On 26 June, OECD adopted a set of updated and corrected Test Guidelines for chemicals safety testing to keep pace with scientific progress for OECD members and Mutual Acceptance of Data (MAD) adhering countries.
Eight Test Guidelines have been updated (TG 437, TG 458, TG 488, TG 491) and corrected (TG 405, TG 439, TG 442C et TG 471):
The OECD Test Guidelines Programme regularly receives proposals for new and innovative test methods for chemical safety testing. These methods may contain elements protected by intellectual property. Forms of protection may include patents for examples, but are sometimes just protected under the claim of Confidential Business Information. As the goal of the Test Guidelines Programme is to develop and standardise relevant and reliable methods, transparency is important from a regulatory perspective. Therefore the Test Guidelines Programme is developing a policy to deal with confidentiality claims so that it remains an attractive programme for innovative methods, while ensuring that developers identify other means to protect their assets.
In order to evaluate the potential impact, advantages and disadvantages of this policy on the test developer community (academic, business) and the views of regulators and the broader community, the OECD wishes to collect feedback on the following questions by 31 August 2020.
The OECD Guidelines for the Testing of Chemicals are a unique tool for assessing the potential effects of chemicals on human health and the environment. Accepted internationally as standard methods for safety testing, the Guidelines are used by professionals in industry, academia and government involved in the testing and assessment of chemicals (industrial chemicals, pesticides, personal care products, etc.). These Guidelines are continuously expanded and updated to ensure they reflect the state-of-the-art science and techniques to meet member countries regulatory needs. The Guidelines are elaborated with the assistance of experts from regulatory agencies, academia, industry, environmental and animal welfare organisations.
OECD Test Guidelines are covered by the OECD Mutual Acceptance of Data (MAD) system. Under this system, laboratory test results related to the safety of chemicals that are generated in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practices are accepted in all OECD countries and adherent countries for the purpose of safety assessment and other uses relating to the protection of human health and the environment.
The OECD Guidelines for the Testing of Chemicals are split into five sections:
The full list of adopted Test Guidelines, the draft TGs under public commenting rounds, the draft Guidance and review documents are available on the Test Guidelines Programme.
Publications in the Series of Testing and Assessment
This Series includes publications related to testing and assessment of chemicals; some of them support the development of OECD Test Guidelines (e.g. validation reports, guidance documents, detailed review papers).
Find out more about our work
The Test Guidelines that have been deleted should not be used for new testing. They are included here because it may be useful to consult them in the framework of the assessment of substances based on old study reports. The guaranties of Mutual Acceptance of Data (MAD) would not apply if these Test Guidelines were used for new testing.
In November 2012, the Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology decided on a transition period of 18 months, between the Council Decision and the effective deletion, for Test Guidelines that have been updated or deleted. For more information, please read the presentation: Update of Test Guidelines and the Mutual Acceptance of Data.