Biocides: eight new ‘low risk’ active substances approved in EU
Eight new ‘low risk’ active substances have been assessed by the European Chemicals Agency (ECHA) and will be included in Annex I of the Biocidal Products Regulation (BPR). In March this year, citric acid was added as a disinfectant/algaecide not intended for direct application to humans or animals, and a further seven will be included as repellent or attractant actives from 1 June 2021.
Companies looking to market products containing these actives may also benefit from the European Union’s simplified authorisation procedure, designed to expedite the launch of ‘minimum risk biocidal products’ under the BPR.
Annex I amendment
Until now, 19 actives have been identified as low-risk substances in Annex I of the BPR, including food additives (e.g. sodium benzoate), pheromones (e.g. Oct-1-en-3-ol), weak acids, alcohols and vegetable oils (e.g. peppermint oil).
Following the recent food and feed derogation, seven additional active substances have been assessed and will be included in Annex I of the BPR as repellent or attractant actives from 1 June 2021. The active substances are:
- Vinegar (maximum of 10% acetic acid) CAS No 8028-52-2
- Saccharomyces cerevisiae CAS No 68876-77-7
- Powdered eggs
- Honey CAS No 8028-66-8
- D-fructose CAS No 57-48-7
- Concentrated apple juice
In addition, citric acid CAS No 77-92-9 has been assessed as eligible for use as a disinfectant/algaecide not intended for direct application to humans or animals. It was added to Annex I on 29 March 2021.
Simplified authorisation procedure
The simplified authorisation procedure also means that once authorisation has been granted by one European Union (EU) Member State, companies only need to submit a notification in each relevant Member State 30 days before placing the product on the market in that particular territory. This makes it an easy way to access the EU’s 27 countries, as well as Switzerland and Norway. In addition, there are no specific restrictions on the product’s claims/statements as long as they follow the BPR guidelines applicable to all biocidal products, low risk or not.
Opportunities for US manufacturers
If your company has a product placed on the US market that contains either citric acid or peppermint oil, you may be eligible to launch this product on the EU market provided that the conditions of Article 25 of the BPR are met (see opposite). Citric acid and peppermint oil are eligible under FIFRA’s Minimum Risk Pesticide Exemption, also known as FIFRA 25(b)s, and are also included in Annex I of the BPR.
How TSG can help
Our team of regulatory consultants have many years’ experience assisting clients in navigating the BPR, from active substance applications to gaining product authorisations throughout the EU for a wide range of products and uses.
We can help:
- Review the product against the BPR minimum risk product conditions
- Assess the relevance and quality of existing studies
- Prepare and submit biocidal product dossiers
- Provide guidance on label claims and data packages
- Submit applications to add an active substance to Annex I
If you have any questions about our services, or would like to schedule a call with our team of regulatory experts, please get in touch at [email protected]
What is the EU Biocidal Product Regulation?
The EU Biocidal Product Regulation No 528/2012 (BPR) regulates the placing on the market of effective active substances and biocidal products that have acceptable risk for humans, animals and the environment.
What are minimum risk biocides?
In the US, the Environmental Protection Agency (EPA) has exempted certain substances identified as ‘minimum risk pesticides’ from the requirement of registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A similar approach has been taken in the EU under the BPR.
The US list of actives eligible under 40 CFR 152.25 (f) is known as Annex I under BPR. All active substances listed in Annex I have been identified as presenting a low risk without giving rise to concern.
However, the conditions for a biocidal product to qualify as a ‘minimum risk product’ differ from one continent to another. In the EU, biocidal products eligible for a simplified authorisation procedure must comply with all of the following conditions according to Article 25 of the BPR:
- All the active substances in the biocidal product must be on Annex I
- The biocidal product does not contain any inert substance of concern
- The biocidal product does not contain any nanomaterials
- The biocidal product is sufficiently effective
- The handling of the biocidal product and its intended use do not require PPE