Lysine as an essential nutrient
L-lysine is an essential amino acid required for protein synthesis, collagen formation, and calcium absorption. The hydrochloride salt delivers the same lysine that occurs naturally in meat, fish, dairy and legumes. No additional pharmacological effect arises from the salt form at food-additive use levels.
L-lysine is classified as an essential amino acid for humans; the human body cannot synthesise it and must obtain it from diet. The WHO/FAO/UNU (2007) report on protein and amino acid requirements lists the adult average requirement for lysine at around 30mg per kg body weight per day.
2007RegulatoryWHO/FAO/UNU Joint Expert Consultation, Protein and Amino Acid Requirements in Human Nutrition
Safety evaluation at food-additive use levels
Regulatory bodies in the EU and UK have evaluated lysine hydrochloride as a food additive. Because lysine is an ordinary dietary constituent and the hydrochloride counterion is also ubiquitous in food, no special toxicological concern has been identified at the low concentrations used as a flavour enhancer or fortifier.
The Scientific Committee on Food (SCF) and subsequently EFSA have not identified a need to set a numerical acceptable daily intake for lysine hydrochloride when used as a food additive, reflecting its status as a normal dietary amino acid at the levels of use intended.
Regulatory reviewEuropean Food Safety Authority (EFSA), Food Additives database; Scientific Committee on Food opinions on amino acid additives
E642 does not appear in Annex II of the assimilated Regulation (EC) No 1333/2008, and the FSA's food additive authorisations register holds no entry for it, so no food category or maximum level is set for it in Great Britain.
2008RegulatoryEU Regulation 1333/2008 on food additives, Annex II
High-dose supplementation studies
Studies using lysine as a dietary supplement at doses far higher than food-additive use levels have investigated effects on cold sore (herpes simplex) recurrence and anxiety. These doses (typically 1,000mg to 3,000mg per day as supplements) are orders of magnitude above what E642 contributes in food, so findings from supplement research do not translate directly to the additive context.
A clinical trial found that supplemental L-lysine at 1,248mg per day reduced the frequency of herpes simplex recurrence compared to placebo, but this is a therapeutic supplementation dose, not a food-additive exposure level.
1987RCTGriffith et al., Dermatologica