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FRANCE – ANSES: Glyphosate – Publication of decisions and results of the comparative assessment

Following the renewal of the approval of the active substance glyphosate, ANSES issued on 30 September 2020 decisions on 6 applications of renewal and 3 new applications for marketing authorisation for plant protection products. Three renewal applications and one new application for authorisation were refused due to a potential risk of adverse effects on human health due to the possible formation of the relevant impurity N-nitrosoglyphosate during the storage of the product.

 

In parallel, ANSES has also published on 09 October 2020 the results of its comparative assessment carried out under Article 50.2 of the European Regulation (EC) 1107/2009. Thus, the practical or economic drawbacks of currently available non-chemical alternatives have been identified for the 4 main areas of agricultural uses: fruit trees, viticulture, arable crops and forestry. ANSES based the assessment on different sources of information among them three reports issued by INRAE (INRAE’s report on fruit trees, INRAE’s report on  viticulture and INRAE’s report on arable crops) and data provided by ONF (“Office National des Forêts” / National Forestry Office) and CNPF (“Centre National de la Propriété Forestière” / National Center for forest ownership).

The conclusions are the following:

Uses Fruit trees Viticulture Arable crops (cereals, oilseeds, peas…) Forestry
Possible alternatives = Ban on using glyphosate Between the rows:

– Mechanical weeding

– Grassed areas

Between the rows:

– Mechanical weeding

– Grassed areas

When the plot has been ploughed between two crops Alternative non-chemical methods for killing tree stumps
Substitution not possible = Authorised use of glyphosate Mechanical weeding  not possible:

– Mechanical harvesting of fruits on the ground

– Bushy crops

Unavailability in the short term of agricultural machinery for weeding under the row

Mechanical weeding  not possible: steeply sloping or terraced vineyards, stony ground, rootstock nurseries

Unavailability in the short term of agricultural machinery for weeding under the row

In situations of regulated mandatory control Forest maintenance during the stand establishment period

Forest nurseries and seed orchards

Restriction of rates Maximum 900 g of glyphosate per year and per hectare and application limited to 40% of the plot area = 60% reduction of the maximum rate currently authorised Maximum 450 g of glyphosate per year and per hectare and application limited to 20% of the plot area = 80% reduction of the maximum rate currently authorised Maximum 1080 g of glyphosate per year and per hectare = 60% reduction of the maximum rate currently authorised /

As for the non-crop uses of glyphosate, they cannot be fully substituted by non-chemical alternatives. Reducing the use of glyphosate in these different situations cannot therefore be addressed by a restriction laid down in the marketing authorisations, but needs to be considered as part of a change in weed-control practices.

These restrictions will now be taken into account and will apply to each product placed on the market and within 6 months for products which were renewed.

 

To download: 

Comparative assessment report – Products containing glyphosate – Examination of alternatives in arboriculture (in French)

Comparative assessment report – Products containing glyphosate – Examination of alternatives in viticulture (in French)

Comparative assessment report – Products containing glyphosate – Examination of alternatives in arable crops (in French)

Comparative assessment report – Products containing glyphosate – Examination of alternatives in forestry (in French)

 

See also our previous articles: 

FRANCE – ANSES: Withdrawal of 36 glyphosate-based products

FRANCE: Glyphosate phase-out plan issued

 

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

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

 

FRANCE: Glyphosate – Withdrawal of the consortium selected to conduct complementary toxicological studies

Following the selection of the teams as part of the call for tenders for the conduct of several complementary in vitro and in vivo studies on the potential carcinogenicity classification of glyphosate, harsh criticism has called into question the deontology and independence of ANSES. The consortium selected and composed of seven laboratories was accused of being linked to members of the Agency’s expert committee who had participated in the development of the study programme.

In order to avoid any climate of tension and suspicion regarding the results of the studies and thus impact the scientific debates, the consortium has announced the withdrawal of its participation. The project conducted by the International agency for research on cancer (IARC) is maintained and will be funded by ANSES. An original study to explore potential genotoxic effects of glyphosate following long-term exposure of cell cultures was proposed.

