Table 3 EU referral procedures related to potential environment risks according to Article 35 of Regulation 2001/82/EC having taken place since the implementation of that regulation
Substance | Species | Route of administration | Concern | CVMP conclusion | Product type | Commission Decision |
|---|---|---|---|---|---|---|
Moxidectin | Cattle, sheep and horses | Oral, topical or subcutaneous | Establish if this substance is a PBT and address the need for risk management measures | Positive benefit/risk balance subject to amendments to product information, and to the condition that marketing authorisation holders conduct a post-authorisation study on the fate and behaviour of the substance in the environment when used according to the product information | Antiparasitic | 2017 [26] |
Zinc oxide | Pigs | Oral | Persistence of zinc in soil may lead to long-term risks to soil as well as water compartments and increase of the prevalence of antibiotic-resistant bacteria | Negative benefit/risk balance The benefits of zinc for the prevention of diarrhoea in pigs do not outweigh the risks for the soil and aquatic compartments. It is acknowledged that there is a risk of co-selection for resistance associated with the use of zinc oxide, although such risk is not quantifiable at present | Antidiarrheal | 2017a [7] |
Doramectin | Mammals | Topical, subcutaneous and intramuscular | Discrepancies in the risk mitigation measures included in the product information in relation to the risk to the environment | Positive benefit/risk balance Harmonisation of risk mitigation measures included in the product information | Antiparasitic | 2013 [27] |
Toltrazuril | Poultry | Chicken, turkey, broilers, breeders, pullets | Risk to plants when manure obtained from treated animals is applied to agricultural land | Positive benefit/risk balance The assessment of the risk presented by toltrazuril and its major metabolite, toltrazuril sulfone, to terrestrial plants and to groundwater demonstrated that use of products containing this substance is acceptable. Dosing regimes and indications were harmonised to ensure that the environmental exposure would not surpass a maximum safety load | Coccidiostat | 2008 [28] |
Altrenogest | Pigs and horses | Oral | High risk to aquatic organisms given the potential endocrine disrupting properties of the substance | Positive risk/benefit balance A risk for fish and other aquatic organisms associated with the zootechnical use of veterinary medicinal products containing altrenogest in gilts cannot be excluded for certain geographical areas, but there are important benefits of the product in modern pig production and lack of alternatives. Risk mitigation measures included in product information | Steroid hormone | 2016 [29] |