Posts

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 defined in Regulation (EU) No. 546/2011. It is noted that a revision of this Regulation is ongoing and is expected to be adopted soon (SANTE/10094/2015). In the absence of regulatory threshold values ​​(e.g. acute risk – bumble bees, chronic risk and risk for larvae – honey bees and bumble bees), Anses indicates that the risk quotients should be compared to the threshold values ​​defined in the current EFSA guidance document (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 – 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/

 

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

The Draft Order that has just been published for public consultation until 5 August 2019 aims at strengthening  the requirements for the authorisation of plant protection products for “amateur” uses in order to guarantee:

– a better safety for the non professional users and for the consumers of products treated with these products,

– a better protection of the environment when using these products.

This Order will consolidate and repeal 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 draft Order completes the eligibility criteria for “amateur” plant protection products  in accordance with the recommendations made by Anses in the Opinion dated 16 February 2015. New hazard statements are therefore added 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.

In addition, the draft Order specifies some packaging and labelling requirements in order to guarantee minimal exposure to non professional users. For example, this draft Order aims to ban dustable powders (DP) and to better regulate the packaging of wettable powders (WP) intended for the amateur market.

At last,  the draft Order sets that the compliance of authorised products with these new provisions shall be checked within 6 months after the entry into force of the Order.

The dossier for consultation is available on the website vie publique (in French).

 

To download: 

Draft Order regarding the conditions of authorisation of plant protection products for “amateur“ uses  (in French)

 

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

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

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

On 26 June 2019, the French Council of State (‘Conseil d’État’) cancelled several provisions of the inter-ministerial Order of 4 May 2017 concerning the placing on the market and the use of plant protection products and their adjuvants “on the grounds that these provisions did not sufficiently protect public health and the environment”.

 

At the end of 2017, two environmental protection associations had appealed against this order on the grounds of ultra vires. The Council of State partially agree with them by pronouncing the cancellation of four provisions considered as insufficient.

– The Council of State notes that the Order does not set any general provision for the protection of residents of treated agricultural areas. Indeed the current risk mitigations measures only concern places with vulnerable people (playgrounds and spaces usually frequented by young children, establishments for health, elderly centers and public leisure spaces);

– the Council of State highlights that the current measures for preventing water contamination only concern application by spraying or by dusting. There is no measure for other types of application that can also lead to surface water contamination, especially by run-off (granules application, soil injection, etc). Therefore the Council of State deletes the text ‘by spraying or by dusting;

– the Council of State considers the Order as illegal on the grounds that the re-entry periods are set only when products are applied on vegetated areas. No measure exists for applications on bare soil. Therefore the Council of State deletes the text ‘vegetated areas’;

– lastly, the Council of State cancels the article 2 of the Order since it does not set concrete measures in order to prevent contamination by run-off in case of heavy rainfalls.

The State Minister and the Ministers for the ecological and inclusive transition, for agriculture and food, for economy and finance and for solidarity and health have to take the regulatory measures resulting from this decision within six months.

 

For further details:

Council of State decision of  26 June 2019, Pesticides regulation (in French)

 

See also our previous articles: 

FRANCE: The new Order on the Use of PPPs and adjuvants is finally published! 

 

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

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

FRANCE: Ban of home and garden plant protection products

From 1st January 2019, sales, dispensing, use and possession of plant protection products by non professional users will be banned in France except for biocontrol products officially listed by the Ministry of Agriculture in accordance with articles L.253-5 and L.253-7 of the Rural Code, for low risk products as defined by Regulation (EC) No.1107/2009 and for organic farming (UAB) products authorised for non professional users (“mention emploi autorisé dans les jardins (EAJ)”). This provision was set by the Law on the use of PPPs (Labbé’s law of February 2014) for entry into force on 1st January 2022. The entry into force was then brought forward to 1st January 2019 by the Energetic transition law from the Ministry of Ecology (August 2015). The aim is to reduce the risks associated to the use of pesticides by amateurs.

The implementation modalities of this ban are set by a Notice of the Ministry of Agriculture published in the French Official Journal of 22 December 2018.

