FRANCE – ANSES: Memo on grace periods and label update

ANSES published a memo on grace periods granted by ANSES and label update deadlines in the event of withdrawal, modification or non-renewal of an authorisation or a parallel trade permit for plant protection products.

It is reminded that the grace periods and delays of label update correspond to different and uncorrelated notions.

Regarding grace periods, as a reminder:

– a lack of indication of grace periods in a decision means that no delay has been granted;

– when grace periods are granted, they are mentioned in the decision and cannot exceed 6 months for the sales and distribution and 12 additional months for storage and use.

Concerning the timelines for label update, as a reminder:

– an absence of indication concerning the timeline to update the labels in a decision means that the default time limits apply: 6 months for the label update (or 12 months in case of addition of new uses or lighter precautions of use) and an additional 12 months for the use of stocks with the old labelling;

– Authorisation decisions may include different deadlines (shorter or longer).

 

To download:  

Délais de grâce octroyés par l’Anses et délais de mise à jour des étiquettes en cas de retrait, de modification ou de non-renouvellement d’une autorisation de mise sur le marché (AMM) ou d’un permis de commerce parallèle de produits phytopharmaceutiques (in French)

 

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

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

 

EUROPE: ECPA Conference 7-8 March 2018

Lynxee consulting will participate to the 5th European Regulatory Conference on Crop protection organised by ECPA to be held on 7-8 March 2018 in Brussels. For this new edition, the interventions will be provided by representatives of Member States, EFSA, DG SANTE, Industry and others.

Please do not hesitate to contact us to arrange a meeting: http://lynxee.consulting/en/contact/

 

For more information:  5th ECPA Regulatory Conference 2018

 

EUROPE: EFSA update the neonicotinoids risk assessments for bees: risk confirmed

EFSA has published an update of its bee risk assessments of the three neonicotinoids clothianidin, imidacloprid and thiamethoxam, when used as seed treatment or granules. These neonicotinoids are currently subject to restrictions in the EU because of the threat they pose to bees.

For the new assessments, wild bees (bumble bees and solitary bees) were considered in addition to honey bees and the recent guidance on risk assessment on bees (EFSA, 2013) was applied. Besides, an extensive data collection was performed to gather all the relevant available scientific evidences, including all those generated since the previous evaluations in 2013. In line with the former assessments, three routes of exposure of bees were considered: residues in pollen and nectar, dust drift during sowing/application and water consumption.

The new risk assessments highlighted a high risk for at least one bee type and one route of exposure for all the outdoor uses of clothianidin, imidacloprid and thiamethoxam. It was found that in many cases, bees foraging on the treated crop as well as in its vicinity are likely to be exposed to harmful levels of the neonicotinoid pesticides. Besides, EFSA underlined that in some situations, the persistence and accumulation of neonicotinoids in the soil could also lead to harmful residue levels in newly grown plants. EFSA thus concluded that the risk that pose neonicotinoids used as seed treatment or granules to bees is confirmed.

To download:  

Peer review of the pesticide risk assessment for bees for the active substance clothianidin considering the uses as seed treatments and granules.

Peer review of the pesticide risk assessment for bees for the active substance imidacloprid considering the uses as seed treatments and granules.

Peer review of the pesticide risk assessment for bees for the active substance thiamethoxam considering the uses as seed treatments and granules.

Evaluation of the data on clothianidin, imidacloprid and thiamethoxam for the updated risk assessment to bees for seed treatments and granules in the EU.

Q&A: Conclusions on neonicotinoids 2018.

 

See also our previous articles:

FRANCE: Public consultation on a draft Decree on neonicotinoids

FRANCE: ANSES recommends strengthening the conditions of use of Neonicotinoids

EFSA Pesticides and bees : call for data

 

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

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

LYNXEE: Appointment of Adrien Margerit as Expert in Ecotoxicology

Lynxee consulting’s team is pleased to announce the appointment of Adrien Margerit.

Adrien Margerit, PhD in Ecotoxicology, had various experiences of research in ecotoxicology laboratories and then conducted a PhD at IRSN (French Institute of Radioprotection and Nuclear Safety) on the combined effects of uranium and cadmium in the nematode Caenorhabditis elegans using empirical and mechanistic modeling tools.

He then worked as scientific assessor in ecotoxicology in the Ecotoxicology and Environmental Fate Unit of ANSES (French Agency for food, environmental and occupational health and safety) where he dealt with both, plant protection active substance and product dossiers.

With 6 years of experience in the field of ecotoxicology, Adrien joined Lynxee consulting, where he is in charge of, among other things, study monitoring and risk assessments in ecotoxicology.

