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The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019

Type Statutory-Instrument

Publication 2019-03-27

Last updated 2025-02-27

State In force

Department King's Printer of Acts of Parliament

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(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. (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. (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

54

Omit Articles 54, 60, 61 and 62.

55

In Annex I—

(a) in point 1.1.2.2.2.(a)(i), for “Part 3 of Annex VI or in the classification and labelling inventory” substitute “ GB mandatory classification and labelling list or in the GB notification database ”;

(b) in point 1.1.2.2.2.(a)(ii), for “Part 3 of Annex VI or in the classification and labelling inventory” in both places it occurs substitute “ the GB mandatory classification and labelling list or in the GB notification database ”;

(c) in point 1.1.2.2.2.(a)(iii), for “Part 3 of Annex VI or in the classification and labelling inventory” substitute “ the GB mandatory classification and labelling list or in the GB notification database ”;

(d) in point 1.1.2.2.2.(a)(iv), for “Part 3 of Annex VI or in the classification and labelling inventory” substitute “ the GB mandatory classification and labelling list or in the GB notification database ”;

(e) in point 1.1.2.2.2.(b)(i), for “Part 3 of Annex VI or in the classification and labelling inventory” substitute “ the GB mandatory classification and labelling list or in the GB notification database ”;

(f) in point 1.1.2.2.2.(b)(ii), for “Part 3 of Annex VI or in the classification and labelling inventory” substitute “ the GB mandatory classification and labelling list or in the GB notification database ”.

56

In Annex II—

(a) in point 1.2.5, in the second paragraph, for “Part 3 of Annex VI” substitute “ the GB mandatory classification and labelling list ”;

(b) in point 2.10, in the second indent under the fifth indent, omit “Community”;

(c) in part 4, for “Article 16 of Directive 91/414/EEC and Annex V of that Directive, the labelling for plant protection products subject to Directive 91/414/EEC” substitute “ Article 65 of Regulation (EC) No 1107/2009 and Regulation (EC) No 547/2011 as regards labelling requirements for plant protection products subject to Regulation (EC) No 1107/2009 ”.

57

(1) Annex VI is amended as follows.

(2) In the title, for “Harmonised” substitute “ Mandatory ”.

(3) In the introduction—

(a) in the first paragraph, for “harmonised” substitute “ mandatory ” and for “Table 3” substitute “ the GB mandatory classification and labelling list ”;

(b) in the second paragraph, for “harmonised” substitute “ mandatory ” and omit “at Union level”;

(4) In Part 1—

(a) in the title, for “harmonised” substitute “ mandatory ”;

(b) in point 1.1.1.1, for “Part 3” substitute “ the GB mandatory classification and labelling list ”;

(c) in point 1.1.1.4, in the fifth paragraph, for “Part 3” substitute “ the GB mandatory classification and labelling list ”;

(d) in point 1.1.1.5, in the first, second and fourth paragraphs, for “Part 3” substitute “ the GB mandatory classification and labelling list ”, and in the second paragraph for “this Annex” substitute “ the list ”;

(e) in point 1.1.2, for “Table 3” substitute “ the GB mandatory classification and labelling list ”;

(f) in point 1.1.2.3, for “in this Annex” substitute “ in the list ”, and for “table 3” and “Table 3” in each place they occur substitute “ the GB mandatory classification and labelling list ”;

(g) in point 1.1.3.1—

(i) in Note A in the first and second paragraph, Note B in the second paragraph, Note D in the first paragraph, Note F, and Note J, for “Part 3” substitute “ the GB mandatory classification and labelling list ”;

(ii) in Note K, omit “(Table 3.1) or the S-phrases (2-) 9-16 (Table 3.2)” and for “Part 3” substitute “ the GB mandatory classification and labelling list ”;

(iii) in Note L, Note M, and Note N, for “Part 3” substitute “ the GB mandatory classification and labelling list ”;

(iv) in Note P in the second paragraph, omit “(Table 3.1) or the S-phrases (2-) 23-24-62 (Table 3.2)” and in the third paragraph for “Part 3” substitute “ the GB mandatory classification and labelling list ”;

(v) in Note S, in the first paragraph omit “(Table 3.1)” and omit the second paragraph;

(h) in point 1.2.1, for “this Annex” in both places it occurs substitute “ the GB mandatory classification and labelling list ”, and for “Table 3” substitute “ the GB mandatory classification and labelling list ”;

(i) in point 1.2.2, for “in Table 3” substitute “ in the GB mandatory classification and labelling list ”;

(j) in point 1.2.3 for “in Table 3” substitute “ in the GB mandatory classification and labelling list ”;

(k) in point 1.2.4, for “in Table 3” substitute “ in the GB mandatory classification and labelling list ”.

(5) Omit Part 3.

Commission Regulation (EU) No 544/2011

58

(1) Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances is amended as follows.

(2) In the Annex, in Part A—

(a) in point 1.4—

(i) for the words from “Annex VI” to “Council” substitute “ the GB mandatory classification and labelling list ”;

(ii) for “Regulation” in the second place it occurs substitute “ list ”;

(b) after point 1.4 insert—

(1) In point 1.4, “the GB mandatory classification and labelling list” means the list of mandatory classification and labelling requirements of substances and groups of substances established and maintained in accordance with Article 38A of Regulation (EC) No 1272/2008.

Commission Regulation (EU) No 545/2011

59

(1) Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products is amended as follows.

(2) In the Annex—

(a) in the Introduction, after point 4 insert—

(5) In this Annex, “the GB mandatory classification and labelling list” means the list of mandatory classification and labelling requirements of substances and groups of substances established and maintained in accordance with Article 38A of Regulation (EC) No 1272/2008.

(b) in Part A, in point 1.4.3, in the first sentence—

(i) for “Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”;

(ii) for “Regulation” in the second place it occurs substitute “ list ”;

(i) for “Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”;

(ii) for “Regulation” in the second place it occurs substitute “ list ”.

Commission Regulation (EU) No 547/2011

60

(1) Commission Regulation (EU) No 547/2011 of 8 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products is amended as follows.

(2) In Annex I—

(a) in point (1)(c), in the second sentence, for “the list contained in Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council” substitute “ the GB mandatory classification and labelling list ”;

(b) after point (1) insert—

(1A) In point (1)(c), the “GB mandatory classification and labelling list” means the list of mandatory classification and labelling requirements of substances and groups of substances established and maintained in accordance with Article 38A of Regulation (EC) No 1272/2008.

Regulation (EU) No 528/2012

61

Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products is amended in accordance with paragraphs 62 to 143.

62

(1) Article 1 is amended as follows.

(2) In paragraph 1—

(a) omit “internal”;

(b) omit “the harmonisation of the”.

(3) In paragraph 2—

(a) for “Union” substitute “ Great Britain ”;

(b) omit point (c);

63

(1) Article 2 is amended as follows.

(2) In paragraph 2, in the first subparagraph—

(a) in the opening sentence omit “Union”;

(b) for point (b) substitute “the Medical Devices Regulations 2002”;

(d) for point (k) substitute “the Toys (Safety) Regulations 2011”.

(3) In paragraph 6, for “Chapter VIII” substitute “ Chapter VI ”.

(4) In paragraph 7, for “Member States” substitute “ the competent authority or any other relevant authority from ”.

(5) In paragraph 8, for “Member States” substitute “ The Secretary of State ”.

(6) In paragraph 9, omit “the Union and”.

64

(1) Article 3 is amended as follows.

