, including potential effects on jobs, the competitive position of the EU industry, and the cost of compliance with the proposed classification and who will bear such cost. b) Social implications, including potential effects on consumer/industry access to goods and services, job loss and competitivity. A third party shall review the socio- economic impact assessment as part of the classification process for a comprehensive and neutral review. Parts of the socio- economic impact assessment could be made publicly available, subject to the protection of confidential business information (CBI).

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 7 b (new)

Regulation (EC) 1272/2008
Article 10 b (new)

(7b) The following Article 10 b is added: In the process of classifying a substance or mixture under CLP regulation, it shall be necessary to identify, assess, and clearly communicate the regulatory links between the CLP Regulation and other relevant pieces of EU legislation. This is to ensure consistent and effective risk management across all relevant regulatory contexts and prevent double regulation. The downstream impact assessment shall take into account case- specific factors. For example, in cases where a substance is present as an impurity in other substances or mixtures, the impact assessment should consider the socio-economic implications for industries relying on the recycling of these substances or mixtures. This is specially relevant for special mixtures such as metals and inorganics. The European Chemicals Agency (ECHA), in cooperation with relevant national authorities, shall ensure that the consequences of proposed classifications, including the regulatory links and downstream impacts, are clearly communicated to all relevant stakeholders to prevent classifications from existing in a vacuum disconnected from the other pieces of legislation affecting the substance or mixture in question. The assessment of regulatory links and downstream impacts, and the communication of these links and impacts, shall be regularly reviewed and updated as part of the continuous evolution of the CLP regulation and in light of new scientific evidence or changes in socio-economic conditions.

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 7 c (new)

Regulation (EC) 1272/2008
Article 10 c (new)

(7c) The following Article 10 c is added: When calculating the concentration of a classified substance in a special mixture, such as those containing metals and other inorganic substances, specific considerations shall apply. This is in recognition of the fact that these mixtures may have distinct properties and behaviours compared to mixtures of organic chemical substances. Rather than calculating the concentration of a classified substance in a special mixture using the full mixture weight, a different method shall be employed. This method shall be based on a scientifically valid approach that considers the specific physical, chemical, and toxicological properties of the classified substance and the nature of the special mixture. The European Chemicals Agency (ECHA) and steered by the Commission shall provide detailed guidance on the adjusted calculation method for special mixtures. This guidance shall be developed in consultation with relevant scientific experts and industry stakeholders, steered by the European Commission, and shall be regularly reviewed and updated in light of new evidence. The adjusted calculation method for special mixtures, and the associated guidance from ECHA, shall be taken into account when implementing and enforcing other relevant pieces of EU legislation, including but not limited to the SEVESO Directive. This is to ensure a consistent and fair approach to the classification and management of special mixtures across all regulatory contexts.

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 7 d (new)

Regulation (EC° 1272/2008
Article 10 d (new)

(7d) The following Article 10 d is added: The Competent Authorities for REACH and CLP (CARACAL) platform shall enhance its transparency beyond meeting agendas. This includes making meeting minutes, including discussions and decisions related to CLP classification proposals, publicly available. All such information shall be made accessible in a user-friendly manner to facilitate understanding by non-expert stakeholders. In recognition of the specific interests and expertise of industry stakeholders, special measures shall be taken to ensure their informed participation in the CLP classification process. This includes, but is not limited to, providing clear and comprehensive information on the classification process and its implications for industry, and facilitating industry representation in CARACAL discussions.

2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Article 1 – paragraph 1 – point 8

Regulation 1272/2008
Article 23 – paragraph 1 – point e a (new)

In Article 23, the following point ea is added: '(ea) disposable electronic cigarettes, single use cartridges and refill containers as defined in Directive 2014/40/EU.'

