Is the current Feed Additives legislation fit for purpose? What’s going on and what are Pen & Tec’s views on the EC initiative to evaluate it?

Posted 18 July, 2019

The European Commission launched an initiative for an evaluation of the feed additives Regulation in 2017. In December 2018, a public consultation started and lasted 4 months, ending in April 2019. The objective of this initiative was to evaluate whether the current feed additives legislation Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 is fit for purpose. In the 14 years since it entered into force, the evaluation is useful for assessing its performance, how it has delivered its objectives, to what extent it fits current issues and what needs to be updated or reshaped.

This evaluation wants to cover the overall effectiveness, efficiency, relevance, coherence, and EU added value of the regulation, with the objective of identifying the current legislative framework’s possible regulatory burdens, overlaps, inconsistencies, obsolete measures and gaps that would lead to an improved framework. It will also help investigate if it is still relevant in current times & can answer industry and society needs.

Pen & Tec, as feed experts with over 18 years’ experience of providing companies with continuous regulatory advice and helping with diverse issues and requests, has contributed to the public consultation. One of Pen & Tec’s main priorities is helping to ensure a safe food chain for consumers by building a regulatory framework that provides flexibility, transparency, predictability, and allows for innovation to support companies in developing new and creative feed additives.

Science & technology moves at a much faster pace than regulators, and industry is developing new & innovative products to meet current challenges (e.g. antibiotic alternatives, more sustainable food production, reducing the impact of traditional farming practices on the environment, improving animal welfare, etc.). The current framework lacks the flexibility to adapt to scientific & technological advancements.

In general, there is a need for greater versatility, and in the public consultation, Pen & Tec suggested the following:

  • Allowing holder-specific authorisations in all feed additive categories to protect innovation & creativity (especially of the most frequent innovators, SMEs).
  • Addition of feed additive categories, such as an “Other” functional group in each category and a novel feed additive category.
  • Pen & Tec believe that Commission acknowledgement of the work & guidelines of other scientific bodies &/or evaluating agencies would contribute to objectivity and help apply the 3R principle (reduce, refine, replace) which we should be moving towards.
  • EFSA guidelines should be aligned with and not more demanding than the regulations.
  • EFSA should make the full evaluation of all studies submitted available to the Commission; this would allow the Commission to decide on whether to take this information into account for their decision because they would have all facts available.
  • Regarding efficacy studies, more flexibility is needed in study design & endpoints, alternative testing methods (e.g. in vitro, ex-vitro) and the 3R principle, which encourages EFSA to recognise the work of other scientific bodies &/or evaluating agencies.

The harmonisation of the “food chain legislation” is essential because ensuring feed/food quality and standards protects the health of consumers and provides relevant and accurate information. In Pen & Tec’s opinion, the provisions in feed additive Regulation (EU) 1831/2003 are not fully consistent with other areas of EU legislation, because there are different safety approaches taken towards the same active substance/agent used in different areas of the food chain. Therefore, the evaluation of fitness for purpose should cover the feed additives Regulation (EU) 1831/2003 together with other relevant legislation (e.g. feed hygiene, feed marketing, feed materials, medicated feed, pesticides, biocides, biostimulants, food ingredients & food additives).

On 8 July 2019, an online survey of stakeholders and of Member State Competent Authorities was launched, which will be open until 7th of September 2019. The online survey will provide a key source of primary data and information for the REFIT evaluation of Regulation 1831/2003.