Lynxee consulting’s team welcomes Adrien and encourages you to entrust him with the monitoring of your studies as well as the drafting of risk assessments in ecotoxicology. You will appreciate his great scientific rigour and his attention to details.

FRANCE: Publication of phytopharmacovigilance (monitoring system) sheets

Through synthetic data sheets, each dedicated to an active substance, ANSES makes available all the data collected from monitoring and vigilance systems that are partners of phytopharmacovigilance.

Nine sheets were uploaded on 02/02/2018: Chlormequat, Chlorothalonil, Famoxadone, Flumioxazine, Iodosulfuron, Iprodione, Picolinafen, Thifensulfuron-methyl et Bentazone.

These sheets describe the knowledge available in France based on descriptive information from ANSES’ phytopharmacovigilance partners and are intended for:

  • Managers, for the definition of cross-functional management measures;
  • ANSES, in the context of individual decisions related to the review of applications for plant protection products, in addition to the information made available by applicants. This instruction is carried out for each product, taking into account their formulation and conditions of use. The decentralised State services are responsible for the local management of individual situations where the regulatory thresholds indicated in this document are exceeded.

For each active substance, the associated sheet describes the status of the substance, the authorised uses and market data. Information related to monitoring of water, food and feed, air and pollinator matrices is provided. Finally, an inventory of epidemiological studies in human health and reports relating to wildlife and domestic animals are reported.

 

To download: Phytopharmacovigilance sheets (in French)

 

See also our previous articles:

FRANCE: Publication of the Order regarding the list of organisations for phytopharmacovigilance (monitoring system)

FRANCE: publication of the Decree “Phytopharmacovigilance” (monitoring system)

 

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

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

FRANCE: Withdrawal of products based on iprodione

As a result of the entry into force of Regulation (EU) 2017/2091 concerning the non-renewal of iprodione approval, ANSES has withdrawn 16 authorisations and 3 parallel trade permits for plant protection products containing this active substance.

The authorisations are withdrawn on 05/03/2018.
The end of sales and distribution is set on 05/06/2018.
The end of use of the stocks of products is fixed on 05/06/2018.

To download: List of withdrawal of products based on iprodione (in French)

 

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

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

EUROPE: Allocation of MS for AIR4 and AIR5 active substances

Regulation (EU) 686/2012 indicates for each active substance a rapporteur member state (RMS) and a co-rapporteur member state (cRMS) that have been allocated for the renewal procedure.

AIR4 active substances are substances whose approval expires after 31 December 2018 and not later than 31 December 2021. In view of the length of the evaluation process and the recent notification by the United Kingdom pursuant to Article 50 of the Treaty on European Union, it was necessary to re-allocate the evaluation of the active substances for which the United Kingdom was the RMS or the cRMS, and for which no supplementary dossier had been submitted yet. The updates set by Regulation (EU) 2018/155 concern the following active substances: Aluminium ammonium sulphate, Azoxystrobin, Bupirimate, Carbetamide, Chlormequat, Ethylene, Fenbuconazole, Fluopicolide, Fluquinconazole, Flutriafol, Garlic extract, Metazachlor, Myclobutanil, Paclobutrazol, Pepper, Plant oils/Citronella oil, Propaquizafop, Quizalofop-P-ethyl, Quizalofop-P-tefuryl, Tri-allate and Urea.

AIR5 active substances are substances whose approval expires after 31 December 2021 and not later than 31 December 2024 and for which the evaluation had not been allocated yet. The allocation of RMS and cRMS is set by Regulation (EU) 2018/155 for each AIR5 active substance.

 

To download:  

COMMISSION IMPLEMENTING REGULATION (EU) 2018/155 of 31 January 2018 amending Implementing Regulation (EU) No 686/2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances

 

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

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

 

FRANCE: Update of the official list of biocontrol products – January 2018

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 19 October 2017 and entered into force on 22 January 2018.

As well as providing some typographical corrections on products already listed, this note includes a total of 16 new products: 4 in Part A (products containing micro-organisms), 3 in Part B (products containing chemical mediators), 9 in Part C (products containing natural substances of plant, animal or mineral origin). Part D (insect traps) remains unchanged. It has to be noted that 3 products are taken off the list (Part C).

The next update will be issued in March 2018 on the basis of products authorised on 28 February 2018.

 

To download: Note DGAL/SDQSPV/2018-54 du 22/01/2018 (in French)

 

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

 

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

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

 

FRANCE: 2018 National memos on the sustainable management of resistance to fungicides

Two National memos on the sustainable management of resistance to fungicides were published:

  • Management of resistance to fungicides used to control cereals diseases (in French)
  • Management of resistance to fungicides used to control vineyard diseases: downy mildew, powdery mildew, grey mould (in French)

 

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

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