FRANCE: Usable in Organic farming (UAB) claim granted to more than 50 new products

The French National Institute of Origin and Quality (INAO) has decided to include PPP registered for amateur uses and products authorised for use after harvest, according to their criteria, in the register of inputs which can be used in organic farming.

This decision is issued in the context of the implementation of significant restrictions on the sales of products for amateur use pursuant to Labbé’s law (February 2014) and modified by the Energetic transition law (August 2015) as of 1 January 2019: products with the UAB claim will remain on the market and will continue to be used by amateurs.

Thus, more than 50 products are awarded UAB claim.


As a reminder, on the E-phy website and in the open data file of the catalogue of PPPs, products with the mention UAB can be easily found by applying a filter on searches.

See also our previous articles:

FRANCE: Focus on the bans of Amenity uses and Home & Garden products

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FRANCE: Update of the Appendix to the guidelines for the delivery of approvals by ANSES

ANSES has published an update of the risk-mitigation measures that appear the most frequently and that are described in the Annex to the Guidelines for the delivery of approvals of plant protection products and adjuvants on 02/04/2018. This update follows, inter alia, the publication of the Order of 4 May 2017 on the use of plant protection products and their adjuvants, repealing the Order of 12 September 2016.

The main changes are as follows:

  • Measures concerning residues and consumer exposure: two new measures to manage the risk of MRL exceedance for perennial crops
  • Measures concerning risks to the environment:
    • Aquatic organisms:
      • New SPe 2 phrases relating to soil types, products to be incorporated into the soil, depth of sowing and wastewater discharges from off-ground greenhouses
      • New SPe 3 phrases for unsprayed buffer zone to water surface bodies for uses on potato
      • Unsprayed buffer zone to water surface bodies up to more than 100 meters
    • Birds and mammals: new SPe 5 and SPe 6 phrases relative to treated seeds

To download: Annexe aux lignes directrices pour la délivrance des décisions relatives à la mise sur le marché des produits phytopharmaceutiques et adjuvants (in French)

See also our previous articles:

FRANCE: The new Order on the Use of PPPs and adjuvants is finally published!

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

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FRANCE: Risks/Benefits of neonicotinoids compared to their alternatives

The French Agency Anses published on May 30th the final opinion regarding risks and benefits for plant protection products containing neonicotinoids and their alternatives. The assessment was initiated in 2016 as part of the implementation of the Law for biodiversity regrowth, nature and landscapes. This Law sets a ban for products containing  active substances from the neonicotinoids family and for seeds treated with these products from 1st September 2018, exemptions being possible until 1st July 2020 based on a comparative assessment performed by Anses of the benefits and risks linked to the uses of these products and of available substitution products and alternative strategies.

It is to be noted that restriction measures regarding the use of this insecticide family are also set at EU level. Indeed, the use of Imidacloprid, Clothianidin and Thiamethoxam has just been restricted to permanent greenhouses or to the treatment of seeds intended to be used only in permanent greenhouses by Regulations (EU) 2018/783, 2018/784 and 2018/785 published on May 30th. The resulting crop must stay within a permanent greenhouse during its entire life cycle. Member States shall amend or withdraw existing authorisations for products containing these active substances by 19 September 2018 at the latest, with a grace period, if any, expiring by 19 December 2018 at the latest.

Anses opinion is composed of 3 volumes:

– ldentification of alternatives to the authorised uses of neonicotinoids

Chemical and non-chemical alternatives were identified for most of the 130 authorised uses of neonicotinoids. In six cases, no alternative was identified.

Chemical alternatives rely on the same family of active substances, or on a single active substance active or a single marketed product.

In the current state of knowledge, the non-chemical methods appearing to be most suitable for immediately, effectively and sustainably replacing neonicotinoids are biological control, physical control by applying a protective layer (paraffin oil, clay, etc.) and mating disruption, when these methods are already available in France or easily transferable.

– ldentification of risk indicators for human health and  for environment, including pollinators

Two risk indicators for human health (dietary and non-dietary exposure) and six risk indicators  for environment (risks for birds, mammals, earthworms, aquatic organisms, bees and groundwater) were used but did not permit to globally and concisely conclude regarding substances with the least unfavourable risk profiles compared to that of neonicotinoids.

