In brief
In a workplace that works with a carcinogenic or mutagenic substance, the first step is to try replacing the substance with a less hazardous one; if that is not possible, a closed system follows, and if that is not possible either, exposure is reduced to the lowest level. The employer keeps an up-to-date list of exposed employees and exposure records. These records, together with health surveillance records, are kept for at least 40 years after exposure ends.
Why is working with carcinogens subject to separate rules?
When working with carcinogens, the damage often appears years later. The employee has no complaints today; the trace of exposure comes back as a diagnosis long after they have left the job. For a significant proportion of carcinogens that affect genetic material, no level of exposure can be shown to be safe. The legislation therefore lays down a separate set of obligations on top of the general chemical rules.
This set is laid down by the Regulation on Health and Safety Measures in Work with Carcinogens or Mutagens (Official Gazette 06.08.2013, No. 28730). The regulation applies to all workplaces covered by Law No. 6331 where work is carried out in which employees are at risk of exposure to carcinogens or mutagens (Art. 2). In work with asbestos, it is applied together with the asbestos regulation. We explained general chemical obligations in our article on the chemical agents regulation; this article focuses only on four topics specific to carcinogens and mutagens: substitution, closed systems, the list of exposed employees and long-term records.
List of carcinogenic substances: which substances are covered?
The regulation defines a carcinogen as substances and preparations which, if inhaled, ingested or if they penetrate the skin, may cause cancer or increase its incidence. A mutagen is a substance that can cause heritable genetic damage by the same routes (Art. 4). There is no single "list of carcinogenic substances"; the scope is determined from three sources:
- Classification: Art. 18 requires the classification in the legislation on classifying hazardous substances to be taken into account; lists published by the World Health Organization may also be considered. Its practical equivalent on site is the safety data sheet (SDS): a substance whose Section 2 carries the statement H350 (may cause cancer) or H340 (may cause genetic defects) is covered. Assess H351 or H341 (suspected) statements together with your workplace physician.
- Annex 1 processes: Certain processes are covered even if the resulting substance is not separately classified.
- Annex 2 limit values: Binding occupational exposure limits have been set for three substances.
| Source | Content | Note |
|---|---|---|
| Annex 1 / 1 | Manufacture of auramine | Covered as a process |
| Annex 1 / 2 | Exposure to polycyclic aromatic hydrocarbons in coal soot, coal tar and pitch | Work involving pitch and tar |
| Annex 1 / 3 | Dust, fumes and sprays produced during the roasting and electrorefining of cupro-nickel mattes | Metallurgy |
| Annex 1 / 4 | Production of isopropyl alcohol by the strong acid process | Chemical production |
| Annex 1 / 5 | Work involving exposure to hardwood dust | Furniture and woodworking |
| Annex 2 | Benzene: 3.25 mg/m³ (1 ppm), also skin exposure | 8-hour value |
| Annex 2 | Vinyl chloride monomer: 7.77 mg/m³ (3 ppm) | 8-hour value |
| Annex 2 | Hardwood dusts: 5 mg/m³ | Applies to the whole mixture if mixed with other wood dusts |
Common examples in chemicals and plastics businesses include vinyl chloride monomer in PVC production, benzene in some solvent and petrochemical streams, formaldehyde used in resin production and 1,3-butadiene used in synthetic rubber. Always verify the classification from your supplier's current SDS; we explained how to read an SDS in our article on how to read a safety data sheet. If you do not have an inventory, start with the step of preparing a chemical inventory.
Substitution first: try replacing the substance before anything else
The carcinogens and mutagens regulation puts substitution at the top of the order of measures. Where technically possible, the employer reduces the use of carcinogens or mutagens by using a non-hazardous or less hazardous substance, preparation or process; and provides the results of its research into substitution to the Ministry on request (Art. 6). The information the Ministry may request explicitly includes "whether substitution has been possible" (Art. 8/f). In other words, substitution is not just something to be done but something to be documented.
A substitution assessment record should include:
- The current substance, its purpose, the annual quantity and the departments where it is used.
- The alternatives assessed: another substance, another physical form (granules or paste instead of powder) or another process.
- The SDS for each alternative. If the new substance brings another serious hazard, substitution has moved the problem rather than solved it.
- Technical trial results: product quality, process suitability.
- The decision, justification, date and signature.
- The date for reassessment; the assessment is repeated as new alternatives come onto the market.
A justification such as "the customer specifies this raw material" may be acceptable; but it must be in writing and questioned again at the next assessment. For the general logic of the order of measures, see our article on the hierarchy of controls.
Closed system working and minimising exposure
If substitution is not technically possible, the substance is kept in a closed system in its production and use as far as technically possible. If a closed system is not possible either, exposure is reduced to the lowest possible level, and the limit values in Annex 2 may not be exceeded under any circumstances (Art. 7/1). On site, closed system working looks like this: closed transfer with leak-tight connections, a vapour return line when filling tanks, closed sampling points, automatic dosing and, where necessary, glovebox enclosures.
