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.

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

 

FRANCE – ANSES: Management of PPPs applications following the renewal of active substances approval

ANSES published on 18.10.2018 a memo describing the management of applications for PPPs authorisation following the renewal of active substances approval. This memo recalls the regulatory context of the active substances renewal in the framework of Regulation (EC) No. 1107/2009 and describes the consequences of the active substances renewal for the applications for PPPs authorisation before and after the active substance renewal, in the case of applications for new PPPs authorisation as well as in the case of PPPs already approved (Article 43).

Applications related to PPPs for which the authorisation is being renewed under article 43 are classified into three categories described in the memo: applications essentially administrative that may be processed during the process of authorisation renewal, applications that cannot be processed by ANSES during the period of evaluation of the authorisation renewal (frozen period) and applications that may be processed in parallel with the renewal authorisation, for which the evaluation cannot be finalised before  the renewal evaluation is complete.

Finally, the theoretical timelines for the renewal of PPP authorisations pursuant to Article 43 of Regulation (EC) No.1107/2009 and to the Guidance document on the Renewal of Authorisations is set out in appendix and details on the definition of the frozen period are given.

 

To download:

Gestion des demandes relatives à la mise sur le marché de produits phytopharmaceutiques suite au renouvellement de l’approbation de substances actives (in French)

 

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

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

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.

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

 

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/

 

UK – Brexit: scenarios in case of no-deal

The Health and Safety Executive (HSE) have issued technical notices detailing what will happen if the UK leaves the EU without an agreement (‘no deal’).

Regarding PPPs, in a no deal scenario, the UK would establish an independent standalone PPP regime, with all decision making repatriated from the EU to the UK. HSE would continue to operate as the national regulator.

All current active substance approvals, PPP authorisations, and Maximum Residue Levels (MRLs) in place on 29 March 2019 would remain valid in the UK after the Brexit, so businesses could continue to trade and products would continue to be available.

After the Brexit, all applications for products to be authorised in the UK, and all active substances and MRLs would be considered under the national regime. The format of applications and basic data requirements would remain the same as under the current regime. Applications for EU approvals would need to be submitted separately to the EU for their consideration.

To ensure that processes run smoothly, there would be an extension of three years to active substance approvals which are due to expire in the three years after the Brexit. This would provide time for establishment of national renewal arrangements.

Applications which are being considered by the UK at the point of exit will be progressed to completion under the national regime.

At medium or long-term, HSE envisage developing a UK legislation divergent from the EU legislation.

Action for business:

  • No immediate action is required in respect of current active substance approvals, PPP authorisations, and MRLs. These will all remain valid in the UK and EU after exit day as now.
  • Start to consider what new applications businesses might wish to make under both the UK and EU regimes in the period after EU exit, and to plan ahead for any applications under each regime relating to renewals of existing approvals and authorisations as they expire over time.
  • Keep in touch with HSE as the regulator with respect to any current applications.

To download:

Plant Protection Products (PPP) regulation – ‘Regulating pesticides if there’s no Brexit deal’

Classification, Labelling and Packaging (CLP) regulation – ‘Classifying, labelling and packaging chemicals if there’s no Brexit deal’

Biocidal Products Regulation (BPR) – ‘Regulating biocidal products if there’s no Brexit deal’

Prior Informed Consent (PIC) regulation – ‘Export and import of hazardous chemicals if there’s no Brexit deal’

Regulation on mercury – ‘Control on mercury if there’s no Brexit deal’

Regulating Persistent Organic Pollutants (POPs) – ‘Control on Persistent Organic Pollutants if there’s no Brexit deal’

Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) regulation – ‘Regulating chemicals (REACH) if there’s no Brexit deal’

 

See also our previous article:

UK: Notice on the BREXIT impact for applicants

 

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

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