REACH24H Consulting Group

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US FDA Approved REACH24H’s new FCN Application in October Featured

REACH24H Consulting Group (hereinafter referred to as the "REACH24H") recently received the final letter from U.S. Food & Drug Administration (hereinafter referred to as the “FDA”) on October 25, 2017. According to the final letter from FDA, food contact notification (FCN 1821) will come into effect on November 21, 2017. REACH24H once again helped its client get FCN in US, it will be beneficial to the relevant manufacturers to overcome technical barriers and export their products to the US market successfully in the near future.

A senior consultant from REACH24 said that submitting food contact material is a new type of optical brightener, which is mainly used in paper and paperboard to improve the whiteness and gloss of paper products. The client of REACH24H is also the first producer who has completed the application of FCN for this new type of optical brightener in the world.

In order to ensure food safety, the U.S. government issued relevant regulations in 1958, requiring the pre-market approval on all food additives. In?the light?of the indirect food additives(also known as “food contact substances”), FDA also established a food contact notification (FCN) program, it stipulates that the new substance has not been approved by the FDA must submit detailed application materials to FDA for its intended use.

Each material passed the FCN evaluation will obtain a unique number, such as “FCN1821”, and be included in "the list of effective notifications" on FDA official website. The substance obtained from FCN is exclusive, which means that the FCN of the substance is only valid for the FCN applicant (e.g. producer) applying the substance for its intended use identified in the notification. For any other manufacturers of the same product shall submit the FCN again to the FDA for the permission to enter the U.S. market.

Obtaining the application of FCN, enterprises can not only protect their interests, but also greatly improve their market competitiveness and seize?the?opportunity?to?grab?market?share among other competitors and get more benefits as well.

As the only consulting agency in Asia who has successfully completes the entire process of the FCN application independently, REACH24H accumulates rich experience in dealing with United States food contact substances (FDA /FCN / 21 CFR) and could provide tailor-made compliance services for enterprises. If you have further questions, please contact Ms. Anthea Zhou +86 571-8700 7548 zhouzijian@reach24h.cn or cyl@reach24h.cn.

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