Legalize / United Kingdom / Statutory-Instrument

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

Source legislation.gov.uk

PDF Download

articles Not indexed

Reform history JSON API

(b) in paragraph 2—

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

(ii) for “Annex V” substitute “ Part 4 or 5 of the GB PIC list ”.

160

In Article 16—

(a) in paragraph 2—

(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 ”;

(b) omit paragraph 3;

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

(ii) for “paragraph 3” substitute “ paragraph 2 ”.

161

In Article 17—

(a) in paragraph 1—

(i) for “Directive 98/8/EC” substitute “ Regulation (EU) No 528/2012 ”;

(ii) for “Union legislation” substitute “ retained EU law ”;

(iii) for “the importing Parties or other countries” substitute “importing Parties, other countries or Northern Ireland”;

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

162

(1) Article 18 is amended as follows.

(2) In the heading, for “authorities of the Member States” substitute “ Designated National Authority ”.

(3) In paragraph 1—

(a) in the first subparagraph—

(i) for the words from the beginning to “authorities that” substitute “ The Designated National Authority ”;

(ii) for the words from “Annex I” to the end substitute “ Parts 1, 2 and 3 of the GB PIC list ”;

(b) in the second subparagraph, for the words from the beginning to “Member States” substitute “ The Designated National Authority ”.

(4) Omit paragraphs 2 and 3.

163

In Article 19—

(a) in paragraph 1, omit the words from “(box 44” to the end;

(b) in paragraph 2, for “using the Database” substitute “ from the exporter's Designated National Authority ”;

164

In Article 20—

(a) in paragraph 1—

(i) in the first subparagraph, for the words from the beginning to “Member States” substitute “The Secretary of State”;

(ii) in the second sub-paragraph—

(aa) for the words from the beginning to “Agency as necessary” substitute “The Secretary of State,”;

(bb) in point (b), for “Parties and other countries” substitute “a Party, other country or Northern Ireland”;

(b) in paragraph 2—

(i) for the words from the beginning to “Agency” substitute “The Secretary of State and the Designated National Authority”;

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

(c) in paragraph 3, for the words from “Directive” to “environmental information” substitute “ the Environmental Information Regulations 2004 and the Environmental Information (Scotland) Regulations 2004 ”;

(d) in paragraph 4, for “Agency” substitute “ Designated National Authority ”.

165

In Article 21—

(a) in the first paragraph—

(i) for the words from the beginning to “Agency” substitute “ The Secretary of State ”;

(ii) for “cooperate in promoting” substitute “ promote ”;

(b) in the third paragraph—

(i) for “The Commission and the Member States”, in both places it occurs, substitute “ The Secretary of State ”;

(ii) for “they are” substitute “ the Secretary of State is ”.

166

Omit Article 22.

167

In Article 23—

(a) in the heading, for “annexes” substitute “ the GB PIC list ”;

(b) in paragraph 1—

(i) before “list” insert “ Secretary of State must review the ”;

(ii) for “Annex I shall be reviewed by the Commission” substitute “ the GB PIC list ”;

(iii) for “Union” substitute “ retained EU ”;

(i) omit “at Union level” in both places it occurs;

(ii) for “Annex I”, in both places it occurs, substitute “ the GB PIC list ”;

(d) in paragraph 3—

(i) after “The” insert “ Secretary of State must take the ”;

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

(iii) omit “shall be taken”;

(e) in paragraph 4, from “Commission” to the end substitute “ Secretary of State may by regulations amend Annexes II, IV and VI ”;

(f) after paragraph 4, insert—

(5) The function of the Secretary of State under paragraph 3 is subject to the consent requirement in Article 23B.

168

After Article 23, insert—

(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. (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 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

169

Omit Articles 24 to 31.

170

Omit Annex I.

171

(1) Annex II is amended as follows.

(2) In paragraph 1(d), for “CUS number (European Customs Inventory of Chemical Substances) and Combined Nomenclature code” substitute “ a classification code in accordance with section 8 of the Taxation (Cross-border Trade) Act 2018 ”.

(3) In paragraph 2—

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

(b) in point (c), for “CUS number (European Customs Inventory of Chemical Substances) and Combined Nomenclature code” substitute “ a classification code in accordance with section 8 of the Taxation (Cross-border Trade) Act 2018 ”.

(4) In paragraph 3(b), for “Annex I” substitute “ Part 1, 2 or 3 of the GB PIC list ”.

(5) In paragraph 5—

(a) for “Designated national authorities” substitute “ Designated National Authority ”;

(b) in point (a), for “designated authority in the Union” substitute “ Designated National Authority ”.

(6) In paragraph 8—

(a) in the first line, for “the Union” substitute “Great Britain”;

(b) in paragraph (a), for “Union” substitute “Great Britain”;

172

Omit Annex III.

173

In Annex IV, in paragraph 1, in point (f), for “the Union” substitute “Great Britain”.

174

Omit Annex V.

175

Omit Annex VII.

Commission Regulation (EU) No 283/2013

176

(1) Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market is amended as follows.

(2) In the Annex, in Part A, in Section 1—

(a) in point 1.4—

(i) for “Part III of 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 ”;

(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 284/2013

177

(1) Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market is amended as follows.

(2) In the Annex—

(a) in Part A—

(i) in point 1.4.3—

(aa) for “Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council” substitute “ the GB mandatory classification and labelling list ”;

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

(ii) after point 1.4.3 insert—

(1) In point 1.4.3, “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 B—

(i) in point 1.4(iii)—

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

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

(ii) after point 1.4 insert—

(1) In point 1.4(iii), “the GB mandatory classification and labelling list” has the same meaning as in point 1.4.3.1 of Part A.

Regulation (EU) No 354/2013

178

Commission Delegated Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council is amended in accordance with paragraphs 179 to 193.

179

In Article 2, in paragraph 2—

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

(b) for the second subparagraph substitute—

The opinion must be delivered within 45 days following receipt of the request and payment of the appropriate fee. In this Regulation, “appropriate fee” means the fee payable for the activity concerned in relations 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.

