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NattoPharma (OSL:NATTO) (Lysaker, Norway 17 November 2008) The European Food Safety Authority (EFSA) has published a positive scientific opinion on vitamin K2, MK-7 from natto as a dietary supplement and food ingredient. The positive EFSA-opinion gives NattoPharma ASA a solid platform for wide distribution of MenaQ7(TM) in Europe.
- This is an important milestone for NattoPharma. It concludes the important process of a scientific safety evaluation performed by EFSA, a process that has lasted for nearly three and a half years. We have provided thorough documentation to EU scientific bodies and the EFSA opinion provides us with a strong scientific and legal platform for the distribution of MenaQ7(TM) in Europe, says Egil Greve, President and Chief Executive Officer of NattoPharma.
- The publication of the positive scientific opinion is the go-ahead signal many NattoPharma customers have been waiting for to step up commercial activities, Greve comments.
EFSA provides independent scientific evaluation and advice on existing and emerging risks of a product or an ingredient. NattoPharma's vitamin K2 product belongs to a group of vitamins known to EFSA. However, NattoPharma has invested in the approval of this specific form of vitamin K to ensure the MenaQ7(TM) product's uniqueness. It is one of the first times that EFSA provides a positive opinion on a new vitamin under the new EU legislation for fortified food. - We are extremely happy to learn that the opinion is based upon proprietary data as well as information specific for our product. It is also the first time that an ingredient is to be adopted simultaneously as novel food, as dietary supplement and food ingredient, says Greve.
NattoPharma`s product has in clinical trials shown to have optimal properties compared to vitamin K1. This ensures adequate supply of vitamin K2 to bones and vasculature. It is well documented that the western population is vitamin K deficient, and that there is correlation between this deficiency and high prevalence of diseases such as osteoporosis and cardiovascular calcification.
- MenaQ7(TM) can prevent vitamin K deficiencies, and we see strong effects on clinical important biomarkers associated with improved bone and cardiovascular health not previously seen. This is exciting and our clinical research shows that MenaQ7(TM) is a powerful form of vitamin K2 that we are proud to continue working with comments Egil Greve.
From the time of publication, EFSA`s opinion represents the official scientific opinion in all EU-countries. When the scientific opinion is adopted by the European Commission, vitamin K2 as Menaquinone-7 from natto will be amended to the annexes in the legislation for food supplements and fortified food. This will simultaneously give us approval as novel food.
According to the scientific opinion, EFSA concludes that there is no safety concerns related to the proposed use levels of MenaQ7 in the general population. - We will now study the scientific opinion and examine the various market possibilities that this EFSA opinion gives us. Simultaneously we are working with MenaQ7 health claims and continue our R&D program, says Egil Greve. This opinion gives us great opportunities in the market place and a strong competitive position, not only in Europe, but also in other parts of the world that is influenced by regulatory decisions taken in EU.
The Norway-based NattoPharma is listed on the Oslo Axess list at the Oslo Stock Exchange and is the exclusive supplier of MenaQ7(TM). Natural vitamin K2, branded by NattoPharma as MenaQ7(TM), is produced by J. Oil Mills Japan and the worldwide distribution is assigned to NattoPharma from the Japanese company Sumitomo Corporation.
NattoPharma has established an extensive research and development program aimed at documenting the benefits of the K2 vitamin as a dietary supplement and food ingredient. MenaQ7(TM) is extracted from the Japanese food natto (fermented soy beans). Research shows that our vitamin K2 is essential to develop and maintain strong bones as well as to avoid calcium deposits in the arteries.
For further information, please contact Egil Greve, ph. +47 95 10 95 65
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