The New Rulebook on CMR Substances: A Complete Guide to the 2025 Changes

From CM to CMR: what does it mean for your company?

On 1 November 2025, the new Rulebook on preventive measures for safe and healthy work when exposed to carcinogenic, mutagenic or reproductive toxic substances (“Official Gazette of RS”, No 92/2025) entered into force, replacing the old Rulebook from 2011 (No 96/11 and 117/17).

This change is not cosmetic. The new regulation brings a fundamental extension of scope that will directly affect thousands of companies across Serbia, from the chemical industry and metalworking, through car repair shops and transport companies, to carpenters and plastics manufacturing.

While most of the discussion focuses on exposure limit values, the most significant change lies in the acronym itself: instead of CM (carcinogens and mutagens), the rulebook now covers CMR, adding reproductive toxicants to the full regulatory regime.

In this article we will go through all the key changes, the practical implications and the concrete steps employers must take to comply with the new requirements.

1. Main changes: What is new in Rulebook 92/2025?

1.1. Extension of scope to reproductive toxicants

Old rulebook (96/11 and 117/17): Covered only carcinogenic and mutagenic substances.

New rulebook (92/2025): Adds reproductive toxicants of categories 1A and 1B according to the GHS classification.

Under Article 3, paragraph 1, point 3) of the new rulebook, a reproductive toxicant is:

A substance or mixture classified as Reproductive toxicity, category 1A or 1B
A reproductive toxicant without a threshold, for which there is no safe level of exposure
A reproductive toxicant with a threshold, for which there is a safe level below which there is no risk

In practice this means that substances which:

Affect sexual function and fertility in adults
Cause developmental toxicity (effects on the development of the unborn child)
May affect lactation or act via breast milk

are now covered.

1.2. New processes and exposures in Annex 1

Annex 1 of the rulebook lists processes that are considered carcinogenic even if the substances themselves are not formally classified. The new rulebook adds three critical items:

Point 5: Work involving exposure to hardwood dust

This covers:

Joinery workshops
Furniture manufacturing
Parquet manufacturing
Wood processing (oak, ash, beech, walnut, etc.)

Note: This is NOT ordinary dust protection. Records of exposure to hardwood dust are kept for 40 years because it is classified as carcinogenic.

Point 7: Work involving dermal exposure to mineral oils that have previously been used in internal combustion engines

This covers:

Car mechanics who change oil
Service technicians who handle used oil
Workers at recycling centres
Employees in industrial waste oil processing

Point 8: Work involving exposure to diesel engine exhaust emissions

This covers:

Truck and bus drivers
Forklift operators in enclosed warehouses
Workers in garages and car repair shops
Employees in tunnels and mines (where diesel equipment is used)

2. Reproductive toxicants: What does it mean in practice?

2.1. Which substances fall into the “R” category?

Here are the most common ones:

Phthalates (plasticisers)

DEHP (di(2-ethylhexyl) phthalate)
DBP (dibutyl phthalate)
BBP (benzyl butyl phthalate)
Used in PVC products, rubber, paints, adhesives

Bisphenol A (BPA)

Polycarbonate plastics
Epoxy resins
Thermal paper (receipts, fiscal slips)

Lead and lead compounds

Battery industries
Metallurgy
Smelters (temperature stabilisers in liquid metals)
IMPORTANT: Lead is now both a carcinogen and a reproductive toxicant

Ethylene glycol ether solvents

2-methoxyethanol
2-ethoxyethanol
Used in paints, lacquers, printing inks

Organic solvents

DMF (dimethylformamide)
NMP (N-methyl-2-pyrrolidone)
Rubber industry, pharmaceutical industry

PFAS compounds (certain members of the family)

Perfluorooctanoic acid (PFOA)
Perfluorooctane sulfonate (PFOS)
Firefighting foams, waterproof fabrics, industrial coatings

2.2. Implications for different industries

Plastics industry: Companies that use phthalates as plasticisers must now implement the full CMR regime: risk assessments, health surveillance, exposure records.

Pharmaceutical industry: The use of certain solvents (DMF, NMP) requires strict exposure monitoring and the use of closed systems wherever possible.

Automotive industry and repair shops: Work with used engine oil (point 7, Annex 1) now requires formal CMR treatment, including an assessment of dermal exposure.

Construction and insulation: Certain insulation materials containing flame retardants with reproductive toxic properties.

3. Biological limit values: Annex 4 (NEW!)

Biological monitoring:

The level of lead in blood (PbB) is measured by absorption spectrometry or an equivalent method.

