The State Food and Drug Administration issued a notice requesting the ban of plasticizers in health products

The State Food and Drug Administration recently issued a notice requesting that in the formulation of health foods containing phthalate ester plasticizers, phthalate esters should be removed or used as an alternative to the relevant regulations.

The notice said that in order to further strengthen the supervision and management of health foods and ensure food safety, according to the Ministry of Health's announcement No. 16 of 2011, within three months from the date of this announcement, phthalates were included in health food formulas. In case of substances, the applicant shall apply for the use of triethyl citrate, triacetin or other substances that comply with the relevant regulations in place of the phthalates, or apply for the removal of phthalates from the formulation.

The applicant shall provide the specific ingredients of the coating formulation, the basis for the use and dosage of coating materials, the daily safe dosage, and the product production process, quality standards, research data, stability test report, three batches of pilot production verification data and product self-tests. Reports and other information. Applications for the removal of phthalates from formulas do not require a daily safe amount of coating ingredients.

The applicant should go to the local provincial food and drug supervision and management department to submit relevant information. After the provincial food and drug supervision and administration department accepts and applies for review, if the data is complete, it shall be submitted to the State Food and Drug Administration for technical review in a timely manner. After the technical review and administrative approval consider that it meets the requirements, the State Food and Drug Administration shall issue a new health food approval certificate and recover the original approval certificate. The relevant time limit requirements refer to the relevant provisions of the New Product Registration in the "Measures for the Registration of Health Food Registration (Trial)".