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point a

Regulation (EC) 1272/2008
Article 29 – paragraph 1

1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label or a fold-out label in the languages of the Member ~~State~~ in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with sections 1.5.1.1. and 1.5.1.2. of Annex I.; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 29 - paragraph 1)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 12

Regulation (EC) 1272/2008
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 618 months after the results of the new evaluation referred to in Article 15(4) were obtained. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 30 - paragraph 1)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 13

Regulation (EC) 1272/2008
Article 31– paragraph 3

3. The label elements referred to in Article 17(1) shall be clearly and indelibly marked. They shall stand out clearly from the background and they shall be of such size and spacing as to be easily read. (Th~~ey shall be formatted in accordance with section 1.2.1 of Annex I.;~~ is amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 31- paragraph 3Justification)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) 1272/2008
Article 34b – paragraph 1 – point d

(d) the digital label shall be accessible free of charge, without the need to register, download or install specific applications, or to provide a password; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 34)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) 1272/2008
Article 34b – paragraph 1 – point f

~~(f) the information on the digital label shall be accessible with no more than two clicks;~~ deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 34)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 15

Regulation (EC) 1272/2008
Article 34b – paragraph 1 – point h

(h) when the digital label is available in more than one language, the choice of language shall not be ~~conditioned on the geographical location;~~ restricted by geographical location; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 34)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point f

Regulation (EC) 1272/2008
Article 37 – paragraph 8 a (new)

In Article 37, the following paragraph 8a is added: '8a. Without prejudice to paragraphs 1 to 5, in the case that additional classification criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I, are integrated to this regulation, new data in relation to those criteria and available to manufacturers, importers and downstream users, not having been previously submitted for evaluation under the processes of Regulation (EC) No. 1107/2009 or Regulation (EU) No 528/2012 or Regulation (EU) No 2017/2100, shall be evaluated at minimum through a simplified process by the Risk Assessment Committee of the Agency before inclusion in Table 3.2 of Part 3 of Annex VI of conclusions on classification and labelling relating to the criteria concerned.' (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 21

Regulation (EC) 1272/2008
Article 42 – paragraph 1 – subparagraph 3

(21) in Article 42(1), the third subparagraph is replaced by the following: ‘The following information shall be made publicly available free of charge online: (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; (b) in the case of group notifications, the identity of the importer or manufacturer submitting the information on behalf of the other members of the group; (c) information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006. The Agency shall grant access to the information in the inventory that concerns a substance and is not referred to in the first subparagraph to other parties subject to Article 118 of Regulation (EC) No 1907/2006.;’deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 23

Regulation (EC) 1272/2008
Article 48

(23) Article 48 is replaced by the following: ‘Article 48 Advertisement 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. 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.’ deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 48)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 24

Regulation (EC) 1272/2008
Article 48 a

~~(24) the following Article 48a is added: ‘Article 48a Distance sales offers Su~~deleted (This amendment appliers ~~placing substances or mixtures on the market through distance sales shall clearly indicate the label elements referred to i~~throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article ~~17.;’~~ 48 a)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 30

Regulation (EC) 1272/2008
Article 61 – paragraph 7

Substances ~~and 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 1824 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]. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 61 – paragraph 7))

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 30

In the Article 61, the following 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 36 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 60 months after the date of entry into force of this Regulation].’ (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 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]:

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 2 – point d a (new)

(da) 2a. The following provisions shall apply to mixtures from [OP: please insert the date = the first day of the month following 36 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.

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 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 and mixtures 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 mixture 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:

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008
Annex I – part 1 – section 1.2.1.4

The dimensions of the label and of each pictogram~~, and the font size of letters shall be as follows:~~ shall be as follows: (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Annex I, 1.2.1.4)

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex I – paragraph 1 – point 2

Regulation (EC) No 1272/2008
Annex I – part 1 – section 1.2.1.4. – Table 1.3 – title

Minimum dimensions of labels, and pictograms ~~and font size~~ (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Annex I, 1.2.1.4)

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex I – Paragraph 1 – point 2

