CELEX 02008R1272 · v20250901

TITLE VI / COMPETENT AUTHORITIES AND ENFORCEMENT

TITLE VI

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 43

Appointment of competent authorities and enforcement authorities and cooperation between authorities

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 44

Helpdesk

Article 45

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

▼M36

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 appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:

(a)

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

and

▼M36

(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.

▼B

The information shall not be used for other purposes.

The appointed bodies shall have at their disposal all the information required from the importers and downstream users responsible for marketing to carry out the tasks for which they are responsible.

▼M20

The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Annex VIII to further harmonise the information relating to emergency health response and preventative measures, following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT).

▼B

Article 45

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

▼M36 ▼M36

▼B ▼B

The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:

(a)

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

and

▼M36

(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.

▼B

The information shall not be used for other purposes.

The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:

(a)

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

and

▼M36

(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.

▼B

The information shall not be used for other purposes.

The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:

(a)

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

and

(a)

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

and

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

and

▼M36 ▼M36

(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.

(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.

▼B ▼B

The information shall not be used for other purposes.

The appointed bodies shall have at their disposal all the information required from the importers and downstream users responsible for marketing to carry out the tasks for which they are responsible.

▼M20 ▼M20

▼B ▼B

Article 46

Enforcement and reporting

Member States shall take all necessary measures, including maintaining a system of official controls, to ensure that substances and mixtures are not placed on the market, unless they have been classified, labelled, notified and packaged in accordance with this Regulation.

▼M36

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.

▼B

Member States shall submit a report to the Agency every five years by 1 July on the results of the official controls, and other enforcement measures taken. The first report shall be submitted by 20 January 2012. The Agency shall make those reports available to the Commission, which shall take them into account for its report under Article 117 of Regulation (EC) No 1907/2006.

The Forum referred to in Article 76(1)(f) of Regulation (EC) No 1907/2006 shall undertake the tasks specified in Article 77(4)(a) to (g) of Regulation (EC) No 1907/2006 concerning enforcement of this Regulation.

Article 46

Enforcement and reporting

▼M36 ▼M36

1a.

▼B ▼B

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.

Article 47

Penalties for non-compliance

TITLE VII

Article 48

Any advertisement for a substance classified as hazardous shall mention the hazard classes or hazard categories concerned.

Any advertisement for a mixture classified as hazardous or covered by Article 25(6) which allows a member of the general public to conclude a contract for purchase without first having sight of the label shall mention the type or types of hazard indicated on the label.

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 ( 5 ).

Article 49

Obligation to maintain information and requests for information

The supplier shall assemble and keep available all the information used by that supplier for the purposes of classification and labelling under this Regulation for a period of at least 10 years after the substance or the mixture was last supplied by that supplier.

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

In the event of a supplier ceasing activity, or transferring part or all of his operations to a third party, the party responsible for liquidating the supplier's undertaking or assuming responsibility for the placing on the market of the substance or mixture concerned shall be bound by the obligation in paragraph 1 in place of the supplier.

The competent authority or the enforcement authorities of a Member State in which a supplier is established or the Agency may require the supplier to submit to it any information referred to in the first subparagraph of paragraph 1.

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

The Agency shall provide the Member States and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with this Regulation.

The Secretariat of the Agency shall:

▼M36

(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.

▼M36

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 referred to in Article 45(1) to the relevant appointed body or bodies of the appointing Member State to fulfil their tasks with regard to emergency health response and preventative measures.

The Agency shall be provided with adequate resources to support its work.

▼B

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

Where a Member State has justifiable grounds for believing that a substance or a mixture, although satisfying the requirements of this Regulation, constitutes a serious risk to human health or the environment due to reasons of classification, labelling or packaging, it may take appropriate provisional measures. The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving the reasons for its decision.

▼M36

Within 60 days of receipt of the information from the Member State, the Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 54(2) either to authorise the provisional measure for a period defined in the decision or to require the Member State to revoke the provisional measure.

