We offer support for the authorisation of chemicals or microbials as feed additives according to European regulations. We provide you with effective and timely solutions related to the characterisation, efficacy and safety aspects of feed additives. All the regulatory aspects related to your feed additive are in safe hands with us, making sure that your products can be placed on the market.
GAB Consulting is keen to provide you with competent scientific support during all stages of physical-chemical, toxicological and environmental tests for chemicals and microbials and also in trials to demonstrate efficacy according to the current EFSA guidance. We have established a network of laboratories and research institutions who will conduct studies using the most up to date and accurate methods. Together with them we will design experiments and produce high quality reports which will prevent unnecessary investments of time and money.
Our expertise in the preparation of dossiers for biocides, agrochemicals, biopesticides, industrial chemicals and feed additives enables us to prepare a product dossier covering multiple categories, allowing you to market your products as widely as possible. Multiple dossiers can be prepared at the same time considering specific data requirements according to different EU and overseas regulations. This strategy reduces workload and therefore the cost for the dossier compilation.
Our One-Stop Service concept provides our clients with high-quality regulatory services. Clients may choose the services that meet their specific needs best – in packages or stand-alone.
We will prepare your applications for the authorisation of additives for use in animal nutrition in accordance with Regulation (EC) No. 1831/2003, Regulation (EC) No. 429/2008 and No. 885/2009 or represent your company in consortia for joint applications.
Our experts will help you to prove the efficacy and safety of your product for the target species, the user, the consumer and the environment. This covers communication with the European Commission, the EU Reference Laboratory and the European Food Safety Authority including submission of Administrative Documents (Annex A–E) and the Technical Dossier (Sections I-V).
Follow-up Activities & Dossier Defence (selected services)
- Review and commenting of authorities‘ assessments on EU and national level
- Risk refinements
- Expert discussions and negotiations with authorities
Dossier Preparation (selected services)
- Identification and evaluation of data gaps in the data package according to current EU requirements (Check of Completeness) and preliminary risk assessments (human & environmental exposure, risk characterisation human health & environment)
- Cost analysis for completion of the data package (including statements) and preparation of a registration dossier
- Time schedule for study conduction and dossier preparation
- Support in the selection of contract laboratories,
contracting of studies
- Scientific support and study monitoring
General Consultancy & Project Management (selected services)
- Assistance in assessing the category of your product as a feed additive, biocide or veterinary drug
- A thorough search of the published literature and evaluation of your unpublished data will be the basis for identification of possible data gaps according to the relevant data requirements
- In addition we take care of all the regulatory aspects related to the feed additive, active substance and product, making sure that your products can be placed on the market