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 with the claim “emploi autorisé dans les jardins” (for amateur use) are allowed to be sold by self-service. The biocontrol products authorised for professional use cannot be sold to amateur users.

The note also highlights that parallel trade product are covered by the list.

In addition, 32 products have been added to the list of biocontrol products.

 

To download: Note DGAL/SDQSPV/2017-635 du 28/07/2017

 

See our previous articles:

FRANCE: First update of the official list of biocontrol products

FRANCE: publication of the official list of biocontrol products

 

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

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EUROPE: Release of a Biopesticides 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 the evaluation of biopesticides based on the data requirements and uniform principles under Regulation (EC) No. 1107/2009. Mainly issues that need further explanation are addressed. Where needed, important information from the Regulations or additional explanations and interpretations are provided.

 

To download:  

Ctgb – Evaluation Manual for the Authorisation of Biopesticides according to Regulation (EC) No 1107/2009 – Microorganisms, Botanicals, Semiochemicals – version 1.0; July 2017

 

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

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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 1st October 2017 but the new cerfa forms can be used right now!

 

To download:  

Arrêté du 30 juin 2017 fixant la composition et les modalités de présentation des dossiers de demandes relatives à des autorisations de mise sur le marché et à des permis d’expérimentation et de commerce parallèle de produits phytopharmaceutiques, de leurs adjuvants ou de produits mixtes (in French)

Note, formulaires Cerfa et notices à utiliser (05/07/2017) (in French)

 

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

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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”.

 

IMPORTANT: Scientific agencies have not yet conducted detailed work substance by substance to verify their endocrine character based on the definition adopted by the Member States.
Substances can therefore be withdrawn or added to this list.

 

To download:  

Liste de produits pesticides susceptibles de contenir des substances perturbatrices endocriniennes

 

Our previous article:

Adoption of Endocrine disruptors criteria

 

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

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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 during which the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) – mandated by the Commission – will be finalising a joint guidance document for their implementation.A public consultation is expected in autumn.

As for pesticides and biocides, the Commission will not delay any action and will already apply the criteria to substances for which assessment or re-evaluation is undergoing or for which confirmatory data concerning endocrine properties have been requested.

The impact assessment (page 112/404), published last year, identified 26 substances potentially affected by the definition based on option 2 (WHO definition): 2,4-D, 8-hydroxyquinoline, Boscalid, Cypermethrin, Desmedipham, Fenamidone, Flubendiamide, Iprodione, Lenacil, Malathion, Mancozeb, Maneb, Metiram, Myclobutanil, Oxadiazon, Pendimethalin, Propyzamide, Spirodiclofen, Tebuconazole, Tepraloxydim, Tetraconazole, Thiophanate-methyl, Thiram, Tralkoxydim, Triflusulfuron, and Ziram.

 

At French level, in a joint press release issued by the Ministries of Ecological and Solidarity Transition, Solidarity and Health, and Agriculture and Food, the French Government announced additional National measures and a revision of the the National strategy adopted in April 2014 on endocrine disrupters.

Pending the Commission’s assessment of the provisions of the text leading to the exemption of certain substances acting as endocrine disruptors, where concerns are expressed, the Government undertakes to use the procedure laid down by EU law that allows, on the basis of scientific and technical analyses carried out at National level, to prohibit the placing on the French market of products containing these substances.

Among the measures announced, Ministers of the Ecological and Solidarity Transition, Solidarity and Health, and Agriculture and Food, will seize ANSES to conduct a risk assessment of the most widely used products containing these substances.

The list of plant protection products containing at least one substance identified by the Commission as an endocrine disruptor will be published by 14 July.

 

Our previous articles:

EUROPE: Presentation of criteria to identify endocrine disruptors

FRANCE: ANSES Opinion on the definition of endocrine disruptors

 

To download:  

SANTE-2016-12020-REV 4 – DRAFT COMMISSION REGULATION (EU) …/… of XXX amending Annex II to Regulation (EC) 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties  

 

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

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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. Since the new available data clearly show that dermal absorption is significantly affected by the concentration of active substance in the product and by the type of formulation, the new default values are categorised by formulation type or concentrated and diluted pesticide formulations.

A comparison of new and current default values is presented below:

2017 Guidance Document:

Formulation type Concentration status Default dermal absorption  value
Organic solvent-based(a) or other(b) Concentrate 25%
Dilution 70%
Water-based(c) or solid(d) Concentrate 10%
Dilution 50%

(a): Formulation types: emulsifiable concentrate (EC), emulsion, oil in water (EW), suspo-emulsion (SE), dispersible concentrate (DC), oil miscible liquids (OL/OF), oil-based suspension concentrates (OD), emulsion for seed treatment (ES), microemulsion (ME).

(b): Formulation types: bait concentrate (CB), capsule suspension (CS), gel for direct application (GEL/GD), bait, ready for use (RB), mixture of capsule suspension and suspension concentrate (ZC), seed coated with a pesticide (PS), experimental solution of active substances in solvent (AI).

(c): Formulation types: soluble concentrate (SL), suspension concentrate (SC), flowable concentrate for seed treatment (FS), flowable (FL) (=SC).

(d): Formulation types: wettable powder (WP), water-dispersible granules (WG/WDG), water-soluble granules (SG), water-soluble powder (SP), powder for dry seed treatment (DS).

 

2012 Guidance Document:

Default dermal absorption value
Concentrate

(> 5% a.s., 50 g/kg for solids or 50 g/L for liquids)

25%
Dilution

(≤ 5% a.s.)

75%
Active substance with

log Pow < -1 or > 4 and MW > 500

10%

 

A technical meeting with stakeholders will be held in Parma on 27-28 September 2017 to explain how the document differs from the guidance issued in 2012, answer questions and collect feedback.

 

To download:

Guidance on dermal absorption (EFSA Guidance, 24/05/2017)

Outcome of the public consultation on the draft EFSA Guidance on dermal absorption (EFSA Technical report, 24/05/2017)

 

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

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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:

  • Plant protection products:
    • Revision of the amount of the fee levied by ANSES (fixed by the decree of 12 April 2017 – Articles 4 and 5, entered into force on 01/07/2017) when applying for a trial permit. The trials are divided into two categories: research trials and experiments, and development trials and experiments, with two levels of fees. A reduced fee is introduced for biocontrol products.
    • Introduction of a definition for the term “experimental site”.
    • Effective implementation of the SIDEP service online (https://sidep.anses.fr/#/login) since 06/04/2017 to manage two categories of declarations:
      • The declaration prior to the trial setting up in the context of exemptions to applications for trial permits, to be submitted to SIDEP no later than 10 working days prior to the implementation of the trial or experiment;
      • The declaration of setting up (before the end of the assessmentsand no later than 20 days after the first application of the products tested) and end of officially recognised trials (no later than 20 days after the end of the assessments or crop destruction).
  • Fertilisers and crop substrates: revision of the amount of the fee levied by ANSES (fixed by the decree of 12 April 2017 – Article 7, point V, entered into force on 01/07/2017): fixing a single tariff of 1000 € per request.

 

To download (in French):  

Note relative aux essais et expérimentations de produits réglementés (produits phytopharmaceutiques / matières fertilisantes) actualisée au 19/06/2017

Arrêté du 12 avril 2017 fixant le barème de la taxe fiscale affectée perçue par l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relative à la mise sur le marché des produits phytopharmaceutiques et de leurs adjuvants, des matières fertilisantes et de leurs adjuvants et des supports de culture

 

See also our previous articles:

FRANCE – Anses : New fees

FRANCE – Memo relative to trials and experiments

 

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

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