MAKING SAFE MACHINES

A STANDARD IN INDIA
Insights and Recommendations from
Comparing Regulations in India and Germany

Indo-German Working Group on Quality Infrastructure | Knowledge Series 2

in collaboration with
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Editors
Khushwant Singh, Alok Kesari

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Seema Sethi Design LLP, New Delhi, India

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December 2018, New Delhi, India

MAKING SAFE MACHINES
A STANDARD IN INDIA
Insights and Recommendations from
Comparing Regulations in India and Germany
2

ABOUT THIS PUBLICATION

This publication was funded by the German Federal Ministry for Economic Affairs and
Energy as part of its Global Project Quality Infrastructure (GPQI). The Global Project Quality
Infrastructure facilitates political and technical dialogues with partner countries. Its goal is to
reduce technical barriers to trade, enhance product safety, and strengthen consumer protection.
The dialogues focus on opportunities and challenges related to legislation, market surveillance,
standardisation, conformity assessment and accreditation, and market surveillance. They
include relevant line ministries, regulators, public agencies, accreditation and standards bodies,
industry associations, companies, technical and scientific institutions. The Deutsche Gesellschaft
für Internationale Zusammenarbeit (GIZ) GmbH – the German Agency for International
Cooperation – has been commissioned by the German Federal Ministry for Economic Affairs and
Energy to support the implementation of GPQI in Brazil, China, India and Mexico.

In India, the German Federal Ministry for Economic Affairs and Energy and the Indian
Ministry for Consumer Affairs, Food & Public Distribution have established the Indo-German
Working Group on Quality Infrastructure to strengthen bilateral collaboration. The Working
Group brings together representatives from relevant ministries, including the Ministry of
Commerce and Industry (MoCI), Ministry of Electronics and Information Technology (MeitY),
Ministry of Heavy Industries and Public Enterprises (MoHI), Ministry of Road Transport and
Highways (MoRTH), Ministry of Power (MoP) as well as experts from the Bureau of Indian
Standard (BIS), industry, associations including the Confederation of Indian Industry (CII) and
accreditation bodies including the Quality Council of India (QCI). The mutually agreed work
plan reflects key areas of the economic relations between both countries. It covers topics ranging
from automotive, electric vehicle and charging infrastructure, machinery safety, Industry 4.0,
IT security and data protection to market surveillance. The Indian country component of GPQI
supports the implementation of the mutually agreed annual work plan of the Working Group.

This publication is a result of the activities of the Indo-German Working Group on Quality
Infrastructure. It was prepared in collaboration with expert members of the Mechanical
Engineering Industry Association (VDMA), Samir Kanchan from Macsafe India, and with
support of BDB India Private Limited and Dr. Kari Hiepko-Odermann. It is the second volume
in a series of publications on quality infrastructure.

The presentation of the material in this publication does not imply the expression of any opinion
whatsoever by the German or Indian Government. The publication was produced without formal
editing from the German Federal Ministry for Economic Affairs and Energy or any Indian
Ministry.
 3

FOREWORD

We all benefit from safe machines. Machines that conform to relevant safety requirements protect
workers and the environment. Safe machines also contribute to efficient production processes and
thus are a key pillar of a robust economy.

A working culture that acknowledges the importance of machinery safety requires comprehensive
regulations substantiated through high standards and elaborated conformity assessment
procedures.

The Indo-German Working Group on Quality Infrastructure has been a very conducive forum to
discuss the significance of machinery safety. German and Indian regulators and industry experts
have not only exchanged information to understand each other’s approaches. They also shared
experiences on how to develop new and existing regulations and standards related to functional
and electrical safety while drawing on good practices from Germany.

This publication is the result outcome of the many constructive fruitful exchanges in the Working
Group. It provides an overview of the regulatory framework in India with regards to machinery
safety, and challenges faced by the industry. It also compares machinery regulations in India with
those in the European Union (EU).

This study is of interest for regulators, managers and industry associations alike. I am hopeful
that it will contribute to strengthening machinery safety in India, and further deepen the Indo-
German industrial collaboration, for the benefit of both sides.