▼B

In the case of an authorisation of a provisional measure related to classification or labelling of a substance as referred to in paragraph 2, the competent authority of the Member State concerned shall in accordance with the procedure laid down in Article 37 submit a proposal to the Agency for harmonised classification and labelling, within three months of the date of the Commission decision.

Article 53

Adaptations to technical and scientific progress

▼M20

The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases.

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

▼M36

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.

▼M36

The Commission, acting on behalf of the Union, and the Member States shall, in a manner appropriate to their role in the relevant UN fora, cooperate with a view to promoting the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic and very persistent and very mobile substances as well as the adaptation of criteria for alternative approaches, in particular non-animal test methods, and the assessment of the need for new criteria for immunotoxic and neurotoxic substances.

▼M36

The Commission shall regularly evaluate the development of alternative approaches such as the alternative methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, in particular non-animal test methods, and adopt delegated acts in accordance with Article 53a to update Annex I to this Regulation to reflect such technical progress, if relevant. The Commission shall adopt a delegated act in accordance with Article 53a to update Annex I to this Regulation to adapt the criteria, preferably within 18 months from the date the criteria for non-animal data being included in harmonised criteria for classification and labelling at the level of the UN.

▼M20

Article 53a

Exercise of the delegation

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

▼M36

The power to adopt delegated acts referred to in Article 5(8), Article 37(5) and (7), Article 45(4), and Article 53(1), (1a), (1b) and (3) shall be conferred on the Commission for a period of five years from 10 December 2024. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

The delegation of power referred to in Article 5(8), Article 37(5) and(7), Article 45(4), and Article 53(1), (1a), (1b) and (3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

▼M20

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making ( 6 ).

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

▼M36

A delegated act adopted pursuant to Article 5(8), Article 37(5) and (7), Article 45(4) or Article 53(1), (1a), (1b) or (3) 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. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

▼M20

Article 53b

Urgency procedure

Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.

Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 53a(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.

▼M36

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.

▼B

Article 54

Committee procedure

▼M36

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 of the European Parliament and of the Council ( 7 ).

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

▼M20 —————

▼M36

Article 54a

Reporting and review

By 11 December 2029, the Commission shall present a scientific report to the European Parliament and to the Council regarding the examination of the information on substances containing more than one constituent extracted from plants. The report may be accompanied, if appropriate, by a legislative proposal.

By 11 December 2029, the Commission shall present an evaluation report to the European Parliament, the Council and the European Economic and Social Committee, assessing the need to extend requirements in sections 3.1 and 3.2 of Annex II on child-resistant fastenings and tactile warnings to other hazard classes. If justified by the results of the report, the Commission shall act in accordance with Article 53(1).

▼B

Article 55

Amendments to Directive 67/548/EEC

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

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

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 ( *1 ), 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;

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.’;

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.’;

Article 22(3) and (4) shall be deleted;

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’;

Article 24(4) second subparagraph shall be deleted;

Article 28 shall be deleted;

Article 31(2) and (3) shall be deleted;

10.

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.’;

11.

Annex I shall be deleted.

Article 56

Amendments to Directive 1999/45/EC

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

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 ( *2 ).

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;

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’;

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:

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 ( *3 );

(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;’;

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.’;

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.’;

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.’;

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

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’;

Title XI shall be deleted;

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;

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’;

10.

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)’;

11.

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:

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:’;

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.’;

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.’;

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;’;

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

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.’;

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:’;

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.’;

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.’;

10.

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

11.

in Annex VI, sections 4.1, 4.2 and 4.3 shall be replaced by the following:

‘4.1 The 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),

4.2 The resulting hazard label for the substance(s), resulting from the application of Title III of Regulation (EC) No 1272/2008,

4.3 Specific 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.’;

12.

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.’;

13.

in Annex IX, column 2, point 8.7, the second and third paragraphs shall be replaced by the following:

14.