(2) In paragraph 1—

(a) in point (d), after the words “on 14 May 2000” insert “ , in a country which was a Member State of the EU on that date, ”;

(b) in point (e), after the words “on 14 May 2000” insert “ in a country which was a Member State of the EU on that date ”;

(d) in point (k), for “the Union” substitute “Great Britain”;

(e) in point (m)—

(i) omit “of a Member State”;

(ii) omit “in its territory or part thereof”;

(f) for point (n), substitute—

(n) ‘Union authorisation’ means the administrative act by which the Commission authorised the making available on the market and use of a biocidal product or a product family in the territory of the Union or part thereof before IP completion day;

(g) in point (o), omit “, Union authorisation”;

(h) in point (p)—

(i) for “within the Union” substitute “ in the United Kingdom ”;

(ii) for “a particular Member State or in the Union” substitute “ Great Britain ”;

(i) in point (t), for “competent authorities, the Agency, or the Commission” insert “ the competent authority ”;

(j) omit point (x);

(k) after point (ae) insert—

(af) ‘the consent requirement’ means the requirement for consent in accordance with Article 83B; (ag) ‘the UK List’ means the list of approved substances established and maintained in accordance with Article 8A; (ah) ‘the Simplified Active Substance List’ means the list of active substances which can be used in biocidal products that qualify for the simplified authorisation procedure, established and maintained in accordance with Article 24A. (ai) “appropriate fee” means the fee payable for the activity concerned in regulations made under section 43 of the Health and Safety at Work etc. Act 1974 where the competent authority is appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013; (aj) “Devolved Authority” means— (i) the Scottish Ministers, or (ii) the Welsh Ministers.

(3) For paragraphs 3 and 4, substitute—

(3) The Secretary of State may issue a decision which is to be published, as to whether a substance is a nanomaterial, having regard in particular to Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial and whether a specific product or group of products is a biocidal product or a treated article or neither. (4) A decision issued under paragraph 3 above is subject to the consent requirement. (5) The Secretary of State may by regulations adapt the definition of nanomaterial set out in point (z) of paragraph 1 of this Article in view of technical and scientific progress, taking into account the Recommendation referred to in paragraph 3 above. (6) Regulations made under paragraph 5 above are subject to the consent requirement. (7) Where any of the Devolved Authorities makes proposals in relation to adaptations under paragraph 5 above, the Secretary of State must have regard to such proposals in deciding whether to exercise functions in that paragraph.

65

In Article 5—

(a) in paragraph 1, in point (d), for the words from “, on the basis” to “subparagraphs of paragraph 3,” substitute “ meet the criteria in Regulation (EU) No 2100/2017 ”;

(b) in paragraph 2, omit the final sentence;

66

(1) Article 6 is amended as follows.

(2) In paragraph 2, omit “evaluating”.

(3) In paragraph 4, for “Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying criteria” substitute “ Secretary of State may by regulations amend the criteria ”.

(4) After paragraph 4, insert—

(5) Regulations made under paragraph 4 above are subject to the consent requirement. (6) Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 4 above, the Secretary of State must have regard to such proposals when deciding whether to exercise functions under that paragraph.

67

(1) Article 7 is amended as follows.

(2) For paragraph 1 substitute—

(1) The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, to the competent authority.

(3) Omit paragraph 2.

(4) In paragraph 3—

(a) in the first subparagraph—

(i) for “Agency accepting” substitute “ competent authority receiving ”;

(ii) for “the evaluating competent authority” substitute “ it ”;

(b) in the second subparagraph omit “evaluating”;

(i) omit “evaluating”;

(ii) for “the Agency has accepted” substitute “ it has received ”;

(iii) omit “under Article 80(2)”.

(5) In paragraph 4—

(a) omit “evaluating” in each place it occurs;

(b) in the third subparagraph—

(i) omit “and the Agency accordingly”;

(ii) omit “in accordance with Article 80(1) and (2)”.

(6) In paragraph 5—

(a) omit “evaluating”;

(b) omit “, the Agency and other competent authorities”.

(7) Omit paragraph 6.

68

(1) Article 8 is amended as follows.

(2) In the first subparagraph of paragraph 1—

(a) omit “evaluating”;

(b) for “send” substitute “ produce ”;

(3) For the second subparagraph of paragraph 1 substitute—

The competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The competent authority shall take due account of those comments.

(4) In paragraph 2—

(a) omit “evaluating” in both places it occurs;

(b) omit “, and shall inform the Agency accordingly”.

(5) After paragraph 2, insert—

(2A) The competent authority may request from the applicant available information on, and take into account, evaluations undertaken by third countries in order to complete its evaluation. The weight given to those third country evaluations shall take into account the equivalence of the evaluation process.

(6) In paragraph 3, omit “evaluating”.

(7) For paragraph 4 substitute—

(4) Within 270 days of producing its assessment reports and evaluation conclusions the competent authority shall prepare and submit an opinion on the approval of the active substance to the Secretary of State and the Devolved Authorities.

69

After Article 8 insert—

The competent authority shall establish, maintain and make electronically available to the public a list of approved active substances (“the GB List”).

70

(1) Article 9 is amended as follows.

(2) In paragraph 1—

(a) for “Commission” substitute “ Secretary of State ”;

(b) for “Agency” substitute “ competent authority ”;

(d) in point (b), for “adopt an implementing” substitute “ issue a ”;

(e) omit the subparagraph after point (b).

(3) After paragraph 1, insert—

(1A) A decision issued under paragraph 1 is subject to the consent requirement.

(4) For paragraph 2, substitute—

(2) Approved active substances shall be included in the GB List established under Article 8A of this Regulation.

71

(1) Article 10 is amended as follows.

(2) In paragraph 2, for “Agency” substitute “ competent authority ”.

(3) In paragraph 3—

(a) for “Commission” substitute “ Secretary of State and the Devolved Authorities ”;

(b) for “Agency” in both places it occurs substitute “ competent authority ”.

(4) In paragraph 5, for “Regulation adopted” substitute “ decision issued ”.

72

Omit Article 11.

73

In Article 12—

(a) in paragraph 1, for “Commission” substitute “ Secretary of State ”;

(b) in paragraph 2, for “Commission” substitute “ Secretary of State ”;

(d) after paragraph 3, insert—

(4) The renewal of an approval under paragraph 1 or amendment of the conditions in paragraph 2 is subject to the consent requirement.

74

In Article 13—

(a) in paragraph 1, for “Agency” substitute “ competent authority ”;

(b) omit paragraph 3;

75

(1) Article 14 is amended as follows.

(2) In paragraph 1—

(a) omit “evaluating”;

(b) for “the Agency accepting” substitute “ receiving ”;

(3) In paragraph 2—

(a) omit “evaluating” in each place it occurs;

(b) in the second subparagraph—

(i) for “the Agency accepting” substitute “ receiving ”;

(ii) for “13(3)” substitute “ 13 ”;

(iii) for “Agency” substitute “ Secretary of State and the Devolved Authorities ”;

(i) for “the Agency has accepted” substitute “ it has received ”;

(ii) for “fees payable under Article 80(2)” substitute “ appropriate fees ”.

(4) In paragraph 3—

(a) for “receipt of a recommendation from the evaluating competent authority” substitute “ the completion of the evaluation conclusions ”;

(b) for “Agency” substitute “ competent authority ”;

(5) In paragraph 4—

(a) for “Commission” substitute “ Secretary of State ”;

(b) for “Agency” substitute “ competent authority ”;

(d) in point (a), for “an implementing regulation” substitute “ a decision ”;

(e) in point (b), omit “an implementing” substitute “ a ”;

(f) omit the penultimate subparagraph.

