Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)

• (h) where the information on the digital label is accessible in more than one language, the choice of language shall not be conditioned by the geographical location from which that information is accessed.

TITLE IV PACKAGING

Article 35

Packaging

• (a) the packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed;

• (b) the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents;

• (c) the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;

• (d) packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping.

Where the packaging contains a substance or mixture which meets the requirements in section 3.1.1 of Annex II it shall have a child-resistant fastening in accordance with sections 3.1.2, 3.1.3 and 3.1.4.2 of Annex II.

Where the packaging contains a substance or mixture which meets the requirements in section 3.2.1 of Annex II it shall bear a tactile warning of danger in accordance with section 3.2.2 of Annex II.

Where a liquid consumer laundry detergent, as defined in Article 2(1a) of Regulation (EC) No 648/2004 of the European Parliament and of the Council ([^E0005]), is contained in a soluble packaging for single use, the additional requirements of section 3.3 of Annex II shall apply.

2a. Hazardous substances or mixtures may be supplied to consumers and professional users via refill stations only if the conditions laid down in section 3.4 of Annex II are fulfilled.

The first subparagraph shall not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3).

TITLE V HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES AND THE CLASSIFICATION AND LABELLING INVENTORY

CHAPTER 1 Establishing harmonised classification and labelling of substances

Article 36

Harmonisation of classification and labelling of substances

• (a) respiratory sensitisation, category 1, 1A or 1B (Annex I, section 3.4);

• (b) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);

• (c) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);

• (d) reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7);

• (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 (Annex I, section 4.3);

• (h) very persistent, very bioaccumulative (Annex I, section 4.3);

• (i) persistent, mobile and toxic (Annex I, section 4.4);

• (j) very persistent, very mobile (Annex I, section 4.4).

Article 37

Procedure for harmonisation of classification and labelling of substances

The Commission may request the Agency or the European Food Safety Authority (the ‘Authority’) established in accordance with Article 1(2) of Regulation (EC) No 178/2002 to prepare a proposal for harmonised classification and labelling of a substance or a group 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 for harmonised classification and labelling of a substance or a group of substances 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.

1a. Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling shall aim to prioritise groups of substances rather than individual substances.

1b. The Agency and the Authority may, on their own initiative, provide scientific advice to the competent authorities and the Commission indicating that a harmonised classification and labelling of a substance or a group of substances would be appropriate.

The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.

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.

Where the Commission has requested the preparation of a proposal pursuant to paragraph 1, second subparagraph, it shall notify the Agency of that request.

Within one week of receipt of the notification referred to in the first and the second subparagraphs, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance or substances, 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 paragraphs (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.

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.

• (a) include substances by 11 June 2026 as endocrine disruption for human health category 1, as endocrine disruption for the environment category 1, as persistent, bioaccumulative and toxic, or as very persistent, very bioaccumulative, together with relevant classification and label elements on the basis of respective criteria where by 11 June 2025, those substances:
• (i) have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006 as having endocrine-disrupting properties for human health or the environment, as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative,
• (ii) have been identified as having endocrine-disrupting properties in accordance with section 3.6.5 or section 3.8.2 of Annex II to Regulation (EC) No 1107/2009, or as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative in accordance with section 3.7.2 or 3.7.3 of Annex II to that Regulation and a decision on the application for approval or the renewal of approval of those substances has been adopted under that Regulation;
• (iii) have been identified as having endocrine-disrupting properties in accordance with Article 1 of Delegated Regulation (EU) 2017/2100, or as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative in accordance with Article 5(1), point (e), of Regulation (EU) No 528/2012 and a decision on the application for approval or renewal of approval of those substances has been adopted under Regulation (EU) No 528/2012; and

