Weekly Review of Food Standards and Regulations

Announcement of CFDAabout Giving a Certain Transitional Period for “Registration Administration of Formula Food for Special Medical Uses”

“Administrative Measures for the Registration of Formula Food for Special Medical Uses”(Decree No. 24 of CFDA) will go into effect as of 1^stJuly, 2016.To guarantee the normal supply of formula food for special medical uses in China, an announcement about giving transitional period for “registration administration of formula food for special medical uses” is hereby made as follows:

Before January 1^st, 2018, the formula food for special medical use that are approved to be manufactured in China or exported to China may be sold before expiration date.From January 1^st, 2018,the formula food for special medical use that are manufactured in China or exported to China shall according to law obtain the registration certificate of formula food for special medical use.

Announcement of CFDA about Related Matters ofImplementing “Administrative Measures forRegistration and Filing of Health Food”

After July 1^st2016, CFDA administrative accepting institution is in charge of receiving applications for registration of health food; the provincial food and drug administrative department will no longer receive applications for registration.

Any applicant who has finished the re-check test and onsite inspection to products according to the relevant provisions before July 1^st2016shall submit the test reports, onsite inspection reports and other materials for review.

Any applicant who is required to supplement the materials before July 1^st2016 according to the review opinions shall fully submit the supplementary materials in strict accordance with “Notice ofReview Opinions” and relevant provisions.

Any registrant applying for extending the registration since January1^st, 2017 shall file an application at six months before expiration of theregistered certificate according to the relevant provisions.

Announcement of National Health and Family Planning Commission about Approving New Variety of Food Additives including Calcium alginate, etc

According to the provisions of “Food Safety Law”,safety assessment materials concerning 10 new varieties of food additives including calcium alginate, etc., application scope extension or use level of 19 kinds of food additives including L (+)－tartaric acid, etc., 3 new varieties of food nutritional fortification substances including magnesium L-threonate, etc., as well as use level enlargement of food nutritional fortification substances including L-carnitine, have been reviewed and approved by experts of review institution.