Consultation on nicosulfuron RAR

EFSA opened on 11.04.2024 a consultation on the RAR of nicosulfuron.

Nicosulfuron is an AIR 3.4 substance with an expiry date of 31.03.2027. RMS Latvia produced a RAR in August 2022, 68 months after receipt of the supplementary dossier submitted by a task force comprising 7 companies. This first version of the RAR is now published by EFSA for public commenting.

The proposed decision covers only a few lines of blacked out text, and the particular conditions proposed to manage the risks identified, another few lines of blacked out text. However, from the table under section 3.1., it can be concluded that renewal is being proposed for this product, an herbicide for the control of broad-leaved and grass weeds in maize.

The RMS has kept the tables with critical areas of concern and with the issues that could not be finalized blank. But, again, looking into the table under section 3.1 no major points can be identified, in any of the sections, that potentially lead to a major concern. Nevertheless, two additional studies (amphibians and aquatic organisms) are considered necessary to conclude on ED properties of nicosulfuron on non-target organisms. This seems to indicate that a stop of the clock will be granted for the generation of this data.

The minimum purity of the active substance is listed as 910 g/kg, which is equal to the current specification and FAO specifications. No relevant impurities are listed.

The public consultation ends on the 10.06 2024.


🔬 EFSA consultation on Sedaxane application dossier

On 22.02.2024 EFSA opened a consultation on the application dossier submitted by Syngenta for the renewal of sedaxane.

The public IUCLID dossier is available for consultation. This consultation aims at identifying whether other relevant scientific data, studies and other information are available.

Comments can be submitted through “EFSAconnect” website, until 22.04.2024.


🔬 EFSA consultation on Chlorantraniliprole application dossier

On 19.02.2024 EFSA opened a consultation on the application dossier submitted by FMC for the renewal of chlorantraniliprole.

The public IUCLID dossier is available for consultation. This consultation aims at identifying whether other relevant scientific data, studies and other information are available.

Comments can be submitted through “EFSAconnect” website, until 19.04.2024.


🔬 EFSA consultation on Quinmerac application dossier

On 19.02.2024 EFSA opened a consultation on the application dossier submitted by BASF for the renewal of quinmerac.

The public IUCLID dossier is available for consultation. This consultation aims at identifying whether other relevant scientific data, studies and other information are available.

Comments can be submitted through “EFSAconnect” website, until 19.04.2024.


💡 Polish report on SCoPAFF Legislation March 2024

The Polish competent authority released its travel report on the SCoPAFF Legislation meeting of 20-21.03.2024

A machine-translated and edited version of the Polish report is available via this LINK.

The report contains background information on the following agenda items:

A-points (discussion)

  • A.04 EFSA reports
    • renewals
      • Tritosulfuron
      • Mecoprop-p
      • Dichloprop-p
  • A.05 Review/Renewal Reports for discussion:
    • new substances
      • Pydiflumetofen
    • renewals
      • Milbemectin
      • Folpet
      • Sulfur
      • Metribuzin
  • A. 07 Guidance Documents:
    • Compendium risk mitigation measures (to endorse)
  • A.13 Amendments to Regulation (EU) No547/2011

B-points (proposals for vote)

  • B.01: Captan, renewal with restricions
  • B.02: Dimethomorph, non-renewal
  • B.03: Mepanipyrimnon-renewal
  • B.04: Extension of approval period of 21 substances:
    • 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, dithianon, dodine, fluometuron, hexythiazox, isoxaben, lime sulphur, orange oil, prosulfuron, quinmerac, sintofen, sodium silver thiosulfate, tau-fluvalinate, tebufenozide, tembotrione and zinc phosphide.
  • B.05: Extension of approval period of 6 substances:
    • dodemorph, lauric acid, methyl octanoate, methyl decanoate, oleic acid and Trichoderma atroviride (formerly T. harzianum) strain IMI 206040

C-points (proposals for discussion)

  • C.01: Metrafenone, renewal
  • C.02: Metconazolerenewal
  • C.03: Acibenzolar-S-methyl withdrawing the approval

🔬 Consultation on sulcotrione RAR

EFSA opened on 19.02.2024 a public consultation on the RAR of sulcotrione.

Sulcotrione is an AIR 4.4 substance with an expiry date of 30.11.2026. RMS Germany produced a RAR in November 2023, 45 months after receipt of the supplementary dossier submitted by Ascenza and ADAMA. The RAR has already been amended following completeness check by EFSA and after accordance with ECHA. This version of the RAR is now published for public commenting.

The proposed decision covers 1 page of blacked out text, and the particular conditions proposed to manage the risks identified another page of blacked out text; from the table under section 3.1. it can be concluded that non-renewal is being proposed for this product, an herbicide for the control of broad-leaved and some grass weeds in maize and sorghum.

