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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

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 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
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
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
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
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
  1. aMember States are able to defer the withdrawal of the marketing authorisations for up to 5 years following the Commission Decision if they consider that immediate action may have an adverse impact in their territory given the lack of availability for therapeutic alternatives and the changes required in pig farming practices