Animal feed and Veterinary products

Veterinary products

In the European Union, Regulation (EU) 2019/6 establishes the rules on veterinary medicinal products (VMPs), ensuring the protection of human and animal health and the environment. Any product placed on the market must have a marketing authorisation and companies must provide a data dossier to support their application; the pharmacologically active substance must have been approved and listed. The EU registration process ensures that only those products of a defined standard, which have been thoroughly tested and carefully reviewed by independent experts, reach the marketplace. The application for marketing authorisation must include all of the scientific documentation necessary for demonstrating the quality, safety and efficacy of the VMP.

Products for animal use that fall outside the scope of these regulations include, for example, insect repellents, or products applied topically to disinfect teats and udders. They are regulated under the Biocidal Products Regulation, as are disinfectants used for animal housing.

Bibra scientists have, for many years, provided expert support to companies working in the market for active substances – be it pharmaceuticals, veterinary products, or biocides. Our advice is particularly sought on the toxicological risks posed by the non-active components of any formulation – excipients, processing aids, and manufacturing impurities. With our wide-ranging skills in the hazard and risk assessment of chemicals, data searching, exposure modelling, and extensive use of the concepts of structure-activity relationships (SARs) and the threshold of toxicological concern (TTC), we are your ideal partner to support your veterinary product registration.

 

Animal Feeds

Legislation on animal feed is harmonised at EU level. It applies principally to feed for farmed livestock, but also covers feed for horses, pets, farmed fish, zoo and circus animals, and creatures living freely in the wild.

Animal feed additives must be authorised in accordance with the provisions of Regulation (EC) No 1831/2003 (as subsequently amended, the latest version being Regulation (EU) No 2019/962). The manufacturers of products containing these feed additives must submit a substance dossier to the European Commission that contains data and studies demonstrating the efficacy of the product for animals and its safety for animals, humans and the environment.

For many years we have provided expert advice on toxicological issues relating to food and feed additives. We would be happy to help support your regulatory submissions.

 

Examples of the services we can provide on veterinary product and animal feed additive registrations
  • Applications for veterinary product market authorisations and approvals
  • Veterinary product expert reports and dossier submissions
  • Human health risk assessment for professional use of a veterinary product
  • Update of a health risk assessment and expert reports for an OTC veterinary product
  • Hazard and risk assessment of non-active formulation components and additives
  • Hazard assessment of potential animal feed contaminants

 

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