AOECS position statement on medicines and cosmetics
Version 2 / 2024
Summary
The AOECS Licensing System, based on the AOECS Standard for pre-packaged food products, does not permit the use of the Crossed Grain Trademark on the packaging of medicines, cosmetics, or hygiene products. This text and the position paper which you can download here explains the rationale for this decision.
Understanding Excipients in Pharmaceuticals
Medicines are composed of an active ingredient, which provides the desired effect, and excipients, which are substances added to support the medication's stability, shape, and flavour.
Excipients like wheat starch are sometimes used in medicines, which may contain trace amounts of gluten. While this usually poses no risk to coeliacs, caution is advised, particularly with long-term medication use.
Importance of Excipients for Coeliacs
Although some medicines contain gluten, they are generally safe for coeliacs. Wheat starch, an excipient used in some tablets, capsules, and pills, may contain gluten depending on its quality.
However, the levels are typically so low that they do not pose a risk. The European Pharmacopoeia sets strict limits on protein content in excipients, aligning with gluten-free food standards.
EU regulations require certain excipients to be declared, usually in the medicine’s leaflet, though ‘gluten’ does not need to be explicitly mentioned.
Doctors should consider gluten content when prescribing medication to coeliac patients, especially those requiring long-term or high-dose treatments.
Are Medicines Safe for Coeliacs?
Yes, medicines in the European market are safe for coeliacs and those with Herpetiformis Dermatitis. However, patients with hypersensitivity should consult their doctor, as alternative formulations without gluten may be available. Any side effects that mimic gluten ingestion symptoms should be discussed with a healthcare professional.
Hygiene and Cosmetic Products
For coeliacs, gluten is only problematic when ingested. Hygiene products, cosmetics, and even toothpaste and lipsticks, which may contain gluten, are not a risk as they are used externally and do not typically enter the digestive system. The molecules in these products are too large to penetrate intact skin and cause a reaction.
Though there is no specific allergen legislation for these products, the INCI system helps identify ingredients. Cosmetics Europe advises against using 'gluten-free' claims as they may not offer real consumer benefits and could be misleading.
Download the full position statement for a more detailed reading.