Regulation introduction to food contact material(FCM)


FCM - Those products made of paper, bamboo, wood, metals, porcelain, ceramics, plastics, rubber, natural fibers, synthetic fibers, glass and composite packaging materials that are used for packing and holding food; and coatings in contact with food; and the equipments, pipes, conveyor belts, containers, tools and utensils that are in contact with food during the production and sales of food.
 
In China, food contact materials (FCMs) are regulated by China Food Safety Law issued in 2009. The Article 32 & 62 of China Food Safety Law prohibits the importation, use or purchase of food-related products (e.g., food additive, food packaging materials) not complying with applicable Chinese Food Safety Standards. There are currently over 130 National Standards & 125 Industry Standards for food package materials & containers in China and they set specific safety requirements (evaporation residue, migration of hazardous) on FCMs from three levels:

1. Specific material groups(paper & paper products, metal products, ceramics,);
2. Specific products;
3. Food contact additives;

 
In 2011, the Ministry of Health (MOH) has published the Measures on Administrative Permission of New Varieties of Food Related Products and the measures have set detailed requirements regarding notification of new varieties of food related products (including new food packaging materials and new food contact additives). According to the measures, the following documents are required for food contact notifications.

1. Application form and phys-chemical properties;
2. Technical necessity, uses and conditions of use;
3. Description of manufacturing process;
4. Quality and safety control, analytical methods and test reports;
5. Toxicology safety assessment data;
6. Migration limit test, estimation and assessment of dietary exposure;
7. Whether the additive has been approved or used in other countries;
8. Other information which is helpful to review;

 
It shall be noted that the required toxicology safety assessment data depends on the overall migration (OM). If the OM is very low, lots of toxicology data can then be exempted. According to MOH's draft guidance regarding approval of new food-related species, the following toxicology studies are required for food contact notification:

1. OM<0.01mg/kg: QSAR, read-across and literature data;
2. OM<0.01~0.05mg/kg: genetic toxicity test;
3. OM<0.05~5 mg/kg: genetic toxicity test, 90d oral study;
4. OM<5~60mg/kg: acute toxicity, genotoxicity, 90d oral, teratogenicity, reproductive toxicity, chronic toxicity and carcinogenicity.

 
Since the publication of the measures in 2011, 3 new food contact additives have been approved in the MOH’s notice 2012-11 in accordance with the measures.

About Us and Contact

Initially set up by China Inspection and Quarantine(CIQ) Bureau in 2007 to provide REACH compliance services to Chinese chemical industry, CIRS has grown to be a leading provider of comprehensive chemical compliance services for companies doing businesses in/with China.
 
Our services cover new substance notification, registration of the import and export of toxic chemicals, registration of hazardous chemicals, classification and labeling in according to China GHS, Chinese SDS, risk assessment of industrial chemicals, food additives and cosmetic ingredients. We provide one-stop solutions to your regulatory issues in China.We also deliver the most up-to-date regulatory information about chemical control laws in China.

 
  • Ms. Cathy Yu, Senior Consultant, Food Safety Regulation, CIRS China
    11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
    Tel : +86 571 8720 6538 | Fax : +86 571 8720 6533
    Email: cathy.yu@cirs-group.com

     
① 凡本网注明"稿件来源:“杭州瑞旭科技集团有限公司"的所有文字、图片和音视频稿件,版权均属杭州瑞旭科技集团有限公司所有,任何媒体、网站或个人未经本网协议授权不得转载、链接、转贴或以其他方式复制发表。已经本网协议授权的媒体、网站,在下载使用时必须注明"稿件来源:杭州瑞旭科技集团有限公司",违者本网将依法追究责任。
② 本网未注明"稿件来源:杭州瑞旭科技集团有限公司 "的文/图等稿件均为转载稿,本网转载出于传递更多信息之目的,并不意味着赞同其观点或证实其内容的真实性。如其他媒体、网站或个人从本网下载使用,必须保留本网注明的"稿件来源",并自负版权等法律责任。如擅自篡改为"稿件来源:杭州瑞旭科技集团有限公司",本网将依法追究责任。如对稿件内容有疑议,请及时与我们联系。
③ 如本网转载稿涉及版权等问题,请作者在两周内速来电或来函与杭州瑞旭科技集团有限公司联系。
Regulations & Standards
Contact Us
Tel:+86 (0) 571 87206538
Email:cathy.yu@cirs-group.com
ADD: 11/F., Bldg 1, Dongguan Hi-Tech Park, 288 Qiuyi Rd Binjiang District Hangzhou, China