Hot topics in novel food news
The positive EFSA opinion (2017 ) on Ocean Spray cranberry extract had two effects on the food supplement market. On the one hand some may have had a positive reading confirming the high chances of success of a novel food application. Indeed here a perfectly characterized ingredient, with a good decrease of consumption on the source, cranberry fruit, juice as well as various types of extracts and a good exposure calculation was recognized as safe, even without any toxicity data in the animal presented. EFSA’s position was indeed based on clinical studies conducted with other cranberry extracts and three studies on the requested extract. On the other hand, this opinion has generated a great concern among those who consider that if cranberry fruit and juice is food, a cranberry extract has been recognized as novel food. Indeed it should be noted that the type of extract authorized here by the novel food route is the one widely used in food supplements for the urinary tract. The legitimate question asked at the time was that if an extract as classic as cranberry extract is considered as novel food, what about all the plant extracts used in food supplements?
The subject cranberry extract novel food must be put back in its context which was that the initial application, for use in various food matrices such as beverages, yoghurts, had been recognized as responding to novel food for the authorities. It was then during the evaluation by EFSA that the subject deviated and was reduced for safety reasons to the positive opinion that we know. Asked about this, the Commission replied that it did not consider that all cranberry extracts should be considered as novel food, but that only those corresponding to the specifications of Ocean Spray should be considered as novel food.
Turmeric has been in the news since Italy’s alert on cases of hepatotoxicity in 2019, which led France and Norway, Denmark having already done so since 2018, to set or reduce the maximum daily dose of curcumin, authorised as a dietary supplement, to 210 mg, which corresponds to the safety dose defined by EFSA at 3 mg/kg/day for the additive curcumin E100. In addition to this aspect of curcumin dose, the type of preparation of curcuma, novel food or not arises. The Belgian and British authorities have already given their opinion. For Belgians, curcumin (extract titrated at 95% curcumin) is not considered as novel food in food supplements and the intake of curcuminoids with their natural bioavailability (original, present by nature) must be limited to 500 mg of curcuminoids per day. For the British, turmeric oleoresin extract or pure curcumin powder are novel foods. If it is obvious that the very many new turmeric preparations whose aim is to improve natural properties (increased bioavailability, improved solubility, pure or synthetic curcumin, etc.) are novel foods, what about the historical extract of turmeric root with 95% curcuminoids? Asked about this subject, the Commission’s answer shows that the situation is not so clear for historical turmeric extract, as this subject does not appear in the Novel Food Catalogue because it has never been discussed by Member States. As for cranberry, if such a classic extract as turmeric as a food supplement were considered a novel food, what would happen to most other plant extracts?
bay of maqui
The bay of maqui is a good illustration of one of the first positive opinions in the consultation procedure, authorised as a food supplement only and novel food, thanks to Italy’s position alone. This berry, in powder and juice form, has also been the subject of a request for traditional novel food. EFSA raised objections and comments concerning safety of use. According to the Novel Food Catalogue berries are not novel food only in food supplements. On the other hand the extract appears as novel food.
Concerning cannabis and CBD, which represent a huge market given the pressure from many operators and trade unions for their use in food, the position of the national (Member States) and European (Commission) authorities expressed in the Novel Food Catalogue is very clear. The seed, its oil and seed meal are allowed while hemp extracts and derived products containing cannabinoids or CBD and CBD obtained by synthesis are clearly novel food. Thus the consultation procedure concluded that the CBD isolate (purity > 98%) is novel food as or in food. Similarly, trans-cannabidiol, synthetic trans-cannabidiol and chemically derived cannabidiol are the subject of ongoing novel food applications.
To keep in mind
The various examples presented here show that it is not sufficient that one plant or part of a plant is authorised for all its preparations to be authorised. The assessment must be made on a case-by-case basis, depending on the type of preparation and whether or not it is possible to defend significant food consumption in the European Union before 1997.
You may also like
- Insects as novel food: publication of a first EFSA opinion
- European case law on CBD
- EFSA positive opinion for the authorisation as a novel food of AstraGin
- Novel food success for Nutraveris with Chia seeds protein and fibers extracts
- Update on the regulatory status of CBD in food in Europe
- Cannabidiol has the potential to reduce cue-induced craving and anxiety, a treatment option for opioid use disorder
- Cannabidiol and Cannabinoids now clearly considered as Novel Food
- Safety Authority for the orthosilicic acid-vanillin complex (OSA-VC)
- Novel Food authorization for Vitamin K2 oil
- Novel Food authorization for DHA-rich oil
Our experts are at your disposal to guide you through the regulations. With more than 10 years of experience in the industry and success, we offer a complete and tailor-made service in Novel Food dossiers.