13 Sep 2016

Looking to Future Changes in the Industry

Access to the food market in China provides a tremendous opportunity for food ingredient, additive, and supplement manufacturers based on the sheer size of the market in comparison to other countries. However, to date, obtaining approvals for these ingredients in China has been fraught with complex and in-depth approval requirements, changing regulatory frameworks, and lengthy review times.

Even now, we are tracking several changes that are making their way through the Chinese government. Companies considering seeking approval for their food-related ingredients/products will want to be aware of the following key changes in the regulatory frameworks in China:

    1. Novel food ingredients, food additives, and food contact materials are undergoing a change in the review processes/procedures (e.g., the food additive approval process may shift from panel evaluation to a national standard-setting model). The ultimate impact to industry is not clear during this initial transition period as the NHPFC/China Food and Drug Administration has not yet finalized its decision on the various changes;
    2. Following enactment of the Food Safety Law in 2015, the CFDA has published new regulations for:
      1. health foods (supplements) called "Administrative Measures for Registration and Filing of Health Foods" and
      2. Foods for Special Medical Purposes (FSMP) called "Administrative Measures for Registration of Foods for Special Medical Purposes"

These came into effect on July 1st, 2016. We are waiting for the publication of the technical guidance documents for health foods to review the specific details of how the changes will affect applications in practice.

The FSMP regulation creates a new pre-market approval process that manufacturers will need to comply with prior to marketing their FSMP.

  1. Infant Formula and Follow-up formula or (Food for infant and young children): based on the Food Safety Law, the CFDA will require manufacturers to submit product registrations prior to marketing, even though they comply with existing standards. Technical guidance documents are pending and will hopefully provide clarity for the industry that is reeling from this new requirement.

We will be closely monitoring these regulations and the forthcoming publication of the technical guidance documents so as to provide our clients with the most up-to-date and product-specific guidance on these changes. Stay tuned for further updates on these and other regulatory topics. If you have any questions about these regulations please contact us directly food.sci-reg@intertek.com

Need to know more about regulations in China?

For those traveling to Supply Side West Expo in Las Vegas, Nevada (October 6th to 7th), Intertek will be hosting a wine and cheese networking reception with Ms. Sandy Lin on Thursday, October 6th at booth PP170, from 3:30-4:30 pm to provide attendees the opportunity to discuss their business goals in this challenging jurisdiction.

To learn more about our scientific and regulatory service offerings visit: https://www.intertek.com/food/consulting/.


Sandy Lin,
Director, China Office, Intertek Scientific & Regulatory Consultancy