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China introduces new safety requirements

A National Center for Food Safety Risk Assessment policy welcomes new application rules for food ingredients from genetically modified microorganisms.

On 13 September 2024, China’s National Center for Food Safety Risk Assessment issued a notice regarding its plans to improve safety evaluation data requirements for three new foods, a move that progresses synthetic biotechnology materials.

Operating under the National Health Commission, the Center announced that these requirements would apply to new food additives, food ingredients, and food contact materials. The National Center is the main institution leading the adoption of the new approach methodologies.

Following this safety evaluation update, new food additives and new food ingredients are now two different terms in China.

In recent years, various approvals for food ingredients produced from genetically modified microorganisms (GMMs) have raised the profile of synthetic biotechnology materials in China. First, in 2017, China announced it would accept GMM’s new enzyme preparation applications. Then in 2021, the country stated it would receive GMM’s new food additive applications. Confirmation that China will accept new food ingredient applications from mid-September 2024 marks the country’s latest move to support GMM-based foods.

New safety requirements

The new policy officially allows the application of new food ingredients, new food additives, and food-related products derived from GMMs. Previously, substances derived from GMMs were not eligible for application as new food ingredients.

“Although China has opened channels for the application of new enzyme preparations and new food additives derived from GMM, the specific requirements for application documents were not clearly defined,” Chris Wang, a China compliance expert from ZMUni Compliance Centre, told Ingredients Network.

Following the announcement of the new GMM-based food ingredient applications, Wang said, “This document clarifies the requirements for application documents, making the review process more transparent.”

Applicants wanting to register their new GMM-based food ingredients must submit relevant materials as per the Requirements for Safety Evaluation Application Materials for GMMs Used in Food Processing. The application primarily includes product information, relevant information on GMMs, safety evaluation of the recipient microorganism, and the safety evaluation of genetic modifications.

Food brands and manufacturers need to ensure the final product does not contain residual exogenous genes or live cells of GMMs. Previously, when applying for products with GMMs, the authority required evaluations from two regulatory authorities: the National Health Commission and the Ministry of Agriculture and Rural Affairs. “Now, for Class I and Class II products, only an evaluation and approval from the National Health Commission is necessary,” said Wang. “This document optimises the application process, accelerating the approval timeline,” Wang added.

Biotech developments spur new GMM food focus

Consumer demand for new food ingredients is on the rise, including calls for healthier and more sustainable products that can be produced through genetic modification technology.

“With advancements in biotechnology, genetic modification techniques have become increasingly mature and many GMM-derived food ingredients have been proven safe and approved for use in multiple countries and regions,” Wang explained.

“Relevant departments in China are gradually establishing a comprehensive evaluation system to ensure that GMM-derived food ingredients entering the market have undergone rigorous safety assessments and meet national food safety standards,” Wang added.

Since 2021, food companies have been applying for new food additives and new food ingredients in China. “New food ingredients are used more extensively in the food industry compared to new food additives and can be said to have greater market value,” said Wang, adding that the voices from businesses are very strong.

At the same time, the application process for new food additives derived from GMMs has been open for three years, enabling the country’s health and agricultural services to gather data and insights. Based on the accumulated review experience over these past few years, the National Health Commission and the Ministry of Agriculture and Rural Affairs have gradually agreed on the review requirements. The regulatory authorities have responded to an increasing demand for approvals and aim to act in alignment with industry development needs.

“The regulatory authorities have expedited the approval process by clarifying the requirements for application documents and directly conducting safety assessments for certain new food items involving GMMs through the National Health Commission,” said Wang.

Significance of GMM-based foods

Opening applications for GMM-derived food ingredients marks a significant step toward fostering innovation in the food industry. Wang explained that alongside promoting research and technology advancements, it will enable the development of safer, healthier, and more sustainable food products.

Through a robust regulatory framework, the government ensures strict safety assessments and protects consumer health. This initiative also supports industrial growth by creating agriculture and food processing opportunities, aligning with international standards, and boosting global trade, Wang added

“It also addresses consumers’ evolving demands for diverse, nutritious foods, contributing to economic development and environmental sustainability,” said Wang.

Impact on manufacturers

China’s introduction of safety evaluation data requirements for three new foods hopes to open up opportunities for manufacturers. “The policy opening, along with the market’s focus on synthetic biotechnology companies, is expected to encourage more domestic enterprises to invest in the application of synthetic biotechnology in the food industry,” Wang noted.

Due to this new requirement, the food sector in China also anticipates a significant increase in applications for new food ingredients derived from synthetic biotechnology.