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EUROPE – EFSA: first cumulative risk reports of pesticides in food published

After a 2-month period of public consultation, EFSA released the final reports of assessments on the risks posed to humans by residues of multiple pesticides in food, one considering chronic effects on the thyroid system and the other acute effects on the nervous system.

The overall conclusion for both assessments is that consumer risk from dietary cumulative exposure is, with varying degrees of certainty, below the threshold that triggers regulatory action for all the population groups covered.

Assessments covering the effects of pesticides on other organs and body functions will follow in the coming years. EFSA is currently defining a comprehensive implementation plan with the European Commission.

 

To download: 

Cumulative dietary risk characterisation of pesticides that have chronic effects on the thyroid

Outcome of the public consultation on draft scientific report on the cumulative dietary risk characterisation of pesticides that have chronic effects on the thyroid

Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system

Outcome of the public consultation on the draft scientific report on the cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system

Cumulative risk assessment of pesticides: FAQ

 

See also our previous article: 

EUROPE – EFSA: Public consultation on cumulative risk assessment (CRA) of pesticides in food

 

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

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

 

EUROPE – EFSA: Recurring issues in mammalian toxicology

During the EFSA peer review of pesticide active substances under Regulation (EC) No. 1107/2009, several aspects in the area of mammalian toxicology were identified by EFSA that needed discussion with experts from National Authorities in order to enhance the harmonisation of the risk assessment of active substances.

A new discussion was held at the Pesticide Peer Review Meeting 17 of October 2019. The following topics were addressed:

  • Experience gained and feedback on the assessment of endocrine disrupting (ED) properties with the EFSA/ECHA guidance (2018) – Points for a potential update of the guidance,
  • Possibility to apply to pesticides the new ECHA guidance on impurities in biocides (to be published),
  • Issues related to the assessment of isomers (EFSA guidance 2019),
  • Issues related to the assessment of relevant metabolite in groundwater as regards genotoxicity,
  • Assessment of genotoxicity in chemical mixtures,
  • Use of in silico method for predicting genotoxicity endpoints,
  • Toxicological assessment of metabolites found as residues (EFSA guidance 2016),
  • Possibility to use Benchmark Dose (BMD) when a NOAEL cannot be set in toxicological studies,
  • Top dose selection in (chronic) toxicology studies.

EFSA also presented an update on the following ongoing projects:

  • Use of in vitro interspecies comparative metabolism studies,
  • Update of the OECD guidance notes on dermal absorption (ENV/JM/MONO(2011)36),
  • Development of integrated approaches to testing and assessment (IATA) case studies on developmental neurotoxicity (DNT) risk assessment,
  • Development of adverse Outcome Pathway (AOP) for substances having ED properties.

Other issues (such as the use of historical control data in toxicology studies) were raised by experts and are reported for consideration in future discussions.

 

To download: 

EFSA Technical Report – Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology (26 March 2020)

 

See also our previous articles: 

EUROPE – EFSA: Recurring issues in mammalian toxicology (2018)

EUROPE – EFSA: Recurring issues in mammalian toxicology (2016)

 

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

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

 

FRANCE: Safety distances near habitations, better understanding

The Ministry of Agriculture has published a comprehensive memo (in French) on the implementation of safety distances for residents.

In particular a list of the products concerned by the incompressible safety distance of 20 meters is made available.

A series of questions and answers aimed at clarifying the implementation of this new system is also given.

 

To download: 

List of products concerned by the incompressible safety distance of 20 mètres (in French)

”Question-answer” on the implementation of the Decree No. 2019-1500 of 27 December 2019 and of the Order of 27 December 2019 (in French)

 

See also our previous articles: 

FRANCE – Implementation of the New System for Protecting Residents from PPP Spray Drift

FRANCE – Public consultation: new system for protecting residents when using plant protection products

 

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

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

 

FRANCE – Implementation of the New System for Protecting Residents from PPP Spray Drift

With the entry into force on 01 January 2020 of the Order and Decree of 27 December 2019 that aim at strengthening the protection of residents living nearby crop areas treated with plant protection products (PPP), the French Ministry of Agriculture and Food has published a Technical Instruction providing additional details to the Prefects and to the (Regional) Departments for Food, Agriculture and Forestry (DRAAF and DAAF) for the implementation of the new system.

