FRANCE: ANSES’ Newsletter on Marketing Authorisations

The first newsletter on marketing authorisations of plant protection products and adjuvants was published by ANSES (December 2018). The newsletters will present at the beginning of each month an overview of the withdrawals of authorisation, the new authorisations and the major modifications of authorisation (e.g. new uses or use withdrawals, modified conditions of use) which occurred in the previous month. It is noted that additionnal trade names will not be reported in the newsletters.

The newsletters will also include some regulatory news highlighted by ANSES each month.

The newsletter of December 2018 is marked by the withdrawal of numerous glyphosate-based products given the expiration of the marketing authorisations for which no renewal dossiers have been sent subsequently to the renewal of glyphosate.

 

Link to Anses Web page for the monthly newsletters:

https://www.anses.fr/fr/content/bulletin-mensuel-des-autorisations-de-mise-sur-le-march%C3%A9-des-produits-phytopharmaceutiques (In French)

 

To download:

Newsletter of December 2018 (in French)

 

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

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EUROPE: Corrigendum to the Implementation Modalities of the EFSA Guidance on Dermal Absorption

The Standing Committee on Plants, Animals, Food and Feed, which adopted the new EFSA guidance on dermal absorption on 25 May 2018, adopted on 24 October 2018 a corrigendum (minor correction) to the implementation modalities of the guidance.

The correction concerns the threshold distinguishing whether a plant protection product should be considered as a concentrate or as a dilution: a plant protection product with an active substance amount of exactly 50 g/L or g/kg (i.e. 5%), initially considered as concentrate, should now be considered as a dilution.

For more information on the implementation modalities of the guidance, please refer to our previous post on the topic which has been revised accordingly.

 

To download:

Guidance on dermal absorption (SANTE/2018/10591) – rev.1, 24 October 2018

 

See also our previous articles:

EUROPE: Adoption of the new EFSA guidance document for dermal absorption

EUROPE: New EFSA GD on Dermal absorption

 

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

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EUROPE – EFSA: Database of Ecological and Residue Data Used in Assessments for Birds and Mammals

EFSA published the outcome of the data collection conducted with the aim of developing a unified database of ecological data and residue data to be used for the risk assessment of plant protection products for birds and mammals. This data collection, outsourced to a consortium consisting of the Alterra institute (Wageningen University, the Netherlands), the Austrian Agency for Health & Food Safety (AGES) and the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), was initiated in 2015.

Data were collected among the data submitted in active substance and plant protection product dossiers and via a systematic literature review. Data were scored on the basis of quality criteria and organised in 3 Excel spreadsheets (one for birds, one for mammals and one for residue studies), that can be downloaded as Supplements to the report.

The ecological information collected for birds and mammals consisted of data used (or that could be used) for the determination of focal species (notably, the frequency of observation in the field and the frequency of observation per survey), the estimation of the proportion of an animal’s daily diet obtained in a treated habitat (PT) and the assessment of the composition of the diet obtained from a treated area (PD). Entries for 18-21 crop groups, 150 bird species and 70 mammal species were collected. Nearly half of the records for birds come from protected company study reports while it is less than 10% for mammals.

The information gathered on residues focussed on initial residue levels and on residue decline (notably, DT50 and DT90). Entries for 190 substances and 18 crop groups were collected. Around 75% of these records come from protected company study reports.

In a first step, the databases may be used by EFSA and Member states for the peer review of active substances and for the registration of plant protection products in order to reach a higher level of harmonisation and more robust assessments. In a second step, EFSA planned to use the databases as inputs for the revision of the guidance on birds and mammals (EFSA Journal 2009; 7(12):1438).

 

To download:

Lahr et al., 2018 – EFSA Supporting publication 2018:EN-1513: Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals (the report and the 3 databases as supplements).

 

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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.

