China’s regulation of so-called “novel food” is changing.

On October 1, 2013 the “Administrative Measures for Safety Review of New Food Materials” (the “New Measures”) will come into force, thus repealing the former 2007 regulation.

The New Measures provide some important modifications to the regulation of this important foodcategory mainly in terms of definitions and procedures; they are also the first regulation passed by the newly-established National Health and Family Planning Commission (NHFPC), which in March 2013 has merged the former Ministry of Health and the National Population and Family Planning Commission.

Novel food – whose official definition under the new regulation becomes “new food material” – includes animals, plants, microorganisms, substances derived from those, food substances whose structure has been altered, new developed food materials which have not been traditionally consumed in China, i.e. have not been produced/sold in the last 30 years and are not included in the Chinese pharmacopeia.

Health food, GMF and food additives are not included.

The New Measures modify the procedure for the safety review of new food materials – which shall have attributes of normal food, comply with nutrition standards, be toxin-free and not cause any acute, sub-acute, chronic disease or hazard. This procedure is crucial as only approved new food materials can be imported, sold or used in food production/process.

Applicants – producers or importers – need to submit to the NHFPC a dossier including also reports on the production and safety of the products, standards, labels, scientific studies/literature as well as a sample.

The procedure now requires public comments solicitation as well as review by a panel of experts. If necessary, these experts can conduct on-site study/verification, summon the applicant for technical discussions and ask for supplementary material. To improve transparency, experts that conduct onsite verification can not vote for the final safety assessment decision.

If the final food safety evaluation is positive, the new food ingredients are approved and a public notice is issued, which basically acts as a simple standard for such new food material. The procedure can also be terminated if the new food ingredient actually is deemed as ordinary food or equivalent to already approved new food materials. Approvals can anyway be revoked in case of science/technology discoveries questioning its safety.

Very important, the New Measures now allow the applicant to request the NHFPC to keep confidentiality over the submitted documents (making their content not accessible to the public). As new food ingredients are normally the result of years of research and development, some companies choose not to apply for patent and keep them as secret know-how: this provision should reassure applicants that choose this strategy.

Applicants who conceal important information or submit false information/materials are punished with a one-year ban from re-applying for the same new food material.