The National Health and Family Planning Commission, a new authority that established on March 2013 by the merger of the former Ministry of Health with the National Population and Family planning Commission issued the Administrative Measures for Safety Review of New Food Materials. Those Measures will enter in force from October 1st and will repeal the 2007 provisions.

The main novelty of the new legislation is with no doubt the confidentiality covenant binding the competent authority towards the applicants: all information given to the competent authority for review and approval shall not be disclosed to third parties and shall not be made public; such provision should in theory protect all applicants from having their trade secrets on food researches (that usually involve huge investments in time and funds, and that rarely results in patent application, that involve total disclosure to general public of confidential information) delivered to their competitors. In addition to the above, other provisions generally define the term “novel food”, which includes animals, plants, microorganisms and substances derived from, food elements whose structure has been modified, new developed food products which have not been used in China in the previous 30 years and that are not included in the Chinese medicinal list, and amend the procedures for approval on import, production and distribution of such “novel food”.

In short, each applicant shall submit to competent authority a report regarding the production and the safety of the novel food (for example, such food shall comply with nutrition standards, not contain toxins or cause acute, sub-acute or chronic disease, not contain hazardous substances, and shall have the attributes of normal food), the labels to be used, etc. A panel of experts shall be created for the evaluation, technical inspection on – site may be carried out, the applicant may be required to provide additional explanatory documentation and public comments shall be solicited. In case of approval of the application, a public notice will be issued: however, in case subsequent studies will reveal problems or hazards, such approval may be revoked.

Finally, in case applicants mislead the evaluation commission by providing false information or by not disclosing important information in their possession, such applicants will be banned from re-applying for the same “novel food” for one year.

Leave a reply