Pharmanager Development, provider of services and tools to guarantee the conformity and effectiveness of your products
Phinn connection
Phinn connection
Accueil > Animal hygiene products

Animal hygiene products: regulatory framework and scientific support in Europe

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.

Which regulations apply?

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.

1272/2008/EC  (CLP) 

Relating to the classification, labelling and packaging of substances and mixtures, it requires a precise assessment of the product’s 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.

1907/2006/EC  (REACH) 

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.

2023/988/EU 

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.

Formula and labelling compliance validation

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.

Regulatory positioning audit

Analysis of the product’s regulatory status and assessment of the risk of reclassification under another regulatory framework. 

Safety assessment

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. 

Preparation of the technical file and completion of regulatory notifications where applicable.

Compilation of a comprehensive technical file gathering all documentation required to demonstrate the product’s regulatory compliance and safety, including, where applicable, support with the relevant notification procedures depending on the product’s specifications and regulatory status.

Regulatory review of your communication

Analysis of your marketing materials, website content and commercial statements in order to secure the claims made for your animal hygiene products.

Our regulatory expertise supporting your animal hygiene products

Pharmanager Development supports you in ensuring the regulatory compliance of your animal hygiene products in Europe through:

  • In-depth knowledge of CLP and REACH Regulations
  • Expertise in human cosmetics applied to products handled by users
  • Strong understanding of Regulation (EU) 2023/988
  • A scientific safety assessment carried out by our toxicologist
Contactez-nous

Regulation of animal hygiene products

Are animal cosmetic products subject to the European Cosmetic Regulation? 

No. The European Cosmetic Regulation applies exclusively to products intended for human use. Products within the pet care sector, including animal hygiene products, are governed by distinct cross-sector regulatory frameworks.

Is the European regulation of animal hygiene products harmonised? 

No. Animal hygiene products are not covered by a specific harmonised regulation at European level. However, they are subject to cross-sector regulations, such as REACH and CLP, which are harmonised across the European Union.

Is a safety assessment required for an animal hygiene product? 

Yes. Any product placed on the market, including animal hygiene products, may only be marketed if it is safe under normal or reasonably foreseeable conditions of use. 

Can a dog shampoo be reclassified under another regulatory status? 

Yes. Depending on its conditions of use and the claims made on its labelling, a dog shampoo may fall under another regulatory framework, particularly if it claims a disinfectant or antiparasitic action. A regulatory status analysis is necessary to secure its positioning. 

Do you need guidance or have a question in this constantly evolving and increasingly demanding regulatory environment? Are you looking for the expertise of a specialist?

Contactez-nous