EUROPE: News in the Assessment of Metabolites in Groundwaters

The European Commission released a new version (revision 11) of the guidance document SANCO/221/200 as regards the assessment of the relevance of metabolites in groundwater. Previous version (revision 10) dated 2003.

This new version will apply to dossiers submitted from 01.05.2022 but can be applied earlier by applicants.

The main changes concern Stage 2 of Step 3 as regards the assessment of genotoxicity. The section was amended to:

  • Ensure that the evaluation of the genotoxic potential cover all of the following aspects: gene mutation, structural chromosomal alterations (clastogenicity) and numerical chromosomal alterations (aneugenicity);
  • Give an example of a suitable battery of tests: (i) Ames test, (ii) in vitro Mammalian Cell Gene Mutation Test (tk or hprt locus) and (iii) in vitro micronucleus test;
  • Provide instructions for alternative/further studies in case of metabolite specificities and in case of equivocal, inconclusive or positive results.

Other changes were made to reflect the new Regulations and guidance documents that were released since 2003. Clarifications on the scope of the document as regards metabolites formed by microbial pest control agents (micro-organisms) are given.

 

To download: 

Guidance Document On The Assessment Of The Relevance Of Metabolites In Groundwater Of Substances Regulated Under Regulation (EC) No 1107/2009 – Sanco/221/2000, rev.11, 21 October 2021

 

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

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FRANCE – ANSES: Update of the Surface Water Information Notice

Anses updated its Information Notice as regards the Surface Water risk assessment for plant protection products and the use of the FOCUSsw tool.

No significant change was made to the newly released version. The notice was updated as regards the more recent versions of the reference documents for the surface water risk assessment. Rewordings were also performed to adjust the text.

 

To download (in French): 

Information notice as regards the risk of surface water contamination with plant protection products in the framework of Regulation (EC) No. 1107/2009: use of FOCUSsw tool – Revision 2 (18 October 2021)

 

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

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FRANCE – ANSES: Upcoming Evolutions for Bees and Other Pollinators

In a context of evolution of the pollinator protection policy at national level in France and at the European level, Anses published a note summarising the requirements and the reference legal acts currently in force as well as the upcoming developments as regards plant protection products (PPP). The note will be updated on a regular basis.

Changes will take place (i) when the new Order (repealing the 2003 Order) on the protection of bees and other pollinators is adopted in France and (ii) when the new EFSA bee guidance document is adopted (revision of the 2013 version; EFSA Journal 2013;11(7):3295) and when the data requirements and decision-making criteria are updated at European level (update of Regulations (EU) No. 284/2013 and 546/2011, respectively).

As of the entry into force of the new French “Bees” Order, the request for an exemption for PPP application during the flowering period will necessitate, in addition to CEB 230 trials (current requirement), a homing flight test in the case of an insecticide targeting the central nervous system of insects and which may occur during the flowering period. Further studies may be necessary if refinements of the risk assessment are needed.

Then, when adopted, the new EFSA guidance document and the updated European data requirements and decision-making criteria will serve as framework for the pollinator risk assessment. The new French regulation for an exemption for PPP application during the flowering period will continue to apply.

 

To download (in French): 

Anses Note on Current and Future Reference Documents and Requirements as Regards the Risk Assessment of PPP for Bees and Other Pollinators – version 1, 18 October 2021.

 

See also our previous articles: 

FRANCE: Public Consultation on New Measures to Protect Pollinators

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

 

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

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FRANCE – ANSES : Update of the memo on advices to applicants in the framework of Regulation (EC) n° 1107/2009 for the evaluation of plant protection (rev. 2)

On 18.10.2021, ANSES published an update of its memo on advices to applicants in the framework of Regulation (EC) n° 1107/2009 for the evaluation of plant protection. The latest version dated 2015.

The update concerns the Toxicology and Ecotoxicology sections. 

In toxicology, the EFSA model (2014) has been replacing the BBA exposure model for evaluation of operator exposure and the Europoem II exposure model for worker exposure and bystander exposure since 01.01.2016. However, the recommendations on the exposure assessments not covered by the EFSA guidance document (EFSA Journal 2014;12(10):3874 ) are maintained. 

In ecotoxicology, the data and risk assessments requirements for bees and other pollinators are detailed in a note also published on 18.10.2021. 

To download: Advices to applicants in the framework of Regulation (EC) n° 1107/2009 for the evaluation of plant protection products (revision 2 –18 October 2021)

See also our article: 

FRANCE – ANSES: Upcoming Evolutions for Bees and Other Pollinators

 

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

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

EUROPE – COM : Update of guidance documents physical, chemical and technical properties of plant protection products (SANCO/10473/2003– rev 5)

The Commission published an update of guidance documents SANCO/10473/2003 ‘for generation and evaluation of data on the physical, chemical and technical properties of plant protection products under regulation (EC) N° 1107/2009’. The intention of this guidance document is to describe the physical, chemical and technical data required to support the registration and/or authorisation of a formulation as set out in Regulation (EU) No. 284/2013.

This latest version 5 describes the relevant physical, chemical and technical properties to plant protection products and the appropriate analytical methods for their measurements. It also details the requirements for the technical characteristics and the means of generating data by type of formulation. The currently used liquid, solid, seed treatment and miscellaneous preparations are mentioned.

This 5th version applies to submissions made from 01.11.2021.

 

To download: SANCO/10473/2003 –rev.5

 

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

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EUROPE – COM : Update of guidance documents on new active substance data post approval, on rules for revision of assessment reports and on data matching

The Commission published an update of the following guidance documents:

SANCO/10328/2004. The SANCO 10328/2004 document on the evaluation of new active substance data post (renewal of) approval gives a systematic overview on the different reasons for submissions of further active substance data after its (renewal of) approval. The new version 9 replaces revision 8 dated 2012 and clarifies in great detail the assessment process taking into account the kind of new active substance data submitted. This updated version applies to submissions made from 1 November 2021.

