By: European Federation of Associations of Health Product Manufacturers (EHPM)
The Nutrition and Health Claims Regulation (NHCR) was designed to improve consumer protection and has been successful in removing many fraudulent claims from labelling. However, it has also led to the removal of many ‘generic’ health claims widely accepted in the scientific community. The current European Framework for health claims has therefore moved way beyond the original spirit and intention of the NHCR and is in need of considerable reform.
From 2006, when the regulation was adopted, until now there has been a very limited number of approvals. Even the number of approved claims is not reflective of a real success rate as all vitamin and mineral claims were approved automatically, without any clinical trials. So in reality almost 90% of the original health claims submitted have not survived.
Initially requirements for the health claims dossier were unclear but over time it became apparent that three clinical trials were required. However, since this time, we have not seen an improvement in success rates. In a process that is already highly complex and high risk, both in terms of costs and NPD for applicants, guidance in the process could be the difference between success and failure and continued innovation in the sector. Currently, EHPM attributes this to a lack of dialogue between EFSA and applicants. If this situation prolongs, the result will be a reduced investment in the sector as companies reassess their strategies and look of alternative avenues and alternative markets.
What exacerbates the situation further is that industry can see an effective and workable model in the European Medicine’s Agency (EMA), one which is facilitating innovation and investment. However the food industry is faced with a double standard without reason or explanation. If dialogue is possible between EMA and EFSA, without compromising integrity, surely it is possible between EFSA and the food industry.
Are these flaws acknowledged or being addressed?
The recent REFIT of General Food Law offered the food industry and opportunity to express their opinions and they did, by calling for increased dialogue with EFSA through the form of pre-submission meetings for applicants for authorizations in the various areas impacted by EFSA’s assessments including those seeking health claims. Although ‘consultation meetings’ were included in a draft proposal from the Commission, these are completely insufficient to meet the needs of the industry as detailed discussions on clinical trial design and outcomes are deliberately excluded. It also remains unclear if the proposal can be agreed during the lifetime of the current European Parliament - European Parliament elections will be held in May 2019.
In general, the current regulatory framework is not consistent with the EU’s frequently stated desire to promote innovation in all areas of the EU economy, including the food sector. Until the European Commission wakes up to this reality and engages in the genuine reform needed to put a sensible regulatory framework in place, innovation in the EU food sector will continue to be severely hampered. Genuine reform would involve:
1. Ensuring that applicants to EFSA are given access to same due process and fairness as applicants to other EU agencies such as EMA receive.
2. Establishing sensible standards for the justification of health claims that takes into account the following:
- Pre-existing national best practice and internationally accepted science
- The fact that food and food supplements can help maintain and indeed improve physical condition/performance in certain situations
- Food and food supplements are not drugs and should not be assessed as if they are
- The marginal health improvement or relief that the consumption of a particular nutrient can deliver cannot be measured in the same way that you measure the drastic health improvement a medicine delivers in a sick patient
For more information on EU Regulations and your product come and listen to Patrick Ahern, Director General, European Federation of Associations of Health Product Manufacturers (EHPM) on Tuesday, 27 November, 13.30 – 15.30 at the Industry Insights Theatre.