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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

 

GLYPHOSATE: EFSA conclusion on the peer review, unlikely to be carcinogenic

The conclusions of EFSA, following the peer review of the initial risk assessments carried out by the rapporteur Member State Germany, for the pesticide active substance glyphosate have been published last Thursday (12/11/2015).

 

Unlikely to be carcinogenic

Following a second mandate from the European Commission to consider the findings from the International Agency for Research on Cancer (IARC) regarding the potential carcinogenicity of glyphosate or glyphosate-containing plant protection products in the on-going peer review of the active substance, EFSA concluded that glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential according to Regulation (EC) No.1272/2008. The evaluation considered a large body of evidence, including a number of studies not assessed by the IARC which is one of the reasons for reaching different conclusions.

 

New end-points

The review proposed new toxicological safety thresholds for risk assessment of glyphosate (Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate):

an acute reference dose (ARfD) of 0.5 mg/kg b.w., the first time such an exposure threshold has been applied to the substance,

an acceptable operator exposure level (AOEL) of 0.1 mg/kg b.w./day, instead of 0.2 mg/kg b.w./day in the past,

an acceptable daily intake (ADI) for consumers of 0.5 mg/kg b.w./day in line with the ARfD.

 

Next steps

The EFSA conclusion will inform the European Commission in deciding whether or not to retain the substance on the EU list of approved active substances. This is a condition for enabling Member States to authorise its continued use in pesticides in the EU.

 

Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate

EFSA explains the carcinogenicity assessment of glyphosate

  

POE-tallowamine (Glyphosate coformulant): EFSA toxicological assessment

EFSA was asked by the European Commission to prepare a statement on the co-formulant polyethoxylated (POE) tallowamine (CAS no. 61791-26-2) based on the toxicological evaluation of POE-tallowamine presented by the Rapporteur Member State (RMS) Germany in the context of the peer review of glyphosate.

POE-tallowamine belongs to a group of substances used as surfactants, which are present in many glyphosate-based formulations. The RMS considered that a toxicological assessment of this surfactant could be necessary at Member State or zonal level for plant protection product authorisations, and therefore a toxicological evaluation including health-based reference values was provided in the RAR.

EFSA did not have the possibility to review the original data for most of the endpoints summarised in chapter B.6.13 of the RAR, and some endpoints are not fully addressed, therefore EFSA cannot support the RMS’s current assessment and considers that reliable reference values Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL), and Acute Reference Dose (ARfD) cannot be established and further data have to be submitted. Therefore the exposure assessment for operators, workers, bystanders, residents and consumers could not be performed. Compared to glyphosate, a higher toxicity of the POE-tallowamine was observed on all endpoints investigated.

The hypothesis of a possible synergistic toxicity between glyphosate and tallowamine co-formulant could not be verified. Dose additivity may be expected, at least regarding the irritation potential of the mixture to eyes and possibly mucosal tissues as both compounds share these irritation properties. Considering the low oral toxicity of glyphosate after single or repeated administrations, a likely explanation for the poisoning occurrences observed in humans is that it is mostly driven by the POE-tallowamine component of the formulation.

The genotoxicity, long-term toxicity and carcinogenicity, reproductive/developmental toxicity and endocrine disrupting potential of POE-tallowamine should be further clarified. There is no information regarding the residues in plants and livestock  and limited information is available on ecotoxicology. Therefore, the available data are insufficient to perform a risk assessment in the area of human and animal health  or on the effects on the environment for the co-formulant POE-tallowamine.

Data gaps were identified and listed (see EFSA Journal 2015;13(11):4303, pp 10-11).

 

Request for the evaluation of the toxicological assessment of the co-formulant POE-tallowamine