– Impact assessment of the ban of concerned PPPs on agricultural activity

Carrying out an assessment of the agricultural impact of the ban on neonicotinoids, aside from the fact that it does not address the environmental, health and social consequences for which there is no scientific consensus, raises a number of challenges that were not resolved, especially concerning the methodology, and data availability and reliability. The opportunities for alternative practices have yet to be confirmed and economical analysis methods devoted to the transformation and adaptation capacities of agricultural systems need to be developed.

To conclude, Anses remind that a combination of different methods is needed to fight efficiently against pests. The Agency warns about the fact that the ban on the use of substances belonging to the neonicotinoid family risks causing increased resistance to other insecticides, especially pyrethrinoids, if they are used as alternatives. According to Anses, it is currently difficult to predict the impact of this ban on agricultural activity. Anses recommend speeding up the implementation of effective alternative methods for crop protection and management that are safer for humans and the environment (chemical mediators, beneficial insects, etc.).

 

To download (in French):

AVIS et RAPPORT de l’Anses “Risques et bénéfices relatifs des alternatives aux produits phytopharmaceutiques comportant des néonicotinoïdes” – Tome 1

AVIS et RAPPORT de l’Anses “Risques et bénéfices relatifs des alternatives aux produits phytopharmaceutiques comportant des néonicotinoïdes” – Tome 2

AVIS et RAPPORT de l’Anses “Risques et bénéfices relatifs des alternatives aux produits phytopharmaceutiques comportant des néonicotinoïdes” – Tome 3

 

See also our previous articles:

EUROPE: Neonicotinoids ban for outdoor uses

FRANCE: ANSES recommends strengthening the conditions of use of Neonicotinoids

 

EUROPE: Guidance for the dose expression for vertical crops (Belgium and Central zone)

This guidance document, drawn up in December 2017 and which has just been published, explains how Belgium has been dealing for many years with the expression of the doses per hectare Leaf Wall Area (LWA) for the application of plant protection products to the canopy of vertical crops. This document contains all the information necessary to allow approval holders of plant protection products to calculate a dose per hectare of LWA and to prepare the application dossier according to the Belgian requirements. Meanwhile, the completeness check procedure and the draft Registration Report format have also been adapted. The guidance document thus contains both instructions for approval holders and for the Authorities on the assessment of the applications for authorisation. These new criteria will apply to all applications submitted in Belgium after 31st December 2018.

At last, this document reminds decisions made for the Central zone regarding the dose expression for vertical crops:

  • The LWA concept should first become effective in the efficacy evaluation in grapevine, pome fruit and high growing vegetables;
  • In these crops, application dossiers for new products (under Article 33) will only be accepted when trials were planned and carried out based on LWA (to become effective from 01.01.2020);
  • Accordingly, the respective trials must be planned and carried out based on LWA (to become effective from 01.01.2018);
  • The LWA dose rate shall be indicated in the GAP table.

To download: Dose expression for vertical crops

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

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FRANCE: New spray drift reduction equipments

The French list of spray drift reduction equipments which allow the reduction of the width of unsprayed buffer zones from water bodies was updated by DGAL/SDQSPV/2018-347 note of 27 April  2018. This note repeals the previous Note DGAL/SDQSPV/2017-437 of 23 May 2017 (see our previous article: FRANCE: Update of the list of spray drift reduction equipment – May 2017).

This note aims at updating the list of spraying equipments characterised by a minimum efficacy of 66% for drift reduction. New equipments were added for vineyards, orchards and low crops.

To download:

Note de service DGAL/SDQSPV/2018-347 (in French)

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

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FRANCE: Action plan for plant protection products

The French action plan on plant protection products and on a less pesticide-dependent agriculture was presented on 25 April 2018. It incorporates the proposals of the stakeholders consulted since last February, 15th.

This action plan is structured around four priorities:

 

  • Rapidly reduce the use of substances of greatest health and environmental concerns

 

In this context, France will ask the European Commission to put an end as soon as possible to the approval of substances that are subject to cut-off criteria under the EU regulation: carcinogens category 1, mutagens category 1 or toxic for the reproduction category 1, or endocrine disruptors for humans or the environment, persistent bioaccumulative and toxic substances, or very persistent and very bioaccumulative substances. France will systematically oppose the extension and renewal of these substances.

