Compliance
CMR registration: which products count and what do you record?
A sealant in a tube, a hand disinfectant based on ethanol. Products that sit in the cupboard at many workplaces. Yet such a product can fall under the CMR registration: the record the law asks for when people work with carcinogenic, mutagenic and reprotoxic substances. In a test with ten random safety data sheets we came across it in an ordinary sealant: the SDS lists carcinogenic ingredients from 0.1 %. Miss that, and your registration is incomplete without you knowing it.
What the law asks
The basis is European: Directive 2004/37/EC on carcinogens, mutagens and reprotoxic substances (the CMRD). When an employee works with such a substance, or may be exposed to it, extra duties apply. You replace the substance where that is technically possible, keep exposure as low as possible and record what you do, including a list of exposed workers. In the Netherlands these rules sit in the Working Conditions Decree (Arbobesluit): the registration in article 4.13 and the list of exposed workers in article 4.15. National details differ per country; this article follows the Dutch rules.
Note the word "may". Someone working with a closed system can still be exposed, for example during maintenance or a breakdown. A closed system does not take a product out of the registration. It is a measure you record in it.
Which products count?
A substance falls under the rules when it meets the criteria for category 1A or 1B. On the SDS you recognise it by the H-statements:
- carcinogenic: H350 or H350i
- mutagenic: H340
- reprotoxic: H360 and its variants, such as H360D or H360Fd
Reprotoxic substances were added by the EU amendment 2022/431; in the Netherlands they have counted since 22 May 2024.
The SDS is not the only source. Twice a year the Dutch government publishes the SZW list: substances that in any case count as carcinogenic, mutagenic or reprotoxic, including ones assessed that way by the Dutch Health Council. So a product can count without H350 on its SDS. An example that surprises many people is ethanol: it is on the SZW list, and according to the government's Arboportaal the CMR rules apply to it as well.
From which concentration?
A mixture counts once a CMR ingredient is above the limit from the CLP Regulation:
- 0.1 % for carcinogenic and mutagenic substances
- 0.3 % for reprotoxic substances
These limits are low, and that is where the surprise lies. A product does not have to be known as dangerous to count. So always check section 3 of the SDS, which lists the ingredients with their concentration. For substances that are only on the SZW list, the law sets no limit of its own. In practice you follow the same CLP approach.
Does the SDS give a range that crosses the limit, or no percentage at all? Then count the product. When in doubt, counting it is the safe choice.
What do you record?
The law prescribes no format; the Dutch Labour Inspectorate does offer an example spreadsheet. For each CMR substance the registration covers:
- why you use the substance and why replacing it is not technically possible
- how much you use, produce or store per year
- what kind of work is done with it
- how many employees are or may be exposed
- which measures you have taken
- which personal protective equipment is used
- in which cases the substance was replaced
Alongside it you keep a list of exposed workers, with each person's exposure. Employees have the right to a copy of their own data. In the Netherlands you keep this data for 40 years, also for reprotoxic substances. The EU asks five years for reprotoxic substances; the Netherlands goes further here.
Suspected CMR: a smaller registration
Does the SDS show H361 or H362, or is an ingredient on the SZW list as reprotoxic category 2? Then the substance is suspected, but it does not fall under the full registration. The Dutch rules (article 4.2a) do ask for a smaller registration in your risk inventory (RI&E): the quantity per year, the number of employees and how the work is done.
For suspected carcinogens or mutagens (H351, H341) there is no extra registration duty. It is still wise to mark them as "suspected", so they stay in view.
Where it goes wrong in practice
Searching on H-statements only. Filter your register on H350 and you miss the products that count through the SZW list, such as products containing ethanol.
Treating a closed system as an exception. As long as employees may be exposed, the product counts. The closed system belongs in the registration, as a measure.
Throwing the registration away with the product. You keep the data on exposed workers for 40 years, even when the product has long gone. So keep the registration of products you no longer use.
Filling it in once. Quantities, headcounts and ways of working change, and the SZW list is updated twice a year. Review the registration regularly, for example once a year.
How to go about it
1. Map which products count. By H-statements and by the SZW list, with the concentrations from section 3.
2. Record the registration per product. Quantity, kind of work, number of employees, measures, PPE and why replacing is not possible.
3. Keep the list of names in your own records. With each employee's exposure, kept for 40 years.
4. Share the overview. With the occupational physician and the works council, who need it for their own tasks.
5. Keep it up to date. With every new product, new SDS version, change in working method and every new SZW list.
How Chemspark helps
Chemspark supports the CMR registration from your substance register. It recognises the products that count by their H-statements and by ingredients on the SZW list, using the concentration limits above. An unknown percentage or a range across the limit counts. On the Compliance page you see per product why it counts. Under the screening you answer a few short questions per product: the quantity per year, the number of employees and their role, and why replacing is not possible. The kind of work, the measures and the PPE come from your risk assessment, so you don't enter them twice. The worklist shows where something is still missing, and the CMR register quick report puts everything in one overview, for example for the occupational physician or the works council. When a product stops, its registration is kept as "no longer in use". Chemspark deliberately does not store employee names: you keep that list in your own HR records.
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