(6) After paragraph 4 insert—

(4A) The competent authority shall update the GB List with details of the renewal of the approval of the active substance

(7) For paragraph 5, insert—

(5) Where, for reasons beyond the control of the applicant, the approval of the active substance is likely to expire before a decision has been taken on its renewal, the Secretary of State shall issue a decision postponing the expiry date of approval for a period sufficient to enable the competent authority to examine the application.

(8) After paragraph 5, insert—

(5A) A decision issued under paragraph 4 or 5 above is subject to the consent requirement.

(9) In paragraph 6—

(a) for “Commission” substitute “ Secretary of State ”;

(b) for “Member States or, in the case of a Union authorisation, the Commission” substitute “ competent authority ”.

76

For Article 15, substitute—

(1) The Secretary of State may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Secretary of State may also review the approval of an active substance for one or more product-types at the request of the competent authority if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Secretary of State shall make publically available the information that it is carrying out a review and shall provide an opportunity for the applicant to submit comments. The Secretary of State shall take due account of those comments in the review. (2) Where any of the Devolved Authorities proposes that an active substance should be reviewed the Secretary of State shall have regard to such proposals in deciding whether to review the approval of an active substance. (3) Where those indications are confirmed, the Secretary of State shall issue a decision amending the conditions of approval of an active substance or cancelling its approval. Article 9(2) shall apply. The competent authority shall inform the initial applicants for the approval accordingly. (4) On duly justified imperative grounds of urgency the Secretary of State may issue immediately applicable decisions. (5) Paragraphs 1, 3 and 4 are subject to the consent requirement. (6) Where the Secretary of State decides to cancel or amend the approval of an active substance for one or more product-types the competent authority shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.

77

Omit Article 16.

78

(1) Article 17 is amended as follows.

(2) In paragraph 2—

(a) in the first subparagraph after “prospective authorisation holder” insert “ to the competent authority ”;

(b) omit the second subparagraph;

(3) In paragraph 5, for “Member States” substitute “ The competent authority ”.

(4) In paragraph 6—

(a) for “authorisation holder shall notify each competent authority that has granted a national authorisation for a biocidal product family” substitute “ biocidal product family authorisation holder shall notify the competent authority ”;

(b) omit the final sentence.

(5) Omit paragraph 7.

79

Omit Article 18.

80

In Article 19—

(a) in paragraph 1, in point (a), for “Annex I” substitute “ the Simplified Active Substance List ”;

(b) in paragraph 4, omit point (a);

(d) omit paragraph 8.

81

In Article 20—

(a) in paragraph 1, after point (a)(iii) insert—

the competent authority may refuse to accept a letter of access for the purposes of this Article if it does not hold the relevant data.

(b) for paragraph 2 substitute—

(2) Applications must be submitted in English.

82

In Article 21, omit paragraph 3.

83

(1) Article 23 is amended as follows.

(2) In paragraph 1, for “receiving competent authority, or in the case of an evaluation of an application for a Union authorisation, the evaluating competent authority,” substitute “ competent authority ”.

(3) Omit paragraph 2.

(4) In paragraph 3—

(a) for “receiving competent authority or, in the case of a decision on the application for a Union authorisation, the Commission” substitute “ competent authority ”;

(b) omit “, performed in accordance with the technical guidance notes referred to in Article 24,”.

(5) Omit paragraph 5.

84

Omit Article 24.

85

Before Article 25, insert—

The competent authority must establish, maintain and make electronically available “the Simplified Active Substance List” of active substances that can be used in products that qualify for the simplified authorisation procedure under Article 25 of this Regulation.

86

In Article 25, paragraph 1, in point (a)—

(a) for “Annex I” substitute “ the Simplified Active Substance List ”;

(b) for “that Annex” substitute “ that list ”.

87

(1) Article 26 is amended as follows.

(2) Omit “evaluating” in each place it occurs.

(3) In paragraph 1—

(a) for “Agency” substitute “ competent authority ”;

(b) omit the words from “informing” to the end of that paragraph.

(4) In paragraph 2, for “fees payable under Article 80(2)” in both places it occurs substitute “ appropriate fees ”.

(5) In paragraph 4, omit “paid in accordance with Article 80(2)”.

88

Omit Article 27.

89

In Article 28—

(a) in the heading, for “Annex I” substitute “ the Simplified Active Substance List ”;

(b) for paragraph 1, substitute—

(1) The competent authority must, after receiving the decision of the Secretary of State, update the Simplified Active Substance List in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2 of this Article.

(3) The Secretary of State may agree to the restriction or removal of an entry of an active substance to the Simplified Active Substance List on the recommendation of the competent authority if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25. (4) Paragraph 1 or 3 shall apply at the initiative of the Secretary of State or at the request of an economic operator or at the request of a Devolved Authority providing the necessary evidence as referred to in those paragraphs. (5) The Secretary of State may make regulations to further specify the procedures to be followed with respect to the amendment of the Simplified Active Substance List. (6) A decision issued or a function carried out under paragraph 1, 3 or 5 is subject to the consent requirement. (7) Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 5 above, the Secretary of State must have regard to such proposals when deciding whether to exercise functions under that paragraph.

90

(1) Article 29 is amended as follows.

(2) Omit “receiving” in each place it occurs.

(3) In paragraph 1, for “fees payable under Article 80(2)” in both places it occurs substitute “ appropriate fees ”.

(4) In paragraph 2—

(a) for “it complies with the following requirements:” substitute “ the relevant information referred to in Article 20 has been submitted ”;

(b) omit points (a) and (b).

(5) Omit paragraph 4.

91

In Article 30, omit “receiving” in each place it occurs.

92

In Article 31—

(a) omit “receiving” in each place it occurs;

(b) in paragraph 4, for “fees payable under Article 80(2)” in both places it occurs substitute “ appropriate fees ”.

93

Omit Articles 32 to 46.

94

In Article 47—

(a) in paragraph 1, omit “that granted the national authorisation and the Agency or, in the case of a Union authorisation, the Commission and the Agency”;

(b) in paragraph 2, omit “that granted the national authorisation or, in the case of a Union authorisation, the Agency”;

95

(1) Article 48 is amended as follows.

(2) In paragraph 1, omit “of a Member State or, in the case of a Union authorisation, the Commission”.

(3) In paragraph 2—

(a) omit “or, in the case of a Union authorisation, the Commission,”;

(b) for “evaluating competent authority or, in the case of a Union authorisation, the Commission,” substitute “ competent authority ”.

(4) In paragraph 3—

(a) omit “or, in the case of a Union authorisation, the Commission,”;

(b) omit “, the competent authorities of other Member States and, where relevant, the Commission”;

(d) omit the final subparagraph.

96

In Article 49—

(a) omit “that granted the national authorisation or, in the case of a Union authorisation, the Commission,”;

(b) omit the final sentence.

97

(1) Article 50 is amended as follows.

(2) Omit paragraph 1.

(3) In paragraph 2—

(a) for “authorities of relevant Member States having authorised the biocidal product concerned, or in the case of a Union authorisation, the Agency” substitute “ authority ”;

(b) for “Those competent authorities shall decide, or, in the case of a Union authorisation, the Agency shall examine and the Commission” substitute “ The competent authority shall ”;

98

Omit Article 51.

99

In Article 52, omit “or, in the case of a biocidal product authorised at Union level, the Commission,”.

100

Omit Article 53.

101

In Article 54—

(a) for “Agency” in each place it occurs substitute “ competent authority ”;

(b) in paragraph 3, for “fees payable under Article 80(1)” substitute “ appropriate fees ”;

(d) omit paragraph 6;

(e) omit paragraph 8.

