The application refers to a request by the multinational to delete the term ‘synthetic’ from the designation of the novel food as listed in the Union list and from the labelling of foodstuffs.
Details contained in the application revealed that DSM asked for the change “to alleviate any potential negative economic impact that the use of the term ‘synthetic’ may cause due to the negative connotation of the term ‘synthetic’”.
DSM added that those selling food supplements containing authorised synthetic novel foods that did not carry the term ‘synthetic’ on their labelling would “most probably not experience potential negative economic impact.”
‘Consistency with synthetic substances’
There are a number of synthetic substances currently authorised and listed in the Union list of novel foods, of which the counterparts from natural origin exist. One example is lycopene.
Both synthetic and natural forms can be used in food supplements. However, those synthetic substances are not selected as synthetic in the Union list and are not labelled as such.
“The change in the designation and labelling of synthetic zeaxanthin will ensure consistency with the designation and labelling of those synthetic substances,” the EC said in its decision.
While zeaxanthin has been renamed, no changes have been made to its proposed uses and use levels when used as an ingredient in food supplements, with a maximum level of 2mg/day permitted.
“The implementation of the new labelling requirement in accordance with this Implementing Regulation might involve changes for the business operators who currently place synthetic zeaxanthin on the market,” the EC said. “Therefore, it is appropriate to provide for a transitional period.”
Synthetic zeaxanthin has been authorised as a novel food ingredient since 2013, after DSM Nutritional Products made an application to the EC for its approval.
Hoodia parviflora decision
Meanwhile the EC has also authorised the placing on the market of dried aerial parts of Hoodia parviflora as a novel food for use as a supplemental weight loss aid.
Conditions under which the botanical plant may be used include a maximum level of 9.4 milligrams per day (mg/day) with the use of the plants’ dried aerial parts specifically stated in the food supplement’s labelling.
The applicant, Israeli-based Desert Labs had planned to use the ingredient in foods including beverages, biscuits, confectionary, savoury snacks, soups and broths, tea, coffee and water as well as food supplements.
The decision comes as ID Nutra, the commercial partner for Desert Labs in the EU, received a novel food application for the ingredient’s role in weight loss and metabolism management by the European Food Safety Authority (EFSA) in September 2017.
In that opinion, EFSA did not establish the safety of dried aerial parts of Hoodia parviflora in foods at the uses and use levels proposed by ID Nutra because the intake would’ve exceed the level which is considered as safe (0,134 mg/kg bw).
Food supplement use only
However, EFSA concluded that dried aerial parts of Hoodia parviflora were safe for adults when added to food supplements at a maximum daily dose of 9.4 mg, which corresponds to the safe level of intake for an adult with a default body weight of 70 kg.
This opinion gives sufficient grounds to establish that dried aerial parts of Hoodia parviflora in the proposed uses and use levels when used as an ingredient in food supplements, comply with Article 12(1) of Regulation (EU) 2015/2283.
Desert Labs now become the only firm authorised for placing the ingredient on the market within the Union until 3 September 2023.