Rank: New forum user 
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Hi All, I've been asked to prepare an SDS for a chemical mixture that we manufacture. I'm confident that each component is present at a concentration that is non-hazardous to health but I'm not sure whether I need to declare all ingredients that at higher concentrations would be hazardous to health. For example, sodium azide is present at a concentration of 0.02%. Would I need to declare that in section 3 (composition/information on ingredients) and section 8 (Exposure controls/ personal protection) even though its below the 0.1% limit? Thanks.
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Rank: Super forum user 
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Where do you get the idea 0.1% is a cut-off? That concept has long since been dismissed. https://echa.europa.eu/regulations/clp/understanding-clp
It is also not only human health but environmental considerations that must be taken in to account.
In the realms of preservatives such as methylisothazalone much lower thresholds are declared thanks to listed specific concentration limits impacting what hazard classification applies. In Section 3 anything that (as a 100% w/w concentration) carries a hazard classification should be declared - this details the constituents of a mixture.
If you list a substance here the information should also appear in Section 8 noting that in addition to WEL's the regulations talk about DNEL (Derived No Effect Limit - human helath) and PNEC (Perceived No Effect Concentration - environmental health) information being made available.
This information then repeats in Section 11 & 12. Section 2 is the classification of the product where you name those substances which contribute to the products overall hazard classification "Contains". I would suggest you look up the components on ECHA rather than relying upon your suppliers Safety Data Sheets - remembering the UK has its own Mandatory Classification List which is similar but not identical to the EU Harmonised Classification (CLH) aka Appendix 6. https://www.hse.gov.uk/chemical-classification/classification/harmonised-classification-self-classification.htm
https://echa.europa.eu/information-on-chemicals/annex-vi-to-clp
The ECHA guidance on compiling SDS (followed by the HSE) states people preparing an SDS must be competent (although it does not define what form competence takes). You may wish to consider an external authoring company given the potential rammifications of getting the classification and thereby the product labelling / Safety Data Sheet content wrong.
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Rank: Super forum user
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Where do you get the idea 0.1% is a cut-off? That concept has long since been dismissed. https://echa.europa.eu/regulations/clp/understanding-clp
It is also not only human health but environmental considerations that must be taken in to account.
In the realms of preservatives such as methylisothazalone much lower thresholds are declared thanks to listed specific concentration limits impacting what hazard classification applies. In Section 3 anything that (as a 100% w/w concentration) carries a hazard classification should be declared - this details the constituents of a mixture.
If you list a substance here the information should also appear in Section 8 noting that in addition to WEL's the regulations talk about DNEL (Derived No Effect Limit - human helath) and PNEC (Perceived No Effect Concentration - environmental health) information being made available.
This information then repeats in Section 11 & 12. Section 2 is the classification of the product where you name those substances which contribute to the products overall hazard classification "Contains". I would suggest you look up the components on ECHA rather than relying upon your suppliers Safety Data Sheets - remembering the UK has its own Mandatory Classification List which is similar but not identical to the EU Harmonised Classification (CLH) aka Appendix 6. https://www.hse.gov.uk/chemical-classification/classification/harmonised-classification-self-classification.htm
https://echa.europa.eu/information-on-chemicals/annex-vi-to-clp
The ECHA guidance on compiling SDS (followed by the HSE) states people preparing an SDS must be competent (although it does not define what form competence takes). You may wish to consider an external authoring company given the potential rammifications of getting the classification and thereby the product labelling / Safety Data Sheet content wrong.
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Rank: Super forum user 
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I personally would refuse such a request and get a company with expertise in the area to write the sds.
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 1 user thanked Kate for this useful post.
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