Legal provisions of COM(2022)748 - Amendment of Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2022)748 - Amendment of Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures. |
|---|---|
| document | COM(2022)748  |
| date | December 19, 2022 |
Article 1
(1) in Article 1(1), the following point (f) is added:
‘(f) providing an obligation for downstream users, importers and distributors referred to in Article 45(1) to submit information relevant for providing an adequate emergency health response to appointed bodies in accordance with Annex VIII.’;
(2) in Article 2, the following points 7a and 38 are added:
‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.
38. ‘acute toxicity estimates’ means numeric criteria according to which substances and mixtures are classified in one of four acute toxicity hazard categories based on the oral, dermal or inhalation exposure route.’;
(3) in Article 4, paragraph 10 is replaced by the following:
‘10. A substance or a mixture shall not be placed on the market unless a supplier has ensured in the course of an industrial or professional activity that the substance or the mixture fulfils the requirements set out in this Regulation.’;
(4) in Article 5, the following paragraph 3 is added:
‘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.
For the evaluation of multi-constituent 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 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.
Relevant available information on the multi-constituent substance itself shall be taken into account where one of the following conditions are met:
(a)the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disrupting properties for human health or the environment;
(b)the information supports the conclusions based on the relevant available information on the constituents in the substance.
Relevant available information on the multi-constituent substance itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance.
For the evaluation of multi-constituent 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 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.
Relevant available information on the multi-constituent substance itself shall be taken into account where one of the following conditions are met:
(a)the information demonstrates biodegradation, persistence, mobility and bioaccumulation properties.
(b)the information supports the conclusions based on the relevant available information on the constituents in the substance.
Relevant available information on the multi-constituent substance itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance.
(5) in Article 6, paragraphs 3 and 4 are replaced by the following:
‘3. For the evaluation of mixtures 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 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 .
However, where the available test data on the mixture itself demonstrates germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disrupting properties for human health or the environment 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.
4. For the evaluation of mixtures pursuant to Chapter 2 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 ’;
(6) in Article 9, paragraphs 3 and 4 are replaced by the following:
‘3. Where the criteria referred to in paragraph 1 cannot be applied directly to 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.
4. When evaluating hazard information for mixtures, manufacturers, importers and downstream users shall, where test data for the mixture itself are inadequate or unavailable, apply the bridging principles referred to in section 1.1.3. of Annex I and in each section of Parts 3 and 4 of that Annex for the purposes of the evaluation.
When applying the bridging principles, manufacturers, importers and downstream users may integrate 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 mixture, and in accordance with section 1.2. of Annex XI to Regulation (EC) No 1907/2006. The rules on bridging principles in section 1.1.3 of Annex I shall remain applicable even in a weight of evidence determination.
When evaluating the hazard information for mixtures, manufacturers, importers and downstream users shall, where that information does not permit the application of the bridging principles in accordance with the first and second subparagraphs, evaluate the information by applying the other method or methods set out in Parts 3 and 4 of Annex I.’;
(7) Article 10 is replaced by the following:
‘Article 10
Concentration limits, M-factors and acute toxicity estimates for classification of substances and mixtures
1. Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.
Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when the substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I.
In exceptional circumstances specific concentration limits may be set by the manufacturer, importer or downstream user where that manufacturer, importer or downstream user has adequate, reliable and conclusive scientific information that a hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.
2. M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, shall be established by manufacturers, importers and downstream users.
3. Acute toxicity estimates for substances classified as acutely toxic for human health shall be established by manufacturers, importers and downstream users.
4. By way of derogation from paragraph 1, specific concentration limits shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which a specific concentration limit is given in that Part.
5. By way of derogation from paragraph 2, M-factors shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an M-factor is given in that Part.
6. By way of derogation from paragraph 3, acute toxicity estimates shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an acute toxicity estimate is given in that Part.
7. When setting the specific concentration limit, M-factor or acute toxicity estimate, manufacturers, importers and downstream users shall take into account any specific concentration limits, M-factors or acute toxicity estimate for that substance which have been included in the classification and labelling inventory.
However, where an M-factor is not given in Part 3 of Annex VI for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, an M-factor based on available data for the substance shall be set by the manufacturer, importer or downstream user. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, this M-factor shall be used.
