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Newsletter - No.16 - June/July 2017
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REGULATORY NEWS

Plant Protection Products
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Dear readers,

This month was marked by a huge number of regulatory news, especially in France.

In Europe, the Endocrine disruptor criteria were adopted, a Manual on Biopesticides was released by the Ctgb, and the new GD on Dermal absorption and updated GDs on AIR4 programme were published.

In France, a second update of the official list of biocontrol products, new application procedures and cerfa forms, a list of PPPs that may contain EDs and an update of the memo relative to trials  and experiments were published.

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 at last, we wish you a very pleasant, relaxing and fun summer holiday :-)
 
Lynxee consulting's Team
Events to come

Events to come

 
Karine Mavet and Emilie Vianay will attend the following conferences:
- 2017 Informa Conference: AgChem Annual Regulatory Conference on 6-7 September 2017 in Nice (France).
- 2017 ABIM Conference: Global biocontrol industry meeting on 23-25 October 2017 in Basel (Switzerland).
- 11th CIRAA Conference: Conference on arthropod pests and beneficials on 25-26 October 2017 in Montpellier (France).
- The Development and Regulation of Crop protection Technologies in Southern Europe on 30 November - 1st December 2017 in Barcelona (Spain). It is the first year for this conference dedicated to Southern Europe.
 
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Adoption of Endocrine disruptors criteria

Member States representatives finally voted on July 4th in favour of the European Commission’s proposal on scientific criteria to identify endocrine disruptors in the field of plant protection products. The criteria endorsed concerning substances falling within the plant protection products legislation are based on the World Health Organisation (WHO) definition. They identify known and presumed endocrine disruptors.

The criteria will apply after a short transitional period of 6 months [...]

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EUROPE: Release of a Biopesticide Manual on microorganisms, botanicals and semiochemicals

Ctgb, the Authorities from the Netherlands, has released a Manual on Biopesticides. It concerns microorganisms (including viruses), botanicals and semiochemicals (e.g. pheromons).

This Manual gives an overview of data requirements and risk assessments for biopesticides in all areas: phys-chem properties and analytical methods, mammalian toxicology, residues, fate and behaviour, effects on non-target species and efficacy.

This Evaluation Manual addresses [...]

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EUROPE: New EFSA GD on Dermal absorption

EFSA was asked by the European Commission to assess the scientific quality of newly available human in vitro studies on dermal absorption and, based on the evaluation of the studies, to revise the EFSA PPR Panel guidance on dermal absorption (EFSA PPR Panel, 2012).

The guidance proposed new default values to be used in absence of experimental data. [...]

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EUROPE: Updates of AIR4 Guidance documents

A number of SANCO and SANTE guidance documents have been updated again for the AIR4 programme [...]

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FRANCE: 2nd update of the official list of biocontrol products

The French Ministry of Agriculture, Food and Forestry has published the 2nd 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.

The new note specifies notably that as a result of the ban on self-service sales to non-professional users since 1 January 2017, only biocontrol products from the list [...]

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FRANCE - ANSES: Procedures for applications for approval and new cerfa forms!

A new Order setting out the composition and procedures for the submission of applications for approval and for the trial permits of PPPs, adjuvants and PPP+fertiliser products was published on July, 12 2017.

In parallel, a new information Note and the awaited new cerfa forms have also been published online by Anses!

These new provisions enter into force on [...]

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FRANCE: List of PPPs that may contain Endocrine Disruptors (EDs) 

As announced in our post dated 12th July, the list of plant protection products that may contain endocrine disruptor substances has been published in France.

The products listed are products containing one or more active substances included in the impact assessment of the European Commission as falling within the definition as proposed by the European Commission. The definition adopted is broader, including suspected endocrine disrupters, and substances for which endocrine disrupting action is “plausible”. [...]

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FRANCE: Update of the memo relative to trials and experiments of regulated products

ANSES has issued a new version of the Memo relative to trials and experiments of regulated products (plant protection products/fertilisers) dated 19/06/2017; the previous Memo was dated December 2016. The main changes are as follows [...]

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If you want to follow all our regulatory news as soon as they are published:
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