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FRANCE – ANSES: Epoxiconazole-based products ban

On 28 May 2019, Anses opinion on endocrine-disrupting properties of the active substance epoxiconazole was published and the  withdrawal of marketing authorisations of epoxiconazole-based products was announced.

Epoxiconazole is a fungicide active substance listed as candidate for substitution by Regulation (EU)  2015/408. This substance is persistent and toxic, a suspected carcinogen (C2) and presumed human reproductive toxicant (R1B). The authorisation of epoxiconazole is under evaluation at EU level. A decision should be taken by 30 April 2020.

Further to the adoption of the European legislation on endocrine disruptors in December 2017 and to the implementation of the guidance document on identification published on 5 June 2018, ANSES immediately issued an internal assessment of endocrine-disrupting properties of epoxiconazole.

Based on this evaluation, Anses have concluded that epoxiconazole is an endocrine disruptor for humans and non-target organisms.

For this reason, ANSES has notified the authorisation holders of its intention to withdraw 76 epoxiconazole-based products from the French  market.

To download:

ANSES OPINION on endocrine-disrupting properties of epoxiconazole (in French)

 

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FRANCE: New National Strategy on Endocrine disruptors

The second draft national strategy on endocrine disruptors (SNPE 2) was published in mid-January by the Ministries of Health and Ecological Transition. This new action plan will update the first national strategy, initiated in 2014. A public consultation was initiated on 14 January and will run until 8 February.

Three main objectives have been presented as part of this new national strategy:

Protect the population, train and inform

As part of this 1st objective, ANSES will be responsible for establishing a unique and scientifically robust list of endocrine disrupting substances (ED) by the end of 2021. This list will be based in particular on data from the scientific literature as well as on different already existing lists. The idea is to produce a continuously updated list shared with other Member States.

The government also wants to promote at the European level a common definition of ED in all chemical regulations ‒ which would consider 3 levels of evidence: proven, presumed and suspected.

Other actions will also be undertaken to facilitate access to information on the risks associated with the use of certain chemicals by the general public (e.g. informative website, communication campaign).

Prevent environmental contamination

As part of this 2nd objective, a platform will be created on the data.gouv.fr portal by 2020 in order to collect and centralise all the data concerning the occurrence of PE in the environmental compartments. The government also plans to strengthen the collection of data by conducting monitoring campaigns in soil and air, and by continuing and further developing the monitoring in aquatic compartments that are already in place in the context of the Water Framework Directive.

The French Agency for Biodiversity will be mandated to carry out a review of the effects of ED on the environment, as well as to discuss a possible modification of the regulatory acceptable limits of PE in environmental compartments, in consultation with the French National Institute for Industrial Environment and Risks.

In addition, ED will be included in the next Total Diet Study conducted by ANSES in order to monitor exposure of the population to chemicals present in foods.

Improve knowledge on endocrine disruptors

Under this 3rd objective, the executive plans to strengthen scientific research around the impact of ED on human health and the environment. A reflection will also be conducted to broaden the monitoring of ED to other health indicators, taking into account the diversity of disorders and pathologies reported in the literature.

Finally, the French government will promote the substitution of ED to industry stakeholders through working groups and projects involving various actors from industry, consumer associations, etc.

To download (in French):

Draft of strategic goals

Draft action plan

Draft of the 13 main measures

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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.

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

The Commission notice of 24th September 2018 indicates that the new EFSA/ECHA guidance document on how to identify endocrine disruptors, adopted and published in June 2018, will apply as of the date of application of Regulation (EU) No. 2018/605, 10th November 2018, to address points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No. 1107/2009.

EFSA/ECHA guidance document and the scientific criteria to identify endocrine disruptors, as defined in Regulation (EU) No. 2018/605, will apply to on-going and future applications for approval or renewal of active substances, safeners or synergists.

 

To download:

Commission notice about the availability and applicability of a guidance document to implement Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards endocrine disrupting properties (24/09/2018)

 

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 guidance document EFSA/ECHA on identifying endocrine disruptors

The European Food Safety Authority (EFSA) and the European CHemicals Agency (ECHA) published on 7 June 2018 the first version of the common guidance document on how to identify endocrine disruptors (EDs) contained in plant protection products and biocides.

Started in 2017, the drafting of the document was finalised with the integration of the scientific criteria to identify active substances used in plant protection and having ED properties (adopted in April with Regulation (EU) 2018/605), and the consideration of all comments received during the public consultations held in December 2017 and January 2018.

The guidance document immediately applies to biocides. For active substances used in plant protection, the document will apply to those substances for which a decision is scheduled on or after 10 November 2018.

 

To download (pre-publication version):

Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009

 

See also our previous article:

EUROPE: Publication of Endocrine disruptors criteria

EUROPE: Public consultation on draft guidance for identifying endocrine disruptors

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

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EUROPE: Publication of Endocrine disruptors criteria

On 20 April 2018 was published the Commission Regulation (EU) 2018/605 setting out the scientific criteria to identify the substances used in plant protection which are endocrine disruptors (EDs).