8. Specific concentration limits set in accordance with paragraph 1 shall take precedence over the concentration limits set out in the relevant sections of Part 2 of Annex I or the generic concentration limits for classification set out in the relevant sections of Parts 3, 4 and 5 of that Annex.
9. The Agency shall provide further guidance for the application of paragraphs 1, 2 and 3.
10. Where a mixture contains a substance which is classified as hazardous solely due to the presence of an identified impurity, additive or individual constituent, the concentration limits referred to in paragraph 1 shall apply to the concentration of that identified impurity, additive or individual constituent in the mixture.
11. Where a mixture contains another mixture, the concentration limits referred to in paragraph 1 shall apply to the concentration of the identified impurity, additive or individual constituent referred to in paragraph 10 in the resulting final mixture.’;
(8) in Article 23, the following point (g) is added:
‘(g) ammunition as defined in Article 1(1), point (3), of Directive (EU) 2021/555 of the European Parliament and of the Council* unless it falls within the definition of an article in Article 2, point (9), of this Regulation.
* Directive (EU) 2021/555 of the European Parliament and of the Council of 24 March 2021 on control of the acquisition and possession of weapons (OJ L 115, 6.4.2021, p. 1).’;
(9) Article 25 is amended as follows:
(a)in paragraph 6, the first subparagraph is replaced by the following:
(10) ‘6. The specific labelling rules set out in Part 2 of Annex II shall apply to mixtures containing substances referred to in that Annex.’;
(a)the following paragraph 9 is added:
‘9. Label elements resulting from requirements set out in other Union acts shall be placed in the section for supplemental information on the label.’;
(11) Article 29 is amended as follows:
(a)paragraph 1 is replaced by the following:
‘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.’;
(b)paragraph 3 is replaced by the following:
‘3. Where a hazardous substance or mixture referred to in Part 5 of Annex II is supplied to the general public without packaging, the labelling information shall be provided in accordance with the provision referring to that substance or mixture in that Part.’;
(c)the following paragraphs 4b and 4c are inserted:
‘4b. By derogation from Article 17(1), the labelling requirement set out in that Article shall not apply to packaging of ammunition that is used by defence forces in combat zones or shipped to such zones where labelling in accordance with that requirement would constitute an unacceptable security risk for the cargo, the soldiers and the staff, and sufficient camouflaging cannot be ensured.
4c. Where paragraph 4b applies, manufactures, importers or downstream users shall provide to the defence force the safety data sheet or a leaflet containing the information referred to in Article 17(1).’;
(12) Article 30 is replaced by the following:
‘Article 30
Updating information on labels
1. In case of a change regarding the classification and labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier shall ensure that the label is updated within 6 months after the results of the new evaluation referred to in Article 15(4) were obtained.
2. Where a change regarding the classification and labelling of a substance or a mixture is required other than that referred to in paragraph 1, the supplier shall ensure that the label is updated within 18 months after the results of the new evaluation referred to in Article 15(4) were obtained.
3. Paragraphs 1 and 2 shall not apply where a change regarding the classification and labelling of a substance or a mixture was triggered by a harmonised classification and labelling of a substance set out in a delegated act adopted pursuant to Article 37(5) or by a provision set out in a delegated act adopted pursuant to Article 53(1). In such cases, the supplier shall ensure that the label is updated by the date set out in the respective delegated act.
4. The supplier of a substance or mixture that falls within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall update the label in accordance with those Regulations’;
(13) in Article 31(3), the following sentence is added:
‘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. They shall be formatted in accordance with section 1.2.1 of Annex I.’;
(14) in Article 32, paragraph 6 is deleted;
(15) in Title III, the following Chapter 3 is added:
‘CHAPTER 3
Formats of the labelling
Article 34 - a Physical and digital labelling
1. The label elements referred to in Article 17 shall be provided:(a) on a label in a physical form (‘physical label’); or
(b) both on a physical label and on a label in a digital form (‘digital label’).
2. By way of derogation from paragraph 1, the suppliers may provide the label elements set out in section 1.6. of Annex I on a digital label only.
