# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division: Circumstances in which required

Extent: E+W+S+N.I.

The decision as to whether it is necessary to carry out processing studies will depend on:
the importance of a processed product in the human or animal diet,
the level of residue in the plant or plant product to be processed,
the physico-chemical properties of the active substance or relevant metabolites, and
the possibility that degradation products of toxicological significance may be found after processing of the plant or plant product.
Processing studies are not normally necessary if no significant or no analytically determinable residues occur in the plant or plant product which would be processed, or if the total theoretical maximum daily intake (TMDI) is less than 10 % of the ADI. In addition, processing studies are not normally required for plants or plant products mostly eaten raw except for those with inedible portions such as citrus, banana or kiwi fruit where data on the distribution of the residue in peel/pulp may be required.
‘Significant residues’ generally refer to residues above 0,1 mg/kg. If the pesticide concerned has a high acute toxicity and/or a low ADI, consideration must be given to conducting processing studies for determinable residues below 0,1 mg/kg.
Studies on the effects on the nature of the residue are not normally required where only simple physical operations, not involving a change in temperature of the plant or the plant product, are involved such as washing, trimming or pressing.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/6/division/6.5/division/1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-6/division-6.5/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.