FRANCE: Update of the memo relative to trials and experiments of regulated products
1 July 2017
Adoption of Endocrine disruptors criteria
12 July 2017
EFSA was asked by the European Commission to assess the scientific quality of newly available human in vitro studies on dermal absorption and, based on the evaluation of the studies, to revise the EFSA PPR Panel guidance on dermal absorption (EFSA PPR Panel, 2012).
The guidance proposed new default values to be used in absence of experimental data. Since the new available data clearly show that dermal absorption is significantly affected by the concentration of active substance in the product and by the type of formulation, the new default values are categorised by formulation type or concentrated and diluted pesticide formulations.
A comparison of new and current default values is presented below:
2017 Guidance Document:
| Formulation type | Concentration status | Default dermal absorption value |
| Organic solvent-based(a) or other(b) | Concentrate | 25% |
| Dilution | 70% | |
| Water-based(c) or solid(d) | Concentrate | 10% |
| Dilution | 50% |
(a): Formulation types: emulsifiable concentrate (EC), emulsion, oil in water (EW), suspo-emulsion (SE), dispersible concentrate (DC), oil miscible liquids (OL/OF), oil-based suspension concentrates (OD), emulsion for seed treatment (ES), microemulsion (ME).
(b): Formulation types: bait concentrate (CB), capsule suspension (CS), gel for direct application (GEL/GD), bait, ready for use (RB), mixture of capsule suspension and suspension concentrate (ZC), seed coated with a pesticide (PS), experimental solution of active substances in solvent (AI).
(c): Formulation types: soluble concentrate (SL), suspension concentrate (SC), flowable concentrate for seed treatment (FS), flowable (FL) (=SC).
(d): Formulation types: wettable powder (WP), water-dispersible granules (WG/WDG), water-soluble granules (SG), water-soluble powder (SP), powder for dry seed treatment (DS).
2012 Guidance Document:
| Default dermal absorption value | |
| Concentrate
(> 5% a.s., 50 g/kg for solids or 50 g/L for liquids) |
25% |
| Dilution
(≤ 5% a.s.) |
75% |
| Active substance with
log Pow < -1 or > 4 and MW > 500 |
10% |
A technical meeting with stakeholders will be held in Parma on 27-28 September 2017 to explain how the document differs from the guidance issued in 2012, answer questions and collect feedback.
To download:
Guidance on dermal absorption (EFSA Guidance, 24/05/2017)
Outcome of the public consultation on the draft EFSA Guidance on dermal absorption (EFSA Technical report, 24/05/2017)
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