Animal tissue is widely used in various medical procedures with collagen proving to be a particularly valuable and accepted material for such purposes. Being one of the first biomedical materials used its properties of possessing high tensile strength and compatibility with human tissue, makes it a highly valued raw material utilised by medical practitioners and surgeons worldwide.

Being the most abundant protein in the human body and the main component of skin, tendons and ligaments, collagen has received global regulatory approvals for cosmetic, mobility and life saving procedures and products that contribute to an improved quality of life for those patients who have been the recipients of such procedures. However, increasing concern over the safe use of animal tissue in medical and other applications, where the end user is to be human, has resulted in the development of strict international compliance guidelines that necessitate medical products meet certain criteria.

As bovine collagen is one of the more popular animal tissue utilised in human applications, much has been written and formalised by many international governments on guidelines on its use. Safety guidelines include the following critical issues:

- All animal tissue in a product must have its source specifically identified as to what part of the animal has been used.

- Any bovine material should come from cattle that originate from countries which have a proven and recorded history of not containing or having a significant risk of introducing BSE.

- Traceable records should be maintained by the manufacturer for each lot of bovine material imported.

The source of the material is the most important parameter of the safety of the product. For bovine tissue, the best source is from a country or zone identified according to the International Animal Health Code (IAHC) as Bovine spongiform encephalopathy (BSE) free. The IAHC provides five categories for a countries BSE status, which are outlined below:

- BSE free country or zone

- BSE provisionally free country or zone

- Country or zone with minimal BSE risk

- Country or zone with moderate BSE risk

- Country or zone with high BSE risk

The assessment and ranking of countries and zones by this international organisation is determined based on the outcome of a risk assessment identifying all potential factors for the occurrence of BSE. These include the presence of an awareness program for all workers involved in the industry to encourage early identification and reporting, the implementation of an accredited BSE surveillance and monitoring system with approved and frequent laboratory tests, along with a ban on identified cattle feed sources known to contribute to the development of the disease.

It is becoming evident that any source of animal tissue that is to be used in any human medical procedure must be sourced from a country that not only remains BSE free, but has the regulations and programs in place to ensure that it remains this way. The quality of the products being produced, whether medical or not, can only be as good as the source of animal tissue being used in the production of such materials. Few countries are categorised as level one according to strict international standards. As a level one country, New Zealand has received high praise, not only in its ability to supply animal tissue that is contaminant and disease free, but in its stringent control programs that ensure the industry retains these high standards.

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