SILFAR® 350 is a polydimethylsiloxane obtained by hydrolysis and polycondensation of dichlorodimethylsilane and chlorotrimethylsilane. The degree of polymerization (n) is such that the mean kinematic viscosity is 350mm²/s at 25°C.
Use as pharmaceutical excipient:
SILFAR® 350 complies with the requirements set down in the monographs Dimeticone (EP) and "Dimethicone" (USP / NF). Wacker explicitly rules out the use of SILFAR® 350 for parenteral applications.
Direct Food additive:
SILFAR® 350 is listed in the Regulation (EC) No 1333/2008 Annex II and III as amended by Regulations (EU) Nos 1129/2011 and 1130/2011 as E 900 polydimethylsiloxane. It meets the purity requirements as laid down in Regulation (EU) No. 231/2012 and is therefore approved as direct food additive within the EC under observance of the use restrictions in force for polydimethylsiloxane (E 900). SILFAR® 350 is certified according to HACCP principles. Hence, it meets the requirements on food hygiene in accordance with Regulation (EC) No. 852/2004.
SILFAR® 350 complies with the Recommendation "XV Silicones" of the BfR concerning the manufacture of essential commodities that have contact with food.
SILFAR® 350 is listed under PM-Nr. 76721 in Regulation (EU) No. 10/2011 as an additive for plastic materials to come into contact with food and meets the specifications under column (4) and (10). The product is not subject to a specific migration limit (SML).
SILFAR® 350 is suitable for use under FDA 21 CFR as follows:
§175.300 (RESINOUS AND POLYMERIC COATINGS),
§176.170 (COMPONENTS OF PAPER AND PAPERBOARD IN CONTACT WITH AQUEOUS AND FATTY FOODS)
§176.180 (COMPONENTS OF PAPER AND PAPERBOARD IN CONTACT WITH DRY FOOD).
§176.200 (DEFOAMING AGENTS USED IN COATINGS)
§176.210 (DEFOAMING AGENTS USED IN THE MANUFACTURE OF PAPER AND PAPERBOARD)
§177.1210 (CLOSURES WITH SEALING GASKETS FOR FOOD CONTAINERS).
§177.2800 (TEXTILES AND TEXTILE FIBERS).
§178.3120 (ANIMAL GLUE).
§178.3570 (LUBRICANTS WITH INCIDENTAL FOOD CONTACT)
§178.3910 (SURFACE LUBRICANTS USED IN THE MANUFACTURE OF METALLIC ARTICLES)
§181.28 (RELEASE AGENTS)
SILFAR® 350 meets the criteria for an exemption from the requirements of a tolerance when used as an additive in pesticide formulations to be applied to growing crops or raw agricultural commodities after harvest as specified in 40 CR 180.960.
National regulations applicable in the countries concerned must be observed.
Further information for storage: Keep container tightly closed. Store container(s) at room temperature in a dry, well-ventilated place.
Storage beyond the shelf life does not necessarily mean that the product is no longer usable. In this case however, the properties required for the intended use must be checked for quality assurance reasons.
Shelf life: 720 days
Produced according ISO 9001, ISO 14001