FRANCE: Ban of home and garden plant protection products

From 1st January 2019, sales, dispensing, use and possession of plant protection products by non professional users will be banned in France except for biocontrol products officially listed by the Ministry of Agriculture in accordance with articles L.253-5 and L.253-7 of the Rural Code, for low risk products as defined by Regulation (EC) No.1107/2009 and for organic farming (UAB) products authorised for non professional users (“mention emploi autorisé dans les jardins (EAJ)”). This provision was set by the Law on the use of PPPs (Labbé’s law of February 2014) for entry into force on 1st January 2022. The entry into force was then brought forward to 1st January 2019 by the Energetic transition law from the Ministry of Ecology (August 2015). The aim is to reduce the risks associated to the use of pesticides by amateurs.

The implementation modalities of this ban are set by a Notice of the Ministry of Agriculture published in the French Official Journal of 22 December 2018.

Two lists of products have been published by the Ministry of Agriculture: one for the products still authorised for amateur uses from 1st January 2019 and one for the products with an authorisation in force in December 2018 but that are no longer authorised from 1st January 2019.

The stocks of products banned from 1st January 2019 held by non professional distributors can be sold to professional users by distributors certified for the distribution of plant protection products to professional users.

The unused products and packaging held by non professional users must be disposed of in a waste collection site or a temporary collection point for household chemical waste set up by the eco-organism Eco-DDS.

 

To download:

Avis aux opérateurs économiques concernés par l’interdiction à compter du 1er janvier 2019 de la mise sur le marché, la délivrance, l’utilisation et la détention de certains produits phytopharmaceutiques pour un usage non professionnel (in French)

Liste actuelle des produits phytopharmaceutiques restant autorisés pour les amateurs à partir du 1er janvier 2019 (in French)

Liste des produits possédant une autorisation de mise sur le marché en vigueur en décembre 2018 et qui ne sont plus autorisés à partir du 1er janvier 2019 (in French)

 

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FRANCE: Tax on Diffuse Pollution – Evolutions for 2019

The new list of substances concerned by the French tax on diffuse pollution has been published in the Order of 28 December 2018. The new list will apply by 1st January 2019.

As a reminder, concerned substances are those known for their human health or/and Environment hazards:

  • Acute toxicity for human, category 1, 2 or 3;
  • Specific target organ systemic toxicity, category 1 (single or multiple exposure);
  • CMR, category 1A or 1B;
  • Effects on or via lactation;
  • Environmental hazards (acute or chronic).

(Note: hazard classes/categories according to Regulation (EC) No. 1272/2008)

 

Besides, the French finance law for 2019 introduces a revision of the tax by 1st January 2019. The new rates will range from 0.90 to 9 euros / kilogram of substance while the current rates range from 0.90 to 5.1 euros. An additional rate is also defined for substances not meeting the approval criteria of Regulation (EC) No. 1107/2009 or for substances subject to the substitution scheme. This evolution is part of the French action plan on plant protection products and on a less pesticide-dependent agriculture. The tax on diffuse pollution is strengthened to encourage a reduction of the use of PPPs (in particular those with substances of concern) and to help financially for the transitions.

 

To download:

Order of 28 December 2018 modifying the Order of 22 november 2010 establishing the list of substances defined by Article R. 213-48-13 of the Environment code as regards the tax on diffuse pollution (in French)

Finance law No. 2018-1317 of 28 décember 2018 for 2019 (Article 234) (in French)

Explantory note MTES/DGALN/DEB – 20.11.2018 (in French)

 

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EUROPE: Updates of AIR 3 and AIR 4 working documents

AIR 3 programme

SANCO/2012-11284 – Rev. 22 – December 2018 – Draft working document – AIR III Renewal programme

This 22nd revision contains new expiry dates set by Regulation (EU) No. 2018/1262 of 20 September 2018 (for: 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide,  deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron) and by Regulation (EU) No. 2018/1796 of 20 November 2018 (for amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron).

 

AIR 4 programme

SANTE-2016-10616Rev. 10 – December 2018 – Draft working document – AIR IV Renewal programme

SANTE-2016-11734 – Rev. 11 – December 2018 – Draft working document – 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

These new versions update revision 9 and 10 of June 2018 of guidance documents SANTE-2016-10616 (AIR IV Renewal programme) and SANTE-2016-11734 (application overview for AIR IV substances).

