TITLE IIMAXIMUM RESIDUE LIMITS

CHAPTER IRisk assessment and risk management

Section 1Pharmacologically active substances intended for use in veterinary medicinal products in the Community

Article 6Scientific risk assessment

1

The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in relevant animal species, the type of residues and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk expressed in terms of acceptable daily intake (ADI). Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 13(2).

2

The scientific risk assessment shall concern the following:

a

the type and amount of residue considered not to present a safety concern for human health;

b

the risk of toxicological, pharmacological or microbiological effects in human beings;

c

residues that occur in food of plant origin or that come from the environment.

3

If the metabolism and depletion of the substance cannot be assessed, the scientific risk assessment may take into account monitoring data or exposure data.