PROJECT DESCRIPTION
BACKGROUND
The EU REACH Regulation promotes a new vision for handling chemical substances. It requires information from manufacturers and/or importers confirming that chemical substances have been evaluated as safe for the intended use.
The use of non-animal alternative methods has been foreseen within REACH. In particular, the use of computational means to calculate properties of chemicals is explicitly mentioned by the Regulation, and the criteria are also defined for the so-called (quantitative) structure-activity relationship, (Q)SAR.
Presently there is a lack of experience in Europe on the use of (Q)SAR models, although they have been used for decades in regulatory processes in the United States of America.
By adopting (Q)SAR, chemical companies will not only be able to avoid producing unsafe chemicals, even before their synthesis, they will also save money and resources.
OBJECTIVES
The PROSIL project aimed to facilitate a proactive attitude amongst chemical companies about the REACH Regulation. This would help to promote a transition towards a more responsible environmental approach, and lead to reductions in health risks. Project work would cover both existing and new chemicals, to enable the industry to take account of relevant toxicity properties right from the planning phase of chemical plants.
The main objectives included:
- Establishing a network of REACH-related laboratories for the chemical industry;
- Exploiting in silico methods for assessing particular situations of chemical substances: chemical categories and mixtures of chemicals of natural origin;
- Integrating (Q)SAR models within mainstream industrial procedures;
- Screening new chemicals to ensure they are safe;Exploiting methods to generate structural alerts from confidential data;
- Producing case studies in the following industrial sectors: dyes, leather, and pesticides; andImproving standardisation on the use of non-testing methods.
RESULTS
The LIFE PROSIL project team demonstrated that "in silico" methods can be used as reliable tools to assess the toxicity of chemical compounds, in line with the requirements of the REACH Regulation. The Non-Testing Methods (NTMs) enable SMEs that need to register new substances to drastically reduce the costs of the tests, giving them more possibility to comply with the regulation and meet the foreseen deadlines.
Non-Testing Methods can also significantly reduce impacts on the environment and human health. They make it possible to quickly implement preliminary screening on a large set of compounds, so identifying the ones that can be harmful. The decreased need to perform "in vitro" tests thanks to the use of Non-Testing Methods also saves on the number of laboratory animals needed. Finally, the intensive dissemination and networking activities carried out have significantly contributed to enhanced acceptance of Non-Testing Methods by relevant regulatory bodies.
The project team’s activities have:
- Demonstrated, with reliable testing procedures, that Non-Testing Methods (QSAR, read-across and grouping) can be used to predict the toxicity of chemicals used in the dyes, leather and pesticides sectors, according to the requirements of REACH Regulation.
- Enhanced the substitution of toxic compounds in the dyes sector with safer analogues. The project team identified that 8% of the dyes tested show toxicity in all the endpoints, assessed while 30% of the sample is safe. The Non-Testing Methods are able therefore to easily detect toxic substances and reliable substitutes among a large set of compounds.
- Developed software for the prediction of toxicity integrating of QSAR and read-across. The tool is freely available for the industries that can use it autonomously preserving the confidentiality of the results.
- Established a network of experts from industry, regulatory bodies and scientific institutions, who will work to improve standardisation of the use of Non-Testing Methods.
- Increased the use of Non-Testing Methods for the production of dossiers to be submitted for the registration of substances under REACH.
- Increased the acceptance of the regulatory bodies to the use of Non-Testing Methods for the production of dossiers to be submitted for the registration of substances under REACH.
Further information on the project can be found in the project's layman report and After-LIFE Communication Plan (see "Read more" section).