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EUROPE: Adoption of Timelines for Additional Data on ED for AIR III Active Substances

As adopted by the Commission, the new scientific criteria to identify endocrine disruptors (ED) (Reg. (EU) 2018/605) and the associated EFSA/ECHA guidance (EFSA Journal 2018;16(6):5311) are applicable for the assessment of all active substances (AS) since 10 November 2018, including the AS being under renewal (AIR III renewal programm) for which no draft regulation has been voted by the Committee.

For those AS still being under renewal by 10 November 2018, the Reg. (EU) No 2018/1659, recently adopted, amends Reg. (EU) No 844/2012 to define new timelines specifically dedicated to the submission and assessment of complementary data as regards endocrine disruption. A summary of the new timelines is presented below.

AS for which the new EFSA conclusion is not adopted by 10 November 2018:

  • If additional data are deemed necessary by Member States (MS) and EFSA to assess if the ED criteria are met: data expected are detailed and justified, and a period between 3 and 30 months is set for the submission by the applicant (depending on the type of data required).
  • If no additional data are deemed necessary by MS and EFSA to assess if the ED criteria are met: after having been informed, the applicant may submit additional data as regards ED properties of the AS within 3 months.
  • For both situations described above, the applicant may also provide supporting information as regards the potential derogation for ED active substances according to Article 4(7) of Reg. (EC) No 1107/2009 within the respective period set.
  • After the submission of data by the applicant, the RMS shall produce a revised renewal assessment report (RAR) within 90 days. Then, after the submission of the revised RAR, a conclusion on the AS shall be adopted by EFSA within 120 days. This period includes a consultation of MS and of the applicant on the revised RAR.
  • Non-requested data or data submitted by the applicant after the expiry of the period set for its submission will not be considered.

AS for which the new EFSA conclusion is adopted by 10 November 2018 (but no draft Regulation has been voted by the Committee):

  • The Commission may consider that additional information as regards endocrine disruption are needed to apply the adopted criteria and hence request a revision of the assessment by EFSA within a reasonable time period.
  • In the case of a revision request, same conditions and timelines as presented above (AS for which the new EFSA conclusion is not adopted by 10 November 2018) apply.
  • If no data are submitted by the applicant, EFSA shall conclude the assessment within 30 days.

 

To download:

Regulation (EU) No 2018/1659 of 7 November 2018 amending Reg. (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Reg. (EU) No 2018/605.

 

See also our previous articles:

EUROPE – COM: Availability and applicability of the EFSA/ECHA guidance on identifying endocrine disruptors

 

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

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FRANCE: ANSES Announced the Withdrawal of Authorisations for Metam-Sodium-based Products

ANSES announced in a press release of 5 October 2018 its intention to withdraw all marketing authorisations for the products containing the active substance metam-sodium, which are currently authorised in France for soil disinfection.

Indeed, reassessment by ANSES of the conditions of use of authorised metam-sodium-based products following approval of the active substance’s at EU level, indicated that a risk for human health and the environment cannot be excluded for all authorised uses. The Agency has therefore notified the companies of its intention to withdraw the marketing authorisations of these products.

This announcement occurs after the decision of the French government in late October to suspend as a precautionary measure, for three months, all the marketing authorisation of metam-sodium-based products (French Order of 25 October 2018), in light of three cases of intoxication which affected residents and operators in France.

In its press release, ANSES reminds professional stakeholders that the reporting of adverse effects is a regulatory requirement in the framework of the ‘phytopharmacovigilance’ (French monitoring system) and enables the Agency to act promptly to prevent and control risks.

 

To download:

Press release from ANSES – Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations.

Press release from the ministries of “Transition Écologique et Solidaire”, “Solidarités et de la Santé”, “Economie et des Finances” and “Agriculture et de l’Alimentation” (in French) – François de Rugy, Agnès Buzyn, Bruno Le Maire et Didier Guillaume suspendent l’utilisation des produits phytopharmaceutiques contenant du métam-sodium.