CRITICAL: Gradual reduction of the BLV:

Phase 1 (until 31 December 2028):

Biological limit value: 30 μg Pb/100 ml of blood
Employees whose level was already above 30 μg but below 70 μg before 9 April 2026 may continue working under regular monitoring if the level is decreasing towards the 30 μg limit

Phase 2 (from 1 January 2029):

Biological limit value: 15 μg Pb/100 ml of blood (twice as strict!)
Employees whose level was already between 15-30 μg before 9 April 2026 may continue working under regular monitoring if the level is decreasing

SPECIFICALLY FOR WOMEN OF REPRODUCTIVE AGE:

Recommended biological guidance value: 4.5 μg Pb/100 ml of blood

When monitoring is mandatory:

If exposure to lead in air is > 0.015 mg/m³ (40 h per week)
If a level > 9 μg Pb/100 ml of blood has been measured in any employee
For female employees of reproductive age if > 4.5 μg Pb/100 ml

3.2. Practical implications for industry

Battery industry, smelters, accumulator manufacturing: The days when it was enough to keep the BLV below 70 μg are over. From 2029, the limit value drops to 15 μg, which will require:

Significant investment in closed systems
Improved ventilation
More frequent medical examinations and monitoring
Possible reorganisation of work processes

Welding and soldering: If you use lead-containing solders or weld alloys that contain lead, biological monitoring becomes mandatory.

4. Employer obligations: What you must do NOW

4.1. Risk assessment (Article 4)

The employer is obliged to carry out a risk assessment for all jobs in which employees are or may be exposed to CMR substances.

The assessment must cover:

The nature, degree and duration of exposure
All routes of exposure (not only inhalation, but dermal too!)
Identification of employees exposed to particular risk
Measures to eliminate or reduce the risk

When the assessment is renewed:

With every change in the technological process
When new substances/mixtures are introduced
When new hazards or harmful factors emerge

4.2. Hierarchy of measures (Articles 5 and 6)

The rulebook prescribes a clear hierarchy:

1. SUBSTITUTION (priority #1)
The employer is obliged to replace the CMR substance with a substance/mixture/process that is not hazardous or is less hazardous, where this is technically feasible.

2. CLOSED SYSTEM
If substitution is not possible, the CMR substance must be manufactured and used in a closed system, wherever this is technically feasible.

3. MINIMISING EXPOSURE
If a closed system is not possible, exposure is reduced to the lowest technically achievable level.

4. PREVENTIVE MEASURES (Article 6, paragraph 7)
These include:

Limiting the quantity of CMR substances to a minimum
Reducing the number of exposed employees
Local and general ventilation
Appropriate work procedures
Collective protective measures
Additional personal protective equipment (only if everything else is not enough!)
Hygiene measures
Information and marking of hazardous areas
Emergency plans

4.3. Health surveillance (Article 15)

Pre-employment and periodic examinations:
For jobs with increased risk (as determined by the risk assessment act).

Targeted medical examinations:
For jobs not classified as “with increased risk” where employees are or may be exposed to CMR substances.

Biological monitoring:
Mandatory where a biological limit value has been set in Annex 4 (currently: lead).

IMPORTANT: The healthcare institution may order surveillance to continue even after exposure ends, for as long as it considers necessary.

4.4. Records and documentation (Article 16)

AN UP-TO-DATE LIST OF EXPOSED EMPLOYEES must contain:

The employee’s identification data
The job and the tasks performed
The nature of exposure (which CMR substance)
The degree of exposure (if data are available)

Record retention:

Carcinogens and mutagens: 40 years after exposure ends
Reproductive toxicants: At least 5 years after exposure ends

Before ceasing business:

List of exposed employees → Labour Inspectorate
Health records → Institute of Public Health

4.5. Training and informing employees (Article 12)

The employer is obliged to provide:

Information on risks (including the synergistic effect of smoking)
Training on preventive measures
Instructions on wearing and using protective equipment
Information on emergency measures

Training is adapted to:

Changes in processes
New CMR substances
Changed working circumstances

For healthcare institutions:

Periodic training for employees exposed to CMR substances
Special training when new hazardous medicinal products are introduced

5. The most common mistakes and doubts

Mistake #1: “We’ll wait for the inspector to explain what’s needed”

The rulebook entered into force on 1 November 2025. The obligations run from that date, not from the moment an inspector comes for a check. Waiting can lead to:

Misdemeanour fines
Production stoppage
Health risks for employees

Mistake #2: “We don’t have chemicals, this doesn’t apply to us”

If your employees:

Drive diesel vehicles (long-haul transport)
Work wood (hardwood dust)
Change oil in vehicles (car repair shops)
Use certain paints, adhesives, solvents

…then you definitely fall within the scope of the rulebook, even if you don’t handle “classic” chemicals.

