{"id":5206,"date":"2026-10-12T09:46:34","date_gmt":"2026-10-12T07:46:34","guid":{"rendered":"https:\/\/igifoodlaw.com\/?p=5206"},"modified":"2026-10-12T09:46:34","modified_gmt":"2026-10-12T07:46:34","slug":"case-before-the-cjeu-where-is-the-boundary-between-a-food-additive-and-a-processing-aid-manufacture-of-food-supplements","status":"publish","type":"post","link":"https:\/\/igifoodlaw.com\/en\/case-before-the-cjeu-where-is-the-boundary-between-a-food-additive-and-a-processing-aid-manufacture-of-food-supplements\/","title":{"rendered":"Case before the CJEU: Where is the boundary between a food additive and a processing aid? Manufacture of food supplements"},"content":{"rendered":"<p>Does classification of a substance as a food additive require it to continue to exert a technological effect in the final product? Does classification as a processing aid require its removal to the greatest possible extent after use? These two issues are the subject of questions referred for a preliminary ruling in Case C\u2011727\/26, Vital Products.<\/p>\n<p><strong><span style=\"color: #666699;\">\u00a9 IGI FOOD LAW. All rights reserved. Copying, publishing or using copyright-protected passages of this text in other works requires the prior consent of IGI FOOD LAW, except where permitted by law. IGI FOOD LAW reserves the right to pursue claims in the event of copyright infringement.<\/span><\/strong><\/p>\n<p>By a request dated 2 July 2026, the Bayerischer Verwaltungsgerichtshof \u2014 the Bavarian Higher Administrative Court \u2014 asked the Court of Justice of the European Union to interpret Article 3(2)(a) and (b) of Regulation (EC) No 1333\/2008 on food additives. The questions concern the criteria for distinguishing between two legal categories that determine the requirements applicable to the use of substances during food manufacture.<\/p>\n<h3>Subject matter of the dispute<\/h3>\n<p>Vital Products used Nu\u2011Rice, Nu\u2011Flow and Nu\u2011Mag, manufactured by the US company Ribus, in the manufacture of food supplements. According to the description in the request, these products comprised rice bran extract, rice seed extract, and a blend of rice bran extract, rice fibre, gum arabic and sunflower oil. The products were added to the mixture of ingredients before capsule filling or tablet formation. Their purpose was to give the mixture the properties necessary for these operations, particularly by preventing clumping and facilitating the feeding of the mixture into the equipment. In the manufacturing process, they replaced the magnesium stearate \u2014 E 470b \u2014 previously used.<br \/>\nFollowing a notification through the Rapid Alert System for Food and Feed (RASFF) initiated by Belgium, the Bavarian authorities challenged the use of these substances as unauthorised food additives. The manufacturer ceased using them and amended the formulations, but continued to seek a judicial declaration that it had not used them as food additives in the process described.<\/p>\n<h3>Positions of the manufacturer and the competent authority<\/h3>\n<p>The manufacturer maintained that the substances were used as processing aids. It argued that their function was limited to the manufacturing stage: they enabled capsule filling or tablet formation, whereas the finished products no longer required an anti-caking effect. It also asserted that only residues remained in the final product.<br \/>\nThe competent authority classified the substances as food additives. In its view, a substance may constitute a food additive even where it is technologically necessary only during manufacture. The relevant factors are its intentional addition for a technological purpose and the fact that the substance itself or its by-products remain, or may remain, in the food. The authority also disputed whether the conditions for classification as a processing aid were met. It considered that the presence of the substances in the final product went beyond unintentional but technically unavoidable residues. Under the classification adopted by the authority, the absence of the relevant authorisation meant that their use was not permitted.<\/p>\n<p>The court of first instance dismissed the manufacturer\u2019s action. Among other matters, it found that no convincing explanation had been provided as to how the quantity of the substances added would be reduced during the process described.<\/p>\n<h3>Questions referred to the CJEU<\/h3>\n<p><span style=\"text-decoration: underline;\"><strong>First question: technological effect in the final product<\/strong><\/span><\/p>\n<p>The CJEU is asked whether Article 3(2)(a) of Regulation No 1333\/2008 should be interpreted as meaning that a substance constitutes a food additive only where it still exerts the intended or any other technological effect in the final product. Alternatively, the referring court asks whether it is sufficient that the substance is intentionally added to food for a technological purpose and that the substance itself or its by-products become, or may become, a component of that food. The question therefore concerns a condition for classification of a substance as a food additive, rather than a requirement for the continued action of a substance whose status as an additive has already been established.