What is a Health Claim?
A health claim is a descriptor of the beneficial physiological effect of a nutrient on the human organism. Health claims are used for the promotion of products to consumers via all means of commercial communications - printed material, tv, radio and internet.
What is the Relevant Legislation?
The nutrition and health claims regulation (Regulation (EC) No 1924/2006 - NHCR) and its implementing regulation establishing an approved community list (Regulation (EU) No 432/2012 as amended) define the conditions of use for health claims on ingredients
Brief History of the Health Claims Regulation
The European Health Claims Regulation 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 health claims widely accepted in scientific community. The current European Framework for health claims is in need of reform.
From 2006 when the regulation was adopted until now there have been 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.
Source: EHPM, 2017
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 do not see 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.
The Current Situation
During 2017, the REFIT of the General Food Law (GFL) began. The term ‘REFIT’ refers to the European Commission’s regulatory fitness and performance programme and is an evaluation which is designed to ensure that laws remain simple and that unnecessary or obsolete legislation can be adapted or removed, where appropriate. The GFL, established in 2002, is the cornerstone of EU regulation governing the entire foodchain and therefore has a significant impact on health claims for food and food supplements.
During the later part of 2017, industry submitted contributions to support areas for improvement in relation to the GFL. EHPM emphasized strongly the need for pre-submission meetings between the European Food Safety Authority [EFSA] and applicants (for health claims, novel foods etc.) as did the UEAPME the European SME umbrella group of which EHPM is a member. The proposal ultimately put forward by the European Commission did include a provision for pre-submission meetings albeit one that needs to be significantly strengthened.
There was broad industry agreement across multiple sectors on the need for pre-submission meetings. The Commission did propose pre-submission meetings but stipulated that these would only be with EFSA staff and not the relevant EFSA scientific panel and that the meeting would not cover clinical trials. In the case of applications where companies are seeking permission to claim a specific health benefit on labelling, clinical trials are the key piece of evidence sought by EFSA. Experience has shown that to have any chance of success, 3 trials are needed that cost in the region of €1.5 million. Up to now, despite huge investments in clinical trials, about 95% of applications have been rejected. One of the main reasons for rejections cited by EFSA has been the inadequacy of different elements of clinical trials. Nevertheless, EFSA refuses to discuss trial design with applicants in advance, relying on providing written guidance that is clearly inadequate given the huge rejection rate. By contrast, pharmaceutical companies seeking to secure the approval of a medicinal product are free to discuss the various requirements with the European Medicine’s Agency. EFSA, with the support of the European Commission refuses to engage in a similar process on the basis that it would compromise the integrity of those accessing the applications
There was broad industry agreement across multiple sectors on the need for pre-submission meetings. The Commission did propose pre-submission meetings but stipulated that these would only be with EFSA staff and not the relevant EFSA scientific panel and that the meeting would not cover clinical trials.
What can we expect now?
It is now clear the that REFIT process will be halted until the new parliament are in place (May 2019). EHPM do not consider that this is automatically such a negative development. Unfortunately, the proposal from the Commission did not really address many of the failures in the current framework, such as a significant lack of transparency in risk management and also the absence of a genuine proposal for pre-submission meeting for applicants to the European Food Safety Authority (EFSA) for authorisations.
EHPM would prefer that a much more thorough proposal incorporating an impact assessment on the pre-submission meeting issue be brought forward in the next Commission, instead of what is currently on table. 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.
To see a case study on how the General Food Law impacts upon your business click on the link below
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