Article 34 - b Requirements for digital labelling
1. The digital label for substances and mixtures shall satisfy the following general rules and technical requirements:(a)all label elements referred to in Article 17(1) shall be provided in one place and separated from other information;
(b)the information on the digital label shall be searchable;
(c)the information on the digital label shall be accessible to all users in the Union,
(d)the digital label shall be accessible free of charge, without the need to register, download or install applications, or to provide a password;
(e)the information on the digital label shall be presented in a way that also addresses the needs of vulnerable groups and support, as relevant, the necessary adaptations to facilitate access to the information by those groups;
(f)the information on the digital label shall be accessible with no more than two clicks;
(g)the digital label shall be accessible through digital technologies widely used and compatible with all major operating systems and browsers;
(h)when the digital label is available in more than one language, the choice of language shall not be conditioned on the geographical location;
(i)the link to the digital label shall be printed or placed physically, visibly and legibly on the product in such a way that it can be processed automatically by digital devices widely used by consumers;
(j)the digital label shall remain available for a period of 10 years, including after an insolvency, a liquidation or a cessation of activity in the Union of the supplier that created it, or for such longer period required under other Union legislation covering the information that it contains.
2. Suppliers shall provide, on oral or written demand or when the digital label is temporarily unavailable at the time of purchase of the substance or mixture, the label elements provided on a digital label only in accordance with Article 34a(2) by alternative means. Suppliers shall provide those elements independently of a purchase and free of charge.
3. It is prohibited to track, analyse or use any usage information for purposes going beyond what is absolutely necessary for provision of digital labelling’;
(16) in Article 35, the following paragraph 2a is added:
‘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.’;
(17) in Article 36, paragraph 1 is amended as follows:
(a)point (a) is replaced by the following:
‘(a) respiratory sensitisation, category 1, 1A or 1B (Annex I, section 3.4.)’;
(b)the following points (e) to (j) are added:
‘(e) endocrine disruption for human health, category 1 or 2 (Annex I, section 3.11.);
(f) endocrine disruption for the environment, category 1 or 2 (Annex I, section 4.2.);
(g) persistent, bioaccumulative and toxic (PBT) (Annex I, section 4.3.);
(h) very persistent, very bioaccumulative (vPvB) (Annex I, section 4.3.);
(i) persistent, mobile and toxic (PMT) (Annex I, section 4.4.);
(j) very persistent, very mobile (vPvM) (Annex I, section 4.4).’;
(c)paragraph 2 is replaced by the following:
‘2. Substances that are active substances falling within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) 528/2012 shall be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37(1), (4), (5) and (6) shall apply.’;
(18) Article 37 is amended as follows:
(a)paragraph 1 is replaced by the following:
‘1. A competent authority may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof.
The Commission may ask the Agency or the European Food Safety Authority established in accordance with Article 1(2) of Regulation (EC) No 178/2002* to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency.
The proposals referred to in the first and the second subparagraphs shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.
* Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p.1)’;
(b)in paragraph 2, the first subparagraph is replaced by the following:
‘2. Manufacturers, importers or downstream users of substances may submit to the Agency a proposal for harmonised classification and labelling of those substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, provided that there is no entry in Part 3 of Annex VI for such substances in relation to the hazard class or differentiation covered by that proposal.’;
(c)the following paragraph 2a is inserted:
‘2a. Before submitting a proposal to the Agency, a competent authority, manufacturer, importer or downstream user shall notify the Agency of its intention to submit a proposal for harmonised classification and labelling and, in the case of the Commission, the request to the Agency or the European Food Safety Authority to prepare such proposal.
Within one week from receipt of the notification, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance(s), the status of the proposal and the name of the submitter. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in Article 37(4) and (5).
Where a competent authority receives a proposal in accordance with paragraph 6, it shall notify the Agency and provide any relevant information on its reason for accepting or refusing the proposal. The Agency shall share that information with the other competent authorities.’;
(d)paragraph 3 is replaced by the following:
‘3. Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of substances in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission in accordance with the procedure referred to in Article 54(2).’;
(e)paragraphs 5 and 6 are replaced by the following:
‘5. The Commission shall adopt without undue delay, 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.
Where, in the case of harmonisation of classification and labelling of substances, imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.
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.’;
(f) The following paragraphs 7 and 8 are inserted:
‘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 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.
The inclusion of the substances, referred to in the first subparagraph, in Table 3 of Part 3 of Annex VI to this Regulation shall be carried out on the basis of the respective criteria for which those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.’
