{"id":3208,"date":"2026-01-14T10:09:29","date_gmt":"2026-01-14T09:09:29","guid":{"rendered":"https:\/\/nordiik.com\/en\/?p=3208"},"modified":"2026-01-14T10:09:29","modified_gmt":"2026-01-14T09:09:29","slug":"extension-of-data-protection-for-active-substances","status":"publish","type":"post","link":"https:\/\/nordiik.com\/en\/biocides\/extension-of-data-protection-for-active-substances\/","title":{"rendered":"Extension of data protection for active substances under the Biocidal Products Regulation"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_column_text css=\u00bb\u00bb]<\/p>\n<h1><strong>Extension of data protection for active substances under the Biocidal Products Regulation<\/strong><\/h1>\n<p>The European Commission has put forward a proposal to amend Regulation (EU) No 528\/2012 in order to address the <a href=\"https:\/\/nordiik.com\/en\/biocides\/article-95-data-protection\/\"><strong><em>expiration of data protection for active substances<\/em><\/strong><\/a> scheduled for 31 December 2025. This proposal is a direct consequence of the repeated delays affecting the review of active substances included in the regulatory assessment programme.<\/p>\n<p>&nbsp;<\/p>\n<p>The aim is to strike an appropriate balance between <strong><em>data protection<\/em><\/strong> and regulatory simplification, while continuing to ensure a high level of protection for human health, animal health and the environment.<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>Regulatory context and delays in the review programme<\/strong><\/h4>\n<p>The review programme for biocidal active substances was launched in 2000 and was originally expected to be completed by 2010.<\/p>\n<p>&nbsp;<\/p>\n<p>However, due to persistent structural delays, its completion has now been postponed until 31 December 2030.<\/p>\n<p>&nbsp;<\/p>\n<p>These delays are mainly attributable to limited resources within national competent authorities, as well as the need to generate additional data, including studies required under the scientific criteria for <strong><em>endocrine disruptors<\/em><\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>Challenges linked to the expiration of data protection<\/strong><\/h4>\n<p>Under the current legal framework, <strong><em>data protection for existing active substances under review<\/em><\/strong> would expire on 31 December 2025. As a result, regulatory data could become accessible before the review process has been finalised.<\/p>\n<p>&nbsp;<\/p>\n<p>According to the EU, this situation would jeopardise significant investments made in regulatory studies, particularly data generated since 2018, such as studies addressing <strong><em>endocrine-disrupting properties<\/em><\/strong>. Moreover, the lack of protection would encourage so-called \u201cfree-riding\u201d, allowing third parties to rely on data owned by others without providing compensation.<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>Proposal to extend protection until 2030<\/strong><\/h4>\n<p>The Commission\u2019s proposal provides for an extension of <strong><em>data protection<\/em><\/strong> until 31 December 2030 for all active substances and product-type combinations that were still under review on 7 June 2018.<\/p>\n<p>&nbsp;<\/p>\n<p>The extension applies to the entire data package contained in the dossier and is not limited to specific endpoints, such as endocrine disruption.<\/p>\n<p>&nbsp;<\/p>\n<p>A temporary protection gap is anticipated between 1 January 2026 and the entry into force of the amended regulation. During this period, <strong><em>data owners<\/em><\/strong> would be entitled to seek financial compensation from suppliers that have benefited from the absence of protection.<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>Implications for the sector and competition<\/strong><\/h4>\n<p>The proposed extension is intended to safeguard <strong><em>data owners<\/em><\/strong> by allowing them to recover investments made in complex and costly regulatory studies. According to the EU, it also aims to support <strong><em>fair competition<\/em><\/strong> and prevent unfair market practices within the biocides sector. Nevertheless, the measure may lead to increased costs for alternative suppliers, who may need to negotiate <strong><em>letters of access<\/em><\/strong> or pay compensation.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Do you need support to comply with the Biocidal Products Regulation? <\/strong><a href=\"https:\/\/nordiik.com\/en\/contact-nordiik\/\">Nordiik can support you throughout the regulatory process \u2014 <strong><em>contact us<\/em><\/strong>.<\/a><\/p>\n<p><strong>Source: <a href=\"https:\/\/food.ec.europa.eu\/document\/download\/d8c35be0-ecc9-432b-a645-fd363681f5d3_en?filename=horiz_omnibus_reg_com-2025-1020-1-p1.pdf\">EU<\/a><\/strong>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Extension of data protection for active substances under the Biocidal Products Regulation. EC agree to extend this period until 2030.<\/p>\n","protected":false},"author":1,"featured_media":3209,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[122],"tags":[102,266,96,95,17,98,270,97],"class_list":["post-3208","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biocides","tag-active-substances","tag-article-95-list","tag-biocidal-products","tag-biocides","tag-bpr","tag-bpr-regulation","tag-data-protection-of-active-substances","tag-regulation-ue-528-2012"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Extension of data protection for active substances | Nordiik<\/title>\n<meta name=\"description\" content=\"Extension of data protection for active substances under the Biocidal Products Regulation. 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