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Newsletter - No.29 - July 2019
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REGULATORY NEWS

Plant Protection Products
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Dear readers,

We would like to let you know that the 2 new positions are still open! We are currently looking for a Regulatory Expert in Chemistry and a Regulatory Expert in Residues. Both jobs are home-based. Find more in our post below.

As usual before summer, July was a very fruitful month for regulatory news.
In Europe, EFSA published a statement on bats risk assessment, a technical report on recurring issues in Ecotox and a workplan for the revision of the Bee Guidance. And public consultations were opened for the amendment of the Organic Production Regulation and the draft list of unacceptable coformulants.
In France, ANSES issued an Opinion on protection measures for residents and withdrew PPPs containing Propiconazole, Quinoxyfen and Flurtamone. A public consultation was also opened on the new Order for the authorisation of PPP for "amateur" uses. At last ANSES provided an update on SDHI issue.

We summarised this information for you throughout articles that you will find below.
We hope you enjoy reading these notes and stay at your disposal for regulatory advice.

And above all, we wish you a DELIGHTING summer time!

Lynxee consulting's Team
Events to come

Events to come

 
ABIM 2019: Annual Biocontrol Industry Meeting on 21-23 October 2019 in Basel (Switzerland). Please feel free to contact Karine Mavet or Adrien Margerit to arrange a meeting.
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Lynxee consulting recruit an Expert in Chemistry and an Expert in Residues!

With 5 staff, our dynamic team grows again! We are looking for a Regulatory Expert in Chemistry (physico-chemical properties and analytical methods) and a Residues Regulatory Expert for project coordination, dossiers drafting, study monitoring etc…

Are you interested in this position? Have a look at the 2 job descriptions and submit your application through our website!

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July 2019

EUROPE-EFSA : Statement on the coverage of bats by current risk assessment

EFSA has published a scientific statement that considers whether the current risk assessment performed for birds and ground dwelling mammals exposed to pesticides is also protective of bats.

Bats are not specifically mentioned under the current risk assessment for pesticides methodology however they are an important group of mammals, frequently foraging in farmland and potentially exposed to pesticides. Bats help to regulate arthropod populations.

EFSA PPR Panel addressed three main issues:  [...]

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EUROPE-COM: public consultation for the amendment of the Organic Production Regulation

A draft amendment to the Organic Production Regulation (EC) No 889/2008 was published by the EU Commission for public consultation from 19 July 2019 to 16 August 2019.

This draft Regulation adds a number of substances to the list of pesticides that are permitted for use in organic production (Annex II): maltodextrin, hydrogen peroxide, terpenes (eugenol, geraniol and thymol), sodium chloride, cerevisane and pyrethrins from other plants than Chrysanthemum cinerariaefolium. [...]

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

The EU 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) was discussed in the SCoPAFF meeting of 16 and 17 July 2019.

Co-formulants are unacceptable in plant protection products if it is established that their use or their residues have a harmful effect on human or animal health or have an unacceptable effect on plants or on the environment.

According to the draft list, the following co-formulants are considered as unacceptable [...]

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EUROPE-EFSA: Recurring Issues in Ecotoxicology

EFSA published a technical report on the outcome of expert’s discussions in Ecotoxicology that took place during Pesticide Peer Review Meeting 185 in October 2018.

Numerous general and specific issues are addressed. The specific issues discussed are related to risk assessment for terrestrial vertebrates, aquatic organisms, non-target arthropods, soil organisms and non-target terrestrial plants. [...]

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

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 just released the timelines for the guidance review (available to download below).

The first consultation will begin in a few weeks. Stakeholder and Member State representatives will be invited to give their views on the current guidance document. As announced in May 2019, the stakeholder feedback will be provided by a consultation group which has been selected by EFSA. The details of the consultation group members has also been released by EFSA [...]

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FRANCE – ANSES: Opinion on protection measures for residents

ANSES was seized on January 28, 2019 by DGAL for a request for scientific and technical support on the protection measures for residents during the use of plant protection products.

It is recalled that a risk assessment is always conducted during the evaluation of the applications for authorisation. The methodology currently used in the assessment of plant protection product dossiers is based on EFSA guidance document (EFSA, 2014). For residents, EFSA’s guidance document currently describes an assessment methodology that covers spray application only. For other methods of application, a dedicated evaluation methodology should be used. EFSA will update the guidance document in early 2021. [...]

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FRANCE: Withdrawal of propiconazole-based products

As a result of the entry into force of Regulation (EU) 2018/1865 of 28th November 2018 concerning the non-renewal of propiconazole approval, ANSES has withdrawn 23 authorisations and 9 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 19.09.2019.

The end of use of the stocks of products is set on 19.12.2019. [...]

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FRANCE: Withdrawal of quinoxyfen-based products

As a result of the entry into force of Regulation (EU) 2018/1914 of 6th December 2018 concerning the non-renewalof quinoxyfen approval, ANSES has withdrawn 5 authorisations and 9 parallel trade permits for plant protection products containing this active substance.

For three of the parallel trade permits (ARIUS SYSTEM CAZO, OÏMAX, QUINFENPLUS DUO), no grace period is granted.

For the other products:

The end of sales and distribution is set on 27.09.2019.

The end of use of the stocks of products is set on 27.12.2019. [...]

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FRANCE: Withdrawal of flurtamone-based products

As a result of the entry into force of Regulation (EU) 2018/1917 of 6th December 2018 concerning the non-renewal of flurtamone approval, ANSES has withdrawn 2 authorisations and 2 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 27.09.2019.

The end of use of the stocks of products is set on 27.12.2019. [...]

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FRANCE: Public consultation on the new Order for the authorisation of PPP for “amateur” uses

The Draft Order that has just been published for public consultation until 5 August 2019 aims at strengthening  the requirements for the authorisation of plant protection products for “amateur” uses in order to guarantee:

– a better safety for the non professional users and for the consumers of products treated with these products,

– a better protection of the environment when using these products.

This Order will consolidate and repeal the Order of 30 December 2010 banning the use of some plant protection products by non professional users and the Order of 30 December 2010 concerning packaging and labelling requirements  of plant protection products that can be used by non professional users. The draft Order completes the eligibility criteria for “amateur” plant protection products  in accordance with the recommendations made by Anses in the Opinion dated 16 February 2015. New hazard statements are therefore added for both products and active substances [...]

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FRANCE-ANSES: Update on the SDHI issue

Following an opinion published on 16/04/2018 by a group of scientists alerting on the risks related to the use of SDHI in agriculture, ANSES organised an expertise of the available scientific data and published their findings on 14/01/2019, concluding that there was no Human health alert that could lead to the withdrawal of approvals for these fungicides.

Since then, ANSES has further investigated in three directions: drawing up and financing specific research projects, detecting possible health effects that can be observed in the field via existing monitoring systems, and finally exchanging with research organisations and Human health agencies responsible for the evaluation of these substances, including the European Food Safety Authority (EFSA) [...]

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