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The Applicant Guide: How do I generate data on the chemistry of the formulation and toxicology ?

How do I generate data on the chemistry of the formulation?

Which applications will require an assessment of formulation chemistry?

Formulation physico-chemical properties and storage stability are dependent upon the formulation constituents and the packaging of the product. This aspect should be addressed for the following applications:

  1. New product with a formulation never previously authorised.
  2. Changes to the formulation of an authorised product.
  3. Changes to the packaging for an authorised product.
  4. Any other changes that may affect the physico-chemical properties of the formulation.

How will the assessment of formulation chemistry be carried out?

Formulation changes

Any application for a formulation never previously considered (new products or changes to existing products) must be supported by:

  1. New physico-chemical properties data; or,
  2. A reasoned case based on extrapolation of previously evaluated physico-chemical properties data from another authorised formulation. A comparison should be presented between the components of the proposed and authorised formulations with a case addressing why the previously evaluated data are relevant to the new formulation. This should take into account the formulation type and the quantities, chemical nature and functions of the individual constituents.

Guidance on which changes can be considered non-significant and therefore are considered unlikely to affect the physico-chemical properties and storage stability of an authorised formulation can be found in Guidance on significant and non-significant formulation changes, SANCO/12638/2011. Note for any change in dyes present the suitability of the dye with respect to their toxicology should be addressed.

Any other changes should be fully addressed with reasoned cases or data.

Packaging changes

For any application, including packaging never previously considered (new products or changes to existing products), the applicant must address the effect of the packaging on the storage stability of the formulation either with data or reasoned cases. For details of packaging extrapolations that are considered acceptable between packaging types and materials consult the Guidance document for the generation of data on the physical, chemical and technical properties of plant protection products under Regulation (EC) No. 1107/2009 of the EU Parliament and Council on placing plant protection products on the market.

How do I generate data on the toxicology of the active substance?

The toxicology evaluation will be performed in accordance with uniform principles. Data on formulated products should be provided in accordance with Commission Regulation (EU) 284/2013. Further information is available on the pesticide toxicology webpages (link to toxicology data requirements guidance).

Further information

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Updated 2016-09-29