
Regulatory Matters
General information on gelatine regulations
Gelatine has a worldwide definition given by the Food and Agriculture Organization in 1992:
A protein produced by partial hydrolysis of collagen in skin, tendons, ligaments, bones etc… of animals.
This definition means that it is always an animal product and that vegetable or vegetal gelatine does not exist. It is a food ingredient and it is not an additive with an E number.
Food and pharmaceutical regulations
As an animal food product, gelatine is strictly regulated everywhere in the world to guarantee its safety. The raw materials, the production, the labeling and other parameters such as microbiological quality are guaranteed by the national veterinary authorities in line with the guidelines of the World Organization for Animal Health. www.oie.int.
Rousselot gelatines are produced in establishments duly registered by the national authorities for the production of edible gelatine. Gelatine is traded between countries with a health certificate signed by an official veterinarian who guarantees that the gelatine has been put on the market in compliance with national and/or international regulations.
When Rousselot gelatines are used as pharmaceutical ingredients, they comply with additional guarantees which depend on the geographical area. The same criteria applies to other applications such as photographic gelatine.
Our target: to comply everywhere for all uses
Rousselot gelatines must comply with many worldwide regulations depending on the animal species from which they are produced, country of production, country of use, and the final applications. One of the main goals of Rousselot is to produce gelatines compliant with the most stringent regulations in the world such as those of the United States of America and the European Union.
Rousselot organization
Due to the importance of the regulations for the production, the trade and the use of gelatines, Rousselot has always considered Regulatory Affairs as a central department in its structure. In addition to a strong corporate department, each affiliate has a dedicated person to answer any questions on local or international regulations.