As a reminder, from 01 January 2020, new minimum safety distances apply between PPP spreading zones (in agricultural and non-agricultural areas) and residential areas or places with vulnerable people. Safety distances can be reduced near homes via Charters of Commitments at the departmental level proposed by PPP users. These Charters will be subject to public consultation and will become applicable after their approval by the Prefects.

The Instruction specifies that to date only drift reduction technologies approved by the French Ministry of Agriculture for their effectiveness can allow a reduction in safety distances. In the future, alternative methods (e.g. hedges, nets) could be taken into account providing that studies demonstrate their effectiveness and that the methods are acknowledged by Anses.

The Instruction reminds that in the absence of an approved Charter, or when the commitments of the approved Charter cannot be implemented, PPP applications must comply with safety distances, without any reduction possible. However, users involved in a draft Charter proposal subject to public consultation are allowed to anticipate the reductions in safety distances – provided drift reduction technologies as defined in Annex 4 to the Order of 27 December 2019 are applied – pending approval of the Charter and until 30 June 2020.

Finally, the Prefects will have to ensure that before 30 June 2020, the existing measures for the protection of vulnerable people (set in application of Article L.253-7-1 of the French Rural Code) are consistent with the new Order of 27 December 2019: i.e. the safety distances must at least be equal to that defined in the Order.

 

To download: 

Technical Instruction DGAL/SDQSPV/2020-87 of 03 february 2020 as regards enforcement of the new system for protecting residents protection des riverains that might be exposed to plant protection products (No. NOR AGRG2003727C) (in French).

 

See also our previous articles: 

FRANCE – Enforcement of the new system for protecting residents when using plant protection products

 

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

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

 

FRANCE – Enforcement of the new system for protecting residents when using plant protection products

The order and the decree regarding the new framework for the use of plant protection products near habitations were published in the French official journal of 29 December 2019.

This system is aimed in particular at strengthening the protection of health of the populations living nearby crop areas treated with plant protection products, as well as that of farmers.

The Order of 27 December 2019 reviews several articles of the Order of 4 May 2017. The existing measures regarding the protection of health and environment are extended to applications other than spraying and powdering and ban applications during heavy rains. The provisions regarding personal protective equipment are updated and minimum distances are set between the spreading zones and both residential areas and places with vulnerable people.

 

The minimum distances to be respected are as follows:

20 m minimum (without reduction possibility) for the treatment of plant aerial part  with plant protection products classified H300, H310, H330, H331, H334, H340, H350, H350i, H360, H360F, H360D, H360FD, H360Fd H360Df, H370, H372 or containing an active substance considered as having endocrine disruptor effects.

For other plant protection products, except biocontrol products as defined by article L. 253-6 of the French Rural Code and products containing only basic or low risk substances:

10 m minimum for orchards, grapes, trees and shrubs, forest, small fruits and ornamentals crops higher than 50 cm, banana and hops,

5 m minimum for other agricultural and non-agricultural uses.

These minimum safety distances do not apply to treatments necessary for the destruction and the prevention of the spread of regulated pests.

Within the framework of charters validated at the department level, these minimum distances can be reduced in accordance with the provisions set by the order further to Anses opinion, in the case of spreading zones closed to residential areas as defined by Article L 253-8 (III) of the French Rural Code, i.e. from 10 m to 5 m for orchards, from 10 m to 5 m or 3 m for grapes and from 5 m to 3 m for other agricultural and non-agricultural uses.

The list of environmentally efficient spraying equipments to be used for reducing minimal distances will be published by the Ministry of agriculture.

 

As for the Decree of 27 December 2019, it sets the procedures of elaboration, consultation and validation as well as the content of the concerted commitment charters.

