NOT SURE IF YOUR PRODUCT QUALIFIES AS A FEED ADDITIVE OR WHICH CATEGORY TO APPLY FOR?
In the EU, feed additives are defined as products which are intentionally added to feed or water in order to favourably affect the quality of feed and the quality of food from animal origin.
In order to protect human health, animal health and the environment, feed additives must undergo a pre-market safety assessment via a centralised procedure following Regulations (EC) Nº 1831/2003 and 429/2008 before being placed on the EU market. The scientific safety assessment is carried out by the European Food Safety Authority (EFSA) and the authorisation of the additive is granted by the European Commission (EC).
They typical feed additive evaluation process is outlined below:
Pen & Tec has over 20-years’ experience in feed additive legislation and has submitted over 250 dossiers. There are five feed additive categories and within each category are functional groups which describe the specific function of a feed additive. Feed additives could fall under several categories and functional groups. Some categories may offer cheaper or quicker routes to market, and we can help you to identify the best strategy taking into account your regulatory, scientific and commercial needs.
Pen & Tec has extensive experience in all Feed Additive categories and functional groups and has a proven track record in helping our clients achieve regulatory success.
Pen & Tec can help you at any stage and we offer a full regulatory service from concept to approval.
We have been preparing feed additive applications since 2000 & over this time, we have amassed a great amount of experience in registering feed additives. Our services include:
- Regulatory feasibility assessments & product classification
- Data audits, gap analyses & regulatory road maps
- Renewal dossiers
- Species extension
- Evaluation of data requirements, financial planning and timelines,
- Study design & statistics
- Literature searches and expert reports
- Preparation and submission of feed additive dossiers
- Help with answering post-submission questions
- Dealing with negative opinions
- Communication with relevant EU authorities: EC, EFSA, EURL