Ciba® IRGAGUARD® antimicrobials are registered in the US with the EPA for specified uses only, and cleared by the EPA where distributors of products containing the additive may not make claims of antimicrobial activity other than the protection of the product against the growth of bacteria, mold, mildew and fungi in or on the treated product. For further guidance on treated article label claims, please refer to 40 C.F.R. §152.25(a) and any additional guidance or policies issued by the US Environmental Protection Agency and FDA for specified food contact applications.
The IRGAGUARD® B products have Drug Master File (DMF) with the US FDA. The Ciba® IRGAGUARD® antimicrobials have NSF 51 Certification for food processing and food service equipment approval.
Ciba® IRGAGUARD® B antimicrobials are notified under the European Biocidal Products Directive 98/8/EC (BPD) and registration dossiers are being submitted in accordance with Art.11 of the BPD to apply for the inclusion of the substances in Annex I (positive list) to the BPD.
Regarding the European legislation governing food contact applications we confirm that our products Ciba® IRGAGUARD® B 1000, B 5000 and B 7000 are in accordance with Article 3 of the European Regulation 1935/2004/EC (Framework Regulation) and the Commission Directive 2002/72/EC (Plastics Directive), according to the Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) and are listed in the synoptic document. However, the respective specific migration limits (SML) as set by the European Food Safety Agency (EFSA) have to be observed during the production of food contact articles.
Ciba® IRGAGUARD® B 7000 series have been controlled by independent toxicologists and assessed as harmless to human health and therefore have received Oeko-Tex Standard 100 approval for biological active finishes in textile applications.
| IRGAGUARD | Chemical Identity | FDA | EFSA | NSF | Oeko-Tex |
| B 1000 | Triclosan | No | SML 5 mg/kg | Yes | No |
| B 5000 | Silver Zinc Zeolite | Yes | SML 0.05 mg/kg | Yes | No |
| B 6000 | Silver Glass | Yes | | Yes | No |
| B 7000 | Silver Zinc Glass | Yes | SML 0.05 mg/kg | Yes | Yes |
| F 3000 | Thiabendazole | No | | No | No |
It is a violation of US Federal law to use this product in a manner inconsistent with its labeling. Use only under an agreement with Ciba. IRGAGUARD® products are intended for use as an additive into the materials and substances as part of the manufacturing process in order to provide built-in antibacterial and antifungal activity in manufactured materials and finished products in order to protect the finished product itself. IRGAGUARD® products inhibits the growth of non-health related microorganisms such as bacteria, mold, mildew and fungus that may cause odor, stain, discoloration, unsightly texture, decay, or deterioration of physical properties of the material and finished product.
For further information, please contact us.
Information as of July 2007.
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