FRANCE: Withdrawal of chlorothalonil-based products

As a result of the entry into force of Regulation (EU) 2019/677 of 29th April 2019 concerning the non-renewal of chlorothalonil approval, ANSES withdraw 25 authorisations and 8 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 20.02.2020.

The end of use of the stocks of products is set on 20.05.2020.

 

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

 

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

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

FRANCE: Order as regards the experimental use of pilotless aircrafts for pesticides spraying

The French Order regarding the implementation of the experimental use of pilotless aircrafts  for pesticides spraying was published on 08th October 2019 pursuant to Article 82 of the Agriculture and Food law, also called EGalim.

This Order sets the conditions of implementation of the trials performed as part of this experiment planned for maximum 3 years.

 

To download: 

Order regarding the experimental use of pilotless aircrafts for pesticides spraying (In French)

 

Our previous articles: 

FRANCE: Experimental use of pilotless aircrafts for pesticides spraying

 

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/

FRANCE: Updated list of substances concerned by the Tax on Diffuse Pollution for public consultation

The Tax on Diffuse Pollution was set by the law for water and aquatic environments No.2006-1772. This tax aims at decreasing the contamination of  aquatic environments by substances contained by plant protection products.

The list of substances concerned by the Tax on Diffuse Pollution is set by the Order of 22th Novembre 2010 and is updated every year in order to consider the evolution of substance classification.

The draft order updating the list of substances for 2020 has been published for public consultation from 11th to 31th October 2019.

In comparison to the list of 2019, the status of 16 substances is updated, 5 substances are withdrawn from the list since their new hazard statements do not enter in the Tax on Diffuse Pollution base, and 11 substances are added to the list. Among the newly entries, 8 are not approved anymore but they can be contained by products authorised for emergency use according to article 53 of Regulation (EC) No.1107/2009.

 

Our previous article:

FRANCE: Tax on Diffuse Pollution – Evolutions for 2019

 

To download: 

Presentation of the draft order for 2020 Tax on Diffuse Pollution (in French)

Draft order as regards the Tax on Diffuse Pollution for 2020 (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 – two neonicotinoid-like active substances to be banned

The French law EGAlim of 30 October 2018 (law for achieving a balance in trade relations in the agricultural sector and for healthy, sustainable and affordable food), modified Article L253-8 of the French Rural Code to extend the ban of neonicotinoids to all active substances with a similar mode of action.

As the modalities of implementation remained to be set, the government started on 11 September 2019 a public consultation on the draft Decree listing the active substances used in plant protection products with a neonicotinoid-like mode of action. This draft Decree includes two active substances: flupyradifurone and sulfoxaflor. The ban of neonicotinoid based-products in France would therefore be extended to the products containing these substances by the end of the year.

The public consultation will be closed on 4 October 2019.

 

To download: 

Government press release as regards the draft French Decree to ban the use of two active substances with a neonicotinoid-like mode of action (in French).

The draft French Decree listing the active substances used in plant protection products with neonicotinoid-like mode of action (in French).

 

See also our previous articles: 

FRANCE: New Agriculture and Food law published

FRANCE: Withdrawal and restrictions on the use of neonicotinoid-based PPPs

 

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: Withdrawal of epoxiconazole-based products

In Anses Opinion dated 19 April 2019, Anses concluded that Epoxiconazole is an endocrine disruptor for humans and non-target organisms. Further to this evaluation, Anses has withdrawn 24 authorisations and 52 parallel trade permits for plant protection products containing this active substance on 30 July 2019.

 

The end of sales and distribution is set on 30.11.2019.

The end of use of the stocks of products is set on 30.07.2020.

 

To download:

List of withdrawal of products based on epoxiconazole (in French)

 

Our previous articles:

FRANCE – ANSES: Epoxiconazole-based products ban

 

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

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

 

EUROPE – EFSA: Guidance on risk assessments for substances, impurities and transformation products that may have stereoisomers

EFSA has published a guidance on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities. The document also proposes guidance to be used for active substances that, without containing any stereogenic element, may generate transformation products or metabolites  that do contain them. As a general principle, stereoisomers need to be treated as different chemical components for the risk assessment.

The draft version was proposed to public consultation in April – May 2019. A report presenting the  comments received and how they have been considered by EFSA has been made available.

In this guidance, Regulation (EU) 283/2013 on the data requirements for the plant protection active  substances is analysed, and recommendations are given on how to best address and assess the data requirements for active substances containing stereoisomers. Furthermore, the guidance gives recommendations on how to make the best  use of the available information to perform the risk assessment of these substances, particularly in situations when the information on individual isomers is not available or difficult to obtain, with the primary objective to reduce the need to repeat vertebrate animal testing.

One special situation is when active substances, that without containing any stereogenic element, may generate transformation products that do contain them. In these cases, it is appropriate to refer to metabolites containing stereoisomers. For these substances, the guidance should not be applied to the active substance but should be applied to assess metabolites that contain a stereogenic element.

 

To download: 

Guidance of EFSA on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers

 

Outcome of the public consultation on the draft guidance on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers

 

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

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

EUROPE – COM: Technical Guidelines on Data Protection

These technical Guidelines are intended to help Member States and Applicants for practical application of the legal provisions of Articles 59 – 62 and 80 of Regulation (EC) No 1107/2009. This Commission Notice replaces SANCO/12576/2012– rev. 1.1, 01.02.2013. The use of these revised Guidelines is recommended for any applications for active substance and/or plant protection products submitted after 3 October 2019.

This document covers 2 main areas:

  • Section 1 – explaining the periods of protection applied to studies under different circumstances – the “why, when and how long”
  • Section 2 – clarification of the special procedures and provisions that apply to vertebrate data sharing

The following parts have been revised compared to the first version of the document dating from 1 February 2013:

  • Change to provisions for protection of confirmatory data.
  • Clarification of general requirements for applying protection via increased emphasis of paragraph 6.
  • Clarification of other points of the technical Guidelines which were raised by Member States, thanks to their gained experience and while developing other guidelines, such as the one on Article 43 of Regulation (EC) No 1107/2009.
  • Change of rules for the acceptance of duplicate studies.

 

To download: 

COMMISSION NOTICE Technical Guidelines on Data Protection according to Regulation (EC) No 1107/2009 (08.07.2019)

 

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

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