When preparing safety data sheets, the question of how substances (must) be named arises frequently. Especially if you would rather not specify certain substances because they are a trade secret. However, there are actually very strict rules on how substances are named and what must be done to name the substance differently.
The naming of substances according to the CLP Regulation
But first, let’s look at the basics of how substances actually have to be named. Contrary to what is often assumed, the specific requirements for this cannot be found in the REACH Regulation, which describes the safety data sheet in detail. Instead, naming is part of the product identifier, which is set out in detail in the CLP Regulation and referenced in the REACH Regulation. [1], [2]
Substance naming follows a fixed sequence, depending on whether the substance appears in certain official lists, so the first applicable case is the correct naming:
- Substance name according to the table for harmonized classification and labelling (legal classification, CLP Regulation, Annex VI, Part 3)
- Substance name according to the classification and labeling inventory (C&L Inventory)
- IUPAC name or another international designation that refers to the associated CAS number (Chemical Abstracts Service)
- IUPAC name or other international name if no CAS number is available
- Further exemption if the IUPAC name has more than 100 characters
Is an alternative designation even possible?
It is indeed possible in the EU jurisdiction to apply for the use of an alternative chemical name under Article 24 of the CLP Regulation. The intention behind this application should be to protect one’s own trade secrets, in particular intellectual property rights [3]. In addition, the application is subject to a fee and may well be rejected.
If approval is granted, the alternative name may be used in the EU.
Which substances come into question?
In fact, not every substance can be protected, certain conditions must be met, which are described in Annex I, 1.4.1. Here is a brief summary:
- There is no EU limit value for the substance
- It must be possible to demonstrate that the alternative chemical name continues to guarantee occupational health and safety
- Only certain classifications may occur. For example, since a substance cannot be both Skin Corr. 1 and 2 at the same time, the condition that category 2 may occur automatically excludes the presence of category 1.
The following hazards may be present for an application to use an alternative chemical name for the substance concerned:
- Physico-chemical hazards (as listed in Part 2 of Annex I)
- Acute toxicity category 4: Causes damage through short-term exposure at low doses.
- Skin corrosion/irritation category 2: Causes skin irritation.
- Serious eye damage/eye irritation category 2: Causes eye irritation.
- Specific target organ toxicity – single exposure (STOT SE) category 2 or 3: Possible risk of damage to certain organs through single exposure.
- Specific target organ toxicity – repeated exposure (STOT RE) category 2: Risk of organ damage through repeated exposure.
- Hazardous to the aquatic environment – chronic – category 3 or 4: Long-term adverse effects on aquatic environments.
Conclusion
It is therefore not simply possible to change substance names at will, but the rules for product identifiers must be observed. If a renaming is to take place, this is possible via an application in accordance with Article 24 of the CLP Regulation.
Sources:
[1] REACH Regulation, consolidated version of 01.12.2023
[2] CLP Regulation, consolidated version of 01.12.2023
[3] European Chemicals Agency (ECHA), website, accessed April 2024
[4] HGF of the REACH-CLP Biocides Helpdesk on the topic, accessed April 2024