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Guidelines to assess confidentiality claims for biocides

The biocidal product regulation (BPR) sets specific rules regarding the confidentiality and electronic public access to certain types of information held by ECHA and the competent authorities.

Information submitted under the biocides regulation shall be either disclosed upon request (Article 66 of the BPR) or made publicly available, free of charge on ECHA’s website (Article 67 of the BPR).

Article 66(4) of the BPR foresees the possibility for the applicant to request confidential treatment of the information it has submitted which would otherwise be disseminated.

This requires the submission of a justification as to why the disclosure of such information would be potentially harmful for its commercial interests or those of any other party concerned. The competent authority assesses the justification and decides on the confidentiality request (acceptance or rejection).

If you are preparing applications under biocides regulation, take a look at ECHA new guidelines related to confidentiality claims. These guidelines are based on experience gained so far in assessing confidentiality claims. They will also be used by authorities to harmonise their practices when assessing the claims.

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Source: ECHA

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