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Regulation 13 Amendment of Regulation (EC) No 648/2004

Original text. Later amendments are not shown.

(1)

Article 10 is amended as follows.

(2)

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

(3)

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.”.

(4)

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).”.