FRANCE: ANSES Opinion on the definition of endocrine disruptors

ANSES issued an Opinion on 19 July 2016 to propose criteria for endocrine disruptors (EDs) that can be used to define the French contribution to the ongoing community discussions on this issue.

This review is based firstly on the 4 options defined by the European Commission (EC) in the roadmap on EDs subject to public consultation in 2014. And secondly, it integrates the proposal of criteria for EDs identification that the EC made public on 15 June 2016 as well as several texts proposing a draft amendment to the regulations in force concerning plant protection products and biocidal products.

As a reminder, the 4 options of the 2014 roadmap were:

  • Option 1: No policy change. No criteria are specified. The interim criteria set in the Biocidal Products and the Plant Protection Products Regulations could continue to apply;
  • Option 2: WHO/IPCS definition (hazard identification);
  • Option 3: WHO/IPCS definition and introduction of additional categories based on the different strength of evidence (cat. I, II, III);
  • Option 4: WHO/IPCS definition and inclusion of potency (hazard identification and characterisation).

ANSES considers that the current choice of the EC, only partially corresponding to option 2 leads to identify only the “known” EDs and not the “presumed” EDs. The experts regret that choice. ANSES supports Option 3 that differentiates the concepts “known” EDs, “suspected” EDs and “endocrine active substances”.

The agency also recommends the application of criteria including the weight of evidence, considering that such a system would allow the application of a single classification and a management adapted to the different regulatory frameworks according to the uses and populations.

ANSES emphasizes the need to distinguish the definition and the identification of an ED (either to human health or the environment) which should be conducted by a single body at European level (e.g. ECHA), from the approval procedures for these substances according to their use.

 

To download:

ANSES Opinion No. 2016-SA-0133 relative to “the definition of scientific criteria defining endocrine disruptors”

Draft legal act under the Plant Protection legislation

Draft legal act under the Biocidal Products legislation

European Commission – Defining criteria for identifying Endocrine Disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation (June 2014)

 

Our previous article:

Europe: Presentation of criteria to identify endocrine disruptors

 

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

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FRANCE: ANSES published a report on agricultural professional exposure to pesticides

Anses auto-seised itself on 20 July 2011 to carry out a collective expertise to “identify, assess and characterise the risk exposure of farm workers to pesticides in agriculture in order to propose target reduction actions and proportionate prevention measures”.

Note that the term “pesticides” includes here plant protection products, biocides and veterinary medicines.

The expertise was organised around several areas of research:

  • Hearings of stakeholder experts
  • Review of the literature on the French situations
  • Data from medical monitoring systems
  • Case studies
  • Agricultural statistics
  • Scientific literature on foreign situations
  • Exposure data and regulatory assessment

 

ANSES published its report on 25 July 2016 and particularly recommends:

  • Continuing work at European level to harmonise and regularly develop a priori exposure and risk assessment methods as part of the marketing authorisation procedures for substances whose examination may depend on different regulations, depending on their uses.
  • Continuing work to improve knowledge of the effectiveness of protective equipment, which must be compatible with the activity of people working in agriculture.
  • In an independent framework, strengthening advice and training actions for pesticide users, in particular on the hazards, risks and safety of use. Certain exposure situations concerning sensitive or vulnerable populations, exposure when re-entering treated areas, or uses in the overseas territories, for example, require special efforts.

Lastly, in a context where the current available data  are often in short supply, the Agency recommends improving understanding of exposure of agricultural workers to pesticides:

  • By strengthening the description of actual exposure situations in order to consolidate risk assessments or epidemiological studies, and also to assess the effectiveness of the recommended preventive measures,
  • By strengthening the work on knowledge of exposure to mixtures of pesticides,
  • By improving the accessibility, pooling, exploitation and capitalisation of information relating to pesticides, especially that concerning the exposure of people working in agriculture.

 

To download:

OPINION AND REPORTS from  ANSES related to “The exposure of agricultural workers to pesticides”

Volume 1: Main volume (in French)

Volume 2: Reviw of the literature on the French situations (in French)

Volume 3: Case study on sheep breeding (in French)

Volume 4: Case study on the re-entry in fruit tree crops (in French)

Volume 5: Possible use of agricultural statistics to support the charaterisation of farms, practices and exposure to pesticides in agriculture in France (in French)

Volume 6: Informations available in the vigilance monitoring systems, in the tables of occupational disease, the the SUMER survey and in the matrices jobs/exposure or crop/exposure (in French)

Volume 7: Exposure and registration of pesticides (in French)

 

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

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FRANCE: ANSES published the list of 126 products containing Glyphosate and POE-tallowamine withdrawn

Anses announced on 20 June the withdrawal of the authorisations of plant protection products containing glyphosate and POE-tallowamine. The list of the 126 authorisations withdrawn on 1 July 2016 has been published on E-PHY website.