Arrêté du 25 octobre 2018 relatif à la suspension de l’utilisation des produits phytopharmaceutiques contenant la substance active « métam » ou « métam-sodium » (in French).

 

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FRANCE: Operational PPE Recommendations as regards Re-Entry – Answer from ANSES

Requests were sent to ANSES on 31 July 2017 and on 3 April 2018 by the Directorate for Food (DGAL) of the French Ministry of Agriculture (Referral 2017-SA-0174) as regards its recommendations on the use of personal protective equipments (PPE) by workers re-entering a crop post-treatment.

This request was initiated because most of the recent marketing authorisations recommend the use of PPE for re-entry activities with no indication of a delay after the last treatment and with no distinction as regards the type of activities, which raises questions among professionals and seems to lead to practical difficulties.

In particular, ANSES was asked to deliver more operational PPE recommendations for re-entry activities (e.g. distinguish/limit the use of PPE to certain types of products or to certain activities or depending on the application schedule), pending the outcome of ongoing works which should allow more accurate risk assessments for worker exposure. Ongoing studies aim, for example, at determining transfer coefficients and foliar residue declines.

After a context analysis, ANSES concludes that the data currently available neither allow for activity-specific exposure risk assessments nor allow for making recommendations as regards a potential interval after treatment, after which PPE would be no more necessary to ensure the safety of workers.   

ANSES however underlines that the exposure risk assessments conducted in accordance with the EFSA guidance (EFSA Journal 2014;12(10):3874) could be refined on the basis of foliar residue decline, in agreement with the approach proposed in the guidance. Besides, new exposure data for re-entry activities of workers and new foliar residue decline data (in particular on grapevine) have been generated and are being assessed by the United Kingdom. These data should allow a more accurate estimation of worker exposures and of protection levels offered by PPE. For his part, EFSA started the update of its guidance (EFSA, 2014), which should allow the integration of any new data.

Besides, ANSES reminds that:

  • re-entry intervals as defined in the French Order of 4 May 2017 are aimed at preventing exposure and effects;
  • if a personal protection is required, it corresponds to a PPE as defined in Regulation (EU) 2016/425, which should be associated with the basic precautionary measures (e.g. hand wash, compliance with instructions of how to put on and to put off PPE);
  • within the framework of the responsibility to protect workers, the re-entry interval set is only an indication of the risk level that the employer have to integrate in its assessment with a selection of relevant PPE as regards the risk level, the suitability of the PPE with the worker activity and the availability of PPE;
  • more generally, reducing the use of plant protection products and preferring products with less severe human health hazard potential should be aimed at in order to reduce exposure of agricultural workers.

As regards products based on active substance(s) for which no toxicological reference value has been set, ANSES encourages applicants to include a justification of specific recommendations for these product types as regards the hazard and risk levels which might be considered as low.

Finally, ANSES recommends to carry on with training and awareness campaigns for agricultural workers regarding the compliance with the conditions of use of plant protection products and of PPE and the health issue that represents.

 

To download:

10 October 2018 – Note from ANSES as regards its recommendations on the use of personal protective equipments (PPE) by workers re-entering a crop post-treatment (in French).

 

See also our previous articles:

FRANCE: is it necessary to wear PPE after the re-entry period ? Answer from Anses

 

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

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EUROPE: Publication of the supporting study for the ‘REFIT’ of Reg. (EC) No. 1107/2009 and No. 396/2005

The European Commission started in 2016 the application of the Regulatory Fitness and Performance programme (REFIT) to the European Regulation on pesticides (Regulation (EC) No. 1107/2009) and their residues (Regulation (EC) No. 396/2005). The aim of applying the REFIT programme is to assess if the current Regulations are ‘fit for purpose’ and meet the needs of citizens, businesses and public institutions in an efficient manner. In particular, the evaluation addresses synergies, gaps, inefficiencies and administrative burdens.

