Latest EU Update: S-Adenosyl-L-Methionine Disulfate Tosylate was Considered a Novel Food

Recently, the European Commission’s novel food status has updated the information regarding S-adenosyl-L-methionine disulfate tosylate (also referred to as Sadenosyl-L-methionine disulfate p-toluenesulfonate). According to the latest novel food status, this ingredient has now been recognized as a novel food.

In the context of the consultation with Member States, the European Union concluded that, as no evidence was identified demonstrating a significant history of consumption of S-adenosyl-L-methionine disulfate tosylate as a food or food supplement within the EU prior to 15 May 1997, the substance may be considered a novel food.

What is the EU novel food status?

The EU novel food status is a reference tool maintained by the European Commission, primarily used to assist competent authorities in member states and businesses in determining whether a particular ingredient may qualify as a “novel food”. It is important to note that the novel food status itself is not a regulatory text, nor is it equivalent to an official authorization list; however, it serves as a valuable reference for businesses in determining the regulatory status of ingredients and assessing market access pathways.

Generally, once an ingredient is explicitly designated with novel food status, it implies that the ingredient lacks a history of significant consumption in the EU prior to May 15, 1997. Consequently, products containing such ingredients typically require Novel Food authorization under the EU Novel Food Regulation (EU) 2015/2283 before they can be placed on the market.

Why is SAMe-related products drawing attention?

The application concerns S-adenosyl-L-methionine disulfate tosylate (also referred to as Sadenosyl-L-methionine disulfate p-toluenesulfonate). It is a salt form of S-adenosyl-Lmethionine (SAMe), a naturally occurring compound involved in human metabolism. The substance under assessment is a chemically defined derivative of SAMe used in food supplements, in particular to improve its stability. As the global market for functional ingredients continues to expand rapidly, companies are paying increasing attention to the regulatory compliance strategy for SAMe-related products in the European and U.S. markets.

CIRS recommends that relevant companies planning to use this ingredient in food or dietary supplements in the EU market must comply with the regulatory requirements for novel foods. If a product contains S-adenosyl-L-methionine disulfate tosylate, companies must verify whether it has obtained EU Novel Food authorization. If authorization has not yet been granted, companies may need to conduct a Novel Food application. CIRS Group will continue to monitor developments in EU Novel Food regulations and provide companies with Novel Food compliance assessments, application strategy development, and global market access support.

Understanding the relevant EU Novel Food regulations is essential for ensuring compliant product exports to the European market. If you have any questions or require assistance regarding EU Novel Food authorization applications or dietary supplement (health food) regulatory services in the EU, please feel free to contact the Food Division of CIRS Group.

About CIRS

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, feed and pet food, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of team members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% hold Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.