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:

(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.’;

15.

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’;

16.

in the table in Annex XVII, the column ‘Designation of the substance, of the groups of substances or of the mixture’ shall be amended as follows:

(a)

entry 3 shall be replaced by the following:

‘3. Liquid substances or mixtures which are regarded as dangerous in accordance with Directive 1999/45/EC or are fulfilling 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.’;

(b)

entry 40 shall be replaced by the following:

‘40. Substances classified as flammable gases category 1 or 2, flammable liquids categories 1, 2 or 3, flammable solids category 1 or 2, substances and mixtures which, in contact with water, emit flammable gases, category 1, 2 or 3, pyrophoric liquids category 1 or pyrophoric solids category 1, regardless of whether they appear in Part 3 of Annex VI to that Regulation or not’.

Article 59

Amendments to Regulation (EC) No 1907/2006 from 1 June 2015

Regulation (EC) No 1907/2006 shall be amended from 1 June 2015 as follows:

Article 14(2) shall be replaced by the following:

‘2.

A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than

(a)

the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008;

(b)

0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.’;

Article 31 shall be amended as follows:

(a)

in paragraph 1, point (a) shall be replaced by the following:

‘(a)

where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or’;

(b)

paragraph 3 shall be replaced by the following:

‘3.

The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:

(a)

in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or

(b)

in an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or

(c)

a substance for which there are Community workplace exposure limits’;

(c)

paragraph 4 shall be replaced by the following:

‘4.

The safety data sheet need not be supplied where hazardous substances or mixtures 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.’;

Article 56(6)(b) shall be replaced by the following:

‘(b)

for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.’;

in Article 65 the words ‘and Directive 1999/45/EC’ shall be deleted;

Annex II shall be amended as follows:

(a)

point 1.1 shall be replaced by:

‘1.1. Identification of the substance or mixture

The term used for identification of a substance shall be identical to that provided on the label in accordance with Article 18(2) of Regulation (EC) No 1272/2008.

The term used for identification of a mixture shall be identical to that provided on the label in accordance with Article 18(3)(a) of Regulation (EC) No 1272/2008.’;

(b)

footnote 1 to point 3.3(a), first indent, shall be deleted;

(c)

point 3.6 shall be replaced by:

‘3.6. Where, in accordance with Article 24 of Regulation (EC) No 1272/2008, the Agency has agreed that the chemical identity of a substance may be kept confidential on the label and in the safety data sheet, their chemical nature shall be described under heading 3 in order to ensure safe handling.

The name used on the safety data sheet (including for the purposes of paragraphs 1.1, 3.2, 3.3 and 3.5) shall be the same as that used on the label, agreed in accordance with the procedure set out in Article 24 of Regulation (EC) No 1272/2008.’;

in Annex VI section 4.3 shall be replaced by the following:

‘4.3 Specific concentration limits, where applicable, resulting from the application of Article 10 of Regulation (EC) No 1272/2008.’;

Annex XVII shall be amended as follows:

(a)

in the column ‘Designation of the substance, of the groups of substances or of the mixture’ of the table in entry 3, the words ‘which are regarded as dangerous in accordance with Directive 1999/45/EC or are’ shall be deleted;

(b)

in the column ‘Conditions of restriction’ of the table, entry 28 shall be amended as follows:

(i)

the second indent of point 1 shall be replaced by the following:

—

‘—

the relevant generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008.’;

(ii)

point 2 (d) shall be replaced by the following:

‘(d)

artists’ paints covered by Regulation (EC) No 1272/2008’.

Article 60

Repeal

Directive 67/548/EEC and Directive 1999/45/EC shall be repealed with effect from 1 June 2015.

Article 61

Transitional provisions

Until 1 December 2010, substances shall be classified, labelled and packaged in accordance with Directive 67/548/EEC.

