Sensitiser containing products
Products may contain sensitisers where they are present at concentrations triggering:
- the formal CLP/GHS classification(s) of Skin Sens 1, H317, and/or Resp Sens 1, H334 apply;
- formal CLP/GHS classification and reporting level for EUH208
- reporting on the label at EUH208 only
Note that where EUH208 applies and there is no other classification, EUH210 also applies (unless the product is consumer-only).
It is considered good practice that all sensitisers at H317, H334 and EUH208 concentrations are all listed on the label, so that anyone who is already sensitised to a particular substance is given information on this at the point of use.
In theory, this goes against the requirement that a maximum of 4 substances are listed under “contains” on the label, but in terms of preventing people having an allergic reaction, and Duty of Care, human health should take precedence, particularly when a severe allergic reaction can lead to anaphylactic shock and even death.
The substances should all be listed in one place on the label, as follows:
- if the product is classified at GHS level only (H317 and/or H334), all of the relevant sensitisers should be listed under “contains”, below the trade name (or substance name, if the product is a substance containing sensitising impurities)
- if the product is classified at EUH208 level, all of the relevant sensitisers should be listed under the EUH208 statement, “Contains (name of sensitising substance(s)). May produce an allergic reaction“. The EUH208 statement should be placed in the “supplementary information” part of the label
- if the product is classified at both GHS level and EUH208 level, all of the EUH208 substances should be listed under “contains” below the product name, and the EUH208 text should be omitted
The sensitising substances should be placed on the SDS in section 3.1 (if impurities) or section 3.2 (if component substances). Both the EUH208 and GHS (H317, H334) substances should be listed, and also any sensitisers at sub-classification level, that is 10% of the label threshold (which may be based on the sensitiser type, or on any Specific Concentration Limit which may apply). For more details, see the sensitising mixtures classification pages at https://ttenvironmenta.wpengine.com/clp-knowledgebase/health-hazard-classification-of-mixtures/ .