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Key Summary: A harmonised classification (CLP, Annex VI) is a legal minimum, not a complete list. For hazard classes that are not harmonised, you as a manufacturer, importer or user are legally required to classify the substance yourself on the basis of all available, reliable information (CLP, Articles 4 and 5). In the Netherlands an occupational-safety layer is added on top: the risk inventory and evaluation (RI&E) must cover the actual hazards of a substance, including those that come from a Health Council advisory or another serious source. This is why a substance can legitimately carry an H-statement or CMR classification that does not appear in the harmonised list. DOHSBase shows the classifications from all serious sources side by side, with their origin noted, so you can meet that assessment duty. Which classifications you adopt remains your own responsibility.
The practical question
For xylene (CAS 1330-20-7), DOHSBase shows the hazard statement H361d (“suspected of damaging the unborn child”). A logical question from an occupational hygienist: why is it shown, when H361d does not appear in the harmonised CLP classification of xylene and is barely notified in the C&L Inventory?
The answer goes to the heart of why DOHSBase exists: the harmonised list is not the whole list, and you are legally required to look further.
The legal duty: you must assess all available information
The CLP Regulation (EC) No 1272/2008 places the duty to classify on the company, not on a list:
- Article 4 requires manufacturers, importers and downstream users to classify a substance before it is placed on the market.
- Article 4(3) makes the distinction explicit: if a substance falls under a harmonised classification (Annex VI), that classification is mandatory for the hazard classes it covers. But for all hazard classes it does not cover, you must classify the substance yourself. The harmonised classification is therefore a floor, not an end point.
- Article 5 requires you to identify and examine “the relevant available information” to determine whether a substance presents a hazard. That explicitly involves more than one source: test and epidemiological data, recognised scientific assessments and other reliable information.
In other words, the law does not ask “is it on the harmonised list?”, but “what is known about this substance, on the basis of all serious sources?”.
The Dutch layer: the Working Conditions Decree and the CMR list
In the workplace, occupational-safety duties are added on top. The Dutch Working Conditions Decree (Arbobesluit) (Chapter 4, Hazardous substances) requires the employer to assess the nature, degree and duration of exposure in the risk inventory and evaluation (Article 4.2), with additional obligations for carcinogenic, mutagenic and reprotoxic substances (Article 4.2a). That assessment can only be correct if it starts from the actual hazards of the substance, not just from the harmonised classification.
An important Dutch example is the Dutch CMR list (published twice a year in the Government Gazette (Staatscourant) by the Ministry of Social Affairs and Employment, SZW; not to be confused with the SZW list / Annex XIII of statutory exposure limits). Substances are placed on it partly through the EU harmonised classification, but partly also on the basis of an advisory from the Health Council of the Netherlands (Gezondheidsraad). Xylene is on that CMR list on the basis of a Health Council assessment, precisely a case where the harmonised EU list would not inform you sufficiently. For the broader context, see CMR substances and SVHC and the REACH Candidate List.
The sources DOHSBase brings together
Not every company can or wants to work through all sources itself. That is why DOHSBase shows the classifications of the main serious sources side by side, each time with the origin noted:
- ECHA — harmonised classification (CLH), the legal minimum;
- Health Council (Gr), IARC, SCOEL/RAC and comparable authoritative assessments;
- around 200,000 registered and notified CLP classifications from ECHA’s C&L Inventory.
Because each classification sits with its source, you see at once whether an H-statement comes from the harmonised list, from a Health Council advisory or from notifications, and you can make that assessment on a sound basis. That this completeness is valuable is also reflected in the fact that the Dutch Labour Inspectorate values this broader, source-based approach. The data DOHSBase brings together per substance is described in DOHSBase capabilities; the H-statements themselves are explained in H-statements: complete reference.
You assess, you decide
DOHSBase does not take the assessment out of your hands and does not prescribe which classification you must use. The system makes the sources visible; the judgement of which classifications you adopt, and the responsibility for it, remain with you. That is also exactly what the law asks: a substantiated, independent assessment based on all available information. You can look up a substance and review its limit values and sources in DOHSBase Online.
Frequently asked questions
May I use only the harmonised classification? No. The harmonised classification is mandatory for the hazard classes it covers, but for the remaining classes you must classify the substance yourself on the basis of all available information (CLP Article 4(3) and Article 5).
Why does DOHSBase show an H-statement that is not harmonised? Because an authoritative source, for example the Health Council, substantiates that classification, and the law requires you to take it into account. DOHSBase notes the origin so you can verify the source.
What is a notified classification? A classification that companies have themselves notified to ECHA for the C&L Inventory. These classifications vary and are not legally binding, but they are relevant information to include in your assessment.
Why is xylene on the CMR list without a harmonised CMR H-statement? Because the SZW CMR list also includes substances on the basis of a Health Council advisory, separate from the EU harmonised classification.