Two lists of products have been published by the Ministry of Agriculture: one for the products still authorised for amateur uses from 1st January 2019 and one for the products with an authorisation in force in December 2018 but that are no longer authorised from 1st January 2019.

The stocks of products banned from 1st January 2019 held by non professional distributors can be sold to professional users by distributors certified for the distribution of plant protection products to professional users.

The unused products and packaging held by non professional users must be disposed of in a waste collection site or a temporary collection point for household chemical waste set up by the eco-organism Eco-DDS.

 

To download:

Avis aux opérateurs économiques concernés par l’interdiction à compter du 1er janvier 2019 de la mise sur le marché, la délivrance, l’utilisation et la détention de certains produits phytopharmaceutiques pour un usage non professionnel (in French)

Liste actuelle des produits phytopharmaceutiques restant autorisés pour les amateurs à partir du 1er janvier 2019 (in French)

Liste des produits possédant une autorisation de mise sur le marché en vigueur en décembre 2018 et qui ne sont plus autorisés à partir du 1er janvier 2019 (in French)

 

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

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

FRANCE: Tax on Diffuse Pollution – Evolutions for 2019

The new list of substances concerned by the French tax on diffuse pollution has been published in the Order of 28 December 2018. The new list will apply by 1st January 2019.

As a reminder, concerned substances are those known for their human health or/and Environment hazards:

  • Acute toxicity for human, category 1, 2 or 3;
  • Specific target organ systemic toxicity, category 1 (single or multiple exposure);
  • CMR, category 1A or 1B;
  • Effects on or via lactation;
  • Environmental hazards (acute or chronic).

(Note: hazard classes/categories according to Regulation (EC) No. 1272/2008)

 

Besides, the French finance law for 2019 introduces a revision of the tax by 1st January 2019. The new rates will range from 0.90 to 9 euros / kilogram of substance while the current rates range from 0.90 to 5.1 euros. An additional rate is also defined for substances not meeting the approval criteria of Regulation (EC) No. 1107/2009 or for substances subject to the substitution scheme. This evolution is part of the French action plan on plant protection products and on a less pesticide-dependent agriculture. The tax on diffuse pollution is strengthened to encourage a reduction of the use of PPPs (in particular those with substances of concern) and to help financially for the transitions.

 

To download:

Order of 28 December 2018 modifying the Order of 22 november 2010 establishing the list of substances defined by Article R. 213-48-13 of the Environment code as regards the tax on diffuse pollution (in French)

Finance law No. 2018-1317 of 28 décember 2018 for 2019 (Article 234) (in French)

Explantory note MTES/DGALN/DEB – 20.11.2018 (in French)

 

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

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

 

FRANCE: Public consultation on Ecophyto II+

The French government has started on 20 November 2018 the public consultation on the different lines of action of the Ecophyto II+ plan. The consultation closes on 10 December 2018 (access the consultation).

As a reminder, Ecophyto II+ plan features the actions set in the French action plan of 25 April 2018 on plant protection products (PPP) and on a less pesticide-dependent agriculture, and those in the French action plan of 22 June 2018 for a ban of glyphosate within three years. Ecophyto II+ thereby strengthens the measures taken to reach the goal of 50% reduction in pesticide use in France by 2025.

Main Ecophyto II+ objectives are:

  • Speed up the withdrawal of substances of greatest concern, on the one hand, and promote the use of biocontrol products and of ‘natural’ preparations of low concern (denominated Préparations Naturelles Peu Préoccupantes, PNPP), on the other hand.
  • Strengthen the measures to avoid population exposure to PPP and to reduce the impact of PPP on the Environment.
  • Support research on the risks and effects of PPP use and demonstrate the effectiveness of farming programs with low PPP use.
  • Support farmers in this transition with notably (i) financial and technical supports, (ii) the separation of sale and consultancy activities of PPP (French EGalim law of 30 October 2018), and (iii) revise the French tax on diffuse pollution to make it more incentive.