180

Omit Article 3.

181

(1) Article 4 is amended as follows.

(2) In paragraph 2, in point (d), for “Member State evaluating the application in accordance with Article 7(4) or 8(4), or in the case of a change of Union authorisation, the Agency,” substitute “ competent authority ”.

(3) In the subparagraph after point (d)—

(a) omit “or 12”;

(b) omit “or 13”.

182

(1) Article 5 is amended as follows.

(2) In point (1)—

(a) omit “as available from the Register for Biocidal Products”;

(b) omit points (b) to (d);

(i) omit “in, as appropriate”;

(ii) omit points (1) and (2).

(3) In point (4), after the words “Article 19 or 25 of Regulation (EU) No 528/2012;” insert “ , including any further information requested by the competent authority. ”

(4) Omit point (5).

183

In the heading of Chapter II, for “products authorised by member states” substitute “ authorised products ”.

184

(1) Article 6 is amended as follows.

(2) In paragraph 1—

(a) omit “simultaneously to all Member States concerned”;

(b) after “a notification” insert “ to the competent authority ”;

(d) for “fee payable in accordance with Article 80(2) of Regulation (EU) No 528/2012” substitute “ appropriate fee ”.

(3) In paragraph 3—

(a) in the first subparagraph—

(i) for “one of the Member States concerned” substitute “ the competent authority ”;

(ii) for “that Member State” substitute “ the competent authority ”;

(iii) omit “and the other Member States concerned”;

(b) in the second subparagraph—

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

(ii) for “that Member State” substitute “ it ”.

(4) In paragraph 4—

(a) for “Each of the Member States concerned which” substitute “ Where the competent authority ”;

(b) after “with paragraph 3” insert “ it ”.

185

(1) Article 7 is amended as follows.

(2) For “reference Member State” in each place it occurs substitute “ competent authority ”.

(3) In paragraph 1, omit “simultaneously to all Member States concerned”.

(4) In paragraph 2—

(a) for “Each Member State concerned” substitute “ The competent authority ”;

(b) for “the fee payable in accordance with Article 80(2) of Regulation (EU) No 528/2012” substitute “ the appropriate fee ”;

(d) for “Member State concerned” in both places it occurs substitute “ competent authority ”.

(5) In paragraph 3, omit “and the Member States concerned” in both places it occurs.

(6) In paragraph 4, omit “to the Member States concerned and”.

(7) In paragraph 5, omit “and the Member States concerned”.

(8) Omit paragraph 6.

(9) For paragraph 7 substitute—

(7) Where authorisation of the change is granted, the competent authority shall, within 30 days, amend the authorisation of the biocidal product in conformity with the change.

186

(1) Article 8 is amended as follows.

(2) For “reference Member State” in each place it occurs substitute “ competent authority ”.

(3) In paragraph 1, for “simultaneously to all Member States concerned” substitute “ to the competent authority ”.

(4) In paragraph 2—

(a) for “Each Member State concerned” substitute “ The competent authority ”;

(b) for “fee payable in accordance with Article 80(2) of Regulation (EU) No 528/2012” substitute “ appropriate fee ”;

(d) omit “and the other Member States concerned”.

(5) In paragraph 3 omit “and the Member States concerned” in both places it occurs.

(6) In paragraph 4 omit “to the Member States concerned and”.

(7) In paragraph 5 omit “and the Member States concerned”.

(8) Omit paragraph 6.

(9) For paragraph 7 substitute—

(7) Where authorisation of the change is granted, the competent authority shall, within 30 days, amend the authorisation of the biocidal product in conformity with the change.

187

Omit Articles 9 to 13.

188

(1) Article 14 is amended as follows.

(2) In paragraph 1—

(a) for “Articles 6 and 11” in both places it occurs substitute “ Article 6 ”;

(b) for “Member State or, in the case of changes of a product authorised by Union authorisation, the Commission” substitute “ competent authority ”.

(3) In paragraph 2, for “relevant Member States or, in the case of changes of a product authorised by Union authorisation, the Commission” substitute “ competent authority ”.

189

(1) Article 15 is amended as follows.

(2) Omit paragraphs 1 and 2.

(3) In paragraph 3—

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

(b) for “reference Member State” substitute “ competent authority ”;

(c) for “made the agreement available in the Register for Biocidal Products” insert “ informed the applicant that it has agreed to the change ”.

190

In Article 16, for “concerned Member States have or, in the case of changes of a product authorised by Union authorisation, the Commission” substitute “ competent authority ”.

191

In Article 17—

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

(b) for “requesting” substitute “ competent ”.

192

Omit Article 18.

193

(1) Section 1 of Title 1 of the Annex is amended as follows.

(2) In point 3, for “European Economic Area (EEA)” substitute “ United Kingdom ”.

(3) In point 4, for “EEA” substitute “ United Kingdom ”.

(4) In point 5, for “Agency” substitute “ competent authority ”.

Commission Implementing Regulation (EU) No 414/2013

194

Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council is amended in accordance with paragraphs 195 to 205.

195

In Article 1—

(a) after “which has been authorised and registered” insert “in the United Kingdom”;

(b) after “and of the Council or” insert “authorised or registered in the United Kingdom in accordance with”;

(c) after “Regulation (EU) No 528/2012,” insert “or authorised or registered in Great Britain in accordance with this Regulation,”.

196

In Article 2—

(a) in the first sentence omit “and the information requirements in Article 43(1) thereof,”;

(b) in point (a) for the words “the application number” to the end substitute “ the application number of the related reference product provided by the competent authority on submission of that application ”.

197

(1) Article 3 is amended as follows.

(2) In the heading omit “national”.

(3) In paragraph 1—

(a) after “by national authorisation” insert “in the United Kingdom (before IP completion day) or in Great Britain (from IP completion day)”;

(b) after “for such an authorisation” insert “in Great Britain”;

(4) Omit paragraph 1a.