 

To download: 

Study of the carcinogenic potential of glyphosate: ANSES announces the withdrawal of the consortium selected to conduct complementary toxicological studies (in French)

 

See also our previous articles: 

FRANCE: Glyphosate – Teams selected to conduct complementary studies

 

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

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

 

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.

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

 

FRANCE – ANSES: Withdrawal of 36 glyphosate-based products

ANSES announces the withdrawal of 36 glyphosate-based products out of the 69 products being under renewal. These products will be withdrawn from the market and will no longer be allowed to be used from the end of 2020, due to the lack or insufficient scientific data to rule out any genotoxic risk. In 2018, these products accounted for almost three quarters of the tonnage of glyphosate products sold in France, for agricultural and non-agricultural uses.

Moreover, 4 refusal decisions were notified out of the 11 new applications submitted since January 2018 and under evaluation.

The decisions and conclusions of evaluation are available in the Register of decisions on Anses website.

The comparative evaluation with available non-chemical alternatives continues. The entire evaluation process will be finalised by 31 December 2020.

 

To download: 

List of products based on glyphosate withdrawn on 29 November 2019 (in French)

 

See also our previous articles: 

FRANCE: Parliamentary report on the strategy relative to glyphosate phase out

FRANCE: Glyphosate phase-out plan issued

FRANCE: Towards glyphosate phase out

EUROPE: Renewal of glyphosate approval

 

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

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

FRANCE: Parliamentary report on the strategy relative to glyphosate phase out

The joint information mission on monitoring the glyphosate phase out strategy provided an information report to the government on 12th November.

The purpose of this mission is to monitor the transition of the French Agriculture towards the ban of the main uses of glyphosate from 1st January 2021 and all its uses on 1st January 2023, in accordance with the commitments of the French Government.

The first part of the report concerns the difficulty of establishing a “T Zero” panorama of the use of glyphosate in France.

The second part of the report deals with the agronomic obstacles that persist. Indeed the authors highlight that two years after the INRA report dated November 2017 “Uses and alternatives to glyphosate in French agriculture” which focused on several technical dead ends, these are still existing and impose crucial choices. They result in serious agronomic dilemmas, especially when the only effective alternative to glyphosate currently available would be to question the “no-till” approach of conservation agriculture developed to fight against soil erosion and depletion. These technical dead ends also give rise to economic, territorial or health difficulties: the ban of glyphosate could lead to the outright cessation of cultivation of certain crops but also to the end of the agricultural exploitation of important parts of our territory, or even the essential fight against plants harmful to human health.

The parliamentary report indicates that this transition will have a high cost, regardless of the sector and whatever alternatives are available. A cost that will weigh heavily on operators whose economic balance is often precarious. So it seems essential to think about a real financial support for farmers.

Facing these concerns, sometimes these hesitations, the mission expects the Government to clarify its message to farmers, namely: what uses will benefit from a derogation on 1st January 2021 and what regulatory or legislative measures will be taken?

 

To download: Information report No.2406 of the joint information mission on the monitoring of the strategy relative to glyphosate phase out (in French)

 

See also our previous articles: 

FRANCE: Glyphosate phase-out plan issued

FRANCE: Towards glyphosate phase out

 

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

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

 

FRANCE: Towards glyphosate phase out

The renewal of the glyphosate approval for five years was adopted in December 2017 by the European Commission. The evaluation by ANSES (French Agency for Food, Environmental and Occupational Health & Safety) of applications for the renewal of authorisation of glyphosate-based PPPs according to Article 43 of Regulation (EC) 1107/2009 is in progress.

To date, 190 glyphosate-based products are authorised in France or benefit from a parallel trade permit. 58 applications for PPPs renewal and 11 applications for new PPPs approval were submitted to ANSES. Regarding the 132 products for which  renewal application was submitted, ANSES notified the products’ holders of the expiry of approvals or parallel trade permits as from 15 December 2018. The list of products concerned has been published on the E-phy website.

For products intended for professional use, the end of sale and distribution of the products is set to 15/03/2019 and the end of use of the products and stocks is set to 15/06/2019.
For products intended for amateur use, no grace period is granted in view of the entry into force on 1 January 2019 of the Labbé’s law (February 2014) amended by the Energetic transition law (August 2015) and the Potier’s law (March 2017), prohibiting the marketing and holding of non-professional PPPs.

