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Newsletter - No.6 - June 2016
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REGULATORY NEWS

Plant Protection Products
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Dear readers,
Of course this month was marked by the Brexit but it is too early to see all the consequences that this will have on the business. But for sure it is a new challenge for all of us.

For the rest this month was marked in Europe by the extension of the approval period of Glyphosate, by the presentation of the draft regulation on Endocrine Disruptors criteria and by the release of the new version of the guidance document on micro-organisms.

In France, e-phy open data were online, approvals for PPP containing Glyphosate and POE-tallowamine were withdrawn, Anses issued 2 memos on trials and on the composition of renewal dossiers and at last a call for proposals was issued for Ecophyto II.

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 dossier drafting.

Lynxee consulting's Team
Events to come

Events to come

 
Karine Mavet and Emilie Vianay will attend the following conferences:
- Informa, AgChem forum: European conference on the regulation of agrochemical, biocontrol and biostimulant products on 06-08 September 2016 in Nice (France),
- AFPP, 4e conférence JEVI: Conference on Amenity areas in France on 19-20 October 2016 in Toulouse (France),
- AFPP, Conférence Columa: Conference on Herbicides in France on 06-08 December 2016 in Dijon (France).
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contact us to arrange a meeting
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Need help to prepare administrative dossiers for France?
Contact Lynxee consulting, we will do it for you!
 

EUROPE: The Commission adopted the extension of Glyphosate approval for 18 months

The European Commission adopted the extension of the current approval of glyphosate until the European Chemical Agency (ECHA) has concluded its review (revision of the harmonised classification of glyphosate) – 31 December 2017. Indeed, no qualified majority was reached by Member States at either the Standing Committee  on June, 6th or the Appeal Committee on June 24th.

In parallel to the extension of the approval [...]

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EUROPE: Presentation of criteria to identify endocrine disruptors

The European Commission presented on 15 June 2016 draft regulations which set the criteria to identify endocrine disruptors under pesticides and biocides regulations. These drafts will then need to be adopted, involving the European Parliament and the Council.

The scientific criteria endorsed by the Commission are based on the World Health Organisation’s (WHO) definition of an endocrine disruptor. [...]

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EUROPE: List of obsolete guidance documents

A guidance document (SANTE/11073/2015 rev. 0), published by the European Commission, lists 13 Guidance Documents that currently still appear on the SANTE-website but that are considered obsolete or without purpose in the sense that either they still refer to procedures related to Directive 91/414/EEC or in the meantime new revised guidance documents have been noted on these specific issues. [...]

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EUROPE - Micro-organisms: review of guidance document on dossiers preparation

The European Commission has just published a revised version of the guidance document on preparing dossiers for the approval or renewal of approval of a micro-organism in compliance with the Table of Contents described in Part B of the Annex to Regulation (EU) No.283/2013 and Part B of the Annex to Regulation (EU) No.284/2013 (SANCO/12545/2014– rev. 2, March 2016). This Guidance Document addresses the following aspects: [...]

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FRANCE: E-phy Open data are online

Anses has given free access to all data of e-phy website.

The downloadable files contain the characteristics of each product: approval number, trade name, product type, active substance and related data (risk phrases, active substance content …) and uses of the product.

There are two types of files [...]

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FRANCE: Withdrawal of 132 authorisations for products containing glyphosate and POE-tallowamine

As announced in February 2016, Anses had engaged a review of the marketing authorisations of plant protection products containing glyphosate and POE-tallowamine. As unacceptable risks, mainly to human health, cannot be ruled out for these products, the conditions laid down in Article 29 of the Regulation (EC) No.1107/2009 are not verified.

As provided for in the European procedure, in April 2016, ANSES informed approval holders [...]

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FRANCE: Memo relative to trials and experiments


ANSES have issued a memo summarising the requirements for:
- Applications for trial permits (replacing ‘ADE’), including: Exemption from trial permit applications, 
Preliminary declaration of trials, Exemption of crop destruct,
-The declaration of officially recognised trials [...]
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FRANCE: Memo on the composition of renewal dossiers (art. 43)

ANSES published a memo and a form specifying the pieces necessary to the constitution of renewal dossier under Article 43.

The memo takes into account 3 cases [...]

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FRANCE: Call for proposals for Ecophyto II National Plan

In France, a call for efficient and innovative proposals for the implementation of certain actions of Ecophyto II Plan was launched by the Ministry for Agriculture and the Ministry for the Environment.

It contains 13 types of projects for a total budget of over 5 millions euros. [...]

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