Paragraph 42 I1

For Article 52 substitute—

“Article 52

Adoption of decisions under substance evaluation

1

This Article applies where the Agency has circulated its draft decision in accordance with Article 46.

2

If the Agency receives no comments from the registrant or the downstream user, the Agency must make its decision in the version circulated under paragraph 1.

3

If the Agency receives any comments from the registrant or the downstream user, the Agency must—

(a)

take the comments into account, and

(b)

make its decision (whether that is to make the decision in the version circulated or vary the decision circulated).

4

The Agency must notify the registrant or the downstream user, and the appropriate authorities, of the decision made under paragraph 2 or 3.

5

An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.”.