REACH24H Consulting Group

杭州华测瑞欧科技有限公司 www.keyllico.com Value in Compliance

FDA FCM/ FCN (Food Contact Notification)

FDA Food Contact Material Regulation

The USA FDA has regulated food contact materials since 1958 and has developed a very wide-ranging set of regulations covering most classes of food packaging materials, according to the two main regulations Federal Food, Drug and Cosmetic Act and Code of Federal Regulation(mainly in chapter 21). FCM manufactures who want to place food contact substances/materials in the USA market would be required to comply with FDA FCM regulations. According to 21CFR, for a new substance (not in positive FCM substances list), it’s necessary to summit a FCN (Food Contact Material Regulation).

FCN (Food Contact Notification)

In order to ensure the safety of food, all food additives(direct and indirect) must be approved by FDA in 1958. As for the indirect food additive(food contact substance),FDA established a FCN(food contact notification) procedure. The regulation requires enterprise must summit FCN (food contact notification) with detailed material if the food contact substance is not approved and not forbidden by FDA. The summit process is FCN(food contact notification).

Our Service Includes:

>>Compliance strategy for food contact material
>> Making compliance proposal
>> FDA FCM Compliance consulting report
>>Chemicals in FDA FCM Positive List
>> Making DOC complying with FDA FCM regulations
>> FCN (food contact notification) submission
>> Customized projects on migration test
>> Making risk assessment report

Our Strength
>>Experienced?Expert Team Support
>>Strict?Quality Control System
>>Close Collaboration with Plenty of?Certified Test Facilities
>>Good Communication with?Competent Authorities
>>Fast Response to Clients Inquiries and Controlling Cost
>>Obeying the Code of Ethics, Respecting the Confidentiality and Privacy of our Clients
>>Excellent Project Management

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