 

To download:

List of glyphosate products subject to withdrawal with effect from 1 July 2016 (in French)

 

Our previous articles:

POE-tallowamine (Glyphosate coformulant): EFSA toxicological assessment

FRANCE: withdrawal of some PPPs containing Glyphosate and tallowamines (tallow fatty amines) by the end of March 2016?

FRANCE: Withdrawal of 132 authorisations for products containing glyphosate and POE-tallowamine

 

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

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

 

FRANCE: Opinion for applicants and approval holders (recommendations in term of PPE)

An Opinion intended for applicants and approval  holders of plant protection products and manufacturers of these products was published on 13 July 2016 in the French Official Journal.  It lists the most appropriate general recommendations in terms of PPE when using plant protection products, for professional use.

A first Opinion was published in the same context on 09 July 2016. This first Opinion was intended for manufacturers, distributors and users of personal protective equipment which protect from plant protection products. For more detailed information, see our corresponding article: FRANCE: Opinion for manufacturers, distributors and users of PPE (coveralls)

 

The Opinion of 13 July 2016 details the:

General recommendations for PPPs with mechanised or manual spray application
in greenhouses and open field

Protection categoryType of protectionPhases concernedPPP concerned
Eye protectiongoggles or face shield EN 166:2002 (EC, 3)– preparation, mixing, loading
  • PPP classified H300, H301, H310, H311, H314, H317, H318, H319
  • Wettable powders (WP)
Respiratory protectionhalf-mask or mask EN 140:1998,

equipped with a P3 filter EN 143:2006
or an A2P3 filter EN 14387:2008

– preparation, mixing, loading
  • powders
  • PPP containing a volatile coformulant (except water)
  • PPP classified H335, H336, H330, H331
Body protectiongarment PPE (as detailed in the Opinion of 9 July 2016)

+  blouse or long-sleeved apron type 3 or PB3 EN 14605+A1:2009
coveralls type 3 ou 4 EN 14605+A1:2009

– preparation, mixing, loading

– cleaning

All

garment PPE (as detailed in the Opinion of 9 July 2016)

→  tractor with closed cab

→ tractor without cab with downward spraying

→ lance for low crops without intensive contact with vegetation
coveralls EN 14605+A1:2009 type 4, with a hood

→ tractor without cab with upward spraying

→ lance, for high crops
(> 50 cm, without intensive contact with vegetation)

→ knapsack sprayer (herbicide applications including sucker suppression, fungicide and insecticide applications, without intensive contact with vegetation)
coveralls EN 14605+A1:2009, type 3, with a hood

→  lance, knapsack sprayer for high and low crops, with intensive contact with vegetation

– application

All

Hands protectionreusable nitrile gloves EN 374-1:2004 and EN 374-3:2004– preparation, mixing, loading,

– cleaning,

– application (lance or knapsack sprayer)

All

disposable nitrile gloves EN 374-1 and EN 374-2 or EN 374-1:2004 and EN 374-3:2004– application with tractor without cab

– application with tractor with closed cab in case of intervention outside (in this case, gloves must be stored and worn outside of the cab)

All

Feet protection– boots EN 13 832-3:2006– manual application in open field or in greenhouse

All

 

IMPORTANT:

Applicants and approval holders must justify the certification of the recommended PPE, including chemical protection or provide all data necessary to ANSES to assess the adequacy between the proposed PPE and the product authorised or for which the application is submitted:

– For authorised products, approval holders review and justify their recommendations in terms of PPE in relation to the requirements of this Opinion within a period of 24 months for CMR (13 July 2018) and 30 months for all other products (13 January 2019) after the publication of this Opinion (13 July 2016);

– For new applications for new products, extensions of uses and renewals submitted from 1 December 2017.

In case a read-across is proposed from existing results with products having similar characteristics, this should be justified.

 

To download :

July 13, 2016 – Opinion for applicants and approval holders of plant protection products and manufacturers of these products relative to personal protective equipment (PPE) as part of the placing on the market of products plant protection (in French)

 

Lynxee consulting’s team is at your disposal to prepare your PPE recommendations.

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

 

FRANCE: Opinion for manufacturers, distributors and users of PPE (coveralls)

An Opinion intended for manufacturers, distributors and users of personal protective equipment which protect from plant protection products was published on 9 July 2016  in the French Official Journal. This opinion aims at specifying the methods ensuring that the coveralls (and trousers and jacket sets) worn by users meet the essential health and safety Directive 89/686/EEC on the design and placing on the market of personal protective equipment (PPE). 

The French authorities have undertaken the process of revision of ISO 27065: 2011 standard. It is therefore a transitional measure, pending the adoption of such a standard, that the assessment of the conformity of coveralls can be performed in the manner specified in this Opinion.

