Type B 250/30 (10000135)

We, PB Leiner Brazil, division of Tessenderlo Group, hereby state that the gelatin produced by the site do not contain any substances listed as allergen in annex II of Regulation 1169/2011, Brazilian Resolution RDC26, July 2015 and in the Food Allergen Labeling and Consumer Protection Act (FALCPA), with the exception of sulphur dioxide, which is 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 50mg sulphur dioxide/kg of gelatin. 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 Brazil produces 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 Note: This product should not be consumed by people with alpha gal syndrome.