102

For Article 55, substitute—

(1) By way of derogation from Articles 17 and 19, the competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means. On receipt of a reasoned request from the competent authority, the Secretary of State or a Devolved Authority shall issue a decision, with or without conditions, on whether the action taken may be extended for a period not exceeding 550 days if they have competence to exercise the derogation within the meaning in paragraphs 4 to 8. (2) By way of derogation from point (a) of Article 19(1) and until an active substance is approved, the competent authority may authorise, for a period not exceeding three years, a biocidal product containing a new active substance. Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the competent authority has produced an assessment report and evaluation conclusions on the new active substance and consider that the biocidal product is expected to comply with points (b), (c) and (d) of Article 19(1) taking into account the factors set out in Article 19(2). If the Secretary of State decides not to approve the new active substance, the competent authority shall cancel that authorisation. Where a decision on the approval of the new active substance has not yet been made by the Secretary of State when the period of three years expires, the competent authority may extend the provisional authorisation for a period not exceeding one year, provided that there are good reasons to believe that the active substance will satisfy the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2). (3) By way of derogation from point (a) of Article 19(1), the Secretary of State or a Devolved Authority shall issue a decision allowing the competent authority to authorise a biocidal product containing a non-approved active substance if the Secretary of State or a Devolved Authority is satisfied that that active substance is essential for the protection of cultural heritage and that no appropriate alternatives are available. To obtain such a derogation, the competent authority shall apply to the Secretary of State or a Devolved Authority providing due justification. (4) The Secretary of State has competence to grant a derogation under paragraph 1 or 3 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 ) ... (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (5) The Scottish Ministers have competence to grant a derogation under paragraph 1 or 3 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). (6) The Welsh Ministers have competence to exercise a derogation under paragraph 1 or 3 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). (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (7) Where the Secretary of State grants a derogation, the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority exercises a derogation, it must immediately inform the other Devolved Authority and the Secretary of State giving reasons for the decision.

103

(1) Article 56 is amended as follows.

(2) In paragraph 2—

(a) omit “of the Member State where the experiment or test will occur”;

(b) for “authorities” substitute “ authority ”.

(3) In paragraph 3—

(a) for “relevant competent authority of the Member State concerned” substitute “ competent authority ”;

(b) omit the final sentence.

(4) Omit paragraph 4.

104

In Article 57, omit “ 27,”.

105

(1) Article 58 is amended as follows.

(2) In paragraph 2, for “Annex I” substitute “ the Simplified Active Substance List ”.

(3) In paragraph 6, for “the official language or languages of the Member State of introduction, unless that Member State provides otherwise” substitute “ English ”.

(4) Omit paragraph 7.

(5) In paragraph 8—

(a) for “the Commission” substitute “ the Secretary of State ”;

(b) for “Annex I” substitute “ the Simplified Active Substance List ”.

(6) After paragraph 8 insert—

(9) Where any of the Devolved Authorities proposes that an active substance should be reviewed in accordance with paragraph 8 above, the Secretary of State shall have regard to such proposals in deciding whether to review the active substance.

106

(1) Article 59 is amended as follows.

(2) For the heading, substitute “ Protection of data held by the competent authority ”.

(3) In paragraph 1, for “competent authorities or the Agency” substitute “ the competent authority ”.

(4) In paragraph 2—

(a) for “a”, in the first place it occurs, substitute “ the ”;

(b) omit “or to the Agency”.

(5) In paragraph 3, omit “or the Agency”.

(6) Omit paragraph 4.

107

(1) Article 60 is amended as follows.

(2) In paragraph 3, for “, 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5)”, in both places it occurs, substitute “ or 30(1) ”.

(3) After paragraph 3 insert—

(4) The protection period for data submitted for biocidal products containing only existing active substances which were authorised in the United Kingdom prior to IP completion day shall end 10 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5) of this Regulation as it had effect immediately before IP completion day. (5) The protection period for data submitted for biocidal products containing a new active substance which were authorised in the United Kingdom prior to IP completion day shall end 15 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5) of this Regulation as it had effect immediately before IP completion day.

108

In Article 62(2)—

(a) in the first subparagraph, after point (b)—

(i) in the first place it occurs, for “Agency” substitute “competent authority”;

(ii) omit “Agency or to a”;

(iii) after “under this Regulation” insert “or Regulation (EU) No 528/2012 as it had effect immediately before IP completion day”;

(iv) for “The Agency shall” substitute “The competent authority must”;

(v) at the end, insert “and whether the competent authority has access to the tests or studies”;

(b) in the second subparagraph—

(i) omit “Agency or to a”;

(ii) after “under this Regulation” insert “or Regulation (EU) No 528/2012 as it had effect immediately before IP completion day”;

(iii) for “the Agency shall” substitute “and where the competent authority has access to the tests or studies the competent authority must”.

109

In Article 63—

(a) in paragraph 3, for “Agency” in each place it occurs substitute “ competent authority ”;

(b) in paragraph 4, for “established by the Agency” substitute “ either specified or referred to by the competent authority ”;

110

(1) Article 64 is amended as follows.

(2) In paragraph 1—

(a) for “the receiving competent authority or the Agency” in each place it occurs substitute “ the competent authority ”;

(b) in the first and second sub paragraphs, after “the first applicant” in both places it occurs insert “ , where the data was provided to the competent authority, ”;

(3) In paragraph 2, for “receiving competent authority or the Agency” substitute “ competent authority ”.

111

(1) Article 65 is amended as follows.

(2) In paragraph 1, for “Member States” substitute “ The competent authority ”.

(3) In paragraph 2—

(a) in the first subparagraph for “Member States” substitute “ The competent authority ”;

(b) in the second subparagraph, for “on the Union market” substitute “on the market in Great Britain”;

(d) in the final subparagraph for “Member States” substitute “ the competent authority ”.

(4) Omit paragraph 3.

(5) Omit paragraph 4.

112

(1) Article 66 is amended as follows.

(2) Omit paragraph 1.

(3) In paragraph 2—

(a) for “Agency and the competent authorities” substitute “ competent authority ”;

(b) for “Agency or the competent authorities” substitute “ competent authority ”.

(4) In paragraph 4, omit “Agency or a”.

113

(1) Article 67 is amended as follows.

(2) In paragraph 1—

(a) for “Commission adopts an implementing Regulation” substitute “ Secretary of State issues a decision ”;

(b) after the words “up-to-date information” insert “ , where ”;

(3) In paragraph 2, for the first sentence substitute “ From the date on which a biocidal product is authorised, the following up-to-date information, where held by the competent authority, shall be made publicly and easily available free of charge— ”.

(4) In paragraph 3—

(a) for “Commission adopts an implementing Regulation” substitute “ Secretary of State issues a decision ”;

(b) for “Agency” substitute “ competent authority ”;

(d) after the words “up-to-date information” insert “ where held by the competent authority ”.

(5) In paragraph 4—

(a) for “Agency” substitute “ competent authority ”;

(b) omit “or the Agency”;

114

In Article 68, omit paragraph 2.

115

(1) Article 69 is amended as follows.

(2) In paragraph 1, omit “, and with Directive 1999/45/EC”.

(3) In paragraph 2—

(a) in point (c), omit “or the Commission”;

(b) in point (o), for “Directive 2000/45/EC” substitute “the Control of Substances Hazardous to Health Regulations 2002.

(4) In paragraph 3—

(a) for “Member States” substitute “ The competent authority ”;

(b) for “in their territories be labelled in their official language or languages” substitute “ be labelled in English ”.

116

Omit Article 70.

117

(1) Article 71 is amended as follows.

(2) For the heading substitute “ Exchange of information ”.

(3) For paragraph 1, substitute—

(1) The competent authority shall establish and maintain a system for the exchange of information between the competent authority and applicants.

