Enartis Zenith Cold Stability Amendments Closer to U.S. Approval
September 13, 2018
The United States Food and Drug Administration issued a letter of understanding on September 11 that will allow two products–Zenith Uno and Zenith Color–to be called GRAS (Generally Recognized As Safe) compounds.
Developed by Enartis, Zenith Uno and Zenith Color are amendments that can be added to a wine to achieve cold stability without that wine having to be seeded and chilled or subjected to electrodialysis. The active compound in both products is a polymer of aspartic acid.
Zenith Uno and Zenith Color are both approved for use in the European Union, but to-date have not been approved for use by TTB. The letter of understanding is an important step towards that approval.
The two products make a wine permanently stabilized from tartrate precipitation, unlike the relatively temporary stabilization by carboxymethyl cellulose. Zenith Color provides cold stabilization for red wines without a concomitant drop in color stability that happens with just about all other methods of cold stabilization. Wineries would be permitted to use up to 300 mg/L of the active compound, and because of the GRAS identification, a winery does not have to declare a wine contains potassium polyaspartate.
Another advantage to the use of the Zenith products is that wineries will no longer need to add large amounts of refrigeration capacity so that wines can be chilled to 28° F. The cost savings in infrastructure will be enhanced, as wines will need only to be held at cellar temperature.
The use of Zenith Color will allow wineries to begin selling certain types of red wine during the first year after harvest. Production techniques will be similar to those for white wines. This also will be an additional capital return for the winery.
The next step is TTB approval, but that will be granted only if there is sufficient demand by the wine industry in the U.S. It is therefore important that wineries who want to use either product apply to the TTB for its use in “experimental” studies and then report the results to the agency with a request for permanent use.
José Santos, president of Enartis USA, is willing to advise wineries on the proper procedures to obtain both Zenith products as well as how to conduct the proper testing and reporting. Enartis sponsored all the necessary toxicity studies in the European trials. They submitted the results of those studies to the FDA for their use in evaluating the products and reaching its agreement with the European evaluation of the compound.
The letter of understanding, which has been posted on the TTB website, shows the extent to which FDA reviews additives and what Enartis had to fund in order to get the Zenith products classified as GRAS.