{"id":14401,"date":"2025-10-27T12:20:44","date_gmt":"2025-10-27T10:20:44","guid":{"rendered":"https:\/\/servireach.com\/blog\/new-biocidal-active-substances\/"},"modified":"2025-10-28T12:58:52","modified_gmt":"2025-10-28T10:58:52","slug":"new-biocidal-active-substances","status":"publish","type":"post","link":"https:\/\/servireach.com\/en\/blog\/new-biocidal-active-substances\/","title":{"rendered":"New biocidal active substances"},"content":{"rendered":"\n

Do you market biocidal products?
Find out what a new active substance is, how it is approved in the EU, and which steps to follow to ensure compliance with the Biocidal Products Regulation (BPR). <\/p>\n\n\n\n

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The approval of new biocidal active substances<\/strong> is a crucial step for innovation in the biocides sector. It enables the development of more effective, sustainable products adapted to emerging needs \u2014 but it also represents a complex regulatory challenge<\/strong> that requires investment, technical expertise, and a well-defined strategy. <\/p>\n\n\n\n

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Under the Biocidal Products Regulation (EU) No 528\/2012<\/a>, any new active substance must undergo a complete evaluation and approval process before it can be used in biocidal products placed on the EU market. <\/p>\n\n\n\n

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What is considered a new active substance?<\/strong><\/h2>\n\n\n\n
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A new active substance<\/strong> is defined as one that was not placed on the market<\/strong> as part of a biocidal product before 14 May 2000<\/strong>.
Unlike existing active substances (which are included in the EU Review Programme), new ones cannot be used in biocidal products until they have been approved through the formal regulatory procedure. <\/p>\n<\/div>\n\n\n\n

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Step-by-Step approval process<\/strong><\/h2>\n\n\n\n
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  1. Submission of the Dossier and initial evaluation<\/strong><\/strong><\/li>\n<\/ol>\n\n\n\n

    The applicant prepares a technical dossier and submits it to an evaluating Member State. The authority assesses whether the substance can be considered safe and effective for use as a biocide. <\/p>\n\n\n\n

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    1. Opinion of the Biocidal Products Committee (BPC)<\/strong><\/strong> <\/li>\n<\/ol>\n\n\n\n

      ECHA\u2019s Biocidal Products Committee (BPC) reviews the report from the evaluating Member State and issues a scientific opinion on the suitability of the substance. <\/p>\n\n\n\n

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      1. Decision by the European Commission<\/strong> <\/li>\n<\/ol>\n\n\n\n

        Based on the BPC opinion, the European Commission adopts the final approval decision, including the conditions of use<\/strong> and the date of entry into force<\/strong>. <\/p>\n\n\n\n

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        1. Authorisation of products containing the substance<\/strong><\/li>\n<\/ol>\n\n\n\n

          Once the substance has been approved, any biocidal product containing it must obtain product authorisation<\/strong> before being placed on the EU market <\/p>\n\n\n\n

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          Key Points to consider<\/strong><\/h2>\n\n\n\n