Regulation (EU) No 1272/2008
Annex I – Part 1 – Section 1.2.1.4. – Table 1.3

Capacity of the Dimensions of the Dimensions of each ~~Minimum font-size~~ package label (in pictogram (in millimetres) for the millimetres) information required by Article 17 Not exceeding 3 If possible, at least Not smaller than ~~8pt~~ litres: 52x74 10x10 If possible, at least ~~16x16~~ 16x16 Greater than 3 At least 74x105 At least 23x23 ~~12pt~~ litres but not exceeding 50 litres: Greater than 50 At least 105x148 At least 32x32 ~~16pt~~ litres but not exceeding 500 litres: Greater than 500 At least 148x210 At least 46x46 ~~20pt’;~~ litres:

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008
Annex I – Part 1 – point 2– Section 1.2.1.5

1.2.1.5. The text on the label shall have the following characteristics: (a) the background of the label shall be white; (b) shall be equal or above 120 % of the font size; (c) easily legible and without serifs; (d) the letter spacing shall be appropriate for the selected font to be comfortably legible. For the labelling of inner packaging where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains legible for a person with average eyesight, where itis deemed important to place the most critical hazard statement and where the outer packaging meets the requirements of Article 17.deleted the distance between two lines a single font shall be used that is (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5

The text on the label shall have the following characteristics: (a) be white; (b) shall be equal or above 120 % of the font size; (c) easily legible and without serifs; (d) appropriate for the selected font to be comfortably legible.deleted the background of the label shall the distance between two lines a single font shall be used that is the letter spacing shall be (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex I – paragraph 1 – point 3

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5 – paragraph 2

For the labelling of inner packaging where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains legible for a person with average eyesight, where itis deemed important to place the most critical hazard statement and where the outer packaging meets the requirements of Article 17. deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Annex I – paragraph 1 – point 4 a (new)

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.3.7 a (new)

(4a) In Part 1 of Annex I, the following Section 1.3.7.a is added: 1.3.7.a Mixtures designed to be inhaled via electronic cigarettes and contained in refill containers The labelling elements referred to in Article 17(1) shall only be provided on the outer packaging of disposable electronic cigarettes and single use cartridges. The elements referred to in Article 17(1) (d) to (g) shall only apply if the mixture contained is classified as having respiratory sensitisation and/or acute inhalation toxicity properties. This applies accordingly to the application of Articles 48 and 48a. For refill containers, the label elements in accordance with the first subparagraph of Article 17(2) shall be provided in accordance with sections 1.5.1 and 1.5.1.2 of Annex I. A tie-on tag shall not be used.

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex I – paragraph 1 – point 4 a (new)

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.3.7. a (new)

(4a) In Point 1 of Annex I, the following Section 1.3.7.a is added: 1.3.7.a By derogation from Article 5(3), hydrocarbon substances with more than one constituent, impurity or additive, can be classified using all available reliable whole substance or constituent data in a weight of evidence approach according to Regulation (EC) No 1907/2006 (Annex XI section 1.5 Grouping of substances and read-across approach).

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point e

(e) overfilling packaging is ~~technically prevented;~~prevented by technical or organisational means (f) filling a substance or mixture into unsuitable packaging is prevented by technical or organisational means; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex II – paragraph 1 – point 1

Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4 – point ii

(ii) Specific target organ toxicity – Single exposure, categories 1~~, 2 and 3;~~ and 2; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI

Proposal for a regulation
Annex II – paragraph 1 – point 2

Regulation (EC) No 1272/2008
Annex II – Part 5 – paragraph 2

‘For a substance or a mixture supplied at a f~~illing~~uel service station and directly pumped into a receptacle, thate forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the label elements referred to in Article 17 shall be provided on the respective pump.;llowing label elements shall be provided on or next to the respective pump: Product identifier for the substance or trade name or designation of the mixture; Hazard pictogram; Hazard and precautionary statements; Signal word. Fuel service stations shall not be considered as refill stations in the sense of Annex II part 3.4.’ (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

2023/05/16
Committee: ENVI