(5) In paragraph 2, for “paragraphs 2 and 4” substitute “paragraph 2”.

198

Omit Article 4.

199

In Article 4a, in paragraph 1, omit “that has granted or is requested to grant the authorisation of the related reference product”.

200

Omit Article 4b.

201

In Article 5—

(a) in the heading omit “national”;

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

202

Omit Article 6.

203

In Article 6a—

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

(b) omit paragraph 3.

204

(1) Article 7 is amended as follows.

(2) In paragraph 1, for “Register for Biocidal Products shall show a” substitute “ competent authority shall record the ”.

(3) In paragraph 2 —

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

(b) omit “or, where relevant, the Agency”;

205

Omit Article 8.

Commission Implementing Regulation (EU) No 88/2014

206

Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying a procedure for the amendment of Annex I to 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 207 to 212.

207

In Article 1—

(a) in the first paragraph, for “Annex I to” substitute “ the Simplified Active Substance List under ”;

(b) in point (a), for “that Annex” substitute “ the Simplified Active Substance List ”.

208

(1) Article 3 is amended as follows.

(2) In paragraph 1—

(a) omit “(2),”;

(b) omit “, and Article 7(6)”.

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

209

(1) Article 4 is amended as follows.

(2) In paragraph 1—

(a) in the first subparagraph—

(i) omit “evaluating”;

(ii) for “assessment report and the conclusions of its evaluation” substitute “opinion”;

(iii) for the words from “European Chemicals Agency” to “(“the Agency”)” substitute “Secretary of State, the Scottish Ministers and the Welsh Ministers”;

(iv) in the first place it occurs, for “Annex I to” substitute “the Simplified Active Substance List under”;

(v) in the first place it occurs, for “the assessment report and the conclusions” substitute “the opinion”;

(vi) in the second place it occurs, for “Annex I to” substitute “the Simplified Active Substance List under”;

(vii) in the second place it occurs, for “the assessment report and the conclusions” substitute “the opinion”;

(b) in the second subparagraph—

(i) for “conclusions” substitute “opinion”;

(ii) for “Agency” substitute “Secretary of State, the Scottish Ministers and the Welsh Ministers,”;

(iii) in the first place it occurs, omit “evaluating”;

(iv) for “assessment report and on the conclusions of the evaluation” substitute “opinion”;

(v) in the second place it occurs, omit “evaluating”;

(vi) for “evaluation” substitute “opinion”.

(3) In paragraph 2—

(a) for “carry out the evaluation” substitute “ provide the opinion ”;

(b) omit “evaluating”;

(4) In paragraph 3, for “Annex I to” in both places it occurs substitute “ the Simplified Active Substance List under ”.

(5) Omit paragraph 4.

210

(1) Article 5 is amended as follows.

(2) For the heading substitute “ Decision on inclusion of an active substance in the Simplified Active Substance List ”.

(3) For “Commission may adopt” substitute “ Secretary of State may with the consent of the Scottish Ministers and the Welsh Ministers, issue ”.

(4) For “Annex I to” substitute “ the Simplified Active Substance List under ”.

(5) For “Agency” substitute “ competent authority ”.

(6) In point (a)—

(a) for “(4)” substitute “ (1) ”;

(b) after “this Regulation;” insert “ or ”.

(7) In point (b) omit “; or”.

(8) Omit point (c).

211

Omit Article 6.

212

In the Annex—

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

(b) for “Annex I to” in both places it occurs substitute “ the Simplified Active Substance List under ”.

Commission Delegated Regulation (EU) No 1062/2014

213

Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council is amended in accordance with paragraphs 214 to 241.

214

(1) Article 2 is amended as follows.

(2) For point (a), substitute—

(a) ‘non-approval decision’ means a decision— (i) pursuant to Article 9(1)(b) of Regulation (EU) No 528/2012 not to approve a substance/product-type combination; (ii) made before IP completion day, pursuant to the third subparagraph of Article 89(1) of that Regulation as it had effect immediately before IP completion day, not to approve a substance/product-type combination; (iii) made after IP completion day, pursuant to Article 89(5) of that Regulation, not to approve a substance/product-type combination; or (iv) not to include it in Annex I or IA to Directive 98/8/EC.

(3) In point (b)(i)—

(a) in the second indent after the words “a Regulation” insert “ , made before IP completion day, ”;

(b) after the second indent, insert— “ — a decision issued by the Secretary of State pursuant to Article 89(5) of Regulation (EU) No 528/2012 after IP completion day; ”.

(4) For point (d), substitute—

(d) “competent authority” means the authority appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013;

(5) After point (d) insert—

(e) “the consent requirement” means the requirement for consent in accordance with Article 83B of Regulation (EU) No 528/2012; (f) “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; (g) “Devolved Authority” means— (i) the Scottish Ministers, or (ii) the Welsh Ministers.

215

(1) Article 3 is amended as follows.

(2) In the heading, for “Annex I to Regulation (EU) No 528/2012” substitute “ the Simplified Active Substance List ”.

(3) For “Agency” in both places it occurs substitute “ competent authority ”.

(4) In paragraph 1—

(a) for “Annex I to Regulation (EU) No 528/2012” in both places it occurs substitute “ the Simplified Active Substance List ”;

(b) in the second subparagraph, for “Annex” substitute “ list ”.

216

For Article 4 substitute—

The competent authority shall inform the participant of the appropriate fee within 30 days after the competent authority has accepted the application. If the participant fails to pay the fee within 30 days of notification of the fee, the competent authority shall reject the application and inform the participant accordingly.

217

(1) Article 5 is amended as follows.

(2) In the heading, for the words “Annex I to Regulation (EU) No 528/2012” substitute “ the Simplified Active Substance List ”.

(3) For paragraph 1 substitute—

(1) Where an application for approval or inclusion in category 6 of the Simplified Active Substance List containing the data required in accordance with Article 6(1) and (2) of Regulation (EU) No 528/2012 has been accepted by the competent authority and the appropriate fee has been paid pursuant to Article 4 the competent authority shall validate the application within 30 days of that payment.

