Alternative Methods for Toxicology

Acceptance of alternative methods

The validation of alternative methods is a scientific process that ends with an independent peer review in which the users of the methods (i.p. authorities) have to examine the applicability of the methods for the various regulatory areas. A method validated for the assessment of chemicals, for example, does not necessarily have to be suitable for the evaluation of the safety of medical devices.

Due to the urgent need for alternative methods because of e.g. the implementation of the EU Chemicals Ordinance (REACH) and the 7th Amendment Directive of the Cosmetics Regulation, the recognition process of new methods has been accelerated both in the OECD and in the EU.

OECD Working Group

For tests that are developed for the assessment of chemicals, plant protection products or biocides the acceptance process takes place in the OECD test guideline program that is coordinated by the "Working Group of the National Coordinators of the Test Guideline Program (WNT)". This working group consists of nominated representatives from each of the 3 OECD member states. Germany has nominated a National Coordinator for the area of Human Health and a second for test methods addressing environmental safety. The national coordinators are supported by experts that are examining the applicability of a new method for the respective regulatory requirements in each of the OECD Member States.

EU Working Group

At the European level, the recognition process is similar to that of the OECD, but new methods that are proposed for validation are first evaluated for the potential regulatory relevance by EU Member State Representatives before a study is performed. This process is called PARERE (Preliminary Assessment of Regulatory Relevance) and is intended to prevent methods with insufficient usability for regulatory processes to go into a cost and time-intensive validation process.

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