In the case of many products, it is not always immediately clear what type of product this is. There is also uncertainty as to the legislation under which the products fall and what the corresponding safety and quality requirements are.
There are quite a few laws bordering on cosmetics legislation:
- Medical device legislation (93/42/EC); any instrument, appliance, application, software, material or other article whose function is to diagnose, prevent, monitor, treat or alleviate a disease, injury or handicap, or that is a contraceptive. The primary objective is not attained by pharmacological, immunological or metabolic processes.
- Pharmaceutical legislation (2001/83/EC); substances preventing and curing diseases. Medications attain their primary objective by means of physiological effect.
- Biocide legislation (98/8/EC); substances that combat harmful organisms.
In borderline cases, the legislation with which products must comply is determined on a case-by-case basis. This may vary depending on the expected use, the function of the product, and even the manner in which the product is presented. The latter may change. Thus, products that are the same may fall under various types of legislation, depending on the manner of presentation.
An example of a borderline case is hand soap. Depending on the function, the product may fall under various types of legislation:
- Product is intended to clean hands: cosmetics legislation.
- Product is intended to disinfect hands: the substance contains a biocide and falls under the biocide legislation.
- Product is intended for pre-operative use: medical device legislation.
Another example of a borderline case is mouthwash. If the mouthwash contains alcohol and is presented as a disinfectant, the mouthwash falls under the medical device legislation. If the product is presented as cleansing or in order to have fresh breath, it falls under cosmetics legislation.