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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.

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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/

 

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 170 of December 2017. Recommendations were made on:

  • Genotoxicity of plant protection products
  • Use of (Q)SARs
  • Use of Read-Across approaches for metabolites

These recommendations will be applied during the EFSA peer review of the active substances.

 

In addition, brief discussions of the following topics were also made:

  • EFSA guidance 2016 on the residue definition
  • EFSA guidance 2017 on dermal absorption
  • Current and planned EFSA activities in the area of pesticides:
    • Developmental neurotoxicity
    • Cumulative assessment groups
    • Epidemiology
    • Planned workshops (in vitro comparative metabolism, phototoxicity, historical control data)
    • Update of EFSA guidance 2014 on the assessment of exposure of operators, workers, residents and bystanders

 

To download:

EFSA Technical Report – Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology (25 August 2018)

 

See also our previous articles:

EUROPE – EFSA: Recurring issues in mammalian toxicology

 

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

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

 

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

Nearly one year ago, the European Food Safety Agency (EFSA) published a revised version of its guidance document on dermal absorption (EFSA Journal 2017;15(6):4873) which defines new default values to be used in absence of experimental data.

The new guidance document was adopted at the Standing Committee on Plants, Animals, Food and Feed of 25 May 2018. This document will start to be used for any active substance or plant protection product applications submitted after 25 August 2018.

For the purpose of this guidance document, a plant protection product is considered:

  • as a concentrate, when the amount of active substance is >50 g/L or g/kg, i.e. >5%, or
  • as a dilution, when the amount of active substance is 50 g/L or g/kg, i.e. 5%.

Member States may decide in the future to carry out a further more precise analysis in order to refine the trigger value of 5%.

 

To download:

Guidance on dermal absorption (SANTE/2018/10591)

 

See also our previous articles:

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/

EUROPE: New EFSA GD on Dermal absorption

EFSA was asked by the European Commission to assess the scientific quality of newly available human in vitro studies on dermal absorption and, based on the evaluation of the studies, to revise the EFSA PPR Panel guidance on dermal absorption (EFSA PPR Panel, 2012).

The guidance proposed new default values to be used in absence of experimental data. Since the new available data clearly show that dermal absorption is significantly affected by the concentration of active substance in the product and by the type of formulation, the new default values are categorised by formulation type or concentrated and diluted pesticide formulations.

A comparison of new and current default values is presented below:

2017 Guidance Document:

Formulation type Concentration status Default dermal absorption  value
Organic solvent-based(a) or other(b) Concentrate 25%
Dilution 70%
Water-based(c) or solid(d) Concentrate 10%
Dilution 50%

(a): Formulation types: emulsifiable concentrate (EC), emulsion, oil in water (EW), suspo-emulsion (SE), dispersible concentrate (DC), oil miscible liquids (OL/OF), oil-based suspension concentrates (OD), emulsion for seed treatment (ES), microemulsion (ME).

(b): Formulation types: bait concentrate (CB), capsule suspension (CS), gel for direct application (GEL/GD), bait, ready for use (RB), mixture of capsule suspension and suspension concentrate (ZC), seed coated with a pesticide (PS), experimental solution of active substances in solvent (AI).

(c): Formulation types: soluble concentrate (SL), suspension concentrate (SC), flowable concentrate for seed treatment (FS), flowable (FL) (=SC).

(d): Formulation types: wettable powder (WP), water-dispersible granules (WG/WDG), water-soluble granules (SG), water-soluble powder (SP), powder for dry seed treatment (DS).

 

2012 Guidance Document:

Default dermal absorption value
Concentrate

(> 5% a.s., 50 g/kg for solids or 50 g/L for liquids)

25%
Dilution

(≤ 5% a.s.)

75%
Active substance with

log Pow < -1 or > 4 and MW > 500

10%

 

A technical meeting with stakeholders will be held in Parma on 27-28 September 2017 to explain how the document differs from the guidance issued in 2012, answer questions and collect feedback.

 

To download:

Guidance on dermal absorption (EFSA Guidance, 24/05/2017)

Outcome of the public consultation on the draft EFSA Guidance on dermal absorption (EFSA Technical report, 24/05/2017)

 

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

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

 

EUROPE: Review of exposure data to pesticides

Over the last 30-40 years there has been growing concern regarding the contamination of the environment by pesticides and public concerns regarding their own exposure to pesticides began to gain momentum around the early 2000s. In 2014, the ‘EFSA Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products’ and a spreadsheet calculator to facilitate calculation of exposures were published. The datasets on which the calculations are made are restricted in terms of there being a limited number of studies and incompleteness. Consequently, EFSA have commissioned a study to review and evaluate all published data related to the exposure to pesticides for residents and bystanders and for environmental risk assessment.

This document constitutes the final report for the EFSA project. The overall aim of this project is to collate all published data (predominately peer-reviewed publications supplemented by grey-literature) for the last 25-years relating to resident and bystander exposure to pesticides and to develop and populate a database to support non-dietary exposure assessments for regulatory purposes. More specifically it covers the following 4 themes:

  • Resident and bystander exposure to pesticides;
  • Air concentrations (vapours and aerosols) of plant protection substances;
  • Drift values from spray, seed and granular applications both in the field and undercover;
  • Dislodgeable foliar residues.

 

To download:  Review of the published exposure data to pesticides for residents and bystanders, and for environmental risk assessment: Final report

 

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

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

 

EUROPE: Update on Guidance Document on the operator, worker, resident and bystander exposures

Guidance Document SANTE-10832-2015 rev. 1.7 of 24 January 2017 is an update of the first version of May 2015.

Some issues are clarified such as the use of an AAOEL (Acute Acceptable Operator Exposure Level for acute risk assessment) and the use of the model for operator, bystander and resident risk assessments.

In order to improve harmonisation, rev. 1.7 of this GD will apply to applications for the approval or renewal of approval of active substances and to the applications to authorise or renew authorisations for plant protection products submitted from the 1st March 2017 as follows:

Where necessary, an AAOEL should be proposed during the EU peer-review taking into account the Annex to this Commission guidance document.

To download:

SANTE-10832-2015 rev. 1.7 –  24 January 2017 – Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products

 

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

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