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)

 

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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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EUROPE: Corrigendum to the Implementation Modalities of the EFSA Guidance on Dermal Absorption

The Standing Committee on Plants, Animals, Food and Feed, which adopted the new EFSA guidance on dermal absorption on 25 May 2018, adopted on 24 October 2018 a corrigendum (minor correction) to the implementation modalities of the guidance.

The correction concerns the threshold distinguishing whether a plant protection product should be considered as a concentrate or as a dilution: a plant protection product with an active substance amount of exactly 50 g/L or g/kg (i.e. 5%), initially considered as concentrate, should now be considered as a dilution.

For more information on the implementation modalities of the guidance, please refer to our previous post on the topic which has been revised accordingly.

 

To download:

Guidance on dermal absorption (SANTE/2018/10591) – rev.1, 24 October 2018

 

See also our previous articles:

EUROPE: Adoption of the new EFSA guidance document for dermal absorption

EUROPE: New EFSA GD on Dermal absorption

 

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EUROPE – EFSA: Database of Ecological and Residue Data Used in Assessments for Birds and Mammals

EFSA published the outcome of the data collection conducted with the aim of developing a unified database of ecological data and residue data to be used for the risk assessment of plant protection products for birds and mammals. This data collection, outsourced to a consortium consisting of the Alterra institute (Wageningen University, the Netherlands), the Austrian Agency for Health & Food Safety (AGES) and the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), was initiated in 2015.

Data were collected among the data submitted in active substance and plant protection product dossiers and via a systematic literature review. Data were scored on the basis of quality criteria and organised in 3 Excel spreadsheets (one for birds, one for mammals and one for residue studies), that can be downloaded as Supplements to the report.

The ecological information collected for birds and mammals consisted of data used (or that could be used) for the determination of focal species (notably, the frequency of observation in the field and the frequency of observation per survey), the estimation of the proportion of an animal’s daily diet obtained in a treated habitat (PT) and the assessment of the composition of the diet obtained from a treated area (PD). Entries for 18-21 crop groups, 150 bird species and 70 mammal species were collected. Nearly half of the records for birds come from protected company study reports while it is less than 10% for mammals.

The information gathered on residues focussed on initial residue levels and on residue decline (notably, DT50 and DT90). Entries for 190 substances and 18 crop groups were collected. Around 75% of these records come from protected company study reports.

In a first step, the databases may be used by EFSA and Member states for the peer review of active substances and for the registration of plant protection products in order to reach a higher level of harmonisation and more robust assessments. In a second step, EFSA planned to use the databases as inputs for the revision of the guidance on birds and mammals (EFSA Journal 2009; 7(12):1438).

 

To download:

Lahr et al., 2018 – EFSA Supporting publication 2018:EN-1513: Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals (the report and the 3 databases as supplements).

 

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FRANCE: Public consultation on Ecophyto II+

The French government has started on 20 November 2018 the public consultation on the different lines of action of the Ecophyto II+ plan. The consultation closes on 10 December 2018 (access the consultation).

As a reminder, Ecophyto II+ plan features the actions set in the French action plan of 25 April 2018 on plant protection products (PPP) and on a less pesticide-dependent agriculture, and those in the French action plan of 22 June 2018 for a ban of glyphosate within three years. Ecophyto II+ thereby strengthens the measures taken to reach the goal of 50% reduction in pesticide use in France by 2025.

Main Ecophyto II+ objectives are:

  • Speed up the withdrawal of substances of greatest concern, on the one hand, and promote the use of biocontrol products and of ‘natural’ preparations of low concern (denominated Préparations Naturelles Peu Préoccupantes, PNPP), on the other hand.
  • Strengthen the measures to avoid population exposure to PPP and to reduce the impact of PPP on the Environment.
  • Support research on the risks and effects of PPP use and demonstrate the effectiveness of farming programs with low PPP use.
  • Support farmers in this transition with notably (i) financial and technical supports, (ii) the separation of sale and consultancy activities of PPP (French EGalim law of 30 October 2018), and (iii) revise the French tax on diffuse pollution to make it more incentive.

 

To download:

Press release of 20 November 2018 – Consultation on the Ecophyto II+ plan (in French)

 

See also our previous articles:

FRANCE: Ecophyto II+, update and improvement of Ecophyto II

FRANCE: New Agriculture and Food law published

 

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EUROPE: EFSA Public consultation – threshold of toxicological concern approach

The public consultation on the guidance document proposed by EFSA for the use of the threshold of toxicological concern (TTC) is opened from 13 November 2018 to 08 January 2019.

This document updates the Scientific Committee opinion of 2012 by considering the latest developments in the field. This is a guidance for EFSA’s scientific panels and staff for the use of the TTC approach as a screening and prioritisation tool for the safety assessment of chemicals, when hazard data are incomplete and human exposure can be estimated as low.

The TTC approach is not applicable where substance-specific data exist or where they are required under EU legislation.

To download: Public consultation: guidance on threshold of toxicological concern approach (en anglais)

 

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FRANCE: New spray drift reduction equipments – November 2018

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/2018-833 note of 16 November 2018. This note repeals the previous DGAL/SDQSPV/2018-347 note of 27 April 2018 (see our previous article: FRANCE: New spray drift reduction equipments – May 2018).

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/2018-833 (in French)

 

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