8. The Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI by inclusion of substances 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. the delegated act on the new hazard classes - reference to be added once adopted] those substances have not been approved, under Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 or have been approved with derogation in accordance with the relevant provisions of those Regulations, due to either of the following characteristics:
(a) endocrine disruptor in accordance with Section 3.6.5 or Section 3.8.2 of Annex II to Regulation (EC) No 1107/2009;
(b) persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with Section 3.7.2. or 3.7.3. of Annex II to Regulation (EC) No 1107/2009;
(c) endocrine disruptor for human health or for the environment in accordance with Article 1 of Commission Delegated Regulation (EU) 2017/2100*;
(d) persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with Article 5(1), point (e), of Regulation (EU) No 528/2012.
The inclusion of the substances, referred to in the first subparagraph, in Table 3 of Part 3 of Annex VI shall be carried out on the basis of the respective criteria that they meet in accordance with the acts referred to in that subparagraph, points (a) to (d).’;
* Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301 of 17.11.2017 p.1.’;
(19) In Article 38(1), point (c) is replaced by the following:
‘(c) the specific concentration limits, M-factors or acute toxicity estimates, where applicable;’;
(20) Article 40 is amended as follows:
(a)paragraph 1, the first subparagraph is amended as follows:
(i) point (e) is replaced by the following:
‘(e) specific concentration limits, M-factors or acute toxicity estimates, where applicable, in accordance with Article 10, together with a justification referred to in the relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;’
(ii) points (g) and (h) are added:
‘(g) where applicable, the reason for divergence from the most severe classification per hazard class included in the inventory referred to in Article 42;
(h) where applicable, the reason for introducing a more severe classification per hazard class compared to those included in the inventory referred to in Article 42.’;
(b)paragraph 2 is replaced by the following:
‘2. The information listed in paragraph 1 shall be notified to the Agency by the notifier(s) concerned at the latest 6 months after a decision to change the classification and labelling of the substance has been taken pursuant to the review referred to in Article 15(1).’;
(21) in Article 42(1), the third subparagraph is replaced by the following:
‘3. 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.’;
(22) Article 45 is amended as follows:
(a)paragraph 1 is replaced by the following:
‘1. Member States shall appoint a body or bodies responsible for receiving the relevant harmonised information relating to emergency health response and preventative measures, in accordance with Annex VIII.’;
(b)the following paragraphs 1a, 1b and 1c are inserted:
‘1a. Member States may appoint the Agency as the body responsible for receiving information relating to emergency health response and preventative measures referred to in paragraph 1.’;
1b. Importers and downstream users placing on the market mixtures that are classified as hazardous on the basis of their health effects or physical effects, shall submit to the body or bodies appointed in accordance with paragraph 1 the harmonised information referred to in Part B of Annex VIII.
1c. Distributors placing on the market mixtures that are classified as hazardous on the basis of their health effects or physical effects, shall submit to the appointed body or bodies the harmonised information referred to in Part B of Annex VIII where they further distribute those mixtures in other Member States, or where they rebrand or relabel the mixtures. This obligation does not apply if the distributors can demonstrate that the appointed body or bodies already received the same information from importers or downstream users.’;
(c)in paragraph 2, point (b) is replaced by the following:
‘(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.’;
(d)paragraph 3 is replaced by the following:
‘3. The appointed bodies shall have at their disposal all the information required from importers, downstream users and distributors referred to in paragraph 1c, to carry out the tasks for which they are responsible.’;
(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.
(24) the following Article 48a is added:
‘Article 48a
Distance sales offers
Suppliers placing substances or mixtures on the market through distance sales shall clearly indicate the label elements referred to in Article 17.’;
(25) Article 50 is amended as follows:
(a)in paragraph 2, point (b) is replaced by the following:
‘(b) provide competent authorities with 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.’;
(b)the following paragraph 3 is added:
‘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.’
