Important Allergen Information for Manufacturers re dimethyl fumarate – DMF

In January 2009 Member States of the EU voted to ban dimethyl fumarate (DMF) from consumer products1. DMF is an anti-fungal/biocidal agent and is known to cause physical reactions like dermatitis or allergies. It has been banned from the European market in consumer products as of 1 May 2009. Member states of the EU have the responsibility to ensure that products containing DMF are prohibited from being placed or made available on the market; products already on the market containing more than 0.1 mg/kg will also have to be removed from shelves and may not be sold as of 1 May 2009.

DMF is a fine white crystalline powder, which is used in consumer products to prevent the growth of fungi and mold species. DMF is most often used in sachets or pouches fixed inside furniture or added to footwear boxes. The substance evaporates and impregnates the product, protecting it from moulds. Due to this mode of action, consumers are also affected though the evaporation of DMF through the clothes and onto the skin where it can cause painful contact dermatitis. The symptoms of contact dermatitis include itching, irritation, redness, and burns. Inhalation irritancy has also been reported as has eye irritation where contact is made with the eye.

A significant impact of this ban is that there is an obligation to remove products from the market where it is known that the product, or even parts of the product, contain more than 0.1 mg/kg DMF. High risk products are leather shoes and furniture and those products bearing an ‘antimould’ statement. Soft toys containing DMF have also featured on the EU’s rapid alert system for dangerous consumer products2(RAPEX). It is important to note that the new legislation covers all types of products and is not simply restricted to footwear, furniture and toys.

Allergy Standards Limited is a physician-led global certification body. Our certification incorporates, among other aspects, limits for the presence of certain allergenic or irritant chemicals. Together with our sister company, Allergy Standards Consulting, we are available to assist you with any inquiries that you may have regarding this, or any other consumer protection issue.

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