Posts

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/

 

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: Withdrawal of desmedipham-based products

As a result of the entry into force of Regulation (EU) 2019/1100 of 27 June 2019 concerning the non-renewal of desmedipham approval, ANSES has withdrawn, from 01 January 2020, 7 authorisations and 12 parallel trade permits for plant protection products containing this substance.

The end of sales and distribution initially set on 01.04.2020 is extended by two months, so up to 01.06.2020.

The end of use of the stocks of products is set on 01.07.2020.

 

To download: 

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

 

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

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

 

FRANCE: Withdrawal of chlorpyrifos and chlorpyrifos-methyl-based products

As a result of the entry into force of Regulations (EU) 2020/18 and 2020/17 of 10 January 2020 concerning respectively the non-renewal of chlorpyrifos and chlorpyrifos-methyl approval, ANSES has withdrawn, from 16 February 2020, 9 authorisations and 1 parallel trade permit for plant protection products containing these substances.

The end of sales and distribution is set on 16.04.2020.

The end of use of the stocks of products is set on 16.04.2020.

 

To download: 

List of withdrawal of products based on chlorpyrifos and chlorpyrifos-methyl (in French)

 

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

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

 

FRANCE: Withdrawal of chlorpropham-based products

As a result of the entry into force of Regulation (EU) 2019/989 of 17 June 2019 concerning the non-renewal of chlorpropham approval, ANSES has withdrawn 22 authorisations and 8 parallel trade permits for plant protection products containing this active substance.

The end of sales and distribution is set on 08.04.2020.

The end of use of the stocks of products is set on 08.08.2020.

 

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

 

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

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

FRANCE: Withdrawal of chloridazon-, imazaquin- and quinoclamine-based products

Further to the expiry of approval of chloridazon, imazaquin and quinoclamine on 31 December 2018, ANSES withdraw 9 authorisations and 1 parallel trade permit for plant protection products containing these active substances.

 

The authorisations are withdrawn on 31.12.2019.

The end of sales and distribution is set on 30.06.2020.

The end of use of the stocks of products is set on 31.12.2020.

 

To download: List of withdrawal of products based on chloridazon, imazaquin and quinoclamine (in French)

 

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

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

 

Keywords: pesticides ban

 

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 – Anses: Recommendations for the Risk Assessment for Bees and Other Pollinators

In 2018, the Ministries of Agriculture and Ecological Transition asked Anses to make recommendations aimed at strengthening the regulatory framework for the protection of bees and other pollinators in France. Following this request and the first issued recommendations (Referral No. 2018-SA-0147in French), Anses began working on an update of the risk assessment procedure for bees and other pollinators in the context of Plant Protection Products authorisations (PPPs). On 28 October 2019, Anses published the conclusions of this work and its recommendations (Referral No. 2019-SA-0097in French).

Anses recommends replacing the current bee risk assessment scheme (based on SANCO/10329, 2002 and EPPO, 2010), by an approach based on the current version of the EFSA Bee guidance document (version of 4 July 2014, EFSA Journal 2013;11(7):3295), pending an harmonised approach is validated at European level. It is noted that the EFSA guidance document (2013) has not been adopted at EU level and is currently under revision by EFSA subsequent to a mandate from the European Commission (see our previous articles on this topic).

Anses recommendations concerning the new risk assessment scheme for bees and other pollinators are detailed below.

Effect assessment

Studies conducted with PPPs are recommended regardless of the type of PPP and regardless of the number of active substances they contain. Studies on honey bees and bumble bees are currently recommended.

Recommended laboratory toxicity studies

* on 14 June 2019

** Study required for all PPPs as soon as a chronic exposure to PPP cannot be excluded for any of the EFSA exposure scenario.

Recommended semi-field (tunnel) and field studies

Honey bees

When an acceptable risk cannot be demonstrated with laboratory studies, the recommended higher tier studies are those referred to in the European Commission documents in relation to Regulations (EU) No. 283/2013 and 284/2013:

Anses also refers to recommendations for tunnel and field studies from the EPPO Standard PP1/170 (4) (EPPO, 2010).

