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Newsletter - No.3 - March 2016
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REGULATORY NEWS

Plant Protection Products
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Dear readers,

This month was remarkable by 2 major regulatory conferences:
AFPP and ECCA-ECPA Conferences.
We reported the most important points here below.

This month was also marked by the following news:
In Europe, the draft GD on residue definition is under public consultation and ECHA released a searchable list of harmonised entries.
In France, the list of risk phrases authorised for PPPs to be applied in or near places with vulnerable people was published, the Tax on the sale of PPPs was fixed and new E-phy website was launched.

We summarised this information for you throughout articles that you will find below.
We hope you enjoy reading these notes and stay at your disposal for regulatory advice and dossier drafting.

Lynxee consulting's Team
Event of the month

Events of the month


Karine Mavet and Emilie Vianay attended AFPP Conference on the regulation of PPPs held on 08 March 2016 in Paris.
This one-day conference was a new opportunity for Anses to present their organisation set up last July.
Anses exposed the number of dossiers dealt with and confirmed that there is a backlog of dossiers of 2 years. New people were employed in 2015 and processes are being simplified, thus the situation is expected to be back to normal in 2018, with better timelines.
Regarding comparative assessment, France evaluated about 20 dossiers since August 2015. No substitution was recommended because of minor uses or resistance aspects.
New administrative forms (to replace existing cerfa forms) should be released mid-2016.
The conference also focused on Biocontrol products with presentations on current working groups on pheromones and micro-organisms.
At last, presentations dealt with 120-day emergency authorisations, CEPP (plant protection products saving Certificates, minor crops. endocrine disruptors and new e-phy website.

Karine Mavet and Emilie Vianay also attended ECCA-ECPA European Regulatory Conference held on 09-10 March 2016 in Brussels.
This two-day conference was first striking by he number of participants and by the quality of the presentations and organisation. A very valuable conference!
The conference started by a presentation of the new  system for PPPs applications in Europe (PPPAMS) and was followed by a presentation of the Dutch Green Deal (National Action Plan) and of the new Minor Uses Coordination Facility.
A status update of EFSA works was given. To be noted that a draft implementation plan of the Bee Guidance Document (GD) is about to be published. A draft GD on negligible exposure is also under preparation. A public consultation on the use of epidemiological studies in risk assessments will take place in November 2016.
More generally, Member States (MS) and the Industry gave their feedback on the current system and highlighted the problems they are facing. Basically, timelines are not respected in a number of MS due to an increasing workload and a limited staff, and only a few countries use Mutual Recognition effectively (e.g. Czech Republic, Portugal).
Timelines of Article 43 (product renewal) were also strongly discussed. A GD on Article 43  is under preparation.
A new GD on Seed treatment dealing with new risk assessment on dust and exposure assessment should be made available mid-2016.
 
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FRANCE: plant protection products authorised in or near places with vulnerable people

 
In France, the use of plant protection products is banned in or near places with vulnerable people, with 2 exceptions for low-risk products and products for which the classification only contains some risk phrases. The Authorities have just set the list of phrases [...]
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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 [...]

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EFSA Public consultation: Draft Guidance Document on the establishment of the residue definition for dietary risk assessment

 
The public consultation on the draft guidance document of the EFSA Panel on Plant Protection Products and their Residues on the establishment of the residue definition for dietary risk assessment is opened until 2 May 2016. [...]
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CLP: Searchable list of harmonised entries in Annex VI now available!

ECHA has published an easy-to-search list containing the harmonised classification and labelling of hazardous substances (Table 3.1 of Annex VI to the Regulation (EC) No.1272/2008, called CLP regulation). All the information on the harmonised classification and labelling up until the Seventh Adaptation to Technical Progress (i.e. Commission Regulation (EU) No.2015/1221)  is now readily available in a single Excel file. [...]

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FRANCE: E-phy website is back on-line

 

As part of its new responsibilities regarding approvals of plant protection products, fertilisers and growing media, and adjuvants, Anses is now in charge of E-Phy database, the national reference for the authorised uses of these products in France. Anses has just achieved the revision of the tool.

The new version, characterised by a more modern and intuitive user interface, is now available. [...]

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