Biocides hot topics intro
Biocidal products are used to protect people and animals against harmful organisms, like pests or bacteria. Each biocidal product contains one or several active substances that are designed to control viruses, fungi and other microbes before they cause harm. In some cases, biocides are designed to repel or attract organisms, such as insects.
Biocides are crucial for preventing and controlling the spread of infectious diseases in hospitals and other health facilities. They help restaurants and the food industry keep harmful pathogens out of our food and ensure our drinking water is safe. Biocides are also important in many industrial processes to prevent microorganisms from growing. They play a key role in livestock farming, oil and gas extraction, as well as in the marine industry. Some biocides are intended to preserve materials such as medicines, construction materials and furniture.
However, biocides are not only harmful to the organisms they are meant to control but they can pose risks to people, animals and the environment when used. Therefore, to use biocidal products safely and appropriately, their risks and effectiveness need to be assessed.
The Biocidal Products Regulation (BPR) requires all biocidal products to be authorised before they can be placed on the EU market and used, and their active substances must be approved at EU level. ECHA’s Biocidal Products Committee (BPC) adopts science-based opinions on active substance approvals and Union-wide product authorisations. The European Commission then uses these opinions when deciding whether to authorise the use of the biocidal products or approve the active substances.
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Anticoagulant – or anti-vitamin K (AVK) – rodenticides work to control rodents by interfering with the activation of vitamin K, which is critical for blood clotting. When rodents like rats and mice are exposed, they die from internal bleeding.
Anticoagulant rodenticides contain active substances that are of particular concern to people, animals and the environment, which make them candidates for substitution under the Biocidal Products Regulation (BPR). So, before their use can be authorised, a comparative assessment must be done to know whether there are other, sufficiently effective products or non-chemical control methods available that lowers risks for people, animals and the environment.
In May 2021, the European Commission asked ECHA to carry out a comparative assessment ahead of the renewal of all AVK rodenticides in the EU. ECHA’s Biocidal Products Committee (BPC) finalised its opinion in November 2022.
For the comparative assessment, both chemical and non-chemical alternatives were analysed. Alpha chloralose and cholecalciferol were considered as chemical alternatives for professional users to control mice infestations indoors. Alpha chloralose has been linked to cases of pet poisoning and may be persistent and toxic, potentially fulfilling the substitution criteria. Cholecalciferol is an endocrine disruptor. In addition, like AVKs, high risks for primary and secondary poisoning of domestic animals or wildlife have been concluded for both chemical alternatives. Therefore, the committee could not conclude if these substances are safer for people, animals and the environment, compared to anticoagulant rodenticides.
For non-chemical alternatives, the BPC identifies rodent traps as a suitable alternative for indoor control of mice. This opinion is based on a test carried out inside a farm with one type of rodent trap. The test was done following existing EU guidance and showed that the rodent trap was effective.
Permanent baiting is a preventive method used to avoid infestations. Using anticoagulant rodenticides in permanent baiting is controversial as it is suspected of making rodents resistant to these chemicals, as well as causing poisoning of predators like birds of prey. The use of chemical alternatives is similarly debated, where for alpha chloralose and cholecalciferol a similar conclusion was reached as described above. Carbon dioxide is considered to be a safer alternative than anticoagulant rodenticides.
No conclusion could be drawn whether rodent traps are effective alternatives for permanent baiting, mainly due to the limited information available at the time of opinion making.
The opinion of the BPC was sent to the European Commission in February 2023. The Commission’s eventual decision will support Member States when they start receiving applications for product authorisations for anticoagulant rodenticides.
In 2019, the European Commission requested ECHA to prepare a guidance document for assessing the risks to arthropod pollinators (including bees) when they are exposed to biocides. This initiative is part of actions under the EU biodiversity strategy for 2030 and the Pollinators Initiative, which aim to reverse pollinator decline and preserve biodiversity.
