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Newsletter - No.10 - October/November 2016
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REGULATORY NEWS

Plant Protection Products
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Dear readers,

The last two months were marked in Europe by the publication of a number of working documents relating to article 43, AIR3 and AIR4 renewal procedures and MRLs.

In France, the Decree on "Phytopharmacovigilance (monitoring system) and the official list of biocontrol products were published, and E-phy database was upgraded.

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.

And we wish you a Merry Christmas and a festive holiday season!
 
Lynxee consulting's Team

 
Events to come

Events of the month

Karine Mavet and Emilie Vianay attended the JEVI Conference on amenity areas in France held on 19-20 October 2016 in Toulouse (France).
Lynxee consulting summarised in a poster the key elements to better understand the current regulations and their declination as two ranges of uses: professionals and amateurs. The poster was presented [...]
Events to come

Events to come

 
Karine Mavet and Emilie Vianay will attend the following conferences:
- IBMA France, Colloque Biocontrôle 2017: Conference on Biocontrole in France on 31 January 2017 in Paris (France),
- ECPA/ECCA, Regulatory Conference 2017: 4th Annual Regulatory Conference on 15-16 March 2017 in Brussels (Belgium),
- AFPP, Conférence COMAPPI: 6th conference on Integrated Pest Management in France on 21-23 March 2017 in Lille (France).
.
 
contact us to arrange a meeting
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EUROPE: Update of GD on Renewals according to Art. 43 

This new revision (Rev. 14) of SANCO/2010/13170 on renewals according to Article 43 replaces revision 13 dated July 2015.

The update is based on the first experience gained [...]

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EUROPE - AIR 3 Working documents – Updates 

The EU Commission has released 2 working documents regarding AIR 3 renewal programme:

  • SANCO/2012/11284 –rev. 17 (October 2016)

This new revision replaces Revision 14 dated December 2014. This document provides an overview of indicative submission dates for supplementary dossiers for the renewal of AIR 3 substances.

New expiry dates are given [...]

  • SANCO/10148/2014 – Rev. 10 (November 2016)

This new revision replaces Revision 6 (+ Revision 9, October 2016). This working document provides an update of applicants who supported AIR 3 active substances  [...]

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EUROPE - AIR 4 Working Documents Release 

The EU Commission has released 2 working documents regarding AIR 4 renewal programme:

  • SANTE-2016-10616–rev 4 (October 2016)

This new revision replaces Revision 3 dated July 2016. This document provides an overview of indicative submission dates for supplementary dossiers for the renewal of AIR 4 active substances. [...]

  • SANTE-2016-11734–rev.1 (November 2016)

This new working document lists applicants who supported AIR 4 active substances.

It should be noted that several active substances were not supported  [...]

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EUROPE - New update of SANCO 7525/VI/95 on comparability, extrapolation, group tolerances and data requirements for setting MRLs

Revision 10.2 of Guidance document SANCO 7525/VI/95 concerning residue trials was adopted by the European Commission on 23 September 2016 and became effective immediately.

This new revision applies to [...]

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FRANCE: Publication of the Decree “Phytopharmacovigilance” (monitoring system)  

The Decree No. 2016-1595 on the French monitoring system called “Phytopharmacovigilance” (or “PPV”) was published on 24 November.

The objective of the system is to trace back to ANSES all the undesirable effects of plant protection products on man, livestock, crops, biodiversity, wildlife, water, soil, air quality, food, as well as on the development of resistances.

The public that has to report the information is very broad  [...]

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FRANCE: Publication of the official list of biocontrol products 

The French Ministry of Agriculture, Food and Forestry has published in an official note the list of biocontrol plant protection products in accordance with articles L.253-5 and L.253-7 of the Rural Code. This list will be updated whenever necessary, biannually at least.

Products from this list are exempted from the following bans and obligations which generally concern all the plant protection products mentioned in article L.253-1 [...]

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FRANCE: E-Phy: New data fields in CSV table 

As part of the monthly update of E-Phy open data, new data fields were added in the CSV files to answer users’ requests.

The following fields are now available: ‘second brand names’, ‘registration holder’, ‘trade type’’ and ‘range of uses’. In addition, authorised claims and active substances were added for each product. [...]

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