ECHA Opinion on the OECD Non-Animal Skin Sensitization Assessment to Help Apply the EU REACH Regulation

ECHA said that the application of this directive would advance the use of non-animal testing methods, while protecting people against allergies.

In silicoskin chemical sensitization assessment toolsHave

Posted in June 2021, OECD Guideline 497 on defined approaches for skin sensitizationHaveHavewas the first directive describing how to use in silicoTools, or computer simulation, to assess skin sensitization. Centered on more than 10 years of collaborative work between the major in chemistry BASF and the major in perfumery Givaudan, the guideline details a multi-pronged skin sensitization assessment strategy that crosses data from three distinct non-animal methods.

ECHA now wanted to highlight how industry could apply this directive under the REACH Regulation and had published a guidance documentSummarizing the OECD non-animal skin sensitization tests, describing how they could be used and indicating to what extent these assessments met the REACH information requirements.

“This is an important step in advancing the use of alternative methods to assess chemical risks”, said Mike Rasenberg, Director of Risk Assessment at ECHA. “With the new directive, we are ensuring that this approach can be used to protect people from skin sensitization, without the need for animal testing.”Have

Rasenberg said that ECHA had “Contributed significantly”To the guideline, to work ” in close collaboration “With the OECD, the Joint Research Center and other organizations.

“Defined approaches” for the evaluation of skin sensitization without animals Have

ECHA also highlighted the QSAR Toolkitwhich was part of the OECD Guideline – a free software application developed by the agency and the OECD designed to support repeatable and transparent chemical risk assessment.

ECHA said the OECD guideline and the QSAR Toolkit could be used by companies that had already submitted in chemistryWhere in vitro, To assess whether these data would be accepted under REACH. It would also prove invaluable for registrants looking to select the most appropriate tests to generate new data for the substances, the agency said.

“The guideline contains defined approaches to assess whether a substance is a skin sensitizer and to categorize whether the sensitization is high or moderate. This categorization is particularly important, because REACH requires the evaluation of the power of skin sensitization ”,ECHA said.

“If the defined approach leads to a conclusion on skin sensitization and potency, it can replace the approach currently in use. in vivo Local Lymph Gang Assay method, reducing animal testing.Have

Below ECHA Classification and Labeling Inventory, There were over 14,000 substances on the EU market identified with an indication of a skin sensitization problem, many of which were already restricted under REACH.

Timely advice amid beauty retreat around REACH animal dataHave

ECHA’s decision to publish advice on how to apply the OECD Guideline was particularly timely, given that the agency and its Board of Appeal had been under fire for some time due to animal data requests that the cosmetics and personal care industry has reported undermined the European ban on animal testing of cosmetics.

While ECHA has long argued that animal testing should only be used as a last resort, and said it is the European Commission in charge of the EU cosmetics regulation, in Under REACH, currently some animal testing was still required for safety assessments around environmental effects, long-term worker safety and pre-registration of certain new chemicals. The industry had come together to call this evil with joint open letters, statements and working with NGOs and global associations to call for change.

In the latest development on the matter, the European Parliament voted last month in favor of an EU-wide plan to completely eliminate animal testing – a move intended to step up the fight against cosmetics industry to protect the current sectoral ban. The European Commission was to react to the vote of MEPs in the coming months.

Next week October 18e, the OECD to host online webinardetailing how the Approaches defined on skin sensitizationThis directive could be applied to chemical safety in EU member states.

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