Stefan Schnorr

Director General
Digital and Innovation Policy
Federal Ministry for Economic Affairs and Energy
Germany
CONTENTS

Foreword . ............................................................................................................................. 3
List of Figures And Tables ............................................................................................ 6
List of Abbreviations ...................................................................................................... 7
Executive Summary ................................................... ..................................................... 8

INTRODUCTION .................................................................................. ................................ 10

REGULATORY FRAMEWORK IN INDIA .......................................................................... 12

Ministry of Labour & Employment ...................................................................... 13

Bureau of Indian Standards ................................................................................. 17
Ministry of Heavy Industries & Public Enterprises .......................................... 23

LEGAL FIELDS IN THE EUROPEAN UNION AND TRANSPOSITION IN GERMANY .. 25

EU Machinery Legislation ..................................................................................... 25

Comparison of European Union And Indian Systems .................................... 29

INDUSTRY CHALLENGES .................................................................................................. 30

RECOMMENDATIONS ........................................................................................................ 31

References ................................................................................................................ 33
Methodology ............................................................................................................. 34
Questionnaire ........................................................................................................... 36
6

LIST OF FIGURES AND TABLES

Figure 1 – Regulatory Framework in India......................................................................................................12
Figure 2 – Standards Development Process..................................................................................................18
Figure 3 – India Net Imports and Exports...................................................................................................... 23
Figure 4 – EU Machinery Legislation................................................................................................................. 25
Figure 5 – Compliance evaluation based on Machinery Directive................................................. 27

Table 1 – List of Published Indian Standards (Non-electrotechnical).........................................19

Table 2 - List of Draft Indian Standards (Non-electrotechnical)...........................................19-21
Table 3 – List of Indian Standards (Electrotechnial)......................................................................21-22
Table 4 – List of Draft Indian Standard (Electrotechnical)................................................................ 22
Table 5 – Standards related to machinery safety..................................................................................... 26
Table 6 – EU-India System Comparison........................................................................................................... 29
Table 7 – Overview of Objectives and Methodology................................................................................. 34
Table 8 - Respondents Profile................................................................................................................................. 34
Table 9 – Respondents List....................................................................................................................................... 35
 7

LIST OF ABBREVIATIONS
BIS Bureau of Indian Standards
CE European Conformity
CEN European Committee of Standardisation
CENLEC European Committee for Electrotechnical Standardization
CII Confederation of Indian Industry
DGFASLI Directorate General Factory Advice Services & Labour Institutes
EC European Commission
EN European Standard
EU European Union
GIZ Deutsche Gesellschaft für Internationale Zusammenarbeit
GoI Government of India
GPQI Global Project Quality Infrastructure
IEC International Electrotechnical Commission
ISO International Organization for Standardization
MD Machinery Directive
MED Mechanical Engineering Department
MeitY Ministry of Electronics and Information Technology
MoC Ministry of Commerce and Industry
MoHI Ministry of Heavy Industries and Public Enterprises
MoL&E Ministry of Labour & Employment
MoP Ministry of Power
MoRTH Ministry of Road Transport and Highways
OEM Original Equipment Manufacturer
OHS Occupational Health and Safety
QCI Quality Council of India
TC Technical Committee
VDMA Mechanical Engineering Industry Association
WG Working Group
8

EXECUTIVE SUMMARY
Reports show that several thousand occupational accidents take place annually in India. Only
20 percent of India’s 465 million workers are covered under its existing health and safety legal
framework. One factory inspector is responsible for over 500 factories. These figures demonstrate
why improving machinery and worker safety is important in India.

New opportunities for the machinery industry have opened through a focus on manufacturing,
especially through the Make in India initiative. Launched in 2014, it has the objective of job
creation and skill enhancement which will lead to transforming India into a global design and
manufacturing hub.

In 2016, the Indian government introduced the National Capital Goods Policy which highlights
the need of mandatory standards, minimum acceptable safety, and environment and performance
standards for machinery. A technical committee for machinery standards was also established by
the Bureau of Indian Standards (BIS). Certain safety regulations, new for Indian manufacturing,
and an established part of European manufacturing, will increase the demand in India for high-
quality machines, manufacturing components and technologies, and at the same time ensure the
safety of Indian workers.

Recognising these recent developments, this study, conducted within the framework of the Indo-
German Working Group on Quality Infrastructure provides a comprehensive look at the current
situation in India and challenges faced by the industry, and also compares machinery directives
in India and the European Union (EU). The study identifies and recommends cooperation
opportunities between India and Germany.

