SILFAR® E 1049
SILFAR® E 1049 is a silicone fluid emulsion suitable for a variety of applications including uses in the food and pharmaceutical industry.
SILFAR® E 1049 comprises components compliant with the requirements laid down in the corresponding EP and USP monographs and can be used as an excipient in pharmaceutical products but not as an active pharmaceutical ingredient.
Besides, we recommend the SILFAR® E 1049 silicone fluid emulsion for applying a water-repellent coating to glassware used for pharmaceutical products, e.g. bottles, vials and ampoules. Suitable measures must be taken to ensure that the active ingredient in SILFAR® E 1049 is completely and permanently immobilized on the surface of the product in question.
The emulsion may be diluted further with water. Good results are produced by an active content of only 0.5%.
2.Use for food processing
SILFAR® E 1049 is a silicone fluid emulsion based on E 900 and may only be used as a processing aid for food. Therefore, it has to be ensured by the producer of the foodstuff, that only technically unavoidable traces of SILFAR® E 1049 remain in the final food.
3.Contact with food
The ingredients of SILFAR® E 1049 are contained in the positive lists of the following regulations for essential commodities intended to come into contact with food:
Recommendations of the BfR:
XIV. Plastics Dispersions
XXXVI: Paper and Board for Food Contact Europe: Regulation (EU) No. 10/2011 superseding Directive 2002/72/EC.
FDA 21 CFR:
§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
Regulatory sanctioning of the ingredients in a product does not imply that the finished product manufactured from those ingredients is considered safe by regulatory bodies. Responsibility for compliance with specific limits e.g. on migration/extraction resides with the manufacturer of the finished product.
Further details and information on potential restrictions please see the datasheet on Regulatory Product Information.
The 'Best use before end' date of each batch is shown on the product label.
Storage beyond the date specified on the label 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.
SILFAR® E 1049 should be gently homogenized by stirring before us.