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Newsletter - No.18 - Oct/Nov/December 2017
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REGULATORY NEWS

Plant Protection Products
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Dear readers,

First of all we hope you had a lovely Christmas break and wish you a happy New Year with lots of joyful little things, great plans and time to pause every now and then! :-)

Secondly, we are delighted to inform you that our Research Tax Credit accreditation (French CIR) has been renewed for 2018, 2019 and 2020. This is great news for our French clients! 

We were so busy at the end of the year that we did not have time to send our monthly Newsletter. We are thus catching up the last 3 months!
In October, in Europe, the Parliament rejected the ED criteria and the new EPPO Standard of low-risk PPPs was released. In France, a new update of the list of biocontrol products was published and ANSES updated the memo on trials and experiments.
In November-December, ECHA and EFSA proposed a draft GD on identifying EDs for public consultation, a combined template for assessment reports and proposals for classification was published, the EU COM released new GDs on analytical methods, Glyphosate was renewed, and AIR 3-AIR 4 GDs were updated.

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 in 2018!
 
Lynxee consulting's Team

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Events to come

Events to come

 
Emilie Vianay will attend the following conference:

- The 5th Annual Plant Protection Regulatory Conference organised by ECPA on 07-08 March 2018 in Brussels (Belgium).
.
 
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NEWS: French CIR (Research Tax Credit) accreditation renewed for 2018, 2019 and 2020

We are pleased to inform you that our French Research Tax Credit (CIR) accreditation has been renewed for 2018, 2019 and 2020!

As a reminder, thanks to this approval, French clients can benefit from a tax credit of 30% of the total amount of R&D services eligible.

We remain at your disposal for any further information and quotation request. [...]

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October 2017

EUROPE: Parliament rejects criteria for endocrine disruptors

On 4 October 2017, the European Parliament voted to object to the European Commission’s draft regulation setting out criteria for identifying endocrine disruptors in the area of plant protection products (PPPs).

The Parliament objection regards the last paragraph of the draft regulation. The criteria proposed in the draft regulation provide [...]

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EUROPE: New EPPO standard on efficacy evaluation of low-risk plant protection products published

The EPPO standard “PP 1/296 (1) Principles of efficacy evaluation for low-risk plant protection products” has been first approved in September 2017 and released on 13 October 2017.

This Standard describes the principles for determining the requirements for an efficacy evaluation of low-risk plant protection products in a registration procedure, based on addressing the data requirements as specified by Regulation (EC) 1107/2009. This standard is intended for [...]

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FRANCE: New update of the official list of biocontrol products

The French Ministry of Agriculture, Food and Forestry has published a new 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. This note repeals the previous one dated 28 July 2017 and entered into force on 17 October 2017.

As well as providing some typographical corrections on products already included, this note includes a total of 16 new products [...]

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FRANCE: New 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 01/09/2017; the previous Memo was dated 19/06/2017. The changes are as followpermiss:

The form to be filled in for an application for plant protection product trial permit (CERFA 15720*01) as well as the explanatory note (Cerfa N°52171#01) are specified. [...]

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November - December 2017

EUROPE: Public consultation on draft guidance for identifying endocrine disruptors

ECHA and EFSA are inviting interested parties to comment on the draft guidance document for identifying endocrine disruptors. The deadline for providing comments is 31 January 2018.

The European Commission will organise a workshop on 1-2 February 2018 to test the applicability of the draft guidance on the basis of case studies using active substances currently under assessment in the context of the pesticides and biocides Regulations. Two experts per Member State (one for pesticides, one for biocides) plus the speakers presenting selected case studies will be reimbursed. Stakeholders will also be invited.

The final guidance will be applicable to [...]

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EUROPE: Combined template to be used for assessment reports and proposals for classification

A revised template to be used for Assessment Reports according to Regulation (EC) No 1107/2009 and Proposals for Harmonised Classification and Labelling according to Regulation (EC) No 1272/2008 has been published by the Commission (SANCO/12592/2012 rev. 1.2).

This revised template was agreed by the PAFF Standing Committee on 6 October 2017. It should be used for combined assessment and CLH reports prepared for active substances [...]

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EUROPE: Update of analytical guidance documents

Two updated guidance documents have been published by the European Commission as regards analytical methods:

– Guidance document on analytical quality control and method validation procedures for pesticide residues analysis in food and feed – SANTE/11813/2017 rev.0, 21 – 22 November 2017

– Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods – SANTE 2017/10632 rev.3, 22 November 2017

[...]

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EUROPE: Renewal of glyphosate approval

Implementing Regulation (EU) 2017/2324 renewing the approval of the active substance glyphosate and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 was published on 15 December 2017. The approval of glyphosate is renewed for 5 years from the 16 December 2017.

In order to take into account the conclusions of the glyphosate review report, Member States must pay particular attention to [...]

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EUROPE: Updates of AIR 3 and AIR 4 Guidance documents

A number of SANCO and SANTE guidance documents have been updated:

AIR 3 programme

SANCO/2012/11284 – Rev. 19 – November 2017 – Draft working document – AIR III Renewal programme

AIR 4 programme

SANTE-2016-10616–rev 8 – October 2017 – Draft working document – AIR IV Renewal Programme

SANTE-2016-11734–rev.7 October 2017 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

 [...]

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