PROJECT DESCRIPTION
BACKGROUND
Biocides not only kill pathogens that are targeted, but can also kill non-pathogens. This can have undesirable side-effects for human health and the environment. Such risks have yet to be sufficiently investigated for most biocides on the EU market because in different environmental compartments (e.g. soil, groundwater and air) active substances undergo degradation to metabolites that may be more toxic than the original compound. In this context, novel tools are necessary for the identification and substitution of biocides of ecotoxicological concern. Computational toxicology is a subdiscipline of toxicology that aims to use mathematics, statistics, chemistry and computer modelling to predict the toxic effects of chemicals on human health and the environment. Predictive toxicology is of increasingly interest due to new legal requirements imposed by the Biocides Product Regulation, Regulation (EU) 258/2012 (BPR). Under this legislation, a large amount of animal (in vivo) testing is needed to demonstrate the safety of new chemical compounds, requiring much time and cost as well as raising ethical questions. The use of alternative non-animal methods (e.g. computer models), as foreseen under the BPR, would reduce the need for animal testing. The availability of such methods would allow the screening of many chemicals in a simplified way, and would particularly help SMEs identify metabolites of ecotoxicological concern to facilitate the registering of biocides under the BPR.
OBJECTIVES
The LIFE-COMBASE project would demonstrate a new computational tool for assessing and reducing the impact of biocides of ecotoxicological concern, and would promote their substitution with safer substances. This flexible, open-source, online decision-support tool, for assessing the ecotoxicity of both biocidal products and their metabolites, would be based on a series of predictive in silico (computational) models; building on previous initiatives (namely, the projects ANTARES, CALEIDOS and PROSIL LIFE). The tool would enable simulations to be performed on the ecotoxicity potential of new candidate chemicals before their synthesis in a safe, residue-free and environmentally friendly way. Its operability and effectiveness would be demonstrated at four trophic levels: bacteria, algae, common water fleas (Daphnia) and fish. Project results would be communicated to the Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA), in order to boost replicability. The project would make a special contribution to the BPR, especially regarding the precautionary principle (taking into account metabolites of ecotoxicological concern); the promotion of low-risk substances (depending on their ecotoxicological profile); and the reduction of animal testing (in common with Directive 2010/63/EU, which revised Directive 86/609/EEC on the protection of animals used for scientific purposes).
RESULTS
LIFE COMBASE promoted the sustainable use of biocidal active substances (BAS) from a life cycle perspective, by means of an online information system. The project demonstrated the suitability of computational models to obtain the ecotoxicological profile of BAS and metabolites.
The project beneficiaries:
- Defined a detailed list of Biocidal Active Substances and their corresponding metabolites containing in vivo and in vitro experimental data of their ecotoxicologial properties and a proposal for the categorisation of substances in agreement with the EU Regulation (EC) No 1272/2008;
- Created a database of relevant stakeholders;
- Carried out experimental assays (in vitro and in vivo toxicity assays);
- Developed ecotoxicity predictive models for algae, activated sludge, Daphnia magna and fish;
- Developed two COMBASE software platforms: COMBASE DSS (decision support system) and a mobile App.
Both COMBASE software platforms were presented to a range of stakeholders, mainly companies dealing with active substances and/or biocidal products. The project team created four e-learning modules for training purposes, which are available on the project website (http://www.life-combase.com/index.php/en/learning-section).
It is a particular challenge for SMEs, with their limited resources, to fulfil the requirements of the Biocides Product Regulation (BPR) and REACH. Thanks to the COMBASE project, SMEs will benefit from low-cost tools to help them meet regulatory requirements, and an increase in professional expertise (e.g. in alignment with the European Commission’s Communication ‘New Skills for New Jobs’).
By establishing a framework to substitute active substances of high concern, the project helps reduce the negative effects of biocides on human health.
From an economic perspective, the European Commission estimates that the total savings due to the implementation of the BPR by industry will amount to €2.7 billion over a period of 10 years. This will mainly be achieved by avoiding the duplication of efforts in animal testing, due to the introduction of an obligation to share data on animal tests. The project’s impact is therefore expected to be twofold: reducing the costs of authorising substances and enhancing animal welfare. In particular, within the LIFE-COMBASE project the use of in silico models for the prediction of metabolites generation from active substances and their associated ecotoxicological profile are proposed as a screening tool in order to reduce the need for animal testing.
Further information on the project can be found in the project's layman report (see "Read more" section).
