Clarification of information requirements under REACH
23 changes were adopted on March 25, 2022 concerning the information obligations related to Annexes VI to X of the REACH regulation. These changes, which have been debated within the chemical industry as well as by some NGOs, are the result of a series of changes made to the REACH regulation.
These changes, which range from the addition of a few words to the substitution of entire paragraphs, include a limitation on in vivo studies conducted by the dermal or inhalation route. Clarifications have also been made on the following points:
- structural similarities with regard to read across
- the conditions required to dispense with more extensive sexual function and fertility testing,
- the non-necessity of sub-chronic toxicity studies in some cases,
- the use of existing data
- the abandonment of environmental behavior studies
- adaptations of reproductive toxicity studies
- etc.
You can find all the changes here. To understand how these changes impact your files, do not hesitate to contact our REACH experts.
Clarifications that have caused debate
When the draft amendment was published in 2021, responses to these clarifications from industry and NGOs alike were mixed.
The main purpose of these clarifications was to clarify certain information requirements for REACH registration dossiers, but they are also part of a more general effort to address non-compliant registration dossiers under the Joint Action Plan between ECHA and the European Commission.
Cefic and other industry associations have criticized the fact that the regulation goes beyond simple clarifications of the annexes. In particular, it is denounced that the implications would be profound, on the use of animals and on the compliance of dossiers.
Some animal rights groups have also said that these changes could greatly increase animal data requirements. The Commission had also criticized the lack of a thorough assessment of the proposal up front.
In contrast, human health and environmental associations supported the changes, which is because the clarifications are considered relevant to their explanation of the testing requirements under REACH.
Clarification of information requirements under REACH
23 changes were adopted on March 25, 2022 concerning the information obligations related to Annexes VI to X of the REACH regulation. These changes, which have been debated within the chemical industry as well as by some NGOs, are the result of a series of changes made to the REACH regulation.
These changes, which range from the addition of a few words to the substitution of entire paragraphs, include a limitation on in vivo studies conducted by the dermal or inhalation route. Clarifications have also been made on the following points:
- structural similarities with regard to read across
- the conditions required to dispense with more extensive sexual function and fertility testing,
- the non-necessity of sub-chronic toxicity studies in some cases,
- the use of existing data
- the abandonment of environmental behavior studies
- adaptations of reproductive toxicity studies
- etc.
You can find all the changes here. To understand how these changes impact your files, do not hesitate to contact our REACH experts.
Clarifications that have caused debate
When the draft amendment was published in 2021, responses to these clarifications from industry and NGOs alike were mixed.
The main purpose of these clarifications was to clarify certain information requirements for REACH registration dossiers, but they are also part of a more general effort to address non-compliant registration dossiers under the Joint Action Plan between ECHA and the European Commission.
Cefic and other industry associations have criticized the fact that the regulation goes beyond simple clarifications of the annexes. In particular, it is denounced that the implications would be profound, on the use of animals and on the compliance of dossiers.
Some animal rights groups have also said that these changes could greatly increase animal data requirements. The Commission had also criticized the lack of a thorough assessment of the proposal up front.
In contrast, human health and environmental associations supported the changes, which is because the clarifications are considered relevant to their explanation of the testing requirements under REACH.
