January Regulatory Updates


New IUCLID pharmaceutical datasets support alternatives to animal testing

ECHA has published IUCLID structured datasets for 348 approved pharmaceuticals, with results from non-clinical animal studies and human information.

Helsinki, 24 January 2023 – The new datasets provides robust pharmaceutical information for industry and research in a structured format. They support toxicity assessment of structurally similar chemicals in order to decrease the dependency on animal testing.

They can also be utilized to develop predictive models and to analyse correlations based on animal and human data. Users can assess the relevance of animal models to humans by comparing results of animal tests with effects in humans.

Ofelia Bercaru, ECHA’s Director of Prioritisation and Integration claimed:

“We welcome the datasets as one further step to combine and assess available data on chemicals. The data will be useful for developing read-across or weight of evidence approaches and supports our reinforced priority to reduce the need for animal testing.”

The datasets relied on extracting animal and human data from files offered by the United States’ Food and Drug Administration. These included studies related to carcinogenicity as well as repeat-dose, developmental and reproductive toxicity. They also have information on the effects medicines have on humans, extracted from standard product labels of approved drugs.

Later in 2023, a total of 530 datasets for pharmaceuticals will be available. A scientific paper will also be released later this year to give details on their development and architecture.



Changes to completeness checks of REACH registrations.

The European Commission revised some of the information prerequisites for registering chemicals under REACH in 2021 and 2022. As of 1 May 2023, ECHA will start checking both new registrations and updates to existing ones against the changed requirements.

Helsinki, 23 January 2023 – ECHA carries out a completeness check on each incoming registration as set out in Article 20(2) of the REACH Regulation.

The new and amended checks will take effect as of 1 May 2023 and will apply to both new registrations and updates of existing ones. Registrants should, therefore, prepare for the changes as registrations presented before may no longer pass the completeness check.

The new and amended checks concern:

  1. Substance identity: guaranteeing correct and consistent identification of a substance’s boundary composition and its constituents and additives determined by clarifications made to Annex VI.
  2. Standard information requirements based on Annexes VII-XI: supporting registrants in reporting information for endpoints regarding mutagenicity, degradation and aquatic toxicity based on Annex VII-XI information requirements. Registrants adding a new weight-of-evidence adaptation will be prompted to give arguments for the approach in a more structured format.

Alongside, limited revisions have been made to the completeness check in other areas, such as use information.

The IUCLID validation assistant will also be updated with the amended completeness check rules when the new version of IUCLID is released at the end of April 2023. Registrants are prompted to utilize the validation assistant to check their registrations before presenting them to ECHA.