SANCO/10180/2013. The SANCO/10180/2013 document on rules for revision of assessment reports is a complement to the ‘Template to be used for Assessment Reports’ (SANCO/12592/2012) as it provides guidance on when and how to update assessment reports and also presents a way to keep track of the different versions and how to name files to identify them in a unique way. In the new version 2, the condition to incorporate new data and/or new assessments during the processes of evaluation of new active substance data post (renewal of) approval under Regulation (EC) No 1107/2009 have been added. This updated version should be used for assessment reports prepared for active substances submitted to the Commission as from 1 November 2021.

 – SANTE/2016/11449. The SANTE/2016/11449 document on data matching for applications for PPP authorisations according to Art. 33 and 43 of Regulation (EC) No. 1107/2009 was initially a ‘Template for Submission Demonstrating Access to a Complete Package According to Regulation (EU) No. 283/2013 and for the Data Matching Step’. Between 2019 and 2021, many reviews have contributed to elaborate a detailed guidance on how to build a data matching request in connection to the renewal of an existing product, or a Cat. 4 extension. In this last version 1.5, some minor text clarifications have been added after commenting in the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) including a table of contents and some minor additions to appendix 1 (email template), in line with the agreements in the guidance document.

To download: 

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

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FRANCE: Withdrawal of alpha-cypermethrin, carbetamide, cyproconazole, fenoxycarb, myclobutanil and oryzalin-based products

As a result of the entry into force of Regulation (EU) 2021/795 of 17 May 2021 concerning the non-renewal of alpha-cypermethrin approval,  the last authorisation containing this substance is withdrawn from 7 December 2021.

The end of sales and distribution is set on 07.06.2022.

The end of use of the stocks of product is set on 07.12.2022.

In addition, further to the expiry of the approval of the active substances carbetamide, cyproconazole, fenoxycarb, myclobutanil and oryzalin, 11 authorisations and 10 parallel trade permits for plant protection products containing these substances were withdrawn from 02.08.2021, 02.08.2021, 19.07.2021, 19.07.2021 and 13.08.2021.

The end of sales and distribution is set on 30.11.2021.

The end of use of the stocks of products is set on 31.05.2022.

 

To download: 

List of withdrawal of products (in French)

 

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

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PestiRiv : Pesticide exposure of people living in winegrowing areas.

The French Agency for Food, Environmental and Occupational Health & Safety (Anses) and the National Public Health Agency (SPF) are launching the PestiRiv study, which aims at assessing the exposure to plant protection products of people living near vineyards and those living far from any cultivated areas. The study will permit to better understand pesticide exposure and to adapt the risk mitigation measures.

This study will also help to:

– know the exposure sources to pesticides, 

– study the effect of the distance from the vineyard on exposure, 

– study the links between the different sources of exposure and their impacts on overall exposure, 

– describe the exposure variation over time.

The PestiRiv study started in October 2021 and will finish in August 2022. It involves 3 3350 participants, takes place in 6 winegrowing regions: Auvergne-Rhône-Alpes, Bourgogne-Franche-Comté, Grand Est, Nouvelle-Aquitaine, Occitanie, Provence-Alpes-Côte d’Azur and concerns adults aged 18-79 and children aged 3-17.

The full report of the study results will be published on the websites of the Anses and SPF in 2024.

 

To download: Press release ANSES-SPF (in French)

 

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

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EUROPE: New draft rules for the use of microorganisms in PPP

The EU Commission launched on 26 October 2021 until 23 November 2021, four consultations on draft acts as regards the revision of the current rules for the use of microorganisms in plant protection products.

These initiatives will:

adapt Part II of the uniform principles for evaluating and authorising plant protection products to accommodate the characteristics of these microorganisms, as they are different to those of chemical substances,

specify approval criteria for microbial active substances in Annex II to Regulation (EC) No 1107/2009 in order to reflect the particularities of these substances, which are different from chemical substances,

adapt the current data requirements (in part B of the Annex to Regulation 284/2013) to accommodate the characteristics of the microorganisms in these products, as they are different to those of chemical active substances,

adapt the current data requirements (in part B of the Annex to Regulation 283/2013) to accommodate the characteristics of the microorganisms in these products, as they are different to those of chemical active substances.

These adaptations of the current rules are in line with the EU’s ‘farm to fork’ strategy that aims at reducing dependency on chemical plant protection products, including by facilitating the placing on the market of biological alternatives such as microorganisms.

 

See the links to the draft act feedback initiatives:

Pesticides – new uniform principles for evaluating and authorising products

Biopesticides – approval criteria for microbial active substances

Pesticides – new data requirements for authorising products

Pesticides – new data requirements for approving active substances

 

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

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LYNXEE: Appointment of Tanalou Djae as Expert in Physico-chemistry, Analytical methods and Residues

Lynxee consulting’s team is pleased to announce the appointment of Tanalou Djae.

PhD in environmental geoscience and graduated with a Master 2 in environmental analytical chemistry, Tanalou began her career with various experiences of research on field testing and in chemical analysis laboratories before conducting a PhD co-financed by CIRAD (French agricultural research and cooperation organization working for the sustainable development) and l’ADEME (French Agency for Environmental and Energy Management) on the phytoavailability of copper in soils amended with organic waste products.

Tanalou 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, and then in the Residue Unit where she was in charge of the assessment of active substances and plant protection products dossiers.

With her 6-year experience in field, laboratory and scientific assessment, Tanalou joined Lynxee consulting, where she is involved, among others, in the study monitoring and in the drafting of registration dossiers (Physico-chemical properties, Analytical methods and Residues).

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

 

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

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