 

To download:

Press release of 20 November 2018 – Consultation on the Ecophyto II+ plan (in French)

 

See also our previous articles:

FRANCE: Ecophyto II+, update and improvement of Ecophyto II

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: Ecophyto II+, update and improvement of Ecophyto II

Version II+ of Ecophyto plan, updating and improving Ecophyto II, was examined during the Strategic Orientation Committee (COS) of 27 July 2018. This new version features the actions planned in the French action plan of 25 April 2018 on plant protection products and on a less pesticide-dependent agriculture  and in the French action plan of 22 June 2018 for a ban of glyphosate within three years .

Among the issues, the ministers notably announced that, in a first step, renewals of authorisations of glyphosate-based products will only be obtained for a maximum period of three years. Besides, the uses for which comparative assessments will underline that non-chemical alternative solutions are available and are commonly used, will be banned progressively.

With regard to neonicotinoids, ministers indicated that only few exemptions to the ban are envisaged. Those exemptions will only concern acetamiprid-based products, for low volumes and after a comprehensive risk assessment.

The public consultation for Ecophyto II+, initially announced for July 2018, will be held in Autumn 2018. The plan is expected to be published by the end of 2018.

 

To download:

Press release of 27 July 2018 – Strategic orientation committee of Ecophyto plan (in French)

 

See also our previous articles:

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: Action plan for plant protection products

The French action plan on plant protection products and on a less pesticide-dependent agriculture was presented on 25 April 2018. It incorporates the proposals of the stakeholders consulted since last February, 15th.

This action plan is structured around four priorities:

 

  • Rapidly reduce the use of substances of greatest health and environmental concerns

 

In this context, France will ask the European Commission to put an end as soon as possible to the approval of substances that are subject to cut-off criteria under the EU regulation: carcinogens category 1, mutagens category 1 or toxic for the reproduction category 1, or endocrine disruptors for humans or the environment, persistent bioaccumulative and toxic substances, or very persistent and very bioaccumulative substances. France will systematically oppose the extension and renewal of these substances.

France will also ask ANSES to start as early as 2018 a scientific review of the substances of greatest concern for health and the environment mentioned by the CGAAER-IGAS-CGEDD mission and whose European approval expires after 2018.

The plan provides for a separation of distribution and advising activities and a revision of the tax for diffuse pollution (RPPD) to encourage incentives to reduce the use of PPPs and help financially for the transitions.

 

  • Better know the impacts to better inform, protect the population and the professionals and preserve the environment

 

 

  • Amplify the research and development of alternatives and the implementation of these solutions by farmers

 

France will notably strengthen its support for the development of biocontrol by supporting the innovation of very small, small and medium-sized companies by mobilising the major investment plan and improving the approval process for biocontrol products (in particular by shortening timelines) and to propose at European level the recognition of biocontrol products in the context of the revision of Regulation (EC) No 1107/2009.

France will also support farmers towards the ban of glyphosate and the reduction of plant protection products within 3 years.

 

  • Strengthen the Ecophyto 2 plan, improve its governance and functioning

 

 

The Action Plan is accompanied by a timetable and a method of implementation:

  • Several working groups are set up in order to implement certain actions of the plan
  • Two referrals of scientific organisms have already been made, including one to ANSES:
    • development of specifications to launch an experimental study on the carcinogenicity of glyphosate

and 3 new referrals will be sent to ANSES in one month:

  • establishment of a list of the substances of greatest concern with regard to the risks they may pose to public health or the environment, in particular carcinogens, mutagens, reproductive toxins and endocrine disruptors which will still be approved after 2018;
  • identification of the substances of concern for which the Government will intervene with the European Commission so that they can be included as soon as possible in the list of substances candidates  for substitution;
  • proposals to strengthen existing regulations on pollinators, taking into account the safety of operators.

The Ecophyto 2 plan will be adapted to integrate the priorities of this action plan. The Ecophyto 2+ plan will be submitted for public consultation in July 2018.

 

To download:

Plan d’actions sur les produits phytopharmaceutiques et une agriculture moins dépendante aux pesticides (in French)

Mise en oeuvre du plan d’actions – Calendrier et méthode (in French)

 

See also our previous articles:

FRANCE: 18 actives on the hot seat: new action plan to reduce the use of PPPs

 

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

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