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Parliamentary questions
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25 April 2017
Answer given by Mr Vella on behalf of the Commission
Question reference: E-001156/2017

1. While it is recognised that animal carcinogenicity tests have certain limitations, no generally applicable non-animal approach to assess carcinogenic potential is currently available. Under the Registration, Evaluation, Authorisation and restriction of Chemicals Regulation (REACH), requirements for a carcinogenicity test in animals are very limited and only apply for substances produced in very high volumes, and if there is high human exposure together with hints for carcinogenic potential.

Known mutagens are presumed to be also carcinogens, thus further limiting the need for carcinogenicity tests. Under REACH, alternative approaches(1) can be used to avoid unnecessary animal testing, including for informing on carcinogenic potential of substances. Other EU Regulations, like biocides, pesticides and pharmaceuticals, apply testing requirements that are adapted to the use of a substance and the resulting human exposure in order to ensure that use of these chemicals are as safe as possible (notably no testing or predictive approach can give absolute certainty as to the presence or absence of an effect).

2. Over the last decades, the EU has provided significant support to research into the development of alternative methods, through funding of more than EUR 35 million per year. This contribution also includes alternative methods for assessing carcinogenic properties of chemicals(2).

The EU supports efforts to further limit carcinogenicity testing through improved use of other relevant data to decide on carcinogenic potential, e.g. through the work of the European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM), the European Partnership for Alternative Approaches to Animal Testing (EPAA)(3), and in the framework of the Organisation for Economic Cooperation and Development , where work on Quantitative Structure-Activity Relationships , as well as on integrated approaches to testing and assessment for non-genotoxic carcinogens is conducted.

(1)For example read-across from information for related substances, Quantitative Structure-Activity Relationship (QSAR) and Weight of evidence using available information from various sources
(2)For example. projects Carcinogenomics http://cordis.europa.eu/project/rcn/85030_en.html, Scarlet https://ec.europa.eu/research/fp6/ssp/scarlet_en.htm

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