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, the Commission has already presented to Member States a series of recommendations on the use of glyphosate:

1) ban the co-formulant POE-tallowamine from glyphosate-based products;

2) minimise the use of the substance in public parks, public playgrounds and gardens;

3) minimise the pre-harvest use of glyphosate.

Apart from ECHA’s upcoming opinion, EFSA continues its on-going review of the existing Maximum Residue Levels (MRLs) for glyphosate.

 

For more information:

http://europa.eu/rapid/press-release_MEMO-16-2012_fr.htm

 

See our other article:

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

 

Lynxee consulting’s team is at your disposal to answer your questions.

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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.

Note that the files do not contain emergency 120-day authorisations or parallel trade permits.

There are two types of files:

  • XML files: they contain all the approximately 13 000 authorised and withdrawn products (plant protection products, fertilisers and growing media, adjuvants, combined products and mixtures).
    The data are divided into multiple XML files. An XSD description file containing the fields and relationships is also available.
  • CSV file: it contains only the about 3000 authorised plant protection products. The active substances are unfortunately not included in this table.

The files should be updated monthly. The version online is dated 13/06/2016.

 

Note: when e-phy data are reproduced in a document, the source “Ephy data – Anses – Date of data update” should be cited.

 

Useful link: www. data.gouv.fr

 

Lynxee consulting’s team is at your disposal to answer your questions.

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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 of glyphosate-based products containing POE-tallowamine of its intention to withdraw them from the market.

At the end of the adversarial procedure period, and after having examined the observations of the approval holders, the Agency withdrew on 20 June 2016 the marketing authorisations for 132 products from the French market.

 

See also our previous articles:

FRANCE: withdrawal of some PPPs containing Glyphosate and tallowamines (tallow fatty amines) by the end of March 2016?

POE-tallowamine (Glyphosate coformulant): EFSA toxicological assessment

 

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.

The WHO defines a substance as an endocrine disruptor if:

– it has an adverse effect on human health;

– it has an endocrine mode of action;

– and if there is a causal link between the adverse effect and the mode of action.

The criteria endorsed by the Commission also specify how the identification of an endocrine disruptor should be carried out:

– by making use of all relevant scientific evidence;

– using a weight of an evidence-based approach;

– and applying a robust systematic review.

As for pesticides, to ensure that swift action is taken, EFSA was asked by the Commission to begin looking at whether approved individual substances that show indications of being endocrine disruptors can be identified as endocrine disruptors according to the criteria in the draft text. This will also help to ensure that the regulatory Agency is ready to apply the criteria as presented by the Commission, and in accordance with the applicable regulatory procedures, once the criteria enter into force.

The Commission is also proposing to adjust the ground for possible derogations under the plant protection products legislation in order to take into account the latest scientific knowledge. The ‘hazard-based’ approach of the Pesticides Regulation will be maintained, meaning that substances are banned on the basis of hazard without taking into account the exposure. However, the grounds for possible derogations have been adjusted so that they are based on scientific knowledge and make the best use of available scientific evidence including information related to exposure and risk.

 

C(2016) 3751 projet – draft Commission Regulation setting out scientific criteria for the determination of endocrine disrupting properties and amending Annex II to Regulation (EC) No.1107/2009

 

Lynxee consulting’s team is at your disposal to answer your questions.

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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

Memo relative to trials and experiments of regulated products (plant protection products / fertilisers) (in French)

 

Note that a new version of the declaration form of EOR trials (06.07.2016) is available:

Form for the declaration of officially recognised trials (in French)

 

See also our previous articles:

FRANCE: new form for the declaration of Officially Recognised Trials

FRANCE: the order for the “Exemption from application for trial permit” is published!

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

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:

1- Application for renewal of a plant protection product: Category 4 without on-going study

2- Application for renewal of a plant protection product for which Category 4 studies are on-going

3- Application for renewal of a plant protection product containing two active substances whose renewal date is spaced less than one year (with or without on-going Category 4 study)

As a reminder, these dossiers must be submitted within 3 months after the renewal of approval of active substances, safeners or synergists.

 

Memo and form: COMPOSITION OF RENEWAL DOSSIERS (article 43 of regulation (EC) No. 1107/2009) (in French)

 

Lynxee consulting’s team is at your disposal to prepare your renewal dossiers.

Contact us! http://lynxee.consulting/en/contact/

 

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. For reference purposes these Guidance Documents will be filed in a special folder on CIRCABC.

 

Lynxee consulting’s team is at your disposal to answer your questions.

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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:

  • Data points from OECD Table of Contents to revised EU Table of Contents;
  • Electronic Submission (CADDY) Table of Contents;
  • Documents to be included in the Submission Dossier.

This revision of the guidance includes some clarifications regarding the Table of Contents and the EU numbering system for the Caddy format. It was noted in March 2016 and should be used for dossiers for which an application for the approval or renewal of approval has been submitted as from 1 October 2016.
The current document should be followed also for the supplementary dossiers submitted according to Regulation (EU) 2016/183 setting the RMS and co-RMS for the AIR4 programme.

Lynxee consulting’s team is at your disposal to answer your questions.

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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.

Notable among the proposed projects: “Promoting and developing biocontrol”.

The response deadline is July 4, 2016.

 

Call for proposals for Ecophyto II National Plan (in French)