Food & Feed - SYNCAL FAQ

SYNCAL® Saccharin- Questions Answered

SYNCAL® brand saccharin products meet very exacting standards as specified by the FDA and are suitable for food and drug applications. SYNCAL® Saccharin is made in the United States by PMC Specialties Group. We are the only manufacturer of saccharin in the USA. A certificate of Analysis is sent along with a current MSDS for every lot of SYNCAL® Saccharin that we ship.

Below are answer some frequently asked questions about SYNCAL® Saccharin:

• What is SYNCAL® Saccharin?
• What is the nutritional status of SYNCAL® Saccharin?
• BSE – Bovine Spongiform Encephalopathy “Mad Cow Disease” Statement
  
  
• Food Grade Status
• Genetically Modified Organism Status
• Ruminant Derived Protein Status
  
  
• Subject: Good Manufacturing Practices for SYNCAL® Sodium Saccharin
• Lot Identification and Recallability for SYNCAL® Saccharin products
• Organic Volatile Impurities (OVI) in Saccharin (all forms)
  
  
• Allergen Statement – SYNCAL®
• Certificate of Continuing Guarantee
• Shelf Life Documentation
• Animal Testing

What is SYNCAL® Saccharin? [top]

SYNCAL® Saccharin is available as three different molecules:

Calcium Saccharin
Sodium Saccharin
Insoluble Saccharin

What is the nutritional status of SYNCAL® Saccharin? [top]

SYNCAL® Saccharin has no nutritional value or calories. Studies have shown saccharin passes through the body unchanged, Therefore, saccharin is not an energy source. Saccharin contains no protein, carbohydrate, fat, fatty acid, fiber, or vitamins.

BSE – Bovine Spongiform Encephalopathy “Mad Cow Disease” Statement [top]

None of the raw materials that are used in the manufacturing of SYNCAL ® Sodium Saccharin are of animal or human origin. The equipment used in the manufacturing process, including packaging, is not also used for the manufacture or packaging of animal origin products or products containing ingredients of animal origin.

Food Grade Status [top]

SYNCAL® Saccharin products meet or exceed Food Chemical Codex (FCC) specification required by the Food and Drug Administration. (21 CFR, revised as of 4/1/80, Section 180.37)

Genetically Modified Organism Status [top]

SYNCAL® Saccharin products are made entirely from synthetic chemical sources. They contain no genetically modified organisms.

Ruminant Derived Protein Status [top]

SYNCAL® Saccharin products are made entirely from synthetic chemical sources. No ruminant derived protein is used to make these products.

Subject: Good Manufacturing Practices for SYNCAL® Sodium Saccharin [top]

SYNCAL® Saccharin products are produced exclusively by PMC Specialties Group, a Division of PMC, Inc. at the Cincinnati Plant. SYNCAL® is produced under Good Manufacturing Practices as mandated by the FDA in 21 CFR, Parts 20, 110, and 211.

Lot Identification and Recallability for SYNCAL® Saccharin products [top]

SYNCAL® products are made in a continuous process. Product is packed out in sequential batches, which are identified as lots. Samples are taken of each lot according to a sampling plan. These samples are analyzed to provide the data for the Certificate of Analysis for each lot.

Samples from each lot are retained. These retains can be re-analyzed in the future if there is any question about a given lot meeting the specifications.

All product is identified with a lot number. Only lots, which have been analyzed and shown to meet all specifications, are approved for shipment. A Certificate of Analysis is sent for each lot delivered to a customer.

Our inventory system provides a record of all customers who are shipped a given lot of SYNCAL® Saccharin. If we were to need to recall a lot of product, the inventory system would provide a list of customers to contact.

Organic Volatile Impurities (OVI) in Saccharin (all forms) [top]

SYNCAL® Sodium Saccharin products produced by PMC Specialties Group, Inc., a Division of PMC, Inc., meet the requirements of Organic Volatile Impurities as specified in United States Pharmacopeia (USP-27)/National Formulary (NF-22), and the ICH Guideline for Residual Solvents (CPMP/ICH/283/95).

SYNCAL® also meets the organic volatile impurity (OVI) requirement of section <467> as described in the First Supplement to the USP-27/NF-22 for Class 1, Class 2, Class 3, and “other residual solvents” listed. We use none of the OVI solvents in our process. Based on knowledge of the manufacturing process and controlled handling, shipping, and storage of the SYNCAL? products, we believe there is no potential for the OVI’s or the ICH residual solvents to be present and that our product, if tested, will comply with established standards.

OVI tests are run in accordance with a reduced testing protocol, and a statement of conformance is included on all Certificates of Analysis.

Allergen Statement – SYNCAL® [top]

Our SYNCAL® Sodium Saccharin is not adulterated with any other material including wheat, fish/shellfish, eggs, milk, sesame seeds, tree nuts, peanuts, lactose, gluten, artificial color or flavor, starch, barley, rye, oats, spelt, corn.

Certificate of Guarantee [top]

In regards to a Certificate of Guarantee, PMC will guarantee that all our SYNCAL® Saccharin products meet or exceed Food Chemical Codex (FCC), United States Pharmacopeia (USP) specifications and European Pharmacopeia standards and will not ship unless all specifications are met.

Shelf Life Documentation [top]

PMC Specialties Group recommends storing SYNCAL® Saccharin products in a warehouse that is of normal ambient temperature and humidity. Our stability tests of these products indicate the products remain stable for more than five years when stored in their sealed container in a non-air-conditioned warehouse. Ambient conditions of Average monthly temperature = 64º F, standard deviation = 18.

Average Dew point = 44º F, standard deviation = 15.

Animal Testing [top]

The testing for Saccharin was performed by the International Life Sciences Institute at the University of Nebraska Medical Center in Omaha, Nebraska from 1979 thru 1987. The researcher in charge was Dr. Samuel Cohen who conducted testing on Rats. Additional testing by NCI involved Orangutan's, Specia Monkeys, and Chimpanzees to determine that saccharin does NOT cause cancer in primates. Tests are complete and not ongoing. Products containing Saccharin no longer require a warning label per the Sweetest Act of 2000.