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Table 2 EU referral procedures under Article 33(4) of Directive 2001/82/EC related to potential environmental risks (ERA environmental risk assessment)

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

Product Active substance Species Route of administration Concern CVMP conclusion Product type Commission decision
Gutal premix 1000 mg/g Zinc oxide Pigs (piglets) Oral Persistence of zinc in soil may lead to long-term risks to soil and water compartments Positive benefit/risk balance
ERA Phase I and II
The addition of risk mitigation measures in the product information to limit the load of zinc to agricultural soils, resulting from slurry application to land, was needed
Antidiarrheal 2015
[13]
Suifertil 4 mg/ml Altrenogest Pigs Oral Hormonal properties of the product might be a risk to aquatic organisms at very low concentrations, despite PECsoil being < 100 µg/kg Positive benefit/risk balance
Conclusions on this procedure were made pending the outcome of the Article 35 referral procedure on altrenogest (see Table 3 below)
Steroid hormone 2013
[14]
Cevazuril 50 mg/ml Toltrazuril Piglets Oral Persistence of the main metabolite toltrazuril sulphone despite the PECsoil being < 100 µg/kg Positive benefit/risk balance
ERA Phase I
PECsoil for the metabolite was below the trigger for a higher tier assessment of PECsoil < 100 µg/kg. There was reference to the previous outcome from the Article 35 referral on toltrazuril (see Table 3). No Phase II assessment was conducted
Coccidiostat 2010
[15]
Ecomectin paste Ivermectin Horses Oral Potential risk to dung fauna Positive benefit/risk balance
ERA Phase I
The product is intended for individual animal treatment in minor species. As a result, the environmental exposure was accepted to be limited when compared to that of products containing the same active ingredient for major species
Parasiticide 2008
[16]
Enro-K/Unisol 10% Enrofloxacin Chicken, turkeys Oral Potential risk to blue-green algae and to terrestrial plants Positive benefit/risk balance
ERA Phase I and II. Environmental exposure of enrofloxacin was confirmed to be below the threshold values of environmental concerns
Antimicrobial 2009
[17, 18]
Fenflor and Shotaflor 300 mg/ml Florfenicol Cattle Intramuscular injection Adequacy of the exposure assessment related to the number of treated animals Positive benefit/risk balance
ERA Phase I
The re-assessment of the exposure of florfenicol to the environment from the treatment of cattle concluded with a PEC < 100 µg/kg, hence a more in-depth risk assessment was not required
Antimicrobial 2009
[19, 20]
Pharmasin 100% w/w Tylosin tartrate Calves, pigs, chicken and turkeys Oral Potential risk to blue-green algae, terrestrial plants and soil microorganisms Negative benefit/risk balance (i.e., authorisation was not granted)
ERA Phase I and II
Risk to algae, terrestrial plants and soil microorganisms could not be excluded despite consideration of mitigation measures
Antimicrobial 2010
[8]
Prontax 5 mg/ml and 10 mg/ml Doramectin Cattle, sheep and pigs Topical use Inadequacy of data to support the ERA Positive benefit/risk balance
ERA Phase I and II
Risks identified for aquatic organisms and dung fauna. Risk mitigation measures included in the product information to reduce the overall environmental exposure and minimise risks
Parasiticide 2012
[21, 22]
Deltanil
10 mg/ml
Deltamethrin Cattle and sheep Topical use Inadequacy of data to support the ERA Positive benefit/risk balance
ERA Phase I and II
Long-term effects to dung fauna identified. Risk mitigation measures included in product information to reduce the overall environmental exposure and minimise risks
Parasiticide 2013
[23]
Strenzen 500/125 mg/g Amoxicilin and clavularic acid Pigs Oral Inadequacy of fate data and environmental concerns due to very high PECsoil due to slurry application to land Positive benefit/risk balance
No risk identified when additional data were made available for the risk assessment
Antimicrobial 2013
[24]
Norbonex 5 mg/ml Eprinomectin Cattle Topical use Potential PBT substance Positive benefit/risk balance
The substance fulfils the criteria for ‘T’ and ‘P’, but not for ‘B’. No risk identified for secondary poisoning or for dung fauna. A risk mitigation measure was added to the product information
Parasiticide 2014
[25]