EUROPE: Public consultation on draft guidance for identifying endocrine disruptors

ECHA and EFSA are inviting interested parties to comment on the draft guidance document for identifying endocrine disruptors.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The European Commission will organise a workshop on 1-2 February 2018 to test the applicability of the draft guidance on the basis of case studies using active substances currently under assessment in the context of the pesticides and biocides Regulations.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To download:  Draft guidance for identifying endocrine disruptors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

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EUROPE: Combined template to be used for assessment reports and proposals for classification

A revised template to be used for Assessment Reports according to Regulation (EC) No 1107/2009 and Proposals for Harmonised Classification and Labelling according to Regulation (EC) No 1272/2008 has been published by the Commission (SANCO/12592/2012 rev. 1.2).

This revised template was agreed by the PAFF Standing Committee on 6 October 2017. It should be used for combined assessment and CLH reports prepared for active substances covered by Commission Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 and for active substances for which an application for the approval has been submitted as from 6 October 2017.

To download: template to be used for for assessment reports and Proposals for classification

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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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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

 

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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/2012/11284 – Rev. 19 – November 2017 – Draft working document – AIR III Renewal programme

The new revision contains new expiry dates for substances in batch 1, batch 2, batch 3, batch 5, 6, and 7.

Note that revision 19 replaces revision 18 that was uploaded prematurely by mistake. The extensions for batches 3 and 7 (all from 31.01.2018 to 31.01.2019) were deleted.

 

AIR 4 programme

SANTE-2016-10616–rev 8 – October 2017 – Draft working document – AIR IV Renewal Programme

The new revision shows the non-approval of tall oil pitch and tall oil crude, and the phase out of triflumizole and spirodiclofen (no applications received). A new page is added to the Working Document, with implementing Regulations (extensions).

SANTE-2016-11734–rev.7 October 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

This revision presents an overview of received applications, namely carbon dioxide (name change of the Carbon Dioxide Renewal Taskforce), cyflufenamid (applicant is Envigo, on behalf of Nisso Chemical Europe) and flonicamid (an application was received on 29.08.2017, name of the applicant not provided).

 

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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)

 

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FRANCE: New update of the official list of biocontrol products

The French Ministry of Agriculture, Food and Forestry has published a new update of the official list of biocontrol plant protection products in accordance with articles L.253-5 and L.253-7 of the Rural Code. This note repeals the previous one dated 28 July 2017 and entered into force on 17 October 2017.

As well as providing some typographical corrections on products already included, this note includes a total of 16 new products: 3 in Part A (products containing micro-organisms), 1 in Part B (products containing chemical mediators), 11 in Part C (products containing natural substances of plant, animal or mineral origin) and 1 in Part D (insects traps).

The next update will take place in January 2018 on the basis of products authorised on 31 December 2017.

 

To download: Note DGAL/SDQSPV/2017-826 du 18/10/2017 (in French)

 

See our previous articles: 2nd update of the official list of biocontrol products

 

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FRANCE: New update of the memo relative to trials and experiments of regulated products

ANSES has issued a new version of the Memo relative to trials and experiments of regulated products (plant protection products/fertilisers) dated 01/09/2017; the previous Memo was dated 19/06/2017. The changes are as followpermiss:

The form to be filled in for an application for plant protection product trial permit (CERFA 15720*01) as well as the explanatory note (Cerfa N°52171#01) are specified.

In the case of fertilisers and crop substrates, the amount of the fee levied by ANSES (fixed by the decree of 12 April 2017 – Article 7, point V and IX, paragraph 2, entered into force on 01/07/2017) for a trial permit application was revised and set at 1000 € for a single product and 2000 € for a set of products.

 

To download (in French):  

Note relative aux essais et expérimentations de produits réglementés (produits phytopharmaceutiques / matières fertilisantes) actualisée au 01/09/2017

Arrêté du 12 avril 2017 fixant le barème de la taxe fiscale affectée perçue par l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relative à la mise sur le marché des produits phytopharmaceutiques et de leurs adjuvants, des matières fertilisantes et de leurs adjuvants et des supports de culture

 

See also our previous articles:

FRANCE: Update of the memo relative to trials and experiments of regulated products

FRANCE – Anses : New fees

 

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EUROPE: New EPPO standard on efficacy evaluation for low-risk plant protection products is published

The EPPO standard “PP 1/296 (1) Principles of efficacy evaluation for low-risk plant protection products” has been first approved in September 2017 and released on 13 October 2017.

This Standard describes the principles for determining the requirements for an efficacy evaluation of low-risk plant protection products in a registration procedure, based on addressing the data requirements as specified by Regulation (EC) 1107/2009. This standard is intended for the harmonization of requirements for the efficacy evaluation of low-risk plant protection products to facilitate their placement on the market.

This document provides a framework for the minimum efficacy data requirements needed to demonstrate that a low-risk plant protection product is sufficiently effective and crop safe for authorisation, taking into consideration that a more specialised approach may be used compared to other plant protection products because they often have different properties and modes of action, and that a more flexible efficacy evaluation may be followed.

 

To download: PP 1/296 (1) Principles of efficacy evaluation for low-risk plant protection products

 

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UK: Notice on the BREXIT impact for applicants

This Notice from DG SANTE reminds applicants that, unless the withdrawal agreement (‘Brexit’) establishes another date or the period is extended by the European Council, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019 (‘the withdrawal date’). The United Kingdom will then become a ‘third country’.

In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, all applicants for an active substance or plant protection product are reminded of certain legal repercussions.

In particular, applicants should consider that, according to Union law, UK as a third country will not be able to act as rapporteur Member State, zonal rapporteur Member State or evaluating Member State for MRLs anymore.

As regards submissions of new applications, applicants should take into account the expected timelines of different regulatory procedures in which the UK would be acting and should consider taking the relevant actions. For example, where there is a risk that those procedures are not concluded by the date when the UK will leave the Union, applicants may choose by preference another Member State to carry out the evaluation or assessment.

Concerning those on-going procedures for which the UK is currently carrying out an assessment or evaluation, applicants  should carefully monitor their progress. Where there are clear indications that the procedure will not be concluded by the withdrawal date, taking account of the uncertainties as well as the regulatory framework, applicants  should consider taking the necessary actions. For example, a change of the rapporteur or evaluating Member State may be required.

The Commission Services are working with Member States and EEA countries in order to establish a coordinated way forward for a timely communication, agreement and technical transfer of the file in case that change is needed. This will be particularly relevant for the review programme of existing active substances, for which the UK was assigned by law (Commission Implementing Regulation (EU) 686/2012) as rapporteur and co-rapporteur Member State.

The Commission Services stand ready to provide further clarification and will provide a series of Questions & Answers (Q&A) in relation to Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005. They will be made publicly available on a dedicated page of the Directorate-General for Health and Food Safety: http://ec.europa.eu/food/plant/pesticides/approval_active_substances_en

This page will be updated with further practical information and relevant Q&A pairs, and will be subsequently expanded, where necessary.

 

To download:  

Notice to business operators in the field of regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin

Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to plant protection products and pesticides residues

 

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