France will also ask ANSES to start as early as 2018 a scientific review of the substances of greatest concern for health and the environment mentioned by the CGAAER-IGAS-CGEDD mission and whose European approval expires after 2018.

The plan provides for a separation of distribution and advising activities and a revision of the tax for diffuse pollution (RPPD) to encourage incentives to reduce the use of PPPs and help financially for the transitions.

 

  • Better know the impacts to better inform, protect the population and the professionals and preserve the environment

 

 

  • Amplify the research and development of alternatives and the implementation of these solutions by farmers

 

France will notably strengthen its support for the development of biocontrol by supporting the innovation of very small, small and medium-sized companies by mobilising the major investment plan and improving the approval process for biocontrol products (in particular by shortening timelines) and to propose at European level the recognition of biocontrol products in the context of the revision of Regulation (EC) No 1107/2009.

France will also support farmers towards the ban of glyphosate and the reduction of plant protection products within 3 years.

 

  • Strengthen the Ecophyto 2 plan, improve its governance and functioning

 

 

The Action Plan is accompanied by a timetable and a method of implementation:

  • Several working groups are set up in order to implement certain actions of the plan
  • Two referrals of scientific organisms have already been made, including one to ANSES:
    • development of specifications to launch an experimental study on the carcinogenicity of glyphosate

and 3 new referrals will be sent to ANSES in one month:

  • establishment of a list of the substances of greatest concern with regard to the risks they may pose to public health or the environment, in particular carcinogens, mutagens, reproductive toxins and endocrine disruptors which will still be approved after 2018;
  • identification of the substances of concern for which the Government will intervene with the European Commission so that they can be included as soon as possible in the list of substances candidates  for substitution;
  • proposals to strengthen existing regulations on pollinators, taking into account the safety of operators.

The Ecophyto 2 plan will be adapted to integrate the priorities of this action plan. The Ecophyto 2+ plan will be submitted for public consultation in July 2018.

 

To download:

Plan d’actions sur les produits phytopharmaceutiques et une agriculture moins dépendante aux pesticides (in French)

Mise en oeuvre du plan d’actions – Calendrier et méthode (in French)

 

See also our previous articles:

FRANCE: 18 actives on the hot seat: new action plan to reduce the use of PPPs

 

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

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FRANCE: Guidance on extensions for minor uses (Article 51)

The French procedure for the authorisation of minor uses under Article 51 of  Regulation (EC) No.1107/2009 was published in the Official Bulletin of the Ministry of Agriculture on 27 April 2018 as a Note of information.

Article 51 of  Regulation (EC) No.1107/2009 sets that not only the authorisation holder but also official or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users may ask for the authorisation of a plant protection product already authorised in the Member State concerned to be extended to minor uses not yet covered by that authorisation. The corresponding extensions of authorisation shall  be granted provided that they are in the public interest and that they do not present harmful effects to human or animal health or inacceptable effects on the environment.

The intended extension is in the public interest when it fulfills at least one of the following criteria:

  • it is intended to fill gaps of uses  with no or few alternatives
  • it is a low risk product (Art. 47 of Reg. 1107/2009)
  • it is a biocontrol plant protection product (list set in accordance with Article L 253-5 of French Rural Code)
  • it is a protective measure against categories 1 and 2 phytosanitary dangers (French Decree of 15 December 2014 concerning the list of categories 1 and 2 phytosanitary dangers for plant species)

The content of the application dossier is set by the French Decree of 30 June 2017 and is to be sent to Anses.

The application goes through Anses scientific evaluation. When possible the request is to be identified as part of the inventory tasks for technical gaps performed by the Commission of orphan uses (‘Commission des usages orphelins’ or ‘CUO’). This is a Commission of consultation and expertise of the Ministry of Agriculture constituted by representatives of stakeholders and ANSES. Efficacy and crop safety data are not mandatory for such applications. The ‘public interest’ status is evaluated by the Ministry of Agriculture.

In order to fasten the evaluation process, the data used to demonstrate that the application fulfills the eligibility criteria of Article 51 procedure can be transmitted to the CUO secretariat prior to the application to ANSES.

