Division I.6

Biological substances other than those identified in Article 1(2)(a) of Regulation (EC) No 470/2009 of the European Parliament and of the Council^f1 shall be:

1. (a)

   subject to a normal MRL where the biological substance is chemical-like insofar as it could be produced by chemical synthesis and so presents similar concerns to chemical substances and can be expected to leave residues in the same way as chemical substances (e.g. cytokines, hormones);

2. (b)

   evaluated on a case-by-case basis where the biological substance is chemical-unlike insofar as being more complex than chemically synthesised pharmacologically active substances and so may contain multiple chemical types whose residues may generally be cells, amino acids, lipids, carbohydrates, nucleic acids and their breakdown products.