The study:
» documents the current regulatory framework in India for machinery safety.
» examines policy trends for machinery safety in India.
» offers a reference for existing standards, standards currently being developed, and their
harmonisation with international standards.
» compares the current Indian regulations and European Machinery Directives.
» identifies specific technical regulation challenges faced by German industry in India.

Regulatory framework in India is supported by three governmental pillars:

The first pillar is the Ministry of Labour & Employment (MoL&E). It is responsible for the
health, safety, and welfare of workers. Of the several labour related statutes enacted by the Central
Government, the Factories Act of 1948, amended by the Factories (Amendment) Act, 1987 and the
National Policy on Safety, Health & Environment at Work Place have been elaborated on in this
study because of their importance. The government agency which provides technical assistance to
the ministry in formulating national policies, the Directorate General Factory Advice and Service
Institute (DGFASLI), coordinates the administration of the Factories Act.

The second pillar of the regulatory framework is the Bureau of Indian Standards (BIS) which
formulates Indian Standards for machinery safety through its technical committees.
The third pillar is the Ministry of Heavy Industries & Public Enterprises (MHI&PE) which
introduced the National Capital Goods Policy in 2016 outlining minimum acceptable safety,
environmental impact standards, and performance requirements for machinery.

A comparison of the European/German system and the Indian system shows that the EU
framework is based on two well-established but separate legal frameworks. The Machinery
Directive is for the provisioning of safe machines on the market and addressed to the
manufacturer. The second one is for workplace safety addressed to the employer and shall provide
 9

a safe environment for machinery and labour. While in India, safety obligations are directed
towards occupational health and safety (OHS) requirements prescribed in the Indian Factories
Act. Other differences in conformity assessment procedures and enforcement of the regulations
are highlighted as a part of this study.

The main concerns of the European machine manufacturers are the lack of a comprehensive
machinery safety regulation in India and discrepancies in the enforcement of the existing
regulations between the federal states. These concerns ultimately have a bearing on the price of
machines – and factor into their competitiveness.

The limited scope of the Indian Factories Act, 1948 clearly establishes the need for more
comprehensive regulations. These new regulations need to meet safety standards ensuring both
workplace and machinery safety, while at the same time considering the leverage of emerging
manufacturing processes in India, like Industry 4.0.

This study recommends a comprehensive approach including measures such as strengthening the
regulatory framework, classification of ISO and IEC standards adopted without modification,
awareness among the users and decision makers, and conformity assessment for both new and
used machines.
10 Introduction

INTRODUCTION
The International Labour Organization (ILO) reports that more than 2.3 million workers
around the world die in occupational accidents or from work-related diseases each year. Available
information from India indicates that several thousand annual occupational fatalities happen.
And, if incidents from the unorganised manufacturing sector were also factored in, the actual
numbers in India would likely be much higher. Machinery related accidents effect the lives of
workers and their families and can also harm the environment. On average there is only one
factory inspector for every 500 Indian factories, and less than a quarter of India’s 465 million
workers are covered under the country’s existing health and safety legal framework.1

Beyond the ethical responsibility, the short- and long-term financial benefits of ensuring safe work
Beyond equipment like machinery and safe workplaces are finally being recognized. Accidents damage the
the ethical reputation of firms and lead to production losses. The ILO estimates that accidents and work-
responsibility, related diseases cost the global economy around three trillion US dollars annually.2 These aspects
the short- and illustrate why both machinery and worker safety are crucial topics for every firm, every worker,
long-term and every policy framework. The application of the ILO-recommendations is the first step to
financial benefits improve workplace safety. The proposed technical requirements of the ILO-recommendations are
of ensuring very close to the requirements of the EU Legislation regarding workplace safety.
safe work
environments Safer work environments are receiving increased attention not only in India, but in other
are finally being emerging economies where industry best practices are being actively adopted. During the past
recognized. few decades, a growing number of countries have recognized the value of these measures and
developed and introduced safety requirements in accordance to their national laws. Successful
implementation of safety culture involves a specific understanding of the needs, standards,
technical regulations, and the conformity challenges a country faces. Separate national
developments have created various standards for identical products and vastly different procedures
for gaining access to markets.

