Article 4 Assessment reportF3

Where an application for a new or amended maximum residue limit for a substance intended for use in a veterinary medicinal product is made under Article 8, the Secretary of State must produce an assessment report which includes a scientific risk assessment and risk management recommendations for the purposes of establishing maximum residue limits for the substance in question.

The scientific risk assessment and the risk management recommendations shall aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products. F2The assessment report must take account of any relevant findings of internationally recognised scientific bodies.