The weak moments of a closed system are well known: sampling, filter changes, maintenance and breakdowns. For work such as maintenance and repair where exposure may increase, the regulation also requires measures to be set after consulting employees or their representatives, the duration to be shortened, protective clothing and respiratory protection to be used, and the area to be marked and unauthorised access prevented (Art. 10). The on-site equivalent of the measures in Art. 7/1-d:
| Measure (Art. 7/1-d) | What does it look like on site? |
|---|---|
| Limiting the quantity of the substance to what the work requires | One shift's quantity at the station; main stock in a separate store |
| Minimising the number of exposed employees | Access to the area only for assigned staff, card-controlled or locked door |
| Engineering controls and extraction at source | Local exhaust ventilation, closed transfer, an indicator showing the extraction is working |
| Early detection of leaks | Fixed detector or regular leak checks |
| Using PPE as a last resort | Protection selected on the basis of measurement when other measures are not enough |
| Regular cleaning of surfaces | Cleaning plan; vacuum or wet methods instead of dry sweeping |
| Warning signs | Risk area sign; no smoking, eating and drinking signs |
| Emergency plan | Scenarios that could lead to high exposure written into the plan |
| Labelled, leak-tight containers and waste | Closed containers, labels; separate labelled containers for waste |
Hygiene rules are also set out separately: eating, drinking and smoking are prevented in areas where contamination is possible; protective clothing is provided, with separate lockers to keep it apart from everyday clothes; washing facilities, toilets and cleaning materials are provided; and PPE is checked and cleaned after every use. The cost of these measures may not be passed on to employees (Art. 12).
How are records of exposed employees kept?
The employer keeps an up-to-date list of employees working in jobs that the risk assessment shows to be risky in terms of health and safety, together with records showing their exposure (Art. 14/4). This list and these records may be inspected by the workplace physician, the persons responsible for health and safety in the workplace and the competent authorities. Each employee has the right to receive their own personal information on the list; employees and their representatives may receive all the information in anonymised form (Art. 14/5–7). In the risk assessment, the type, level and duration of exposure are determined for all routes of entry, including the skin; the wishes of those who do not want to work with these substances are also given particular consideration (Art. 5).
A practical exposed employee record includes these fields:
- Employee's name, staff number, department and job
- Substance name, CAS number and H statement
- Route of exposure: inhalation, skin or both
- Frequency and duration of exposure: for example, "sampling every shift, about 10 minutes"
- Workplace measurement result, date and report number
- Control measures applied and PPE used
- Accidents, leaks or unexpected high-exposure events (Art. 9)
- Start and end dates of exposure
- Only a reference to the health surveillance file (not medical results)
The last item matters: examination results stay in the confidential health file kept by the workplace physician. We explained how to preserve this distinction when sharing the list with human resources in our article on employee health data and data protection law.
Health surveillance and keeping records for 40 years
The employer places employees under health surveillance before exposure and at regular intervals afterwards (Art. 16/1). Under Annex 3, surveillance includes occupational and medical history records, examinations, biological monitoring where possible and up-to-date tests. If a health problem is found to result from exposure, the risk assessment and measures are reviewed and measures are applied, including assigning the employee to other work without exposure; if the physician considers it necessary, other employees with similar exposure are also placed under surveillance. All cancer cases provisionally diagnosed as related to exposure are notified under Art. 14 of Law No. 6331 (Art. 16/5). We plan tests with authorised laboratories and healthcare providers within the scope set by the workplace physician.
Forty years means several changes of OSGB, software changes and even changes of company ownership. Your archive plan should include: the employer owns the records and they stay at the workplace when the service provider changes; digital records are backed up in a readable format; physical files are protected from damp and fire; and, on a transfer or merger, a handover record of the records to the new employer.
Documents requested in an inspection
In a workplace using carcinogens or mutagens, check before an inspection that the following documents are ready:
- Chemical inventory and current SDSs
- Written substitution assessment and its justification
- Risk assessment showing the type, level and duration of exposure
- Workplace measurement reports from an authorised laboratory
- Up-to-date list of exposed employees and exposure records
- Training records covering the topics in Art. 13 (including the additional risks of tobacco)
- Warning signs and access restriction
- Emergency plan including high-exposure scenarios
- Health surveillance plan and the 40-year retention arrangement for records
In our risk assessment service we deal with the substitution assessment, the weak points of the closed system and the list of exposed employees together; we also link the health surveillance plan to this list. We plan measurements with authorised laboratories and enter the results into the risk assessment. Other risks in the sector are on our chemicals and plastics page; to track measurement and examination dates, you can use the OHS calendar tool. For additional restrictions concerning pregnant and breastfeeding employees, see our article on pregnant and breastfeeding employees.
Frequently Asked Questions
Where is the list of carcinogenic substances published?
There is no single list. Annex 1 of the regulation lists five processes, and Annex 2 gives the limit values for three substances. Other substances are determined according to classification legislation; in practice, the H350 and H340 statements in the SDS show the scope. World Health Organization lists may also be taken into account.
Is setting up a closed system mandatory in every case?
No, there is an order. Substitution is tried first; if substitution is not technically possible, a closed system is used as far as technically possible. If a closed system is not possible either, exposure is reduced to the lowest level. You must be able to show in writing at which stage you stopped and why.
Who can see the list of exposed employees?
The workplace physician, the persons responsible for health and safety in the workplace and the competent authorities can inspect it. Each employee can receive their own information, and employees and their representatives can receive all the information in anonymised form.
What happens to the 40-year records if the workplace closes?
When activity ceases, the employer hands the list, exposure and health surveillance records over to the SGK provincial directorate. Keep the handover record and an inventory of the files handed over.
A risk assessment that identifies and scores hazards on site, links each measure to an owner and a date, and has a clear renewal schedule.
Bursa SİSTEMER OSGB Technical Team — written from the field experience of our OHS specialists and workplace physicians. Legal information is valid as of the publication/update date; contact us for an assessment specific to your business.