Eight years post implementation, the Commission has confirmed its intention to update Regulation (EC) 429/2008 that covers the rules on the preparation and presentation of feed additive applications and their evaluation.
Diederik Standaert, head of the feed, GMOs and tobacco products division within the Federal Public Service Health, Food Chain Safety and Environment of DG Animals, Plants and Food in Belgium, gave us his perspective on the recasting.
“We are very much in the consultation phase on this. The Commission is awaiting comments from the European Food Safety Authority (EFSA) on how the guidelines should be revised. The Authority has indicated it will submit that input in July. So we could see a first draft [of the updated guidelines] issued this summer. But a final text would be highly unlikely before the end of December this year or even early 2017,” he said.
Belgium’s standpoint is that the Commission should take a pragmatic approach in terms of the efficacy constraints for technical additives in the revamped guidelines.
“Our position is that we are waiting for concrete text before submitting comments but our basic line is that the new guidelines need to focus more on safety and a bit less on efficacy,” he said. “The regulations should be less rigid in relation to the number of studies per species requirement and allow for more extrapolation from other species to reduce the number of trials needed.”
For example, he said, if a study shows efficacy for piglets, which is the most sensitive life stage, then that finding should be applied to pigs for fattening as well. “This would speed up the authorization process,” said Standaert.
While this has been happening in practice in some of the opinions published by EFSA’s FEEDAP, he said such extrapolation should be foreseen in the revision of the guidance.
“Early indications are that the Commission agrees with a more open approach on the efficacy side,” he added.
Genotoxicity testing guidance
There have been new functional groups in the intervening years such as mycotoxin binders and hygiene condition enhancers that the revamping exercise will have to take account of: “Some specific guidance is needed on those," said Standaert.
In terms of new safety considerations, genotoxicity testing for products developed as part of a fermentation process needs to be addressed in the guidelines, he said. “Furthermore, detailed guidance is also required for operators on ensuring their products are completely free of GMO producing strains,” said the Belgian regulatory expert.
And he said there should be more emphasis on the cascade approach to analytical methods, requiring applicants to use official ISO/CEN methods when possible and not in-house ones for enzyme unit measurement for example. “Such harmonization would save time and resources at official control level,” said Standaert.
Rather than the discussions around the revision taking place in the monthly meetings of the Standing Committee on Plants, Animals, Food and Feed Section Animal Nutrition (SCoPAFF), Standaert thinks the Commission will create a specific working group to move the process forward: "This would be the preferred option in terms of efficiency," he said.
And he envisages the Commission putting transitional measures in place to allow industry adapt to the new guidelines once the final text is approved.
FEFAC, FEFANA and other industry stakeholders have been involved in preliminary discussions with DG Sante on the recasting of the regulation, most recently in February.
FEFANA has stated the main objective for its members in relation to the new guidance is to ensure improved transparency and a level platform across feed businesses.
“Risk assessment should be as predictable as possible and innovation should also be included as part of the guidelines. This requires a guideline that clearly defines the content of the dossiers, the information needed for the assessment and the data that can be waived upon sound justification by the applicant,” officials wrote in FEFANA’s activity report published in December.
The trade association said it will continue to provide its contribution to the authorities to achieve its goal of a fair, science-based assessment of feed additives.