EUROPE-EFSA : Statement on the coverage of bats by current risk assessment

EFSA has published a scientific statement that considers whether the current risk assessment performed for birds and ground dwelling mammals exposed to pesticides is also protective of bats.

Bats are not specifically mentioned under the current risk assessment for pesticides methodology however they are an important group of mammals, frequently foraging in farmland and potentially exposed to pesticides. Bats help to regulate arthropod populations.

EFSA PPR Panel addressed three main issues:

– whether bats are toxicologically more or less sensitive than the most sensitive birds and mammals;

– whether oral exposure of bats to pesticides is greater or lower than in ground dwelling mammals and birds;

– whether there are other important exposure routes relevant to bats.

Based on the evidence compiled, the PPR Panel concludes that bats are not adequately covered by the current risk assessment approach, and that there is a need to develop a bat-specific risk assessment scheme. Based on the current assessment, this should include a focus on:

(a) oral exposure via residues in insects and grooming,

(b) dermal exposure and

(c) exposure of pups via milk.

It is important to highlight that any risk assessment scheme should consider the total body burden from all exposure routes as bats foraging in the field will be exposed to residues in insects, and via dermal and inhalation routes.

In general, there was scarcity of data to assess the risks for bats exposed to pesticides. Recommendations for research are made, including identification of alternatives to laboratory testing of bats to assess toxicological effects.

 

To download: 

Scientific statement on the coverage of bats by the current pesticide risk assessment for birds and mammals (EFSA Journal 2019;17(7):5758)

 

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FRANCE-ANSES: Update on the SDHI issue

Following an opinion published on 16/04/2018 by a group of scientists alerting on the risks related to the use of SDHI in agriculture, ANSES organised an expertise of the available scientific data and published their findings on 14/01/2019, concluding that there was no Human health alert that could lead to the withdrawal of approvals for these fungicides.

Since then, ANSES has further investigated in three directions: drawing up and financing specific research projects, detecting possible health effects that can be observed in the field via existing monitoring systems, and finally exchanging with research organisations and Human health agencies responsible for the evaluation of these substances, including the European Food Safety Authority (EFSA).

ANSES informed the European authorities, the Member States and the North American agencies of the alert about SDHI fungicides and their work on the subject in 2018, and forwarded their conclusions to EFSA, ECHA and the Member States in January 2018, so that they pay particular attention to any new data during the ongoing evaluation and renewal processes.

So far, no new information has arised to confirm the existence of a Human health alert that would lead to the withdrawal of existing approvals, in accordance with National and European regulations relating to plant protection products.

ANSES has also indicated that they are continuously improving  their plant protection products risk assessment methods. Besides the work in progress on the SDHI issue, ANSES has voluntarily decided to investigate the issue of cumulative food exposures to different SDHI in 2019. This work will be completed in the first half of 2020.

 

To learn more:

SDHI: ANSES updates on the work launched following the opinion of January 2019 (in French)

See also our previous articles: 

FRANCE: ANSES conclusions on the assessment of SDHI are available

 

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EUROPE-COM: public consultation for the amendment of the Organic Production Regulation

A draft amendment to the Organic Production Regulation (EC) No 889/2008 was published by the EU Commission for public consultation from 19 July 2019 to 16 August 2019.

This draft Regulation adds a number of substances to the list of pesticides that are permitted for use in organic production (Annex II): maltodextrin, hydrogen peroxide, terpenes (eugenol, geraniol and thymol), sodium chloride, cerevisane and pyrethrins from other plants than Chrysanthemum cinerariaefolium.

To download: 

Draft implementing regulation and its Annex

 

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EUROPE-COM : draft list of co-formulants banned in PPP

The EU draft regulation implementing the list of co-formulants that shall not be used in plant protection products or adjuvants (Annex III of Regulation (EC) No. 1107/2009) was discussed in the SCoPAFF meeting of 16 and 17 July 2019.

Co-formulants are unacceptable in plant protection products if it is established that their use or their residues have a harmful effect on human or animal health or have an unacceptable effect on plants or on the environment.

According to the draft list, the following co-formulants are considered as unacceptable:

– substances with a harmonized classification as carcinogens, category 1A or 1B, or as cell mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B,

– substances identified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB),

– substances identified as substances of very high concern due to endocrine disrupting properties,

– substances identified as Persistent Organic Pollutants (POP),

– substances restricted under REACH where their use as a co-formulant in plant protection products is covered by the restriction,

– substances already identified as unacceptable co-formulants for plant protection products by Member States (Austria, Belgium, France, Germany, Italy, Lithuania, Spain and Norway) or during the renewal of approval process of active substance (i.e. POE-tallowamines),

– in-can preservatives that were not approved under the Biocide Regulation (EU) No 528/2012 due to unacceptable risks for human health and the environment (i.e. PHMB),

 

The draft regulation sets that unacceptable co-formulants may be present as unintentional impurities in other co-formulants provided their individual concentration in the finished plant protection product or adjuvant is less than 0.01 % (w/w) unless a different LoQ (Limit of Quantification) is provided.

At last, the draft Regulation sets that Member States must withdraw authorisations of products containing any of the listed unacceptable co-formulants at the latest by 2 years after entry into force of the list. A grace period of 12 months may be granted.

To download:

Draft Commission Regulation modifying Annex III of Regulation (EC) 1107/2009 and its Annex

 

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FRANCE – ANSES: Opinion on protection measures for residents

ANSES was seized on January 28, 2019 by DGAL for a request for scientific and technical support on the protection measures for residents during the use of plant protection products.