The main evaluation criteria set out to be addressed in relation to this REFIT Evaluation are:

  • Effectiveness of the intervention
  • Efficiency in relation to resources used
  • Relevance in relation to identified needs and problems
  • Coherence with other interventions with common objective
  • EU added value compared to what could have been achieved by EU country or international action.

The evaluation study, based on those criteria, which will support the REFIT evaluation was conducted between 2017 and 2018 by external contractors. The final report of the study was recently published (18 October 2018) and can be downloaded from the links below.

The analysis is based on data collected via case studies and consultation of stakeholders (EFSA, European Commission, Member State competent authorities, SME panel, etc.) and via an open public consultation which involved almost 10,000 citizens. The data analysis notably included timeline tracking and an analysis of the costs and benefits of the Regulations.

The main conclusions of the external evaluation study are:

  • The pesticide Regulation (EC) No. 1107/2009 led to an improved harmonisation of active substance and plant protection product (PPP) registration procedures in the EU, and it contributes to the protection of both human health and the environment. Nevertheless, important issues affecting the regulatory processes were identified. The lack of capacity and resources in MSs and at EFSA and the zonal system (in particular mutual recognition) not delivering as expected are among the key issues identified.
  • The MRL Regulation (EC) No. 396/2005 is generally effective in achieving its objectives. It ensures a high level of consumer protection and facilitates the functioning of the internal EU market. The main difficulties identified are related to the MRL revision procedure according to Art. 12, which is considered not ‘fit for purpose’. Besides, the current provisions for setting MRLs for non-chemical active substances are deemed inadequate.

The following issues were also underlined for both Regulations:

  • The delay for implementing and applying several provisions (e.g. assessment of the cumulative risk for consumers) creates obstacles to ensuring a high level of protection for both human health and the environment.
  • Active substances and PPPs not assessed in a timely manner often lead to unsatisfactory evaluations in light of the latest scientific and technical knowledge. The delays also lead to uncertainty and unpredictability which affect companies, particularly SMEs, in their capacity to innovate and to propose alternative solutions to replace hazardous substances.

The Commission REFIT evaluation, based on the results of this external evaluation study, is foreseen to be finalised in the first half of 2019.

 

To download:

Study supporting the REFIT Evaluation of the EU legislation on plant protection products and pesticides residues (Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005)

Executive summary

Final report

Annexe I : Synopsis report

Annexe II : Methodology and cost calculations

Annexe III : Consultation activities – surveys and interviews

 

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

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OECD: Revision of the OECD GD 150 on Standardised Test Guidelines for Evaluating Chemicals for ED

In the context of the adoption of the scientific criteria to identify the substances used in plant protection which are endocrine disruptors (EDs) (Reg. (EU) 2018/605) and of the publication of the common EFSA/ECHA guidance on identifying endocrine disruptors (EFSA Journal 2018;16(6):5311), OECD published on 3 September 2018 a revision of the Guidance Document 150 dealing with the standardised test guidelines for evaluating chemicals for endocrine disruption.

The OECD GD 150 provides guidance on how test results might be interpreted given the outcome of standardised assays and on how to evaluate the overall strength of the evidence that a chemical may be acting as an ED. The approach involves a conceptual framework which allow organising data into five levels of increasingly biologically complex information. The guidance also provides advice on the next step in testing (if any) which might be appropriate to investigate given the various data scenarios. The document is primarily focused on ED operating via Estrogen / Androgen / Thyroid / Steroidogenesis (EATS-) modalities but other modalities are also discussed.

As a first update to the guidance issued in 2012, this revised version includes:

  • the new and updated test guidelines that have been validated (or are currently in the validation process) at the different levels of the conceptual framework; for example, the new ED parameters to be measured as defined in the latest versions of OECD TG 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents) and of OECD TG 414 (Prenatal Developmental Toxicity Study) were added,
  • a revision of the conceptual framework itself,
  • a discussion of cross-cutting issues: the application of new approaches to toxicity testing, such as integrated approaches to testing and assessment (IATA), use of adverse outcome pathways for evaluating endocrine disruption, extrapolating assay results across mammalian and non-mammalian vertebrate species (e.g. fish, amphibian), and approaches for evaluating chemicals with multiple modes of action, and
  • a summary of some experiences gained since the publication of the initial version.

