Adaptations

An adaptation to a standard information requirement means that instead of performing a test, you provide a justification that is either based on general rules or on specific rules. The general rules are detailed in Annex XI to REACH, while the specific rules and adaptation possibilities for each information requirement are detailed in Column 2 of Annexes VII to X.

 

Adapt information requirements, if possible
  • Study the general and specific rules for adaptations available in REACH.
  • Always clearly state the justification to adapt the standard information. Either refer to the appropriate specific rules in Column 2 or to the general rules in Annex XI.

 

Justify and document your adaptation properly
  • The level of confidence in the information provided by any adaptation needs to be comparable to that of the information provided by the standard test.
  • Make sure that the results of your adaptation can be used later for classification and labelling and for risk assessment – if not, the adaptation will be rejected by ECHA.
  • Some adaptations can never be accepted. For example, ECHA is currently not aware of any in vitro methods or QSAR models which could reliably predict higher-tier endpoints (e.g. for repeated-dose toxicity, carcinogenicity, developmental or reproductive toxicity studies) – such adaptations will be rejected by ECHA.
  • Some adaptations which cannot be used for an endpoint as a one-to-one replacement may still be useful as part of a weight-of-evidence approach. This is often the case for data from in vitro models, which may need to be supported by additional information.
  • For a read-across or grouping (category) approach, you need to show that the substances are very likely to be similar (eco-)toxicologically and justify it with a data matrix – if not, the adaptation will be rejected by ECHA.
  • A read-across approach will only be accepted by ECHA if you provide a credible hypothesis with proper justification and reliable source data, e.g. data on the lower-tier endpoints for the source and target substance(s) that confirm the hypothesis and the prediction.
  • You can rely on data from analogue substances only if you have lawful access to the study reports and data.
  • You can rely on data from computer models only if you can ensure that the model is reliable and that your substance falls within the validated dataset. You need to provide the related documentation in your dossier – if not, the adaptation will be rejected by ECHA.
  • ECHA can only assess information provided in your registration dossier. This means that for each source of information, you need an endpoint study record containing a study summary or robust study summary. This need also applies to calculated values.
  • Carefully review the decision you receive from ECHA, as it explains why an adaptation was not accepted. As a consequence, ECHA will request the submission of a standard test by a certain deadline.
  • Carefully consider whether you can provide an improved adaptation addressing the deficiencies listed by ECHA, thinking specifically about whether the improvements are feasible within the given time frame. If you cannot, conduct the standard test as requested in the decision.

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