Currently, two main models are being used. In one, countries place responsibility on
manufacturers and importers. This model is generally combined with effective market
surveillance; where authorities prevent unsafe products from entering the market. In other
countries, a restrictive concept has been introduced, based on obligatory certification. Both
versions have advantages and limitations. The differences between these models shows that a
harmonization of individual national standards and conformity assessment procedures with
international standards and international procedures has become important in facilitating trade.

Manufacturers and trade agencies working between

Europe and India encounter several specific challenges. “With the support of the Global
These challenges can be attributed to the high Project Quality Infrastructure,
bureaucratic effort and time investment required for the Indo-German Working Group
market entry with differing state and national regulations on Quality Infrastructure has
creating time consuming hurdles. The repercussions helped to level the playing field for
of these delays then greatly influence the initial and machinery safety in India. For the
life-cycle cost of products. Recognizing this, the Indian first time, comparable standards
government introduced the National Capital Goods were introduced. This is actually a
Policy in 2016 which highlights the need for mandatory game changer.
standards, minimum acceptable safety, and environment Heinrich Bruellau
and performance standards for machinery. A technical Former COO
committee for machinery standards was also established Schmersal India Pvt. Ltd.
by the Bureau of Indian Standards (BIS).

1 https://www.weforum.org/agenda/2017/03/workplace-death-health-safety-ilo-fluor/;
https://timesofindia.indiatimes.com/business/india-business/48000-die-due-to-occupational-accidents-yearly-study/
articleshow/61725283.cms;
https://indianexpress.com/article/india/india-others/2010-12-over-4000-died-on-shop-floor-but-thats-fraction-of-total/;
http://www.dgfasli.nic.in/dashboard/dashboard_annexure2.pdf;
https://www.deccanchronicle.com/lifestyle/health-and-wellbeing/201117/almost-48000-people-die-in-occupational-accidents-every-
year-study.html
2 https://www.weforum.org/agenda/2017/03/workplace-death-health-safety-ilo-fluor/
 11

The Indo-German Working Group on Quality Infrastructure recognised the further development
and importance of machine standards in India and conducted the following study with the
support of the Indian country component of the Global Project Quality Infrastructure (GPQI).

This study provides a comparative overview of India and Europe’s machinery directives. It
showcases the acts, legislations and structures that created the current regulatory situation in
India. It also identifies the challenges faced by the industry, based not only on the comparative
analysis of regulations but on feedback and input from German and European industry experts.
Based on these findings, specific recommendations are offered for cooperation activities between
India and Germany, which could also minimise technical barriers to trade.
12 Regulatory Framework In India

REGULATORY FRAMEWORK IN INDIA

The regulatory framework in India is supported by three governmental pillars, the Ministry of
Labour & Employment, the Bureau of Indian Standards, and the Ministry of Heavy Industries
& Public Enterprises. This section offers an overview of the legal and organizational structure
for labour welfare and machine regulation in India. The three key ministries and their internal
structure are shown along with a catalogue of the relevant legislation.

Government of India (GoI)

Ministry of Labour Ministry of Heavy

& Employment (MoLE) Industries & Public
Enterprises
The Factory Act, 1948 are
pertaining to worker safety and
Health while other 42 Acts are
pertaining to Welfare, wages &
Health of Labour

Directorate General
Department
Factory Advice Services
Bureau of Indian Standards of Heavy
& Labour Institutes
(BIS) - National Standards Industries
( DGFASLI)
Body of India
Assist the Ministry in technical Responsible for developing
aspects of occupational safety Responsible setting & promoting & promoting engineering
CENTRAL LEVEL

& health in factories & ports standards for products and s ystems, industry and improve
organisation and m  anagement competitiveness
of testing laboratories, creating
consumer awareness and maintaining
close liaison with international
standards bodies.

National Policy on Safety,  Formulations of Standards National

Health & Environment at  Certification Schemes Capital Goods Policy
Workplace 2009  Enforcement Activities 2016
 Promotion of Indian Standards
 To improve the safety,  Promoting Exports
health and environment  Increase Domestic
at workplace through Production
increased awareness  Technology Improvement
 Setting standards and  Mandatory
compliance on safety, Standardisation of
health & environment machines & equipment
 Enforcement at state by adopting ISO
level as per directive  Reduce Sub-standard
principles of state policy imports through
under Factory Act, 1948 standardisation
 Skill development
STATE LEVEL

The State Governments are also competent to enact legislations, as labour is a subject in the concurrent list under the Constitution of India.
States like Maharashtra, Karnataka, Tamil Nadu & Gujarat have made amendments in Factory Act at the state level.

