FRANCE – ANSES: Glyphosate – Publication of decisions and results of the comparative assessment

Following the renewal of the approval of the active substance glyphosate, ANSES issued on 30 September 2020 decisions on 6 applications of renewal and 3 new applications for marketing authorisation for plant protection products. Three renewal applications and one new application for authorisation were refused due to a potential risk of adverse effects on human health due to the possible formation of the relevant impurity N-nitrosoglyphosate during the storage of the product.

 

In parallel, ANSES has also published on 09 October 2020 the results of its comparative assessment carried out under Article 50.2 of the European Regulation (EC) 1107/2009. Thus, the practical or economic drawbacks of currently available non-chemical alternatives have been identified for the 4 main areas of agricultural uses: fruit trees, viticulture, arable crops and forestry. ANSES based the assessment on different sources of information among them three reports issued by INRAE (INRAE’s report on fruit trees, INRAE’s report on  viticulture and INRAE’s report on arable crops) and data provided by ONF (“Office National des Forêts” / National Forestry Office) and CNPF (“Centre National de la Propriété Forestière” / National Center for forest ownership).

The conclusions are the following:

Uses Fruit trees Viticulture Arable crops (cereals, oilseeds, peas…) Forestry
Possible alternatives = Ban on using glyphosate Between the rows:

– Mechanical weeding

– Grassed areas

Between the rows:

– Mechanical weeding

– Grassed areas

When the plot has been ploughed between two crops Alternative non-chemical methods for killing tree stumps
Substitution not possible = Authorised use of glyphosate Mechanical weeding  not possible:

– Mechanical harvesting of fruits on the ground

– Bushy crops

Unavailability in the short term of agricultural machinery for weeding under the row

Mechanical weeding  not possible: steeply sloping or terraced vineyards, stony ground, rootstock nurseries

Unavailability in the short term of agricultural machinery for weeding under the row

In situations of regulated mandatory control Forest maintenance during the stand establishment period

Forest nurseries and seed orchards

Restriction of rates Maximum 900 g of glyphosate per year and per hectare and application limited to 40% of the plot area = 60% reduction of the maximum rate currently authorised Maximum 450 g of glyphosate per year and per hectare and application limited to 20% of the plot area = 80% reduction of the maximum rate currently authorised Maximum 1080 g of glyphosate per year and per hectare = 60% reduction of the maximum rate currently authorised /

As for the non-crop uses of glyphosate, they cannot be fully substituted by non-chemical alternatives. Reducing the use of glyphosate in these different situations cannot therefore be addressed by a restriction laid down in the marketing authorisations, but needs to be considered as part of a change in weed-control practices.

These restrictions will now be taken into account and will apply to each product placed on the market and within 6 months for products which were renewed.

 

To download: 

Comparative assessment report – Products containing glyphosate – Examination of alternatives in arboriculture (in French)

Comparative assessment report – Products containing glyphosate – Examination of alternatives in viticulture (in French)

Comparative assessment report – Products containing glyphosate – Examination of alternatives in arable crops (in French)

Comparative assessment report – Products containing glyphosate – Examination of alternatives in forestry (in French)

 

See also our previous articles: 

FRANCE – ANSES: Withdrawal of 36 glyphosate-based products

FRANCE: Glyphosate phase-out plan issued

 

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

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

 

ANSES – E-Phy: Website evolution

A new FAQ section as well as an access to the contact form are now available on the E-Phy website, via the footer banner. The FAQ section contains the questions most frequently asked by the users and the answers provided. Any remark, suggestion to improve the interface of the website or any request to correct data will be sent by using the contact form.

 

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

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

 

UK – BREXIT: Last information from HSE

The HSE (Health and Safety Executive) has published on its website information concerning Brexit whose transition period soon expires on 31 December 2020.

Thus from 01.01.2021, a new independent pesticides regulatory regime will operate in Great Britain with national decisions based on national rules. In Northern Ireland, the EU pesticides regime will continue to apply after the end of the transition period, in the same way as during the transition period.

The HSE will remain the sole national regulator for the whole UK.

Firms are informed on how to prepare different kind of dossiers in Great Britain:

– For active substance approvals: For the existing ones, they will continue to be valid in Great Britain until their current expiry date which will nevertheless be extended for 3 years for substances that expire before December 2023. For new active substances, Great Britain and the HSE will make their own decisions. A statutory register for approved active substances will be published on the HSE website from 01.01.2021. A specific program is actually in development for the review of the safety of active substances.

