BiolaneTM GLME was first introduced to the New Zealand market in April 1974. Since then, the demand for this product has spread to over 30 countries worldwide. Although the product is derived from a shellfish, which is extensively consumed as food, it has been subjected to both toxicity and teratogenic trials to ensure that the derived material is as safe to consume as the original food source.
Extensive study on toxicity has been carried out on BiolaneTM GLME and no toxic effects were found at 120 times the standard dose. Not only was BiolaneTM GLME safe at very high dosages, but it also had no teratogenic effects. These studies are similar in design to those conducted by pharmaceutical companies to show that a drug is safe to use in people.
It is pertinent to comment that a significant amount of this product has been consumed by human subjects under the strict supervision of clinicians during clinical studies carried out in New Zealand, Australia, United Kingdom, and France.
Shellfish used to produce BiolaneTM GLME are from cultivated sources (marine farms) and the farms are licensed by the New Zealand Government. The fact that the farms are licensed ensures that they are located in suitable (unpolluted) areas of the coastal waters and also that shellfish may only be harvested from them when conditions are appropriate.
Government has established a Biotoxins Management Committee to monitor areas of the coastal waters where farming of shellfish takes place. Regular sampling of the phytoplankton is done which is present in water to ensure that algal species with Biotoxins are not much in numbers to cause toxicity. Moreover the samples of mussels are sent to laboratories to detect the presence of Biotoxins.
Because marine farming is essentially a coastal water operation, it is subject to the influence of land drainage and other discharges, which have the potential to cause microbiological contamination of the waters. Mussels are filter-feeding animals and thus are able to concentrate contaminants as well as foods from their surrounding waters. Although the licensing criteria for marine farms require that they be situated away from areas directly influenced by sewage and other such discharges there is always the possibility of microbiological contaminants from sea birds, run off waters from grazing pastures etc being present in the waters of the farm area.
To prevent any risk of microbiological contaminants being present in cultivated mussels, or the extract processed from them, routine monitoring of the waters is carried out and, in addition, every batch of mussels received for processing is subjected to microbiological assays at the factory on arrival. Further, the factory quality control programme requires that the processing of the mussels, through the several stages from shellfish to powder or capsules, be monitored by sampling and analysis for microbial levels by the in house laboratory.
As a final safeguard, the end product in powder or capsule form is subjected to microbiological assay and certification by an independent, Government approved laboratory.
most countries to which the mussel extract product is exported have mandatory maximum levels for the content of heavy metal contaminants in food products they will accept. New Zealand is not an industrialized nation thus there is not a huge extend of metal contaminants that can cause issues in marine derived products. However the samples of the final product are sent for analysis to government approved laboratories to certify it.
The herbicide and pesticide residue testing is done on mussels and on random batches of final mussel extract to attain the full safety of a product
The manufacturing process for BiolaneTM GLME is carried out to a Hazard Analysis Critical Control Point (HACCP) programme as required by the USFDA for products acceptable to the USA. The programme has been approved by the Regulatory Authority (MAF) appointed by the USFDA for local administration under a Memorandum of Understanding between the two countries. The Company has an HACCP Coordinator on staff and the requirements of the programme ensure that reception of shellfish and subsequent manufacture is all carried out to the approved standards. In addition the Company has its own laboratory and quality assurance and control programme which monitors the reception of raw materials and their progress through the processing stages.
As mentioned above, BiolaneTM GLME has been subjected to both toxicity and teratogenic studies by the Department of Medicine at the University of Auckland. Although the Green Lipped Mussel Extract is a food these studies were conducted to the standard protocol as used for new drug products since they apply equally to food or drugs. The product has been shown to be nontoxic and not teratogenic.
BiolaneTM GLME processed in the manner and to the standards described above is a safe product for consumption on a continuous and regular basis.