Biocides submission manual : Process of confidentiality requests for biocide applications

In accordance with Article 67 of the Biocidal Product Regulation (BPR), the European Chemicals Agency (ECHA) is required to publish information it holds on active substances and biocidal products free of charge on the internet. However, in certain cases information can be withheld according to Article 66(4), if the person submitting the information also submits a justification as to why publishing the information could be harmful for their commercial interests or those of any other party concerned. Such justifications will be assessed by the Authorities (the MSCA or ECHA) in accordance with Article 67(3) and 67(4), and where the justification is accepted as valid, the information concerned will not be published. This manual is part of the Biocides Submission Manual (BSM) series and should help readers understand: - The legal basis of the dissemination process - How to make confidentiality claims in IUCLID in general: how to set the flags and insert a justification - Which information from the dossier can be claimed confidential for active substances and biocidal products and where to place the flags in IUCLID - How to draft confidentiality claim justifications. This manual provides information on the content of confidentiality claims and aims to help those in industry, who are responsible for preparing IUCLID dossiers. Please see Biocide Submission Manual ‘Technical guide: using IUCLID’ on the ECHA website for information on preparing a general IUCLID dossier for biocides applications. All the Biocides Submission Manuals can be accessed from the ECHA website. It should be noted that in cases where urgent action is essential to protect human health, animal health, safety or the environment or for other reasons of overriding public interest, the authorities shall disclose information which would normally be considered confidential, in accordance with Article 66(2)