The RMS identifies several critical areas of concern which do not comply with article 4 of Regulation 1107/2009. Amongst those critical areas of concern, the ones potentially leading to a non-renewal decision, in case they are not reverted, are genotoxicity of parent, relevance of one GW metabolite, levels in GW of parent and one metabolite and equivalency of the batches used in the ecotoxicity studies with the reference specification. Other critical areas of concern were identified, but they relate only to some of the uses or reference formulations. Amongst the issues that could not be finalized, the ED properties for humans and wild mammals and aquatic organisms are listed, due to missing data. Nevertheless, they are not listed as a critical area of concern.

The minimum purity of the active substance is listed as 950 g/kg, which is equal to the current specification. There is also no change in the specification regarding impurities: hydrogen cyanide (max. 80 mg/kg) and toluene (max. 4 g/kg).

The public consultation ends on the 19.04 2024.


🔬 Consultation on dichlorprop-p RAR

EFSA opened on 15.02.2024 a public consultation on the RAR of dichlorprop-p.

Dichlorprop-p is an AIR 3.3 substance with an expiry date of 15.03.2025. RMS Ireland produced a RAR in October 2023, 96 months after receipt of the supplementary dossier submitted by Nufarm UK Ltd. In February 2024 the RAR was updated to extend the existing approval to include the ester variant dichlorprop-p 2-EHE. This version of the RAR is now published for public commenting.

The proposed decision covers 1 page of blacked out text; but from the table under section 3.1. it seems that renewal is proposed for this product, an herbicide for the control of broad-leaved weeds in cereals, grassland and grass seed crops. Some critical areas of concern are identified. However, they all state “potentially unacceptable risk”, and some have mitigation measures that can address the identified risk.

The minimum purity of the active substance is listed as 920 g/kg, which is higher than the current approval, set at min. 900 g/kg. No relevant impurities are proposed.

The public consultation runs until 15.04 2024.


🔬 Fosetyl-Al ED consultation

EFSA has ongoing a public consultation on the ED-updated RAR of fosetyl.

A consultation was already held on the original RAR for Fosetyl, produced by RMS France in July 2017, just before the ED-criteria were published. An ED Stop-the-Clock was granted to generate and submit ED studies/information, which are now published in the updated RAR.

The RMS does not consider Fosetyl to be an endocrine disruptor for humans and for non-target organisms. Compared with the previous version, the updated RAR has the critical area on consumer acute risk removed. This means that there are no critical areas of concern on Fosetyl RAR. Furthermore, the issue not finalized of risk to Birds on Tier 1 was also removed. Some issues that could not be finalized remain, but only for some of the uses/companies.

So far, the renewal process has taken 8.5 years since the date of submission of the renewal dossier:

The public consultation runs from 08.02-08.04.2024.


🔬 EFSA consultation on Use and reporting on the use of Historical Control Data for regulatory studies

EFSA has opened a consultation for a scientific opinion on the Use and reporting on the use of Historical Control Data for regulatory studies.

Regulation (EU) No 283/2013 in its section on toxicological and metabolism studies, states that Historical Control Data (HCD), where available, shall be provided routinely for endpoints that could represent critical adverse effects, particularly for long-term toxicity and carcinogenicity studies, and reproductive toxicity studies. HCD are referred to as a collection of data from toxicity studies conducted under the same or sufficiently similar conditions as the toxicity study under assessment (the index study).

Although there are some generally agreed principles in the different legal/advisory texts, in practice, the collation, use and interpretation of HCD is not harmonised.

This Opinion proposes a stepwise, quantitative approach using a decision scheme that covers planning, evaluation and analysis of the HCD, and use of HCD in the context of the index study. The Opinion offers templates that should improve harmonisation for submission of data, as well as making the data submitter aware of all necessary information related to study conditions and potential confounders.

This consultation ends on the 29.04.2024.


💡Voting results of SCoPAFF Legislation 20-21 March 2024

The formal voting results of B-points from SCoPAFF Legislation meeting of 20-21.03.2024 were made available.

The results were:

B-points (proposals for vote)

  • B.01: Captan, renewal with restricions
    • Vote postponed

 

  • B.02: Dimethomorph, non-renewal
    • Favourable vote – 26 MSs representing 95.77% of EU population.

 

  • B.03: Mepanipyrimnon-renewal
    • Favourable vote – 26 MSs representing 95.77% of EU population.

 

  • B.04: Extension of approval period of 21 substances:
    • 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, dithianon, dodine, fluometuron, hexythiazox, isoxaben, lime sulphur, orange oil, prosulfuron, quinmerac, sintofen, sodium silver thiosulfate, tau-fluvalinate, tebufenozide, tembotrione and zinc phosphide.
    • Favourable vote – 24 MSs representing 61.94% of EU population; 2 MS representing 33.83% of EU population abstained.

