How to Register New Varieties of Food Contact Materials in China: Requirements and Step-by-Step Process

Introduction

With the rise of new technologies and shifting consumer demands, the food contact material (FCM) industry is evolving rapidly. Innovative materials and processes are continually being introduced to better meet the needs of modern food production. However, such innovations may pose potential risks to food safety in the absence of regulatory measures.

In China’s regulatory system, new varieties of food contact materials—those not yet approved by national standards or official announcements—must undergo a safety assessment and receive official approval before entering the market.

This article outlines how to register new FCM varieties in China, what documentation is needed, and what the process involves.

What Are Considered "New Varieties"of Food Contact Materials?

In China, the following materials must undergo new variety registration before they can be used:

• Food packaging materials, containers, and additives that are not yet included in Chinese national standards or officially permitted by the National Health Commission (NHC).

• Materials or additives whose intended use or usage level is expanded beyond existing approvals.

• New materials or additives used in food production tools or equipment that come into direct contact with food.

Legal Basis for FCM New Variety Registration

According to Article 37 of China’s Food Safety Law, for manufacturing foodstuffs using new food ingredients, or producing new varieties of food additives or new varieties of food-related products, safety assessment dossiers for the relevant products shall be submitted to the health administrative department under the State Council (currently the NHC). These products can only be produced or sold after receiving regulatory approval.

What Are "Food-Related Products"?

The Food Safety Law clearly defines the scope of food-related products as including:

• Food packaging materials and containers

• Tools and equipment used in food production or operation

• Detergents and disinfectants

Food contact materials and articles, as a subset of food-related products, refer to materials that are either intended to contact food or may transfer their components into food. Public water delivery facilities, detergents and disinfectantsare not encompassed within this definition.

Regulatory References

Companies applying for approval of a new FCM variety should refer to the following official documents:

• Provisions on Application and Acceptance of New Varieties of Food-related Products

• Provisions on Administration of Administrative Licensing for New Varieties of Food-related Products

These regulations detail the scope, required documents, and application procedures for new varieties.

What Documents Are Required for a New Variety Application?

The application type generally falls into two categories:

1. Completely new materials or additives not yet listed in the national standard or NHC bulletins.

2. Applications to extend the use scope or usage amount of approved materials or additives.

Basic documents required include:

For foreign companies applying for the approval of an imported new variety for the first time, additional documents are required:

• A certificate from the competent authority in the exporting country stating the product is allowed for production or sale domestically.

• A certification or inspection report issued by a governmental agency in the country of manufacture.

Step-by-Step New Variety Application Process

Conclusion: Stay Ahead of Regulatory Compliance

If you're unsure about whether your material qualifies as a “new variety,” or need assistance with safety data compilation and submission, REACH24H offers full-service regulatory support.

From technical documentation to communication with authorities, we help you streamline your FCM approval process in China—efficiently and compliantly.