FRANCE: publication of the Decree “Phytopharmacovigilance” (monitoring system)

The Decree No. 2016-1595 on the French monitoring system called “Phytopharmacovigilance” (or “PPV”) was published on 24 November.

The objective of the system is to trace back to ANSES all the undesirable effects of plant protection products on man, livestock, crops, biodiversity, wildlife, water, soil, air quality, food, as well as on the development of resistances.

The public that has to report the information is very broad, since it concerns the holders of authorisations or parallel trade permits and trial permits of plant protection products and adjuvants; manufacturers, importers, distributors, professional users, advisers and trainers of users of these products; and organisations involved in phytopharmacovigilance.

ANSES use the information collected and evaluate the risks and take measures to prevent or stop these undesirable effects.

The list of entities included in the system as well as the methods of transmission of the information will be the subject of an order.

This decree specifies the organisation, the obligations of the designated bodies and the information system.

In addition, the decree also establishes:

  • The period of authorisation of an adjuvant to 10 years;
  • A crop destruct exemption for products containing active substances listed in Annex IV to Regulation No. 396/2005 (MRL exemption) or based on semiochemicals used by passive diffusion without direct contact with vegetation.

To download:

Decree No. 2016-1595 of 24 Novembre 2016 relative to phytopharmacovigilance and amending various other provisions of the rural code and maritime fisheries relating to plant protection (in French)

 

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EUROPE: Update of GD on Renewals according to Art. 43

This new revision (Rev. 14) of SANCO/2010/13170 on renewals according to Article 43 replaces revision 13 dated July 2015.

The update is based on the first experience gained regarding: notifications, list of studies relied upon, lists of end-points, data matching and specification checks, Cat. 4 data processes.

It should be applied from 1st January 2017 onwards.

 

To download:

SANCO/2010/13170 rev. 14, 7 October 2016, Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009

 

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

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EUROPE: AIR 3 working documents – Updates

The EU Commission has released 2 working documents regarding AIR 3 renewal programme:

 

  • SANCO/2012/11284 –rev. 17 (October 2016)

This new revision replaces Revision 14 dated December 2014. This document provides an overview of indicative submission dates for supplementary dossiers for the renewal of AIR 3 substances.

New expiry dates are given for:

batch 3.3: benzoic acid, flazasulfuron, mecoprop-p, mesosulfuron, propineb, propiconazole, propoxycarbazone, propyzamide, pyraclostrobin and zoxamide: 31.01.2018 (instead of 31.01.2017)

batch 3.4: acetamiprid, mepanipyrim, Pseudomonas chlororaphis strain MA 342, quinoxyfen and thiacloprid, thiram and ziram: 30.04.2018 (instead of 30.04.2017)

The extension for both Batches 3.3 and 3.4  was adopted and published in the Official Journal: Reg. (EU) 2016/2016 (November 2016).

It should be noted that several active substances were not supported (no supplementary dossier received although an application was made). As a consequence, the following expiry dates will apply:
– Mecoprop (batch 3.3): 31.01.2017
– Maneb (batch 3.7): 31.01.2017
– Fipronil (batch 3.9): 30.09.2017
– Chloridazon (batch 3.10): 31.12.2018

 

  • SANCO/10148/2014 – Rev. 10 (November 2016)

This new revision replaces Revision 6 (+ Revision 9, October 2016). This working document provides an update of applicants who supported AIR 3 active substances:

– name changes: Makhteshim -> Adama, Agriphar -> Arysta, Chemtura -> Arysta
– new co-applicant for dimethomorph (+ clomazone)
– no submission of the supplementary dossier for fipronil by BASF
– information added for applicants of diuron, clomazone, fludioxonil, prosulfocarb, tritosulfuron, amidosulfuron, bifenox, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, fenoxaprop-p, fenpropidin, lenacil, nicosulfuron, picloram, pyriproxyfen and quinoclamine (+  maleic hydrazide)

The working document states that no applications were received for chloridazon, imazaquin and oxadiazon. So far, only the non-application for chloridazon is reflected in SANCO/2012/11284 Rev.17.

To download:

SANCO/2012/11284 –Rev. 17, October 2016, Draft working document, AIR III renewal programme

SANCO/10148/2014 – Rev. 10, November 2016, Applications for renewal of approval of active substances submitted under article 14 of regulation (EU) N.o 1107/2009 and in accordance with regulation (EU) No. 844/2012

COMMISSION IMPLEMENTING REGULATION (EU) 2016/2016 of 17 November 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances acetamiprid, benzoic acid, flazasulfuron, mecoprop-P, mepanipyrim, mesosulfuron, propineb, propoxycarbazon, propyzamide, propiconazole, Pseudomonas chlororaphis Strain: MA 342, pyraclostrobin, quinoxyfen, thiacloprid, thiram, ziram, zoxamide

 

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

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EUROPE: AIR 4 Working Documents Release

The EU Commission has released 2 working documents regarding AIR 4 renewal programme:

 

  • SANTE-2016-10616–rev 4 (October 2016)

This new revision replaces Revision 3 dated July 2016. This document provides an overview of indicative submission dates for supplementary dossiers for the renewal of AIR 4 active substances.

