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European regulation round-up: What’s new on the regulatory landscape for nutraceuticals?

Article-European regulation round-up: What’s new on the regulatory landscape for nutraceuticals?

© iStock/mediaphotos Regulatory round-up: What’s new on the regulatory landscape for nutraceuticals in Europe?
From an approved heart health claim to a biotech beauty-from-within ingredient, Vitafoods Insights gives an overview of the latest regulation news from across the continent.

Health claim referring to the reduction of heart disease risk authorised

On 20 March, the European Union authorised a health claim to be made on food products saying that a combination of certain ingredients can lower the risk of heart disease by reducing the amount of LDL-cholesterol in the blood.

The claim states that a combination is made up of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, procyanidolic oligomers from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin, and inositol hexanicotinate. High LDL-cholesterol is a risk factor in the development of coronary heart disease.

Protein requirements for infant and follow-on formula manufactured from protein hydrolysates published

On 10 January, an amendment was made to Delegated Regulation (EU) 2016/127, relating to the protein requirements for infant and follow-on formula made from protein hydrolysate.

© iStock/ljubaphoto What’s new on the regulatory landscape for nutraceuticals in Europe?

It comes after the European Commission requested a scientific opinion on the nutritional safety and suitability of this type of formula. The opinion, which was issued on 9 March 2022, concluded that the protein hydrolysate used in this formula is safe and suitable for infants, as long as the formula contains a minimum of 0.45 g of protein per 100 kJ (or 1.9 g per 100 kcal) and meets other compositional criteria and amino acid pattern specified in Delegated Regulation (EU) 2016/127.

Biotechnologically produced sodium hyaluronate is not novel in food supplements

On 24­­ February, the European Commission determined that sodium hyaluronate produced through a fermentation process is not considered a novel food in food supplements, according to a consultation request under Article 4 of Regulation (EU) 2015/2283. Sodium hyaluronate is derived from a non-GMO strain of Streptococcus equi subsp. zooepidemicus, and the bacterial cells are inactivated and removed during production, resulting in a purity of more than 90%.

The consultation confirmed that the ingredient is similar to sodium hyaluronate – the salt of hyaluronic acid, an active ingredient prized for its moisturising effect on the skin – and that the biotechnological production process does not significantly alter the composition, structure, or nutritional value of the food.

Carbomer authorised for use in food supplements

On 28 February, the EU authorised the use of the food additive carbomer in liquid and solid food supplements. Carbomer is widely used as a bulking, thickening, suspending, and/or stabilising agent in formulations by the pharmaceutical industry.

The EU approval extends the same functionalities to be used by the nutraceutical sector. The maximum amount allowed for liquid supplements is 30,000 mg/kg and for solid supplements is 200,000 mg/kg. The specifications for carbomer have also been provided and will be included in a later regulation.

Glucosylated steviol glycosides added to approved food additives list

On 1 March, the EU added the sweetener glucosylated steviol glycosides to a list of approved food additives. It can be used in the same categories of food and at the same maximum levels as steviol glycosides. The specifications for glucosylated steviol glycosides have been provided and will be included in a later regulation.

Maximum levels of arsenic in certain foods

On 3 March, an amendment was made to Regulation (EC) No 1881/2006 regarding maximum levels of arsenic in certain foods. Among the categories mentioned are baby food, follow-on and infant formula, as well as foods for special medical purposes intended for infants and young children. Fruit juices and nectars are also listed.

Foodstuffs that were lawfully placed on the market before the amendment was brought in may remain on sale until their date of minimum durability or use-by date.