(4) Omit paragraph 2.

(5) In paragraph 3, for “Register for Biocidal Products” substitute “ system referred to in paragraph 1 ”.

(6) In paragraph 4—

(a) for “Agency” in both places it occurs substitute “ competent authority ”;

(b) omit “and notify the relevant competent authority accordingly without delay”.

(7) Omit paragraphs 5 to 9.

118

Omit Articles 74 to 76.

119

For Article 77, substitute—

(1) Decisions of the competent authority taken pursuant to this Regulation may be appealed against in accordance with regulation 14 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013. (2) Fees may be payable as appropriate by the person bringing an appeal. (3) An appeal lodged pursuant to paragraph 1 shall have suspensive effect.

120

Omit Article 78.

121

For Article 79, substitute—

The competent authority shall specify formats for submission of information. Applicants shall use these formats in their submissions to the competent authority pursuant to this Regulation.

122

Omit Article 80.

123

(1) Article 81 is amended as follows.

(2) For the heading, substitute “ The competent authority ”.

(3) For paragraph 1, substitute—

(1) The competent authority responsible for the application of this Regulation— (a) is the competent authority as appointed by regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013, and (b) must have a sufficient number of suitably qualified and experienced staff to enable the obligations provided for in this Regulation to be carried out efficiently and effectively.

(4) In paragraph 2—

(a) in the first subparagraph—

(i) for “Competent authorities” substitute “ The competent authority ”;

(ii) omit the final sentence;

(b) in the second subparagraph—

(i) for “Competent authorities” substitute “ The competent authority ”;

(ii) for “helpdesks”, in the first place it occurs, substitute “ a helpdesk ”;

124

Omit Articles 82, 83 and 84.

125

Before Article 85 insert—

(1) Regulations made by the Secretary of State under this Regulation are to be made by statutory instrument. (2) Such regulations may— (a) contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments); (b) make different provision for different purposes. (3) A statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament. (1) Where any provision of this Regulation states that a function is subject to the consent requirement, 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 and 3. (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. (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

126

For Article 85, substitute—

(1) The Secretary of State may by regulations amend Annexes II, III and IV to this Regulation to take account of current scientific and technical knowledge. (2) Regulations made under paragraph 1 above shall be subject to the consent requirement.

127

In Article 86, for “for which the Commission has adopted directives including them” substitute “ included ”.

128

Omit Article 87.

129

For Article 88, substitute—

(1) Where on the basis of new evidence the competent authority has justifiable grounds to consider that a biocidal product, although authorised in accordance with this Regulation, constitutes a serious immediate or long-term risk to the health of humans, particularly of vulnerable groups, or animals, or to the environment, it may take appropriate provisional measures. (2) The Secretary of State or a Devolved Authority shall issue a decision to either permit the provisional measure for a time period defined in the decision or require the competent authority to revoke the provisional measure if they have competence to issue the decision within the meaning in paragraphs 3 to 5. (3) The Secretary of State has competence to issue a decision 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) ... (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4) The Scottish Ministers have competence to issue the decision 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). (5) The Welsh Ministers have competence to issue a decision 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). (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (6) Where the Secretary of State issues the decision under paragraph 2 the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority issues the decision under paragraph 2, it must immediately inform the other Devolved Authority and the Secretary of State giving reasons for the decision.

130

For Article 89, substitute—

(1) The competent authority shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC with the aim of achieving it by 31 December 2024. (2) The Secretary of State may by regulations— (a) extend the date for the systematic examination of all existing active substances referred to in this Article; (b) specify matters in relation to the carrying out of the work programme and the related rights and obligations of the competent authority and the participants in the programme. (3) Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 2, the Secretary of State must have regard to such proposals in deciding whether to exercise functions under that paragraph. (4) Regulations made under paragraph 2 above are subject to the consent requirement. (5) In order to facilitate a smooth transition from Directive 98/8/EC to this Regulation, during the work programme the Secretary of State shall either issue decisions providing that an active substance is approved, and under which conditions, or, in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, issue decisions stating that an active substance is not approved. Decisions approving an active substance shall specify the date of approval. Article 9(2) shall apply. (6) A decision made under paragraph 5 is subject to the consent requirement. (7) By way of derogation from Articles 17(1), 19(1) and 20(1) of this Regulation, and without prejudice to paragraphs 1, 2 and 9 of this Article, the current system or practice of making available on the market or using a given biocidal product continues to apply for up to three years after the date of approval of the last of the active substances to be approved in that biocidal product. The competent authority may, in accordance with the current system or practice, authorise the making available on the market or use of a biocidal product containing only— (a) existing active substances which— (i) have been evaluated under Commission Regulation (EC) No 1062/2014 but which have not yet been approved of that product-type; (ii) are being evaluated under that Regulation but have not yet been approved for that product-type; or (b) a combination of active substances referred to in point (a) and active substances approved in accordance with this Regulation. (8) By way of derogation from paragraph 7, in the case of a decision not to approve an active substance, the competent authority may continue to apply its current system or practice of making biocidal products available on the market for up to 12 months after the date of the decision not to approve an active substance in accordance with paragraph 5, and may continue to apply the current system or practice of using biocidal products for up to 18 months after that decision. (9) Following a decision to approve a particular active substance for a specific product-type, the competent authority shall ensure that authorisations for biocidal products of that product-type and containing that active substance are granted, modified or cancelled, as appropriate, in accordance with this Regulation within three years of the date of approval. To that effect, those wishing to apply for the authorisation of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation no later than the date of approval of the active substance or substances. In the case of biocidal products containing more than one active substance, applications shall be submitted no later than the date of approval of the last active substance for that product-type. (10) Where no application for authorisation has been submitted in accordance with paragraph 9 above— (a) the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance or substances; and (b) use of existing stocks of the biocidal product may continue for up to 365 days after the date of approval of the active substance or substances. (11) Where the competent authority decides to reject an application submitted in accordance with paragraph 9 for authorisation of a biocidal product already made available on the market, or decides not to grant an authorisation or to impose conditions for the authorisation making it necessary to change such a product, the following shall apply— (a) a biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 180 days after the date of the decision of the competent authority; and (b) use of existing stocks of the biocidal product may continue for up to 365 days after the date of the decision of the competent authority.

131

(1) Article 90 is amended as follows.

(2) Omit paragraph 1.

(3) In paragraph 2—

(a) omit “Member States'”;

(b) for “has” substitute “ had ”;

(d) for “1451/2007” in both places it occurs substitute “ 1062/2014 ”;

(e) omit the final subparagraph.

132

In Article 91, in the first subparagraph—

(a) for “has” substitute “ had ”;

(b) for “authorities” substitute “ authority ”.

133

In Article 92, after paragraph 1 insert—

1A. The competent authority may request further data relating to the original authorisation as necessary. 1B. It is the duty of the authorisation holder to provide the necessary data within 60 days of such a request. 1C. The competent authority may cancel the authorisation if this Article is not complied with and the period of grace set out in the second paragraph of Article 52 shall apply.

134

(1) Article 93 is amended as follows.

(2) In the first subparagraph—

(a) for “a Member State may continue to apply its” substitute “ the ”;

(b) after the words “on 1 September 2013” insert “ , shall continue to apply— ”;

(3) In point (a)—

(a) for “are” substitute “ were ”;

(b) for “of Article 89(2)” to the end, substitute “ Article 89(7), in Article 89(8) to (10) and in Article 89(11); or ”.

(4) In point (b), for “is” substitute “ was ”.

135

(1) Article 94 is amended as follows.

