Masterarbeit
Classification of Antiseptics and Disinfectants for Human use. The Demarcation between Biocides, Medicinal Products, Medical Devices and Cosmetics ***
Dr. Thomas Flötotto (2013)
Language: English
This thesis addresses the borderline classification of disinfectants/antiseptics for human use, like hand disinfectants, antibacterial hand washes, surgical scrubs, antibacterial deodorants, wound irrigation solutions and related products. The classification of these products is a case-by-case decision, requiring that all characteristics of a particular product be considered. Classification depends especially on factors such as claims, product presentation, composition, mode of action and application mode.
Correct classification of disinfectants/antiseptics can be a difficult task as these products often seemingly meet the legal definition of different product classes (so called “Borderline Products”). For example, hand disinfectants may be classified as biocides as they are intended for combating harmful organisms. They may, however, also fall under the legal definition of a medicinal product by presentation if they are intended to prevent an infection. The borderline between these product classes can be very narrow, with classification depending on a single word in the label claim. A classification manual provides that a surgical hand scrub labeled as “effective” against hepatitis C is a biocide, while the same product should be classified as medicinal if it claims "prevention" of a hepatitis C infection.
Products at the borderline between medicinal products and medical devices are, for example, antimicrobial wound irrigation solutions. These products may be classified as medical devices if the primary function is mechanical cleaning (rinsing) of wounds, the antimicrobial action being supportive. If the primary function of a product is providing an antiseptic effect, it will be classified as medicinal product (e.g. antiseptic wound gels). Wound dressings containing antimicrobial agents (e.g. plaster containing silver), will usually be regarded as medical devices, unless they are specially designed to function as a drug delivery vehicle, in which case they are medicinal products. Antiseptics for use on patients are generally regarded as medicinal products, even if they are used on intact skin (e.g. pre injection swabs).
In comparable concentrations, antibacterial ingredients, such as chlorhexidine or polihexanide, may be used as active ingredients in medicinal products or preservatives in cosmetics. If such cosmetics are used on intact (healthy) skin, they will unusually not be regarded as medicinal products by function as they dont have an appreciable effect on physiological function. However, mouthwash solutions containing these ingredients may be regarded as medicinal products by function if they are liable to act on physiological function. The classification of such products is complicated because of the fact that there is no binding legal definition for the term pharmacological action. Antiseptic or antibacterial claims should generally be allowed for cosmetic products as long as the product in question has a primary cosmetic function. However, if conclusion can be made from a products presentation that it is primary intended to be antimicrobial or antiseptic, it might be classified as medicinal product or biocide.
Considerations must be given to the fact that legal definitions are not interpreted uniformly by the different EU member states authorities. For example, the German authorities regard all hand disinfectants used in medical facilities as medicinal products. Then again, some countries (Italy, Spain) regard all products used on intact skin as biocidal products, including antiseptics used on patients. Some countries currently do not accept claims like "antibacterial" or "disinfecting" for cosmetic products. This lack of harmonisation is a burden for manufacturers operating on the European market.
The new regulations for biocidal products and cosmetics and the proposed new medical devices regulation will not eradicate the borderline classification issues for the aforementioned products, as the legal definitions are essentially the same as those in the directives. However, these new regulations will empower the commission to decide whether a product is a cosmetic product, a biocidal product or medical devices. This should facilitate the harmonisation of product classification within the European Union.
Pages: 64, Annexes: 1 pages 1