As a rule, disinfectants are covered by the Biocidal Products Regulation. However, a product intended be placed in contact with the human skin or with the teeth and the mucous membranes of the oral cavity (and for which no therapeutic claims are made) may classify as a cosmetic if the antiseptic properties are secondary to […]
Yes, you can, but it is important to note that the party/parties you supply with your product is/are responsible for fulfilling the requirements of the Biocidal Products Regulation (BPR, 528/2012/EC). In other words, not the exporter (established outside the EU), but the importer (established in the EU) is bound by the obligations of the BPR. […]
Under normal circumstances, biocidal products, including (hand) disinfectants, must be authorised prior to being made available on the EU market. In case of danger to public health, animal health or the environment, Article 55 of the Biocidal Products Regulation (BPR, 528/2012/EC) allows Member States to permit the placement of biocides on their market that do not […]
Not all biocidal products are yet covered by the Biocidal Products Regulation (BPR). For example, biocidal products containing an active substance included in the Review Programme of the European Commission are subject to national rules pending the final decision on the approval of the active substance (and up to 3 years after). Biocidal products containing […]
It is often assumed that all active substance suppliers must be included on the Article 95 list. However, under the BPR, it is sufficient if one company in the supply chain is listed. Consequentially, if your supplier is not listed in the Article 95 list, this does not necessarily indicate their (and your) non-compliance. […]
The BPR stipulates that the costs associated with active substance approval are to be shared among the suppliers of a given active substance. In order to promote fair competition (and prevent “free-riding”), ECHA has compiled the so-called “Article 95 list”. This list includes only suppliers who demonstrably possess or have access to a complete EU […]
The difference between a biocidal product and a treated article lies in the purpose and function of the product. A biocidal product is defined as: a substance or mixture; consisting of, containing or generating one or more active substances or generated from precursors which themselves are not considered as active substances; with the intention of […]