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The safety of gelatine is guaranteed by national and international regulations. These regulations cover the quality requirements for the whole gelatine process from the definition of the parts of the animals that can be used as raw materials until the finished product, including the requirements regarding the physical processing parameters.
EU Regulations: Edible Gelatine
Regulation (EC) No 853/2004 sets the general conditions for the production of edible gelatine. It covers all aspects from raw materials to delivery of the final product: origin, transport and storage of raw materials, manufacturing conditions, chemical requirements for the gelatine, as well as packaging, storage and transport.
Raw materials are exclusively derived from animals found fit for human consumption, approved by the veterinary authorities and guaranteed by full documentation.
The microbiological requirements for gelatine are also covered by Regulation (EC) No 2073/2005.
The combination of all these regulations sets a very clear framework for the production of gelatine of the highest quality.
EU Regulations: Pharmaceutical Gelatine
Additional requirements for pharmaceutical applications are covered by specific regulations. Consequently, pharmaceutical gelatine not only complies with the requirements of gelatine for human consumption, but it is also regulated by the relevant provisions of the directive 2001/83/EC on medicinal products
Moreover, all bovine gelatines produced for the pharmaceutical market are certified by the EDQM (European Directorate for the Quality of Medicines) for the European market, in compliance with the Note for Guidance of the European Agency for the Evaluation of Medicinal Products (EMEA/410/01 Rev.02). A certificate is issued by the EDQM after review of a complete dossier submitted by the gelatine producer, describing in detail the raw materials as well as the production processes.
The European Pharmacopoeia also provides some specific requirements for the production of pharmaceutical gelatine, as well as physical, chemical and microbiological quality requirements for the finished products.
Gelatine Production Fulfils the Highest Common Factor
Further to these strict regulatory requirements, permanent controls guarantee a perfect security and a total traceability of the gelatine produced both for the edible and pharmaceutical industries. Regular audits performed by the competent authorities and numerous controls all along the production process ensure the highest quality and safety gelatines to consumers.
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