EFSA : Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil

Further to the publication of the new EFSA guidance document (EFSA Journal 2015;13(4):4093), Lynxee consulting focuses on the new tiered approach for the exposure assessment of soil organisms to pesticides. Five tiers are defined with a same protection goal, i.e. the 90th percentile concentration within the area of intended use of a PPP. Both concentrations in total soil and in pore water are estimated over various depths and time windows. The assessments are based on average/mean active substance properties (e.g. half-live, Kom).

In first tiers (Tiers 1, 2B and 2C), PECs are calculated with the new software tool PERSAM (to be downloaded from European Commission Joint Research Centre (JRC) Website). In Tier 2A and higher tiers, PECs are calculated with updated versions of PEARL and PELMO. Crop interception and subsequent dissipation at the crop canopy may be included in higher tiers of the exposure assessment. In addition, an easy-to-use table has been developed for the estimation of the fraction of the dose reaching the soil (Appendix K of the guidance).

The recommended methodology does not consider dissipation processes such as leaching and plant uptake. This procedure works well for parent compound and most of the soil metabolites. However, the scenario selection procedure that forms the basis of Tiers 2A, 3A and 3B is not completely appropriate for certain metabolites (i.e. metabolites that do leach significantly from the top 20 cm of soil and metabolites that do not accumulate over the years). Despite this, it is advised to use the exposure assessment scheme for all soil metabolites until a commonly agreed alternative becomes available.

Note that this EFSA guidance covers only spray applications to annual crops under conventional and reduced tillage and also, with specific adaptations, granular products and row treatments. For permanent crops, crops grown on ridges and no-tillage systems, until new guidance is available, current methods still apply.

ANSES : Opinion concerning the application of European regulations on classification, labelling and packaging of substances and plant protection products

ANSES was seised on 12 March 2015 by the Directorate General of Food (DGAL) a request for an opinion on the implementation of the CLP Regulation on the classification and labelling for tank mixes and use of plant protection products.

Two orders contain provisions relating to the classification and labelling made under old Directives. This is the order of 7 April 2010 on tank mixes of plant protection products and their adjuvants and the order of 12 September 2006 on the marketing and use of plant protection products. These orders should be revised and conform to CLP before 1 June 2015.

Annex VII to the CLP Regulation contains a table of conversion between the classification established by Directive 67/548/EEC on the one hand and the classification according to this second regulation on the other hand. However this conversion table does not allow for a simple transposition of the risk phrases and classification for plant protection products. In this context, ANSES was seised to provide its analysis on the appropriate classification and labelling for these two orders.

Order of 7 April 2010 relating to the use of tank mixes of products referred to in Article L. 253-1 of the French Rural Code

Current text:

“1° Tank mixes comprising:

 – At least one product labelled very toxic (T +);

 – Or at least a toxic product labelled (T);

 – At least two products with one of the risk phrases R 40 or R 68;

 – Or at least two products comprising the risk phrase R 48;

 – Or at least two products with one of the risk phrases R 62 or R 63 or R 64.”

ANSES proposal:

“1° Tank mixes comprising:

– At least one product labelled H300, H301, H310, H311, H330, H331, H360F, H360D, H360Fd, H360Df, H370 or H372;

– At least two products with one of the hazard statements H341, H351, or H371;

– Or at least two products with the hazard statement H373;

– Or at least two products with one of the hazard statements H361d, H361fd, H361, or H362; “

ANSES emphasises that the requirements and criteria mentioned in the annex to the order regarding tank mixes are national risk management measures. Thus, it will be necessary that the national provisions are in line with the harmonised assessment methodologies since the cumulative risk assessment methodologies will be adopted at European level. Since the order on the prohibition of tank mixes is the responsibility of the ministers concerned, ANSES considers that the power to derogate should remain that of the Ministry of Agriculture.

Order of 12 September 2006 on the placing on the market and use of the products referred to in Article L. 253-1 of the French Rural Code

Current text:

“Except as provided by the decisions of approval referred to in Article L. 253-1 of the Rural Code, the reentry period is 6 hours and, when applied in a closed environment, 8 hours. It is increased to 24 hours after applying any product containing one of the risk phrases R36 (irritating to eyes), R38 (irritating to skin) or R41 (risk of serious damage to eyes) and 48 hours for those with one of risk phrases R42 (may cause sensitisation by inhalation) or R43 (may cause sensitisation by skin contact).”

ANSES proposal:

“Except as provided by the decisions of approval referred to in Article R.253-5 of the Rural and Maritime Fisheries Code, the reentry period is 6 hours and, when applied in a closed environment, 8 hours. It is increased to 24 hours after applying any product containing one of the hazard statements H319 (causes serious eye irritation), H315 (causes skin irritation) or H318 (causes serious eye damage) and 48 hours for those with a H334 risk phrases (may cause allergic symptoms or breathing difficulties if inhaled) or H317 (may cause an allergic skin reaction).”

ANSES emphasises that the requirements and criteria mentioned in the order complete the risk assessment to better take into account the effects related to local toxicity such as irritating effects. They are national risk management measures. These provisions are not harmonised at European level.

ANSES Opinion No 2015-SA-0067

ANSES : Public consultation on guidelines for the issue of approval decisions

As of next summer, ANSES, in addition to its role of scientific assessment, will also issue approvals for plant protection products, fertilisers and crop supports and adjuvants.

For transparency, ANSES has developed guidelines to clarify the principles applied by the Agency for issuing approval decisions. These guidelines are subject to public consultation from 12 May 2015 to 5 June 2015.


What can we learn?

  • Decisions taken by the Agency shall be notified to the applicant and will be published in the electronic register of decisions of ANSES, accessible on the Agency website as soon as possible. The conclusions of the assessment will be published in parallel on the same website.

Non-confidential parts of the zonal “Registration Report” (parts A and B), produced by ANSES, will also be made available on its website to provide access in much more detail to the results of the assessment.

  • In some cases, further assessment of the dossier by the DAMM may be required by the nature of the application and / or the result of the assessment, in order to prepare the draft decision. The cases identified are:
    • the case where all or part of the risk management measures associated with the results of the assessment raises questions in terms of feasibility and acceptability in practice to ensure its effectiveness;
    • the case where new data from either the assessment, including data subsequent to the renewal of approval of active substance, or of monitoring networks;
    • the case where data on sanitary and phytosanitary consequences of plant protection issues deserve to be taken into account in the decision process;
    • the case where the product contains an active substance leading to the implementation of comparative assessment and where a thorough analysis on practical / economic consequences of various possible alternatives is needed.
  • The comparative assessment of the product is made in compliance with European guidelines:
    • guidance document SANCO / 11507/2013 Rev.12, “Guidance Document on Comparative Assessment and Substitution of Plant Protection Products in according with Regulation (EC) No 1107/2009”, published by the European Commission dated 10 October 2014;
    • EPPO guidelines PP 1/271 (1), “Guidance on comparative assessment”, published in 2011 by the European and Mediterranean Plant Protection Organisation.

When it is implemented, comparative assessment will be a specific document showing responses at different stages of the process. This document will be attached to the conclusions of the assessment and made public with the conclusions of the assessment.



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



TRAINING: EU Regulation and French requirements

We propose a new training course on EU Regulation (Regulation 1107/2009) and French requirements.
Duration: 1 day. Languages: English or French.
We can customise this training course according to your needs. Please feel free to let us know your specific expectations!