 

As planned, these texts will entry into force on 1 January 2020.

For fields sown before 1st January 2020, the minimum distances of 5 m and 10 m are applicable from 1 July 2020 but the 20-m buffer zones apply from 1st January 2020.

The same minimum distances are applicable to linear infrastructures if their compliance does not result in the technical impossibility to guarantee operational safety and by 1 July 2021 at the latest.

 

To download:

Arrêté du 27 décembre 2019 relatif aux mesures de protection des personnes lors de l’utilisation de produits phytopharmaceutiques et modifiant l’arrêté du 4 mai 2017 relatif à la mise sur le marché et à l’utilisation des produits phytopharmaceutiques et de leurs adjuvants visés à l’article L. 253-1 du code rural et de la pêche maritime (in French)

Décret n° 2019-1500 du 27 décembre 2019 relatif aux mesures de protection des personnes lors de l’utilisation de produits phytopharmaceutiques à proximité des zones d’habitation (in French)

 

Anses opinion on the a request for scientific and technical support on the efficacy equivalence  of combined drift reduction measures for protecting residents when using plant protection products. Saisine 2019-SA-0173, 17.12.2019   (in French)

 

Our previous articles:

FRANCE – Public consultation: new system for protecting residents when using plant protection products

 

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

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

FRANCE – ANSES: Pesti’home, a French study on the use of pesticides at home

This study was conducted between July and November 2014 by ANSES in order to gain a better knowledge of practices and uses of Home & Garden pesticides within French households. A total of 1507 households was selected randomly and interviewed to obtain a better assessment of the population exposure to pesticides.

In this study, all products available for sale for amateurs were taken into account: plant protection products used in plant protection, biocidal products used at home for pest control and also human and veterinary medicinal products for parasitic pest control, i.e. a total of 5400 products were identified.

This study showed that 75% of households had used at least one pesticide during the 12 months prior to the date of the survey. 84% of households that had used pesticides had used insecticides during the year (biocides against flying and crawling insects and also veterinary medicines to control parasitic pests) followed by herbicides (22%), fungicides for plant protection (20%) and then by cutaneous repellent products, e.g. mosquitoes repellents (12%).

Thus, 3 user profiles could be defined (low, strong and very strong pesticide users) and ANSES made 2 main axes evident:

1- The need to better inform users on the use conditions and on the rules for disposal of pesticides.

2- The availability of data from this study in order to allow a better evaluation of exposure and risks related to the use of pesticides at home (in particular for the identification of cumulative exposures to chemical substances).

 

To download: 

Pesti’home study on the use of pesticides at home (in French)

 

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

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

EUROPE – EFSA: Public consultation on cumulative risk assessment (CRA) of pesticides in food

EFSA is carrying out a public consultation on its pilot assessments of the risks posed to humans by residues of multiple pesticides in food.

Interested parties have until 15 November 2019 to submit comments on two assessments: one considers chronic effects on the thyroid system and the other looks at acute effects on the nervous system.

These pilot assessments were conducted as a sequential process:

 

The first step was the establishment of cumulative assessment groups (CAGs) of pesticides for their effects on the nervous system and the thyroid. The methodology rests on the assumption that pesticides causing the same specific effects can produce cumulative toxicity.

Establishment of cumulative assessment groups of pesticides for their effects on the nervous system

All effects of pesticides on the nervous system were reviewed and five were found to meet the criteria established by the PPR Panel and to be specific for consideration in CRA. 

Two CAGs (for brain and/or erythrocyte AChE inhibition and for functional alterations of the motor division) were considered sufficient to cover the cumulative risks associated to all five specific effects.

Establishment of cumulative assessment groups of pesticides for their effects on the thyroid

All effects of pesticides on the thyroid were reviewed and two were found to meet the criteria established by the PPR Panel and to be specific for consideration in CRA (hypothyroidism and C-cell hypertrophy, hyperplasia and neoplasia).