(26) Article 53 is amended as follows:
(a)the following paragraphs 1a to 1b are inserted:
‘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 take into account the societal needs and a high level of protection of human health and the environment;
1b. In order to adjust to technological changes and (future) developments in the field of digitalisation, the Commission is empowered to adopt delegated acts in accordance with Article 53a to supplement this Regulation by laying down further details on the requirements for the digital labelling referred to in Article 34b. Those requirements shall cover, in particular, the IT solutions which may be used, and the alternative means for providing the information. When adopting those delegated acts, the Commission shall:
(a) ensure coherence with other relevant Union acts;
(b) encourage innovation;
(c) ensure technological neutrality by applying no constraints or prescriptions on choices of technology or equipment, within the bounds of compatibility and interference avoidance;
(d) take into account the level of digital readiness among all population groups in the Union;
(e) ensure that digitalisation does not compromise the protection of human health and the environment.
(b)paragraph 2 is replaced by the following:
‘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 as alternative test methods at the level of the UN.’;
(c)the following paragraph 3 is added:
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.
(27) Article 53a is amended as follows:
(a)in paragraph 2, the first sentence is replaced by the following:
‘The power to adopt delegated acts referred to in Articles 37(5), 37(7), 37(8), 45(4) 53(1), 53(1a) and 53(1b) 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] ’;
(b)in paragraph 3, the first sentence is replaced by the following:
‘The delegation of power referred to in Articles 37(5), 37(7) and 37(8), 45(4), 53(1), 53(1a) and 53(1b), may be revoked at any time by the European Parliament or by the Council.’;
(c) in paragraph 6, the first sentence is replaced by the following:
‘A delegated act adopted pursuant to Articles 37(5), 37(7), 37(8), 45(4) 53(1), 53(1a) and 53(1b), 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.’;
(28) Article 53c is replaced by the following:
‘Article 53c
Separate delegated acts for different delegated powers
The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation, with the exception of amendments to Annex VI, where Parts 1 and 2 of that Annex may be amended together with Part 3 of that Annex in one single act.’;
(29) Article 54 is replaced by the following:
‘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*.’;
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
* Regulation (EU) 182/2011 …’;
(30) in Article 61, the following paragraph 7 is added:
‘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 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].
* Regulation (EU) .../... of the European Parliament and of the Council of ... on ... (OJ ...).’;
(31) Annex I is amended as set out in Annex I to this Regulation;
(32) Annex II is amended as set out in Annex II to this Regulation;
(33) Annex VIII is amended as set out in Annex III to this Regulation.
ANNEX I
Part 1 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:
(1) Section 1.1.1.3. is replaced by the following:
‘1.1.1.3. A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, relevant animal data, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. For substances, information from the application of the category approach (grouping, read-across) and (Q)SAR results are also considered. The quality and consistency of the data shall be given appropriate weight. Information on substances related to the substance being classified shall be considered, as appropriate. Information on substances or mixtures related to the mixture being classified shall be considered in accordance with Article 9(4). Information on the site of action and the mechanism or mode of action study results shall also be considered. Both positive and negative results shall be assembled together in a single weight of evidence determination.’;
(2) Section 1.2.1.4. is replaced by the following:
‘1.2.1.4. The dimensions of the label and of each pictogram, and the font size of letters shall be as follows:
Table 1.3
Minimum dimensions of labels, pictograms and font size
| Capacity of the package | Dimensions of the label (in millimetres) for the information required by Article 17 | Dimensions of each pictogram (in millimetres) | Minimum font-size |
| Not exceeding 3 litres: | If possible, at least 52x74 | Not smaller than 10x10 If possible, at least 16x16 | 8pt |
| Greater than 3 litres but not exceeding 50 litres: | At least 74x105 | At least 23x23 | 12pt |
| Greater than 50 litres but not exceeding 500 litres: | At least 105x148 | At least 32x32 | 16pt |
| Greater than 500 litres: | At least 148x210 | At least 46x46 | 20pt’; |
(3) the following Section 1.2.1.5. is added:
‘1.2.1.5. The text on the label shall have the following characteristics:
(a)the background of the label shall be white;
(b)the distance between two lines shall be equal or above 120 % of the font size;
(c)a single font shall be used that is 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.’
