Solugel Prima BD (10001287)

We, PB Leiner Argentina, Division of Tessenderlo Group, hereby state that the hydrolysed gelatin produce by the site do not contain any substances listed as allergen in Annex II of Regulation 1169/2011, with the exception of sulphur dioxide, which is generally present at levels lower than 10 mg/Kg. As a result of pharmacopeia harmonisation, the European Pharmacopeia , the US Pharmacopeia and the Japanese Pharmacopeia last editions specify a limit of 50 mg Sulphur dioxide/Kg gelatine. The same limit is specified in Annex III to Regulation (EC) Nº 853/2004 of European Parliament and the Council laying down specific hygiene rules for food of animal origin as last amended. PB Leiner Argentina produce exclusively gelatine on the gelatine production lines. All the gelatines are handled and transported in a manner in order to prevent subsequent contamination of the product.