More opportunities: China proposes to add six raw materials including DHA for 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.
Once approved, the six raw materials will be added into the Health Food Raw Materials Directory of Nutrition Supplement (2022 version).
The SAMR said that it aimed to promote the health foods filing process – which is a less time consuming and cheaper process as compared to the registration process. Health foods containing raw materials not listed in the Health Food Raw Materials Directory will need to undergo the registration track.
The last time the SAMR officially expanded the Directory was in March 2021, when coenzyme Q10, fish oil, melatonin, spirulina, and Ganoderma lucidum were added.
Protein for immunity
The SAMR proposed that isolated soy protein, whey protein would be able to make immune health claims.
“Based on the list of approved products, the health functions of both products containing these two raw materials are basically about strengthening the immune system.
“According to our evidence studies on the functions of protein based on medical principles, in individuals with a weaken immune system due to the lack of protein, the supplementation of protein could increase their immunity, and we rated the [credibility of] evidence with a B grade,” the SAMR said.
A ‘B’ grade means that the evidence is credible in most circumstances.
The permitted daily intake of these products is six to 25 grams, but adolescents, children, pregnant and lactating women are not recommended to take such products for their safety.
DHA for supplementing of n-3PUFA
As for DHA, the SAMR has proposed that its functional health claim would be “supplementing n-3 polyunsaturated fatty acids (PUFA)”.
It explained that while DHA was an important element of the brain membrane, it also plays important roles in regulating blood lipids levels, blood pressure, and other areas.
As such, it is more appropriate to say that it could supplement n-3 PUFA levels, instead of only focusing on its benefits for the brain.
The proposed recommended daily intake is 200 to 1,000mg, with the product suitable for adults but not for individuals below 17, pregnant and lactating women.
In addition, it proposed that products containing only DHA can undergo filing and the name for all such products should be DHA.
Opportunities for imports
Of the six raw materials, a regulatory consultancy believes that imported DHA products will be eligible for the filing track, but not for the others such as isolated soy protein and whey protein.
“As the function of DHA is to supplement n3-PUFA, this falls under the nutrient supplementation aspect, and so, we believe that companies importing DHA products can go for the filing track.
“[As for isolated soy protein and whey protein], we believe that similar to co-enzyme Q10 and the other raw materials [approved in March 2020], it is likely that only locally manufactured products containing these two functional ingredients would be allowed for filing. Imported products will still need to undergo the registration track,” Hangzhou-based regulatory consultancy CIRS said.
In February last year, we reported that overseas products containing raw materials newly approved for the filing track had to undergo registration, and only local products could undergo the filing track.