 

  • B.05: Extension of approval period of 6 substances:
    • dodemorph, lauric acid, methyl octanoate, methyl decanoate, oleic acid and Trichoderma atroviride (formerly T. harzianum) strain IMI 206040
    • Favourable vote – 26 MSs representing 95.77% of EU population.

💡 New webpage listing existing guidance and supporting documents

DG SANTE has made available on their website, a new page where all guidance and supporting documents on active substances and PPPs are listed.

ECCA was consulted on an early stage and provided some suggestion on how to improve its functionality. At this date, the new webpage coexists with the old one. But the old will be discontinued in July 2024.

The main improvements of this new webpage are:

  • Searchable database as opposed to a static list.
  • Includes a very wide scope of guidance and support information, such as OECD test methods, EFSA and ECHA guidance, etc.
  • Organized by section or as a fully searchable list.
  • Additional information is provided for each item of the list.

The database currently has 500 entries, but it is intended to be continuously updated. Furthermore, users are invited to report any information they consider incorrect, through an “Update request form” available for all entries within the further information pop-up.

ECCA considers this new webpage a significant improvement to the old list of guidance documents and invites everyone to give it a look.


🔬 Inter zonal Steering Committee publishes working document on the interzonal core assessment of Greenhouse uses

The EFSA Guidance Document on emissions from protected crops (greenhouses and crops grown under cover) [EFSA Journal 2014;12(3):3615] presents a categorisation of different systems of protected crops and approaches for exposure assessment for each of these systems.

However, for the interzonal core assessment (izCA) of greenhouses, a practical example was missing. This left member states (MS) with no workable approaches and complicated the harmonised assessment of greenhouse uses.

A harmonized approach was developed at southern zone level (kept in the new published interzonal document). And in 2021 an interzonal working group on protected crops was established to work on a harmonization of the assessment in all 3 zones.

As result of that work, the Interzonal Steering Committee published, two documents on the harmonization of the assessment for Greenhouse uses at iz level:

The provisions of these two documents will be implemented from the 1st September 2024 onwards.

It must be reminded that this assessment is applicable only to uses falling under category ‘greenhouse’ in accordance with the EFSA GD, namely both soil-bound and soil-less uses in high- and low-tech greenhouses.

The assessment for all other protected structures (e.g., walk-in tunnels) is performed at zonal level and not in the izCA.

 

This interim approach was the result of the work of MS from all three zones and intends to give more harmonised and clear guidance to applicants and MS on the requirements for the izCA of greenhouse uses.

 


📆 Agenda SCoPAFF Legislation 20-21 March 2024

DG SANTE published the agenda for the upcoming SCoPAFF Legislation meeting, on 20-21.03.2024.

On the agenda (see LINK for complete agenda), amongst others:

A-points (discussion)

  • A.04 EFSA reports
    • renewals
      • Tritosulfuron
      • Mecoprop-p
      • Dichloprop-p
  • A.05 Review/Renewal Reports for discussion:
    • new substances
      • Pydiflumetofen
    • renewals
      • Milbemectin
      • Pelargonic acid
      • Rape seed oil
      • Flutolanil
      • Folpet
      • Sulfur
      • Aluminium silicate calcinated
      • Metribuzin
    • basic substances
      • Caffeine
      • Onobrychis viciifolia var. Perly (sainfoin) dried pellets
      • Eggshell powder
      • Grape seed extract
      • Allium fistulosum
  • A.06 Confirmatory data
    • Aqueous extract from the germinated seeds of sweet Lupinus albus
    • Pendimethalin
    • Pinoxaden
  • A. 07 Guidance Documents:
    • Joint CLP/PPP templates (to endorse)
    • Compendium risk mitigation measures (to endorse)
    • Impact on water treatment processes (to endorse)
    • Risk assessment of metabolites produced by microorganisms (to endorse)
    • Guidance on emergency authorizations
    • Negligible exposure
    • Bees
    • Birds and Mammals
    • PEC soil calculations
    • FOCUS water scenarios
    • Design and conduct of groundwater monitoring studies
    • Systematic review methodology and open literature review
  • A.10 Specific issues on substances:
    • Sodium hydrogen carbonate
    • SDHI’s common metabolites
    • Pyrethroids common metabolites
    • Zeta-cypermethrin
    • Dimethenamid-p
    • TFA (Trifluoroacetic acid)common metabolite
    • Classification of mixed sodium nitro compounds
  • A.11 Article 21:
    • Flupyradifurone
    • Cyazofamid

B-points (proposals for vote)

