Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilShow full title

TITLE VII U.K. COMMON AND FINAL PROVISIONS

Article 48 U.K. Advertisement

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

2. 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 [F1 the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013] on the protection of consumers in respect of distance contracts.

Textual Amendments

F1 Words in Art. 48(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 47; 2020 c. 1, Sch. 5 para. 1(1)

Article 49 U.K. Obligation to maintain information and requests for information

1. 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.

2. 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.

3. The [F2 competent authorities, enforcing authorities] 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 [F3 in question] shall address itself to the Agency.

[F4 4. For the purposes of this Article, “enforcing authorities” has the meaning given by regulation 18 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013.]

Textual Amendments

F2 Words in Art. 49(3) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 48(a)(i) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 14)

F3 Words in Art. 49(3) inserted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 48(a)(ii) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 14)

F4 Art. 49(4) inserted by S.I. 2019/720, Sch. 2 para. 48(b) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 14)

Article 50 U.K. Tasks of the Agency

F5 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. The F6 ... Agency shall:

(a) provide industry with 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 technical and scientific guidance on the operation of this Regulation and provide support to the [F7 helpdesk] established F8 ... under Article 44.

Textual Amendments

F5 Art. 50(1) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 49(a); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 50(2) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 49(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word in Art. 50(2)(b) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 49(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 50(2)(b) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 49(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F9 Article 51 U.K. Free movement clause

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Textual Amendments

F9 Art. 51 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 50; 2020 c. 1, Sch. 5 para. 1(1)

[F10 Article 52 U.K. Safeguard clause

1. The Secretary of State or a Devolved Authority may take appropriate provisional measures in respect of a substance or mixture if they—

(a) have justifiable grounds for believing that the substance or 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; and

(b) have competence to take the provisional measures, within the meaning of paragraphs 6 to 8.

2. A provisional measure taken by a Devolved Authority applies only in relation to the territory in relation to which it has competence.

3. Where the Secretary of State takes a provisional measure, the Secretary of State must immediately inform the Devolved Authorities, giving the reasons for the decision. Where a Devolved Authority takes a provisional measure, it must immediately inform the other Devolved Authorities and the Secretary of State, giving the reasons for the decision.

4. Within 90 days of a provisional measure being taken—

(a) in the case of a provisional measure relating to classification or labelling of a substance—

(i) where the Secretary of State took the measure, the Secretary of State must request the Agency to produce a proposal for a new or revised mandatory classification and labelling requirement under Article 37A(2),

(ii) where a Devolved Authority took the measure, the Competent Authority for that country must request the Agency to produce a proposal for a new or revised mandatory classification and labelling requirement under Article 37A(2);

(b) in the case of a provisional measure that falls within the scope of Article 53—

(i) where the Secretary of State took the measure, the Secretary of State must decide whether or not to make the measure permanent by making regulations under Article 53,

(ii) where a Devolved Authority took the measure, it must decide whether or not to request the Secretary of State to make the measure permanent by making regulations under Article 53.

5. The taker of the provisional measure must revoke that measure, when—

(a) in the case of a provisional measure relating to the classification or labelling of a substance, the Secretary of State makes a decision under Article 37A;

(b) in the case of a provisional measure that falls within the scope of Article 53—

(i) where paragraph 4(b)(i) of this Article applies, the Secretary of State either decides not to make the measure permanent or makes regulations under Article 53 to make the measure permanent, or

(ii) where paragraph 4(b)(ii) of this Article applies, the Devolved Authority decides not to request the Secretary of State to make the measure permanent.

6. The Secretary of State has competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure—

(a) relates to England;

(b) relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998);

(c) relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

7. The Scottish Ministers have competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

8. The Welsh Ministers have competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).]

Textual Amendments

F10 Art. 52 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 51 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 15); 2020 c. 1, Sch. 5 para. 1(1)

Article 53 U.K. Adaptations to technical and scientific progress

[F11 1 . [F12 The Secretary of State may by regulations amend] 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.

F13 ...]

F14 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F11 Substituted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).

F12 Words in Art. 53(1) substituted (1.11.2022) by The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 7(3)(a)(i)

F13 Words in Art. 53(1) omitted (1.11.2022) by virtue of The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 7(3)(a)(ii)

F14 Art. 53(2) omitted (1.11.2022) by virtue of The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 7(3)(b)

[F15 Article 53A U.K. Regulation making power

1. Any power to make regulations conferred on the Secretary of State by this Regulation is exercisable by statutory instrument.

2. Such regulations may—

(a) contain incidental, supplemental, consequential and transitional provision; and

(b) may make different provision for different purposes.

3. A statutory instrument containing regulations made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.

4. The function of making regulations under this Regulation is subject to the consent requirement in Article 53B.]

Textual Amendments

F15 Arts. 53A, 53B inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 53 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 16); 2020 c. 1, Sch. 5 para. 1(1)

[F15 Article 53B U.K. The consent requirement

1. Where any provision of this Regulation states that a function is subject to the consent requirement in this Article, the function may be exercised in a particular instance only if the person exercising it has obtained the consent or consents (if any) required by paragraphs 2 to 4.

2. The consent of the Scottish Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 54 of the Scotland Act 1998) whether or not the exercise of the function also relates to a part of the United Kingdom other than Scotland.

3. The consent of the Welsh Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006) whether or not the exercise of the function also relates to a part of the United Kingdom other than Wales.]

Textual Amendments

F15 Arts. 53A, 53B inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 53 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 16); 2020 c. 1, Sch. 5 para. 1(1)

F16 Article 53a U.K. Exercise of the delegation

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Textual Amendments

F16 Art. 53a omitted (1.11.2022) by virtue of The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 7(4)

F17 Article 53b U.K. Urgency procedure

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Textual Amendments

F17 Art. 53b omitted (1.11.2022) by virtue of The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 7(5)

F18 Article 53c U.K. Separate delegated acts for different delegated powers

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Textual Amendments

F18 Art. 53c omitted (1.11.2022) by virtue of The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 7(6)

F19 Article 54 U.K. Committee procedure

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Textual Amendments

F19 Art. 54 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 54; 2020 c. 1, Sch. 5 para. 1(1)

Article 55 U.K. 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;

2.

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;

3.

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.’;

4.

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.’;

5.

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

6.

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’;

7.

Article 24(4) second subparagraph shall be deleted;

8.

Article 28 shall be deleted;

9.

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 U.K. 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(2).

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;

3.

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’;

4.

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 U.K. 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(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;’;

2.

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.’;

3.

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.’;

4.

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.’;

5.

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

6.

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’;

7.

Title XI shall be deleted;

8.

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;

9.

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 U.K. 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:’;

2.

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.’;

3.

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.’;

4.

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;’;

5.

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

6.

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.’;

7.

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:’;

8.

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.’;

9.

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:

‘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.’;

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:

‘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.’;

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 U.K. 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:

1.

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.’;

2.

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.’;

3.

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.’;

4.

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

5.

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.’;

6.

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.’;

7.

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’.

F20 Article 60 U.K. Repeal

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Art. 60 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 54; 2020 c. 1, Sch. 5 para. 1(1)

F21 Article 61 U.K. Transitional provisions

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F21 Art. 61 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 54; 2020 c. 1, Sch. 5 para. 1(1)

F22 Article 62 U.K. Entry into force

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F22 Art. 62 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 54; 2020 c. 1, Sch. 5 para. 1(1)

(1)

OJ L 353, 31.12.2008, p. 1’;

(2)

OJ L 353, 31.12.2008, p. 1’;

(3)

OJ L 353, 31.12.2008, p. 1’;