– For PPP authorisations: For the existing ones, they will continue to be valid until their current expiry date. For new applications, same data requirements and same formats as actual will be required by HSE. Active substance must be first approved in Great Britain to be used in a PPP.

– For MRLs: Great Britain will set MRLs based on their assessments but all existing MRLs will remain valid until they are amended.

– For mutual recognition: New applications for mutual recognition of authorisations in European Member States will no longer be accepted, except for existing applications for which a conclusion will be raised under the national British regime.

– For parallel trade permits: New applications for parallel trade permits in Great Britain will no longer be accepted. Existing permits will be valid until their current expiry date or until 31.12.2022 for permits with a later expiry date.

 

See also our previous articles: 

France – ANSES: Brexit impact on mutual recognitions and parallel trade permits

 

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

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

 

FRANCE: National PPP uses catalog – New DGAL memo

For the application of paragraph 1 of article 31 of Regulation (EC) No.1107/2009, the new memo DGAL/SDQSPV/2020-586 unveils the additions made to the current version of the national catalog of PPP uses (NS DGAL/SDQPV/2015-253). Complements are made in the following 3 booklets:
– Arable crops
– All crops
– Non agricultural uses

The other booklets remain unchanged. In addition, no changes were made to the introduction parts of booklets. Only the lists of “associated uses” have been completed,  as detailed below:

For Arable crops booklet, 2 new uses were added:
– 15505904 Linseed*Weedling*During retting
– 15705917 Pastures*Destruction of vegetation cover

 For All crops booklet, 4 new uses were added:
– 11015934 All crops* Destruction of covers and volunteers
– 11015935 All crops*Weeding*Intercrop, fallows and crops destruction
– 11015936 All crops*Weeding*Between rows of cultivated area
– 11015937 All crops*Weeding*Clearing of bushes

 For Non agricultural uses, 3 new uses were added:
– 01001001 Non agricultural uses*Weeding*Railways
– 10015907 Non agricultural uses*Total weeding*Industrial sites and other infrastructures
– 10015908 Non agricultural uses*Weeding*Parks, Gardens, Pavements

It can also be noticed that some uses are now considered as transitional (intended to be progressively replaced):
– 11015924 All crops*Weeding*Before cultivation
– 11015921 All crops*Weeding*Cultivated areas before planting
– 11015925 All crops*Stumps destruction
– 11015911 All crops*Clearing of bushes

– 01001002 Non agricultural uses*Weeding*Industrial sites
– 11015903 Non agricultural uses*Weeding*Paths of parks and gardens, Pavements, Cemeteries, Alleyways

 

To download: 

National PPP uses catalog: Arable crops, All crops and Non agricultural uses (2020) – in French

National PPP uses catalog: general instructions (2015) – in French

 

See also our previous articles: 

FRANCE: Focus on the changes in the catalog of uses

 

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

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

EUROPE – COM: Updated overview of AIR5 applications

The overview of the applications for renewal of approval under article 14 of Regulation (EC) No 1107/2009  for the active substances of the AIR5 programme has just been updated by DG SANTE.

This new version dated September 2020 replaces the previous revision dated June 2020.

 

To download: 

SANTE-2019-13022–rev 3 (September 2020): The 5th renewal programme applications for renewal of approval

 

See also our previous article: 

EUROPE – COM: Updated overview of AIR4 and AIR5 applications

 

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

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

FRANCE: Monitoring or mass trapping with semiochemicals

The rules related to the placing on the market and the use of monitoring and mass traps containing semiochemicals have been specified by the Ministry of Agriculture as regards their uses for the monitoring or the control of crop pests. 

Published in the Official Bulletin of 22 September 2020, the note is part of the national biocontrol deployment strategy planned by Article 80 of the law called “EGAlim”. According to the note, a plant protection product marketing authorisation is not required for monitoring and mass traps that meet the criteria of the official list for biocontrol products (articles L.253-5 et L.253-7 of French Rural Code) as soon as the traps do not contain an insecticide.

Traps labelling shall be compliant with the provisions of Regulation (EC) No 272/2008 (CLP).

However, the marketing authorisation of the trapping device remains necessary when the lethal part of the trap involves an insecticidal active substance.

To be noted: a marketing authorisation is not required for traps containing food as attractant except if they also contain an insecticide active substance.