Source: National Policy on safety, health & environment at workplace 2009,

National Capital Good Policy 2016, National Standard Body of India & BDB Analysis Figure 1 - Regulatory Framework in India
 Ministry of Labour & Employment 13

MINISTRY OF LABOUR & EMPLOYMENT

The Ministry of Labour & Employment (MoL&E) is responsible for the health, safety and
welfare of workers. The main responsibility of this ministry is to protect and safeguard the
interests of workers, providing a healthy work environment for increased production and better
productivity. These objectives are facilitated through the enactment and implementation of
various labour laws. These laws regulate the terms and conditions of service, and the employment
of workers; like the Factories Act of 1948 and the National Policy on Safety, Health & Environment
at Work Place. There are presently 44 labour related statutes enacted by the federal, or Central
Government, dealing with minimum wages, accidental and social security benefits, occupational
safety and health, conditions of employment, disciplinary action, the formation of trade unions,
industrial relations and other issues.3

There are five relevant national, or Central Labour Acts, that have been enacted by the MoL&E,
they are:
» The Factories Act, 1948
» The Mines Act, 1952
» The Dock Workers (Safety, Health and Welfare) Act, 1986
» The Building and Other Constructions Workers’ (Regulation of Employment and Conditions
of Service) Act, 1996
» The Unorganized Workers’ Social Security Act, 2008

In addition to the Central Government, the state governments also have the prerogative to enact
labour legislation under the Constitution of India. Both the federal and state governments are
supported by the Directorate General, Factory Advice and Labour Institutes (DGFASLI). The
DGFASLI was initially created in 1945 to support the administration of the Factories Act and
to coordinate state-level factory inspection services. DGFASLI now serves as the technical arm,
assisting the ministry in formulating national policies.4 It also advises factories on various issues
concerning safety, health, efficiency and the wellbeing of people in work places. It is a subordinate
office of the Ministry of Labour & Employment.

National Policy on Safety, Health and Environment at Workplace, 2009

In February 2009, the Ministry of Labour and Employment announced the National Policy on
Safety, Health and Environment at Workplace.5 This establishes a preventive safety and health
culture in all the sectors of economic activity in India. Its goal is the elimination of work-related
injuries, diseases, fatalities, disasters, and to enhance the well-being of employees. Occupational
health and safety is reinforced in India, like in many other countries, by implementing laws
which regulate a company’s measures to guarantee OHS. This policy and others like it outline the
basic minimum requirements.

The Factories Act, 1948–Amendment 1987

The Factories
The Factories Act regulates the health, safety, welfare, and other working conditions of workers
Act regulates the
in factories. It pre-dates the 1950 constitution of Indian and illustrates how both national and
health, safety,
state governments have historically prioritized a worker safety. The act is enforced by India’s state
welfare, and
governments through their factory inspectors.6 Its main objectives are to regulate the working
other working
conditions in factories, to regulate health, safety welfare, and annual leave and enact special
conditions of
provision for young people, women, and children who work in the factories. The act covers five
workers in
areas: 1. working hours, 2. health, 3. safety, 4. welfare, and 5. penalties.
factories.

3
https://labour.gov.in/about-ministry
4
http://www.dgfasli.nic.in/about.htm
5
https://labour.gov.in/policies/safety-health-and-environment-work-place
6
http://dgfasli.nic.in/statutes5.htm
14

The Factories Act also grants state governments the authority to appoint inspectors, chief
inspectors and others. Every district magistrate is also a district inspector. However, no
inspections are conducted under the act, they are only carried out based on referrals or
complaints.

Chapter IV of the Factories Act concerns personnel safety and does not address machinery safety
other than adding a regulation for so-called “Dangerous Machines” – power thrashers and
agricultural equipment.

Below is a summarization of key points in the Factories Act, 1948 - Amendment 1987, for more
details, see the cited sections:

Section 21 The machinery in every factory shall be properly fenced.

