On August 2, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule defining “gluten- free” for food labeling, which will help consumers, especially those living with celiac disease, be confident that items labeled gluten-free meet a defined standard for gluten content. The compliance date for this final rule was August 5, 2014. The regulation provides a uniform standard for manufacturers who choose to label their products as gluten-free. The term gluten-free also is covered by Commission Implementing Regulation (EU) No 828/2014. It requires that, in order to use the term gluten-free on its label, a food must meet all of the requirements of the definition, only foods that contain 20 parts per million (ppm) or less can be labelled gluten-free. The term can be used on specialist substitute gluten-free products like breads, flours and crackers, which may contain gluten-free (Codex) wheat starch, as well as processed foods that are naturally gluten-free like soups, baked beans and crisps. The ‘gluten-free’ label may also be used for uncontaminated oat products. For oat products labelled gluten-free the oats themselves must also contain no more than 20ppm. This new federal definition standardizes the meaning of gluten-free claims across the food industry in all countries who have been started to produce and selling GF food. The rule also requires foods with the claims “no gluten,” “free of gluten” and “without gluten” to meet the definition for gluten-free. The European Commission has worked with the European Food Safety Authority (EFSA) to develop a list of ingredients which do not have to be labelled as being from a gluten-containing grain. The following ingredients are gluten-free: – glucose syrups derived from wheat or barley including dextrose – wheat based maltodextrins – distilled ingredients made from cereals that contain gluten e.g. alcoholic spirits. Although these ingredients can be made from cereals containing gluten, you do not have to label them as such because the processing has removed the gluten. ‘May contain’ guidance The Food Standards Agency has produced voluntary guidance on when to label a product with a ‘may contain’ statement. You can download this guidance from the Food Standards Agency website. Examples of labelling terms include: – may contain traces of gluten – made on a line handling wheat – made in factory also handling wheat. Before using terms like these, manufacturers should assess the risk that the product could be contaminated with gluten. This allows the consumer to make an informed individual risk assessment and decide whether or not to include the product in their diet. This white paper provides an overview of this new gluten-free regulatory requirement which applies to all FDA & EFSA-regulated packaged foods, including dietary supplements. However, companies can voluntarily choose to meet these gluten-free requirements for any other consumer product, such as cosmetics or personal care products, to demonstrate to concerned shoppers their commitment to gluten-free offerings.