Mei 16, 2025 Changhong Chemical

1.EU Food Additives Regulation

In the European Union, the definition of a food additive as set out in Regulation (EC) No 1333/2008 ‘On Food Additives’ means any substance, whether or not having nutritional value, Not used as an essential ingredient of food and due to technical necessity during processing and production, preparation, handling, packaging, transport or storage of food, is It is intentionally added to food in such a way as to result in the direct or indirect inclusion of such substance or its by-products as a component of food. In addition, the EU definition of food additives does not include nutrient fortifiers, enzyme preparations, food flavourings and processing aids. This is also different from the regulation under China’s food additive GB 2760 system. In EU, the definition of nutrient fortifier, i.e. nutrients in food is implemented according to Regulation (EC) No 1925/2006 ‘On the Addition of Vitamins, Minerals and Other Specific Ingredients to Foods’; enzyme preparations for food are implemented according to Regulation (EC) No 1332/2008 ‘On the Enzymes Used in Foods’; flavourings for food are implemented according to Regulation (EC) No 1334/2008 ‘On the Enzyme Used in Foods’. Regulation (EC) No 1334/2008 ‘Flavourings for Food and Food Ingredients with Flavouring Properties in Food’; for processing aids for food, the EU has not yet issued the corresponding regulations and rules, and can refer to the regulations formulated by the EU member states for implementation, such as the member state France has formulated a decree on processing aids for the food industry as well as a list of the corresponding processing aids; the member state Spain has not yet issued a clear regulation and list, but the member state Spain has not yet issued a clear regulation and list. For example, France has a decree on processing aids for the food industry and a list of corresponding processing aids; Spain, although it does not have clear regulations and lists, has a regulatory code for the industry and a ‘Guide to the mandatory documentation of the requirements for the evaluation of processing aids intended for use in human food’.

2.Regulation of food additives in the EU

The regulation of food additives in the EU is a regulatory model of legislation at the EU level and enforcement by Member States.  The EU adopts a pre-market approval system for food additives, and only food additives that have passed the approval process and are included in the EU ‘positive list’ are allowed to enter the market.

3.Application Process

The authorisation of new food additives can be initiated either on the Commission’s own initiative or following an application by a Member State or an interested body, the generic authorisation procedure being the relevant provisions in Regulation (EC) No 1331/2008 and Regulation (EU) No 234/2011. The application must include detailed information about the food additive, such as its composition, the manufacturing process, the proposed use, and any other information that may be relevant to the risk assessment.Upon receipt of the application, EFSA carries out a risk assessment by means of a safety assessment for the consumer, the effectiveness of the intended technological purpose, and the impact on the environment. After the assessment, a conclusion is given that the intended use is safe and effective, and the European Commission proposes to place the food additive on the ‘positive list’ based on EFSA’s assessment; the EU Member States then review the proposal, and if it is approved, the food additive is placed on the list and allowed to be used in food.

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