Regulatory round up: Cranberry extract, bovine protein & shrimp peptide make cut

Detailing the decision-making process in its official journal, the EC responded to Ocean Spray Cranberries’ application to place cranberry extract powder on the Union market as a novel food.

The application​​ requested for cranberry extract powder to be used in fruit-flavoured beverages, isotonic beverages, tea beverages, vitamin enhanced waters, yogurts and yogurt drinks.

“Authorised on 20 November 2018, this inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283,” ​the document states.

“During the period of data protection the novel food, cranberry extract powder, is authorised for placing on the market within the Union only by Ocean Spray Cranberries Inc.” ​

Citing an end date to this authorisation as the 20 November 2023, the US-based agricultural cooperative must observe a maximum extract intake level of 350 milligrams (mg) per day.

In addition, the designation of the novel food on the labelling of the foodstuffs will be ‘cranberry extract powder.’

Refined shrimp peptide concentrate​

The EC also laid down the law with its decision​​ to place refined shrimp peptide concentrate (RSPC) on the market as a novel food awarding Norwegian-based marine biotechnology company Marealis AS its approval for use in the general adult population.

“As the source of the novel food comes from crustaceans, and may contain traces of fish, of other crustaceans, and of molluscs, which are listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council as substances or products which cause allergies or intolerances,”​ the EC highlighted.

“Food supplements containing refined shrimp peptide concentrate should be appropriately labelled following the requirements of Article 21 of that Regulation.”​

Also citing an end date of data protection as 20 November 2023, authorisation was given for a maximum intake level of 1200 mg/day.

Marealis’ RSPC is already approved by the FDA and Health Canada for use as active ingredient in health products and supplements sold and distributed in USA and Canada.

Having now received approval for the European market, Marealis can now link health claims related to the RSPC’s benefits to blood pressure and general cardiovascular health.

Representing Marealis’ first commercial product the RSPC’s brand name PreCardix exhibits a very potent angiotensin converting-enzyme (ACE) inhibiting effect and comes available in tablet form.

Bovine milk basic whey protein isolate​

Finally, French-based Armor Protéines were successful in its application​​ to place bovine milk basic whey protein isolate obtained from skimmed bovine milk on the Union market as a novel food ingredient.

The application was not without a few setbacks with objections raised by the other Member States, regarding the safety of bovine milk basic whey protein isolate for infants.

The EC consulted the European Food Safety Authority (EFSA) on 11 December 2017, asking it to carry out an additional assessment for bovine milk basic whey protein isolate as a novel food ingredient.

“The opinion gives sufficient grounds to establish that bovine milk basic whey protein isolate, in the proposed uses and use levels when used as an ingredient in infant and follow-on formulae, in total diet replacement foods for weight control, in foods for special medical purposes, and in food supplements,” ​the EC said.

In its opinion on bovine milk basic whey protein isolate, the Authority considered that the data from the 90-day oral toxicity study in rats served as a basis to establish a reference point.

EFSA also deemed the study appropriate to assess whether the margin of exposure in relation to the proposed maximum intake of the novel food by humans was sufficient.

Armor Protéines are permitted to use bovine milk basic whey protein isolate in infant formulae at a maximum level of 30 mg/100 g (powder) and 3.9 mg/100 mL (reconstituted), follow-on formulae (30 mg/100 g (powder)/4.2 mg/100 mL (reconstituted) and total diet replacement foods for weight control (300 mg/day).

Additionally, foods for special medical purposes could use the isolate at a maximum level of 58 mg/day for young children, 380 mg/day for children and adolescents from three to 18 years of age and 610 mg/day for adults.

For food supplements the levels were defined as 58 mg/day for young children, 250 mg/day for children and adolescents from 3 to 18 years of age and 610 mg/day for adults.