• (b) include substances in Table 3 of Part 3 of Annex VI as endocrine disruption for human health category 1, as endocrine disruption for the environment category 1, as persistent, bioaccumulative and toxic, or as very persistent, very bioaccumulative, together with relevant classification and label elements on the basis of the respective criteria where:
• (i) those substances have been included in the candidate list referred to in Article 59 of Regulation (EC) No 1907/2006 before 11 June 2026 as having one of the properties mentioned in the introductory part and for which a dossier as provided for in Annex XV to that Regulation was under assessment by 11 June 2025;
• (ii) a decision on the application for approval or the renewal of approval of those substances identified as having one of the properties mentioned in the introductory part has been adopted under Regulation (EC) No 1107/2009 before 11 June 2032 and an application for approval or renewal of approval of those substances in accordance with the relevant provisions of that Regulation was submitted before 11 June 2025;
• (iii) a decision on the application for approval or the renewal of approval of those substances identified as having one of the properties mentioned in the introductory part has been adopted under Regulation (EU) No 528/2012 before 11 June 2030 and where, by 11 June 2025:
• — the evaluating competent authority has submitted its draft assessment report on the application for approval or renewal of approval to the Agency in accordance with the relevant provisions of Regulation (EU) No 528/2012;
• — the application was submitted for the purposes of Directive 98/8/EC and the Member State evaluation in accordance with that Directive was completed by 1 September 2013, but no decision on the application for approval or renewal of approval was adopted before that date; or
• — the Agency has submitted to the Commission an opinion pursuant to Article 75(1), point (g), of Regulation (EU) No 528/2012 following a request to establish whether the respective criteria are met.

Article 38

Content of opinions and decisions for harmonised classification and labelling in Part 3 of Annex VI; accessibility of information

• (a) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI to Regulation (EC) No 1907/2006;

• (b) the classification of the substance referred to in Article 36, including a statement of reasons;

• (c) the specific concentration limits, M-factors or acute toxicity estimates, where applicable;

• (d) the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance, together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1);

• (e) any other parameter enabling an assessment to be made of the health or environmental hazard of mixtures containing the hazardous substance in question or of substances containing such hazardous substances as identified impurities, additives and constituents, if relevant.

CHAPTER 2 Classification and labelling inventory

Article 39

Scope

This Chapter shall apply to:

• (a) substances subject to registration in accordance with Regulation (EC) No 1907/2006;

• (b) substances within the scope of Article 1 which meet the criteria for classification as hazardous and are placed on the market either on their own or in a mixture above the concentration limits specified in this Regulation or Directive 1999/45/EC, where relevant, which results in the classification of the mixture as hazardous.

Article 40

Obligation to notify the Agency

• (a) the identity of the notifier(s) responsible for placing the substance or substances on the market as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006;

• (b) the identity of the substance or substances as specified in section 2.1 to 2.3.4 to Annex VI to Regulation (EC) No 1907/2006;

• (c) the classification of the substance or substances in accordance with Article 13;

• (d) where a substance has been classified in some but not all hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which are conclusive although insufficient for classification;

• (e) specific concentration limits, M-factors or acute toxicity estimates, where applicable, in accordance with Article 10 of this Regulation, together with a justification as referred to in the relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;

• (f) the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance or substances together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1);

• (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.

The information referred to in points (a) to (h) shall not be notified, if it has been submitted to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006, or if it has already been notified by that notifier.

The notifier shall submit this information in the format specified pursuant to Article 111 of Regulation (EC) No 1907/2006.

However, substances placed on the market before 1 December 2010 may be notified in accordance with paragraph 1 before that date.

Article 41

Agreed entries

Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly.

Article 42

The classification and labelling inventory

The information notified pursuant to Article 40(1) shall be included in the inventory, as well as information submitted as part of registrations under Regulation (EC) No 1907/2006.

The Agency shall make the following information publicly available online and free of charge:

• (a) the information referred to in Article 40(1), point (a);

• (b) the identity of the importer or manufacturer submitting the information on behalf of the other members of the group, in the case of group notifications;

• (c) information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006;

• (d) the date of the latest update of the classification and labelling.

Information referred to in Article 40(1), point (a), shall be made publicly available 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.

