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U.S. Mission to the European Union

MR-59 / Placing products on the EU market: The case of Chemicals, Pesticides, Biocides, Pharmaceutic

Summary
This report gives an overview of EU chemicals legislation and specific rules on products containing chemicals such as pesticides, biocides, pharmaceuticals and cosmetics. It is comparing at one glance the different pieces of legislation, their definition of the product and their procedures for getting the product on the EU market.
This is particularly useful for borderline cases, as this is often the case with pesticides, biocides, pharmaceuticals and cosmetics. For some products, it may be difficult to determine the classification under EU law: is a mosquito repellant suntan lotion or a shampoo that controls dandruff a biocide, a pharmaceutical or a cosmetic under EU legislation? This will depend on the purpose and use of the product, its marketing and ingredients. It is up to manufacturers to determine the classification of their product and it is important that they make informed decision, not only to avoid penalties but simply because product approval procedures are different: no pre-market approval for cosmetics but pre-market authorization for pharmaceuticals, biocides and pesticides.
It is important to note that, for all the products described in this report, no CE mark is required for the EU market.