(4) Omit paragraph 2.

(5) In paragraph 3—

(i) for “paragraphs 1 and 2” substitute “ paragraph 1 ”;

(ii) omit “evaluating”.

(6) In paragraph 4—

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

(b) in the second subparagraph, for “2” substitute “ 1 ”;

(i) in the first sentence omit “and the Agency”;

(ii) in the final sentence, for “fees paid in accordance with Article 80(1) and (2) of Regulation (EU) No 528/2012” substitute “ appropriate fees paid ”;

(d) in the fourth subparagraph, omit “the Agency and other competent authorities accordingly,”.

218

(1) Article 6 is amended as follows.

(2) In paragraph 1—

(a) for point (b) substitute—

(b) where, before IP completion day, the evaluating competent authority in a Member State has accepted the dossier as complete pursuant to Article 13 of Regulation (EC) No 1451/2007 but not yet submitted the competent authority report to the Commission pursuant to Article 14(4) of that Regulation;

(b) in point (c)—

(i) for “Annex I of Regulation (EU) No 528/2012” substitute “ the Simplified Active Substance List ”;

(ii) omit “by the Agency pursuant to Article 4(2)”;

(iii) for “fee” substitute “ appropriate fee ”.

(3) In paragraph 2—

(a) omit “evaluating”;

(b) for “send an assessment report and the conclusions of its evaluation to the Agency” substitute “ produce an assessment report and conclusions of its evaluation ”.

(4) In paragraph 3—

(a) omit “evaluating”;

(b) for “sent” substitute “ produced ”;

(c) in subparagraph (b), for “provided for by Annex III” substitute “ specified by the Secretary of State and Devolved Authorities ”.

(5) In paragraph 4—

(a) for “submitting” substitute “ producing ”;

(b) omit “to the Agency,”;

(6) In paragraph 5, in the first subparagraph—

(a) omit “evaluating”;

(b) omit the words from “, and shall” to the end.

(7) In paragraph 6 omit “evaluating”.

(8) In paragraph 7—

(a) omit “evaluating”;

(b) for “of submission of the assessment report” substitute “ the assessment report is produced ”;

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

(ii) for “Article 37(1)” substitute “ Article 37A(2) ”;

(iii) for “part 3 of Annex VI to that Regulation” substitute “ the UK mandatory classification and labelling list defined in Article 2 of that Regulation ”;

(d) in point (b) for “Agency” substitute “ relevant authority appointed under Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ”.

219

(1) Article 7 is amended as follows.

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

(3) For paragraphs 1 and 2 substitute—

(1) This Article shall apply where the competent authority has produced an assessment report pursuant to Article 6(2) and, where relevant, a proposal or a consultation pursuant to Article 6(7). (2) The competent authority shall within 270 days of completion of the assessment report, prepare and submit an opinion to the Secretary of State and the Devolved Authorities on the approval of the substance/product-type combination or its inclusion in category 1, 2, 3, 4, 5 or 6 of the Simplified Active Substance list or both. The competent authority shall start the preparation of the opinion within 90 days of the completion of the assessment report and evaluation conclusions.

220

In Article 8—

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

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

(c) in paragraph 3, for “Regulation adopted pursuant” to the end substitute “ decision made pursuant to Article 89(5) of that Regulation ”.

221

(1) Article 9 is amended as follows.

(2) For the heading, substitute “ Decision ”.

(3) In the first paragraph—

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

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

(c) for “prepare a draft decision for adoption pursuant to Article 89(1)” substitute “ issue a decision pursuant to Article 89(5) ”.

(4) After the first paragraph, insert—

The Secretary of State's decision is subject to the consent requirement.

222

(1) Article 10 is amended as follows.

(2) For “Agency” in each place it occurs substitute “ competent authority ”.

(3) In paragraph 2—

(a) for “the Register for Biocidal Products” substitute “ the system for the exchange of information between the competent authority and applicants ”;

(b) omit “(hereinafter ‘the Register’)”.

(4) In paragraph 3, for “the information in the Register” substitute “ its records ”.

(5) In paragraph 4, for “Union” substitute “ United Kingdom ”.

223

(1) Article 11 is amended as follows.

(2) In paragraph 1—

(a) in point (a)—

(i) omit “Agency or the evaluating”;

(ii) omit “through the Register”;

(b) in point (c), omit “Article 4(1)”;

(3) In paragraph 2 omit “evaluating”.

224

(1) Article 12 is amended as follows.

(2) For “the Agency” in each place it occurs substitute “ the competent authority ”.

(3) Omit paragraph 1.

(4) In paragraph 2, for “the information in the Register” substitute “ its records ”.

(5) In paragraph 3—

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

(b) omit the words from “thereof” to the end of the sentence.

225

(1) Article 13 is amended as follows.

(2) In paragraph 1—

(a) omit “evaluating”;

(b) omit the final sentence.

(3) In paragraph 2—

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

(b) for “the information in the Register” substitute “ its records ”.

226

In Article 14, in paragraph 1, for “Agency” substitute “ competent authority ”.

227

(1) Article 15 is amended as follows.

(2) For “Annex I to that Regulation” substitute “ the Simplified Active Substance List ”.

(3) In point (a)—

(a) for “the person placing the product on the market” insert “ the product was placed on the market before IP completion day and the person placing the product on the market ”;

(b) after the words “by the Commission” insert “ before IP completion day or the competent authority after IP completion day ”.

(4) After point (a) insert—

(aa) the product was placed on the market after IP completion day and the person placing the product on the market has relied on guidance published by, or written advice received from, the competent authority after IP completion day, where that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of Regulation (EU) No 528/2012, or that the relevant product-type was one for which the active substance had been notified and where that guidance or advice is subsequently reviewed in a decision issued pursuant to Article 3(3) of Regulation (EU) No 528/2012 or in new, authoritative guidance published by the Competent Authority;

(5) In point (b), at the end insert “ and the person placing the product on the market has complied with the time limits provided for by Regulation (EU) No 528/2012 ”.