The Opinion details the applicable provisions:

  • pre-treatment and conditioning before testing (number of cleaning cycles);
  • mechanical requirements (minimum expected performance to tensile strength, tear strength, puncture strength, seams strength, tensile strength of sewing, abrasion strength)
  • requirements for chemical protection (terms and criteria for testing penetration of a plant protection product)
  • requirements for full garment (practical test for performance, comfort)
  • requirements for the content of the instruction leaflet and labelling of coveralls

Within six months after the publication of this Opinion, coveralls to protect from plant protection products must bear the CE marking and meet certification procedures as provided for in Directive 89/686/EEC.

In this context, a second Opinion was published on 13 July 2016. This second Opinion is intended for applicants and approval holders of plant protection products and manufacturers of these products and lists the most appropriate general recommendations in terms of PPE. For more detailed information, see our corresponding article: FRANCE: Opinion for applicants and approval holders (recommendations in term of PPE)

 

To download :

9 July 2016 – Opinion for manufacturers, distributors and users of personal protective equipment to protect from plant protection products (in French)

 

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

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

 

FRANCE: is it necessary to wear PPE after the re-entry period ? Answer from Anses

ANSES was seised on 26 February 2016 by DGAl (Directorate of Food of the French Ministry of Agriculture) on the need to wear personal protective equipment (PPE) after the re-entry period governed by the French Order of 12 September 2006.

This referral comes from the wine growers which consider that following the re-entry period, no PPE should be needed. ANSES also had to study other agricultural sectors.

ANSES emphasizes that the re-entry periods mentioned in the French Order of 12 September 2006 allow reducing worker exposure, but at the end of these periods exposures cannot be considered negligible.

ANSES has issued the following recommendations:

  • setting up studies focused on the re-entry phase that would better quantify the exposure of workers and the level of protection conferred by PPE
  • setting up  dissipation studies of residues on plants
  • integration of these studies in the risk assessment and declined in terms of conditions of use, particularly as re-entry periods
  • applicants may submit in application dossiers, relying on specific exposure measurements, risk assessments to refine the estimate of worker exposure during re-entry and to better tailor prevention measures

And proposed adjustments of the French Order of 12 September 2006:

  • introducing a specific re-entry period, like for preparations classified as irritating or sensitising, for preparations containing substances  classified CMR as defined in Regulation (EC) No 1272/2008
  • in certain exceptional situations, particularly because of a weather emergency, a re-entry may be deemed necessary. This could be considered in the Order based on the results of the risk assessment

Pre-requisite:

  • ensure the feasibility and applicability of these new re-entry periods for the crop management of concerned crops
  • question on the manageability of the various re-entry periods set out in the Order and their implementation at farm level

 

To download :

13 june 2016 – Opinion of Anses on PPE and re-entry period No. 2016-SA-0046 (in French)

Decree of 12 September 2006 on the placing on the market and use of PPPs – consolidated version (in French)

 

 

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

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EUROPE – MRL: New Application form available

A new application form for MRL is available on Europa website.

It is to be used to:

  • Set specific maximum residue level(s) (new active substance not mentioned in Annex II/III/IV of Regulation (EC) No 396/2005);
  • Set specific maximum residue level(s) (changing current EU MRL listed in Annex II or III of Regulation (EC) No 396/2005);
  • Set import tolerance(s) (new active substance not mentioned in Annex II/III/IV of Regulation (EC) No 396/2005);
  • Set import tolerance(s) (changing current EU MRL listed in Annex II or III of Regulation (EC) No 396/2005);
  • Delete maximum residue level(s);
  • Include an active substance in Annex IV;
  • Amend existing residue definition;
  • Include active substance/product combinations into Annex VII as referred to in Article 18 (3) of Regulation (EC) No 396/2005;
  • Evaluate confirmatory data following review according to Article 12 of Regulation (EC) No 396/2005.

 

To download:

MRL Application form (SANCO 4044/2008 rev. 10.2) 16 June 2016

 

Lynxee consulting’s team is at your disposal to prepare your applications.

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

 

FRANCE: Additional new entries into the list of biocontrol products benefiting from a reduced tax on sales

The Note DGAL/SDQPV/2016-447 of 30 May 2016  from the French Ministry of Agriculture, Food and Forestry adds new biocontrol products to the list quoted in Article 1 of French Order of 9 March 2016 setting the tax rate on plant protection product sales revenues.

This note was published as a supplement to the Note DGAL/SDQPV/2016-279 of 31 March 2016 modified by the Note DGAL/SDQPV/2016-427 of 20 May 2016.

See our articles:

FRANCE: List of biocontrol products benefiting from a reduced tax on sales

FRANCE: New entries into the list of biocontrol products benefiting from a reduced tax on sales