(4) the following Section 1.3.7. is added:
‘1.3.7. Ammunition
In the case of ammunition that qualifies as a substance or mixture and that is shot through a firearm, the labelling elements may be provided on the intermediate packaging instead of on the inner packaging, or, if there is no intermediate packaging, on the outer packaging.’;
(5) the heading of Section 1.5.1. is replaced by the following:
‘1.5.1. Exemptions from Article 31 in accordance with Article 29(1)’
(6) Section 1.5.1.1. is replaced by the following:
‘1.5.1.1. Where Article 29(1) applies, the label elements referred to in Article 17 may be provided on a tie-on tag or on an outer packaging.’;
(7) Section 1.5.1.2. is replaced by the following:
‘1.5.1.2. Where section 1.5.1.1. applies, the label on any inner packaging shall contain at least hazard pictograms, the signal word, the trade name or the designation of the mixture referred to in Article 18(3), point (a), and the name and telephone number of the suppliers of the substance or mixture.’;
(8) the heading of Section 1.5.2 is replaced by the following:
‘1.5.2. Exemptions from Article 17 in accordance with Article 29(2)’;
(9) Section 1.5.2.4.1 is replaced by the following:
‘1.5.2.4.1 The label elements required by Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 10 ml and either of the following applies:
(a) the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis and the inner packaging is contained within outer packaging that meets the requirements set out in Article 17;
(b) the substance or mixture does not require labelling in accordance with Part 1, 2 or 4 of Annex II and is not classified in any of the following hazard classes and categories:
(i) Acute toxicity, categories 1 to 4;
(ii) Specific target organ toxicity – Single exposure, categories 1 and
2;
(iii) Specific target organ toxicity – repeated exposure, categories 1
and 2;
(iv) Skin corrosion/irritation, category 1 (sub-categories 1A, 1B and 1C);
(v) Respiratory sensitisation, category 1 (sub-categories 1A and 1B);
(vi) Aspiration hazard;
(vii)Germ cell mutagenicity, any category;
(viii)Carcinogenity, any category;
(ix) Reproductive toxicity, any category;
(x) Flammable solids, categories 1 and 2.;
(xi) Endocrine disruptors for human health, any category;
(c)the substance or mixture requires labelling in accordance with Part 1, 2 or 4 of Annex II but is not classified in any of the hazard classes and categories referred to in point (b) and has an inner packaging that is contained within outer packaging that meets the requirements set out in Article 17.’;
(10) the following Section 1.6. is added:
‘1.6. Label elements that may be provided on a digital label only
(a)Supplemental information referred to in Article 25(3)’;
ANNEX II
Annex II to Regulation (EC) No 1272/2008 is amended as follows:
(1) in Part 3, the following Section 3.4. is added:
‘3.4. Refill stations
Hazardous substances or mixtures referred to in Article 35(2a), shall meet the following conditions:
(a) the labelling and packaging requirements applicable at the date of placing on the market of the hazardous substance or mixture are fulfilled for every refill station;
(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 serifs;
(c) substances and mixtures are only refilled in suitable and clean packaging without any visible residues, which are cleaned before reuse in case of suspected microbiological or other invisible contamination;
(d) the buttons to operate the refill station are out of reach of children and the refill station is not designed in a way to attract the curiosity of children;
(e) overfilling packaging is technically prevented;
(f) filling a substance or mixture into unsuitable packaging is technically prevented;
(g) at the moment of refill, the supplier is reachable for immediate assistance;
(h) refill stations are not operated outdoors and outside business hours where immediate assistance cannot be provided;
(i) the substances or mixtures provided through a refill station do not react with each other in a way that could endanger clients or staff;
(j) staff of the supplier are appropriately trained to minimise safety risks to consumers, professional users and themselves, and follow the necessary hygiene and cleaning protocols;
(k) no substance or mixture provided through a refill station meets the criteria for classification in any of the following hazard classes:
(i) Acute toxicity, categories 1 – 4;
(ii) Specific target organ toxicity – Single exposure, categories 1, 2 and 3;
(iii) Specific target organ toxicity – repeated exposure, categories 1 and 2;
(iv) Skin corrosion/irritation, category 1 (sub-categories 1A, 1B and 1C);
(v) Respiratory sensitisation, category 1 (sub-categories 1A and 1B);
(vi) Aspiration hazard;
(vii) Germ cell mutagenicity, any category;
(viii) Carcinogenicity, any category;
(ix) Reproductive toxicity, any category;
(x) Flammable gases, categories 1 and 2;
(xi) Flammable liquids, categories 1 and 2;
(xii) Flammable solids, categories 1 and 2.
