China’s draft amendments require human studies to substantiate claims

China’s draft amendments require human studies to substantiate claims

China’s draft amendments to its health food regulations published this month will mean more stringent claims substantiation requirements, international food policy consultancy EAS has said.

 

China’s draft amendments to its health food regulations published this month will mean more stringent claims substantiation requirements, international food policy consultancy EAS has said.

Commenting on the Chinese State Food and Drug Administration’s (SFDA) consultation on the draft launched this month; EAS Regional Regulatory Affairs Manager Wai Mun Poon said that with the proposal requiring human data for claims substantiations companies should expect to have to invest more resources to get claims approved for market use.

The proposal states that human data should be used for substantiation unless these are not possible due to limitations of the test methods.

“Since the implementation of the Food Safety Law in February 2009, the SFDA has been intensively reviewing the country’s health food regulations,” said Ms Poon. “The substantiation criteria change means that claims such as ‘improves sleep’ and ‘relieves fatigue’, which currently only require substantiation from animal studies, will require human studies. However, animal studies would still be allowed for certain other claims substantiations where relevant test methods using human models are not yet available.”

The draft also reduces the number of permitted health food claims from 27 to 18, based on safety concerns and insufficient scientific evidence or evaluation methods and has grouped similar claims into one.

“Claims relating to eradicating acne and freckles, for example, are replaced in the draft by the single claim ‘promoting facial skin health’,” said Ms Poon.

The SFDA’s draft amendment is open for public consultation until 31 August 2011.

EAS provides strategic consulting advice on international regulation on food and nutritional products. It provides companies with regulatory and strategic advice for the marketing and approval of their products in Europe, Asia and Latin America.

EAS also advises governments, trade associations and companies on the impact of global policy. EAS has offices in Argentina, Belgium, Italy and Singapore. For more information on EAS Europe, visit www.eas.eu.

For information on EAS Asia, visit www.eas.asia.

For more information on EAS Latin America, visit www.eas-americalatina.com

 

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