(6) Omit point (c).

228

(1) Article 16 is amended as follows.

(2) For paragraph 1, substitute—

(1) A declaration of interest to notify a substance which is eligible for inclusion in the review programme pursuant to Article 15 shall be submitted through the system for the exchange of information between the competent authority and applicants referred to in Article 71 of Regulation (EU) No 528/2012 by any person with an interest to notify a substance/product-type combination to the competent authority at the latest 12 months after the publication of the decision or guidance referred to in point (a) or (aa) of Article 15.

(3) In paragraph 2, after “referred to in point (a)” insert “ or (aa) ”.

(4) In paragraph 3—

(a) for “or (c)” substitute “ or (aa) ”;

(b) for “Commission finds, in consultation with Member States” substitute “ competent authority finds ”;

(d) for “it shall inform the Agency thereof” substitute “ it shall update its records accordingly ”.

(5) In paragraph 4, for “a declaration has been made in the case referred to in point (b) of Article 15, or where the Commission has informed the Agency pursuant to paragraph 3, the Agency” substitute “ the competent authority determines that a declaration made under paragraph 3 is valid, the competent authority ”.

(6) In paragraph 6—

(a) for “points (a) and (c)” substitute “ points (a) and (aa) ”;

(b) in point (b), for “the evaluating Member State” substitute “ the competent authority ”.

229

(1) Article 17 is amended as follows.

(2) For “Agency” in each place it occurs substitute “ competent authority ”.

(3) For paragraph 1, substitute—

(1) Notifications pursuant to Article 14(2) or Article 16(5) shall be made to the competent authority.

(4) In paragraph 2, for “in IUCLID format” substitute “ in accordance with the format specified under Article 79 of Regulation 528/2012 ”.

(5) Omit paragraph 3.

(6) For paragraph 4 substitute—

(4) Upon receipt of a notification, the competent authority shall inform the notifier of the fee payable. If the notifier fails to pay the appropriate fee within 30 days from the receipt of that information, the competent authority shall reject the notification and inform the notifier.

(7) In paragraph 5, omit the words from “, and” to the end of the sentence.

(8) In paragraph 6, omit “paragraph 4 or”.

(9) In paragraph 7—

(a) in point (a), for “update the information in the Register” substitute “ update its records ”;

(b) in point (b) for “inform the Commission of the compliance” substitute “ update its records ”.

230

For Article 18 (except the heading), substitute—

Where a substance/product-type combination is considered notified in accordance with Article 16(6) or 17(7)(b) the Secretary of State shall include the substance/product-type combination in the review programme. The paragraph above is subject to the consent requirement.

231

In Article 19—

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

(b) omit “inform the Member States thereof through the Register and”.

232

(1) Article 20 is amended as follows.

(2) In the heading omit “Commission”.

(3) For the first subparagraph substitute—

The competent authority shall make a recommendation to the Secretary of State to issue a non-approval decision pursuant to the third subparagraph of Article 89(5) of Regulation (EU) No 528/2012 in the following cases:

(4) In point (a)—

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

(ii) for “Commission” substitute “ Secretary of State and the Devolved Authorities ”.

233

(1) Article 21 is amended as follows.

(2) For “(a)” in each place it occurs substitute “ (a) or (aa) ”.

(3) Omit paragraph 1.

(4) In paragraph 2—

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

(b) for the words “point (a) of Article 15” substitute “ point (a) or (aa) of Article 15 shall continue to apply ”;

(a) The biocidal product shall no longer be made available on the market with effect from 24 months after the notification or publication of the decision or guidance referred to in point (a) or (aa) of Article 15. (b) Use of existing stocks of the biocidal product may continue until 30 months after the notification or publication of the decision or guidance referred to in point (a) or (aa) of Article 15.

(5) In paragraph 3—

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

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

234

For Article 22 (except the heading), substitute—

(1) Without prejudice to Article 55(1) of Regulation No 528/2012, within 18 months of the date of a decision not to approve an existing active substance, where the competent authority considers this existing active substance to be essential for one of the reasons referred to in points (b) or (c) of the first subparagraph of Article 5(2) of Regulation (EU) No 528/2012, the competent authority may submit a reasoned application to the Secretary of State or a Devolved Authority for a derogation from point (a) (ii) of Article 89(7) of that Regulation. (2) The competent authority shall make the application, or where relevant, the non-confidential version, publicly available by electronic means. Any person may submit comments within 60 days of publication. (3) Taking account of the comments received, the Secretary of State or a Devolved Authority may exercise a derogation from point (a) (ii) of Article 89(8) of Regulation (EU) No 528/2012 allowing biocidal products consisting of, containing or generating the substance to be made available on the market and used in Great Britain subject to the conditions in paragraph 8 and any further conditions imposed by the Secretary of State or a Devolved Authority if they have competence to exercise the derogation within the meaning of paragraphs 4 to 6. (4) The Secretary of State has competence to exercise the derogation 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 exercise the derogation 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 the derogation 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 exercises the derogation under paragraph 3, the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority exercises the derogation under paragraph 3, it must immediately inform the other Devolved Authority and the Secretary of State giving reasons for the decision. (8) The competent authority shall: (a) ensure that continued use is limited to such cases where and such time during which the conditions of paragraph 1 are fulfilled; (b) impose appropriate risk mitigation measures to ensure the exposure of humans, animals and the environment is minimised; (c) ensure that alternatives are being sought, or that an application for approval of the active substance is being prepared for submission in accordance with Article 7 of Regulation (EU) No 528/2012 in due time before the expiry of the derogation.