 

See also our previous articles:

EUROPE: Updates of AIR 3 and AIR 4 working documents (23 July 2018)

 

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

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EUROPE: Adoption of new EPPO Standards PP 1/306 and PP 1/307 and revision of EPPO Standard PP 1/226

Two new EPPO Standards (PP 1/306(1) and PP 1/307(1)) adopted in September 2018 and the revision of EPPO standards PP 1/226 also dated September 2018 have just been published:

  • The EPPO Standard “PP 1/306 (1) General principles for the development of co-formulated mixtures of plant protection products” sets the definition of a co-formulated mixture and provides guidance for the justification for using mixtures from the point of view of efficacy, plus an examination of the appropriateness of such mixtures in terms of managing resistance. Additional information for specific product types and situations  are provided, the EPPO Standard “PP 1/277 Insecticide co-formulated mixtures” is therefore withdrawn and replaced by this new Standard;
  • The EPPO Standard “PP1/307 (1) Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products” considers the possible impacts of biologically significant changes in chemical composition of PPPs and the requirements to support such changes, the circumstances in which a change in formulation type may be supported by a more limited data package and also discusses the development of a new product which is to be based on the principle of comparing with, and ‘bridging’ to, an existing formulation;
  • The EPPO Standard “PP 1/226(2) Number of efficacy trials”, which provides guidance on the number of trials in target crops needed to demonstrate the efficacy of a plant protection product (PPP) at the recommended dose, has been updated to the version PP1/226(3). The revision follows the adoption of EPPO standard PP 1/307(1).

 

To download:

PP 1/226(3) Number of efficacy trials

PP 1/306 (1) General principles for the development of co-formulated mixtures of plant protection products

PP1/307 (1) Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products

 

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FRANCE: ANSES’ Newsletter on Marketing Authorisations

The first newsletter on marketing authorisations of plant protection products and adjuvants was published by ANSES (December 2018). The newsletters will present at the beginning of each month an overview of the withdrawals of authorisation, the new authorisations and the major modifications of authorisation (e.g. new uses or use withdrawals, modified conditions of use) which occurred in the previous month. It is noted that additionnal trade names will not be reported in the newsletters.

The newsletters will also include some regulatory news highlighted by ANSES each month.

The newsletter of December 2018 is marked by the withdrawal of numerous glyphosate-based products given the expiration of the marketing authorisations for which no renewal dossiers have been sent subsequently to the renewal of glyphosate.

 

Link to Anses Web page for the monthly newsletters:

https://www.anses.fr/fr/content/bulletin-mensuel-des-autorisations-de-mise-sur-le-march%C3%A9-des-produits-phytopharmaceutiques (In French)

 

To download:

Newsletter of December 2018 (in French)

 

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

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EUROPE – EFSA: Technical report on the proportionality approach for residues

In order to enhance the harmonisation of the risk assessment of active substances in the area of residues, EFSA and Member States held discussions that lead to the publication of this technical report on the proportionality approach.

The discussions were based on:

– the  recommendations  on the proportionality  concept as defined at Codex  level and adopted at EU level at the Standing Committee on the Food Chain and Animal Health Meeting in September 2015.

– the   OECD guidance   document on crop   field trials published in September   2016 (ENV/JM/MONO(2011)50/REV1).

The conclusions and recommendations regard specific cases that were not fully covered by  the general principles of the proportionality concept described in the OECD guidance  document or that lead to different interpretation among experts.

Cases where scaling is appropropriate or on the contrary not necessary/not appropriate are illustrated.

Different case studies where the proportionality concept was used are also presented in Appendix.

 

To download: EFSA Technical Report: Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues (06.11.2018)

 

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

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EUROPE: Copper compounds renewal for 7 years

The proposal of the European Commission has been adopted: a renewal of the authorization of copper for 7 years (from 01.01.2019 to 31.12.2025) with a limitation to a maximum application rate of 28 kg of copper per hectare over a period of 7 years (i.e. on average 4 kg/ha/year).

In France, taking into account the risks and potential impacts of an excessive use of copper on the environment and health, the transition to a more sustainable use of copper and the use of alternative products and methods is under way.

A roadmap prepared with stakeholders will be presented at a future Ecophyto strategic orientation and monitoring committee to be held in early 2019. It will be based on the mobilisation of research and the provision of alternatives and accompanying measures for farmers in the evolution of their practices. Its deployment will be monitored as part of a dedicated working group.

