SCHEDULE 34Amendment of Regulation (EC) No 1223/2009 and related amendments

Amendment of Article 10

10.

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 ”.