The Agency shall provide information on legitimate grounds on which confidentiality claims may be made.

The Agency shall take measures to identify undue confidentiality claims, including automated screening and random manual checks.

• (a) whether, in respect of the entry, there is harmonised classification and labelling at Community level by inclusion in Part 3 of Annex VI;

• (b) whether, in respect of the entry, it is a joint entry between registrants of the same substance as referred to in Article 11(1) of Regulation (EC) No 1907/2006;

• (c) whether it is an agreed entry of two or more notifiers or registrants in accordance with Article 41;

• (d) whether the entry differs from another entry on the inventory for the same substance.

The information referred to in (a) shall be updated where a decision is taken in accordance with Article 37(5).

3a. Where the Agency considers that an entry is incomplete, incorrect or obsolete it shall request the notifier to notify the correct entry.

TITLE VI COMPETENT AUTHORITIES AND ENFORCEMENT

Article 43

Appointment of competent authorities and enforcement authorities and cooperation between authorities

Member States shall appoint the competent authority or competent authorities responsible for proposals for harmonised classification and labelling and the authorities responsible for the enforcement of the obligations set out in this Regulation.

The competent authorities and the authorities responsible for enforcement shall cooperate with each other in the performance of their tasks under this Regulation and shall give the corresponding authorities of other Member States all necessary and useful support to this end.

Article 44

Helpdesk

Member States shall establish national helpdesks to provide advice to manufacturers, importers, distributors, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation.

Article 45

Appointment of bodies responsible for receiving information relating to emergency health response

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 or physical effects, shall submit to the body or bodies appointed in accordance with paragraph 1 the 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 or physical effects shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII where they subsequently distribute those mixtures in other Member States, or where they rebrand or relabel the mixtures. That obligation shall not apply if the distributors can demonstrate that the appointed body or bodies already received the same information from importers and downstream users.

• (a) to meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency; and

• (b) where requested by the Member State, the Commission or the Agency, to undertake a statistical analysis to identify where improved risk management measures may be needed.

The information shall not be used for other purposes.

Article 46

Enforcement and reporting

1a. For the purpose of paragraph 1, the authorities responsible for enforcement referred to in Article 43 of this Regulation shall follow up on complaints or reports related to non-compliance with this Regulation, and verify that the corrective action referred to in Article 3, point (16), of Regulation (EU) 2019/1020 has been taken.

Article 47

Penalties for non-compliance

Member States shall introduce penalties for non-compliance with this Regulation and shall take all measures necessary to ensure that this Regulation is applied. The penalties must be effective, proportionate and dissuasive. Member States shall notify the Commission of the provisions for penalties by 20 June 2010 and shall notify it without delay of any subsequent amendment affecting them.

TITLE VII COMMON AND FINAL PROVISIONS

Article 48

Advertisement

The first subparagraph shall be without prejudice to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts ([^E0006]).

Article 49

Obligation to maintain information and requests for information

The supplier shall keep this information together with the information required in Article 36 of Regulation (EC) No 1907/2006.

However, where that information is available to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006 or a notification pursuant to Article 40 of this Regulation, the Agency shall use that information and the authority shall address itself to the Agency.

Article 50

Tasks of the Agency

• (a) provide industry with up-to-date technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by this Regulation;

• (b) provide competent authorities with up-to-date technical and scientific guidance and tools on the application and implementation of this Regulation and provide support to the helpdesks established by Member States under Article 44.

Article 51

Free movement clause

On grounds relating to the classification, labelling or packaging of substances and mixtures within the meaning of this Regulation, Member States shall not prohibit, restrict or impede the placing on the market of substances or mixtures which comply with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation.

Article 52

Safeguard clause

Article 53

Adaptations to technical and scientific progress

Where imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.

