{"id":5131,"date":"2026-02-23T16:50:11","date_gmt":"2026-02-23T15:50:11","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?post_type=sector&p=5131"},"modified":"2026-02-24T14:42:08","modified_gmt":"2026-02-24T13:42:08","slug":"animal-hygiene-products","status":"publish","type":"sector","link":"https:\/\/www.pharmanager-development.com\/en\/secteur\/animal-hygiene-products\/","title":{"rendered":"Animal hygiene\u00a0products"},"content":{"rendered":"\n
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Accueil<\/a><\/span><\/span><\/div> <\/div>\n
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Animal hygiene products: regulatory framework and scientific support in Europe<\/h1>\n

Pharmanager Development supports companies in the development of animal hygiene products, also referred to as animal cosmetic or animal care products. We help you structure market access in Europe, demonstrate regulatory compliance, and substantiate the safety of animal hygiene products.<\/p>\n \n <\/div>\n <\/div>\n <\/div>\n<\/section>\n\n\n\n

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Which regulations apply?<\/h2>\n

Animal hygiene products do not fall under the European Cosmetic Regulation applicable to products intended for human use. Their framework is based on a set of cross-sector regulations harmonised at European Union level.These texts form the foundation of the European regulatory framework applicable to animal hygiene products. However, their application depends on the precise positioning of the product, its claims, and its intended use.<\/p>\n <\/div>\n <\/div>\n

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1272<\/span>\/2008\/<\/span>EC\u202f<\/span>\u00a0<\/span><\/span>(<\/span>CLP)\u00a0<\/span><\/span><\/h3>\n <\/div>\n
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Relating to the classification, labelling and packaging of substances and mixtures, it requires a precise assessment of the product\u2019s hazards and sets out the mandatory information that must appear on the label. Any company placing animal hygiene products on the market must verify the classification of its formulation and ensure that its regulatory information is fully compliant.<\/p>\n <\/div>\n <\/div>\n

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1907\/2006\/<\/span>EC\u202f<\/span>\u00a0<\/span><\/span>(<\/span>REACH<\/span>)\u00a0<\/span><\/span><\/h3>\n <\/div>\n
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It governs the use of chemical substances and sets obligations regarding restrictions, registration, and ingredient compliance. The product composition must be carefully reviewed to ensure that the raw materials used meet the applicable European requirements.<\/p>\n <\/div>\n <\/div>\n

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2023<\/span>\/988\/EU<\/span><\/span>\u202f<\/span><\/span><\/h3>\n <\/div>\n
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Relating to general product safety, it requires that any product placed on the European market be safe under normal or reasonably foreseeable conditions of use. The economic operator must be able to demonstrate the safety of the product for the animal as well as for the human user.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/section>\n\n\n

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Formula and labelling compliance validation<\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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Regulatory analysis of the ingredients contained in the formula and verification of their compliance with the applicable regulations, combined with a review of the labelling of animal hygiene products, in particular with regard to mandatory statements.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/article>\n<\/div>\n <\/div>\n <\/div>\n

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Regulatory positioning audit<\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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Analysis of the product\u2019s regulatory status and assessment of the risk of reclassification under another regulatory framework.\u00a0<\/span><\/span><\/p>\n <\/div>\n <\/div>\n

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Safety assessment<\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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Conducting a safety assessment of the product for the target species and for the human user, supported by our in-house toxicological expertise. You are required to place only safe products on the market. We support you in providing the necessary scientific justification.\u00a0<\/span><\/span><\/p>\n <\/div>\n <\/div>\n

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Preparation of the technical file and completion of regulatory notifications where applicable.<\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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Compilation of a comprehensive technical file gathering all documentation required to demonstrate the product\u2019s regulatory compliance and safety, including, where applicable, support with the relevant notification procedures depending on the product\u2019s specifications and regulatory status.<\/p>\n <\/div>\n <\/div>\n

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Regulatory review of your communication<\/h3>\n \n <\/span>\n <\/span>\n <\/span>\n
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Analysis of your marketing materials, website content and commercial statements in order to secure the claims made for your animal hygiene products.<\/span><\/span><\/p>\n <\/div>\n <\/div>\n <\/div>\n \n

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Our regulatory expertise supporting your animal hygiene products<\/h2>\n

Pharmanager Development supports you in ensuring the regulatory compliance of your animal hygiene products in Europe through:<\/span><\/p>\n