Biocidal active substances
Only approved active substances or existing active substances that are currently under review in the EU’s risk assessment programme may be used in biocidal products. The European Chemicals Agency (ECHA) maintains a product type specific list of active substance suppliers. Active substances may be used in products if the supplier of the active substance or product is included in the list.
Assessing active substances and decision-making
An active substance is assessed and then either approved or banned at the EU level for each product type. Decisions on active substances are made based on risk assessment, opinions of the European Chemical Agency’s (ECHA) Biocidal Products Committee (BPC) and the EU’s Biocidal Products Standing Committee’s vote.
An active substance in a biocidal product is approved with a regulation. The Approval Regulation can contain restrictions on use. An active substance can also be banned by a Commission decision.
The approval is normally valid for 10 years, but the approval of an active substance that is a candidate for substitution is only valid for 7 years. The approval does not cover nanomaterials, unless they are reviewed. The authorisation holder of an active substance must submit an application for renewal of the authorisation 550 days before the existing authorisation expires.
Active substances that cannot be approved
If an active substance contains critical properties, it might not be approved or it is approved only for certain purposes. Active substances that are classified as carcinogenic, mutagenic or toxic for reproduction (category 1A or 1B) cannot be approved. Also active substances that are considered to have endocrine-disrupting properties or that are of high environmental concern (PBT or vPvB substances) cannot be approved.
An active substance that meets the exclusion criteria can be approved in the following situations:
- if the risk from exposure to the substance in the product is negligible due to the manner of use, or
- if the substance is deemed necessary in order to prevent or control serious hazards to human or animal health and the environment
- if non-approval of the substance would cause a disproportionately negative impact on society compared to the risks to human and animal health or the environment arising from use of the substance.
Before the Standing Committee can approve an active substance that meets the exclusion criteria, the EU Commission gathers information on the essential need for further use of the active substance by means of a public consultation.
Active substances that are candidates for substitution
A product containing an active substance that is candidate for substitution is subject to comparative assessment prior to its approval. In this assessment, the product is compared to products already available on the market. If there are better options available, the product containing the active substance that is candidate for substitution will not be approved. An active substance shall be considered a candidate for substitution if any of the following conditions are met:
- the substance meets at least one of the exclusion criteria, but may be approved in accordance with the derogation
- the substance is classified as a respiratory sensitizer
- the toxicological reference values of the substance are significantly lower than the values for most approved active substances of the same product type and with the same usages
- the substance meets two of the criteria for being a PBT substance
- the substance causes concern even with very restrictive risk management measures
- the substance contains a significant proportion of non-active isomers or impurities.
As part of the risk assessment, the ECHA asks via a public consultation for information on possible substitutes or other alternative methods for active substances that are candidates for substitution.