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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 exit day, pursuant to the third subparagraph of Article 89(1) of that Regulation as it had effect immediately before exit day, not to approve a substance/product-type combination;
(iii)made after exit 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 exit 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 exit day;”.
(4) For point (d), substitute—
“(d)‘competent authority’ means the authority appointed in accordance with—
(i)regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013(1);
(ii)regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013(2);”.
(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—
(i)regulations made under section 43 of the Health and Safety at Work etc. Act 1974(3) where the competent authority is appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013; or
(ii)regulations made under Article 40 of the Health and Safety at Work (Northern Ireland) Order 1978(4) where the competent authority is appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013
(g)‘Devolved Authority’ means—
(i)the Scottish Ministers,
(ii)the Welsh Ministers, or
(iii)a Northern Ireland department.”
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