EUROPE–EFSA: Public Consultation on Updated Bird and Mammals Risk Assessment

EFSA has launched the public consultation on the draft updated guidance document on Risk Assessment for Birds and Mammals (Access to the consultation). The document is an update of the current EFSA’s guidance document (EFSA Journal 2009; 7(12):1438).

Comments will be welcomed until 10.11.2021.

 

To download: 

Draft EFSA guidance-document – Risk assessment for birds and mammals – Version of 29.09.2021 for Public Consultation.

Draft Annex B – Deposition values – Version of 29.09.2021 for Public Consultation.

Draft Annex C – HTET Residue Studies – Version of 29.09.2021 for Public Consultation.

Draft Annex D – HTET Ecological Field Studies – Version of 29.09.2021 for Public Consultation.

Draft Annex E – HTET Field Effect Studies – Version of 29.09.2021 for Public Consultation.

Draft Appendix F – Summary of Generic Model Species Parameters – Version of 29.09.2021 for Public Consultation.

 

See also our previous articles: 

EUROPE – EFSA: Database of Ecological and Residue Data Used in Assessments for Birds and Mammals

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EUROPE – COM : Update of MRL setting procedure (SANTE/2015/10595 rev. 6.1)

The Commission published an update of Technical Guidelines SANTE/2015/10595 “MRL setting procedure in accordance with articles 6 to 11 of Regulation (EC) No 396/2005 and article 8 of Regulation (EC) No 1107/2009”.

The last version (rev. 5.5) was dated February 2021. The purpose was to detail the new requirements in the pre-submission phase and submission application procedure in relation with the implementation of the Transparency Regulation (EU) 2019/1381.

In this new version 6.1, the conditions that lead to the setting of temporary MRLs have been detailed for the following ‘exceptional cases’:

  • Cases of emergency authorisations notably where pesticide residues arise as a result from uses of plant protection products.
  • Cases of environmental contamination, of cross-contamination from storage facilities and handling circuits and cases of contamination due to the transfer of residues from the treated parts of the plant to food products in relation with the active substance persistence.  
  • Cases of natural occurrence of substances unauthorised use as a pesticide and of substances with multiple uses whose residues are not a consequence of uses in plant protection.

These new provisions apply to all MRL applications submitted as of 27 March 2021. For all applications submitted before 27 March 2021, all procedural steps as described in SANTE/2015/10595 Rev. 5.4 continue to apply. 

 

To download: 

Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 5.4

Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 5.5

Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 6.1

 

See also our previous articles: 

EUROPE – COM: Update of MRL setting procedure (SANTE/2015/10595 rev. 5.4)

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

EUROPE: New Schedule for Southern Zone Guidelines for Protected Crops

The Southern Member States Steering Committee (SMS SC) has released an updated version of the decision table as regards the assessments and tools that will be requested for protected crops (initial version dated May 2021).

In addition to minor wording adjustments, the September 2021 version postpones the implementation date initially set on 01.12.2021 to a provisional date to be confirmed: 01.06.2022.

 

To download: 

SMS SC – Decision table for protected crops (September 2021)

 

See also our previous articles: 

EUROPE: New Guidelines for Southern Zone Member States

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

GB – HSE : GB adoption of EU guidance document SANTE/2020/12830 (analytical methods)

The EU has recently introduced a new technical guidance document for validation requirements and assessment of analytical methods in support of the registration of plant protection products, SANTE/2020/12830.

HSE has undertaken an assessment of the new guidance, considered its implications, and concluded that it is suitable for use under the GB regime. 

The guidance document will apply to all applications made to HSE in support of GB active substance approvals and GB plant protection product authorisations from 1 November 2021.

 

A télécharger : SANTE/2020/12830 rev 1.

 

Nos articles précédents : EUROPE – COM: Publication of a new guidance document on analytical methods

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/