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Table 4 EU referral procedures under Article 30(3) of Regulation (EC) No 726/2004 related to potential environmental risks

From: Regulatory review of the environmental risk assessment of veterinary medicinal products in the European Union, with particular focus on the centralised authorisation procedure

Substance Species Route of administration Concern CVMP conclusion Type Commission decision
Diclofenac Cattle, pigs and horses Any Potential risk to vultures and other necrophagous birds in the Union exposed to diclofenac as a result of ingesting carcasses containing diclofenac residues in feeding stations or through fallen stock in pastures Positive risk/benefit
Vultures and other necrophagous birds may be at risk in certain scenarios. Additional risk management measures are needed, and efforts should focus on determining the most suitable and effective measures to ensure that contaminated carcasses do not end up in the food chain of vultures and other necrophagous birds. Recommendations on risk management measures were considered but their effectiveness could not be quantified
Non-steroidal anti-inflammatory N/A