Development of OECD Harmonised Templates

 

This page provides a short overview of the previous and ongoing activities with respect to the development of OECD Harmonised Templates.

From 2-4 October 2002 an OECD Workshop on Electronic Tools for Data Submission, Evaluation and Exchange for the Regulation of New and Existing Industrial Chemicals, Agricultural Pesticides and Biocides was held in Ottawa, Canada. One of the specific recommendations made to the OECD was to support harmonisation where possible by the use of templates and XML tags.

The February 2004 OECD Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology agreed to the establishment of an Expert Group to (1) examine existing templates, (2) determine the degree to which governments might be interested in pursuing work on harmonising specific templates (with electronic technologies), and, if appropriate, (3) prepare a proposal for further work. The Joint Meeting also agreed that a small ad hoc group be set up to organise a meeting of the Expert Group.

The OECD Expert Group on Harmonising Templates was organised following the Joint Meeting. After reviewing the existing templates provided by member countries to the OECD Secretariat in response to a July 2003 survey, the ad hoc group selected four endpoints (varying in degree of complexity) which are fairly representative of the major areas of testing: human health, eco-toxicity and environmental fate. The meeting of the Expert Group was held at OECD headquarters on 14-16 June, 2004. The Expert Group agreed (pending testing) to four draft OECD Templates covering endpoints for skin irritation, hydrolysis, repeat dose toxicity (oral) and fish acute toxicity, as well as a template grouping all generic fields (i.e. fields which occur in almost all the templates). The Expert Group also agreed to develop a work plan for developing draft templates on the remaining endpoints, with a focus being on those endpoints which are most important for regulatory decisions. It was recommended to use existing templates as the starting point.

The OECD Secretariat developed templates on 86 endpoints as well as a template grouping all generic fields, which were endorsed by the OECD Joint Meeting and published on the OECD web site in March 2006. Thereafter seven additional templates were developed. When defining the pieces of information of the templates, i.e. fields including context-sensitive help texts and picklists, a number of existing national/regional test guidelines and/or templates were taken into account, particularly

  • OECD Test guidelines
  • NAFTA Pesticides: Evaluation templates for reviewing the scientific studies that are submitted to support applications to register pest control products in Canada and the US
  • Templates drafted by the Working Group Data Submission Formats "Biocides and Beyond", which was established by the German Federal Environmental Agency (UBA) jointly with the European Chemicals Bureau (ECB) (Final drafts dated 17 May 2004)
  • WORD proformas provided in the Technical Notes for Guidance (TNsG) on Preparation of Dossiers and Study Evaluation under Directive 98/8/EC
  • IUCLID 4: The previous system in the EU for data entry of electronic submission of summaries of test results under the EU Existing Substances regulation and the OECD High Production Volume (HPV) Chemicals Programme
  • OECD HPV ExChem: Templates for compiling robust study summaries for submission to the OECD HPV Chemicals Programme
  • EU/New Chemicals: SNIF - Data entry screens for electronic notification of summaries on new chemicals substances

The draft templates underwent a thorough review process before they were endorsed by the OECD Joint Meeting. All comments received from various national authorities as well as from industrial organisations and companies were taken into consideration by the OECD Secretariat as far as possible and used to revise the draft templates. The final OECD Harmonised Templates are the result of this joint effort.