EUROPE: Guidance on Aged Sorption Studies Adopted

The final version of the guidance document on aged sorption studies of plant protection products in soil was endorsed at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF meeting) of 25-26 January 2021.

The final version integrates the revisions suggested by the EFSA PPR panel (EFSA Journal 2015;13(7):4175 and EFSA Journal 2018; 16(8);5382). Additional comments from Member States made at SCoPAFF meetings between May 2019 and January 2021 will be considered in a later revision of the document.

The guidance document was drafted in order to provide a framework on how to conduct and interpret experimental studies aiming to demonstrate an increase in pesticide sorption with time and how to integrate the results in regulatory higher tier risk assessments. This framework was built on the basis of a literature review, experimental work and extensive modelling.

Only aged sorption as investigated in laboratory studies is under the scope of this document. Field studies being much more complex, further development and tests with real world data would be needed.

The guidance document addresses the following topics:

  • Modelling of aged sorption and conceptual definition of equilibrium sorption;
  • Experiments to derive aged sorption parameters;
  • Fitting of kinetic models to data from aged sorption studies;
  • Aged sorption in the tiered pesticide leaching assessment;
  • Special consideration for metabolite.

This new guidance document will apply from 1 April 2021 (date of dossier submission).

 

To download: 

Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments – SANTE/12586/2020–REV 0 – 26 January 2021

 

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

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

 

LYNXEE: Appointment of Marie Surget, Efficacy expert

Lynxee consulting’s team is pleased to announce the appointment of Marie Surget.

Graduated with a Master in plant biotechnology, Marie worked during several years as a field trialist and GEP study Director in different contractors and agrochemical companies. Then she participated in the drafting of BADs within a consulting company and then an agrochemical company.

Marie joined Lynxee consulting in November 2020, where she is in charge of BAD writing.

 

Lynxee consulting’s team now counts four Efficacy Experts. Do not hesitate to contact us for quotes! http://lynxee.consulting/en/contact/

 

Lynxee consulting recruit a regulatory Expert in Residues in ‘home office’. Join our team!

With 7 staff, our dynamic team grows again! We open a new position for a Residues Regulatory Expert for project coordination, dossiers drafting, study monitoring etc…

 

Are you interested in this position? Have a look at the job description and submit your application through our website!

 

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

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

 

EUROPE-EFSA: Latest Progress in the Revision of the 2013 Bee Guidance

In March 2019, the European Commission mandated EFSA for a review of its guidance on the Risk Assessment of Plant Protection Products on Bees (EFSA Journal 2013;11(7):3295). In this context, EFSA released two reports this summer.

The first report is the outcome of the EFSA collection of evidence on background bee mortality rates and in particular considering realistic beekeeping management and natural background mortality. A systematic literature review was supplemented with a survey sent to European bee keepers. The collection, which covers the tree bee groups (honey bees, bumble bees and solitary bees), provides solid grounds on background mortalities and will serve as a base for the revision of the EFSA guidance (2013).

The EFSA working group also published a supporting document addressed to risk managers about possible approaches to defining the specific protection goals (SPGs) that will be used in the EFSA guidance (2013) review. The document proposes 4 alternative approaches:

  1. Establish acceptable effect based on long-term colony survival, or,
  2. Derive threshold of acceptable effect on colony size based on their natural variability, or,
  3. Define acceptable levels on colony/population size (approach currently considered in the EFSA guidance 2013), or,
  4. Define levels of acceptable impact on the provision of the ecosystem services.

More details on approaches and associated pros and cons are available in the report (see the link below).

For the next step, risk managers will have to decide which of the approaches EFSA should use for the revision of the guidance. It is noted that the initial schedule is slightly delayed as this step was initially expected to be done by end of May 2020.

As a reminder, the publication of the revised EFSA guidance on bees is scheduled for Q1 2021.

 

To download: 

EFSA’s review of the evidence on bee background mortality – EFSA Supporting publication 2020:EN-1880.

Supporting document for risk managers on specific protection goals for bees – 22 June 2020.

