Regulation Update August

Regulation Update August

The monthly regulation update for the global nutraceutical and functional food industry.

Europe

The European Court of Justice has redefined ‘milk’. Plant-based milk can no longer be called ‘milk’—if it’s not from an animal, it’s not milk, and that goes for yoghurt, cheese, and all other dairy-derived products. In other milk news, FDA is considering whether plant-based milk should be deemed an ‘imitation’ product. This could have profound effects on the Free From industry as similar rulings could follow for meat imitation products.  

Italy has notified the EC of its intention to bring the BELFRIT list, consolidated with Italy’s own list of botanical legislation, into European law. Following the freeze on health claim authorisations by the European Food Safety Authority (EFSA), Belgium, France and Italy combined forces to harmonise the legislation on botanicals in food supplements and produced the BELFRIT list. Belgium published its decree in February 2017. The Italian consolidated list contains some differences from the BELFRIT list and has not included upper limits for active ingredients, unlike the Belgian list. Some compositional requirements differ from in France and Belgium and manufacturers should still consult each list individually to ensure compliance.

Manufacturers need also be aware EFSA has set a safe level for glutamate food additives and is urging the EC to revise the maximum levels for six food additives—glutamic acid (E 620), sodium glutamate (E 621), potassium glutamate (E 625), calcium glutamate (E 623), ammonium glutamate (E 624) and magnesium glutamate (E 625). The safe level of 30 mg per kilo of body weight is based on the highest dose at which no adverse effect on test animals was observed.

The European Commission has issued a draft recommendation to police website offering novel foods or supplements online. There’s been a fair amount of hoo-hah about the fact physical retailers and manufacturers have so much legislation governing what they do and internet sellers benefit from a lack of enforcement. At the moment, Member State participation is voluntary but compliance is probably likely. It’s interesting because Amazon recently ventured into selling supplements and there are other big names involved here. For the time being, if you buy supplements online, just be super careful and avoid these: agmatine (4-aminobutyl) guanidine sulfate, Acacia rigidula, Epimedium grandiflorum and Hoodie gordonii – they’re unauthorised novel foods and have established health concerns.

The European Commission has threatened to take Spain to the European Court of Justice to ensure free movement of food supplements. Spain has been accused of discriminatory practices that affect their marketing: a company based in Spain must notify local authorities when it places a food supplement on the market, while companies from other EU countries must apply to the Spanish Agency for Food Safety and Nutrition (AECOSAN), which is much more expensive. The EC has given Spain two months to remedy the situation before it decides to refer the case to the European CoJ.

EFSA has delivered two new scientific opinions, concluding dossiers relating to Vibigaba (germinated brown rice) and sugar-free hard confectionary with at least 90 percent erythritol do not provide satisfactory evidence for an authorised claim for ‘contribution to the maintenance of normal blood cholesterol concentration’ and ‘reduction of dental plaque’ respectively. EFSA noted Cargill’s Article 14 claim application for sugar-free hard confectionary and dental caries does not establish a cause-and-effect relationship, while Loc Troi group’s Article 13.5 application for Vibigaba only used one human trial, with EFSA citing ‘important methodological limitations’ for its refusal.

Asia

United Arab Emirates officials have moved to ban 11 ‘dangerous’ supplements, which contain undeclared ingredients and therefore pose a serious health risk to the public. The Ministry of Health and Prevention (MOHAP) says the products claim to be herbal products to improve male sexual performance and contain undeclared quantities of sildenafil, tadalafil (both of which can cause a dramatic decrease in blood pressure) and dapoxetine which is usually only available on prescription. MOHAP says authorities will take measures to withdraw the products from the market and prevent them from entering the UAE.

Omega-3 supplement restrictions in Indonesia have been reversed following pressure from the Global Organization for EPA and DHA Omega-3s (GOED) and the local trade body, Asosiasi Pengusaha Suplemen Keshatan Indonesia (APSKI). The original restrictions from Badan Pom, the National Agency of Drug and Food Control in Indonesia, required supplements with more than 300mg of EPA/DHA to have a health claim and to include warnings for consumers. BPOM has since revised its restrictions, however health supplements containing more EPA than DHA must still carry a warning about consuming anti-coagulants alongside products high in EPA.

The Food Safety and Standards Authority of India (FSSAI) has released standards for functional foods and supplements, and has assured industry any concerns will be addressed. The standards relate primarily to regulations regarding labelling, claims and affordability. General requirements include the quantity of nutrients added to not exceed the recommended daily allowance set by the Indian Council of Medical Research, and all labels must specify the purpose, target consumer, duration of use and detailed instructions and precautions.

Brunei issued new halal laws for manufacturers and retailers, requiring businesses involved in the retail of products for consumption, including pharmaceuticals, health supplements and traditional medicines, to apply for a halal permit for each product. Each business must also employ two Muslim supervisors and at least one must be present on the premises at all times to oversee product handling ethics.

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