SILFAR^® E 1049

1.Pharmaceutical use

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.

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

SILFAR^® E 1049 is a release agent that has been developed for use with food-contact articles.

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:

Germany:

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.

USA:

FDA 21 CFR:

§175.105 ADHESIVES

§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.