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.

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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: Draft report of the PEST Committee on the Union’s authorisation procedure for pesticides

Nine years after the adoption of Regulation (EC) No. 1107/2009 and following the recent controversy about the renewal of the active substance glyphosate, a special committee, the so-called ‘PEST’, was mandated in 2018 by the European Parliament for an analysis of the current authorisation procedure for pesticides in the Union. The final objective of the committee is to present recommendations on the procedure in order to achieve a high level of protection of human and animal health, and the environment.

A draft version of the PEST committee report has recently been made available online (please refer to the link below). A final version of the report is to be expected by the end of the year.

 

To download:

Draft report of the PEST Committee (25 August 2018)

 

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

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EUROPE – EFSA: Recurring issues in mammalian toxicology

During the EFSA peer review of pesticide active substances under Regulation (EC) No. 1107/2009, several aspects in the area of mammalian toxicology were identified by EFSA that needed discussion with experts from National Authorities in order to enhance the harmonisation of the risk assessment of active substances.

A new discussion was held at the Pesticide Peer Review Meeting 170 of December 2017. Recommendations were made on:

  • Genotoxicity of plant protection products
  • Use of (Q)SARs
  • Use of Read-Across approaches for metabolites

These recommendations will be applied during the EFSA peer review of the active substances.

 

In addition, brief discussions of the following topics were also made:

  • EFSA guidance 2016 on the residue definition
  • EFSA guidance 2017 on dermal absorption
  • Current and planned EFSA activities in the area of pesticides:
    • Developmental neurotoxicity
    • Cumulative assessment groups
    • Epidemiology
    • Planned workshops (in vitro comparative metabolism, phototoxicity, historical control data)
    • Update of EFSA guidance 2014 on the assessment of exposure of operators, workers, residents and bystanders

 

To download:

EFSA Technical Report – Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology (25 August 2018)

 

See also our previous articles:

EUROPE – EFSA: Recurring issues in mammalian toxicology

 

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

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FRANCE: Withdrawal and restrictions on the use of neonicotinoid-based PPPs

Further to the adoption in May 2018 of three European regulations limiting the authorisations of imidacloprid, clothianidin and thiamethoxam products (Regulations (EU) No. 2018/783, No. 2018/784 and No. 2018/785) for use under permanent greenhouse or in seed treatment intended to be used only in permanent greenhouse, ANSES has withdrawn 19 approvals or parallel trade permits for products only authorised for field application or for the treatment of seeds intended for use in open field. ANSES also restricted 17 approvals to limit them to greenhouse uses. These withdrawals and modifications of the conditions of use are effective as from 1st September 2018.
Concurrently and in addition to these European provisions, in compliance with Decree 2018-675 of 30 July 2018, the use of acetamiprid, clothianidin, imidacloprid, thiacloprid and thiamethoxam-based products is prohibited in France from 1st September  2018 including for greenhouse uses that remain authorised in the European regulations. The French E-phy database has been updated accordingly for the plant protection products concerned.

To download: List of PPPs based on substances belonging to the neonicotinoids family and withdrawn from the market as from 1st September 2018 (in French)

See also our previous articles:

FRANCE: List of neonicotinoids substances banned

EUROPE: Neonicotinoids ban for outdoor uses

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

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FRANCE: Update of the explanatory note and of the application cerfa form!

ANSES has updated the general note for the submission of applications. It introduces the second version of the explanatory note No. 52173 and of the application cerfa form No. 15722. The previous version was dated from July 2017.

Note that a special version of the cerfa has been created to easily fill in the PDF form.

 

The main changes of this second version of the explanatory note No. 52173 are as follows:

– In the GAP table, new concept for greenhouse uses:

G = Greenhouse (greenhouse / tunnel) to decline according to G1: tunnel or shelter not permeable to water, closed at the time of treatment; permanent greenhouse, soil-bound crops; G2: tunnel or shelter not permeable to water, closed at the time of treatment; permanent greenhouse, above soil-less crops (EFSA Guidance Document for protected crops – EFSA Journal 2014;12(3):3615)

– The term “Mention Abeille” (“Bee Claim”) disappears in favor of “exemption under the Order of November 28, 2003” (in French)

– The notion of “significant composition change” is introduced. It is assimilated to a new application for approval by the standard procedure (Article 33 of Regulation (EC) No. 1107/2009) or by the mutual recognition procedure (Article 40 of Regulation (EC) No. 1107/2009)

– The intracommunity VAT number is requested for companies with headquarters in the European Union

– The case of dose split and how to indicate it in the cerfa form is described

– CDs and DVDs containing the application sent to ANSES must not be re-writable

IMPORTANT: With regard to dRR parts A and B, the applicant must now highlight in grey the information presented in the draft part A and part B which must, pursuant to article 63, remain confidential

– It is made clear that when the product is intended for amateur use, the draft label must be provided with the artwork

– Regarding the electronic format, all study reports must be provided.

