FRANCE: Glyphosate – Teams selected to conduct complementary studies

In August 2019, ANSES launched a call for tenders for the conduct of several complementary in vitro and in vivo studies following the controversy over the carcinogenic classification of glyphosate.

After the evaluation of the proposals and the analysis of relationships of interest, ANSES announce the selection of the following teams: a consortium coordinated by the “Institut Pasteur de Lille” and the International agency for research on cancer (IARC).

These research teams will benefit from a global founding of 1,2 million euros under the Ecophyto II+ plan.

All these additional studies aim to establish the most complete scientific expertise possible on the carcinogenic potential of glyphosate. The results will be considered during the EU review process of glyphosate.

To download: 

Press release of 30 April 2020 (in French)

List of selected research teams (in French)

Anses Opinion and report as regards the specification of a study on the carcinogenic potential of glyphosate (in French)

 

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

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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/

 

FRANCE: Use of copper in agriculture

The French Ministry of Agriculture and Food published an article on its website related to the use of copper in agriculture. This follows the renewal of approval of the active substance “copper compounds” since 1 January 2019 for a period of 7 years.

The main points to highlight are:

  • Limiting the total amount of copper to 28 kg/ha over 7 years, allowing interannual fluctuation around an average theoretical dose of 4 kg/ha/year. This condition is applicable in both conventional agriculture and organic agriculture.
  • Copper compounds are a substance candidate for substitution. Thus, comparative assessment will have to be conducted for all copper-based plant protection products.
  • Copper-based fertilizers are not concerned by the renewal of approval, however copper contents must be deducted in the calculation of annual amounts applied per hectare.

Finally, the article recalls alternative methods which can be used in a complementary way in order to reduce the use of copper or even do without copper.

 

To download: 

Questions / Answers : use of copper in agriculture (in French)

See also our previous articles: 

EUROPE: Copper compounds renewal for 7 years

FRANCE: A road map about the reduction of use of copper in agriculture

 

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

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FRANCE: New requirements for the approval of PPP for “amateur” uses

The Order aiming at strengthening the requirements for the authorisation of plant protection products for “amateur” uses  was published on 10 April 2020. It repeals 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 strengthening is implemented in the context of the “LABBÉ’s” law No. 2014-110 of 6 February 2014. The law set the ban of sales, dispensing, use and possession of plant protection products by non professional users in place since 1st January 2019 with the aim to reduce the risks associated to the use of pesticides by amateurs. There are three exceptions to this ban for products authorised for non professional users (claim “emploi autorisé dans les jardins (EAJ)”):

  • biocontrol products officially listed by the Ministry of Agriculture in accordance with articles L.253-5 and L.253-7 of the Rural Code,
  • low risk products as defined by Regulation (EC) No.1107/2009 (art. 47), and
  • products authorised for organic farming (Regulation (EC) No.889/2008),

New criteria for authorisation granting for amateur uses

The Order adds new hazard statements 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.

The following formulations are also banned by the Order:

  • dustable powders (DP),
  • wettable powders (WP), except for unidoses packaging or any other system that permits to exclude the user’s contact with the product.

Lastly, the Order specifies some packaging and labelling requirements in order to guarantee minimal exposure to amateur users.

Consequences on marketing authorisations

Further to the entry into force of the Order on 11 April 2020, ANSES published a note presenting the consequences of the new provisions on the existing marketing authorisations, on the applications under evaluation and on applications made after 11 April 2020.

 

  • Existing marketing authorisations for amateurs 

The authorisations of amateur products subject to a restriction of use since 1st January 2019 will be withdrawn within 6 months of the entry into force of the Order. Grace periods of 6 months for sales and distribution to professionals and further 12 months for storage and use by professionals will be granted.

For authorised products not subject to a restriction of use, ANSES will check their compliance with the provisions of the Order at their authorisation renewal.

 

  • Applications under evaluation

The ongoing dossiers for products subject to a restriction of use since 1st January 2019 will be closed without specific explicit decision, except for zonal or interzonal applications for which France act as zRMS. In these cases, a Registration Report will be provided to the cMS.

Other applications will be evaluated against the criteria of the Order.

 

  • New applications for amateur uses

A revised version of the Cerfa form 15722 will be available soon. With this revised version, the applicant will be able to identify the type of product (biocontrol list, low risk and/or organic farming).

The procedure for the registration of biocontrol products on the official list of the Ministry of Agriculture (articles L.253-5 and L.253-7 of the Rural Code) remains the same.

The claim “low risk product” will be granted by Anses at the end of the evaluation in compliance with the criteria of article 47 of Regulation (EC) No.1107/2009. The claim will be mentioned in the decision of authorisation and will also appear on E-Phy website (new pictogram).

A new claim for organic farming (“utilisable en agriculture biologique”) is set for amateur uses with a new pictogram “PBA” (production biologique amateurs). The pictogram “UAB” remains only for professional uses. The compliance of amateur products with Regulation (EC) No.889/2008 for organic farming will not be assessed by INAO but by ANSES.

 

To download: 

Order of 6 April 2020 as regards the conditions of approval of plant protection products for amateur uses (in French)

ANSES – Note regarding products for amateur uses (April 2020) (in French)

 

Our previous articles:

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

FRANCE: Ban of home and garden plant protection products

 

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

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

FRANCE – ANSES: Plant protection substances of concern

As part of the French government plan for a less pesticide-dependent agriculture, a CGAAER-CGEDD-IGAS inspection mission listed in 2017 some of the active substances of concern the most frequently identified or mentioned in monitoring reports.

