EUROPE: Adoption of Timelines for Additional Data on ED for AIR III Active Substances

As adopted by the Commission, the new scientific criteria to identify endocrine disruptors (ED) (Reg. (EU) 2018/605) and the associated EFSA/ECHA guidance (EFSA Journal 2018;16(6):5311) are applicable for the assessment of all active substances (AS) since 10 November 2018, including the AS being under renewal (AIR III renewal programm) for which no draft regulation has been voted by the Committee.

For those AS still being under renewal by 10 November 2018, the Reg. (EU) No 2018/1659, recently adopted, amends Reg. (EU) No 844/2012 to define new timelines specifically dedicated to the submission and assessment of complementary data as regards endocrine disruption. A summary of the new timelines is presented below.

AS for which the new EFSA conclusion is not adopted by 10 November 2018:

  • If additional data are deemed necessary by Member States (MS) and EFSA to assess if the ED criteria are met: data expected are detailed and justified, and a period between 3 and 30 months is set for the submission by the applicant (depending on the type of data required).
  • If no additional data are deemed necessary by MS and EFSA to assess if the ED criteria are met: after having been informed, the applicant may submit additional data as regards ED properties of the AS within 3 months.
  • For both situations described above, the applicant may also provide supporting information as regards the potential derogation for ED active substances according to Article 4(7) of Reg. (EC) No 1107/2009 within the respective period set.
  • After the submission of data by the applicant, the RMS shall produce a revised renewal assessment report (RAR) within 90 days. Then, after the submission of the revised RAR, a conclusion on the AS shall be adopted by EFSA within 120 days. This period includes a consultation of MS and of the applicant on the revised RAR.
  • Non-requested data or data submitted by the applicant after the expiry of the period set for its submission will not be considered.

AS for which the new EFSA conclusion is adopted by 10 November 2018 (but no draft Regulation has been voted by the Committee):

  • The Commission may consider that additional information as regards endocrine disruption are needed to apply the adopted criteria and hence request a revision of the assessment by EFSA within a reasonable time period.
  • In the case of a revision request, same conditions and timelines as presented above (AS for which the new EFSA conclusion is not adopted by 10 November 2018) apply.
  • If no data are submitted by the applicant, EFSA shall conclude the assessment within 30 days.

 

To download:

Regulation (EU) No 2018/1659 of 7 November 2018 amending Reg. (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Reg. (EU) No 2018/605.

 

See also our previous articles:

EUROPE – COM: Availability and applicability of the EFSA/ECHA guidance on identifying endocrine disruptors

 

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