Based on the experience gained from assessing confidentiality claims, ECHA has published Guidelines for assessing the confidentiality of the information contained in the Competent Assessment Report (CAR) and Product Assessment Report (PAR)
The guide aims to support the Member State Competent Authorities in assessing the confidentiality of the information submitted either for approval of an active substance or for authorisation of a biocidal product. Consequently, the guide is also relevant for companies making applications under the BPR.
The guide specifies that an applicant requesting confidential treatment of information must substantiate the justification, and furthermore that the confidentiality claims should be made in the IUCLID dossier. Examples of invalid and unsubstantiated justifications are included.
For more information on biocidal products regulation, please contact senior regulatory expert:
Michael Fink
mif@dhigroup.com
Tel +45 4516 9156
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