(2) In paragraph 1—

(a) for “Annex I” substitute “ the Simplified Active Substance List ”;

(b) in point (a), for the words “after 1 September 2016” substitute “ by the Commission after 1 September 2016 but before IP completion day or issued by the Secretary of State after IP completion day ”.

(3) Omit paragraph 2.

136

(1) Article 95 is amended as follows.

(2) In paragraph 1—

(a) in the first subparagraph—

(i) for “As of 1 September 2013, the Agency” substitute “ The competent authority ”;

(ii) for “has been” substitute “ is ”;

(iii) for “a Member State” substitute “ the competent authority ”;

(iv) in the final sentence, for “Agency” substitute “ competent authority ”;

(b) in the second subparagraph—

(i) for “Union” substitute “ United Kingdom ”;

(ii) for “Agency” in both places it occurs substitute “ competent authority ”;

(iii) for “letter of access to a complete substance dossier” substitute “ letter of access which provides the competent authority with access to a complete substance dossier ”;

(iv) in the last sentence omit “evaluating”;

(i) for “Agency” substitute “ competent authority ”;

(ii) for “fees payable under Article 80(1)” substitute “ appropriate fees ”;

(d) in the fourth subparagraph—

(i) for “fees payable under Article 80(1)” substitute “ appropriate fees ”;

(ii) for “Agency” substitute “ competent authority ”.

(3) In paragraph 4, after the words “Article 20(1)” insert “ , where that letter of access gives the competent authority direct access to the information, and where the competent authority holds the relevant data ”.

(4) In paragraph 6, for “Annex I” substitute “ the Simplified Active Substance List ”.

(5) In paragraph 7, for “Agency” in both places it occurs substitute “ competent authority ”.

(6) After paragraph 7, insert—

(8) The competent authority may refuse to accept a letter of access for the purposes of this Article if they do not hold the relevant data.

137

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

138

Omit Article 97.

139

Omit Annex I.

140

(1) Annex II is amended as follows.

(2) In paragraph 2—

(a) in the fourth subparagraph, for “available on the website of the Agency” substitute “ to be made available online by the competent authority ”;

(b) in the fifth subparagraph, omit “that will evaluate the dossier”.

(3) For paragraph 4, substitute—

(4) Dossiers must be formatted, prepared and submitted in accordance with the data requirements and guidance as specified by the competent authority.

(4) In paragraph 6, for “Commission or the Agency” substitute “ competent authority ”.

(5) In paragraph 8, omit “of the Member State concerned”.

141

(1) Annex III is amended as follows.

(2) In paragraph 2—

(a) in the fourth subparagraph, for “Agency” substitute “ competent authority ”;

(b) in the sixth subparagraph, for “available on the website of the Agency” substitute “ to be made available online by the competent authority ”;

(d) in the eighth subparagraph, omit “or Article 44(2)”.

(3) For paragraph 4, substitute

(4) Dossiers must be formatted, prepared and submitted in accordance with the data requirements and guidance as specified by the competent authority.

(4) In paragraph 6, for “Commission or the Agency” substitute “ competent authority ”.

(5) In paragraph 8, omit “of the Member State”.

142

In Annex IV—

(a) in paragraph 1.2. for “Commission” in both places it occurs substitute “ competent authority ”;

(b) in paragraph 1.3., omit the final subparagraph;

(d) in paragraph 3.1., omit the final subparagraph.

143

(1) Annex VI is amended as follows.

(2) In paragraph 1—

(a) for “a Member State or the Commission” substitute “ the competent authority ”;

(b) for “available on the website of the Agency” substitute “ to be made available online by the competent authority ”.

(3) In paragraph 6, for “evaluating body” substitute “ competent authority ”.

(4) In paragraph 8, for “evaluating body” substitute “ competent authority ”.

(5) In paragraph 9—

(a) for “competent authorities or the Commission” substitute “ competent authority or the Secretary of State ”;

(b) for “competent authorities” substitute “ competent authority ”.

(6) In paragraph 10, for “authorities or the Commission” substitute “ authority ”.

(7) In paragraph 11, for “evaluating bodies” substitute “ competent authority ”.

(8) In paragraph 12, for “evaluating body” substitute “ competent authority ”.

(9) In paragraph 13—

(a) omit “evaluating or receiving”;

(b) for “competent authorities” substitute “ competent authority ”.

(10) In paragraph 15, omit the final sentence.

(11) In paragraphs 20, 26, 36, 48, 50, 51, 52, 53, 55, 56, 57, 58, 59, 60, 62, 64, 66, 67, 68, 69, 71, 72, 73, 74, 75, 77, 78 and the paragraph following paragraph 78, for “evaluating body”, in each place it occurs, substitute “ competent authority ”.

(12) In paragraph 52, for “Union” substitute “ Great Britain ”.

(13) In paragraph 75, for “evaluating authority” substitute “ competent authority ”.

(14) In paragraph 77, for “the Member State or, where appropriate, in the Union” substitute “Great Britain”.

Regulation (EU) No 649/2012

144

Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals is amended in accordance with paragraphs 145 to 175.

145

In Article 1—

(a) in paragraph 1, in the second subparagraph—

(i) for “the Union” substitute “Great Britain”;

(ii) for “to Parties and other countries” substitute “to Parties, other countries and Northern Ireland”;

(b) in paragraph 2—

(i) for “the Member States” substitute “Great Britain”;

(ii) for “to other Parties or other countries” substitute “to other Parties, other countries or Northern Ireland”;

(iii) for “of those Parties or other countries” substitute “of those Parties, other countries or Northern Ireland”.

146

(1) Article 2 is amended as follows.

(2) In paragraph 1, in point (b), for “the Union or a Member State” substitute “Great Britain”;

(3) In paragraph 2—

(a) in point (b), for the words from “Council” to the end substitute “ the Ionising Radiations Regulations 2017 ... ”;

(b) in point (c), for the words from “Directive” to the end substitute “ the Waste (England and Wales) Regulations 2011 and the Waste (Scotland) Regulations 2011 ”;

(c) in point (g), for the words from “Directive” to the end substitute “ the Genetically Modified Organisms (Deliberate Release) Regulations 2002 , the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 and the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002 ”;

(d) in point (h)—

(i) for the words from “Directive 2001/83/EC” to “use” substitute “ the Human Medicines Regulations 2012 ”;

(ii) for the words from “Directive 2001/82/EC” to “products” substitute “ the Veterinary Medicines Regulations 2013 ”.

(4) In paragraph 3—

(a) in the first subparagraph, after “each importing country” insert “, or to Northern Ireland,”;

(b) in the second subparagraph, for “using the Database referred to in Article 6(1)(a)” substitute “from the exporter’s Designated National Authority”.

147

(1) Article 3 is amended as follows.

(2) In point (4), for “Union legislation” substitute “ retained EU law ”.

(3) In point (5)(b)—

(a) for the words “Directive” to “market” substitute “ Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ”;

(b) for “Directives 2001/82/EC and 2001/83/EC” substitute “ the Veterinary Medicines Regulations 2013 and the Human Medicines Regulations 2012 ”.

(4) In point (7)—

(a) for “within the Union” substitute “ by retained EU law ”;

(b) for “Annex I” substitute “ the GB PIC list ”.

(5) In point (8)—

(a) in the first sentence, for “within the Union or a Member State” substitute “ by retained EU law ”;

(b) in the second sentence—

(i) for “the Union” substitute “Great Britain”;

(ii) for “Annex I” substitute “the GB PIC list”.

(6) In point (9)—

(a) before “Annex III” insert “ both ”;

(b) for “Annex I to this Regulation” substitute “ the GB PIC list ”.

