China Regulatory Affairs: China Notifies WTO of Draft General Safety Standard for Food-Contact Materials

Date: Jun 24, 2015

On May 22, 2015, China notified to the World Trade Organization (WTO) Committee on Sanitary and Phytosanitary Measures its draft Standard on the General safety requirements for food contact materials and articles for public comment.  The Standard was developed by the National Health and Family Planning Commission (NHFPC), and comments on the Standard will be accepted until July 21, 2015.  We provide below an overview of the Standard and the key aspects of interest to industry.

I.              Standard Application Scope and Definitions

This General Safety Standard applies to all food contact materials and articles marketed in China and all corresponding Food Safety Standards.  It specifies the basic requirements and compliance principles for food contact materials and articles.  The General Safety Standard also includes provisions relating to testing methods, Declarations of Compliance (DoC), traceability, product labeling requirements, etc.

Section 2 of the Standard introduces new definitions for a number of terms under Chinese food packaging regulations.  For example, the Standard defines “non-intentionally added substances” (NIAS), “multi-layer material/article” as well as overall migration limit (OML), and specific migration limit (SML).  These definitions are largely consistent with the definitions contained in EU Regulation No. 10/2011, also known as the “Plastics Regulation.”  Although the Standard does not impose a requirement that food packaging materials comply with a specific OML, the presence of this definition confirms our expectations that the Chinese authorities will soon be adopting the OML concept in its packaging regulations.

II.            Functional Barrier

Section 3 of the Standard sets forth a significant change in China’s food-contact regulatory scheme.  More specifically, this provision contains language that would effectively adopt the functional barrier doctrine in China.  It states that “manufacturers of food contact materials and articles must perform safety assessments and control substances (except carcinogenic, teratogenic, mutagenic substances and nanometer substances) which are not in direct contact with food, are separated from food by an effective barrier layer, and are not contained in existing national Food Safety Standards, such that the amount migrating to food shall not be detectable (DL = 0.01 mg/kg).”  This language would effectively permit the use of uncleared substances in the manufacture of food packaging provided that the substance meets these criteria.  This is a very important and meaningful step forward for both industry and the Chinese authorities as it will permit the continued use of these safe and suitable food packaging materials without burdening the Chinese authorities with the need for premarket review and approval.

III.           Basic Requirements

Section 3 (Basic Requirements) of the Standard contains a number of requirements applicable to all food packaging materials.  Per the Standard’s title, it requires that substances in food contact materials and articles shall not migrate to food at levels that endanger human health.  Further, such food-contact substances must not result in changes to the ingredients, structure or properties of the food (e.g., color, aroma and taste).  Section 3.5 of the Standard also requires that producers of food packaging materials perform safety assessments for NIAS to ensure their safety.  Section 3.7 indicates that, in the case of multi-material materials and articles, where different migration limits exist for the same restricted item, the lowest limit should apply.

IV.           Traceability and Declaration of Compliance

Under Section 7, manufacturers of food contact materials and articles must establish product traceability systems.  In particular, the traceability system should ensure that regulatory authorities and relevant businesses are able to obtain information regarding the origin and destination of food contact materials and articles, as well as compliance information for relevant components.  To this end, Section 8.4 specifies that a DoC should include information on applicable regulations and Standards, restricted substances and their limits, risk assessments for NIAS, as well as the overall migration amount.

V.            Labeling

Section 8 of the Standard requires that products released for sale be accompanied by suitable product labeling and information so that downstream customers have sufficient information to perform safety assessments.  In addition, the Standard requires that molded packaging materials state “for food contact,” “for food packaging”, or contain the following graphic:





Senior Regulatory Counselor