SILFAR^® SE 4

1. Pharmaceutical use

SILFAR^® SE 4 meets the purity requirements of the monograph „Simethicone Emulsion“ under the current version of the US Pharmacopoeia.

A monograph for simethicone emulsions does not exist in of the European Pharmacopoeia. However, the ingredients comply with the purity requirements of the corresponding monographs.

SILFAR^® SE 4, is produced under cGMP and is suitable for use as an active pharmaceutical ingredient (API) e.g. in antiflatulence and antacid preparations. It works by acting as an antifoam agent to prevent or relieve flatulence in alimentary canal and by forming a protective lining on e.g. the gastric mucous membrane.

It is often combined with fermentation preparations.

When administered to patients, preparations containing the antifoam SILFAR^® SE 4 eliminate any flatulence that might hinder X-ray, ultrasonic or gastroscopic examinations.

SILFAR^® SE 4 may also be used to make liquid preparations in suspension form.

SILFAR^® SE 4 is also antifoam in fermentation and downstream processes, such as active-ingredient extraction and solvent recovery, especially when USP/EP compliant products are mandatory.

2. Use in food processing

SILFAR^® SE 4 is a silicone fluid emulsion based on E 900 and may be used in Europe only as a processing aid for food. Therefore, it has to be ensured by the producer of the foodstuff that only technically unavoidable traces of the product remain in the final food.

SILFAR^® SE 4 is used in strongly foaming, aqueous systems in the food sector (e.g. vegetables processing, beverages).

3. Contact with food

The ingredients of SILFAR^® SE 4 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

XV. Silicones

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.

4. Use in Agrochemical formulations

SILFAR^® SE 4 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 CFR 180.910.

National regulations applicable in the countries concerned must be observed.