 

For the second step, cumulative exposure assessments were conducted using probabilistic modelling with two different software tools (MCRA and SAS®). The two tools produced nearly identical results and any observed differences are mainly attributed to the random effect of probabilistic modelling. These minor differences do not impact on the outcome of the exposure assessment.

Monte Carlo Risk Assessment (MCRA) software:

Cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using MCRA software

Cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using MCRA software

SAS® software:

Cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using SAS® software

Cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using SAS® software

 

The third step was a cumulative risk characterisation which was based on the outcome of the first two steps and included an uncertainty analysis.

The draft assessments are the culmination of a multi-year collaboration between EFSA and the National Institute for Public Health and the Environment for the Netherlands (RIVM):

EFSA Scientific report – DRAFT Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system

Overall, taking account of the available data and the uncertainties involved, it is concluded that cumulative exposure to pesticides that have acute effects on the nervous system does not exceed the threshold for regulatory consideration established by risk managers.

EFSA Scientific report – DRAFT Cumulative dietary risk characterisation of pesticides that have chronic effects on the thyroid

Overall, taking account of the available data and the uncertainties involved, it is concluded that cumulative exposure to pesticides that have chronic effects on the thyroid does not exceed the threshold for regulatory consideration established by risk managers.

 

The overall draft conclusion for both assessments is that consumer risk from dietary cumulative exposure is below the threshold that triggers regulatory action for all the population groups covered.

The EU regulation on maximum levels of pesticides in food (MRLs) stipulates that decisions on MRLs should take into account cumulative effects of pesticides as and when the methods to assess such effects become available. In addition, the regulation covering the placing of pesticides on the market stipulates that pesticides should have no harmful effects – including cumulative effects – on humans.

 

For more information: 

Public consultation on the draft EFSA scientific reports on a cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system and chronic effects on the thyroid

 

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

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

 

FRANCE – Public consultation: new system for protecting residents when using plant protection products

The government has launched a public consultation on Monday 09 September, for a period of 3 weeks, a new framework for the use of plant protection products near habitations.

This system is aimed in particular at strengthening the protection of health of the populations living nearby crop areas treated with plant protection products, as well as that of farmers. Two texts are proposed:

 

– a draft decree framing the drafting of the concerted commitment charters introduced by the Agriculture and Food Act (EGalim law – Article 83) and their validation by the department prefect

These charters must make it possible to set up a local dialogue between users and local residents and will define in a concerted and adapted manner a certain number of measures, such as pre-treatment information modalities.

 

– a draft order defining new regulatory measures in response to the decision of the Council of State of 26 June 2019 concerning the partial cancellation of the Order of 4 May 2017.

This draft order defines in particular the minimum distances to be respected between the spreading zones and the residential areas. These minimum distances are based on the recommendations made by ANSES in its opinion of 14 June  2019:

– 10 m minimum for the application of plant protection products classified H300, H304, H310, H330, H331, H334, H340, H350, H350i, H360, H360F, H360D, H360FD, H360Fd H360Df, H370, H372 or containing an active substance considered as an endocrine disruptor;

– for other plant protection products, 10 m minimum for high crops and 5 m minimum for low crops.

These minimum distances can be adapted within the framework of charters validated at the departmental level, after exchanges between the farmers, the local residents and the elected officials.

These minimum distances may be reduced to 3 m for low crops and grapevine and to 5 m for other crops, provided that the most environmentally efficient spraying equipment is used.

 

The entry into force of these texts, which are also subject to consultation with the European Commission, is scheduled for 1 January 2020.

 

The file for consultation is available on the Public Consultations page of the website of the Ministry of Ecological and Solidarity Transition.

 

To download: 

Draft decree and order on measures to protect people when using plant protection products nearby  habitations (in French)

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)

 

Our previous articles:

FRANCE – ANSES: Opinion on protection measures for residents

FRANCE: Partial cancellation of the Order on the use of PPPs and adjuvants

FRANCE: New Agriculture and Food law published

 

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

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

 

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.

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

 

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

 

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

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