The claims that can be made about the use and antimicrobial/biocidal efficacy of Noble Ionic+® products for use in healthcare fabrics may be restricted based on regional regulatory requirements. The user of Ionic+® products will be responsible for understanding this limitation and seeking proper regulatory coverage or conformity within each market of interest. While Noble can offer general guidance on regulatory criteria for markets of interest, it is the user’s responsibility to understand their responsibilities and limitations before entry into a particular region.
While it may be possible for healthcare fabric producers to pursue additional uses and efficacy claims, following are the generally acceptable criteria for use of the Ionic+® products in two critical markets:
United States Distribution: The Ionic+® products are based on the use of EPA-registered products. The substances used for protection of finished articles (identified as “active substances”) are characterized, based on regulatory definition, as providing an antimicrobial property to protect and prevent microbial-related degradation of the finished good. Acceptable product claims are limited to the protection/preservation of the finished article itself and cannot be extended to benefits beyond the finished article nor claimed protection from microorganisms of public health relevance. Users are not legally allowed to make or imply any public health claims when using these Ionic+® products. To make claims beyond these basic material preservation claims will require additional review and approval/clearance by the applicable regulatory agency.
European Union Distribution: The Ionic+® products contain active substances that are currently under Biocidal Products Regulation (BPR) review and are supported and intended for use in BPR Product Type 9 applications, identified as material preservation / anti-odor uses. BPR Product Type 9 applications require that information (“labeling”) be provided to the finished goods customer prior to purchase, indicating that the item contains an article treated with a biocidal active substance for biocidal / material preservation or anti-odor protection of the finished good. The type of claims made about the protection provided in the finished article is a key determinant for classification of products under the BPR. Claims that go beyond BPR Product Type 9 material preservation / odor prevention for the finished good, for example to suggest or state protection from microorganisms of public health relevance, might result in the classification of the finished article under the BPR as a Biocidal Product rather than a Treated Article. Product claims are best limited to the preservation of or odor prevention for the finished good itself.