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 include the label elements that may be put on a digital label only, provided that GHS does not require such label elements to appear on the physical label. When adopting those delegated acts, the Commission shall take into account the level of digital readiness among all population groups in the Union, societal needs and the need for 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 Articles 34a and 34b. Those details shall cover, in particular, the IT solutions which may be used, and the alternative means for providing the information. When adopting such delegated acts, the Commission shall:

• (a) ensure consistency with other relevant Union acts;

• (b) encourage innovation;

• (c) ensure technological neutrality by not imposing constraints or requirements with regard to 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, as well as the readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals;

• (e) ensure that digitalisation does not compromise the protection of human health and the environment.

Article 53a

Exercise of the delegation

Article 53b

Urgency procedure

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 the powers delegated pursuant to Article 37(5) and Article 53(1) to amend Annex VI, where Parts 1 and 2 of that Annex may be amended together with Part 3 of that Annex in one single act.

Article 54

Committee procedure

Article 54a

Reporting and review

Article 55

Amendments to Directive 67/548/EEC

Directive 67/548/EEC shall be amended as follows:

• 1. in Article 1(2), the second subparagraph shall be deleted;

• 1. Article 4 shall be amended as follows:
• (a) paragraph 3 shall be replaced by the following: ‘3. Where an entry containing the harmonised classification and labelling for a particular substance has been included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures ([^E0009]), the substance shall be classified in accordance with that entry and paragraphs 1 and 2 shall not apply to the danger categories covered by that entry.
• (b) paragraph 4 shall be deleted;

• 1. Article 5 shall be amended as follows:
• (a) paragraph 1, second subparagraph shall be deleted;
• (b) paragraph 2 shall be replaced by the following: ‘2. The measures in the first subparagraph of paragraph 1 shall apply until the substance is listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the danger categories covered by that entry or until a decision not to list it has been taken in accordance with the procedure laid down in Article 37 of Regulation (EC) No 1272/2008.’;

• 1. Article 6 shall be replaced by the following: ‘Article 6 Obligation to carry out investigations Manufacturers, distributors and importers of substances which appear in the EINECS but for which no entry has been included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall carry out an investigation to make themselves aware of the relevant and accessible data which exist concerning the properties of such substances. On the basis of this information, they shall package and provisionally label dangerous substances according to the rules laid down in Articles 22 to 25 of this Directive and the criteria in Annex VI to this Directive.’;

• 1. Article 22(3) and (4) shall be deleted;

• 1. Article 23(2) shall be amended as follows:
• (a) in point (a), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
• (b) in point (c), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
• (c) in point (d), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
• (d) in point (e), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
• (e) in point (f), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI of Regulation (EC) No 1272/2008’;

• 1. Article 24(4) second subparagraph shall be deleted;

• 1. Article 28 shall be deleted;

• 1. Article 31(2) and (3) shall be deleted;

• 1. the following Article shall be inserted after Article 32: ‘Article 32a Transitional provision regarding labelling and packaging of substances Articles 22 to 25 shall not apply to substances from 1 December 2010.’;

• 1. Annex I shall be deleted.

Article 56

Amendments to Directive 1999/45/EC

Directive 1999/45/EC shall be amended as follows:

• 1. in Article 3(2), first indent, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures ([^E0010]).

