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EU (European Union)
General health claim
Based on the Article 13 of Regulation (EC) No 1924/2006, experts from the European Food Safety Authority (EFSA) Nutrition Foods, Nutrition and Allergy (NDA) panel finalized 1,745 claims from a list of about 4,700 health claims compiled by Member States and the European Commission. Among others, EFSA evaluated an application for general health claims on effectiveness of branched chain amino acids (BCAA) during exercise (mental state, muscle growth, fatigue recovery). The causal relationship between the use of BCAA and desired health effects has not been confirmed by the EFSA NDA Panel (2010). Since then, no general health claims on amino acid(s) has been made. Users of amino acid preparations that are interested in health claims are recommended to test specific combinations and apply for health claims on brand-specific products.
REACH rules
REACH refers to Regulation (EC) No1907 / 2006 that defines registration, evaluation, approval, and restrictions on chemical substances. REACH entered into force on 1 June 2007 to streamline and improve the existing legal framework for EU chemicals.
REACH compliance requirements apply to EU companies that import, use, and manufacture certain chemicals within the EU, and affect amino acids used for purposes other than food and drugs. The REACH regulations stipulate that amino acids that are not used in food or medical preparations must comply with REACH requirements. REACH requirements are based on the tonnage of substances, enabling data sharing to reduce regulatory and research costs.
See below for guidance details.