Section 22 Only a trained adult male worker, wearing tight fitting clothing which shall
be supplied by the occupier, shall be allowed to work near the machinery
in motion.
Section 23 No young person shall be employed on dangerous machinery, unless he is
fully instructed as to the danger arising in connection with the machine
and the precautions to be observed and he has received sufficient training
in work at the machine
Section 24 Suitable arrangements shall be made to provide striking gear and devices
for cutting off power in case of emergencies.
Section 25 Sufficient precautions shall be taken regarding self-acting machines to
avoid accidents.
Section 26 To prevent danger, all machinery driven by power shall be encased and
effectively guarded.
Section 28 Hoists and Lifts in a factory shall be periodically inspected by the
Competent Person.
Section 29 Lifting Machines, Chains, Ropes and Lifting Tackles in a factory shall be
periodically inspected by the Competent Person
Section 30 Where process of grinding is carried on, a notice indicating the maximum
safe working peripheral speed of every grind-stone or abrasive wheel etc.,
shall be fixed to the revolving machinery.
Section 31 Where any plant or machinery or any part thereof is operated at a
pressure above atmospheric pressure, effective measures shall be taken to
ensure that the safe working pressure of such plant of machinery or part
is not exceeded
Section 32 Floors, stairs and means of access shall be soundly constructed and
properly maintained.
Section 33 Pits, sumps opening in floor etc., shall be either securely covered or
fenced.
Section 34 No workman shall be employed in any factory to lift, carry or move any
load so heavy as to be likely to cause him injury.
Section 35 Necessary protective equipment shall be provided to protect the eyes of
the workman, where the working involves risk of injury to the eyes.
Section 36 Suitable precautionary arrangements shall be taken against dangerous
fumes, gases etc.
 15

Section 37 Every practicable measure shall be taken to prevent any explosion where
the manufacturing process produces dust, gas, fume or vapour….
Section 38 Every practicable measure shall be taken to prevent the outbreak of fire
and its spread, both internally and externally.
Section 39 The Inspector of Factories can ask the Occupier or the Manager of the
Factory to furnish drawings, specification etc., of any building, machinery
or a plant, in case he feels that condition of such building, machinery or
the plant may likely to cause danger to human life.
Section 40 The Inspector of Factories can suggest suitable measures of steps to
take by the Occupier or Manager for implementation, when he feels the
condition of any building, machinery or a plant may likely to cause danger
to human life.
Section 40-B Wherein 1000 or more workmen are employed in a factory, the Occupier
shall appoint a Safety Officer to look after the safety aspects of the
factory.

The Dangerous Machines (Regulation) Act, 1983

The Dangerous Machines (Regulations) Act, 1983 was created to control the trade, commercial
activities, manufacture, supply, allocation, and utilization of commodities of any establishment
that manufactures hazardous equipment. This act reflects changes in the domestic agricultural
industry of India in the early 1980s and focuses solely on power threshers and other machines
intended to be used in the agricultural or rural sectors. Machines are defined as dangerous if they
are “used in the agricultural or rural” sector and the Central Government has classified these
machines as being able to cause an “operator death, dismemberment of any limb or other bodily
injury”.7

Provisions Related To Machinery Safety

The two acts introduced above, the Factories Act, 1948-Amendment 1987 and the Dangerous
Machines (Regulations) Act, 1983 share the legal guidelines for enforcement of machinery
safety in India.

1. Risks related to machinery and tools

Employers must ensure complete mitigation of risks posed by machinery at the work place.
See: The Factories Act, 1948 [No. 63 of 1948] (Sections 21 to 30)

2. Duty of designers and/or manufacturers of machineries in relation to the occupational

safety and health of machine operators
Designers, manufacturers and importers of articles, and substances used in factories are under an
obligation to ensure that the article does not pose health risks to labour. They must adequately test
the product before making it available to workers, and to take steps to ensure that the necessary
information about the article is made available to the workers prior to its use. Consequently,
manufacturers of an article are also under an obligation to ensure the safety of the workers at
different work premises, who are using the manufactured articles.
See: The Factories Act 1948 [No. 63 of 1948], (7B)

The law stipulates that it is the duty of manufacturers, designers, and dealers of dangerous
machinery to ensure the machinery’s compliance with industry standards, and must provide clear
legible indicators on machines, including points beyond which physical human contact must be
avoided.