• 1. the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’ in:
• (a) Article 3(3);
• (b) Article 10(2), points 2.3.1, 2.3.2, 2.3.3 and 2.4 first indent;
• (c) Annex II, points (a) and (b) and the last paragraph of the Introduction;
• (d) Annex II, Part A,
• — point 1.1.1 (a) and (b),
• — point 1.2 (a) and (b),
• — point 2.1.1 (a) and (b),
• — point 2.2 (a) and (b),
• — point 2.3 (a) and (b),
• — point 3.1.1 (a) and (b),
• — point 3.3 (a) and (b),
• — point 3.4 (a) and (b),
• — point 4.1.1 (a) and (b),
• — point 4.2.1 (a) and (b),
• — point 5.1.1 (a) and (b),
• — point 5.2.1 (a) and (b),
• — point 5.3.1 (a) and (b),
• — point 5.4.1 (a) and (b),
• — point 6.1 (a) and (b),
• — point 6.2 (a) and (b),
• — point 7.1 (a) and (b),
• — point 7.2 (a) and (b),
• — point 8.1 (a) and (b),
• — point 8.2 (a) and (b),
• — point 9.1 (a) and (b),
• — point 9.2 (a) and (b),
• — point 9.3 (a) and (b),
• — point 9.4 (a) and (b);
• (e) Annex II, the introductory paragraph of Part B;
• (f) Annex III, point (a) and (b) of the Introduction;
• (g) Annex III, Part A, section (a) Aquatic environment
• — point 1.1 (a) and (b),
• — point 2.1 (a) and (b),
• — point 3.1 (a) and (b),
• — point 4.1 (a) and (b),
• — point 5.1 (a) and (b),
• — point 6.1 (a) and (b),
• (h) Annex III, Part A, section (b) Non-aquatic environment point 1.1 (a) and (b);
• (i) Annex V, section A points 3 and 4;
• (j) Annex V, section B point 9;
• (k) Annex VI, Part A, the third column of the table under point 2;
• (l) Annex VI Part B point 1, first paragraph, and the first column of the table under point 3;
• (m) Annex VIII, Appendix 1, second column of the table;
• (n) Annex VIII, Appendix 2, second column of the table;

• 1. in Annex VI, Part B, point 1, paragraph 3 first indent and paragraph 5, the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;

• 1. in Annex VI, Part B, point 4.2, final paragraph, the words ‘Annex I to Directive 67/548/EEC (19th adaptation)’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’.

Article 57

Amendments to Regulation (EC) No 1907/2006 from the entry into force of this Regulation

Regulation (EC) No 1907/2006 shall be amended as from the entry into force of this Regulation as follows:

• 1. Article 14(2) shall be amended as follows:
• (a) point (b) shall be replaced by the following:
• ‘(b) the specific concentration limits that have been set in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures ([^E0011]);
• (ba) for substances classified as hazardous to the aquatic environment, if a multiplying factor (hereinafter referred to as “M-factor”) has been set in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation;
• (b) point (e) shall be replaced by the following:
• ‘(e) the specific concentration limits given in an agreed entry in the classification and labelling inventory referred to in Article 42 of Regulation (EC) No 1272/2008;
• (ea) for substances classified as hazardous to the aquatic environment, if an M-factor has been set in an agreed entry in the classification and labelling inventory referred to in Article 42 of Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation;’;

• 1. Article 31 shall be amended as follows:
• (a) paragraph 8 shall be replaced by the following: ‘8. A safety data sheet shall be provided free of charge on paper or electronically no later than the date on which the substance or mixture is first supplied.’;
• (b) the following paragraph shall be added: ‘10. Where substances are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 December 2010, that classification may be added in the safety data sheet together with the classification in accordance with Directive 67/548/EEC. From 1 December 2010 until 1 June 2015, the safety data sheets for substances shall contain the classification according to both Directive 67/548/EEC and Regulation (EC) No 1272/2008. Where mixtures are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 June 2015, that classification may be added in the safety data sheet, together with the classification in accordance with Directive 1999/45/EC. However, until 1 June 2015, where substances or mixtures are both classified and labelled in accordance with Regulation (EC) No 1272/2008 that classification shall be provided in the safety data sheet, together with the classification in accordance with Directives 67/548/EEC and 1999/45/EC respectively, for the substance, the mixture and its constituents.’;

• 1. Article 56(6)(b) shall be replaced by the following:
• ‘(b) for all other substances, below the lowest of the concentration limits specified in Directive 1999/45/EC or in Part 3 of Annex VI to Regulation (EC) No 1272/2008 which result in the classification of the mixture as dangerous.’;

• 1. Article 59(2) and 3 shall be amended as follows:
• (a) in paragraph 2, the second sentence shall be replaced by the following: ‘The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.’;
• (b) in paragraph 3, the second sentence shall be replaced by the following: ‘The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.’;