235

After Article 22 insert—

(1) This Article applies where an application was made before IP completion day to a Member State in accordance with Article 3 and accepted under Article 4 of Regulation (EU) No 1062/2014 or Article 9 of Regulation (EC) No 1451/2007 as they had effect immediately before IP completion day and where a decision on approval has not been made before IP completion day. (2) The application will be treated as having been received under Article 4 of this Regulation as it has effect in retained EU law if the participant resubmits their application and supporting dossier to the competent authority within: (a) 90 days after IP completion day where the United Kingdom competent authority was the evaluating competent authority prior to 30 March 2019; or (b) 180 days after IP completion day where the United Kingdom competent authority was not the evaluating competent authority prior to 30 March 2019. (3) Where the applicant does not meet the requirements of this Article, the application is to be treated as having been withdrawn under Article 11(1)(b). (1) This Article applies where a declaration of interest to notify was submitted before IP completion day under Article 16 of Regulation (EU) No 1062/2014 as it had effect immediately before IP completion day. (2) Where a declaration of interest to notify made pursuant to Article 16(1) was declared compliant under Article 16(3) or (4) it will be treated as being compliant under this Regulation as it has effect in retained EU law. (3) If a declaration of interest to notify was made pursuant to Article 16(1) but no decision on whether the declaration is compliant has been made before IP completion day, the person with an interest to notify may submit their declaration of interest under Article 16 of this Regulation to the competent authority within 180 days of IP completion day. (4) In circumstances where the time period for declarations of interest to notify as specified in Article 16(1)(a) of Regulation (EU) 1062/2014 has not expired before IP completion day, applications for declarations of interest to notify may be made to the competent authority under this Regulation at the latest 365 days after the publication of the decision or guidance referred to in point (a) of Article 15 of Regulation (EU) 1062/2014. Where a declaration of interest is made in compliance with paragraph 3 or 4 the declaration shall be treated as having been made under Article 16 of this Regulation. (1) This Article applies in relation to notifications made under Article 14(2) or 16(5) of Regulation (EU) 1062/2014. (2) Where a notification made under Article 14(2) or Article 16(5) was declared compliant under Article 17(5) before IP completion day, the notification will be treated as if it were compliant under this Regulation. The Secretary of State must update Annex II to this Regulation in accordance with Article 89(2) of Regulation 528/2012 if: (a) a declaration of interest to notify is resubmitted to the competent authority; and (b) the information as detailed within Annex I to this Regulation is resubmitted to the competent authority within a period of 180 days of IP completion day. (3) The applications referred to in Article 3(1) must be submitted to the competent authority within two years of the notification of the declaration of compliance made under Article 17(5) of this Regulation. (4) Where a notification made pursuant to either Article 14(2) or Article 16(5) was made in accordance with Regulation (EU) 1062/2014 before IP completion day but for which no declaration of compliance pursuant to Article 17(5) was made before IP completion day, the person may within 180 days of IP completion day resubmit their notification to the competent authority under Article 16 of this Regulation. (5) Where the relevant notification deadline as specified within Article 14(2) or Article 16(5) of Regulation (EU) 1062/2014 has not passed before IP completion day, a person may submit their notification to the competent authority under Article 16 of this Regulation, provided the notification is submitted before that notification deadline has passed. (6) A declaration of compliance made in accordance with paragraph 3 or 4 shall be considered as having been made under Article 17(5) of this Regulation. (1) This Article applies where a dossier was submitted before IP completion day for evaluation by a Member State in accordance with Article 14 of Commission Regulation (EC) No 1451/2007. (2) The application will be treated as having being made under this Regulation if the applicant resubmits their application and supporting dossier to the competent authority within: (a) 90 days of IP completion day, where the United Kingdom competent authority was the evaluating competent authority before 30 March 2019, or (b) 180 days of IP completion day, where the United Kingdom competent authority was not the evaluating competent authority before 30 March 2019. (3) Where the applicant does not meet the requirements of this Article, the application will be treated as having been withdrawn under Article 11(1)(b).

236

Omit Article 23.

237

Omit Article 24.

238

In the text following Article 24, omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”

239

In Annex I, in point (3), for “Annex 1 to regulation (EU) 528/2012” substitute “ the Simplified Active Substance list ”.

240

In Annex II omit the column entitled “Rapporteur Member State”.

241

Omit Annex III.

SCHEDULE 3 — AMENDMENTS TO ANNEX II TO THE EEA AGREEMENT

1

In Annex II to the EEA agreement, in Part 2—

(a) omit point 12n (including the words from “The provisions of the Regulation” to the end);

(b) omit point 12o (including the words from “The provisions of the Regulation” to the end);

(i) omit “32017 R 0542: Commission Regulation (EU) 2017/542 of 22 March 2017 (OJ L.78, 23.3.2017, p.1)”;

(ii) omit “32020 R 0011: Commission Delegated Regulation (EU) 2020/11 of 29 October 2019 (OJ L 6, 10.1.2020, p. 8)”;

(iii) after “The Provisions of Regulation (EC) No 1272/2008 shall, for the purpose of this Agreement, be read with the following adaptations:” omit points (a) and (b);

(d) omit point 12zzf.

Signed

Justin Tomlinson — Parliamentary Under Secretary of State — 2019-03-25

We consent

Rebecca Harris — Craig Whittaker — Two of the Lords Commissioners of Her Majesty's Treasury — 2019-03-27

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 2018 c. 16. Treasury consent has been obtained pursuant to paragraph 3(1) of Schedule 4.

[^f00002]: S.I. 1998/494, amended by S.I. 2015/21.

[^f00003]: S.R. 1999 No. 90, amended by S.R. 2015 No. 265.

[^f00004]: S.I. 2002/2677, amended by S.I. 2015/21.

[^f00005]: S.I. 2002/2776, amended by S.I. 2015/21.

[^f00006]: S.R. 2003 No. 34, amended by S.R. 2015 No. 265.

[^f00007]: S.R. 2003 No. 152, amended by S.R. 2015 No. 265.

[^f00008]: S.I. 2011/2132, amended by S.I. 2016/254.

[^f00009]: S.I. 2013/1506.

[^f00010]: S.R. 2013 No.206.

[^f00011]: S.I. 2014/1663, amended by S.I. 2015/1637.

[^f00012]: S.I. 2015/483.