(7) In point (10)—

(a) in point (a), for “the Union” substitute “ retained EU law ”;

(b) in point (b), for “Union” substitute “Great Britain”.

(8) In point (11)—

(a) in point (a), for “the Union” substitute “ retained EU law ”;

(b) in point (b), for “Union” substitute “Great Britain”.

(9) Omit point (12).

(10) Omit point (15).

(11) For point (16) substitute—

(16) ‘export’ means the export of chemicals from Great Britain: (a) made in accordance with sections 33(4), 35 or 36 of the Taxation (Cross-border Trade) Act 2018 ; or (b) where the chemicals were, immediately prior to export, in a temporary storage facility or subject to the control of any HMRC officer as described in paragraph 1(2) of Schedule 1 to the Taxation (Cross-border Trade) Act 2018, but does not include chemicals which are under a transit procedure by which chargeable goods may be moved between places in Great Britain.

(12) In point (17) for the words from “physical” to the end substitute “ importation into Great Britain and release to a customs procedure, other than a transit procedure by which chargeable goods may be moved between places in Great Britain, of any chemical ”.

(13) In point (18)—

(a) in point (a)—

(i) for “Party or other country” substitute “Party, other country or Northern Ireland”;

(ii) for “the customs territory of the Union” substitute “Great Britain”;

(b) in point (b), for “the customs territory of the Union” substitute “Great Britain”;

(14) In point (19), for “the customs territory of the Union” substitute “Great Britain”.

(15) Omit point (22).

(16) In point (23), omit “, unless otherwise specified in this Regulation”.

(17) After point (23), insert—

(24) ‘Designated National Authority’ means the authority or authorities designated by the Secretary of State under the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 to carry out the administrative functions required by this Regulation; (25) ‘exporter's Designated National Authority’ means the Designated National Authority of the country in which the exporter is established; (26) ‘GB PIC list’ means the list established and maintained in accordance with Articles 7 and 23.

148

Omit Article 4.

149

(1) Article 5 is amended as follows.

(2) In the heading, for “Union” substitute “ United Kingdom ”.

(3) In paragraph 1—

(a) for “a joint” substitute “ the ”;

(b) for “Commission and the Member States” substitute “ Secretary of State ”.

(4) For paragraph 2 substitute—

(2) The Designated National Authority must: (a) transmit Great Britain export notifications to other Parties, countries and Northern Ireland pursuant to Article 8; and (b) receive information from the Secretariat more generally. (2A) The Secretary of State must provide to the Secretariat: (a) notifications of each relevant final regulatory action concerning chemicals qualifying for PIC notification pursuant to Article 11; (b) information concerning other final regulatory actions involving chemicals not qualifying for PIC notification pursuant to Article 12; and (c) Great Britain import responses for chemicals subject to the PIC procedure pursuant to Article 13. (2B) The Secretary of State must also coordinate the United Kingdom input on all technical issues relating to the following: (a) the Convention; (b) the preparation of the Conference of the Parties established by Article 18(1) of the Convention; (c) the Chemical Review Committee established in accordance with Article 18(6) of the Convention; (d) other subsidiary bodies of the Conference of the Parties.

(5) Omit paragraph 3.

150

For Article 6 substitute—

The Designated National Authority must, in addition to the tasks allocated to it under Articles 5, 7, 8, 9, 10, 11, 13, 14, 16, 18, 19 and 20, carry out the following tasks: (a) where appropriate, provide assistance and guidance for industry in order to ensure the effective application of this Regulation; (b) at the request of the Secretary of State, and within the available resources, provide input in drafting of decision guidance documents referred to in Article 7 of the Convention and other technical documents related to the implementation of the Convention; (c) upon request, provide the Secretary of State with technical and scientific input and assist the Secretary of State in order to ensure the effective implementation of this Regulation.

151

(1) Article 7 is amended as follows.

(2) In the heading—

(a) after “PIC notification,” omit “and”;

(b) after “PIC procedure” insert “ , chemicals subject to Regulation (EC) No 850/2004, and chemicals already subject to an export ban ”.

(3) For paragraph 1 substitute—

(1) The Secretary of State must include the following chemicals in the GB PIC list: (a) the chemicals subject to the export notification procedure under Article 8; (b) the chemicals qualifying for the PIC notification procedure under Article 11; (c) the chemicals subject to the PIC procedure as listed in Annex III to the Convention; (d) the chemicals subject to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants; and (e) the chemicals other than persistent organic pollutants as listed in Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants that are already subject to an export ban.

(4) For paragraph 2 substitute—

(2) The Secretary of State must assign chemicals listed in the GB PIC list to one or more of the following groups: (a) Part 1 of the GB PIC list, which lists chemicals that are subject to the export notification procedure laid down in Article 8, with detailed information being given on the identity of the substance, on the use category and/or subcategory subject to restriction, the type of restriction and, where appropriate, additional information, in particular on exemptions to requirements for export notification; (b) Part 2 of the GB PIC list, which lists chemicals that, in addition to being subject to the export notification procedure laid down in Article 8, qualify for the PIC notification procedure set out in Article 11, with detailed information being given on the identity of the substance and on the use category; (c) Part 3 of the GB PIC list, which lists chemicals that are subject to the PIC procedure with the use category being given and, where appropriate, additional information, in particular on any requirements for export notification; (d) Part 4 of the GB PIC list, which lists chemicals that are subject to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants; (e) Part 5 of the GB PIC list, which lists chemicals other than persistent organic pollutants as listed in Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants and are already subject to an export ban.

(5) In paragraph 3—

(a) for the words from the beginning to “made” substitute “ The Designated National Authority must make the GB PIC list ”;

(b) for the words “by means of the Database” substitute “ via its website ”.

152

(1) Article 8 is amended as follows.

(2) In paragraph 1—

(a) for “Annex I” substitute “the GB PIC list”;

(b) for the words from “importing Party” to the end substitute “importing Party, other country or Northern Ireland”.

(3) In paragraph 2—

(a) in the first subparagraph—

(i) for “the Union” substitute “Great Britain”;

(ii) for “to a Party or other country” substitute “to a Party, other country or Northern Ireland”;

(iii) for “designated national authority of the Member State in which he is established (the ‘exporter's Member State’)” substitute “ exporter's Designated National Authority ”;

(iv) for “that designated national authority” substitute “ the Designated National Authority ”;

(v) in the final sentence, omit the words from “and” to the end;

(b) in the second subparagraph—

(i) for “designated national authority of the exporter's Member State” substitute “ exporter's Designated National Authority ”;

(ii) omit the words from “and” to the end;

(i) for “The Agency shall, on behalf of the Commission” substitute “The Designated National Authority must”;

(ii) after the words “designated national authority of the importing Party” insert “or Northern Ireland”;

(d) in the fourth subparagraph—

(i) for “Agency”, in both places it occurs, substitute “ Designated National Authority ”;

(ii) for “shall register each export notification and assign it” substitute “ must maintain a list of export notifications and assign each export notification ”;

(iii) omit “in the Database”;

(iv) omit “and the designated national authorities of the Member States, as appropriate,”;

(v) for “importing Parties and other countries” substitute “importing Parties, other countries and Northern Ireland”;

(vi) for “by means of the Database” substitute “via its website”.

(4) In paragraph (3)—

(a) in the first place it occurs, for “Agency” substitute “Designated National Authority”;

(b) for “importing Party or other country” substitute “importing Party, other country or Northern Ireland”;

(d) in the first place it occurs, omit “, on behalf of the Commission,”;

(e) in the second place it occurs, for “Agency” substitute “Designated National Authority”;

(f) in the second place it occurs, omit “, on behalf of the Commission,”;

(g) after “of the importing Party” insert “or Northern Ireland”.

