EUROPE: AIR5 work programme

Further to the publication in January of Regulation (EU) 2018/155 allocating the MS for the renewal of AIR5 active substances, the Commission has released a work programme:

  • the decision of 06 June 2018 gives priority to the evaluation of active substances that may fail the approval criteria (= that meet the “cut-off” criteria) and of candidates for substitution, and groups the evaluation of active substances with similar properties
  • the draft working document SANTE/2018/10048 provides an overview of indicative dates for application and dossier submission of 66 active substances. They are divided into 2 groups: no change in expiry date, a.s. to be potentially extended.

 

To download:

Commission Implementing Decision of 6 June 2018 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2022, 2023 and 2024 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council

SANTE-2018-10048–rev 1 (June 2018): Draft working document establishing the fifth renewal programme

 

See also our previous article:

EUROPE: Allocation of MS for AIR4 and AIR5 active substances

 

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

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EUROPE: Adoption of the new EFSA guidance document for dermal absorption

Nearly one year ago, the European Food Safety Agency (EFSA) published a revised version of its guidance document on dermal absorption (EFSA Journal 2017;15(6):4873) which defines new default values to be used in absence of experimental data.

The new guidance document was adopted at the Standing Committee on Plants, Animals, Food and Feed of 25 May 2018. This document will start to be used for any active substance or plant protection product applications submitted after 25 August 2018.

For the purpose of this guidance document, a plant protection product is considered:

  • as a concentrate, when the amount of active substance is >50 g/L or g/kg, i.e. >5%, or
  • as a dilution, when the amount of active substance is 50 g/L or g/kg, i.e. 5%.

Member States may decide in the future to carry out a further more precise analysis in order to refine the trigger value of 5%.

 

To download:

Guidance on dermal absorption (SANTE/2018/10591)

 

See also our previous articles:

EUROPE: New EFSA GD on Dermal absorption

 

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

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

FRANCE: Publication of lists of resistance cases identified in France

A series of documents concerning the resistance of fungi, insects, mites and weeds in France has been published on the R4P website on 18/06/2018:

  • Lists of cases of resistance to active substances currently or previously approved, built from experimental data or from literature gathered by French laboratories (INRA and ANSES) and with the assistance of researchers and experts recognised  in each discipline. For each category of pests, two lists are proposed:
    • List I: proven cases of resistance to active substances currently approved in France
    • List II: proven cases of resistance to active substances no longer approved in France
  • Overview of 17 weeds officially resistant in France
  • Maps showing the extent of resistance to herbicides in France, by weed species

 

To download (in French):

  • Lists I (cases of resistance to substances currently approved):

 

See also our previous articles:

FRANCE: New website of a French think tank about resistance to Plant Protection Products (R4P)

 

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

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

EUROPE: Publication of the guidance document EFSA/ECHA on identifying endocrine disruptors

The European Food Safety Authority (EFSA) and the European CHemicals Agency (ECHA) published on 7 June 2018 the first version of the common guidance document on how to identify endocrine disruptors (EDs) contained in plant protection products and biocides.

Started in 2017, the drafting of the document was finalised with the integration of the scientific criteria to identify active substances used in plant protection and having ED properties (adopted in April with Regulation (EU) 2018/605), and the consideration of all comments received during the public consultations held in December 2017 and January 2018.

The guidance document immediately applies to biocides. For active substances used in plant protection, the document will apply to those substances for which a decision is scheduled on or after 10 November 2018.

 

To download (pre-publication version):

Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009

 

See also our previous article:

EUROPE: Publication of Endocrine disruptors criteria

EUROPE: Public consultation on draft guidance for identifying endocrine disruptors

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

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