Re-setting the Gluten-free alarm to 10ppm
On the 5th August the FDA in the USA published a new ruling to define ‘gluten-free’, giving food manufacturers one year to ensure compliance. A regulatory limit of below 20ppm gluten defined in the rule is consistent with the European Regulation (EC) No. 41/2009 and the Codex Alimentarius unified decision (Standard 118.1981). Increasingly, 20ppm is deemed to be the lowest level that can accurately and reliably be detected by ELISA, including the Codex preferred method of analysis. More significantly, this level protects the vast majority of gluten intolerant consumers. Bio-Check believes that gluten-free manufacturers should be working to an upper action limit of below 10ppm gluten to ensure compliance. A recent FAPAS proficiency round (27121) illustrates the analytical need; 90 labs analysed an infant soya formula using an R5 ELISA and reported levels between 10.36 and 33.83 ppm gluten. The consensus, or assigned, value for 27121 was determined to be 21.0ppm gluten; about half of the labs in the round would report results just above the regulatory threshold and half below. The findings are to be expected for an inter-laboratory scheme; while analytical variance is much improved over previous rounds, it raises important analytical questions. Bio-Check believe that FAPAS round 27121 (which used a near borderline sample) serves to illustrate the importance to gluten-free manufacturers of working to action limits well below the regulatory levels to ensure compliance. Bio-Check encourages discussions with laboratories and producers to help them understand such implications with their analysis … click here