(xiii) [insert: Endocrine disruptor for human health, categories 1 and 2].’;
(xiv) [insert: Endocrine disruptor for the environment, category 1 and 2];
(xv) [insert: Persistent, bioaccumulative and toxic (PBT)];
(xvi) [insert: Very persistent and very bioaccumulative (vPvB)];
(xvii) [insert: Persistent, mobile and toxic (PMT)];
(xviii) [insert Very persistent and very mobile (vPvM)].
By way of derogation from point (b), a single label on the refill station may be used for several substances or mixtures for which the label elements referred to in Article 17(1) are identical, provided that the label clearly indicates the name of each substance or mixture that it applies to.’;
(2) Part 5 is replaced by the following:
‘PART 5: HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES
Ready mixed cement and concrete in the wet state shall be accompanied by a copy of the label elements in accordance with Article 17.
For a substance or a mixture supplied at a filling station and directly pumped into a receptacle that 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.’;
ANNEX III
Annex VIII to Regulation (EC) No 1272/2008 is amended as follows:
(1) Part A is amended as follows:
(a)Section 1 is replaced by the following:
‘1. Application
1.1 Importers, downstream users and distributors referred to in Article 45(1c) placing on the market mixtures for consumer use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.
1.2. Importers, downstream users and distributors referred to in Article 45(1c) placing on the market mixtures for professional use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.
1.3. Importers, downstream users and distributors referred to in Article 45(1c) placing on the market mixtures for industrial use or mixtures with an end use not subject to notification within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2024.
1.4. Importers, downstream users and distributors referred to in Article 45(1c) having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability mentioned in Sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025.
1.5. By way of derogation from Section 1.4, if one of the changes described in Section 4.1 of Part B of this Annex occurs before 1 January 2025, importers, downstream users and distributors referred to in Article 45(1c) shall comply with this Annex before placing that mixture, as changed, on the market.’;
(b)Section 2.1 is replaced by the following:
‘2.1 This Annex sets out the requirements that importers, downstream users and distributors referred to in Article 45(1c) (‘submitters’) placing mixtures on the market shall fulfil in respect of the submission of information so that appointed bodies have at their disposal the information required to carry out the tasks for which they are responsible under Article 45.’;
(c) in Section 2.4., first subparagraph, the following point (6) is added:
‘(6) ‘composition conforming with a standard formula specified in Part D’ means a composition which includes all the components listed in one of the standard formulas referred to in Part D of this Annex, where those components are present in the mixture in concentrations within the ranges specified in that standard formula.’;
(2) Part B is amended as follows:
(a) the following Section 1.1a. is inserted:
‘1.1a. Name and product description of standard formula or name of fuel
For mixtures with a composition conforming with a standard formula specified in Part D, the name and product description of the relevant standard formula as indicated in that Part shall be included in the submission.
For fuels listed in Table 3, the name of the fuel shall be provided as indicated in that table.’;
(b) in Section 3.1, the third paragraph is replaced by the following:
‘Components which are not present in a mixture shall not be notified. However, if the components are notified as part of an interchangeable component group in accordance with Section 3.5. or their concentration has been submitted as a range of percentages in accordance with Sections 3.6. or 3.7, they may be notified if it is certain that they will be present in the mixture at some point in time. In addition, for mixtures with a composition conforming with a standard formula specified in Part D for which the composition is notified in accordance with Section 3.6, first indent, components listed in the relevant standard formula shall be notified even if the component is potentially not, or not permanently, present in cases where the indicated concentration range in Part D includes 0 %.’;
(c) the title of Section 3.6. is replaced by the following:
‘3.6. Mixtures with a composition conforming with a standard formula’;
(d) in Section 3.7., the first row of Table 3 is replaced by the following:
| ‘Fuel name | Product description’; |
(e) in Section 4.1, the first paragraph, the following indent is added; :
‘- when there are other changes to a mixture placed on the market which are relevant for the emergency health response referred to in Article 45’;
(3) Part C is amended as follows:
(a) Section 1.2. is replaced by the following:
‘1.2 Identification of the mixture, submitter and contact point
Product identifier
–Complete trade name(s) of the product including, where relevant, brand name(s), name of the product and variant names as they appear on the label, without abbreviations or non-alphanumerical symbols and enabling specific identification of the product.
