In the realm of chemical regulations, ensuring public safety while balancing industrial needs is paramount. The Biocidal Products Regulation (BPR) plays a crucial role in this balance by managing active substances used in biocidal products across the EU. A critical part of this process involves identifying potential candidates for substitution (CfS) and assessing derogations when certain substances meet exclusion criteria.

What is a Candidate for Substitution (CfS)?

Under Article 10(1) of the BPR, if an active substance exhibits hazardous properties—such as being a carcinogen, mutagen, or reprotoxic—it can be identified as a CfS. This status indicates that the substance poses significant risks and should be replaced by safer alternatives where possible. Before ECHA delivers its opinion on the approval or renewal of these substances, it launches a consultation to gather information on potential alternatives.

Exclusion Criteria Under the BPR

In addition to being labeled a CfS, some substances may meet the exclusion criteria outlined in Article 5(1) of the BPR. These criteria include substances that are:

• Carcinogenic, mutagenic, or reprotoxic (CMR), as per categories 1A or 1B of the CLP Regulation.
• Endocrine disruptors.
• Persistent, bioaccumulative, and toxic (PBT).
• Very persistent and very bioaccumulative (vPvB).

Substances meeting these criteria are generally not approved for use. However, certain derogations may apply if the risks posed are minimal, if the substance is essential for preventing significant harm, or if rejecting the substance would negatively affect society.

When Derogations Apply

Derogations, outlined in Article 5(2) of the BPR, offer a pathway for approval of substances that meet exclusion criteria under certain conditions. To justify a derogation, it must be shown that:

• The risk to humans, animals, or the environment is negligible.
• The substance is crucial for controlling a serious threat to public health, animal welfare, or environmental protection.
• Refusing the substance would cause disproportionate harm to society compared to its risks.

If at least one derogation condition is satisfied, the active substance may be approved for up to five years, but only for restricted uses. Additionally, Member States are allowed to authorize biocidal products based on local conditions.

Role of Third-Party Consultations

To assess whether substances qualify for derogations, ECHA conducts third-party consultations, gathering evidence on available alternatives and conditions for meeting derogation criteria. This process ensures transparency and allows for a more comprehensive evaluation of potential risks and benefits.

Why Are These Consultations Important?

These consultations provide industry stakeholders and the public with the opportunity to contribute to the decision-making process. By participating, they can present data on alternative substances or technologies that could replace hazardous materials, supporting safer and more sustainable practices.

For up-to-date information on ongoing third-party consultations, visit ECHA’s dedicated consultation page.

Source