The guidance, published in February 2024, focuses only on bees due to the lack of data on other arthropod pollinators (so called non-bee pollinators). It helps companies applying for active substance approvals or product authorisations to conduct the risk assessment for their applications. It also explains the guiding principles for authorities to evaluate applications and to conclude on a biocidal product’s compliance with the authorisation conditions.
To learn more about the current knowledge on other pollinators than bees, ECHA published in September 2022 a scientific report on the role of non-bee pollinators in pollination, focusing on their biodiversity, ecology and sensitivity to biocides. The aim of this report is to support future research and development of guidance on the assessment of risks of biocides on these pollinators.
The use of creosote as an active substance in the EU is only allowed as wood preservative for two uses: utility poles for electricity and telecommunications, and for railway sleepers. The European Commission took this decision in October 2022, based on the opinion of ECHA’s Biocidal Products Committee (BPC) on the renewal application for this active substance.
Creosote is a mixture containing hundreds of distinct substances, including bi- and polycyclic aromatic hydrocarbons (PAHs), phenols and heterocyclic oxygen-, sulphur- and nitrogen-containing substances. Many of the substances in creosote are harmful to our health or the environment.
Under the Classification, Labelling and Packaging (CLP) Regulation, creosote is classified as a carcinogen in category 1B – meaning that it may cause cancer. It also meets the criteria for being a persistent, bioaccumulative and toxic (PBT) and a very persistent and very bioaccumulative (vPvB) substance. Due to these concerns, creosote meets the exclusion criteria under the Biocidal Products Regulation (BPR). It means that its use is not allowed on the EU market without a specific derogation. As there are currently no suitable alternatives available in certain Member States, the Commission granted the renewal for a maximum of seven years for these two specific uses of creosote.
EU countries can decide if they allow creosote-treated wood to be placed on the market for the two derogated uses and may authorise such products accordingly. On 31 January 2023, the Agency published a list of those Member States where creosote-treated railway sleepers and utility poles may still be placed on the market. The information available on this list came directly from the Member States. From 30 April 2023 onwards, placing these railway sleepers and utility poles on the market is only allowed in Member States listed on ECHA’s website.
Creosote and creosote-related substances are also restricted under the REACH Regulation (entry 31 of Annex XVII). In October 2022, France submitted a new restriction proposal to amend this restriction. This new proposal aims to reduce health and environmental risks associated with the reuse and secondary uses of wood treated with creosote. It is considered necessary as the current restriction is interpreted or applied differently across EU Member States, indicating that the existing regulatory management measures may not be sufficient to control the risks. In addition, the existing restriction is not aligned with the new provisions under the BPR. The BPR also does not cover any supplies of the treated wood after the first placing on the market in any Member State.
Vessels are often treated with antifouling paints, which help prevent algae and molluscs attaching themselves to the hull. Hulls of commercial marine vessels are normally treated by professional users, small leisure boats by their owners.
In 2015, the Biocidal Products Committee’s (BPC) opinion on cybutryne concluded the active substance is persistent and toxic for the environment. This toxicity profile also made it a substance of concern under the EU’s Water Framework Directive.
Following this opinion, the European Commission decided in 2016 not to allow the use of cybutryne on the EU market. However, this decision would not ensure that ships treated with cybutryne would not enter European waters.
To tackle the global problem, cybutryne needed to be added to Annex I to the International Convention on the Control of Harmful Anti-fouling Systems on Ships (AFS) of the United Nations. As a European action, a team of experts from the Commission, ECHA and the European Maritime Safety Agency (EMSA) put forward their concerns about cybutryne to the International Maritime Organisation (IMO) of the United Nations. Since January 2023, the use of cybutryne as an antifouling agent has been prohibited globally.
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- Understanding BPR
- BPR legislation
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- BPC opinions on Union authorisations
- BPC opinions on Article 75 (1) (g)
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- Lists of Member States where wood treated with creosote may be placed on the market for certain uses [PDF] [EN]