After the rejection of the initial regulation project by the European Parliament in October 2017, the new project taking into consideration the claims of the European Parliament (i.e. the deletion of the exemption for substances that have an ‘intended endocrine mode of action’), was voted at the PAFF meeting in December 2017.

According to the Regulation, an active substance, safener or synergist is considered as ED if (i) it shows an adverse effect in an intact organism or its progeny, (ii) it alters the function(s) of the endocrine system, and (iii) the adverse effect is a consequence of the endocrine mode of action.

The new criteria will apply from 20 October 2018 onwards, including the substances for which an assessment or a re-evaluation is ongoing. A feedback regarding the experience gained from the application of these criteria will be presented by the Commission by 20 October 2025.

As a reminder, very similar criteria will apply to biocide substances from 7 June 2018. The European Union is now the first worldwide to have strict legally binding criteria to identify EDs.

Besides, the draft technical guidance document for identifying EDs of ECHA and EFSA is currently being updated with the new criteria set. The guidance document will be available by June 2018.

 

To download: Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties.

 

See also our previous articles:

EUROPE: Public consultation on draft guidance for identifying endocrine disruptors

EUROPE: Parliament rejects criteria for endocrine disruptors

Adoption of Endocrine disruptors criteria

 

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

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EUROPE: Public consultation on draft guidance for identifying endocrine disruptors

ECHA and EFSA are inviting interested parties to comment on the draft guidance document for identifying endocrine disruptors. The deadline for providing comments is 31 January 2018.

The European Commission will organise a workshop on 1-2 February 2018 to test the applicability of the draft guidance on the basis of case studies using active substances currently under assessment in the context of the pesticides and biocides Regulations. Two experts per Member State (one for pesticides, one for biocides) plus the speakers presenting selected case studies will be reimbursed. Stakeholders will also be invited.

The final guidance will be applicable to both biocides and pesticides, provided that the criteria that will in the end be adopted for pesticides will not substantially differ from those adopted for biocides.

As quoted in our previous article, the European Parliament voted to object to the European Commission’s draft regulation setting out criteria for identifying endocrine disruptors in the area of plant protection products (PPPs) in October 2017. In the meantime, the European Commission put to a vote a new proposal for EDs definition at the PAFF meeting of 12-13 December 2017 (SANTE/11992/2017).  The revised draft Regulation is identical to the text voted in July, except for the deletion of the last paragraph with the provision on the growth regulators and the corresponding Recital. The revised draft Regulation thus followed exactly the request of the European Parliament. A favourable opinion with qualified majority (18 Member States in favour, representing 65.79 % of the EU population) was given. The draft Regulation would now be sent to the Council and the European Parliament. They will have 3 months to examine it before final adoption by the Commission.

To download:  Draft guidance for identifying endocrine disruptors

See also our previous article: EUROPE: Parliament rejects criteria for endocrine disruptors

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

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EUROPE: Parliament rejects criteria for endocrine disruptors

On 4 October 2017, the European Parliament voted to object to the European Commission’s draft regulation setting out criteria for identifying endocrine disruptors in the area of plant protection products (PPPs).

The Parliament objection regards the last paragraph of the draft regulation. The criteria proposed in the draft regulation provide for an exemption, or derogation, from the scope of the criteria for identifying EDCs, for substances that have an ‘intended endocrine mode of action’ (i.e. are deliberately designed to attack an organism’s endocrine system).

The Commission regretted Parliament’s vote, reportedly stating that the derogation had been essential in getting a qualified majority among Member States to support the criteria.

Now the Commission has to withdraw the draft regulation and either submit an amended version, do no further action or submit a new draft regulation. In the meantime, the interim criteria continue to apply.

 

To be downloaded:

EU Parliament: Parliament rejects criteria for endocrine disruptors

 

Our previous articles:  

Adoption of endocrine disruptors criteria

FRANCE: List of PPPs that may contain Endocrine Disruptors (EDs)

 

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

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FRANCE: List of PPPs that may contain Endocrine Disruptors (EDs)

As announced in our post dated 12th July, the list of plant protection products that may contain endocrine disruptor substances has been published in France.

The products listed are products containing one or more active substances included in the impact assessment of the European Commission as falling within the definition as proposed by the European Commission. The definition adopted is broader, including suspected endocrine disrupters, and substances for which endocrine disrupting action is “plausible”.

 

IMPORTANT: Scientific agencies have not yet conducted detailed work substance by substance to verify their endocrine character based on the definition adopted by the Member States.
Substances can therefore be withdrawn or added to this list.

 

To download:  

Liste de produits pesticides susceptibles de contenir des substances perturbatrices endocriniennes

 

Our previous article:

Adoption of Endocrine disruptors criteria

 

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

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