The guidance is organised in three main sections. Section A presents:

  • the general background, the conceptual framework and the objectives of the guidance,
  • the assays and endocrine modalities covered,
  • a list of OECD standardised assays with endpoints specific for ED, or with endpoints that may be informative but that are not specific to ED.

Section B provides:

  • guidance on endocrine assessment, assays and endpoints in light of the conceptual framework proposed,
  • a discussion of the use of weight of evidence approaches for integrating information from multiple assays, and
  • regulatory experience as regards the use of this document for evaluating ED.

Section C includes:

  • a thorough description of each of the assays comprised in the conceptual framework, and
  • different example data scenarios and suggestions for a single next testing step if a conclusion cannot be reached.

The EFSA/ECHA guidance on identifying endocrine disruptors (2018) was prepared concomitantly with the revision of the OECD GD 150, and makes reference to the revised OECD guidance and to the conceptual framework defined.

 

To download:

Revised OECD Guidance Document 150

 

See also our previous articles:

EUROPE: Publication of the guidance document EFSA/ECHA on identifying endocrine disruptors

EUROPE: Publication of Endocrine disruptors criteria

 

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

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

 

EUROPE: Publication of the Technical Guidelines for Determining the Magnitude of Residues and Setting MRL in Honey

Endorsed at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF meeting) of 18-19 September 2018, the final version of technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels (MRL) in honey is now available (SANTE/11956/2016 rev. 9).

After some considerations on the residue definition for risk assessment and enforcement in honey, the guidance document provides a decision-making scheme as regards the type of experimental data required and MRL setting in honey. Other bee products (such as pollen, royal jelly, propolis, etc.) are excluded from the decision-making scheme as the consumption of these products by European consumers is considered negligible. Therefore there is no need to generate experimental residue data for such commodities.

The guidance states that the residue definition in honey should cover:

  • the components included in the residue definition in primary crops,
  • the degradations products formed during pasteurisation conditions, and
  • the components included in the residue definition in rotational crops (i.e. persistent compounds that can be taken up by plants from the soil).

The proposed decision-making scheme can be summarised as follow:

  • In case of no residues expected (e.g. application outside flowering and no persistence) or in case of low residue amounts in aerial crop parts, i.e. <0.05 mg/kg, the default MRL is set at 0.05 mg/kg (or at LOQ).
  • In case of residues in aerial crop parts ≥0.05 mg/kg and <0.5 mg/kg, the MRL is derived from the highest measured residue in aerial crop part.
  • In case of residue in aerial crop parts ≥0.5 mg/kg, complementary experimental studies (tunnel or field trials) are triggered to determine more realistic residue levels in honey. Studies can be conducted either with treated syrup (tunnel trials), to mime a worst-case transfer of residues from nectar to honey, or with treated attractive crops (tunnel or field trials).

For the first step, a list of the main agricultural crops in Europe which have melliferous capacity is included as appendix as a help for the determination if residues in honey are to be expected. For the latter steps, guidance on how to conduct the complementary experimental studies are included as appendices.

The technical guidelines will apply from 1 January 2020. Therefore, it will apply to all MRL review according to Article 12 of Reg. (EC) 396/2005 launched (i.e. EFSA data call-in) as from this date and to all applications at Member State level submitted by this date.

 

To download:

Technical guidelines for determining the magnitude of pesticide residues in honey and setting Maximum Residue Levels in honey – SANTE/11956/2016 rev. 9.

Summary Report of the Standing Committee on Plants, Animals, Food and Feed held in brussels on 18 September 2018 – 19 September 2018 – sante.ddg2.g.5(2018)5747771.

 

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

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