REGULATORY NEWS

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, 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.

Find out more on his CV [...]

EUROPE: New version of the Pesticide Residue Intake Model (PRIMo rev. 3)

EFSA has released a new version of PRIMO model.

Since 2007, the EFSA PRIMo model, an Excel-based calculation spreadsheet, is the standard tool used to perform the dietary risk assessment for pesticide residues at EU level.

PRIMo revision 3 should be used for new applications as from 1 February 2018.  [...]

EUROPE: Update of GD SANCO/6895/2009 rev. 2.2 - dRR format

The EU COM has published an update of SANCO/6895/2009 rev 2.2. This version updates the version from October 2016.

This guideline describes in detail the structure and content of the 2016 updated draft registration report (dRR), following revisions based on experience of use and regulatory developments.

It provides advice to applicants [...]

FRANCE: 18 actives on the hot seat: new action plan to reduce the use of PPPs

On 19 January 2018 the French government published a draft action plan on plant protection products to be finalised before the end of the first quarter of 2018.

The consultation will be conducted based on the Ecophyto national plan, which will be reviewed and adapted accordingly.

Overall, the action plan would concern 18 substances: [...]

FRANCE: Publication of a guide for the labelling of plant protection products for professional use

In 2017, IUPP (Union of plant protection industries) member companies conducted a National progress initiative aimed at homogenising the structure and improving the legibility of plant protection products labelling, in consultation with “tester” farmer groups and representatives of the agricultural sector and the administration.

This labelling guide is mainly based on [...]

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. [...]

EUROPE: Allocation of MS for AIR4 and AIR5 active substances

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. 

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.

 [...]

FRANCE: Release of a memo relative to biocontrol products

ANSES has published a memo on 01/03/2018 intended to applicants and relating to biocontrol products. This National note reminds the regulatory framework for biocontrol products and the procedure of  authorisation for this type of product.

As a reminder, biocontrol products are classified into three categories [...]

FRANCE - ANSES: Memo on grace periods and label updates

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. [...]

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 [...]

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.

List of withdrawal [...]

FRANCE: 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 19 October 2017 and entered into force on 22 January 2018. [...]

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
• Management of resistance to fungicides used to control vineyard diseases: downy mildew, powdery mildew, grey mould [...]