Regulatory Changes for Food Allergens

UnitedStates-Europe mergeThere are two significant changes coming into effect. In the USA, the Food and Drug Administration (FDA) Final Rule for defining ‘Gluten-Free’ in the labelling of foods reaches its date for compliance (5th August 2014). In the UK, the Food Standards Agency (FSA) has published its Technical Guidance to assist small and medium sized business comply with the new European Food Information for Consumers Regulation (FIC). The new rules for allergen labelling of pre-packed and non-prepacked foods come into force on the 13th December 2014. Both initiatives follow periods of public consultation. (i) The FDA Final Rule specifies the requirements for a “gluten-free” claim to be made and includes the regulatory threshold of 20 ppm gluten (i.e. below 20 mg gluten per kg of food) consistent with the Codex Standard (118:1979) and the European Regulation (41/2009). When analysis of food is used for the basis of compliance the FDA have specified that they would use a scientifically valid method that can reliably detect the presence of 20ppm gluten in a variety of foods (including both raw and cooked or baked). They decided against specifying analytical methods in order not to limit the testing options, a different position to Codex where a preferred method (R5 Mendez ELISA) is stated; this is currently under review. (ii) The FIC new rules for allergen labelling now include businesses that supply non-prepacked foods who can use a variety of means to declare to their customers the inclusion of any one of the regulated 14 food allergens. Importantly, the allergen information should be accurate, consistent and verifiable upon challenge. For example, any foods where ingredients are unknown or there is uncertainty, would require further investigation before the allergen status of that food can be verified; this could include food analysis when appropriate. Both Regulations establish new requirements and uniform conditions for the provision of food allergen information, which will help ensure that individuals with coeliac disease and /or food allergies are not misled and are provided with truthful and accurate information with respect to foods.

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