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