• 1. in Article 76(1)(c), the words ‘Title XI’ shall be replaced by ‘Title V of Regulation (EC) No 1272/2008’;

• 1. Article 77 shall be amended as follows:
• (a) in paragraph 2, the first sentence of point (e) shall be replaced by the following:
• ‘(e) establishing and maintaining database(s) with information on all registered substances, the classification and labelling inventory and the harmonised classification and labelling list established in accordance with Regulation (EC) No 1272/2008;’;
• (b) in paragraph 3, point (a), the words ‘Titles VI to XI’ shall be replaced by ‘Titles VI to X’;

• 1. Title XI shall be deleted;

• 1. Annex XV, sections I and II shall be amended as follows:
• (a) section I shall be amended as follows:
• (i) the first indent shall be deleted;
• (ii) the second indent shall be replaced by the following:
• — - ‘— the identification of CMRs, PBTs, vPvBs, or a substance of equivalent concern in accordance with Article 59,’;
• (b) in section II, point 1 shall be deleted;

• 1. the table in Annex XVII shall be amended as follows:
• (a) the column ‘Designation of the substance, of the groups of substances or of the preparation’, shall be amended as follows:
• (i) entries 28, 29 and 30 shall be replaced by the following: ‘28.Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as carcinogen category 1A or 1B (Table 3.1) or carcinogen category 1 or 2 (Table 3.2) and listed as follows:
• — Carcinogen category 1A (Table 3.1)/carcinogen category 1 (Table 3.2) listed in Appendix 1
• — Carcinogen category 1B (Table 3.1)/carcinogen category 2 (Table 3.2) listed in Appendix 2 29.Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as germ cell mutagen category 1A or 1B (Table 3.1) or mutagen category 1 or 2 (Table 3.2) and listed as follows:
• — Mutagen category 1A (Table 3.1)/mutagen category 1 (Table 3.2) listed in Appendix 3
• — Mutagen category 1B (Table 3.1)/mutagen category 2 (Table 3.2) listed in Appendix 4 30.Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as toxic to reproduction category 1A or 1B (Table 3.1) or toxic to reproduction category 1 or 2 (Table 3.2) and listed as follows:
• — Reproductive toxicant category 1A adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 1 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 5
• — Reproductive toxicant category 1B adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 2 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 6’;
• (b) in the column ‘Conditions of restriction’, in entry 28, the first indent of point 1 shall be replaced by the following:
• — - ‘— either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or’;