ANSES was seized on 10 July 2018 in order to conduct an expert appraisal of these substances of concern. The corresponding Opinion has just been published.

Based on the findings of this mission report, and taking into account the ban of some substances and the subsequent withdrawal of a number of products, ANSES updated the list of active substances requiring particular attention.

ANSES recommend the non renewal of mancozeb, considered by ECHA as a category 1B reproductive toxicant, and of thiophanate-methyl, classified as a category 2 mutagen.

Moreover, without waiting for the EU renewal assessment of active substances, ANSES also undertake for the 2020-2021 period, a re-assessment of the risks posed by the products containing:

– substances recently classified by ECHA as category 1B carcinogens or reproductive toxicants: 8-hydroxyquinoline, ipconazole, flurochloridone, spirodiclofen, halosulfuron-methyl;

– the active substance prosulfocarb, for which the risk for bystanders and residents will be re-assessed as a result of contaminations of nearby non-target crops, which lead to a change of conditions of use.

Lastly, ANSES start the assessment of the endocrine-disruptor properties of prochloraz without waiting for a possible EU renewal application for this substance.

 

To download: 

Anses Opinion on the plant protection substances identified as giving rise to concern in the CGAAER-CGEDD-IGAS report on the use of plant protection products (in French)

 

Our previous article :

FRANCE : Action plan for plant protection products

 

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

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

 

FRANCE – ANSES: Impacts of Ordinance 2020-306 on grace periods

Ordinance 2020-306 of 25 March 2020 was published in the OJ as part of the health emergency period linked to the spread of Covid-19. The ordinance aims to extend deadlines during the health emergency period and to adapt administrative procedures during this same period.

The provisions of this ordinance directly impact the terms of withdrawal of plant protection products, fertilisers or adjuvants when the grace periods granted have expired or expire between 12 March 2020 and the expiration of a period of one month from the date of cessation of the declared state of health emergency (currently set as of 24 May 2020) i.e. to date 24 June 2020.

In this context, ANSES published a Note concerning the impact of this Ordinance on grace periods which can only be applied within the timelines set at European level.

The grace periods are extended by 3 months (article 3) after the date of cessation of the state of health emergency, that is to say until 24 August 2020, within the limit of 6 months for sale and distribution, and an additional 12 months for the storage and use of existing stocks, unless:

– a European implementing regulation for non-renewal of the approval provides for shorter periods;

– grace periods have been voluntarily limited for reasons of protection of human and animal health or the environment.

The cases of the products concerned are listed at the end of the Note.

 

To download: 

Ordinance No.2020-306 of 25 March 2020 as regards the extension of deadlines that expire during the health emergency period and the adaptation of administrative procedures during this same period   (in French)

ANSES – 14.04.2020 – Note to owners of marketing authorisations and parallel permits regarding the impact of Ordinance No.2020-306 of 25 march 2020 on the terms of withdrawal of products, i.e. on grace periods (in French)

 

To further understand: 

Bulletin of 26 March 2020 – Bulletin presenting the provisions of Title 1 of Ordinance No.2020- 306 of 25 Mars 2020 as regards the extension of deadlines that expire during the health emergency period and the adaptation of administrative procedures during this same period (in French)

 

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 – ANSES: Covid-19 – New temporary procedures for submitting dossiers

In view of the current Covid-19 situation, ANSES has adapted its organisation to allow authorisation and parallel trade permit holders (plant protection products, fertilisers, adjuvants) to submit their dossiers in a dematerialised and secure manner.

Thus, 4 temporary submission procedures are possible:

  • Submission of the dossier on a secure platform of your choice

→ Send an information email to damm.uia@anses.fr, with the following subject: MISE A DISPOSITION D’UNE DEMANDE – NOM PRODUIT – Application code XXXX”. The information on download as well as the duration of availability of the files should be specified.

  • Submission of the dossier on the secure platform of ANSES “Mes Echanges”

→ Send an email to damm.uia@anses.fr, with the following subject: “DEMANDE D’OUVERTURE D’UN DOSSIER SUR MES ECHANGES – NOM PRODUIT – Application code XXXX”. The submission terms, with a link and a password will be sent back by ANSES.

  • Submission of “small” dossiers by email

→ Send the dossier by email to damm.uia@anses.fr, with the following subject: “DEPOT D’UN DOSSIER – NOM PRODUIT – Application code XXXX”. The dossier, with all the required data, must be sent in only one email.

  • Submission by post

→ The mail is picked up twice a week by ANSES. The received dossiers are still registered and handled by the administrative unit.

 

For the first 3 procedures, dossiers should be sent in electronic format (CD/DVD) at the end of confinement. A declaration of identity between data sent dematerialised and data on CD/DVD should also be provided with the application. It should specify the e-mail address of the sender, and the date and time of the email sent.

 

To download: 

Applications for pesticide products, fertilisers and crop supports, and adjuvants – Covid-19: new procedures for submitting dossiers (in French)

 

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

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

 

FRANCE: National memo on sustainable management of fungicides resistance of Sclerotinia sclerotinium in oilseed rape

The national memo on sustainable management of fungicide resistance of Sclerotinia sclerotinium on oilseed rape has been published :

This memo provides an overview of oilseed rape Sclerotinia sclerotinium resistance to the main fungicide families authorised in France and gives recommendations to limit resistance development risks and to maintain the products’ effectiveness.

 

See also our previous articles: 

FRANCE: 2020 National memos on the sustainable management of resistance to fungicides

FRANCE: 2019 National memos on the sustainable management of resistance to fungicides

 

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

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