Article 95 of the EU Biocides Regulation 528/2012 (EU BPR)
As a result of the recent spike in demand for hand sanitizers and disinfectants, we got several questions about the regulatory requirements for importing biocidal active substances or products.
These questions are often focused on compliance with REACH requirements. That makes sense, given that usually manufacturers and importers of chemical substances have to register their substance under REACH. It does, however work differently for biocidal products.
Biocidal active substances as well as biocidal products are – in the EU – regulated under the Biocidal Products Regulation (EU) 528/2012 or BPR. The BPR requires all biocides to undergo an authorization before they can be placed on the market, and the substances in the biocidal product must be (pre)-approved.
Similar to REACH, the BPR is managed and implemented by ECHA, the European Chemicals Agency.
When importing a chemical for biocidal use, it is often the case that the substance is already approved in the EU as an active substance and or Product Type combination. For example, ethanol for use in hand sanitizers. This does not mean however, that you can place it on the market without further regulatory requirements.
Companies placing biocidal products on the market have to ensure that either their substance or product suppliers or themselves are included in the Article 95 list under the Biocidal Products Regulation.
The objective of Article 95 of the EU Biocides Regulation 528/2012 (EU BPR) is to ensure that the costs of generating data and supporting active substances are shared fairly. Importers that do not submit their own dossier on an active substance under the EU BPR can therefore submit a letter of access to ECHA when they apply to be included in the Article 95 alternative suppliers of active substances list.
ECHA updates the Article 95 list on a regular basis. This way, all suppliers who submitted an application in accordance with Article 95 of the BPR, and who have been found compliant by ECHA, can easily be identified by companies purchasing the substances in order to demonstrate compliance to their customers and relevant authorities.
In addition to manufacturers and importers of substances, the amending Regulation (EU) No 334/2014 also allows final product suppliers, such as formulators, to apply to be included in the Article 95 list.
More information on the BPR and the Article 95 list can be found on the ECHA website.
At Ecomatters we are glad to support you in identifying all relevant chemical safety regulations applying to your substance or product.
In order to join the Article 95 suppliers list we can support your company in compiling all necessary information, advice and mediate in the acquisition of a Letter of Access from the data holders, and submitting the registration in the right digital format to ECHA.