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Newsletter - No.13 - March 2017
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REGULATORY NEWS

Plant Protection Products
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Dear readers,

March was marked by a lot of regulatory news.

In Europe, two EFSA Guidance documents were released for public consultation and ECHA concluded on the non carcinogen classification of Glyphosate.

In France, the official list of biocontrol products was updated, National memos on resistance to fungicides were released, the Law 'Potier' on the promotion of biocontrol was published, the PPP saving certificates ('CEPP') were re-implemented and the list of organisations for phytopharmacovigilance was established.

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 of the month

Karine Mavet and Emilie Vianay attended ECPA/ECCA Regulatory Conference  held on 15-16 March 2017 in Brussels (Belgium) and COMAPPI Conference in Integrated Pest Management held on 21-23 March 2017 in Lille (France).
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EFSA Public consultation: Guidance for the identification of biological relevance of adverse/positive health effects from experimental animal and human studies

The public consultation on the draft guidance document of the EFSA Scientific Committee on the identification of biological relevance of adverse/ positive health effects from experimental animal and human studies is opened until 1st May 2017. [...]

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EFSA Public consultation: Guidance on the use of the weight of evidence approach in scientific assessments 

The public consultation on the draft guidance document of the EFSA Scientific Committee on The Use of the Weight of Evidence Approach in Scientific Assessments is opened until 1st May 2017. [...]

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EUROPE: Glyphosate not classified as a carcinogen by ECHA

ECHA’s Committee for Risk Assessment (RAC) agrees to maintain the current harmonised classification of glyphosate as a substance causing serious eye damage (H318) and being toxic to aquatic life with long-lasting effects (H411). RAC concluded that the available scientific evidence did not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction.

Apart from the published studies on glyphosate, the committee also had full access to [...]

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FRANCE: First update of the official list of biocontrol products

The French Ministry of Agriculture, Food and Forestry has published the first update of the official list of biocontrol plant protection products in accordance with articles L.253-5 and L.253-7 of the Rural Code.

Some criteria of inclusion into the list were reviewed. [...]

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FRANCE: 2017 National memos on the sustainable management of resistance to fungicides

Three National memos on the sustainable management of resistance to fungicides were published:

  • Management of resistance to fungicides used to control oilseed rape stem rot (Sclerotinia sclerotiorum) (in French)
  • Management of resistance to fungicides used to control cereals diseases (in French)
  • Management of resistance to fungicides used to control vineyard diseases: downy mildew, powdery mildew, grey mould (in French) [...]
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FRANCE: Promotion of biocontrol - Publication of the Law 'Potier'

The law No.2017-348 concerning the fight against agricultural land grabbing and the development of biocontrol was published on Tuesday 21 March in the French Official Journal.

As for biocontrol, the law first extends the exemptions to the pesticides ban in [...]

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FRANCE: Re-implementation of plant protection products saving certificates ('CEPP')

The law No.2017-348 of 20 March 2017 concerning the fight against agricultural land grabbing and the development of biocontrol re-implements the plant protection products saving certificates (‘CEPP’). Indeed in December 2016, the Ordinance No.2015-1244 of 7 October 2015 regarding the experimental CEPP procedure was called off by the Council of State for procedural reasons further to an appeal of pesticides producers and distributors.

An assessment of the experimental procedure aiming at [...]

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FRANCE: Publication of the Order regarding the list of organisations for phytopharmacovigilance (monitoring system)

As announced in Decree No.2016-1595, the Order of 16 February 2017 establishes in Appendix 1 the list of entities included in the monitoring system and in appendix 2 the list of organisations to which the declarations of manufacturers, importers, distributors, professional users, advisers and trainers of users of plant protection products and adjuvants are addressed. [...]

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