Feed Additive Regulations – what’s NEW?
Posted 9 September, 2019
Pen & Tec Consulting will host an interactive workshop at Feed Additives Europe open to all attendees, to discuss the latest regulatory changes that will affect food and feed additive producers. FeedInfo News Service asked Scientific Director, Dr Hannah Lester, to provide an overview of the most pressing issues.
Question: High on the radar is the implementation of the new Regulation on the transparency and sustainability of the EU risk assessment in the food chain. What can we expect once this new regulation is in force?
Answer: “March 2021 is definitely a date we should all keep in mind, as it is when the Regulation on transparency will enter into force. The Regulation aims to ensure a more robust, independent and transparent risk assessment process for all the products governed under the General Food Law, including feed additives. This will bring some important changes, for both the manufacturers of food and feed as well as the general public. One of the biggest changes is that dossiers submitted to EFSA for risk assessment will be made public after validation, except for the parts that are accepted as confidential. This means that competitors will be able to access information and studies that currently is very hard to get, i.e. you have to submit a PAD request to the European Commission (EC), and you may or may not receive approval, depending whether the holder of that information agrees to disclose. Of course, confidentiality can be re- quested, but what if the EU authorities do not find it justifiable? Among other changes, we are very excited about the implementation of pre-submission consultations with EFSA on the data requirements for dossiers, although this service will mostly be of benefit to SMEs.”
Question: Currently, the EC is evaluating if the current legislation covering feed additives for use in animal nutrition is fit for purpose (REFIT). What are some of the changes that you and the industry would welcome?
Answer: The industry would benefit greatly if all authorisations were hold- er-specific as currently, only authorisations for zootechnical feed additives and coccidiostats benefit from this status. All authorisations for nutritional, technological and sensory feed additive are generic, meaning once one of these products are approved, any other company can sell the same product as long as they meet the specification outlined in the authorisation. We believe that this disincentivises companies to invest in new & novel products that fall within these ‘generic’ feed additive categories because of the financial burden of generating data and then getting no market protection once authorised. It particularly affects small and medium businesses (SMEs), who are usually the ones with innovative ideas and would need the EC to protect their investment. Establishing a favourable regulatory environment for innovative products is especially important in today’s food chain where priority should be given to finding alternatives to antibiotics & novel sources of sustainable protein.
Question: And since its entry into force in October 2003, has the feed additive regulation been updated in line with scientific and technological advances?
Answer: Since 2003, there have been a number of positive changes. The most recent example is the introduction of two new functional groups for feed additives: “Other technological additives” under the technological category and “Physiological condition stabilisers” under the zootechnical category. These new functional groups should allow greater flexibility for applicants. With the REFIT, more positive changes such as new feed additive categories, clearer labelling requirements, clarification on feed additives falling between overlapping categories are anticipated, so watch this space! The public consultation period for the REFIT of the feed addi- tive Regulation ended in April 2019 and a Commission Implementing Act is planned to be adopted in the fourth quarter of 2019.
To find out more about how the new changes to the feed regulations may affect your business, join the Pen & Tec workshop on Thursday 26th September at 13:30 the Cyan room next to the lunchtime networking area.
To see full agenda of the event please click here.
We look forward to seeing you in Amsterdam!