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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/

FRANCE: ANSES published the list of 126 products containing Glyphosate and POE-tallowamine withdrawn

Anses announced on 20 June the withdrawal of the authorisations of plant protection products containing glyphosate and POE-tallowamine. The list of the 126 authorisations withdrawn on 1 July 2016 has been published on E-PHY website.

 

To download:

List of glyphosate products subject to withdrawal with effect from 1 July 2016 (in French)

 

Our previous articles:

POE-tallowamine (Glyphosate coformulant): EFSA toxicological assessment

FRANCE: withdrawal of some PPPs containing Glyphosate and tallowamines (tallow fatty amines) by the end of March 2016?

FRANCE: Withdrawal of 132 authorisations for products containing glyphosate and POE-tallowamine

 

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

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

 

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

The European Commission adopted the extension of the current approval of glyphosate until the European Chemical Agency (ECHA) has concluded its review (revision of the harmonised classification of glyphosate) – 31 December 2017. Indeed, no qualified majority was reached by Member States at either the Standing Committee  on June, 6th or the Appeal Committee on June 24th.

In parallel to the extension of the approval, the Commission has already presented to Member States a series of recommendations on the use of glyphosate:

1) ban the co-formulant POE-tallowamine from glyphosate-based products;

2) minimise the use of the substance in public parks, public playgrounds and gardens;

3) minimise the pre-harvest use of glyphosate.

Apart from ECHA’s upcoming opinion, EFSA continues its on-going review of the existing Maximum Residue Levels (MRLs) for glyphosate.

 

For more information:

http://europa.eu/rapid/press-release_MEMO-16-2012_fr.htm

 

See our other article:

FRANCE: Withdrawal of 132 authorisations for products containing glyphosate and POE-tallowamine

 

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

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

 

FRANCE: Withdrawal of 132 authorisations for products containing glyphosate and POE-tallowamine

As announced in February 2016, Anses had engaged a review of the marketing authorisations of plant protection products containing glyphosate and POE-tallowamine. As unacceptable risks, mainly to human health, cannot be ruled out for these products, the conditions laid down in Article 29 of the Regulation (EC) No.1107/2009 are not verified.

As provided for in the European procedure, in April 2016, ANSES informed approval holders of glyphosate-based products containing POE-tallowamine of its intention to withdraw them from the market.

At the end of the adversarial procedure period, and after having examined the observations of the approval holders, the Agency withdrew on 20 June 2016 the marketing authorisations for 132 products from the French market.

 

See also our previous articles:

FRANCE: withdrawal of some PPPs containing Glyphosate and tallowamines (tallow fatty amines) by the end of March 2016?

POE-tallowamine (Glyphosate coformulant): EFSA toxicological assessment

 

GLYPHOSATE: the EU Parliament agrees to re-authorise Glyphosate for 7 years

On 13 April, the European Parliament adopted a resolution for a 7-year renewal period for Glyphosate, including a number of restrictive measures: a ban on the sale for use in amateur gardens and public parks.

The Commission is also asked to rapidly ensure an independent review of the overall toxicity and classification of glyphosate based on all available scientific evidence, including that relating to carcinogenicity of glyphosate, as well as possible endocrine-disruptive properties.

The Commission and EFSA are also asked to disclose immediately all the scientific evidence that has been the basis for the positive classification of glyphosate and the proposed re-authorisation.

Although this resolution is not legally-binding, it will influence the final proposal of the Commission that should be voted in May 2016 before the expiry date of 30 June 2016.

 
European Parliament resolution of 13 April 2016 on the draft Commission implementing regulation 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 Implementing Regulation (EU) No 540/2011

 

FRANCE: withdrawal of some PPPs containing Glyphosate and tallowamines (tallow fatty amines) by the end of March 2016?

 

Following EFSA’s conclusions on Glyphosate renewal and the divergent IARC (International Agency for Research on Cancer) report finding a potential carcinogenicity of Glyphosate or plant protection products containing Glyphosate, EFSA had been seised again by the European Commission to review IARC findings.

As we explained in our 2 articles of 11/16/2015 “GLYPHOSATE: EFSA conclusion on the peer review, unlikely to be carcinogenic” and “POE-tallowamine (Glyphosate coformulant): EFSA toxicological assessment“, EFSA concluded that it was unlikely that Glyphosate presents a carcinogenic risk to humans. The assessment took into account a number of elements, including a number of studies not evaluated by IARC, which explained in part why the two assessments reached different conclusions.

In parallel, Anses was seised on April 8, 2015 to analyse the data of IARC monograph and those of the European assessment to say whether these were “likely to support a proposal to amend the classification of Glyphosate according to the rules defined in Regulation (EC) No.1272/2008 (CLP) regarding carcinogenicity. “

On October 16, 2015, Anses entrusted the investigation of this referral to an Emergency Collective Expert Assessment Group  (GECU), and in addition, asked the group to identify whether the results of the genotoxicity studies on Glyphosate representative preparation of the European review should lead to further studies on coformulants and/or on preparations.

GECU analysis showed that these differences can be explained in terms of the selection criteria of the studies and the methodology of establishment of the final proof level.

The GECU states that “in view of all the results, the level of evidence of Glyphosate carcinogenicity in animals can be regarded as relatively limited. It is unlikely that Glyphosate has a potential effect on endocrine disruption of dependent pathways of estrogen regulation; further studies could confirm this. In addition, the level of evidence of the genotoxicity of Glyphosate in animals can be considered relatively limited, however additional data will have to be provided regarding preparations containing Glyphosate.”

GECU concludes that “given the one hand, the deadlines for the investigation and secondly, the very large number of studies and publications available, the analysis of the working group was based exclusively on the EU and IARC reports and not directly on the study reports containing raw data, and on the published scientific literature. Consequently, GECU is not able to decide on a classification in category 2 or a no-classification according to Regulation (EC) No.1272/2008. However, the working group believes that the analysis that has been conducted shows that the level of evidence of carcinogenicity in animals can be considered relatively small and does not allow, according to Regulation (EC) No.1272/2008, to classify glyphosate in terms of carcinogenicity in class 1B. “

Given the results of this expertise, Anses consider necessary that Glyphosate classification is promptly reviewed by ECHA.

 

Regarding the coformulants, given the exposure to preparations and concerns raised about the coformulants, especially tallowamine for Glyphosate-based preparations, the Agency shall proceed without delay to the reassessment of preparations combining Glyphosate and tallowamine.

GECU work regarding the potential genotoxicity of coformulants continues and will be subject to an additional report in April 2016.

 

On February 12, 2016, Mrs. Ségolène Royal, Minister of Environment, Energy and Marine, received Anses findings. She then requested Anses “to re-evaluate immediately all preparations containing glyphosate and co-formulants of tallowamines family and invite them to withdraw by the end of March 2016 the approvals of plant protection products presenting concerns.”

 

Documents to download:

Anses (09/02/2016) : OPINION of the French Agency for Food, Environmental and Occupational Health & Safety on the glyphosate request No 2015-SA-0093

MEDDE (12/02/2016) : Ségolène Royal saisit l’ANSES sur les produits phytosanitaires contenant du glyphosate