Regulatory round-up: Latest need-to-know policy developments from South Korea, China, ANZ

11-Feb-2022 - Last updated on 11-Feb-2022 at 01:41 GMT

This round-up features South Korea’s re-evaluation of co-enzyme Q10 and other ingredients use in health functional foods, China’s push for scientific reassessment of certain health foods, and Australia’s refusal to change amygdalin rules.

Co-enzyme Q10, squalene safety: South Korea to re-evaluate nine ingredients’ use in health functional foods

South Korea is re-evaluating the safety and functionality of co-enzyme Q10, squalene, and seven other ingredients’ use in health functional foods (HFFs) this year.

The other seven functional ingredients are conjugated linoleic acid, N-acetylglucosamine, oat fiber, inulin/chicory extract, chitosan/chito-oligosaccharide, xylo-oligosaccharide, and L-carnitine tartrate, the Ministry of Food and Drug Safety (MFDS) said in its announcement.

These ingredients were selected for re-evaluation because they have been approved for use in HFFs a decade ago and new information on their safety and functionality has since sprung up.

China proposes health foods for immunity, memory, fatigue to undergo scientific reassessment

Health foods that claim to strengthen the immunity, aid memory improvement, alleviate physical fatigue etc may need to undergo scientific reassessment, such as redoing animal experiments or human trials, the Chinese authorities have proposed.

The State Administration of Market Regulation (SAMR) announced that it was seeking public consultation on the types of scientific assessment required for permitted health foods claims.

This follows a revamp of the permitted health foods claims that dates back to 2019, when it removed three claims from the list of 27 permitted claims – which are “promotes lactation”, “improves growth and development”, and “improves oily skin”.

Amygdalin and hydrocyanic acid: Australian regulator rules out changes to permitted levels in supplements

Australian regulators have ruled against changing the permitted levels of amygdalin and hydrocyanic acid (HCN) that can be present in supplements and TCM products, despite contradictions with what is allowed for food items.

It comes after TCM practitioners lobbied regulators at the Therapeutic Goods Administration (TGA) to change the Poisons Standard.

Amygdalin may be present in popular TCM ingredients derived from the Prunus and Malus species, while medicinal plants used in western herbal medicine also use ingredients such as Prunus cerasus (‘sour cherry’) and Prunus serotina (‘wild cherry bark’).

For infant formula: FSANZ seeks public comment on use of 2’-FL produced via new GM strains

Regulator Food Standards Australia New Zealand is seeking public comment on the use of 2’-O-fucosyllactose (2’-FL) produced using new genetically modified (GM) strains in infant formula products.

A human milk oligosaccharide (HMO), FSANZ approved 2’-FL for voluntary use in infant formula products and formulated supplementary foods for young children in Dec 2019.

The approved 2’-FL is produced via microbial fermentation using genetically-modified Escherichia coli (E. coli) K12 production strain SCR6.

More opportunities: China proposes to add six raw materials including DHA for filing process

The Chinese authorities is proposing to add six raw materials into the list of raw materials eligible for the health food filing process.

The six raw materials are isolated soy protein, whey protein, DHA, casein phosphopeptides and calcium, tetrahydrofolic acid calcium and tetrahydrofolic acid, and lastly, glucosamine sulfate.

The State Administration of Market Regulation (SAMR) made the announcement on Dec 20 and said that public consultation on the matter would end on Jan 19.