 

See also our previous articles:

EUROPE-EFSA: Workplan for the Revision of the 2013 Bee Guidance Published   

 

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

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

 

FRANCE: National memo on sustainable management of fungicides resistance of Sclerotinia sclerotinium in oilseed rape

The national memo on sustainable management of fungicide resistance of Sclerotinia sclerotinium on oilseed rape has been published :

This memo provides an overview of oilseed rape Sclerotinia sclerotinium resistance to the main fungicide families authorised in France and gives recommendations to limit resistance development risks and to maintain the products’ effectiveness.

 

See also our previous articles: 

FRANCE: 2020 National memos on the sustainable management of resistance to fungicides

FRANCE: 2019 National memos on the sustainable management of resistance to fungicides

 

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

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

 

LYNXEE: Appointment of Clément Coin, Efficacy expert

Lynxee consulting’s team is pleased to announce the appointment of Clément Coin.

Graduated with a Master in crop production specialised in plant protection, Clément worked during several years as a field trialist and project manager for different contractors. Then he participated to the drafting of BADs within an agrochemical company.

Thanks to his strong background both in fields and in GEP reports/BAD writing, he has a good vision of the entire data collecting and analysing chain, from the field to the BAD.

Clément joined Lynxee consulting in 2020, where he is in charge of BAD, comparative assessment and labels writing.

 

Lynxee consulting’team now counts three Efficacy Experts. Do not hesitate to contact us for quotes! http://lynxee.consulting/en/contact/

 

FRANCE: 2020 National memos on the sustainable management of resistance to fungicides

Two national memos on the sustainable management of resistance to fungicides were published:

 

  • Management of resistance to fungicides used to control cereals diseases (in French)

This memo provides an overview, by disease and by mode of action, of resistance to fungicides used to control cereal diseases and makes recommendations to limit the risk of resistance development and to maintain a good level of control.

 

  • Management of resistance to fungicides used to control vineyard diseases: downy mildew, powdery mildew, grey mould, black rot (in French)

The aim of this memo is to present the elements of preventive strategy against resistance development, to describe the 2019 general situation for the resistance of downy mildew, powdery mildew, grey mould and black rot of vine to the main families of authorised active substances, and finally to make recommendations for these resistances with the aim of decreasing and optimising fungicide treatments.

 

See also our previous articles: 

FRANCE: 2019 National memos on the sustainable management of resistance to fungicides

 

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

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

LYNXEE: Appointment of Chloé Trinchese as Expert in Physico-chemistry and Analytical methods

Lynxee consulting’s team is pleased to announce the appointment of Chloé Trinchese.

As a Chemical Engineer, Chloé began her career in formulation laboratories and then worked for ANSES (French Agency for food, environmental and occupational health and safety) as a scientific assessor in the Physical-chemistry and Analytical Methods Unit. She was in charge of the assessment of the relevant sections of the dossiers of authorisation for plant protection products and active substances.

With 5 years of experience in scientific assessment, Chloé joined Lynxee consulting, where she is involved, among others, in the drafting of registration dossiers.

Lynxee consulting’s team welcomes Chloé and encourages you to entrust her with the drafting of your dRR (Physico-chemical properties and analytical methods). You will appreciate the quality and rigour of her work.

EUROPE – COM / Public Consultation: Draft List of Co-formulants Banned in PPP

European Commission started on 16 January 2020 a public consultation on the draft regulation implementing the list of co-formulants that shall not be used in plant protection products or adjuvants (Annex III of Regulation (EC) No. 1107/2009). The consultation will end on 13 February 2020.

Updated versions of the draft regulation and its annex (including the list of banned co-formulants) can be downloaded via the public consultation website or via the download links below.

The new version of the regulation now specify that the grace period that can be granted by Member States for PPP or adjuvants containing a co-formulant listed in Annex III to Regulation (EC) No 1107/2009 shall expire for the sale and distribution at the latest 3 months and for the disposal, storage and use additional 9 months after the amendment or withdrawal of the authorisations.

In the new version of the annex, the following modifications are found for the entries Aluminium silicate (kaolin), Quartz sand and Silicium dioxide (in yellow) in comparison to the version of July 2019:

To download: 

New Draft Commission Regulation modifying Annex III of Regulation (EC) 1107/2009 and its Annex

 

See also our previous articles: 

EUROPE-COM : draft list of co-formulants banned in PPP

 

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

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