 

To download: Draft Regulation for renewal of copper compounds

Communiqué de presse – Ministère de l’Agriculture et de l’Alimentation – 28.11.2018 (in French)

 

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EUROPE – EFSA: Database on processing techniques and factors

EFSA is conducting pan-European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA’s comprehensive food consumption database and pesticide-specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and worldwide.

EFSA therefore launched the project “Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2”. The main overall objective of the project is to develop a database of processing types and processing factors compatible with the EFSA food classification and description system FoodEx 2.

On 26 November 2018, EFSA published a series of 3 external scientific reports as part of this project. Each report corresponds to one of the three objectives:

– Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

– Objective 2: Linking the processing techniques investigated in regulatory studies with the EFSA food classification and description system FoodEx2

– Objective 3: European database of processing factors for pesticides in food

The coding system (objective 2) and the  database (objective 3) are also provided as Excel spreadsheets.

 

To download:

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx2 related to pesticide residues Objective 2: Linking the processing techniques investigated in regulatory studies with the EFSA food classification and description system FoodEx2

Appendix A -FoodEx 2 Coding system

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

EU processing factors database

 

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EUROPE – COM: Update of MRL setting procedure (SANTE/2015/10595 rev. 5.4)

The Commission published an update of Technical Guidelines SANTE/2015/10595 “MRL setting procedure in accordance with articles 6 to 11 of Regulation (EC) No 396/2005 and article 8 of Regulation (EC) No 1107/2009”.

The last version (rev. 4) was dated 2016.

In this new version 5.4, the following points have notably been developed:

  • Procedure when the residue definition or toxicological reference values are amended
  • Steps for new toxicological reference values for setting of import tolerances (i.e. case of substances for which no toxicological reference value was agreed upon at EU level)

and the following procedures have been added:

  • Fast-track procedure to set an MRL for a minor crop (on the basis of an extrapolation carried out from a major crop)
  • Withdrawal of MRL application (when no longer necessary or when not fulfilling the requirements)

 

To download: Technical Guidelines on the MRL Setting Procedure 2018 – SANTE/2015/10595 Rev. 5.4

 

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FRANCE: Towards glyphosate phase out

The renewal of the glyphosate approval for five years was adopted in December 2017 by the European Commission. The evaluation by ANSES (French Agency for Food, Environmental and Occupational Health & Safety) of applications for the renewal of authorisation of glyphosate-based PPPs according to Article 43 of Regulation (EC) 1107/2009 is in progress.

To date, 190 glyphosate-based products are authorised in France or benefit from a parallel trade permit. 58 applications for PPPs renewal and 11 applications for new PPPs approval were submitted to ANSES. Regarding the 132 products for which  renewal application was submitted, ANSES notified the products’ holders of the expiry of approvals or parallel trade permits as from 15 December 2018. The list of products concerned has been published on the E-phy website.

For products intended for professional use, the end of sale and distribution of the products is set to 15/03/2019 and the end of use of the products and stocks is set to 15/06/2019.
For products intended for amateur use, no grace period is granted in view of the entry into force on 1 January 2019 of the Labbé’s law (February 2014) amended by the Energetic transition law (August 2015) and the Potier’s law (March 2017), prohibiting the marketing and holding of non-professional PPPs.

ANSES announces that the evaluation of the new approval applications and renewal applications will be finalized before 31 December 2020, within the three-year period announced by the government.

In addition, the evaluation of the new approval applications and renewal applications will be conducted on the basis of a comparative assessment of the products: based on the information that will be provided on the available alternatives commonly used in France, particularly by INRA (French National Institute for Research in Agriculture), ANSES will compare, for each use, glyphosate products with the non-chemical methods of prevention or control that are available. For each glyphosate-based product, uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.

Finally, in order to support farmers foregoing glyphosate use, the government launched a website sharing experiences from farmers who have already taken part in this initiative and describing possible alternatives to glyphosate. The website also records the plots declared without glyphosate in each department as well as the number of farmers having stop any use of glyphosate and engaged in this way.

 

To download:

Liste des produits à base de glyphosate faisant l’objet d’un retrait du marché à compter du 15 décembre 2018 (in French)

 

See also our previous articles:

EUROPE: Renewal of glyphosate approval

 

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