To be noted: the 2 active substances tetraconazole and malathion moved from Group 3 (“substances that may fail to satisfy the approval criteria“) to Group 4.1 (substances with expiry dates postponed by two years), which means they will receive 2 years of extension before going through the normal renewal process.

 

  • SANTE-2016-11734–rev.1 (November 2016)

This new working document lists applicants who supported AIR 4 active substances.

It should be noted that several active substances were not supported (no application for renewal received):
– Fuberidazole
Bacillus thuringiensis subsp. Tenebrionis strain NB 176 (TM 14 1)
– Fenpropimorph
Phlebiopsis gigantea strains FOC PG B20/5, B22/SP1190/3.2, B22/SP1287/3.1, BU 3, BU 4, SH 1, SP log 5, SP log 6, and 97/1062/116/1.1
Phlebiopsis gigantea strains VRA 1985 and VRA 1986
– Tralkoxydim
Trichoderma atroviride (formerly T. harzianum) strain IMI 206040
Trichoderma polysporum strain IMI 206039
– Limestone
– Methyl nonyl ketone
– Putrescine (1,4-Diaminobutane)
– Sea-algae extract (formerly sea algae extract and seaweeds)
– Sodium hypochlorite
– Triadimenol
For these active substances, the current expiry dates will apply (no extension allowed).

To download:

SANTE-2016-10616– Rev 4, October 2016, Draft working document, AIR IV renewal programme

SANTE-2016-11734– Rev.1, November 2016, 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

 

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

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FRANCE: publication of the official list of biocontrol products

The French Ministry of Agriculture, Food and Forestry has published in an official note the list of biocontrol plant protection products in accordance with articles L.253-5 and L.253-7 of the Rural Code. This list will be updated whenever necessary, biannually at least.

Products from this list are exempted from the following bans and obligations which generally concern all the plant protection products mentioned in article L.253-1:

– Ban on commercial advertising,

– Obligation to implement actions in order to decrease the use of pesticides, within the framework of the implementation of plant protection products saving certificates (‘CEPP’),

– Ban on the use in amenity areas, forests, public roads, and walking paths accessible or opened to the public from 1st January 2017,

– Ban on direct sales in self-service to amateurs from 1st January 2017,

– Ban on placing on the market, delivery, use and holding for amateur use from 1st January 2019.

Moreover, the products quoted in this list will benefit from a reduced tax rate of sales revenues. This tax aims to fund the establishment of the monitoring system called ‘phytopharmacovigilance’ (PPV).

The present note thus repeals Notes DGAL/SDQPV/2016-279 from 31/03/2016, DGAL/SDQPV/2016-427 from 25/05/2016 and DGAL/SDQPV/2016-447 from 30/05/2016.

Products quoted in this list must respect three types of criteria as regards their regulatory status, the nature of their active substance(s) and their human and environmental safety:

– the products must have a French approval

(to be noted: the products authorised for max. 120 days for emergency reasons (article 53 of Regulation (EC) No.1107/2009) are excluded from the list)

– the active substances must be micro-organisms, chemical mediators or natural substances from animal, vegetal or mineral origin

A natural substance means a substance naturally present and identified as it is in the environment. This substance is either extracted from the natural material source or obtained by chemical synthesis provided it is strictly identical to the corresponding natural substance. Substances generated by prokaryotes, unicellular eukaryotes or fungi belong to the category of natural substances.

– the products must not be classified as regards their acute toxicity (categories 1, 2 and 3), their mutagenic, carcinogenic or reprotoxic properties or their specific target organ toxicity. They must not be classified as skin or respiratory sensitisers (except for pheromones release via a dispenser for skin sensitisers).

– the products must not be classified as regards their acute or chronic toxicity (category 1) to the aquatic environment, except if there is no risk of transfer to the environment or if this risk is negligible.

In addition, insecticide products with a large spectrum of action that are authorised for at least one major use, are excluded from the list because of their non-selective effect.

 

To download: Note DGAL/SDQSPV/2016-853 du 03 Novembre 2016 (in French)

 

See our previous articles:

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

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

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

 

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

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