Until 1 June 2015, mixtures shall be classified, labelled and packaged in accordance with Directive 1999/45/EC.

By way of derogation from the second subparagraph of Article 62 of this Regulation and in addition to the requirements of paragraph 1 of this Article, substances and mixtures may, before 1 December 2010 and 1 June 2015 respectively, be classified, labelled and packaged in accordance with this Regulation. In that case, the provisions on labelling and packaging in Directives 67/548/EEC and 1999/45/EC shall not apply.

From 1 December 2010 until 1 June 2015, substances shall be classified in accordance with both Directive 67/548/EEC and this Regulation. They shall be labelled and packaged in accordance with this Regulation.

By way of derogation from the second subparagraph of Article 62 of this Regulation, substances classified, labelled and packaged in accordance with Directive 67/548/EEC and already placed on the market before 1 December 2010, are not required to be relabelled and repackaged in accordance with this Regulation until 1 December 2012.

By way of derogation from the second subparagraph of Article 62 of this Regulation, mixtures classified, labelled and packaged in accordance with Directive 1999/45/EC and already placed on the market before 1 June 2015 are not required to be relabelled and repackaged in accordance with this Regulation until 1 June 2017.

Where a substance or mixture has been classified in accordance with Directive 67/548/EEC or 1999/45/EC before 1 December 2010 or 1 June 2015 respectively, manufacturers, importers and downstream users may amend the classification of the substance or mixture using the conversion table in Annex VII to this Regulation.

Until 1 December 2011 a Member State may maintain any existing and more stringent classification and labelling of substances entered into Part 3 of Annex VI to this Regulation, provided that these classifications and labelling elements have been notified to the Commission in accordance with the safeguard clause in Directive 67/548/EEC before 20 January 2009 and that the Member State submits a proposal for harmonised classification and labelling containing these classifications and labelling elements to the Agency in accordance with Article 37(1) of this Regulation by 1 June 2009.

It is a precondition that a decision on the proposed classification and labelling by the Commission in accordance with the safeguard clause of Directive 67/548/EEC has not yet been taken before 20 January 2009.

If the proposed harmonised classification and labelling submitted under the first subparagraph is not included or is included in an amended form in Part 3 of Annex VI in accordance with Article 37(5), the exemption in the first subparagraph of this paragraph is no longer valid.

▼M36

Substances and mixtures which have been classified, labelled and packaged in accordance with Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 10, Article 25(3), Articles 29 and section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I as applicable on 9 December 2024 and which were placed on the market before 1 July 2026 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council ( 8 ) until 1 July 2028.

Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3), Article 31(3) and section 1.2.1 of Annex I, as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council (8) until 1 January 2029.

▼B

Article 62

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Titles II, III and IV shall apply in respect of substances from 1 December 2010 and in respect of mixtures from 1 June 2015.

ARTICLE 43 / Appointment of competent authorities and enforcement authorities and cooperation between authorities ARTICLE 44 / Helpdesk ARTICLE 45 / Appointment of bodies responsible for receiving information relating to emergency health response ARTICLE 46 / Enforcement and reporting ARTICLE 47 / Penalties for non-compliance

Source: Content sourced from EUR-Lex and licensed under CC BY 4.0. This is an unofficial presentation; only the official EUR-Lex version is legally authentic.

TITLE VI / COMPETENT AUTHORITIES AND ENFORCEMENT

TITLE VI

Article 43

Article 43

Article 44

Article 44

Article 45

Article 45

Article 46

Article 46

Article 47

Article 47

TITLE VII

Article 48

Article 49

Article 50

Article 51

Article 52

Article 53

Article 53a

Article 53b

Article 53c

Article 54

Article 54a

Article 55

Article 56

Article 57

‘Note A:

‘Note D:

‘Note H:

‘Note K:

‘Note S:

Article 58

Article 59

Article 60

Article 61

Article 62

Keyboard Shortcuts

Navigation

Search

General