Regulation 4
1. The GMO Regulations are amended as follows.
2. In regulation 4(3)—
(a)in sub-paragraph (a)—
(i)for “Community” substitute “the Community”;
(ii)for “United Kingdom” substitute “Great Britain”;
(b)in sub-paragraph (c), for the new paragraph 10 to be substituted by that sub-paragraph, substitute—
“10. “Placing on the market” means placing on the market as defined in the specific legislation under which the relevant product is authorised; in other cases, it means “marketed” within the meaning given in section 107(11) of the Environmental Protection Act 1990(1).”;
(c)in sub-paragraph (d), in the new paragraph 13 to be inserted by that sub-paragraph, omit point (d).
3.—(1) Regulation 5 is amended as follows.
(2) In paragraph (3)—
(a)for sub-paragraph (a) substitute—
“(a)in paragraph 10, for subparagraph (a) substitute—
“(a)the permanent or temporary leaving of Great Britain of GMOs which originated—
(i)in Great Britain, or
(ii)in a third country but have entered, and are in free circulation in, Great Britain;”;”;
(b)for sub-paragraph (b) substitute—
“(b)in paragraph 11, for the words from “outside the” to the end substitute “outside Great Britain by an exporter”;”;
(c)for sub-paragraph (c) substitute—
“(c)in paragraph 12, for “the customs territory of the Community”, in both places it occurs, substitute “Great Britain”;”;
(d)after sub-paragraph (d), insert—
“(da)for paragraph 15 substitute—
“15. “Party” means—
(a)Great Britain,
(b)Northern Ireland, or
(c)any other country or regional economic integration organisation being a Party to the Protocol;”;”;
(e)for sub-paragraph (e) substitute—
“(e)in paragraph 19, after ““competent authority”” insert “, other than in the expression “relevant GB competent authority”,”;
(f)after sub-paragraph (e), insert—
“(ea)after paragraph 19, insert—
“19A. “relevant GB competent authority”—
(a)in relation to performing the administrative functions required by the Protocol in England, means the Secretary of State;
(b)in relation to performing the administrative functions required by the Protocol in Wales, means the Welsh Ministers;
(c)in relation to performing the administrative functions required by the Protocol in Scotland, means the Scottish Ministers.”;”;
(g)for sub-paragraph (f) substitute—
“(f)in paragraph 20, after “Party” insert “(other than Great Britain)”;
(fa)after paragraph 20, insert—
“20A. “GB focal point” means the Secretary of State, who has been designated as Great Britain’s entity to be responsible on its behalf for liaising with the Secretariat;”;”;
(h)in sub-paragraph (g)—
(i)in the new paragraph 22 to be inserted by that sub-paragraph, for “, Scotland or Northern Ireland” substitute “or Scotland”;
(ii)in the new paragraph 23 to be inserted by that sub-paragraph—
(aa)after ““relevant” insert “GMO”;
(bb)for “any of the competent authorities” substitute “a relevant GB competent authority”;
(iii)after the new paragraph 23, insert—
“24. “third country” means a country other than Great Britain.”.
(3) In paragraph (4)—
(a)in sub-paragraph (a)—
(i)for “the competent” substitute “the relevant GB competent”;
(ii)for “any” substitute “each”;
(b)in sub-paragraph (b), for “focal” substitute “GB focal”.
(4) In paragraph (5)—
(a)in sub-paragraph (a) for “competent” substitute “relevant GB competent”;
(b)in sub-paragraph (b) for “any” substitute “each”;
(c)in sub-paragraph (c)(i) for “competent authority for any” substitute “relevant GB competent authority for each”.
(5) In paragraph (6)—
(a)in sub-paragraph (a)—
(i)in paragraph (i)(aa) for “focal” substitute “GB focal”;
(ii)in paragraph (i), for sub-paragraph (bb) substitute—
“(bb)for “the Community or use within a Member State” substitute “Great Britain”;”;
(iii)in paragraph (ii), in the subparagraph to be substituted by that paragraph—
(aa)omit point (d), and
(bb)in the words after point (d), for “country outside the United Kingdom” substitute “third country”;
(b)in sub-paragraphs (b) and (c), for “focal” substitute “GB focal”.
(6) For paragraph (7) substitute—
“(7) In Article 10(3), in the second sentence, for the words from “it is authorised” to the end substitute “its use is permitted in Great Britain or the competent authority of the importing country has expressly agreed to the import”.”.
(7) In paragraph (9)—
(a)in sub-paragraph (a), for “competent” substitute “relevant GB competent”;
(b)in sub-paragraph (b)(i)—
(i)in sub-paragraph (aa), for “the United Kingdom” substitute “Great Britain”;
(ii)in sub-paragraphs (aa) and (bb), for “focal” substitute “GB focal”.
