Pharmanager Development, provider of services and tools to guarantee the conformity and effectiveness of your products

Biocides

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.

 

 

What Regulations Apply to Biocidal Products?

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.

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

The European market authorization of such products is governed by specific regulations that ensure both compliance and safe use.

528/2012/EU

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.

1272/2008/EC

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.

1907/2006/EC

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.

Verification and Validation of Compliance

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.

Marketing Authorization Dossier Preparation

We prepare your market authorization dossiers for finished products, including scientific, technical, and safety data, to meet the requirements of competent authorities.

Registrations and Declarations Management

We handle administrative procedures, including specific national processes, to ensure a smooth and compliant market entry for your biocidal products.

Support for a New Active Substance

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.

Regulatory Monitoring on Biocides

We track legislative developments in Europe to keep you informed of regulatory changes affecting your products and help you adapt your strategies accordingly.

Pharmanager Development Supports You In:

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.

Whether it’s 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.

Our Answers to Your Questions

How to Obtain a Market Authorization for a Biocidal Product?

For biocidal products requiring authorization, a comprehensive dossier must be submitted, including data on safety, efficacy, and environmental impact. We assist you in the preparation and submission of this dossier.

What Are the Labeling Requirements for Biocidal Products?
 

Labeling must comply with the Biocidal Products Regulation (EU 528/2012) for biocidal claims and the CLP Regulation (EC 1272/2008) if the product is classified as hazardous.

Can I Use Any Substance to Achieve the Desired Effect in My Biocidal Product?

No. Only specific approved substances listed in various official registers can be used as biocidal active substances (AS):

AS officially approved at the EU level (maintained by the European Chemicals Agency, ECHA).
AS listed in Annex I of Regulation (EU) 528/2012 (Biocidal Regulation).
AS included in Regulation (EU) 1062/2014 (Review Program).
It is important to note that these substances are often restricted to specific product types (PTs). For example, if a substance is only approved for PT1 (Human Hygiene), it cannot be used in a product claiming effects related to PT2 (Surface Disinfection).

Additionally, active substances must be sourced from approved suppliers, except for those listed in Annex I of the Biocidal Regulation. Approved suppliers are listed in the Article 95 List, maintained by ECHA.

Quelles sont les obligations en matière d’étiquetage des produits biocides ?

L’étiquetage doit être conforme au règlement CLP (CE) n° 1272/2008 et inclure des mentions de danger, des pictogrammes, et des instructions d’utilisation.

What Is the Procedure for Placing a Biocidal Product on the Market?

There are two main market authorization procedures depending on the active substances used and the claimed efficacy:

1️⃣ Standard Procedure (Permanent Regime)

  • This is the regular and final regime, which will eventually be the only one in effect.
  • It requires obtaining a market authorization (MA) for each biocidal product.
  • This procedure applies when all active substances in the product are officially approved for the claimed efficacy.

2️⃣ Transitional Regime

  • In some cases, regulations allow the marketing of biocidal products containing active substances that are not yet officially approved.
  • To qualify, the biocidal product must contain an active substance listed in Regulation (EU) 1062/2014.
  • Under this regime, an MA is generally not required (except in rare cases). Instead, national regulations of the country where the product is marketed apply for labeling and registration requirements.

Need Advice or Expert Support in This Evolving and Increasingly Stringent Regulatory Context?