  • B.01: Captan, renewal with restricions
  • B.02: Dimethomorph, non-renewal
  • B.03: Mepanipyrim, non-renewal
  • B.04: Extension of approval period of 21 substances:
    • 1-decanol, 6-benzyladenine, aluminium sulfate, azadirachtin, bupirimate, dithianon, dodine, fluometuron, hexythiazox, isoxaben, lime sulphur, orange oil, prosulfuron, quinmerac, sintofen, sodium silver thiosulfate, tau-fluvalinate, tebufenozide, tembotrione and zinc phosphide.
  • B.05: Extension of approval period of 6 substances:
    • dodemorph, lauric acid, methyl octanoate, methyl decanoate, oleic acid and Trichoderma atroviride (formerly T. harzianum) strain IMI 206040

C-points (proposals for discussion)

  • C.01: Metrafenone, renewal
  • C.02: Metconazole, renewal
  • C.03: Acibenzolar-S-methyl, withdrawing the approval

📓 DG SANTE proposes the renewal of approval of glyphosate

DG SANTE is helding an extraordinary meeting of the SCoPAFF next Friday the 22nd of September, with the renewal of approval of glyphosate as the only point in the agenda.

The draft Regulation and Annexes, and the Renewal Report being discussed have been released.

As a compromise between the 5 years of the previous approval, and the 15 years usually granted to active substance, DG SANTE proposes the renewal for a period of 10 years. However, DG SANTE points out that “the active substance may be reviewed at any time pursuant to Article 21 of Regulation (EC) No 1107/2009“.

As in the previous approval, Members States are requested to pay particular attention to the co-formulants present in glyphosate-containing plant protection products.

Members States are also requested to pay particular attention to other aspects commonly seen in active substances renewals.

However, for the first time, Members States are requested to pay particular attention to indirect effects on biodiversity, via trophic interactions. And when such indirect effects are identified, Member States can set specific conditions or restrictions of use.

But at the same time that this provision is included, it is acknowledged that there are no guidelines to assess such indirect effects and, therefore, the applicant is requested to submit “confirmatory information as regards the potential indirect effects on biodiversity via trophic interactions, within three years from the date of applicability of a relevant guidance document”.

Another singularity of this renewal Regulationk, is the setting by default of “an in-field non-sprayed buffer strip of at least 5 to 10 m and drift reduction nozzles reducing spray drift by at least 75%”. However, such risk mitigation measures can be decreased or removed, if the outcome of risk assessment undertaken for a specific use, indicates there are no unacceptable risks caused by spray drift.

 

EFSA data gaps and issues that could not be finalized, are extensively discussed in the Renewal Report and deemed to be sufficiently addressed.


💡Public consultation on the proposed initiative to ban the export of certain chemical products

The European Commission’s call for evidence on new rules to prohibit exports from hazardous chemicals that have been banned within the EU, closed on Monday 31st July, with about 2700 contributions by participants.

While most of the inputs were by private EU citizens, it is highly remarkable the participation of Crop Protection Industry, food value chain stakeholders and Officials from Europe and third countries who made their voices heard.

Strong messages on not overestimating the role of organic farming (chamber of commerce of Guatemala), on balancing sustainability and food security (from Kenya Pest Control Products Board and Equador banana producers), on securing access to specific crop protection products for paddy fields on Monson regions, currently manufactured but not approved in Europe (Japan Ministry of Agriculture), and on the need for EU to seek a more collaborative approach, avoiding unilateral actions that may disrupt global supply chains (American Chemistry Council and Australian Government Department of Agriculture, Fisheries and Forestry) are strong examples of the importance for the European Commission to perform an in-depth impact assessment of the different alternatives, before any decision is proposed.

Very targeted inputs coming by Industry – ECCA delivered clear messages, in alignment with industry stakeholders – also contributed to bring more “food for thoughts” to the European Commission,  highlighting the importance to explore other options other than a ban, such as strengthening the effectiveness of existing PIC regulation.

Once again, the voice of individual crop protection companies proved been very effective and important, and this is a critical opportunity also for ECCA members to further expand and consolidate in the future.

On the other side, civil society delivered messages about pesticide reduction, but not linked to any real impact assessment or concrete solution to balance the impact of such a potential decision on producers and consumers in Europe and outside Europe.

Our association remains firmly convinced that direct engagement with key decision makers and opinion leaders in Europe, in synergy with other stakeholders, is the win strategy to prevent the European Commission from taking legislative initiatives which will create challenges not only to our sector, but to global food safety and security.

We welcome any feedbacks and inputs members will want to share on the dossier, with a special attention on engagement of National Authorities of Member States and European decision makers.


📆 Agenda SCoPAFF residues meeting

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📓 Extension 37 approvals published

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