Addressing Regulations in Global Markets: Acquiring FCC & FOSHU Approval in Japan

Food with Functions Claim (FFC)

Regulations in Global Markets: Acquiring FFC Approval in Japan’s Market 

Challenge

An American international beverage company needed to introduce five products featuring specific health claims into Japan’s market. The client was unsure about the product classification and path to market.

Challenge

An American international beverage company needed to introduce five products featuring specific health claims into Japan’s market. The client was unsure about the product classification and path to market.

Approach

These products were classified by the Japanese regulation under Food with Function Claim (FFC), which can be a complicated procedure without the right expertise.
The Client leveraged RegASK expertise to assist with the process through our RegAsk capabilities. To obtain FFC approval for the products, RegASK worked on the following:

  • Conducting a Systematic Review to ensure accuracy of stated health claims and functionalities.
  • Submitting a Consumer Affairs Agency application which confirms the basic functions, claims, safety, and labelling of the products.
Approach

These products were classified by the Japanese regulation under Food with Function Claim (FFC), which can be a complicated procedure without the right expertise.
The Client leveraged RegASK expertise to assist with the process through our RegAsk capabilities. To obtain FFC approval for the products, RegASK worked on the following:

  • Conducting a Systematic Review to ensure accuracy of stated health claims and functionalities.
  • Submitting a Consumer Affairs Agency application which confirms the basic functions, claims, safety, and labelling of the products.
Outcome

The success of both tasks requires extensive knowledge and experience in the food and health claims sector. With RegASK expertise, not only did the products receive FFC approval, but all five are now successfully in the market.

Outcome

The success of both tasks requires extensive knowledge and experience in the food and health claims sector. With RegASK expertise, not only did the products receive FFC approval, but all five are now successfully in the market.

Food For Specified Health Uses (FOSHU)

Regulations in Global Markets: RegASK helps Acquire FOSHU Approval

Challenge

A global confectionary company needed to obtain a Food for Specified Health Uses (FOSHU) approval for a product they were planning to launch in Japan. Receiving this certification is difficult, as it requires the company and product to abide to all FOSHU regulations.

Challenge

A global confectionary company needed to obtain a Food for Specified Health Uses (FOSHU) approval for a product they were planning to launch in Japan. Receiving this certification is difficult, as it requires the company and product to abide to all FOSHU regulations.

Approach

Since comprehensive FOSHU regulation knowledge is needed for this product to successfully launch in the market, the Client contacted RegASK for guidance. From ingredient and flavor analysis to package formulation review, our team provided product regulation assessments and dossier preparation up to a successful application and submission process.

Approach

Since comprehensive FOSHU regulation knowledge is needed for this product to successfully launch in the market, the Client contacted RegASK for guidance. From ingredient and flavor analysis to package formulation review, our team provided product regulation assessments and dossier preparation up to a successful application and submission process.

Outcome

Not only did RegASK help the product receive FOSHU approval, the company is now successfully in the market. Given this established relationship with our Client, the RegASK team can offer the company continuing support when seeking future FOSHU approvals.ket.

Outcome

Not only did RegASK help the product receive FOSHU approval, the company is now successfully in the market. Given this established relationship with our Client, the RegASK team can offer the company continuing support when seeking future FOSHU approvals.

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RegASK is a regtech solution to the increasing complexity of regulatory compliance. RegASK serves clients in the food & beverage, personal care, cosmetic, and medical device industries.

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