Tunnel and field studies are assessed in light of the protection goal for bees: it must be demonstrated that “under  field conditions  there are no unacceptable  effects on honeybee larvae,  honeybee behaviour, or colony  survival and development after use  of the plant protection product in accordance  with the proposed conditions of use” (Reg. (EU) No. 546/2011).

Other pollinators

Given the lack of validated standard protocol, no particular test is recommended by Anses. Anses however indicates that the studies should allow the assessment of an expected effect on the colony survival and on the colony ability to produce new fertile individuals that will perpetuate the cycle the following year.

Considered routes of exposure and risk assessments

With some exceptions, Anses recommends that exposure assessments be based on the EFSA Guidance Document (2013) for sprayed PPPs or for PPPs used for granular application or for seed treatment.

Initial risk assessments

For honey bees, it is noted that the scenario of oral exposure via guttation water is currently not recommended by Anses because the EFSA’s assessment method is deemed to be affected by too important uncertainties. In addition, guttation water is not regarded as a major exposure route. Exposure via guttation water may be considered once the methodology has been updated by EFSA.

A risk assessment for effects on the hypopharyngeal glands or for cumulative effects is also not recommended at this time due to the lack of validated experimental protocols available.

For bumble bees, only the acute risk for adults is considered. No further evaluation is recommended at this time due to the lack of validated experimental protocols available.

Regarding solitary bees, no assessment is recommended at this time due to the lack of validated experimental protocols available.

Risk quotients (“HQ”, “ETR”) should be compared to the threshold values as defined in the revision SANTE/10094/2015 (in the course of adoption) of the Regulation (EU) No. 546/2011. This revision will update the threshold values for the honey bee acute risk assessments on the basis of the threshold values defined in the current EFSA guidance document (2013). It is noted that document SANTE/10094/2015 does not mention threshold values for the honey bee chronic and larvae risk assessments, and for the bumble bee acute risk assessments. Nevertheless, in the absence of established threshold values, Anses recommends the use of the threshold values defined in EFSA (2013).

Refined risk assessments

When an acceptable risk cannot be demonstrated with laboratory studies, several options may be proposed:

  • Mitigation measures for problematic scenario (i.e. different variants of the SPe 8 phrase and mitigation measures as reported in EFSA guidance document (2013)).
  • Specific studies supporting the non relevance of certain exposure scenario or studies allowing to refine default exposure levels (residue studies conducted in pollen/nectar, residue dissipation studies, determination of the nectar sugar content of crops, etc.).
  • Higher tier studies (e.g. tunnel or field studies, studies assessing the ability of foragers to return to the hive).
Assessments for microorganism-based PPPs

For microorganism-based PPPs, the same methodology as for chemical-based PPPs is recommended. Adaptations of available experimental protocols are however recommended to justify the lack of pathogenicity/infectivity of microorganisms.

Perspective of the recommended risk assessment scheme

Anses indicates that the recommendations are made on the basis of the current version of the EFSA guidance document (2013) and on the basis of validated experimental guidelines currently available. Therefore, Anses call for:

  • An update of these recommendations after the revision of the EFSA guidance document (expected for March 2021).
  • An update of these recommendations as soon as a new experimental protocol is validated (e.g. acute toxicity assay on adults – solitary bees, chronic toxicity assay on adults and toxicity assay on larvae – bumble and solitary bees).
  • The development of new standardised assays for assessing the effects of microorganism-based PPPs.
  • The determination of regulatory threshold values for the chronic risk assessment for adults and for the risk assessment for larvae.

 

To download (in French): 

AVIS de l’Anses relatif à l’Evolution de la méthodologie d’évaluation du risque vis-à-vis des abeilles domestiques et des insectes pollinisateurs sauvages dans le cadre des dossiers de demande d’AMM des produits phytopharmaceutiques (Saisine n° 2019-SA-0097)

 

See also our previous articles: 

EUROPE-EFSA: Workplan for the Revision of the 2013 Bee Guidance Published

FRANCE – ANSES: recommendations to strengthen the protection of bees

 

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/