Paragraph 10 Amendment of Article 10I1

United Kingdom

In Article 10 (safety assessment)—

(a)

in paragraph 1 omit the words from “The first subparagraph shall” to “referred to in Article 32(2).”;

(b)

in paragraph 2 for “a Member State” substitute “ the Secretary of State ”;

(c)

in paragraph 3—

(i)

for the words from “shall comply with” to “study” substitute “ must comply with the Good Laboratory Practice Regulations 1999 ”M1 ;

(ii)

before “international standards” omit “other”;

(iii)

for “Commission or the ECHA” substitute “ Secretary of State ”.

Annotations

M1: S.I. 1999/3106; regulation 2(1) was amended by S.I. 2004/994; there are some other amendments not relevant to these Regulations.

I1: Sch. 34 para. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1