The conclusions are as follows:

Risk assessment for Human health before placing products on the market

It is recalled that a risk assessment is always conducted during the evaluation of the applications for authorisation. The methodology currently used in the assessment of plant protection product dossiers is based on EFSA guidance document (EFSA, 2014). For residents, EFSA’s guidance document currently describes an assessment methodology that covers spray application only. For other methods of application, a dedicated evaluation methodology should be used. EFSA will update the guidance document in early 2021.

As part of the risk assessment, when the estimated exposure including the risk management measures (distance and drift reduction device) is greater than the reference toxicological value (AOEL or AAOEL), the approval is not granted.

Measurement campaigns in the air and a biomonitoring study of residents are currently underway.

Risk management measures

To limit the exposure of residents during or after spraying, the establishment of safety distances to the occupied buildings and unbuilt areas adjacent to these buildings is recommended. They should be at least equal to the distances introduced in the risk assessment for residents that are based on the type of crop and of material used, or greater, by precaution principle for products classified carcinogenic, mutagenic or toxic for the reproduction.

In order to limit the exposure of persons present during or after spray application, the establishment of safety distances from areas frequented by the public is recommended. Areas likely to be frequented by the public should be defined. The safety distance should be at least equal to the distances introduced in the risk assessment of bystanders that are based on the type of crop and the material used, or greater, by precaution principle for products classified carcinogenic, mutagenic or toxic for the reproduction.

Generalisation of drift-reduction devices (drift nozzles and / or appropriate equipment or application techniques) that would also limit environmental exposure is recommended.

Finally ANSES emphasizes the importance of training programs for farmers on good practices and the importance of programmes to inform residents and in particular the establishment of charters between farmers and neighboring populations.

 

To download: 

ANSES Opinion on a request for scientific support on measures to protect residents when using plant protection products, Saisine no.2019-SA-0020, 14.06.2019 (in French)

 

See also our previous article: 

FRANCE: New Agriculture and Food law published 

 

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

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FRANCE: Withdrawal of propiconazole-based products

As a result of the entry into force of Regulation (EU) 2018/1865 of 28th November 2018 concerning the non-renewal of propiconazole approval, ANSES has withdrawn 23 authorisations and 9 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 19.09.2019.

The end of use of the stocks of products is set on 19.12.2019.

 

To download: List of withdrawal of products based on propiconazole (in French)

 

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

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FRANCE: Withdrawal of quinoxyfen-based products

As a result of the entry into force of Regulation (EU) 2018/1914 of 6th December 2018 concerning the non-renewal of quinoxyfen approval, ANSES has withdrawn 5 authorisations and 9 parallel trade permits for plant protection products containing this active substance.

For three of the parallel trade permits (ARIUS SYSTEM CAZO, OÏMAX, QUINFENPLUS DUO), no grace period is granted.

For the other products:

The end of sales and distribution is set on 27.09.2019.

The end of use of the stocks of products is set on 27.12.2019.

 

To download: List of withdrawal of products based on quinoxyfen (in French)

 

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

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FRANCE: Withdrawal of flurtamone-based products

As a result of the entry into force of Regulation (EU) 2018/1917 of 6th December 2018 concerning the non-renewal of flurtamone approval, ANSES has withdrawn 2 authorisations and 2 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 27.09.2019.

The end of use of the stocks of products is set on 27.12.2019.

 

To download: List of withdrawal of products based on flurtamone (in French)

 

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Keywords: interdiction pesticides

 

FRANCE: Public consultation on the new Order for the authorisation of PPP for “amateur” uses

The Draft Order that has just been published for public consultation until 5 August 2019 aims at strengthening  the requirements for the authorisation of plant protection products for “amateur” uses in order to guarantee:

– a better safety for the non professional users and for the consumers of products treated with these products,

– a better protection of the environment when using these products.

This Order will consolidate and repeal the Order of 30 December 2010 banning the use of some plant protection products by non professional users and the Order of 30 December 2010 concerning packaging and labelling requirements  of plant protection products that can be used by non professional users. The draft Order completes the eligibility criteria for “amateur” plant protection products  in accordance with the recommendations made by Anses in the Opinion dated 16 February 2015. New hazard statements are therefore added for both products and active substances contained by the products to current criteria that do not permit to grant a marketing authorisation for ‘amateur” uses. It is noted that products containing an active substance being an endocrine disruptor or a persistent organic pollutant will not be authorised for “amateur” uses.

In addition, the draft Order specifies some packaging and labelling requirements in order to guarantee minimal exposure to non professional users. For example, this draft Order aims to ban dustable powders (DP) and to better regulate the packaging of wettable powders (WP) intended for the amateur market.

At last,  the draft Order sets that the compliance of authorised products with these new provisions shall be checked within 6 months after the entry into force of the Order.

The dossier for consultation is available on the website vie publique (in French).

 

To download: 

Draft Order regarding the conditions of authorisation of plant protection products for “amateur“ uses  (in French)

 

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EUROPE-EFSA: Recurring Issues in Ecotoxicology

EFSA published a technical report on the outcome of expert’s discussions in Ecotoxicology that took place during Pesticide Peer Review Meeting 185 in October 2018.

Numerous general and specific issues are addressed. The specific issues discussed are related to risk assessment for terrestrial vertebrates, aquatic organisms, non-target arthropods, soil organisms and non-target terrestrial plants.

 

To download: 

Outcome of the Pesticides Peer Review Meeting on general recurring issues in ecotoxicology – EFSA Supporting publication 2019:EN-1673.

 

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