Posts

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

As announced in Decree No.2016-1595, the Order of 16 February 2017 establishes in Appendix 1 the list of entities included in the monitoring system and in appendix 2 the list of organisations to which the declarations of manufacturers, importers, distributors, professional users, advisers and trainers of users of plant protection products and adjuvants are addressed.

To download:

Order of 16 February 2017 relative to organisations involved in “phytopharmacovigilance” system (in French)

 

See our previous article:

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

The Decree No. 2016-1595 on the French monitoring system called “Phytopharmacovigilance” (or “PPV”) was published on 24 November.

The objective of the system is to trace back to ANSES all the undesirable effects of plant protection products on man, livestock, crops, biodiversity, wildlife, water, soil, air quality, food, as well as on the development of resistances.

The public that has to report the information is very broad, since it concerns the holders of authorisations or parallel trade permits and trial permits of plant protection products and adjuvants; manufacturers, importers, distributors, professional users, advisers and trainers of users of these products; and organisations involved in phytopharmacovigilance.

ANSES use the information collected and evaluate the risks and take measures to prevent or stop these undesirable effects.

The list of entities included in the system as well as the methods of transmission of the information will be the subject of an order.

This decree specifies the organisation, the obligations of the designated bodies and the information system.

In addition, the decree also establishes:

  • The period of authorisation of an adjuvant to 10 years;
  • A crop destruct exemption for products containing active substances listed in Annex IV to Regulation No. 396/2005 (MRL exemption) or based on semiochemicals used by passive diffusion without direct contact with vegetation.

To download:

Decree No. 2016-1595 of 24 Novembre 2016 relative to phytopharmacovigilance and amending various other provisions of the rural code and maritime fisheries relating to plant protection (in French)

 

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

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

 

 

FRANCE: Tax on the sale of Plant Protection Products (Order 09 March 2016)

The French Order of March 9 sets the tax rate to 0.2% of sales revenues for conventional plant protection products and 0.1% for biocontrol products.

This tax applies to plant protection products which were the subject of an Authorisation or a parallel trade permit.

This tax is assigned to ANSES to finance the establishment of the monitoring system called ‘phytopharmacovigilance’ (PPV) established by the French law for the future of Agriculture of 13 October 2014.

 

Arrêté du 9 mars 2016 fixant le taux de la taxe sur la vente de produits phytopharmaceutiques

 

France : New responsabilities for Anses from 1 July 2015

From 1 July 2015, in accordance with French legislation for agriculture, food and forestry of 13 October 2014, Anses is in charge of granting  approvals for plant protection products and adjuvants. The Ministry of Agriculture was previously in charge of it.

The décret No.2015-791 of 30 June 2015 on the conditions for the exercise by the Agency of these new missions  specifies the technical conditions of the transfer of the approval granting from the French Minister of Agriculture to Anses Managing Director.

Indeed, since 1 july 2015, Anses Managing Director has authority for approval granting and for  trial permit approval and parallel trade. It has to be noted that the French Ministry of Agriculture keeps the responsibility for the 120-day derogations as defined  in Article 53 of Regulation (EC) No.1107/2009.

The Decree also institutes a declaratory system replacing the prior approval system for some administrative changes of authorisations, to simplify procedures that do not require any assessment by the Agency.

In addition, the decree removes the separate deadlines for the evaluation by Anses and the approval management by the Ministry of Agriculture. Now, the overall timelines given in Regulation No.1107/2009 will apply. The allocation of time between evaluation and approval management now depends on the internal organisation of the Agency.

Finally, the text sets up a shorter procedure for the evaluation and authorisation of biocontrol products.

To ensure the functional separation between scientific assessment and approval granting, two distinct and independent  departments were created. The Department for approval (DAMM) and the Department for the assessment of regulatory products (DEPR, ex-DPR).

The newly formed DAMM consists of two units:

– the Administrative Unit, unique contact point for notifiers for contractual and administrative aspects with Anses, in charge of the dossier completeness check and the processing of administrative dossiers;

– the Approval Decision Unit, in charge of the preparation, follow-up and renewal of approval decisions.

All assessment conclusions and decisions will be published in the Register of authorisations and assessment conclusions.

For transparency, Anses decided to develop guidelines to clarify the principles adopted by the DAMM for the issue of approval decisions.

The draft guidelines were submitted electronically to public consultation from 12 May 2015 to 5 June 2015. The comments received during the public consultation have not challenged the principle of these guidelines. A note summarising the comments received and those taken into account was published by Anses on 1 July 2015.

The DAMM will also contribute to the implementation of the comparative assessment of products available on the market under the new provisions of EU regulation to come into force on 1 August 2015.

Furthermore, in accordance with the law, a Committee of Approvals monitoring will also be formed in autumn 2015. This advisory structure will provide to Anses management further insight to the scientific evaluation to ensure in particular that the risk management measures imposed as part of the authorisations are practicable and effective in a real situation, given the constraints of field practices.

Note, to preserve the independence of the Agency, a Charter on relations with the stakeholders is being developed.

Finally, since 1 July 2015, ANSES is also entrusted with the implementation of a monitoring system called ‘phytopharmacovigilance’ (PPV) of the effects of these products on human health, fauna, flora and environment. This system will strengthen current arrangements for post-authorisation monitoring.

If you have questions about the new missions of ANSES, please do not hesitate to contact us: +33 9 72 50 40 29.

We are also at your disposal for all your questions about the status of Anses opinions or informal appeals not solved by DGAl on 30 June 2015.

ANSES : New responsibilities: granting approvals, control and inspection of products, monitoring

As part of future legislation for agriculture, food and forestry of 13 October 2014, the French government and the parliament decided to give new responsibilities to ANSES. These are:

Issuing authorisations of plant protection products, fertilisers, growing media and adjuvants, previously the responsibility of the Ministry of Agriculture.

Powers of control and inspection of these products, as regards the manufacture, packaging and labeling.

– The establishment of a monitoring plan for organising data collection on the impact of products on Human Health, flora, fauna, and the environment.

These new responsibilities will constitute an important development for the agency, whose mission fell far mainly in the field of scientific expertise.

 

The proposed new organisation is as follows:

DAMM  (Department for approvals)

  • Administrative Unit

→ contact point

→ dossiers completeness check

→ processing of administrative dossiers

  • Approvals decision Unit

→ preparation of approval decisions
→ Implementation of Comparative Assessment

Committee of
Approvals monitoring

→ technical support of DAMM

DEPR  (Department for the assessment of regulated products)

  • Coordination Unit

→ coordination of Assessment Units

  • Assessment Units

→ assessment of applications

→ comparative assessment of products

  • R&D and Scientific watch Unit

→ coordination of studies and research

→ scientific watch

Committee of
Specialised Experts

→ technical support of DEPR

PPV  (Pesticides Monitoring)
→ PPV data collection (Pesticides Residues Observatory, launching new studies, implementation of agreements…)→ analysis and interpretation of data→ transmission to DAMM and DEPR
PPVworking group→ support of PPV

https://www.anses.fr/fr/documents/Annexe-ModalitesdepriseenchargenouvellesMissions.pdf