In recent years, the safety of food and pharmaceutical excipients has continuously received high attention from the market and consumers. As a widely used functional raw material, the edible and pharmaceutical safety basis o

Created on 08.02

Safety Standards Align with International Authoritative Assessments, Raw Material Reaches Highest Safety Level

In recent years, the safety of food and pharmaceutical excipients has continuously received high attention from the market and consumers. As a widely used functional raw material, the edible and pharmaceutical safety basis of silicon dioxide has once again obtained authoritative theoretical support: all core safety requirements of the standards fully align with the safety assessment conclusions of the World Health Organization (WHO) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

scientist inspecting silicon dioxide powder safety in laboratory aligned with WHO JECFA standards

According to the public safety assessment results of WHO/JECFA, the Acceptable Daily Intake (ADI) of silicon dioxide is classified as "not specified". In the international safety evaluation system for food additives, "ADI not specified" represents the highest safety level, meaning that there is no need to strictly limit daily intake within the scope of normal production and compliant use, fully confirming that silicon dioxide is a food and pharmaceutical raw material with extremely high safety.

silicon dioxide ADI not specified highest safety level badge illustration

It is understood that the ADI value is the core benchmark for countries around the world to formulate additive limit standards. JECFA will only issue the "not specified" conclusion when toxicological tests fully prove that the substance has extremely low toxicity and poses no health risks under normal use. At present, relevant domestic and foreign food and pharmacopoeia specifications continue to formulate control requirements with reference to this assessment conclusion, further consolidating the foundation for the compliant application of silicon dioxide in scenarios such as anti-caking agents and pharmaceutical excipients.

silicon dioxide applications in anti-caking agents pharmaceutical excipients and global standard alignment

Industry insiders stated that continuously benchmarking against the WHO/JECFA international safety assessment system can promote the alignment of domestic silicon dioxide production and application standards with global standards, help high-quality food-grade and pharmaceutical-grade silicon dioxide achieve import substitution, provide safe and reliable raw material options for downstream food manufacturing and pharmaceutical production enterprises, and better guarantee the quality and safety of end products.

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