• 1. Appendices 1 to 6 to Annex XVII shall be amended as follows:
• (a) the Foreword shall be amended as follows:
• (i) in the section entitled ‘Substances’, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
• (ii) in the section entitled ‘Index number’, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
• (iii) in the section entitled ‘Notes’, the words ‘the foreword of Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 1 of Annex VI to Regulation (EC) No 1272/2008’;
• (iv) Note A shall be replaced by the following: ‘Note A: Without prejudice to Article 17(2) of Regulation (EC) No 1272/2008, the name of the substance must appear on the label in the form of one of the designations given in Part 3 of Annex VI to that Regulation. In that Part, use is sometimes made of a general description such as “... compounds” or “... salts”. In this case, the supplier who places such a substance on the market is required to state on the label the correct name, due account being taken of Section 1.1.1.4 of Annex VI to Regulation (EC) No 1272/2008. In accordance with Regulation (EC) No 1272/2008, where a substance is included in Part 3 of Annex VI to that Regulation, the labelling elements relevant for each specific classification covered by the entry in that Part shall be included in the label, together with the applicable label elements for any other classification not covered by that entry, and any other applicable label elements in accordance with Article 17 of that Regulation. For substances belonging to one particular group of substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the labelling elements relevant for each specific classification covered by the entry in that Part shall be included in the label, together with the applicable label elements for any other classification not covered by that entry, and any other applicable label elements in accordance with Article 17 of that Regulation. For substances belonging to more than one group of substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the labelling elements relevant for each specific classification covered by both entries in that Part shall be included in the label, together with the applicable label elements for any other classification not covered by that entry, and any other applicable label elements in accordance with Article 17 of that Regulation. In cases where two different classifications are given in the two entries for the same hazard class or differentiation, the classification reflecting the more severe classification shall be used.’;
• (v) Note D shall be replaced by the following: ‘Note D: Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008. However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the supplier who places such a substance on the market must state on the label the name of the substance followed by the words “non-stabilised”.’;
• (vi) Note E shall be deleted;
• (vii) Note H shall be replaced by the following: ‘Note H: The classification and label shown for this substance applies to the hazard or hazards indicated by the hazard statement or hazard statements in combination with the hazard classification shown. The requirements of Article 4 of Regulation (EC) No 1272/2008 on suppliers of this substance apply to all other hazard classes, differentiations and categories. The final label shall follow the requirements of section 1.2 of Annex I to Regulation (EC) No 1272/2008.’;
• (viii) Note K shall be replaced by the following: ‘Note K: The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1  % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 should apply. This note applies only to certain complex oil-derived substances in Part 3 of Annex VI to Regulation (EC) No 1272/2008.’;
• (ix) Note S shall be replaced by the following: ‘Note S: This substance may not require a label according to Article 17 of Regulation (EC) No 1272/2008 (see section 1.3 of Annex I to that Regulation).’;
• (b) in Appendix 1, the title shall be replaced by the following: ‘Point 28 — Carcinogens: category 1A (Table 3.1)/category 1 (Table 3.2)’;
• (c) Appendix 2 shall be amended as follows:
• (i) the title shall be replaced by ‘Point 28 — Carcinogens: category 1B (Table 3.1)/ category 2 (Table 3.2)’;
• (ii) in the entries index Nos 024-017-00-8, 611-024-001, 611-029-00-9, 611-030-00-4 and 650-017-00-8, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Annex VI to Regulation (EC) No 1272/2008.’;
• (d) in Appendix 3, the title shall be replaced by the following: ‘Point 29 — Mutagens: category 1A (Table 3.1)/category 1 (Table 3.2)’;
• (e) in Appendix 4, the title shall be replaced by the following: ‘Point 29 — Mutagens: category 1B (Table 3.1)/category 2 (Table 3.2)’;
• (f) in Appendix 5, the title shall be replaced by the following: ‘Point 30 — Reproductive toxicants: category 1A (Table 3.1)/category 1 (Table 3.2)’;
• (g) in Appendix 6, the title shall be replaced by the following: ‘Point 30 — Reproductive toxicants: category 1B (Table 3.1)/category 2 (Table 3.2)’;

• 1. the word ‘preparation’ or ‘preparations’ within the meaning of Article 3 (2) of Regulation (EC) 1907/2006 shall be replaced by ‘mixture’ or ‘mixtures’ respectively throughout the text.

Article 58

Amendments to Regulation (EC) No 1907/2006 from 1 December 2010

Regulation (EC) No 1907/2006 shall be amended from 1 December 2010 as follows:

• 1. in Article 14(4), the introductory sentence shall be replaced by the following: ‘4. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: (a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1; (d) hazard class 5.1, or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:’;

• 1. Article 31 shall be amended as follows
• (a) paragraph 1(a) shall be replaced by the following:
• ‘(a) where a substance meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008 or a mixture meets the criteria for classification as dangerous in accordance with Directive 1999/45/EC; or’;
• (b) paragraph 4 shall be replaced by the following: ‘4. The safety data sheet need not be supplied where substances that are hazardous in accordance with Regulation (EC) No 1272/2008 or mixtures that are dangerous in accordance with Directive 1999/45/EC, offered or sold to the general public, are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.’;

• 1. Article 40(1) shall be replaced by the following: ‘1. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances above 100 tonnes per year with uses resulting in widespread and diffuse exposure, provided they fulfil the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008: (a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1; (d) hazard class 5.1.’;

