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FRANCE – ANSES: Procedures for updating PPE in marketing authorisations

Following the entry into force on 1 January 2020 of the Order of 27 December 2019 on measures for the protection of persons using plant protection products, users should replace the personal protective equipment (PPE) currently mentioned in the marketing authorisations by equipment complying with the new requirements.

On 26 November 2020, ANSES published a note on procedures for updating PPE:

  • For marketing authorisations issued before 1 January 2020, the user will have to replace the PPE, but without notifying it to ANSES.
  • For marketing authorisations issued after 1 January 2020, a request to update PPE is sent to the authorisation holder, who will have to reply within 2 months by email.
  • For all new marketing authorisation applications submitted from 26 November 2020, PPE proposed by the applicant must comply with the new requirements.
  • For the applications currently under instruction, applicants are encouraged to send a single letter to ANSES to update the PPE in all applications under examination. For each application (including the type of application, the brand name of the product and ANSES reference number), a table of equivalence between the PPE initially proposed and the updated PPE must be provided. If no letter is provided, a request to update PPE will be sent directly to the applicants by ANSES departments.

 

The PPE updates concern in particular clothing and gloves:

PPE type Old requirements New requirements
Clothing Water-repellent working coveralls (polyester 65% / cotton 35% – minimum weight 230 g/m²) Clothing PPE certified NF EN ISO 27065/A1
Reusable gloves Nitrile gloves certified EN 374-3 Nitrile gloves certified NF EN ISO 374-1/A1 and NF EN 16523-1+A1 (type A)
Single use gloves Single use nitrile gloves certified EN 374-2 Single use nitrile gloves certified NF EN ISO 374-1/A1 and NF EN ISO 374-2 (types A, B or C)

 

To download: 

ANSES Note – Updating of personal protective equipments mentioned in the marketing authorisations of plant protection products, in application of article 15 of the Order of 04 May 2017 amended by the Order of  27 December 2019 – Version 1 of 26.11.2020 (in French)

Order of 27 December 2019 relating to measures for the protection of persons using 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: Operational PPE Recommendations as regards Re-Entry – Answer from ANSES

Requests were sent to ANSES on 31 July 2017 and on 3 April 2018 by the Directorate for Food (DGAL) of the French Ministry of Agriculture (Referral 2017-SA-0174) as regards its recommendations on the use of personal protective equipments (PPE) by workers re-entering a crop post-treatment.

This request was initiated because most of the recent marketing authorisations recommend the use of PPE for re-entry activities with no indication of a delay after the last treatment and with no distinction as regards the type of activities, which raises questions among professionals and seems to lead to practical difficulties.

In particular, ANSES was asked to deliver more operational PPE recommendations for re-entry activities (e.g. distinguish/limit the use of PPE to certain types of products or to certain activities or depending on the application schedule), pending the outcome of ongoing works which should allow more accurate risk assessments for worker exposure. Ongoing studies aim, for example, at determining transfer coefficients and foliar residue declines.

After a context analysis, ANSES concludes that the data currently available neither allow for activity-specific exposure risk assessments nor allow for making recommendations as regards a potential interval after treatment, after which PPE would be no more necessary to ensure the safety of workers.   

ANSES however underlines that the exposure risk assessments conducted in accordance with the EFSA guidance (EFSA Journal 2014;12(10):3874) could be refined on the basis of foliar residue decline, in agreement with the approach proposed in the guidance. Besides, new exposure data for re-entry activities of workers and new foliar residue decline data (in particular on grapevine) have been generated and are being assessed by the United Kingdom. These data should allow a more accurate estimation of worker exposures and of protection levels offered by PPE. For his part, EFSA started the update of its guidance (EFSA, 2014), which should allow the integration of any new data.

Besides, ANSES reminds that:

  • re-entry intervals as defined in the French Order of 4 May 2017 are aimed at preventing exposure and effects;
  • if a personal protection is required, it corresponds to a PPE as defined in Regulation (EU) 2016/425, which should be associated with the basic precautionary measures (e.g. hand wash, compliance with instructions of how to put on and to put off PPE);
  • within the framework of the responsibility to protect workers, the re-entry interval set is only an indication of the risk level that the employer have to integrate in its assessment with a selection of relevant PPE as regards the risk level, the suitability of the PPE with the worker activity and the availability of PPE;
  • more generally, reducing the use of plant protection products and preferring products with less severe human health hazard potential should be aimed at in order to reduce exposure of agricultural workers.

As regards products based on active substance(s) for which no toxicological reference value has been set, ANSES encourages applicants to include a justification of specific recommendations for these product types as regards the hazard and risk levels which might be considered as low.

Finally, ANSES recommends to carry on with training and awareness campaigns for agricultural workers regarding the compliance with the conditions of use of plant protection products and of PPE and the health issue that represents.

 

To download:

10 October 2018 – Note from ANSES as regards its recommendations on the use of personal protective equipments (PPE) by workers re-entering a crop post-treatment (in French).

 

See also our previous articles:

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

 

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 category Type of protection Phases concerned PPP concerned
Eye protection goggles 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 protection half-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 protection garment 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 protection reusable 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/