–Unique Formula Identifier(s) (UFI)
–Other identifiers (authorisation number, company product codes)
–In case of group submission, all product identifiers shall be listed.
Name and product description of standard formula or name of fuel
–Standard formula name and product description as specified in Part D (where applicable)
–Fuel name as specified in Table 3 of Part B (where applicable)
Contact details of the submitter and contact point
–Name
–Full address
–Telephone number
–E-mail address
Contact details for rapid access to additional product information (24 hours/7 days). Only for limited submission.
–Name
–Telephone number (accessible 24 hours per day, 7 days per week)
–E-mail address’;
(b) Section 1.4. is replaced by the following:
‘1.4. Information on the mixture components and interchangeable
component groups
Identification of the mixture components
— Chemical/trade name of the components
— CAS number (where applicable)
— EC number (where applicable)
— UFI (where applicable)
— Standard formula name and product description (where applicable)
–Fuel name (where applicable)’;
Name of interchangeable component groups (where applicable)
Concentration and concentration ranges of the mixture components
— Exact concentration or concentration range
Classification of mixture components
— Hazard classification (where applicable)
— Additional identifiers (where applicable and relevant for health
response)
List according to Part B, Section 3.1, fifth subparagraph (where applicable) ’;
(4) Part D is amended as follows:
(a)In section 1, the first row of the tables with standard formulas for cement are replaced by the following:
| ‘Standard formula name | Cement Standard Formula 1’ |
| ‘Standard formula name | Cement Standard Formula 2’ |
| ‘Standard formula name | Cement Standard Formula 3’ |
| ‘Standard formula name | Cement Standard Formula 4’ |
| ‘Standard formula name | Cement Standard Formula 5’ |
| ‘Standard formula name | Cement Standard Formula 6’ |
| ‘Standard formula name | Cement Standard Formula 7’ |
| ‘Standard formula name | Cement Standard Formula 8’ |
| ‘Standard formula name | Cement Standard Formula 9’ |
| ‘Standard formula name | Cement Standard Formula 10’ |
| ‘Standard formula name | Cement Standard Formula 11’ |
| ‘Standard formula name | Cement Standard Formula 12’; |
| ‘Standard formula name | Cement Standard Formula 13’ |
| ‘Standard formula name | Cement Standard Formula 14’ |
| ‘Standard formula name | Cement Standard Formula 15’ |
| ‘Standard formula name | Cement Standard Formula 16’ |
| ‘Standard formula name | Cement Standard Formula 17’ |
| ‘Standard formula name | Cement Standard Formula 18’ |
| ‘Standard formula name | Cement Standard Formula 19’ |
| ‘Standard formula name | Cement Standard Formula 20’; |
(b)In section 2, the two first rows of the table with standard formula for gypsum is replaced by the following:
| ‘Standard formula name | –Gypsum binder Standard Formula |
| Product description | Gypsum binder’; |
(c)In section 3, the two first rows of the tables with standard formulas for ready mixed concrete are replaced by the following:
| ‘Standard formula name | –Ready mixed concrete Standard Formula 1 |
| Product description | –Ready mixed concrete with concrete strength classes C8/10, C12/15, C16/20, C20/25, C25/30, C28/35, C32/40, C35/45, C40/50, C45/55, C50/60, LC8/9, LC12/13, LC16/18, LC20/22, LC25/28, LC30/33, LC35/38, LC40/44, LC45/50, LC50/55, LC55/60’; |
| ‘Standard formula name | –Ready mixed concrete Standard Formula 2 |
| Product description | –Ready mixed concrete with concrete strength classes C55/67, C60/75, C70/85, C80/95, C90/105, C100/105, LC 60/66, LC70/77, LC80/88’. |
Article 2
2. The following provisions shall apply 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]:
(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.
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] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by the following provisions of this Regulation:
(a)Article 1, points (1), (4), (5), (6), (7), (10), (11), (12), (16), (20), (21) and (23);
(b)points (2), (3), (7) and (9) of Annex I;
(c)Annex II;
(d)points (1)(c), (2), (3) and (4) of Annex III.
This Regulation shall be binding in its entirety and directly applicable in all Member States.