39. The duties in the European Union

The national bodies of rules of the Member States transpose Union law. This section brings together what Union law itself requires, and in doing so separates occupational safety and health law from chemicals law and from waste law. Implementation is a matter for the Member States; for a company the duties arise from the respective national law.

Scope of Directive 2004/37/EC

Under Article 3 paragraph 1 the Directive applies “to activities in which workers are or may be exposed to carcinogens, mutagens or reprotoxic substances as a result of their work”. It thus attaches to the exposure during an activity. Article 2 letter a point i defines the carcinogen through the classification criteria of Annex I of Regulation (EC) No 1272/2008 and contains no restriction to substances that are bought, placed on the market or deliberately used. Calcium chromate and sodium chromate are classified in harmonised form as carcinogenic category 1B in Annex VI Part 3 of that Regulation. [233, 63]

In addition, Article 2 letter a point ii covers substances and mixtures that are “released by a process referred to in this Annex”. Annex I contains process-related entries for this, among them work with exposure to respirable crystalline silica dust and to diesel engine exhaust emissions. The Union legislature stated the purpose of this Annex in recital 17 of Directive (EU) 2017/2398: for respirable crystalline silica dust generated by a work process there is no classification under Regulation (EC) No 1272/2008, which is why inclusion in Annex I was held to be appropriate. For a substance arising from a process that carries a harmonised classification, point i therefore already applies. [233, 86]

Article 3 paragraph 2 requires, for every activity in which exposure can occur, the determination of the nature, degree and duration of the exposure and the repeated assessment on any change in the conditions. Article 3 paragraph 3 provides that in the risk assessment “all other routes of exposure, such as absorption into and through the skin, are to be taken into account”. [18]

Replacement, closed system, minimisation

Article 4 paragraph 1 requires the employer to reduce the use, “in particular by replacing it, in so far as is technically possible, by substances, mixtures or processes which, in the conditions of their use, are not or are less dangerous”. Article 5 paragraph 2 requires, for the case that substitution is not technically possible, manufacture and use in a closed system. Article 5 paragraph 3 requires, for the case that this too is not technically possible, that the exposure is “reduced to as low a level as is technically possible”. [233]

Article 5 paragraph 5 names the individual measures. Letter c requires the design of the working processes and of the technical measures with the aim of avoiding the release at the workplace or keeping it as low as possible. Letter l requires that safe storage, handling and transport be ensured, among other things through hermetically sealable and clearly labelled containers. Letter m requires the same for the collection, the storage and the removal of the waste. For the removal, the interim storage and the disposal of a contaminated insulation, all three steps are therefore directly regulated. [233]

The general ranking is set out in the Framework Directive 89/391/EEC. Article 6 paragraph 2 names as principles, among others, the avoidance of risks, combating the hazard at source, taking account of the state of the art and the priority of collective over individual protection. Article 9 paragraph 1 letter a requires the employer to be in possession of an assessment of the risks existing at the workplace; the form of the documentation is left by paragraph 2 to the Member States. [234]

The binding limit value

Annex III Part A of Directive 2004/37/EC carries the entry “chromium(VI) compounds which are carcinogens within the meaning of Article 2 letter a point i (as chromium)” with a limit value of 0.005 mg/m³ as a time weighted average over eight hours. A short term value is not laid down, and the notes column is empty. The transitional column names 0.010 mg/m³ until 17 January 2025 and 0.025 mg/m³ until the same date for welding and plasma cutting work and similar fume generating processes. [233, 86]

Article 5 paragraph 4 provides that the exposure may not exceed the limit values of Annex III. The duties under Articles 3 and 4 and Article 5 paragraphs 1 to 3 do not depend on whether this value is reached; they attach to the result of the assessment. For chromium(VI) Germany applies a lower value of 1 µg/m³, and the Netherlands the same lower value of 0.001 mg/m³, both calculated as chromium. [233, 101]

Register, health surveillance and forty years

The list of exposed workers is set out in Article 12 letter c. Under it the employer keeps an up to date list of the workers employed in activities for which the assessment reveals a risk, “indicating the exposure to which they may have been subjected”, in so far as this information is available. Article 15 paragraph 1 requires, for carcinogens and mutagens, that this list and the health record be kept for at least 40 years after the end of the exposure. [233]

Article 15 paragraph 2 governs the case of the undertaking ceasing to operate: where the undertaking ceases its activity, these documents are to be made available to the competent authority. Article 14 paragraph 8 requires that all cases of cancer identified under national law as resulting from exposure at work be notified to the competent authority. Article 10 paragraph 2 provides that the costs of the hygiene and protective measures may not fall on the workers. [233]

Chemicals law: classification, authorisation, restriction

The harmonised classification is set out in Annex VI Part 3 of Regulation (EC) No 1272/2008. Calcium chromate carries the Index number 024-008-00-9 and is classified as carcinogenic category 1B with H350. Sodium chromate carries the Index number 024-018-00-3 and is classified as carcinogenic, germ cell mutagenic and toxic for reproduction, in each case of category 1B. The collective entry 024-017-00-8 covers “chromium(VI) compounds, with the exception of barium chromate and of those specified elsewhere in this Annex” with H350i. [63]

