On 18 November 2016, the National Health and Family Commission (NHFPC) announced the implementation of 53 food-related standards1, including the long awaited Standard on General Safety Requirements for Food-contact Materials and Articles (GB 4805.1-2016), the Standard on the Use of Additives in Food-contact Materials and Articles (GP9685-2016), in addition to material and testing standards for a broad spectrum of materials and substances.
Under these standards, “food-contact materials and articles” are defined as materials or articles which have been, or are expected to be in contact with food or food additives (collectively “food”), or whose constituents may migrate onto or into the food-product. These include packaging material, containers, tools or equipment used during the production, processing, packaging, transport, storage and sales of food, as well as ink, adhesives and lubricants that may come in to direct or indirect contact with food. Food-contact materials and articles do not include cleansing agents, sterilisation agents and public transfer facilities for water.
Standards on General Safety Requirements (the “Safety Standards”) (Effective from 19 October 2017)
The Safety Standards apply to all food packaging materials and articles to ensure their safety and suitability for their intended use, and set out requirements for basic standards, limitation requirements, principles of compliance, examination methods, traceability as well as product information. For non-intentionally added substances (NIAS), the Safety Standard requires that the producer introduces suitable controls so as to ensure human safety and food quality in the event that such substances migrate onto the food. The Safety Standards set a limit on the amount of material that may be permitted to migrate from the packaging to the food: for packaging that consists of one or multiple layers of material that limit is 0.01mg/kg. Compliance with the Safety Standards is also required for an NIAS.
Standards on Use of Additives (the “Use Standards”) (Effective from 19 October 2017)
The Use Standards specify the principles to be applied regarding the use of additives in food packaging materials and containers, in addition to specifying the types of additives permitted, the scope of application, maximum permitted quantity, the specific migration limit (SML) and total specific migration limit, maximum residue and other restrictive limitations. The term “additives in food-contact materials and articles” is defined in the Use Standards as including: (a) substances added during the manufacturing process of food-contact materials and articles, which are intended to improve the quality and properties of the food-contact materials; and (b) substances added during the same manufacturing process to facilitate production (rather than enhancing the quality and properties of the final products themselves).
The Use Standards contain 5 appendices, which include: a list of 1294 types of additives categorised into 7 tables (Appendix A); total specific migration limits (Appendix B); specific migration limits for metal elements (Appendix C); a list of abbreviation for resins (Appendix D); and a list of all permitted additives sorted by CAS number (Appendix E).
Material Standards and Testing Standards
In addition to the Safety Standards and Use Standards, the NHFPC announcement also included specific standards applicable to a wide range of food packaging materials, including plastic resins, paints, coatings, and further plastic, paper, rubber and metal materials, and articles.
Finally, the NHFPC announcement included various Testing Standards relevant to specific substances found in food packaging materials and articles, in particular with regards to substance determination and measurements, migration testing, and determination of residues and impurities.
The announcement of these Standards will facilitate the standardisation of production in China, and will ensure safety and compliance by the industry players.
Apart from the Safety Standards and the Use Standards, all other Standards listed in the NHFPC announcement will take effect from 19 April 2017. Food packaging companies operating in China should consider carefully these new Standards in order to ensure that their operations are in line with the new requirements.
This article is part of the International Life Sciences and Healthcare update for January 2017