The AOECS Licencing System, which certifies pre-packaged food products through the Crossed Grain Trademark, does not extend this mark to medicines, cosmetics, or hygiene products. AOECS has recently released an updated position paper explaining the rationale behind this decision, addressing the complexities surrounding gluten in non-food items.
The updated Position Paper is intended to serve as a resource for healthcare professionals, producers of medicines and cosmetics, as well as concerned coeliac patients, promoting informed decision-making regarding gluten exposure in non-food products.
Safe use of medicines for coeliacs
The updated position paper emphasizes that European and national regulations ensure the safety of all medicines on the market, making them suitable for individuals with coeliac disease.
However, doctors and pharmacists are encouraged to check the gluten content in medications, especially for patients with gluten hypersensitivity or chronic conditions requiring long-term treatment. In most cases, alternative gluten-free formulations are available.
Patients are advised to consult their healthcare providers if they experience hypersensitivity or symptoms mimicking gluten ingestion after starting new medications. Doctors should work closely with patients to find suitable alternatives or confirm the safety of prescribed medicines.
Excipients with gluten in medicines pose little risk
The role of excipients in medicines is to aid stabilization, formulation, and bioavailability. Excipients such as wheat starch may sometimes contain trace amounts of gluten. However, in most cases, the gluten content in medications is so minimal that it poses no significant risk to individuals with coeliac disease.
The European Pharmacopoeia has established that wheat starch used as an excipient can contain up to 0.3% total protein content, a figure comparable to gluten thresholds in gluten-free food (20 mg/kg). This low level of gluten, especially in small doses found in medicines, is considered safe for coeliacs. Nonetheless, AOECS advises caution, particularly for patients requiring long-term use of gluten-containing medications.
Cosmetics and hygiene products with gluten: low risk for coeliacs
Despite the presence of immune cells in the skin, the primary concern for coeliacs arises from gluten ingestion. Cosmetics and topical products, even if they contain gluten, do not pose a significant risk, as gluten molecules are too large to pass through intact skin into the bloodstream.
Other products like lipsticks and toothpaste, which may be inadvertently ingested, are also considered safe for coeliacs due to the extremely low amounts of gluten present.
AOECS highlights that, while there is no specific legislation for gluten-free claims in cosmetics, the International Nomenclature of Cosmetics Ingredients (INCI) can help consumers identify gluten-containing components.
Read & download statement here