FRANCE: New entries into the list of biocontrol products benefiting from a reduced tax on sales

The Note DGAL/SDQPV/2016-427 of 20 May 2016  from the French Ministry of Agriculture, Food and Forestry adds new biocontrol products to the list quoted in Article 1 of French Order of 9 March 2016 setting the tax rate on plant protection product sales revenues.

This note was published as a supplement to the Note DGAL/SDQPV/2016-279 of 31 March 2016.

 

See our article:

FRANCE: List of biocontrol products benefiting from a reduced tax on sales

EUROPE: The new Guidance Document on semiochemicals is available!

EFSA has published a new Guidance Document on “Semiochemical active substances and plant protection products” (SANTE/12815/2014 rev. 5.2, May 2016).

This guidance document has been built on existing OECD-12 Guidance Document (Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control, OECD Environment, Health and Safety Publications, Series on Pesticides No. 12) and experience gained since then, especially during the peer review of SCLPs (Straight Chain Lepidopteran Pheromones).

Amongst others, a calculation method to estimate natural exposure levels of semiochemicals is given. This value can then be compared to the release rate of the semiochemical Plant Protection Product (PPP).
When the use of the PPP results in lower, similar or comparable exposure to the natural exposure level of the semiochemical, the risk characterisation is concluded and no further information is needed with the exception of identity, characterisation and analytical methods.
When the use of the PPP results in higher exposure to the natural exposure level of the semiochemical, a Tier II is proposed based on mathematical modelling.

This guidance also clarifies other data requirements depending on the type of semiochemical product:

1. Retrievable dispensers

1A) Passive dispensers (extruded or reservoir). The semiochemical diffuses continuously from the device into the air where the active substance becomes diluted.

1B) Active dispensers. The semiochemical is released discontinuously from the device into the air where the active substance becomes diluted.

2. Passive non-retrievable products

2A) Dispensers (extruded or reservoir). The semiochemical diffuses continuously from the device (such as biodegradable dispensers) into the air where the active substance becomes diluted.

2B) Dosable matrix dispensers. The semiochemical is embedded in a matrix, such as a sticky polymeric material. They are not discrete units; application is in-situ by attaching the polymeric mass onto plants or elsewhere at the site of use.

2C) Capsule suspension products. The semiochemical is formulated as a microencapsulation.

2D) Granular products (non-WDG). the semiochemical is formulated in a granular form.

2E) Seed treatment products

 

This guidance document will apply to applications submitted from 1 January 2017 onwards.

 

Lynxee consulting’s team is at your disposal to help you with your dossier preparation.

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

 

FRANCE: Ecophyto II, a new follow-up indicator

During the Strategic Orientation Committee (COS) of Ecophyto, a new composite indicator was introduced. It includes four components: research and innovation, advising and development, agro-ecological diagnosis, follow-up of the quantity used. It will complement the basket of indicators that already included the historical NODU indicator (Number of unit doses) and a pest pressure indicator.

These indicators will allow the implementation of the CEPP Certificates (plant protection products saving certificates) on July 1, 2016.

This new indicator has been well received by farmers and distributors since it allows to value good agricultural practices of farmers.

However CEPP certificates are still being through controversy since the system of penalties is deemed too complex.

 

PRESS RELEASE – operational launch of Ecophyto 2 plan with increased resources (in French)

Read our previous article: FRANCE: Publication of Ecophyto II Plan (in French)

 

FRANCE: National memo on resistance of fungicides for vineyards

A new National memo on resistance has been published:

2016 Fungicides for Vineyards Memo (in French)

This note, co-written by representative from the French Ministry of Agriculture, ANSES, INRA, Champagne Committee, Wine French Institute (IFV) and the Chamber of Agriculture:

  • presents preventive measures to limit the occurrence of resistance,
  • describes the results of 2015 monitoring plans on the resistance of downy mildew, powdery mildew and grey mould on grapevine to the main families of active substances,
  • elaborates general recommendations regarding resistance with the objective of reducing applications.

