{"id":1901,"date":"2024-11-21T11:52:42","date_gmt":"2024-11-21T10:52:42","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?post_type=sector&p=1901"},"modified":"2025-02-03T12:25:19","modified_gmt":"2025-02-03T11:25:19","slug":"biocidal-products","status":"publish","type":"sector","link":"https:\/\/www.pharmanager-development.com\/en\/secteur\/biocidal-products\/","title":{"rendered":"Biocides"},"content":{"rendered":"\n
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Accueil<\/a><\/span><\/span><\/div> <\/div>\n
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Biocides<\/span><\/h1>\n

At Pharmanager Development, we leverage our expertise to support you in the development and compliance of your biocidal products. These products, composed of one or more active substances, are designed to eliminate, repel, or neutralize harmful organisms. They play a key role in protecting human, animal, and environmental health.<\/span><\/p>\n

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What Regulations Apply to Biocidal Products?<\/h2>\n

Biocidal products are classified into 22 product types based on their intended use. These include specific categories such as veterinary hygiene products, disinfectants for surfaces not intended for humans or animals, and repellents or baits for pests.<\/p>\n

Our team, which includes a specialized toxicologist, ensures a comprehensive approach to guarantee the safety, performance, and compliance of your products in Europe.<\/p>\n

The European market authorization of such products is governed by specific regulations that ensure both compliance and safe use.<\/p>\n <\/div>\n <\/div>\n

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528\/2012<\/strong>\/EU<\/h3>\n <\/div>\n
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This regulation establishes the rules for the marketing and use of biocidal products within the European Union. It covers the approval of active substances, product authorization, and labeling and safety requirements, ensuring effective protection for users and the environment.<\/p>\n <\/div>\n <\/div>\n

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1272\/2008<\/strong>\/EC<\/h3>\n <\/div>\n
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This regulation harmonizes the classification, labeling, and packaging of chemical products, including biocides. It mandates hazard statements, safety pictograms, and notification to poison control centers (toxicovigilance) to ensure clear information and controlled product use.<\/p>\n <\/div>\n <\/div>\n

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1907\/2006<\/strong>\/EC<\/strong><\/h3>\n <\/div>\n
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This regulation aims to secure the production and use of chemical substances through a reinforced traceability system. It requires manufacturers to provide appropriate Safety Data Sheets (SDS) and ensure regulatory compliance of the substances used in biocidal products.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n

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Verification and Validation of Compliance <\/span><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We analyze the composition and labeling of your biocidal products to ensure compliance with Regulation (EU) No. 528\/2012 and Regulation (EC) No. 1272\/2008, as well as applicable national regulations.<\/span><\/p>\n <\/div>\n <\/div>\n

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Marketing Authorization Dossier Preparation<\/span><\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We prepare your market authorization dossiers for finished products, including scientific, technical, and safety data, to meet the requirements of competent authorities.<\/span><\/p>\n <\/div>\n <\/div>\n

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Registrations and Declarations Management <\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We handle administrative procedures, including specific national processes, to ensure a smooth and compliant market entry for your biocidal products.<\/span><\/p>\n <\/div>\n <\/div>\n

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Support for a New Active Substance <\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We guide you through the approval process for a new active substance in accordance with Regulation (EU) No. 528\/2012, ensuring compliance with the highest standards.<\/span><\/p>\n <\/div>\n <\/div>\n

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Regulatory Monitoring on Biocides <\/strong><\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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We track legislative developments in Europe to keep you informed of regulatory changes affecting your products and help you adapt your strategies accordingly.<\/span><\/p>\n <\/div>\n <\/div>\n <\/div>\n \n

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Pharmanager Development Supports You In:<\/h2>\n

We assist you at every stage of your biocidal products’ lifecycle, from their initial design to market entry. With our unique expertise and the involvement of our specialized toxicologist, we help ensure the safety of your formulations, regulatory compliance, and approval by competent authorities.<\/p>\n

Whether it\u2019s developing new active substances, demonstrating product efficacy, or validating labeling, our team provides comprehensive and tailored support. We are committed to maximizing your success in the European market by anticipating legislative requirements and ensuring flawless compliance.<\/p>\n \n

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Explore Our Case Studies<\/h2>\n <\/div>\n
\n \n View all case studies<\/span>\n <\/a>\n <\/div>\n \n <\/div>\n
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\n \n <\/span>\n 28 January 2025 <\/span>\n \n Biocides: Comparative analysis of regulation, effectiveness, and reclassification risks<\/a>\n <\/span>\n <\/div>\n <\/div>\n
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\n \n <\/span>\n 8 January 2025 <\/span>\n \n Audit of cosmetic product positioning: understanding and avoiding risks<\/a>\n <\/span>\n <\/div>\n <\/div>\n
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\n \n <\/span>\n 7 January 2025 <\/span>\n \n Case study: regulation and effectiveness of anti-lice sprays<\/a>\n <\/span>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<\/section>\n\n