When the extension of authorisation is granted, the administrative decision is sent to the authorisation holder and, if different, to the applicant. The minor use extension shall be separately identified on the product label if the authorisation holder accepts to revise it. In any case, information regarding the specific conditions of uses of the product for this extension is available for users in the Anses List of marketing authorisation decisions and on E-Phy website.

To download: Note de service DGAL/SDQSPV/2018-344 (in French)

Lynxee consulting’s team is at your disposal if you need support for your applications

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EUROPE: Neonicotinoids ban for outdoor uses

In February 2018, EFSA published updated scientific assessments that confirmed the risks to bees posed by the neonicotinoid active substances imidacloprid, clothianidin and thiamethoxam used as seed treatment or granules. EFSA presented the reports to risk managers from the European Commission and Member States in March 2018.

On 27 April 2018, Member States’ representatives in a Standing Committee have backed the Commission’s proposal to further restrict the use of these three neonicotinoids. The agreed restrictions go beyond the measures already implemented since 2013 (see Regulation (EU) No 485/2013). All outdoor uses will be banned and the neonicotinoids in question will only be allowed in permanent greenhouses where no contact with bees is expected.

The Regulation will now be adopted by the European Commission in the coming weeks and become applicable by the end of the year.

In France, Anses published in March 2018 its second progress report on the alternatives to the use of plant protection preparations containing neonicotinoids, for which the final report will be published in the second quarter of 2018. In this second progress report, alternatives for uses on grapevines, industrial and fodder beets, straw cereals, maize and lettuce were identified, and risk indicators applied to them. Concerning the impact of neonicotinoids on human health, no harmful effects were identified for uses complying with the current marketing authorisations. However, with regard to thiacloprid, given the hazard characteristics of this substance and the significant increase in its use, the Agency recommends minimising its uses.

To learn more:

European Commission: Neonicotinoids

Neonicotinoids: ANSES publishes its second progress report

See also our previous articles:

EUROPE: EFSA update the neonicotinoids risk assessments for bees: risk confirmed

FRANCE: ANSES recommends strengthening the conditions of use of Neonicotinoids

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

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

EUROPE: Publication of Endocrine disruptors criteria

On 20 April 2018 was published the Commission Regulation (EU) 2018/605 setting out the scientific criteria to identify the substances used in plant protection which are endocrine disruptors (EDs).

After the rejection of the initial regulation project by the European Parliament in October 2017, the new project taking into consideration the claims of the European Parliament (i.e. the deletion of the exemption for substances that have an ‘intended endocrine mode of action’), was voted at the PAFF meeting in December 2017.

According to the Regulation, an active substance, safener or synergist is considered as ED if (i) it shows an adverse effect in an intact organism or its progeny, (ii) it alters the function(s) of the endocrine system, and (iii) the adverse effect is a consequence of the endocrine mode of action.

The new criteria will apply from 20 October 2018 onwards, including the substances for which an assessment or a re-evaluation is ongoing. A feedback regarding the experience gained from the application of these criteria will be presented by the Commission by 20 October 2025.

As a reminder, very similar criteria will apply to biocide substances from 7 June 2018. The European Union is now the first worldwide to have strict legally binding criteria to identify EDs.

Besides, the draft technical guidance document for identifying EDs of ECHA and EFSA is currently being updated with the new criteria set. The guidance document will be available by June 2018.

 

To download: Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties.

 

See also our previous articles:

EUROPE: Public consultation on draft guidance for identifying endocrine disruptors

EUROPE: Parliament rejects criteria for endocrine disruptors

Adoption of Endocrine disruptors criteria

 

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

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UK: Final commenting phase on the guidance on physico-chemical data

In 2015, a guidance document on the physical, chemical and technical data required to support the registration/authorisation of plant protection products under Regulation (EC) 1107/2009 was published on the HSE website. This National guidance has since been through commenting phases with other EU Member States, EFSA, Industry and wider Stakeholders in order to become an EU harmonised guidance document.

The updated harmonised version reviewed by CRD further to the consultation processes is now available for final comments. The final commenting phase will be completed by 14 May 2018.

Version for commenting:  Guidance document for the generation of data on the physical, chemical and technical properties of Plant Protection Products (PPPs) under Regulation (EC) 1107/2009.

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