 

France : authorisation of natural biostimulant substances

The French decree concerning the authorisation process of natural substances used as biostimulants was published on April 30, implementing the French law for the future of agriculture of 13 October 2014 (Article 50).

Simplified authorisation process

Natural biostimulant substances are authorised provided they are part of a list published by an order of the Ministry of Agriculture. These substances are of vegetal, animal or mineral origin, excluding “micro-organisms” and GMOs. Products containing  only one or more substances authorised by this order mixed with water are thus accessible to every user and can now be placed on the French market without further procedures. The authorisation of such substances is thus simplified, faster and everyone can produce and market his owned biostimulant products.

PNPP considered as biostimulants

The decree considered the natural preparations of little concern (so called “préparations naturelles peu préoccupantes” or PNPP) as biostimulants and no longer as plant protection products. PNPP must only contain basic substances as defined by ‘article 23’ of Regulation (EC) No.1107/2009 or natural substances used as biostimulants. The production process of PNPP must be known by every final user. The decree states that for PNPP containing exclusively natural substances used as biostimulants,  advertising can only refer to claims concerning the natural origin and the biostimulant effects.

A first list to be widened

A list of more than 100 authorised natural substances was published at the same time as the decree. This list corresponds to the plants authorised by article D4211-11 of French Public Health Code, that can be freely sold apart from pharmacies (for example garlic or nettle).

New natural substances will be added to the list provided Anses evaluation confirms the absence of harmful effects on human and animal health and on the environment.

For download:

Decree N°2016-532 of 27 April 2016 concerning the authorisation process of natural substances used as biostimulants (in French)

Order of 27 April 2016 setting the list of natural substances used as biostimulants (in French)

List of natural substances used as biostimulants (in French)

 

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

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

 

European Commission: Questions and Answers for renewal according to Article 43

The European Commission has published a list of questions and answers that has been conceived as a clarification note of the Commission Services to the Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No.1107/2009 (SANCO/2010/13170 rev. 13, 14 July 2015).

Several key issues are covered and updates to the renewal guidance document are suggested such as the demonstration of data access or the submission of data waivers, the process for data matching work and decision on Cat.4 studies, the change of reference source during the review, the agreement of the cMSs following the decision of the zRMS, the product compliance with conditions and restriction in the active substance regulation, the impact of new scientific guidances on dRR revision, the justification of changes from the registered GAP, the evaluation of minor uses (Article 51), the requirements for the efficacy part.

Legal clarification is still needed regarding the evaluation of ongoing zonal applications following renewal of approval: registration obtained in zRMS before date of application of active substance (a.s.) renewal but not yet in cMSs; registration obtained in zRMS after a.s. renewal date of application but before Article 43 submission date; submission of dRR >18 months prior to the date of application of a.s. renewal but no decision before Article 43 submission.

For download:

Questions and Answers on the Renewal of Authorisations according to Article 43 of Regulation (EC) No.1107/2009 (8 March 2016)

Our previous article:

Sanco 13170 (14 July 2015) on Renewal of the Authorisation of PPP according to Article 43

Lynxee consulting’s team is at your disposal to manage the renewal process of your products.

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

FRANCE: new form for the declaration of Officially Recognised Trials

In France, this new form to be sent to ANSES replaces Coleor portal that served to date for the declaration of Officially Recognised Trials.

This form meets the requirements of Article 9 of the Order of 26 April 2007. It should be sent to ANSES when setting up trials before the end of the assessments and 20 days at the latest after the first application of the test products, and when closing the trials 20 days at the latest after the end of the assessments or crop destruct.

It should be sent both for trials that are conducted following an application for trial permit and for trials carried out under an “exemption from application for trial permit” (see our previous article).

 

For download:

Declaration of Officially Recognised Trials:

Form (in French)

Order of 26 April 2007 (in French)

Declaration of trials carried out under an “exemption from application for trial permit”:

Form (in French)

Order of 9 February 2016 (in French)

 

Our previous article:

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/