– The numbering of the documents to be used in the application has been modified (Appendix IV of the notice)

– The format of the list of studies for data protection in France to be provided in Excel format or in a format compatible with Excel has been modified (Appendix V of the notice)

 

The main changes of this second version of cerfa form No. 15722 are as follows:

– Point 1.3.4: The term “Mention Abeille” (“Bee Claim”) disappears in favor of “exemption under the Order of November 28, 2003”

– Point 1.3.6: introduction of the notion of “significant composition change”. vs “non-significant change”

– Point 8: new concept for greenhouse uses: G = Greenhouse (greenhouse / tunnel) to decline according to G1: tunnel or shelter not permeable to water, closed at the time of treatment; permanent greenhouse, soil-bound crops; G2: tunnel or shelter not permeable to water, closed at the time of treatment; permanent greenhouse, above soil-less crops

– Point 9.2: addition of the box “Without classification”

 

To download:

Note générale pour le dépôt des dossiers (formulaires Cerfa et notices à utiliser) (23/07/2018) (in French)

Notice explicative pour remplir le formulaire relatif à une autorisation de mise sur le marché Cerfa N°52173#02 (pdf) (in French)

Formulaire relatif à une autorisation de mise sur le marché Cerfa N° 15722*02 (word) Cerfa N° 15722*02 (pdf) Cerfa N°15722*02 (pdf à remplir) (in French)

 

See also our previous article:

FRANCE – ANSES: Procedures for applications for approval and new cerfa forms!

 

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

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FRANCE: List of neonicotinoids substances banned

The list of substances from the neonicotinoids family banned from 1st September 2018 in plant protection products and seed treatments was published on 1st August. This ban is planned by the law for biodiversity regrowth, nature and landscapes published in 2016, exemptions being possible on a case by case basis until 1st July 2020.

According to Decree 2018-675 of 30 July issued under article L.253-8 of the French Rural Code, five substances are concerned: acetamiprid, clothianidin, imidacloprid, thiacloprid and thiametoxam. European restrictions are already in place since 2013 for three of them (clothianidin, imidacloprid and thiametoxam) (see Regulation (EU) No.485/2013). These restrictions have just been extended so as to only allow  the use of these three active substances in permanent greenhouses where no contact with bees is expected (Regulations (EU) No. 2018/783, No .2018/784 and No. 2018/785 of 29 May 2018).

 

To download: Décret n° 2018-675 du 30 juillet 2018 relatif à la définition des substances actives de la famille des néonicotinoïdes présentes dans les produits phytopharmaceutiques (in French)

See also our previous articles:

EUROPE: Neonicotinoids ban for outdoor uses

FRANCE: Risks/Benefits of neonicotinoids compared to their alternatives

 

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

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FRANCE: Ecophyto II+, update and improvement of Ecophyto II

Version II+ of Ecophyto plan, updating and improving Ecophyto II, was examined during the Strategic Orientation Committee (COS) of 27 July 2018. This new version features the actions planned in the French action plan of 25 April 2018 on plant protection products and on a less pesticide-dependent agriculture  and in the French action plan of 22 June 2018 for a ban of glyphosate within three years .

Among the issues, the ministers notably announced that, in a first step, renewals of authorisations of glyphosate-based products will only be obtained for a maximum period of three years. Besides, the uses for which comparative assessments will underline that non-chemical alternative solutions are available and are commonly used, will be banned progressively.

With regard to neonicotinoids, ministers indicated that only few exemptions to the ban are envisaged. Those exemptions will only concern acetamiprid-based products, for low volumes and after a comprehensive risk assessment.

The public consultation for Ecophyto II+, initially announced for July 2018, will be held in Autumn 2018. The plan is expected to be published by the end of 2018.

 

To download:

Press release of 27 July 2018 – Strategic orientation committee of Ecophyto plan (in French)

 

See also our previous articles:

FRANCE: Action plan for plant protection products

 

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

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EUROPE: Updates of AIR 3 and AIR 4 working documents

AIR 3 programme

SANCO/2012/11284 – Rev. 21  – June 2018 – Draft working document – AIR III Renewal programme

This 21th revision contains new expiry dates set by Regulation (EU) 2018/524 of 28 March 2018 (Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram) and Regulation (EU) 2018/917 of 27 June 2018 (alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor). It also contains the renewal of active substances (Ampelomyces quisqualis strain AQ10, carfentrazone-ethyl and trifloxystrobin).

 

AIR 4 programme

SANTE-2016-10616-rev 9 – June 2018 – AIR IV Renewal programme

SANTE-2016-11734-rev.10 –  June 2018 – 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

These new versions update revision 8 of October 2017 and 9 of February 2018 of guidance documents SANTE-2016-10616 (AIR IV Renewal programme) and SANTE-2016-11734 (application overview for AIR IV substances).

 

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

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EUROPE: AIR5 work programme

Further to the publication in January of Regulation (EU) 2018/155 allocating the MS for the renewal of AIR5 active substances, the Commission has released a work programme:

  • the decision of 06 June 2018 gives priority to the evaluation of active substances that may fail the approval criteria (= that meet the “cut-off” criteria) and of candidates for substitution, and groups the evaluation of active substances with similar properties
  • the draft working document SANTE/2018/10048 provides an overview of indicative dates for application and dossier submission of 66 active substances. They are divided into 2 groups: no change in expiry date, a.s. to be potentially extended.

 

To download:

Commission Implementing Decision of 6 June 2018 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2022, 2023 and 2024 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council

SANTE-2018-10048–rev 1 (June 2018): Draft working document establishing the fifth renewal programme

 

See also our previous article:

EUROPE: Allocation of MS for AIR4 and AIR5 active substances

 

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

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