• 1. Article 57(a), (b) and (c) shall be replaced by the following:
• ‘(a) substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;
• (b) substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;
• (c) substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation(EC) No 1272/2008;’;

• 1. in Article 65 the words ‘Directive 67/548/EEC’ shall be replaced by ‘Directive 67/548/EEC and Regulation (EC) No 1272/2008’;

• 1. Article 68(2) shall be replaced by the following: ‘2. For a substance on its own, in a mixture or in an article which meets the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, and could be used by consumers and for which restrictions to consumer use are proposed by the Commission, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4). Articles 69 to 73 shall not apply.’;

• 1. Article 119 shall be amended as follows:
• (a) in paragraph 1, point (a) shall be replaced by the following:
• ‘(a) without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
• — hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
• — hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
• — hazard class 4.1;
• — hazard class 5.1.’;
• (b) paragraph 2 shall be amended as follows:
• (i) point (f) shall be replaced by the following:
• ‘(f) subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for non-phase-in substances referred to in paragraph 1(a) of this Article for a period of six years;’
• (ii) in point (g), the introductory phrase shall be replaced by the following:
• ‘(g) subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following:’;

• 1. in Article 138(1), the second sentence of the introductory phrase shall be replaced by the following: ‘However, for substances meeting the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008, the review shall be carried out by 1 June 2014.’;

• 1. Annex III shall be amended as follows:
• (a) point (a) shall be replaced by the following:
• ‘(a) substances for which it is predicted (i.e. by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1A or 1B classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity or the criteria in Annex XIII;’;
• (b) in point (b), point (ii) shall be replaced by the following:
• ‘(ii) for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classification criteria for any health or environmental hazard classes or differentiations under Regulation (EC) No 1272/2008.’;

• 1. in Annex V, point 8, the words ‘Directive 67/548/EEC’ shall be replaced by ‘Regulation (EC) No 1272/2008’;

• 1. in Annex VI, sections 4.1, 4.2 and 4.3 shall be replaced by the following: ‘4.1The hazard classification of the substance(s), resulting from the application of Title I and II of Regulation (EC) No 1272/2008 for all hazard classes and categories in that Regulation, In addition, for each entry, the reasons why no classification is given for a hazard class or differentiation of a hazard class should be provided (i.e. if data are lacking, inconclusive, or conclusive but not sufficient for classification), 4.2The resulting hazard label for the substance(s), resulting from the application of Title III of Regulation (EC) No 1272/2008, 4.3Specific concentration limits, where applicable, resulting from the application of Article 10 of Regulation (EC) No 1272/2008 and Articles 4 to 7 of Directive 1999/45/EC.’;

• 1. Annex VIII shall be amended as follows:
• (a) in column 2, the second indent of point 8.4.2 shall be replaced by the following:
• — - ‘— the substance is known to be carcinogenic category 1A or 1B or germ cell mutagenic category 1A, 1B or 2.’;
• (b) in column 2, the second and third paragraphs of point 8.7.1 shall be replaced by the following: ‘If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered. If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.’;

• 1. in Annex IX, column 2, point 8.7, the second and third paragraphs shall be replaced by the following: ‘If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered. If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.’;

• 1. Annex X shall be amended as follows:
• (a) in column 2, point 8.7, the second and third paragraphs shall be replaced by the following: ‘If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered. If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.’
• (b) in column 2, point 8.9.1, the second indent of the first paragraph shall be replaced by the following:
• — - ‘— the substance is classified as germ cell mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.’
• (c) in column 2, the second paragraph of point 8.9.1 shall be replaced by the following: ‘If the substance is classified as germ cell mutagen category 1A or 1B, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required.’;

• 1. in Annex XIII, the second and third indents of point 1.3 shall be replaced by the following:
• — - ‘— the substance is classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2), or
• — - — there is other evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) according to Regulation (EC) No 1272/2008’;