Regulation 13 I1

Article 10 is amended as follows.

In paragraph 1, for “Member States' competent authorities”, substitute “ The competent authority ”.

In paragraph 2, for the words from “the Member States'” to “necessary measures.”, substitute “the competent authority must make a decision as to whether or not the test concerned produced a false positive result. The competent authority must:

• — make a decision within 90 days of it becoming aware of a concern that the relevant test may have produced a false positive result;

• — take appropriate expert advice and take that advice into account when coming to a decision;

• — after taking a decision, promptly communicate it to the manufacturer concerned together with an explanation of the appeal process set out below.”.

After paragraph 2, insert—

“

3

If the competent authority decides that a test produced false positive results:

• — those results must be disregarded for the purpose of ensuring compliance with the provisions of this Regulation;

• — the manufacturer may, within 14 days of having that decision communicated to it by the competent authority, appeal to the court against the decision.

4

On appeal, the court may:

• — allow the appeal and rule that the tests did not produce false positive results, or

• — dismiss the appeal.

(Article 18A makes further provision concerning appeals).”.