ANSES announces that the evaluation of the new approval applications and renewal applications will be finalized before 31 December 2020, within the three-year period announced by the government.

In addition, the evaluation of the new approval applications and renewal applications will be conducted on the basis of a comparative assessment of the products: based on the information that will be provided on the available alternatives commonly used in France, particularly by INRA (French National Institute for Research in Agriculture), ANSES will compare, for each use, glyphosate products with the non-chemical methods of prevention or control that are available. For each glyphosate-based product, uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.

Finally, in order to support farmers foregoing glyphosate use, the government launched a website sharing experiences from farmers who have already taken part in this initiative and describing possible alternatives to glyphosate. The website also records the plots declared without glyphosate in each department as well as the number of farmers having stop any use of glyphosate and engaged in this way.

 

To download:

Liste des produits à base de glyphosate faisant l’objet d’un retrait du marché à compter du 15 décembre 2018 (in French)

 

See also our previous articles:

EUROPE: Renewal of glyphosate approval

 

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/

EUROPE: Renewal of glyphosate approval

Implementing Regulation (EU) 2017/2324 renewing the approval of the active substance glyphosate and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 was published on 15 December 2017. The approval of glyphosate is renewed for 5 years from the 16 December 2017.

In order to take into account the conclusions of the glyphosate review report, Member States must pay particular attention to:

 

— the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses,

— the protection of operators and amateur users,

— the risk to terrestrial vertebrates and non-target terrestrial plants,

— the risk to diversity and abundance of non-target terrestrial arthropods and vertebrates via trophic interactions,

compliance of pre-harvest uses with good agricultural practices.

Conditions of use shall include risk mitigation measures, where appropriate.

Member States shall ensure that use of plant protection products containing glyphosate is minimised in areas used by the general public or by vulnerable groups.

Member States shall ensure equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicological studies.

Member States shall ensure that plant protection products containing glyphosate do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2).

 

To download:  

COMMISSION IMPLEMENTING REGULATION (EU) 2017/2324 of 12 December 2017 renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

 

See also our previous articles:

EUROPE: Glyphosate not classified as a carcinogen by ECHA

EUROPE – Glyphosate: Publication of the Regulation amending the conditions of approval

 

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

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

EUROPE: Glyphosate not classified as a carcinogen by ECHA

ECHA’s Committee for Risk Assessment (RAC) agrees to maintain the current harmonised classification of glyphosate as a substance causing serious eye damage (H318) and being toxic to aquatic life with long-lasting effects (H411). RAC concluded that the available scientific evidence did not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction.

Apart from the published studies on glyphosate, the committee also had full access to the original reports of studies conducted by industry. RAC has assessed all the scientific data, including any scientifically relevant information received during the public consultation in summer 2016.

The adopted opinion will go through a normal editorial check before it is sent to the European Commission. The opinion will also be made available on ECHA’s website at the same time.

The adopted opinion on the harmonised classification for glyphosate will be taken into account when the Commission and Member States consider whether to renew the approval to use glyphosate as an active substance in pesticides, later this year.

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

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

EUROPE – Glyphosate: Publication of the Regulation amending the conditions of approval

Regulation (EU) 2016/1313 amending Implementation Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glyphosate was published on 2 August 2016.

Further to the extension of Glyphosate approval by the European Commission, this Implentening Regulation sets the following “Specific Provisions” of approval:

Member States:

– must pay particular attention to risks from the use in areas used by the general public or by vulnerable groups, such as public parks and gardens, sports and recreation grounds, school grounds and children’s playgrounds and in the close vicinity of healthcare facilities;

– must pay particular attention to compliance of pre-harvest uses with good agricultural practices.

Member States shall ensure that plant protection products containing glyphosate do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2).

 

These new conditions of approval enter into force on the twentieth day following that of its publication.

 

To download:

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1313 of 1 August 2016 amending Implementation Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glyphosate

 

Our previous article:

EUROPE: The Commission adopted the extension of Glyphosate approval for 18 months

 

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

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