User:Phuong Do Thi/sandbox/Food Contact Material FCM - National provisions

Food Contact Material FCM - National provisions
The information below shows the differences and similarities of Food Contact Material or any other the same authority legislative frameworks across nations.
China
FCM in China are regulated under the Chinese food safety law (2009) that states that it is not allowed to sell food products (including FCM) that do not comply with one of the Chinese standards They are defined as any material in contact with food, including containers, packaging and any other manufacturing or transporting or sales material that come into contact with foods. There are more than 100 standards, among which GB 9685 Standard (version 2008) contained a positive list for 958 substances used in paper, bamboo, wood, metal, enamelware, ceramics, plastics, rubber, natural fibers, synthetic fibers, glass, compound packaging materials, and coatings in contact food, including machinery, pipes, conveyor belts, containers, tools, utensils, etc., used in the production and distribution of food. In addition, there have been standards for resins, plastic articles, metal articles, coatings, paper (GB 11680), ceramic containers (GB 13121), rubber articles (GB 4806.1), composite laminated food packaging bag (GB 9683). To cover also the substances already on the market that were not included in any standard, the Ministry of Health authorised a petition process, under which three more lists (for 107 resins in 2011, for 301 additives in 2012 and for other Thai Laws additives in 2013) were authorised.
New standards have been in development and it was expected that existing standards will be converted to Food Safety National Standards (end 2015-early 2016). A standard on migration testing (based on Regulation (EU) 10/2011) was in preparation. In January 2015, a revised draft of GB9685, under the terms "National Food Safety Standard for Uses of Additives in Food Contact Materials and their Products” was released by the National Health and Family Planning Commission (NHFPC). The Standard defines “food contact materials and articles” to include various materials and articles, including food packaging materials, containers, utensils, coatings that may directly or indirectly contact with food, and coating layers, ink, adhesives, etc., as well as machines, pipes, conveyer belts, containers, utensils, tableware, etc., but does not include detergents, disinfectants or public water facilities. The term “Additives” includes monomers or other starting materials of polymerisation for certain base polymers used during the manufacture of FCMs. The draft contains 1316 FCMs additives permitted to be used in China (vs. 958 in the 2008 version). Significant amendments were made regarding the maximum content, SML, names of substances. The standard includes tables of additives permitted in FC plastics, coatings, rubber, inks, adhesive paper and silicone rubber and other FCMs and their products. It includes appendices for SML(T) and special restriction provisions for metallic element. Further explanations are available online.
The Ministry of Health issued the Management Rules for the Administrative Approval of New Varieties of Food Related Products (new food packaging materials, expanded use of approved additives and packaging materials, food use disinfectants, detergents, food contact tools and equipment) in 2011. To petition for a new material, information such as the physicochemical properties, the technical necessity, use, and conditions of use, the manufacturing process, the quality specifications, the test method, and test report, the toxicological assessment, the migration values, the estimated dietary exposure and the method of determination, the approvals in other countries and relevant documentation must be submitted and the petition will be reviewed by an experts panel (government officials from various disciplines).
Japan
No specific law on FCM exists in Japan. The Food Sanitation Law (1947) forbids the sale of food packaging that can be harmful for human health The Ministry of Health, Labour, and Welfare (MHLW) issued specifications (e.g.: end tests, heavy metals limits, extraction limits, etc., but not positive lists) for 12 plastic materials, for synthetic resins, metal cans, glass, ceramic, enamel, and rubbers. Specific restrictions exist on packaging of milk and milk products, on colorants and on DEHP plasticised PVC. So far, MHLW has only set specifications on finished food utensils, containers and packaging materials The Japan Hygienic Olefin and Styrene Plastic Association (JHOSPA) prepared in 1973 a standard containing a positive list of raw materials to be used for food packaging and utensils and the Standard Methods of Analysis with specifications for each resin. Positive lists were also prepared for PVC, polyvinylidene chloride (PVdC), waxes and rubbers. Negative lists were issued for printing inks and adhesives. The application of such standards though is on voluntary basis (but broadly accepted and followed) and the Ministry is evaluating the possibility of implementing the lists, complementing them to regulate more materials.
Gulf states (Saudi Arabia, Kuwait, Qatar, United Arab Emirates, Oman)
