Assessment of a chemical compound for possible future SVHC investigation

Background

Bibra was asked to assess the likelihood that a chemical used by the client in some of its syntheses might at some point in the future be identified as a Substance of Very High Concern (SVHC) in the context of the REACH regulations. Additionally, we were asked to comment on what the most likely triggers for such a designation would be.

Client

A pharmaceutical company.

Project goals

To provide the client with an objective and high-quality assessment of the likelihood of the substance being identified as a SVHC (e.g. as a EU CLP category 1 carcinogen, mutagen or reproductive toxicant (i.e. a CMR substance)).The client had been aware that the substance had already been assessed by a Member State Competent Authority (MSCA) several years previously, with a conclusion that an SVHC designation was not at that time appropriate. A focused literature search was undertaken by bibra, and the key toxicity data was then critically assessed with respect to the published ECHA guidance on the triggers for an SVHC designation.

Approach

After initial exploration of the Expert Group position, bibra went on to conduct broad searches of the primary literature, using TRACE and the PubMed and Toxline databases. The client was sent the identified hits and subsequently requested a preliminary statement summarising the key points from these studies on ultrasound and food safety. This included an outline of the use of ultrasound by the food industry, a summary of the ultrasound-induced changes in food that had been reported in this selection of papers, and preliminary recommendations about which areas may be worth monitoring or merit further analysis in the future.  In the process of consulting abstracts and a few key papers, bibra identified a number of other potentially relevant papers cited within them that were focussed on the foods of greatest interest to the client; these were listed in an appendix to the report, for consideration in any subsequent extension of the project.

Project outcome

Bibra was able to conclude that there was a low likelihood of the substance being designated (or even reconsidered) as a SVHC in the EU for the foreseeable future. It was determined that if such a ruling were to occur it would most likely focus on a more health precautionary view being taken on the substance’s cancer profile.

Bibra project team

James Hopkins

Richard Young

 

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