Amendment of the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003
5.—(1) The Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003(1) are amended as follows.
(2) In regulation 2(1) (Interpretation), in the definitions of—
(a)“approved product”, for “18(2) of the Deliberate Release Directive or Article 13(2) or (4) of the 1990 Directive”, substitute “18 of the Deliberate Release Directive”;
(b)“Contained Use Directive”, for “Council Directive 90/219/EEC” to the end, substitute “Directive 2009/41/EC of the European Parliament and of the Council on the contained use of genetically modified micro-organisms(2)”;
(c)“the Deliberate Release Directive”, at the end, add “as last amended by Commission Directive (EU) 2018/350(3)”;
(d)“the Food and Feed Regulation”, at the end, add “as last amended by Regulation (EC) 298/2008(4)”.
(3) In regulation 15, (Exempt activities)
(a)for paragraph (e), substitute—
“(e)a genetically modified organism authorised under Regulation (EC) No 726/2004(5) of the European Parliament and the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as last amended by Regulation (EU) 1027/2012(6), is marketed; or”;
(b)in sub-paragraph (f), for “Council Regulation (EC) No. 258/97” to “Regulation 1882/2003”, substitute “Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods(7)”.
(4) In regulation 16 (Applications for consent to market), in paragraph (5), for “either the Deliberate Release Directive or the 1990 Directive”, substitute “the Deliberate Release Directive”.
(5) Omit regulation 17.
(6) In regulation 24 (Decisions by the Department on applications to market genetically modified organisms), in paragraph 5—
(a)after “2002/53/EC”, insert “as last amended by Regulation (EC) 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(8)”;
(b)after “2002/55/EC”, add “as last amended by Commission Implementing Directive (EU) 2016/317(9)”.
S.R. 2003 No. 167, as amended by S.R. 2003 No. 206 and S.R. 2005 No. 272.
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