(5) In paragraph 4, for “Union legislation” substitute “ retained EU law ”.

(6) In paragraph 5—

(a) in both places the words occur, for “the importing Party or other country” substitute “the importing Party, other country or Northern Ireland”;

(b) for the words from “designated” to the end substitute “exporter’s Designated National Authority”.

(7) In paragraph 6—

(a) in the first subparagraph—

(i) in point (b), at the end, insert “, or in the case of Northern Ireland where such a response has been provided to the Secretariat indicating whether or not it consents to the import of the chemical”;

(ii) in point (c)—

(aa) for “Commission” substitute “Designated National Authority”;

(bb) omit the words from “and has forwarded” to the end”;

(b) in the second subparagraph, at the end, insert “, or in the case of Northern Ireland, where export notification by exporting Parties is explicitly required through the import decision relating to Northern Ireland or otherwise”;

(i) in point (a), after “designated national authority of the importing Party”, insert “or Northern Ireland”;

(ii) in point (b)—

(aa) for “Commission” substitute “Designated National Authority”;

(bb) after “designated national authority of the importing Party” insert “or Northern Ireland”;

(cc) for the words from “and has forwarded” to the end substitute “and has made it publicly available via its website”.

(8) In paragraph 7—

(a) for the words from “The Commission” to “Agency” substitute “The Designated National Authority”;

(b) for “importing Parties and other countries” substitute “importing Parties, other countries and Northern Ireland”.

(9) Omit paragraph 8.

153

(1) Article 9 is amended as follows.

(2) In paragraph 1—

(a) omit the first subparagraph;

(b) in the second subparagraph—

(i) for “The Agency shall, on behalf of the Commission,” substitute “ The Designated National Authority must ”;

(ii) after “received” insert “ concerning the export to Great Britain of a chemical the manufacture, use, handling, consumption, transport or sale of which is subject to prohibition or severe restriction under the legislation of a Party, other country or Northern Ireland, ”;

(iii) for the words from “each Party” to the end substitute “each Party, other country or Northern Ireland”;

(3) Omit paragraph 2.

154

(1) Article 10 is amended as follows.

(2) In paragraph 1—

(a) in the first subparagraph

(i) in point (a), for “Annex I” substitute “Part 1, 2 or 3 of the GB PIC list”;

(ii) in point (c), for “Annex I” substitute “the GB PIC list”;

(iii) in the words which follow point (c)—

(aa) for “designated national authority of the exporter’s Member State” substitute “exporter’s Designated National Authority”;

(bb) for “each Party or other country” substitute “each Party, other country or Northern Ireland”;

(cc) for “a Party or other country” substitute “a Party, other country or Northern Ireland”;

(b) in the second subparagraph, in both places it occurs, for “the Union” substitute “Great Britain”.

(3) In paragraph 2, for the words from “Commission” to “Member State,” substitute “ Designated National Authority ”.

(4) In paragraph 3—

(a) omit the first sentence;

(b) for “Agency shall summarise that information at Union level and” substitute “ Designated National Authority ”;

155

(1) Article 11 is amended as follows.

(2) In paragraph 1—

(a) for “Commission” substitute “ Secretary of State ”;

(b) for “Annex I,” substitute “ the GB PIC list ”.

(3) In paragraph 2—

(a) for “Annex I” substitute “ the GB PIC list ”;

(b) for “Commission” substitute “ Secretary of State ”;

(4) In paragraph 4—

(a) in the first subparagraph—

(i) for “Commission” substitute “ Secretary of State ”;

(ii) for “Annex I” substitute “ the GB PIC list ”;

(b) in the second subparagraph, for “Commission” substitute “ Designated National Authority ”.

(5) In paragraph 5 for “Commission”, in both places it occurs, substitute “ Secretary of State ”.

(6) In paragraph 6—

(a) in the first subparagraph, for “Commission” substitute “ Secretary of State ”;

(b) omit the second subparagraph.

(7) In paragraph 7—

(a) omit the first subparagraph;

(b) in the second subparagraph—

(i) for “Where” substitute “ On the basis of the information that the Secretary of State receives from the Secretariat regarding chemicals notified as banned or severely restricted by other Parties, where ”;

(ii) for “Commission” substitute “ Secretary of State ”;

(iii) for “Member States and the Agency” substitute “ Designated National Authority, the Scottish Ministers and the Welsh Ministers ”;

(iv) for “propose” substitute “ take ”;

(v) omit “at Union level”;

(vi) omit “within the Union”.

(8) Omit paragraph 8.

156

In Article 12, for the words from “Annex” to “the Commission” substitute “ the GB PIC list, the Secretary of State ”.

157

(1) Article 13 is amended as follows.

(2) In paragraph 1—

(a) omit the first subparagraph;

(b) in the second subparagraph—

(i) at the beginning, for “The Commission shall, by means of an implementing act” substitute “ Where the Secretary of State receives a decision guidance document from the Secretariat, the Secretary of State must, taking into account the information in the decision guidance document ”;

(ii) omit “on behalf of the Union”;

(iii) omit the second sentence;

(iv) for “Commission” substitute “ Secretary of State ”;

(i) omit “under Union legislation”;

(ii) for “Commission”, in both places it occurs, substitute “ Secretary of State ”;

(iii) omit “, by means of an implementing act,”;

(iv) omit the second sentence.

(3) Omit paragraph 2.

(4) In paragraph 4, for “Commission” substitute “ Secretary of State ”.

(5) In paragraph 5—

(a) for “Each designated national authority of the Member States” substitute “ The Designated National Authority ”;

(b) for the words from “available to those concerned” to the end substitute “ publicly available via its website ”.

(6) In paragraph 6—

(a) for “Commission” substitute “ Secretary of State ”;

(b) for “Member States and the Agency” substitute “ Designated National Authority, the Scottish Ministers and the Welsh Ministers ”;

(d) omit “at Union level”;

(e) omit “within the Union”.

(7) After paragraph 6, insert—

(7) The functions of the Secretary of State under paragraph 1 to adopt an import decision and to adopt a revised import decision are subject to the consent requirement in Article 23B.

158

(1) Article 14 is amended as follows.

(2) In paragraph 1—

(a) for the words from the beginning to “receives” substitute “ The Designated National Authority must make available via its website the information which it receives ”;

(b) omit the second sentence;

(d) for the words “by means of the Database” to the end substitute “ via its website ”.

(3) Omit paragraphs 2 and 3.

(4) In paragraph 4, for “Commission” substitute “ Designated National Authority ”.

(5) In paragraph 5, for the words from the beginning to “Member States” substitute “ The Designated National Authority ”.

(6) In paragraph (6)—

(a) in the first subparagraph—

(i) in the first line, for “Annex I” substitute “the GB PIC list”;

(ii) in point (a)—

(aa) for the words from “designated national authority of the exporter’s” to “Agency” substitute “exporter’s Designated National Authority”;

(bb) after “importing Party” insert “or Northern Ireland”;

(iii) in point (b)—

(aa) for “Annex I” substitute “the GB PIC list”;

(bb) at the end, insert “, or in the case of Northern Ireland the European Union has given consent to import”;

(b) in the second subparagraph—

(i) for “Annex I” substitute “the GB PIC list”;

(ii) for “designated national authority of the exporter’s Member State” substitute “exporter’s Designated National Authority”;

(iii) omit “in consultation with the Commission and on a case-by-case basis,”;

(i) in the first two places it occurs, for “Agency” substitute “Designated National Authority”;

(ii) for “shall, on behalf of the Commission,” substitute “must”;

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