 

To download:

Technical instruction DGAL/SDQSPV/2020-581 of 22.09.2020 – Placing on the market and use of traps containing semiochemicals  used for the monitoring or the control of insect pests in crops.  (in French)

 

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

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

FRANCE: New database: CEB methods online on Végéphyl website

All information related to the CEB methods (French field trial methods of “Commission des Essais Biologiques”) is now available on Végéphyl website. This new database makes it easy to find the desired method(s). Moreover it is possible to order directly online a single method or a right of access  to all methods.

 

To consult: https://www.vegephyl.fr/publications/bases-de-donnees/base-methodes-ceb/

 

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

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

FRANCE: Withdrawal of products for “amateur” uses

As a result of the entry into force of the Order of 6 April 2020 as regards the conditions of approval of plant protection products for “amateur” uses, ANSES has withdrawn, from 01 September 2020, 68 authorisations and 1 parallel trade permit of plant protection products for “amateur” uses.

These products have been subject to a restriction of use since 1st January 2019.

The end of sales and distribution is set on 01.03.2021.

The end of use of the stocks of products is set on 01.03.2022, except for glyphosate-based products for which the end of use is set on 01.09.2021.

 

To download: 

List of withdrawal of products for “amateur” uses as of 01.09.2020 (in French)

 

See also our previous articles: 

FRANCE: New requirements for the approval of PPP for “amateur” uses

 

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

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

 

FRANCE: Update of the declaration cerfa form

ANSES has updated on 01.09.2020 the general note for the submission of applications for a marketing authorisation or a permit for plant protection products. It introduces the second version of the explanatory note No 52174 and its related declaration form No 15723 (cerfa form used for changes in the name or address of a company or for the addition or change of the manufacturing site for a product already authorised).

The main changes in the second version of Cerfa No 15723 are as follows:

  • Delation of the former name of the company in the case of a change in the name of the company holding the authorisation (item 4).
  • Addition of the SIRET number and intra-community VAT number in the case of a change of address of the company holding the authorisation (item 5).
  • Addition of item 8 to list the products concerned by a change of name or address of a company. The trade names and authorisation numbers of the products concerned by the declaration must be completed. It is not necessary to list the second trade names.

 

To download: 

General note for the submission of applications (cerfa forms and explanatory notes) (01.09.2020, in french)

Explanatory note for filling the declaration form for a marketing authorisation or a permit Cerfa No 52174#02 (in French)

Declaration form for a marketing authorisation or a permit Cerfa No 15723*02 (word) Cerfa No 15723*02 (pdf) (in French)

 

See also our previous articles: 

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

 

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

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

 

EUROPE-EFSA: Latest Progress in the Revision of the 2013 Bee Guidance

In March 2019, the European Commission mandated EFSA for a review of its guidance on the Risk Assessment of Plant Protection Products on Bees (EFSA Journal 2013;11(7):3295). In this context, EFSA released two reports this summer.

The first report is the outcome of the EFSA collection of evidence on background bee mortality rates and in particular considering realistic beekeeping management and natural background mortality. A systematic literature review was supplemented with a survey sent to European bee keepers. The collection, which covers the tree bee groups (honey bees, bumble bees and solitary bees), provides solid grounds on background mortalities and will serve as a base for the revision of the EFSA guidance (2013).

The EFSA working group also published a supporting document addressed to risk managers about possible approaches to defining the specific protection goals (SPGs) that will be used in the EFSA guidance (2013) review. The document proposes 4 alternative approaches:

  1. Establish acceptable effect based on long-term colony survival, or,
  2. Derive threshold of acceptable effect on colony size based on their natural variability, or,
  3. Define acceptable levels on colony/population size (approach currently considered in the EFSA guidance 2013), or,
  4. Define levels of acceptable impact on the provision of the ecosystem services.

More details on approaches and associated pros and cons are available in the report (see the link below).

For the next step, risk managers will have to decide which of the approaches EFSA should use for the revision of the guidance. It is noted that the initial schedule is slightly delayed as this step was initially expected to be done by end of May 2020.

As a reminder, the publication of the revised EFSA guidance on bees is scheduled for Q1 2021.

 

To download: 

EFSA’s review of the evidence on bee background mortality – EFSA Supporting publication 2020:EN-1880.

Supporting document for risk managers on specific protection goals for bees – 22 June 2020.

 

See also our previous articles:

EUROPE-EFSA: Workplan for the Revision of the 2013 Bee Guidance Published   

 

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

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