<\/p>\n<p><strong><span style=\"text-decoration: underline;\">Second question: removal of the substance and the meaning of \u201cresidues\u201d<\/span><\/strong><\/p>\n<p>The second question depends on the answer to the first. If classification as a food additive does not require a technological effect in the final product, the CJEU is asked whether classification as a processing aid requires the substance, following use, to be removed to the greatest possible extent, in terms of quantity, by physical or chemical processes. The definition of a processing aid permits the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives, provided that they do not present any health risk and do not have any technological effect on the final product. The dispute concerns how \u201cresidues\u201d should be understood where a substance is added to a mixture and the process does not include a removal stage. The referring court also identifies difficulties in assessing situations in which reducing the quantity of the substance is technically impossible or possible only to a limited extent.<\/p>\n<h3>Position of the referring court<\/h3>\n<p>The referring court favours an interpretation under which a food additive need not continue to exert a technological effect in the final product. It notes that the definition of a food additive also covers the intentional addition of substances during manufacture and processing. It also considers that classification as a processing aid requires the quantity remaining in the final product to be reduced to the greatest possible extent. At the same time, it identifies differences in interpretation, including a different approach in an Austrian judgment cited in the request. The referring court\u2019s position is not a ruling of the CJEU. The document contains the questions referred for a preliminary ruling and the grounds for the reference.<\/p>\n<h3>Significance for businesses<\/h3>\n<p>The case concerns food supplements, but the questions relate to definitions applicable under food law. Their resolution may therefore also be relevant to other processes in which a substance serves a technological function during manufacture and remains in the finished food.<\/p>\n<p><strong>The principal issues for businesses are:<\/strong><\/p>\n<ul>\n<li>Classification of the specific use. A trade name, the plant origin of a raw material or a supplier\u2019s designation of it as a \u201cprocessing aid\u201d does not determine its legal status. The characteristics of the substance and the way it is used must be assessed.<\/li>\n<li>Process documentation. Relevant information includes the purpose of use, the quantity added, the fate of the substance during manufacture, any removal or transformation, and its quantity and function in the final product.<\/li>\n<li>Permissibility of use. Where a particular use falls within the rules on food additives, the relevant authorisation and conditions of use must be verified. Classification as a processing aid does not automatically make every use permissible.<\/li>\n<li>Labelling. Classification may affect the obligation to declare the substance in the list of ingredients. Labelling must nevertheless be assessed separately, taking account of the applicable exemptions and allergen information requirements.<\/li>\n<\/ul>\n<p>The central issue is whether the absence of a technological effect in the final product is sufficient to exclude classification as a food additive, and what significance the limitation of the substance\u2019s presence to residues has for its status as a processing aid. For businesses, this means connecting the regulatory assessment of a raw material with the actual manufacturing process. The case concerns questions referred to the CJEU for a preliminary ruling \u2014 we await the judgment clarifying these issues of interpretation. Awaiting the ruling does not, however, relieve manufacturers of their responsibility to comply with the applicable legislation, including correctly classifying substances and assessing the permissibility of their use.<\/p>\n<p><strong>Do you have questions about the legal classification of an ingredient, the use of a food additive or product labelling? Contact the experts at IGI FOOD LAW \u2014 we will be pleased to help assess the legal requirements applicable to your product and manufacturing process.<\/strong> <a href=\"mailto:igifoodlaw@igifoodlaw.com\" target=\"_blank\" rel=\"noopener\">igifoodlaw@igifoodlaw.com<\/a><\/p>\n<h3>IGI FOOD LAW &#8211; FOOD LAW EXPERTS<\/h3>\n<h3>IGI FOOD LAW &#8211; FOOD ADDITIVES LAW<\/h3>\n","protected":false},"excerpt":{"rendered":"<p>Does classification of a substance as a food additive require it to continue to exert a technological effect in the final product? Does classification as a processing aid require its removal to the greatest possible extent after use? These two issues are the subject of questions referred for a preliminary ruling in Case C\u2011727\/26, Vital [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":5204,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-5206","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Case before the CJEU: Where is the boundary between a food additive and a processing aid? 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