The European Food Safety Authority (EFSA) has concluded that S-acetyl glutathione (SAG) is safe under specified conditions of use as a novel food, marking an important regulatory development for companies interested in glutathione-based supplements and specialized nutrition products in the European market.

According to CIRS Group, EFSA’s Panel on Nutrition, Novel Foods and Food Allergens evaluated SAG following a request from the European Commission under Regulation (EU) 2015/2283 on novel foods.

SAG is an acetylated form of glutathione composed of the amino acids cysteine, glutamic acid and glycine. The novel food evaluated by EFSA contains more than 97% SAG and is produced through chemical synthesis.

The applicant proposed SAG for use in food supplements and foods for special medical purposes at a maximum intake of 300 mg per day. The proposed target population excludes children under 10 years of age as well as pregnant and lactating women.

EFSA determined safe intake levels of up to 190 mg per day for young adolescents aged 10 to under 14 years and 269 mg per day for adolescents aged 14 to under 18 years. For adults, EFSA calculated a safe intake level of 307 mg per day and concluded that the proposed maximum intake of 300 mg per day is safe, excluding pregnant and lactating women.

EFSA also reviewed the ingredient’s manufacturing process, composition and specifications and found no safety concerns. Human clinical data involving orally administered glutathione were also considered supportive of SAG’s safety in adults.

The positive EFSA opinion represents an important step in the EU novel food process but does not itself constitute authorization to market SAG in the European Union. Following EFSA’s scientific assessment, the European Commission and EU Member States determine whether the novel food will be authorized and establish its final conditions of use.

What this means for the dietary supplement industry

The positive safety assessment could create a new opportunity for companies developing glutathione, antioxidant, cellular-health and healthy-aging products for Europe. SAG is designed as a more stable form of glutathione, and an eventual EU novel food authorization could provide supplement formulators with another option for incorporating glutathione into products targeting the European market.

Companies considering SAG should pay particular attention to the age-specific intake levels identified by EFSA and the exclusion of children under 10, pregnant women and lactating women. Manufacturers should also recognize that the regulatory process is not yet complete and should monitor the European Commission’s subsequent authorization decision and final permitted conditions of use.

The development also illustrates the importance of closely monitoring Europe’s novel food pathway as innovative ingredients increasingly move through formal safety assessment and authorization procedures.

CIRS group is an HPA global regulatory strategic partner.

(Source: cirs-group.com & HPA-Global)

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