Division Circumstances in which required

The following points shall be taken into consideration when deciding whether it is necessary to carry out processing studies:

1. (a)

   the dietary burden of a processed product in the human (such as apples) or animal diet (such as apple pomace);

2. (b)

   the level of residue in the plant or plant product to be processed (normally ≥ 0,1 mg/kg);

3. (c)

   the physical and chemical properties of the active substance and its relevant metabolites (such as fat-solubility in case of oil seed processing); and

4. (d)

   the possibility that breakdown products of toxicological significance may occur after processing of the plant or plant product.

If the level of residues is less than 0,1 mg/kg, processing studies shall be carried out if the contribution of the commodity under consideration to the theoretical maximum daily intake (TMDI) is ≥ 10 % of the ADI or if the estimated daily intake is ≥ 10 % of the ARfD for any F1relevant consumer group diet.

Processing studies shall not be required if plants or plant products are exclusively used raw (unprocessed) for food and feed purposes.

In some cases, a simple calculation shall be sufficient to determine the processing factor such as concentration from dehydration or dilution factors, as long as the process under consideration is not expected to have an influence on the nature of residues.