The authorisation requirement under Title VII of Regulation (EC) No 1907/2006 concerns the substances included in Annex XIV. These include chromium trioxide as entry 16, sodium dichromate as entry 18, potassium chromate as entry 21 and sodium chromate as entry 22, in each case with a sunset date in 2017. Calcium chromate is not contained in Annex XIV. Article 56 paragraph 1 prohibits manufacturers, importers and downstream users from placing an Annex XIV substance on the market for a use or from using it themselves, in so far as no authorisation or exemption exists. [235, 66]

The term use is framed widely in Article 3 number 24 and covers, among other things, storing, keeping and treating. Article 2 paragraph 2 excludes waste from the substance concept of the Regulation. Whether the formation of a chromate on a component and its subsequent further use is a use within the meaning of this Regulation is not dealt with in the legal texts and official documents examined; I have not found a source on it. [60, 66]

On 29 April 2025 the European Chemicals Agency published a restriction proposal for chromium(VI) substances. It provides for a ban from which six use categories are to be exempted, provided they comply with the limits laid down for worker exposure and environmental emissions; the categories are the formulation of mixtures, electroplating on plastic and on metal substrates, the use of primers and other slurries, other surface treatment, and functional additives or process aids. The Agency describes the proposal as a possible replacement of the existing authorisation requirement and names a six month consultation starting on 18 June 2025. I could not establish the state of the procedure in October 2026. [236, 59]

The proposal is tailored to chromium(VI) substances placed on the market and deliberately used and to the use categories named. Insulation materials, insulations and chromates formed in situ do not appear in the press release or in the register entry. [236]

Union waste law

Article 7 paragraph 1 of Directive 2008/98/EC provides that the list of waste is binding as regards the determination of the waste to be classified as hazardous. Paragraph 2 allows the Member States to classify a waste as hazardous even where it is not listed as such, provided it displays one of the properties of Annex III. Paragraph 4 prohibits a reclassification as non-hazardous being achieved “by diluting or mixing the waste”. Article 18 paragraph 1 prohibits the mixing of hazardous waste and provides that mixing includes the dilution of hazardous substances. [237]

The list is set out in the Annex to Decision 2000/532/EC. Relevant are 17 06 03* for other insulation materials consisting of or containing dangerous substances, 16 11 03* and 16 11 05* for used linings and refractories from metallurgical and from non-metallurgical processes, and 16 09 02* for chromates. Commission notice 2018/C 124/01 explains the concept of the mirror entries and lists in its annex the standard EN 15192 for the determination of hexavalent chromium in solid materials. [238, 239]

The distance from the Asbestos Directive

Directive 2009/148/EC lays down duties for asbestos that Directive 2004/37/EC does not contain for carcinogens generally. Article 11 requires, before demolition, maintenance or renovation work begins, all necessary steps to identify materials presumed to contain asbestos, by obtaining information from the owner and from relevant registers. Article 4 requires a notification to the competent authority before the work begins, stating among other things the number of workers involved and their training certificates. Article 13 requires a plan of work before the work begins and, after its completion, verification that there is no longer any hazard. Article 14 with Annex Ia lays down minimum requirements for the content, the duration and the frequency of the training, and Article 15 an authorisation of the undertaking. [240]

Directive 2004/37/EC contains no notification before work begins. Its Article 6 requires information to the authority only “on request”. The register and the forty year period are governed in the same way in both Directives. The difference lies in the prior identification, the notification, the plan of work, the minimum requirements for the training and the authorisation of the undertaking. [233, 240]

What the Union does not name

In the legal acts and official documents of the Union examined, the formation of chromates on insulated chromium-alloyed hot components is not named. Examined were the consolidated versions of Directives 2004/37/EC, 89/391/EEC, 2009/148/EC and 2008/98/EC, of Decision 2000/532/EC and of Regulations (EC) No 1907/2006 and No 1272/2008, together with notice 2018/C 124/01 and the accessible publications of the European Agency for Safety and Health at Work. None of the eight process-related entries in Annex I of Directive 2004/37/EC concerns insulations or hot components. [233, 237, 239]

The Commission document closest to the subject deals with chromium(VI) arising from a process exclusively in welding, in thermal cutting and in similar fume generating processes. Thermal insulation materials, calcium oxide and the formation on hot stainless steel surfaces outside these processes do not appear there. That is a finding about the body of material examined and no statement about the duties; these follow from the wording of Articles 2, 3, 4 and 5. [241, 233]

What follows from this

For a company in a Member State the duty arises from the national transposing law. The test applied by Union law is at three points stricter than the question of a measurement. The assessment under Article 3 paragraph 2 is activity-related and is to be repeated on any change in the conditions. Absorption through the skin is expressly to be included under Article 3 paragraph 3. The reduction under Article 5 paragraph 3 is tied to no threshold; it applies as soon as a closed system is not technically possible. A Member State may provide for stricter provisions; the Directive lays down minimum requirements. [233]