Mistake #3: “We have safety data sheets, that’s enough”

Safety data sheets are the starting point, but they are not enough. You need to:

Assess the risk at the specific workplace
Determine actual exposure (measurements)
Implement the hierarchy of control measures
Keep records of exposed employees
Carry out health surveillance

Mistake #4: “We use small quantities, it’s negligible”

The rulebook does not define a quantity threshold below which it does not apply. Even small quantities of CMR substances trigger the obligation to assess risk and, if a risk is identified, all the other obligations as well.

6. Action plan: Steps towards compliance

PHASE 1: IDENTIFICATION (immediately)

Step 1: Make an inventory of all substances and mixtures in use

Step 2: Check the safety data sheets and look for the H-statements for CMR classifications

Step 3: Identify the processes from Annex 1 (diesel, hardwood, used oils)

Step 4: Map which jobs and how many employees are exposed

PHASE 2: RISK ASSESSMENT (as soon as possible)

Step 5: Engage an authorised organisation or a qualified person for the risk assessment

Step 6: Carry out exposure measurements where needed

Step 7: Document the nature, degree and duration of exposure for each job

Step 8: Consider options for substitution or a closed system

PHASE 3: IMPLEMENTING MEASURES (priority: high risk)

Step 9: Implement the hierarchy of control measures

Step 10: Provide additional personal protective equipment (if technical solutions are not enough)

Step 11: Set up emergency systems

Step 12: Mark the hazardous areas

PHASE 4: HEALTH SURVEILLANCE (based on the assessment results)

Step 13: Contract a healthcare institution for occupational medicine

Step 14: Organise pre-employment/periodic/targeted examinations

Step 15: Set up biological monitoring (especially for lead!)

Step 16: Keep individual health records

PHASE 5: DOCUMENTATION AND RECORDS

Step 17: Set up a list of exposed employees

Step 18: Organise record retention (40 years for C+M, at least 5 years for R)

Step 19: Ensure access to the list for the healthcare institution and the inspectorate

Step 20: Update the documentation regularly

PHASE 6: TRAINING AND COMMUNICATION

Step 21: Organise training for all exposed employees

Step 22: Provide written instructions

Step 23: Inform employees of the monitoring results

Step 24: Repeat the training periodically

7. Special cases and exceptions

Pregnant women, women who have recently given birth and breastfeeding women

Under the Rulebook on measures for safe and healthy work of employed women during pregnancy, women who have recently given birth and employees who are breastfeeding (“Official Gazette of RS”, No 102/2016)), an employed woman must not work in jobs with a CMR risk:

During pregnancy: exposure to C, M or R substances
While breastfeeding: exposure to substances that may affect lactation

The employer must:

Consider a temporary transfer to another job
Or allow pregnancy/maternity leave

Before ceasing business

Article 16, paragraph 3 prescribes that the employer must hand over:

Exposure records → Labour Inspectorate
Health records → Institute of Public Health

This is critical because employees have the right to health surveillance even after their employment ends, especially for carcinogens, where the latency period can be decades long.

8. Conclusion and recommendations

The new Rulebook on CMR substances is a significant step forward in protecting the health of employees in Serbia. Extending the scope to reproductive toxicants, introducing biological limit values and defining hazardous processes more precisely set a higher standard of occupational safety and health.

For employers, the key messages are:

Action is urgent: the rulebook has been in force since 1 November 2025.
The scope is wider than you think: many processes and substances you did not consider problematic now fall under the CMR regime.
Records are critical: 40 years for C+M, at least 5 years for R substances.
Biological monitoring for lead is becoming dramatically stricter: from 2029 the BLV drops to 15 μg Pb/100 ml.
Risk assessment is the basis of everything: without a high-quality risk assessment, all other measures are inadequate.

Next steps:

✓ Make an inventory of CMR substances in your company
✓ Identify exposed employees and processes
✓ Engage a qualified person for the risk assessment
✓ Implement the hierarchy of control measures
✓ Set up health surveillance
✓ Organise employee training

If you are not sure whether your company falls within the scope of the rulebook, or you need help interpreting the requirements and implementing the measures, that is exactly why the role of the chemicals adviser exists.

Employee safety and health are not just a legal obligation; they are an investment in productivity, motivation and the long-term sustainability of the business.

Do you need help identifying products and/or processes under the Rulebook on CMR substances? Contact us.

SOURCE: Rulebook on preventive measures for safe and healthy work when exposed to carcinogenic, mutagenic or reproductive toxic substances, “Official Gazette of RS”, No 92/2025

This blog post is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed chemical adviser or a lawyer specialising in chemical regulation.