As part of proposed harmonisation of European food law the European Commission released directive (2003) 424. This related to proposed regulation of Nutrition and Health Claims Made on Foods. Alimentarius were approached by the sports nutrition company Maximuscle to review the directive and provide feedback. As a founder member of the European Specialist Sports Nutrition Alliance (ESSNA) Maximuscle requested that the report specifically addressed the potential impact for its own business, the sports supplement industry in general and consumers. Alimentarius identified two areas of particular concern for ESSNA members, which fell under Article 11 (Prohibited Health Claims) and Article 12 (Generally accepted claims). The feedback from Alimentarius was used to help overturn the Article 11 proposal to prohibit products from carrying claims relating to weight and fat loss. Our feedback relating to article 12 helped to ensure flexibility in health claim wording on pack and in advertising. This meant manufacturers of sports supplements could communicate the benefits of their products effectively, while consumers could easily identify products with the benefits and characteristics they were looking for.
Amino acids have a fundamental role in nutrition and numerous research studies support their role in general health as well as enhancing both mental and physical performance. There is a wealth of peer reviewed scientific data on healthy humans demonstrating the benefits of amino acid supplementation. Despite this, a report from the Scientific Committee on Food (SCF) concluded the addition of amino acids to foods was not necessary except to improve protein quality. The SCF report titled on ‘Composition and specification of food intended to meet the expenditure of intense muscular effort, especially for sportsmen’ was submitted to the European Commission and as a consequence they released directive (SANCO D4/HL/mm/D440182). This stated :-
‘The addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins and only in the proportions necessary for that purpose’
If written into EU law this would have been potentially catastrophic for the functional food industry and consumers, as it would have removed amino acid supplements from the European market. It would also have meant that many products with added amino acids would need to be reformulated to remove them and their associated health claims. Such products include mainstream fat loss supplements, ready to drink energy products, recovery drinks, energy bars, energy gels and protein bars.
As experts in amino acid metabolism and regulatory issues relating to dietary supplements, Maximuscle approached Alimentarius to write their position statement on the amino acid fortification of foods. We prepared this document using peer reviewed scientific data and highlighted numerous cases where amino acid fortification of foods was required for reasons other than improving the nutritional value of proteins. The position statement provided by Alimentarius was subsequently adopted by the European Specialist Sports Nutrition Alliance (ESSNA) to overturn EU directive (SANCO D4/HL/mm/D440182). This has allowed health, energy, sports performance, recovery and muscle building products to remain on the market without reformulation. It has also ensured that foods and supplements can continue to be fortified with amino acids. A full copy of the position position statement on amino acid fortification can be obtained here.
Creatine is one of the most important nutrients for the sports nutrition market and is a key ingredient in sports performance, muscle building and recovery products. It is typically supplemented in 5g daily doses, but to quickly attain maximal tissue creatine levels it can also be ‘loaded’ by supplementing 20g of creatine per day for 5 days.
In 2001 the Scientific Committee on Food (SCF) provided the European Commission with a report on ‘Composition and specification of food intended to meet the expenditure of intense muscular effort, especially for sportsmen’. This report claimed that data were lacking regarding the safety of creatine and that ingestion of more than 2-3g of creatine daily for prolonged periods may not be safe. In 2004 a report complied by the French food safety agency (Agence Française de Sécurité Sanitaire des Aliments, or AFSSA) questioned the safety of creatine loading and long-term creatine supplementation. As a consequence the European Commission released directive (SANCO D4/HL/mm/D440182) limiting the recommended conditions of use for creatine in supplements to 3g per day. This would have been potentially catastrophic for the sports nutrition industry and consumers. Although this low dose supplementation can produce some health benefits, higher doses are needed to produce the performance effects claimed on most products. Therefore, limiting creatine supplementation to 3 g would make most products too deficient in creatine to produce the claimed effects, indirectly removing legitimate creatine ‘health claims’ from the European market.
As experts in both creatine metabolism and regulatory issues relating to dietary supplements, Maximuscle Ltd. approached Alimentarius to write their position statement on creatine safety and toxicity. We prepared this document using peer reviewed scientific data and addressed all the safety concerns expressed by the SCF and AFSSA. Our report demonstrated that creatine monohydrate supplementation at 5 g per day is safe for periods of 5 to10 years. The position statement also showed that in contrast to the unsubstantiated claims in the 2004 AFSSA report, creatine loading was both justified and safe.
This creatine opinion was subsequently adopted by the European Specialist Sports Nutrition Alliance (ESSNA) and was used to overturn the EU directive. This has allowed sports and muscle building products to provide conditions of use that are appropriate to produce the claimed performance effects. The ESSNA position statement is still the most comprehensive document on creatine safety and toxicity available. As such it is widely referenced to support the safety of creatine products by companies such as Lucozade. It also formed part of the evidence reviewed by the European Food Safety Authority (EFSA) when providing their positive article 13.1 opinions on creatine and performance. A summary of the ESSNA position statement on creatine safety and toxicity can be obtained here and a full copy of the report here.