Laws and standards in Asia

In Asia, the number of binding regulations for the design of safe machinery is not really very high. Rapid industrial growth, however, means that the demand for machinery safety components is rising here too. Various certification processes and industrial health and safety laws are in part responsible, defining relevant protective measures and minimum standards.

Russia and the CIS countries have been implementing TR CU certification (Technical Regulations of the Customs Union) for some years. This means that technical devices that fall within a specific product area must undergo a certain certification process.

Machinery and any corresponding technical accessories undergo a type approval test through a European notified body, for example. This test is normally recognised by an approval body based in Russia.

China has introduced CCC certification. Similar to the position in Russia, technical products are subject to mandatory certification through a national approvals body.

Production sites are also inspected. If a technical device falls with the scope of the product list, which is subdivided into 19 categories, certification is mandatory, otherwise it will be necessary to supply a type of "declaration of no objection" from a national notified body.

The Japanese Industrial Safety and Health Law specifies that hazardous machinery or machinery that is used in hazardous environments must be equipped with appropriate protective measures, as defined by the national Ministry. For example this relates to rubber grinding machines, presses, overload protection devices for cranes, sawing machines in woodworking or electrical parts in potentially explosive atmospheres. Some machines require approval from the national Ministry before they are manufactured or used. Boilers, cranes, pressure vessels or lifts fall into this category.

As a "best effort" the health and safety regulations require that machine manufacturers provide information about risks relating to the use of the machine and that employers/machine users carry out a risk assessment.

Above all, the Japanese Industrial Safety & Health Association (JISHA) supports the introduction of risk evaluations and health and safety management systems in Japan. Due to Japanese law, each employer/machine user must ensure that industrial safety measures are in place. Employees are obliged to support the measures that their employer puts in place.

The methodology for risk assessment is stated in Japanese standards (Japanese Industrial Standards, JIS), which are harmonised with international standards. Although the risk assessment is obligatory when certain chemical materials are used, it is currently not required in other industries.

On 28 August 2024, the Indian Ministry of Heavy Industries published the new regulation “Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024” (for short: OTR 2024). This comprehensive regulation was developed by the Bureau of Indian Standards (BIS) and aims to establish uniform safety standards for machinery and electrical equipment manufactured in India or imported into India. In future therefore, only products that comply with the new requirements may be placed on the Indian market.

Overview of the OTR’s aims:

• To set up a transparent, standardised certification process in accordance with Scheme X of the BIS regulations of 2018 (conformity assessment).
• To promote risk assessment and reduction during the design, manufacture and operation of machinery.
• To improve safety compliance for machinery imported into or manufactured in India.
• To reduce the risks associated with the operation of machinery and improve public safety

Limited application range in the initial phase

In the initial implementation phase, OTR 2024 will apply exclusively to machinery and electrical equipment listed in the first annex of the Official Journal. Other product groups that were originally included in the draft, such as consumer electronics or complex industrial equipment, are currently unaffected until a further date is announced. 

Requirements and procedure

The requirements are based on international standards such as ISO 12100:2010 and the Indian standard IS 16819:2018. Type A, Type B1, B2 and Type C standards are applied, depending on the type and complexity of the machines. Compliance is demonstrated through product compliance reports, risk assessments and safety validations. Certification includes document reviews and on-site audits to verify safety and compliance with the regulations.

• Application submission with technical documentation, including risk assessment and validation reports, as well as product compliance reports. 
• Conducting document reviews and on-site audits to verify compliance.
• Payment of applicable fees and submission of performance bank guarantees.
• Inform BIS about the details of the delivery and maintain the validity of the certification.

How does Pilz provide support?

International companies that export machinery or electrical equipment to India should familiarise themselves with the new requirements at an early stage. Because the mandatory adjustment to Indian safety standards will apply when OTR 2024 comes into force. This means that only products that meet the new requirements may be sold on the Indian market. In future, anyone wishing to export to India must also appoint an authorised representative (AIR) based in India. 

Pilz India provides comprehensive support to help prepare for the regulations, meet the requirements and therefore export to India. As well as advising on compliance with IS 16819 and other relevant standards, Pilz also offers support with the preparation of technical documentation, including risk assessments and safety validations. Training courses and workshops on Machinery Safety and BIS certification are also on offer. The extensive product portfolio of certified safety components that meet BIS requirements completes the offer. 

Pilz India is also an active member of the relevant committee of the “Bureau of Indian Standards” and so is always up to date, keeping you informed.