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