Additives in Food: Two EU Regulations Authorize the Use of New Substances in Food Supplements

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Definition

Food additives are substances that are not typically consumed as food or food ingredients but are added to food during its manufacturing, processing, preparation, treatment, packaging, transportation, or storage to fulfill specific technological needs.

Food additives serve particular functions, including ensuring food safety, improving the appearance and taste of food products, creating specific textures, and ensuring the stability of the final product. They can be either natural or synthetic and are identified in the list of ingredients by their name or by their code (E followed by 3 or 4 digits).

Key References for the Regulation of Food Additives in the European Union: Regulation 1333/2008 and Regulation 231/2012

Regulation (EU) 1333/2008 is an important reference for the list of authorized food additives codes in the European Union. This regulation establishes a harmonized list of authorized food additives, their conditions of use, and their maximum limits in food products.

On the other hand, Regulation (EU) 231/2012 defines the purity criteria that food additives must comply with. It sets maximum limits for certain undesirable substances, such as heavy metals, microbiological contaminants, and pesticide residues, in authorized food additives.

These two regulations are important instruments for ensuring the safety and quality of food additives used in food products marketed in the European Union, and they can be useful to mention in the context of food additive regulation.

Regulatory Framework

The European Union has published two regulations regarding the use of food additives in food supplements. Regulation (EU) No. 2023/440 authorizes the use of carbomer (E 1210), while Regulation (EU) No. 2023/447 authorizes the use of glycosylated steviol glycosides (E 960d).

Carbomer (E 1210) is a food additive used as a thickener and stabilizer in a variety of food products. It is often used in cosmetics and pharmaceuticals, but its use in food supplements has been limited due to concerns about its safety. However, after a thorough assessment by the European Food Safety Authority (EFSA), the EU has authorized the use of carbomer in food supplements.

Glycosylated steviol glycosides (E 960d) are natural sweeteners derived from the leaves of the Stevia rebaudiana plant. They are often used as an alternative to artificial sweeteners in food and beverages. The EU has authorized the use of glycosylated steviol glycosides in several categories of food products, including food supplements.

Although the use of these new food additives is authorized, it is important to note that manufacturers of food supplements must still comply with European regulations on food safety. They must perform safety and toxicity tests to ensure that the use of these additives does not pose risks to human health and comply with the purity criteria of Regulation 231/2012. Manufacturers must also adhere to the dosage limits and other restrictions established in EU regulations.

Who is EcoMundo?

We offer a range of services related to regulatory compliance for food supplements, including risk assessment, labeling and packaging compliance, and product registration.

We help manufacturers and distributors of food supplements ensure that their products meet regulatory requirements and are safe for consumption. We also provide guidance on ingredient use, claims, and labeling requirements in different countries around the world. Overall, our expertise lies in helping businesses navigate the complex regulatory landscape of food supplements and ensuring that their products comply with applicable regulations.

For more information, please contact us.

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