Draft Health Claims Guidance Published
The European Food Safety Authority (EFSA) has published its draft Scientific and Technical Guidance for the Preparation and Presentation of an Application for the Authorisation of a Heath Claim.
However, the Draft Guidance only outlines the requirements for applications made under article 14: reduction of disease risk claims and claims for children's development and health. It neither covers applications for claims under article 18, (those on the EU list based on newly developed evidence which include a request for protection of proprietary data), nor Article 13 applications intended for inclusion on the EU positive Register of established 'generic' health claims.
The absence of guidance for Article 18 claims is a particular concern for the food supplement industry because it would appear that EFSA and the European Commission may intend that no submissions can be made under that article until the Article 13 positive list of established health claims has been drawn up. As this will not be until 2010, there would be a three year period when companies wishing to make application would be unable to protect their proprietary data.
Further details of the consultation can be found on: http://www.efsa.europa.eu/en/science/nda/nda_consultation/health_claim.html
To allow interested parties to have an exchange of views on the Draft Guidance, a Technical Meeting organised by EFSA was held on June 11 in Parma, Italy.
In general many delegations stated that the amount and detail of the data required for a submission is too demanding and time-consuming, especially in view of small and medium enterprises. It was especially remarked that the document did not allow for a simpler submission in case of assessment already by other expert panels. It was stressed by EFSA that the document would be continuously updated based on changing scientific environment and experience gained. It was questioned, however, how that would be done in practice.
In general the discussions were felt to be very useful and constructive although it is not clear to see if the guidance notes will be substantially amended and on what aspects.
A report of the meeting can be found at EFSA's website: http://www.efsa.europa.eu/en/stakeholders_efsa/technical_meetings/sh_tm_nda.html
Folic Acid Fortification
In Germany, mandatory fortification with folic acid has been discussed within the German Nutrition Society (DGE) and the German Federal Institute for Risk Assessment (BfR). Both issued statements in 2005 and 2006 respectively. However, there is no national regulatory initiative on mandatory fortification or on maximum levels for folic acid in food supplements.
In this context, the BfR recently translated its question and answer catalogue saying: "BfR primarily recommends that all consumers have a diet which is rich in folic acid. It further recommends that women wishing to start a family and women in the first three months of pregnancy should also take folic acid products. Here it should be borne in mind that the folic acid requirements are higher in the further course of pregnancy and when breastfeeding, too. Doctors, midwives and pharmacists should inform women of childbearing age about the specific action of folic acid and advise them correspondingly. If Germany decides in favour of the mandatory fortification of certain staple foods (for instance flour) with folic acid in order to achieve an even supply of the population, the fortification of other foods should be restricted to maximum 100 microgram per portion in order to avoid the risks related to excessive folic acid intake by the population. Soft drinks should not be fortified at all.The goal of mandatory fortification of staple foods with folic acid is to improve the folic acid supply of the entire population. The folic acid intake which is recommended to prevent neural tube defects cannot be achieved through this however. What would still be needed is the targeted uptake of folic acid from folic acid supplements." (http://www.bfr.bund.de/cd/9289 )
Industry Concern on Supplement Levels
Following the response of the Food Safety Authority of Ireland (FSAI) to the European Commission discussion paper on the setting of maximum levels for vitamins and minerals, the Irish Health Trade Association (IHTA) is engaging in a series of top-level meetings with the Authority.
To the considerable concern and surprise of the Irish food supplements industry, the FSAI response proposes a level of 1 x RDA. However, following a meeting between the FSAI, IHTA members and EHPM Scientific Adviser Dr Derek Shrimpton, the Authority has agreed to re-visit the issue, saying that it 'will be guided by science'.
IHTA has now been asked to provide further scientific data which, it is hoped, could lead FSAI to amend its position. It is also understood that the Irish Association of Health Stores is to mount a campaign aimed at protecting the rights of Irish consumers to buy high strength food supplements.
Noni Juice: Simplified Novel Food Application?
A company has applied to the UK Food Standards Agency (FSA) to sell its noni juice under the simplified procedure for approving novel foods. The applicant considers this to be appropriate because it buys its juice from a company which buys its supplies from a company which has already had its noni juice product approved.
Under the European Novel Foods Regulation, a novel food is defined as a food that does not have a significant history of consumption within the European Union before May 1997, and such foods must be subject to a full safety assessment before they can be market.
A further Regulation makes provision for novel foods or ingredients that are substantially equivalent to an existing product to be placed on the market once the applicant has informed the European Commission. However, in all such cases to date, the Commission has required the applicants to obtain an opinion on equivalence from a Member State: in this instance, the UK.