[^f00013]: S.R. 2015 No. 236.

[^f00014]: S.R. 2015 No. 254.

[^f00015]: S.R. 2015 No. 325.

[^f00016]: S.R. 2015 No. 339.

[^f00017]: S.I. 2016/253.

[^f00018]: OJ No. L 353, 31.12.2008, p. 1, as amended.

[^f00019]: OJ No. L 201, 27.07.2012, p. 60, as amended.

[^f00020]: S.I. 1998/494, amended by S.I. 2015/21.

[^f00021]: S.R. 1999 No. 90; amended by S.R. 2015 No. 265.

[^f00022]: S.I. 2002/2677, amended by S.I. 2015/21.

[^f00023]: S.I. 2002/2776, amended by S.I. 2015/21.

[^f00024]: S.R. 2003 No. 34, amended by S.R. 2015 No. 265.

[^f00025]: S.R. 2003 No. 152, amended by S.R. 2015 No. 265.

[^f00026]: S.I. 2011/2132, amended by S.I. 2016/254.

[^f00027]: S.I. 2012/1657, amended by S.I. 2016/765, 2018/942.

[^f00028]: S.I. 2013/1506.

[^f00029]: S.R. 2013 No.206.

[^f00030]: S.I. 2014/1663, amended by S.I. 2015/1637.

[^f00031]: S.I. 2013/2033, amended by S.I. 2014/599, 2018/761.

[^f00032]: OJ No. L 106, 17.04.2001, p.1.

[^f00033]: S.I. 2015/483.

[^f00034]: S.R. 2015 No. 236.

[^f00035]: S.R. 2015 No. 254

[^f00036]: S.R. 2013 No. 206.

[^f00037]: S.R. 2015 No. 325.

[^f00038]: S.R. 2015 No. 339.

[^f00039]: S.I. 2013/2033 amended by S.I. 2014/599, 2018/761.

[^f00040]: OJ No L 106, 17.04.2001, p. 1.

[^f00041]: S.I. 2016/253.

[^f00042]: The definition of Agency in 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 is being amended to mean the Health and Safety Executive by amendments made elsewhere in these Regulations.

[^f00043]: S.1. 2017/1075.

[^f00044]: S.R. 2017 No.229.

[^f00045]: S.I. 2012/1916.

[^f00046]: S.I. 2013/2033.

[^f00047]: S.I. 2002/618.

[^f00048]: S.I. 2013/1506.

[^f00049]: S.R. 2013 No. 206.

[^f00050]: S.R. 2015 No.236.

[^f00051]: OJ No. L 396, 30.12.2006, p.1.

[^f00052]: OJ No. L 353, 31.12.2008, p.1.

[^f00053]: 1986 c. 14.

[^f00054]: S.I. 2013/3134.

[^f00055]: 1998 c. 46.

[^f00056]: 2006 c. 32. Section 58A was inserted by the Wales Act 2017 (c. 4).

[^f00057]: 1998 c. 47. Section 6 is amended by section 12 of the European Union (Withdrawal) Act 2018 and S.I. 2011/1043.

[^f00058]: 1998 c. 46.

[^f00059]: 2006 c. 32.

[^f00060]: 1998 c. 47.

[^f00061]: 1974 c. 37.

[^f00062]: S.I. 2013/1506.

[^f00063]: S.I. 1978/1039 (N.I. 9).

[^f00064]: S.R. 2013 No. 206.

[^f00065]: 1998 c.46

[^f00066]: 2006 c.32; section 58A was inserted by the Wales Act 2017 (c.4).

[^f00067]: S.I. 2002/2677, amended by S.I. 2004/3386, 2015/21. There other amendments which are not relevant.

[^f00068]: S.R. 2003 No. 34.

[^f00069]: S.I. 2013/1506.

[^f00070]: S.R. 2013 No. 206.

[^f00071]: 1998 c. 46.

[^f00072]: 2006 c. 32.

[^f00073]: 1998 c. 47. Section 6 is amended by section 12 of the European Union (Withdrawal) Act 2018 and S.I. 2011/1043.

[^f00074]: OJ L 139, 14.5.2014, p. 1–6

[^f00075]: OJ L 125, 7.5.2013, p.4-6.

[^f00076]: S.I. 2017/1075.

[^f00077]: S.R. 2017 No. 229.

[^f00078]: S.I. 2011/988.

[^f00079]: S.S.I. 2011/226.

[^f00080]: S.R. 2011 No. 127.

[^f00081]: S.I. 2002/2443.

[^f00082]: S.S.I. 2002/541.

[^f00083]: S.I. 2002/3188 (W.304).

[^f00084]: S.R. 2003 No. 167.

[^f00085]: S.I. 2012/1916.

[^f00086]: S.I. 2013/2033.

[^f00087]: 2018 c. 22.

[^f00088]: S.I. 2013/1506.

[^f00089]: S.I. 2004/3391.

[^f00090]: S.S.I. 2004/520.

[^f00091]: 1998 c. 46.

[^f00092]: 2006 c. 32.

[^f00093]: 1998 c. 47.

[^f00094]: 1974 c. 37.

[^f00095]: S.I. 2013/1506

[^f00096]: S.I. 1978/1039 (N.I. 9).

[^f00097]: S.R. 2013 No. 206.

[^f00098]: S.I. 2013/1506.

[^f00099]: S.R. 2013 No. 206.

[^f00100]: 1974 c. 37.

[^f00101]: S.I. 1978/1039 (N.I. 9).

[^f00102]: 1998 c. 46.

[^f00103]: 2006 c. 32; section 58A was inserted by the Wales Act 2017 (c.4).

[^f00104]: 1998 c. 47; section 6 is amended by section 12 of the European Union Withdrawal Act 2018 and S.I. 2011/1043.

Revocation of Commission Delegated Regulation (EU) No 492/2014

Savings and transitional arrangements

...

