Adaptations

An adaptation to a standard information requirement means that instead of performing a test, you provide a justification. Your justification has to either be based on general rules as explained in Annex XI to REACH, or on specific rules for each information requirement as detailed in Column 2 of Annexes VII to X.

 

To adapt information requirements:
  • Study the general and specific rules for adaptations available in REACH.
  • Refer to the appropriate rules and state your justification clearly

 

Justify and document your adaptation properly
  • Information provided using an adaptation must be as reliable as if it was generated using 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, ECHA will reject your adaptation.
  • Some adaptations may be useful as part of a weigh-of-evidence approach, although they cannot replace an experimental study as such. This could be the case for data generated using in vitro models, which may need to be supported by additional information.
  • Some adaptations can never be accepted and ECHA will reject them. For example, ECHA is currently not aware of any in vitro methods or QSAR models that reliably predict higher-tier endpoints, including repeated-dose toxicity, carcinogenicity, developmental or reproductive toxicity studies.
  • For a read-across or grouping (category) approach, you need to show that the substances are very likely to be similar (eco)toxicologically:
    • Identify the group of substances clearly – describe their structural similarities and differences. Explain how structural differences may (or may not) impact the predicted properties of the substances and consequently your read-across prediction.
    • To apply the read-across approach, you must understand and report the composition of your substance and the available test materials properly.
    • Provide detailed substance identity and analytical information. For multi-constituent substances and those of unknown or variable composition, complex reaction products or of biological materials (UVCBs), you also need to explain the differences and similarities of the constituents between the target and source substances or test materials. With the prediction for the target substance, you also need to address the impact of these differences.
    • Provide a data matrix with all available information (physico-chemical and (eco)toxicological).
  • ECHA can accept a read-across adaptation only if you provide a credible read-across hypothesis with a proper justification and reliable data for each endpoint.
  • If your hypothesis is based on structural similarity which leads to similar properties, you need to have reliable and relevant data on the lower-tier endpoints for both source and target substances to confirm your hypothesis and possibility to predict. This could be done by bridging data, for example from Annex VII or VIII information requirements.
  • If your hypothesis is based on similarity through (bio-)transformation, you need to provide data e.g. on toxicokinetics or metabolism.
  • Explain the trends you use to support your prediction – including all inconsistencies and their impact on your prediction.
  • Use ECHA’s Read-Across Assessment Framework (RAAF) to validate that your read-across adaptation is robust and complete.
  • You can only rely on data from structurally similar/analogue substances if you have lawful access to the study reports and other relevant data generated with those substances.
  • You can only rely on data from computer models if you can ensure that the model is scientifically valid, your substance falls within the applicability domain and the prediction is adequate for the regulatory endpoint in question. You need to provide the related documentation in your dossier – if you cannot, ECHA will reject your adaptation.
  • 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 applies also to calculated or predicted values.
  • If ECHA does not accept your adaptation, you will receive a decision explaining why the adaptation was rejected. ECHA will require you to submit a standard test to be submitted by a given deadline.
  • Consider if you can improve the rejected adaptation or provide a new valid adaptation addressing the deficiencies listed in ECHA’s decision. If you cannot do this within the given timeframe, you will need to conduct the standard test as required in the decision.

Consider if you can improve the rejected adaptation or provide a new valid adaptation addressing the deficiencies listed in ECHA’s decision. If you cannot do this within the given timeframe, you will need to conduct the standard test as required in the decision.