A further update to EU Novel Food Regulations
Intertek's EU food regulatory expert provides insights into how the regulations and guidance documents are shaping up and potential effects on industry.
28 June 2016
Further to the update to the EU novel food regulations, which we discussed in our blog and subsequent webinar in January (Regulation (EU) 2015/2283), the European Food Safety Authority (EFSA) has published draft guidance to help industry comply with the regulations regarding: 1) applications for novel foods and 2) applications for traditional foods from 3rd countries. EFSA is now reviewing public comments on these guidance documents.
Regarding novel food applications, the guidance provides a clear outline regarding the data requirements, including a description of the novel food, the production process, compositional data, history of use, proposed uses and anticipated intakes (see here for our webinar on EFSA's guidance on intake estimates for food enzymes), safety data and information on allergenicity. EFSA highlighted that all data for and against the safety of the novel food needs to be critically appraised and provided, as well as a discussion and justification for any uncertainties within the dataset.
Similar quality requirements are required for traditional foods; however, safety is supported by a comprehensive discussion as to the history of use of the food in other countries, including, extent of use, cultivation/harvesting, consumption levels, role in the diet, specific population characteristics, and preparation precautions. This is not always a simple task!
Having participated in recent government stakeholder meetings in Brussels this spring and reviewing the available documentation, Intertek's EU food regulatory expert, Nigel Baldwin, provides the following insights for novel food applicants:
The allowance for the use of scientific arguments to justify deviations from guidance data requirements, could create delays during the non-scientific screening (i.e., checklist) phase of application submissions as screeners may not be equipped to evaluate the strength of these arguments.
As well the variable quality of these scientific arguments may bog down the process through on-going back-and-forth between applicants and EFSA – note, a goal of these new regulations was to streamline the process and make it transparent.
Flexibility of using scientific arguments will be helpful for those that have the expertise to use it effectively!
The new draft guidance is much better than the old Scientific Committee on Foods Guidance, which was set up mainly with genetically modified foods in mind. It reflects EFSA's current thinking. Applicants must follow the old guidance, until inception of the new regulation on January 1, 2018. Any applications that are pending during that cross-over date will be automatically switched over to the new system. This could create problems for applicants with applications pending as they could be considered incomplete under the new system.
Careful planning of novel food application submission timings now will be important in order to avoid unnecessary delays in the future.
There are various proposed methods for estimating dietary intakes and comments from the workgroup meetings suggested using portion size as an intakes measure. EFSA responded that on a case-by-case basis this may be appropriate.
Understanding the different approaches to conducting intakes estimates and using the most appropriate method will be very important in accurately estimating the potential exposure to the ingredient, while still supporting safety. If in doubt get help!
Changes in Substantial Equivalence dossiers?
Companies will no longer be able to use the simplified (substantially equivalent) notification procedure but will be able to use the same type of reasoned approach within the full application procedure based on a Union list of authorized novel foods. In other words, once a novel food is approved and added to the Union list, any company can market an identical novel food that meets the requirements (unless the scientific data is held as confidential for the 5 year exclusive use period).
This certainly simplifies the process but companies will want to ensure data is held confidentially to give them the 5 years before competitors can "piggy-back" off their approval.
The European Commission reported that there have been approximately 180 novel food applications submitted since 1997 and that approximately 80 have been authorised for use in the EU. Intertek Scientific and Regulatory experts within HERS have been responsible for the success of a third of these authorizations! If you have any questions about the old or new novel food regulations and how you might prepare for the transition, please contact firstname.lastname@example.org.
Today's expert blogger is Nigel Baldwin, an accomplished Scientific & Regulatory Consultant within Intertek Scientific & Regulatory Consultancy. He is a recognized expert in the area of novel foods and food supplements in Europe with extensive practical insight into the areas of food and feed additives, food enzymes, infant formula, functional foods and health claims. As Director of the Food & Nutrition Team in Europe, he has been providing invaluable expertise to international companies seeking to develop and implement strategies for gaining approvals for new products and health claims. Nigel has worked on more than 30 successful regulatory approvals world-wide.