(8) In paragraph (10)(a)—
(a)in paragraph (i)(aa), for “focal” substitute “GB focal”;
(b)in paragraph (iii), in the point to be substituted by that paragraph—
(i)for “relevant authority” substitute “relevant GMO authority”;
(ii)omit the words from “— in Northern Ireland” to “(Northern Ireland) 2003”;
(c)for paragraph (iv) substitute—
“(iv)in point (f), for “the Community’s” substitute “Great Britain’s”;”;
(d)in paragraph (v), in the points to be substituted by that paragraph—
(i)in point (h), omit point (iv);
(ii)in point (i) for “the United Kingdom” substitute “Great Britain”.
(9) In paragraph (11)—
(a)in sub-paragraph (a), for “competent” substitute “relevant GB competent”;
(b)in sub-paragraph (b), for “competent” substitute “relevant GB competent”.
(10) In paragraph (12)(c), in the new paragraph 3 to be inserted by that paragraph—
(a)for “focal” substitute “GB focal”;
(b)for “competent” substitute “relevant GB competent”.
(11) In paragraph (14)(b)—
(a)in paragraph (i), for “focal” substitute “GB focal”;
(b)in paragraph (ii), for “the United Kingdom” substitute “Great Britain”.
(12) In paragraph (16)—
(a)for sub-paragraph (a) substitute—
“(a)in point (c), for “the State of export” substitute “Great Britain”;”;
(b)in sub-paragraph (b), for paragraph (i) substitute—
“(i)for “the State of export”, in the first place it occurs, substitute “Great Britain”;”.
(13) For paragraph (17) substitute—
“(17) In Annex 3, in point (b), for “the originating Party” substitute “Great Britain”.”.
4.—(1) Regulation 6 is amended as follows.
(2) In paragraph (2), in the new Article 1 to be substituted by that paragraph—
(a)in paragraph 1, omit point (d);
(b)for paragraph 2 substitute—
“2. This Regulation does not apply to medicinal products for human and veterinary use authorised under—
(a)Regulation (EC) No 726/2004 of the European Parliament and of the Council,
(b)the Human Medicines Regulations 2012(2), or
(c)the Veterinary Medicines Regulations 2013(3),
or applications for authorisation under such legislation.”.
(3) In paragraph (7)(b), for “the United Kingdom” substitute “Great Britain”.
5.—(1) Regulation 8 is amended as follows.
(2) In paragraph (2), in the Article 1 to be substituted by that paragraph, omit point (d).
(3) In paragraph (6)(c), for paragraph (iii) substitute—
“(iii)in the words after the first paragraph 8, for “the Community” substitute “Great Britain”.”.
(4) In paragraph (7)—
(a)for sub-paragraph (b) substitute—
“(b)in section B, in paragraph 13, for “the Member State(s)” substitute “Great Britain”;”;
(b)in sub-paragraph (c)(ii), for sub-paragraph (aa) substitute—
“(aa)for “the Community” substitute “Great Britain”;”.
6.—(1) Regulation 11 is amended as follows.
(2) In paragraph (2), in the new Article 1 to be substituted by that paragraph, in paragraph 1, omit point (d).
(3) In paragraph (9)(b)—
(a)in paragraph (iv), for “the United Kingdom” substitute “Great Britain”;
(b)for paragraph (vi) substitute—
“(vi)in paragraph 3.1.3, in the first subparagraph, for “the Community” substitute “Great Britain”.”.
(4) In paragraph (13)—
(a)for sub-paragraph (a) substitute—
“(a)for “the Community”, in each place it occurs, substitute “Great Britain”;”;
(b)in sub-paragraph (d)(ii), for “the United Kingdom” substitute “Great Britain”.
(5) In paragraph (16)(d)—
(a)for paragraph (i) substitute—
“(i)for “the Community”, in each place it occurs, substitute “Great Britain”;”;
(b)in paragraph (ii)(dd), for “the United Kingdom” substitute “Great Britain”.
1990 c. 43. Subsection (11) of section 107, as it applies in England, was substituted by regulation 4(6) of S.I. 2002/2443. Subsection (11) of section 107, as it applies in Wales, as substituted by regulation 5(2)(e) of S.I. 2002/3188 (W. 304). Subsection (11) of section 107, as it applies in Scotland, was substituted by regulation 4(6) of S.S.I. 2002/541. There are other amendments to section 107 but none is relevant.
S.I. 2012/1916, to which there are amendments not relevant to these Regulations.
S.I. 2013/2033, to which there are amendments not relevant to these Regulations.