In the Gulf States FCM is regulated by the framework regulation GSO 839/1997 . This standard gives the general requirements for all packages of FCMs, including metal, glass, plastic, paper, carton, multilayered textile, and wood packages, in addition to any other materials for packaging foodstuffs. This regulation defines as food grade materials all materials allowed for food contact and that do not cause any hazards or health threat. It stipulates that potential migration shall not contaminate foodstuffs. Plastics are regulated by GSO 1863/2013 - which includes a positive list of authorised monomers, starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids, with some restrictions (taken from the EU regulation). It also includes information on specific migration (QMA and SML for vinyl chloride, styrene and acrylonitrile) and overall migration (less than 10 mg/dm² or 60 mg/kg). A GSO “Food Packages – Methods of Testing of Plastic Packages” is under preparation.
Customs Union (Russia, Kazakhstan and Belarus)
The Customs Union (CU) includes Russia, Kazakhstan and Belarus: it includes provisions economic integration, remove custom barriers, assure free circulation of goods, and harmonise conformity assessment and certification systems. In this frame it issues Technical Regulations . The Technical Regulation (TR) of the Russia-Kazakhstan-Belarus Customs Union (CU) on Safety of Packaging (TR CU 005/2011) is a key CU regulation covering standards and requirements for packaging, including that of food products, produced both as a finished product and as part of the products’ manufacturing process. The TR was adopted by the CU Commission decision No. 769 of August 16, 2011, and has been in effect since July 1, 2012. It is applicable to all packaging materials, utensils and food production equipment. It introduces the concepts of PQM (Permissible Quantities of the Migration, in mg/L) and MPCw (Maximum Permissible Concentrations of chemicals in potable Water, in mg/L). For foods that have less than 15% content of water the daily average MPC (Maximum Permissible average daily Concentrations of pollutants in ambient air of populated areas, in mg/m3) is calculated. It does not contain a positive list, but it fixes limits for PQM, MPCw, and/or MPC for some substances. The main principles are compliance with rules (technical regulations or Standards), safety (migration should not endanger human health and should not exceed migration limits and the materials should not contain any carcinogenic or mutagenic substance) and hygiene requirements. It also stipulates labelling of FCM, state registration of new materials, and declaration of Conformity.
Thailand
In Thailand FCM are regulated by the Food Act B.E. 2522 (1979)258, issued and enforced by the Ministry of Public Health. It is the major law aimed at protecting and preventing consumers from health hazards occurring from food consumption. According to the Food Act, the Ministry of Public Health is designated to be in charge of the execution of this act. The controls are under the responsibility of the FDA of the Ministry of Public Health that among other tasks sets up food standard, specification and hygienic and labelling requirements, sets and executes controls, approves FCM, and issues GMP certification. Note N°92/2528 of 1985 on Prescription of quality of standards for food containers sets restrictions for plastics, lead and cadmium from ceramics and enameled metals. Notification No. 117/2532 of 1989 regulates baby bottles (regarding BPA, the types of plastics used and specifications and restrictions for natural rubbers and synthetic rubbers), but it is under revision at the moment. Notification No. 295/2548 of 2005 regards the Qualities or standard for a container made from plastic and sets restrictions for migration of lead and cadmium for foods and as well as specific SMLs for milk and milk products. The Thai Industrial Standards Institute (TISI) of the Ministry of Industry issues standards for FCM for which compliance is mandatory, such as the TIS 1136-2535 (1993) on Cling Film (that bans DEHP) and the TIS 2440-2552 (2009) Stainless steel: Seamed Stockpots (that regulates the specific release of lead, Sn, Cr, Zn, cadmium), and voluntary standards (on plastics, resins, metals, ceramics, glass, rubber). Since 2011 the Department of Science Service (DSS) issues Certificates of analysis of FCM for Thai exporters of the ministry of commerce.
India
It the past decade India has developed a framework for FCMs - regulated under the Food Safety and Standards Act (FSSA). In 2006 it repealed and replaced all the former legislation on food and established the Food Safety and Standards Authority of India (FSSAI). The Food Safety and Standards (Packaging and Labelling) Regulation of 2011 provides measures and restriction on FCMs and sets general requirements for utensils and containers used in the "preparation, packaging and storing" of food. The requirements are broad but the underlying principle is that FCMs should not endanger foods. The Bureau of Standards is the official body that issues standards and methods for the evaluation of food and FCMs as well as guidelines for the accreditation and certification of testing laboratories. At present standards exist for glass, metals, paper/board and plastics (10 standards). Given the recent publication of the legislation, implementation and enforcement of specific provisions are not completely developed yet.
For other nations on the list such as Mercosur nations, Mexico, Australia and New Zealand, check the link below.
For other nations on the list such as EEA countries, Norway, Iceland, Liechtenstein, Non-EU countries, USA and Canada check the link below.

External links

Phuong Do Thi, Watroba T. "FCM - National provisions in relevant non-EU countries Part 2". Polyfil - Polymer Filling as the executive solution.

Phuong Do Thi, Watroba T. "FCM - National provisions in relevant non-EU countries Part 1". Polyfil - Polymer Filling as the executive solution.