EU approval of carbomer creates opportunities for supplement manufacturers

Carbomer is a high molecular weight crosslinked polyacrylic acid polymer. Available in white or almost white, fluffy, hygroscopic powder or granules, different carbomer grades can be manufactured depending on the amount of crosslinking that occurs during the polymerisation process.

Carbomer is widely used as a bulking, thickening, suspending and/or stabilising agent in formulations within the pharmaceutical industry. The recent EU approval extends its use to food supplements, allowing the same functionalities to be carried over to the supplement industry.

Commission Regulation (EU) 2023/440 recognises that in solid food supplements, carbomer permits the ‘controlled extended release of nutrients, allowing smaller size of tablets that are easier for consumers to swallow. In liquid food supplements, carbomer is intended for use in formulations with a wide range of flow and rheological properties that are stable with a lower level of polymer.’ This functionality creates opportunities for manufacturers to make supplements for consumers that find it difficult to swallow larger tablets and thicker liquids, such as elderly populations and those that experience dysphagia.

Only food additives which are included in the Union list, within Regulation (EC) No 1333/2008, can be used in the EU and under the conditions of use for that additive. All new food additives must go through an approval process and safety assessment by submitting a dossier to the European Commission. Carbomer has E number E1210 and is now permitted to be used in solid and liquid food supplements as a bulking agent and a stabiliser. The maximum permitted levels for carbomer are 30,000 mg/kg in liquid supplements and 200,000 mg/kg in solid supplements.

Following Brexit, new EU food additive approvals are not directly integrated into the UK.

Leatherhead’s multi-disciplinary team of scientists and regulatory experts has a wealth of experience advising companies on the permissibility of ingredients, such as carbomer, as well as obtaining approvals for additives and novel ingredients. Contact us at [email protected] to find out more about permissibility of ingredients in different global regions or to understand more about obtaining approval for a novel ingredient.