Technical Report 130

Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances in accordance with the PPP Regulation

Data requirements for active substances in accordance with the PPP Regulation are set out in Commission Regulation (EU) No 283/2013 (Commission, 2013a). The specific test methods are listed in a Commission Communication (Commission, 2013b).

In Part A of the Annex to Commission Regulation (EU) No 283/2013 (Commission, 2013a), Section 5 describes toxicological and metabolism studies, and Sub-section 5.8 other toxicological studies, with 5.8.3 describing endocrine disrupting properties:

5.8.3. Endocrine disrupting properties

If there is evidence that the active substance may have endocrine disrupting properties, additional information or specific studies shall be required:

to elucidate the mode/mechanism of action,
to provide sufficient evidence for relevant adverse effects.

Studies required shall be designed on an individual basis and taking into account Union or internationally agreed guidelines, in the light of the particular parameters to be investigated and the objectives to be achieved.