Legal Metrology Sixth Amendment Rules 2025: New Standards for Evidential Breath Analysers

On 28-11-2025, the Ministry of Consumer Affairs, Food and Public Distribution notified the Legal Metrology (General) Sixth Amendment Rules, 2025 to amend the Legal Metrology (General) Rules, 2011. The provisions will come into effect on 1-4-2026.

Key Provisions:

The amendment has introduced a new Part in the Legal Metrology (General) Rules, 2011:

1. Part XIII relates to the Evidential Breath Analyser.

2. Evidential Breath Analysers are quantitative instruments which provide a measurement result of alcohol concentration in exhaled human breath.

3. They are used for the purpose of establishing compliance, for fighting against alocohol abuse and advancement of public safety.

4. These instruments are the principal means by which a definitive alcohol measurement is obtained and are considered “evidential”.

5. Here, alcohol will refer to ethyl alcohol or ethanol in a broader context, but, when dealing with test gas compositions, the exact chemical terminology for each substance will be applied.

6. Breath analysers should have the following special features:

   • prohibit the displaying or reporting of results that do not represent the final measurement result;

   • mandating the inclusion of a printing device;

   • prohibiting operation of the analyser when no paper is detected in the printing device;

   • requiring further printed information in addition to the final measurement result;

   • requiring final measurement results to be displayed and reported in terms other than the alcohol content in exhaled human breath (that is, physiological conditions such as percentage of blood or in terms of other quantities).

7. The scope of this specification will be limited to the types of breath analysers that use mouthpieces for sampling the breath.

8. Schematic Description of Instrument:

   • It provides a means for sampling and then measuring the alcohol content of a sample of end expiratory breath of a human being;

   • It means for conveying the breath sample through the sampling system depends on the kind of alcohol sensor used in the specific EBA;

   • Incorporated into the sampling system is an alcohol sensor which analyses the breath sample and provides signals related to the concentration of alcohol;

   • The sensor signals are then electrically processed to display the results of a measurement in mg/L or another prescribed SI unit;

   • It has a means to check whether the conditions for the acceptance of a breath sample are fulfilled;

   • Major components of the instrument:

     ✓ replaceable mouthpieces to hygienically conduct the breath sample;

     ✓ a hose to convey the breath sample through the sampling system or a sampling probe to convey a sub-sample of the breath sample through the sampling system;

     ✓ a display to monitor the flowrate, time and volume;

     ✓ sensor to measure the alcohol content of the breath sample;

     ✓ data system to process the measurement signal including an indicating device to display the results and messages;

     ✓ an interface to an external data connection;

     ✓ a control facility to initiate and check instrument operations;

     ✓ an adjustment facility to set the instrument operating parameters within prescribed limits.

9. Description of sampling and mouthpiece:

   • A specimen of an end expiratory breath sample from a continuous and uninterrupted expiration shall be analysed for alcohol concentration and the breath sample will not be influenced by breathing techniques;

   • It will be be capable of being used under satisfactory hygienic conditions and the use of individually packaged, replaceable mouthpieces for each measurement shall be indispensable.

10. Measuring range:

    • It will be from 0.00 mg/L to at least 2.00 mg/L;

    • A higher upper limit of the measuring range will be defined by the manufacturer;

    • It will indicate when its upper limit of measurement is exceeded with the mention of the value of the upper limit for example —result > 2 mg/L;

    • It will fulfill the requirements of this specification for the complete specified measuring range.

11. Masking of low results will be deactivated in the metrological test mode.

12. The Evidential Breath Analysers will be fitted with a printing device, internal or external.

13. Parameters that will be recorded for all tests:

    • Date and time;

    • Ambient temperature;

    • Ambient relative humidity;

    • Ambient pressure;

    • Values of the measured;

    • Indications and errors;

    • Functional performance;

    • Correct printout of the internal printer.