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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.

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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.

 

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UK: Final commenting phase on the guidance on physico-chemical data

In 2015, a guidance document on the physical, chemical and technical data required to support the registration/authorisation of plant protection products under Regulation (EC) 1107/2009 was published on the HSE website. This National guidance has since been through commenting phases with other EU Member States, EFSA, Industry and wider Stakeholders in order to become an EU harmonised guidance document.

The updated harmonised version reviewed by CRD further to the consultation processes is now available for final comments. The final commenting phase will be completed by 14 May 2018.

Version for commenting:  Guidance document for the generation of data on the physical, chemical and technical properties of Plant Protection Products (PPPs) under Regulation (EC) 1107/2009.

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

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EUROPE: Update of analytical guidance documents

Two updated guidance documents have been published by the European Commission as regards analytical methods:

Guidance document on analytical quality control and method validation procedures for pesticide residues analysis in food and feed – SANTE/11813/2017 rev.0, 21 – 22 November 2017

It supersedes guidance document SANTE/11945/2015 and will be implemented by 01 January 2018. It describes the method validation and analytical quality control requirements to support the validity of data used for checking compliance with maximum residue limits, enforcement actions, or assessment of consumer exposure to pesticides in the EU.

Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods – SANTE 2017/10632 rev.3, 22 November 2017

The purpose of this guidance document is to give advice on when and how to assess the suitability of the extraction procedures applied in pesticide residue analytical methods, e.g. as required for post-registration monitoring methods in the guidance document SANCO/825/00. However, it is not restricted to post-registration monitoring methods and it is also applicable for pre-registration residue analytical methods used for the quantification of residues in supervised field trials. The guidance document has been developed primarily for the evaluation of extraction efficiency of analytical methods for plant matrices, but the basic principles are also applicable for products of animal origin.

The procedure for evaluating extraction efficiency concerns the data requirements for:

– applications for new active substance approval and renewal of active substances  submitted 2 years after agreement on this document;

– new product authorisations and renewal of product authorisations (the data requirements used for the latest renewal or approval should be considered; no additional proof of extraction efficiency will be required when no change of the MRLs is needed);

– applications for new MRLs made 2 years after agreement on this document;

– MRL reviews and specific MRL assessments (pre- and post-registration analytical methods in line with this document will only be required if it was required for the latest approval or renewal. In case that for the Art. 12 MRL reviews and Art. 43 MRL assessments crops out of the scope of the approval or renewal process are considered, additional proof of extraction efficiency might be required but not available. In those cases no new studies should be requested at this stage; however they will need to be made available at the occasion of a new MRL application or at the next renewal of the substance).

– quality control and method validation procedures for pesticides residues in food and feed (see guidance document SANTE/11945/2015 superseded by guidance document SANTE/11813/2017).

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EFSA Public consultation: effects of pesticides on amphibians and reptiles

The public consultation on the Draft Scientific Opinion of the EFSA Panel on Plant Protection Products and their Residues (PPR) on the state of the science on pesticide risk assessment for amphibians and reptiles is opened until 27 May 2017.

The PPR Panel therefore considers that initial suspicion is given for a thoughtful examination of actual risk-assessment schemes, in order to provide the fundamentals for an operational assessment of active substances and PPPs. The PPR panel recommended already in the scientific opinion on the update of the data requirements (EFSA 2007) that an appropriate risk assessment approach for amphibians should be developed. The aim is to ensure that those products are authorized that have no unacceptable effects on non-target species, biodiversity and the ecosystem as required by current legislation (Regulation (EU) 1107/2009).

The current opinion aims at providing the scientific basis for developing a future risk assessment scheme and covers the following topics:

– Ecology and biology of amphibians and sources of environmental exposure,

– Definition of spatial aspects to be considered in the risk assessment,

– Population dynamics and modelling approach to support the setting of Specific Protection Goals (SPG),

– Specific protection goal options for amphibians and reptiles,

– General framework for developing a risk assessment scheme,

– Uncertainties in the risk assessment for amphibians and reptiles,

– Toxicological endpoints and standard tests relevant for amphibians and reptiles,

– Exposure assessment in the environment,

– Coverage of amphibians and reptiles by existing risk assessment schemes for other groups of organisms.

 

For more information, see EFSA website.

 

EFSA Public consultation: Guidance for the identification of biological relevance of adverse/ positive health effects from experimental animal and human studies

The public consultation on the draft guidance document of the EFSA Scientific Committee on the identification of biological relevance of adverse/ positive health effects from experimental animal and human studies is opened until 1st May 2017.

Generic issues and criteria are given to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a positive health effect) or not. The opinion clarifies a number of definitions and concepts, such as, responses of a biological system to exposure, mode of action and adverse outcome pathways, thresholds, critical effect, modelling approaches, etc. It also proposes several case studies.

For more information, see EFSA website.

 

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

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EFSA Public consultation: Guidance on The Use of the Weight of Evidence Approach in Scientific Assessments

The public consultation on the draft guidance document of the EFSA Scientific Committee on The Use of the Weight of Evidence Approach in Scientific Assessments is opened until 1st May 2017.

The guidance document addresses the use of the weight of evidence in scientific assessments using both qualitative and quantitative approaches. Several case studies covering the various areas under EFSA’s remit are annexed to the guidance document to illustrate the applicability of the proposed approach.

 

For more information, see EFSA website.

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

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EUROPE: Updates of AIR 3 and AIR 4 Guidance documents

A number of SANCO and SANTE guidance documents have been updated:

AIR 3 Programme 

SANCO/10148/2014 – Rev. 11 – January 2017 – Applications for renewal of approval of active substances submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

AIR 4 Programme 

SANTE-2016-10616–rev. 6 – February 2017 – Draft working document – AIR IV Renewal Programme

SANTE-2016-11734–rev. 3 – February 2017 – AIR IV Renewal programme – Applications for renewal of approval submitted under article 14 of Regulation (EU) No. 1107/2009 and in accordance with Regulation (EU) No. 844/2012

 

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EUROPE: New update of SANCO 7525/VI/95 on comparability, extrapolation, group tolerances and data requirements for setting MRLs

Revision 10.2 of Guidance document SANCO 7525/VI/95 concerning residue trials was adopted by the European Commission on 23 September 2016 and became effective immediately.

This new revision applies to new applications but also to those applications where assessment was already carried out by a Member State under the previous version. In such cases EFSA should use the new version to make its assessment. Where applications are already advanced in the EFSA assessment procedure and use of the new guidance would delay the overall procedure, no retroactive amendments should be carried out. The same principles apply to the Art. 12 review process.

The update concerns Table 3 (recommended extrapolations) and Table 4 (Addendum to Table 3). Some mistakes/errors detected after the adoption of version 10.1 were corrected and some clarifications were made.

To download:

SANCO 7525/VI/95 Rev. 10.2 – GUIDANCE DOCUMENT Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs

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EUROPE: List of obsolete guidance documents

A guidance document (SANTE/11073/2015 rev. 0), published by the European Commission, lists 13 Guidance Documents that currently still appear on the SANTE-website but that are considered obsolete or without purpose in the sense that either they still refer to procedures related to Directive 91/414/EEC or in the meantime new revised guidance documents have been noted on these specific issues. For reference purposes these Guidance Documents will be filed in a special folder on CIRCABC.

 

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