78A

After Article 17 insert—

(1) Subject to paragraphs 5-8, a biocidal product is to be treated as if it was authorised by the competent authority under Article 30 or, where relevant, Article 26, under the same terms and conditions as the product is authorised or permitted in Northern Ireland where— (a) each of the following conditions are met— (i) the biocidal product— (aa) is a qualifying Northern Ireland good, and (bb) has a Relevant NI Permission at that time; (ii) the authorisation holder or the person with a Relevant NI Permission (as the case may be) is established in Northern Ireland; (iii) all the active substances in the biocidal product are entered in— (aa) the list prepared pursuant to Article 8A (the GB List), or (bb) the list prepared pursuant to Article 24A (the Simplified Active Substance List); (iv) the person referred to in point (a)(ii) notifies the competent authority no later than 90 days in advance of making the biocidal product available on the market by submitting in full to the competent authority the information that the person submitted in their application under Regulation (EU) No 528/2012 as it has effect in EU law to the evaluating competent authority, reference Member State or Northern Ireland competent authority (as the case may be), for the Relevant NI Permission together with a copy of any relevant NI authorisation or permit; (v) the competent authority takes no action pursuant to paragraph 2; (b) if the person referred to in point (a)(ii) intends to make any changes to the product, that person notifies the competent authority no later than 90 days in advance of the date on which such changes will apply, with the information submitted to the reference Member State pursuant to Article 5 of Commission Implementing Regulation (EU) No 354/2013 as it has effect in EU law, or for administrative changes other than those referred to in the second subparagraph of Article 6(2) of that Regulation, that person notifies the competent authority within 12 months of making the change; (c) if the person referred to in point (a)(ii) intends to renew the authorisation of the product in Northern Ireland, that person notifies the competent authority no later than 90 days in advance of the date of renewal by submitting in full the information that the person submitted to the reference Member State pursuant to Articles 31(1) or 45(1) of Regulation (EU) No 528/2012 as it has effect in EU law or, where relevant, Article 2 of Commission Delegated Regulation (EU) No 492/2014 as it has effect in EU law. (2) The competent authority may prohibit a biocidal product notified under paragraph 1 from being made available on the market in Great Britain where— (a) such action can be justified on any of the following grounds— (i) the protection of the environment, (ii) public policy or security, (iii) the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants, (iv) the protection of national treasures possessing artistic, historic or archaeological value, (v) the target organisms not being present in harmful quantities, or (b) the competent authority considers that the biocidal product does not meet the criteria set out in Articles 19 or 25. (3) The competent authority may amend the terms and conditions under which a biocidal product may be made available on the market in Great Britain where— (a) this can be justified on the grounds in paragraph 2(a), or (b) the competent authority considers that the biocidal product does not meet the criteria set out in Articles 19 or 25. (4) Where the competent authority intends to take action under paragraphs 2 or 3, or identifies concerns as to whether the biocidal product meets the criteria in Articles 19 or 25, the competent authority— (a) must inform the notifier, and (b) may request additional information. (5) The period of 90 days referred to in paragraphs 1(a)(iv), (b) and (c) is suspended— (a) where the competent authority takes action under paragraph 4(b), until the competent authority receives the additional information, and (b) from the point when the competent authority receives the additional information, for a further period of 90 days to allow the competent authority to consider that additional information. (6) Where any information submitted to the competent authority under this Article includes one or more letters of access, the competent authority may reject the letter of access where it does not hold the relevant data. (7) Where the additional information has not been submitted to the competent authority within 90 days of a request under paragraph 4(b), the notification made under paragraph 1 is to be treated as withdrawn. (8) Where the competent authority has amended the terms and conditions under which a biocidal product may be made available on the market under paragraph 3, that product must not be made available and used in Great Britain other than under those amended terms and conditions. (9) Where a biocidal product has been treated as authorised due to meeting the requirements of paragraph 1 but ceases to satisfy those requirements— (a) there is deemed to be a cancellation of the authorisation of that product by the competent authority, and (b) the period of grace provided for in Article 52 applies. (10) For the purposes of this Article— (a) “NI competent authority” means the competent authority appointed by regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013; (b) “qualifying Northern Ireland good” has the meaning given by regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; (c) “Relevant NI Permission” means any of the following— (i) a national authorisation granted by the NI competent authority under Article 30 of Regulation (EU) No 528/2012 as it has effect in EU law or under Article 5 of Regulation (EU) No 414/2013 as it has effect in EU law; (ii) an authorisation granted by mutual recognition by the NI competent authority under Articles 33 or 34 of Regulation (EU) No 528/2012 as it has effect in EU law; (iii) a Union authorisation granted by the Commission under Article 44 of Regulation (EU) No 528/2012 as it has effect in EU law or under Article 6 of Regulation (EU) No 414/2013 as it has effect in EU law; (iv) an authorisation granted by the NI competent authority under the simplified procedure in accordance with Article 26 of Regulation (EU) No 528/2012 as it has effect in EU law or Article 6a of Regulation (EU) No 414/2013 as it has effect in EU law; (v) a biocidal product permitted on the market by the NI competent authority under the Parallel Trade procedure in Article 53(1) of Regulation (EU) No 528/2012 as it has effect in EU law; (vi) a critical use permit granted in Northern Ireland under Article 55(1) of Regulation (EU) No 528/2012 as it has effect in EU law; (vii) a provisional authorisation under Article 55(2) of Regulation (EU) No 528/2012 as it has effect in EU law; (viii) a cultural heritage authorisation granted under Article 55(3) of Regulation (EU) No 528/2012 as it has effect in EU law; (ix) an essential use authorisation granted under regulation 12 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013.

SCHEDULE 4 — Savings, transitional and consequential provision

Provision relating to Regulation (EC) No 1272/2008

1

In relation to Great Britain, a classification which, immediately before IP completion day, is set out in Table 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 is to be treated as if it were approved by the Secretary of State in accordance with Article 37A of Regulation (EC) No 1272/2008.

Provision relating to Regulation (EU) No 528/2012

2

(1) After Article 95 of 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, insert—

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.