Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
|
|
FSA Letter to Enforcement Authorities (PLGEN22003), 21 February 2022
The Food Standards Agency is making local authorities (LAs) aware of various food supplements containing Serratiopeptidase (Serrapeptase), an unauthorised novel food. Advice concerning the position of this unauthorised novel food is detailed below.
The Food Standards Agency (FSA) has become aware of the sale of a food supplement product containing Serratiopeptidase.
Serratiopeptidase is an unauthorised novel food. It is also sold under the name Serrapeptase and marketed as SerraEnzyme capsules.
The FSA is not aware of a significant history of consumption of Serratiopeptidase in the UK and EU prior to 15 May 1997. Unless evidence of a history of consumption can be provided, the FSA consider it to be a novel food under the Retained Regulation (EU) 2015/2283 on Novel Foods. As a novel food, it would need to undergo a mandatory premarket safety assessment and obtain authorisation under the Novel Foods Regulations before it can be legally placed on the market.
As Serratiopeptidase is considered an unauthorised novel food, the FSA advises that products containing Serratiopeptidase be withdrawn from the market. Placing an unauthorised novel food on the market is an offence under regulation 4 of the novel foods regulations for failing to comply with Article 6(2) of Retained Regulation (EU) 2015/2283.
If Serratiopeptidase is added to food for a technical purpose as a food enzyme it is permitted under Retained Regulation 1332/2008. All other uses, such as sale as a food supplement for direct consumption, fall within novel food regulations. LAs will need to consider each product on its own facts to determine whether it is a novel food or a food enzyme
We would request that LAs take appropriate action i.e. request the business to withdraw the product from the market, in line with local enforcement policies, and advise them on the novel food approval process, where implicated products are identified.
LAs will also wish to be aware that there may also be issues regarding unauthorised health claims, contrary to the Nutrition and Health Claims (England) Regulation 2007, and labelling compliance breaches under the Food supplements (England) Regulations 2003. The Department of Health and social Care (DHSC) have confirmed they have no authorised health claims for Serratiopeptidase in the Great Britain Nutrition and Health Claims Register. Any product bearing health claims attributed to the presence of Serratiopeptidae should be investigated in accordance with LA enforcement policies.
Note: The letter was published and made available to subscribers on the FSA 'Smarter Communications' site. To gain access, create an account at: https://smartercommunications.food.gov.uk/login.