7
See: The Dangerous Machines (Regulation) Act, 1983 (Section 3b).
16

The manufacturers of dangerous machinery must ensure that the machinery complies with
established safety requirements. Furthermore, the manufacturers are obliged to label the
machinery with the appropriate danger signals, manufacturing details, and power requirements.
See: Dangerous Machines (Regulation) Act, 1983 [No. 35 of 1983], (13-17)
Dangerous Machines (Regulation) Act, 1983 [No. 35 of 1983] (Chapter IV, Sections 3-17), and
The Factories Act 1948 [No. 63 of 1948], (Sections 7B)

3. Duty of designers, manufacturers, importers or suppliers of machineries to provide

machinery information.
Designers, manufacturers, and importers of articles and substances used in factories are under
a duty to ensure that the article does not pose health risks to the workers, to adequately test the
product before making it available to workers, and to take steps to ensure that the necessary
information about the article is made available to the workers prior to use. These laws make
manufacturers, designers, and dealers of dangerous machinery responsible for ensuring
compliance of the machinery are following industry standards.
See: Dangerous Machines (Regulation) Act, 1983 [No. 35 of 1983] (Chapter IV, Section 13), and
The Factories Act, 1948 [No. 63 of 1948] (Section 7B)

4. Duty to purchase machineries from authorised/certificated suppliers or only if approved/

certificated
Employers are obliged to purchase and use machinery that complies with the prescribed industry
standards.
See: Dangerous Machines (Regulation) Act, 1983 [No. 35 of 1983]

5. Maintenance of machinery and equipment

The law stipulates that employers and users of machinery and equipment in India, are obligated
to conduct periodic maintenance in an organised way, and to ensure that the machinery is
compliant with the prescribed industry standards.
See: The Factories Act, 1948 [No. 63 of 1948]

LIMITATIONS

Act Limitations

Factories Although there are several provisions under the

Act acts for safety, they lack universal enforcement.

The state governments are empowered to

make rules under the enabling provisions as
well as general provision, which vary from
state to state, leading to little uniformity
in enforcement. States like Maharashtra,
Dangerous
Karnataka, Tamil Nadu, and Gujarat have made
Machines
amendments to the Factories Act, however
(Regulation)
these amendments are not successfully
Act
implemented at the ground level.
The Dangerous Machines (Regulation) Act are
to limited machines like power thrashers and
agricultural equipment while other machines
are not considered.
 Bureau of Indian Standards 17

BUREAU OF INDIAN STANDARDS

The second pillar of the regulatory framework is the Bureau of Indian Standards (BIS) – the National
Standards Body, working under the aegis of the Ministry of Consumer Affairs, Food & Public
Distribution. It formulates Indian Standards for machinery safety through its technical committees.

The BIS, was established under the Bureau of Indian Standards Act, 1986 (revised in 2016) for
the “harmonious development of standardisation, conformity assessment, and quality assurance of
goods, articles, processes, systems, and services”.8 The BIS has a long institutional history reaching
back to 1946 when its predecessor, the Indian Standards Institution, was formed. It focuses on both
the interest of consumers and industry, and is involved in various activities including standards
formulation, conformity assessment, laboratory services, training, and information services.

The BIS follows the six principles for standards development that are expressed in the agreement on
Technical Barriers to Trade, commonly referred to as the TBT Agreement, an international treaty
administered by the World Trade Organization. Including openness, transparency, impartiality and
consensus, effectiveness and relevance, coherence and, development dimension. For the formulation of
Indian Standards, BIS functions through the Technical Committee structure comprising of Sectional
Committees, Subcommittees and Panels set up for dealing with specific subjects under respective
Division Councils. To ensure that standards are developed in accord with national interests, the
committee structure of BIS seeks to bring together individuals and groups with substantial interest in
a subject. After considering all significant viewpoints through a process of consultation the decisions
in BIS technical committees are reached through consensus. As a policy, the standards formulation
activity of BIS has been harmonized with the relevant guidelines of the International Organization for
Standardization (ISO).

Procedure for Establishment of Indian Standards

Excerpts from Bureau of Indian Standards Rules, 1987 [Chapter III Section 7, a-h]:
a) Any Ministry of the Central Government, State Governments, Union Territory Administrations,
consumer organizations, industrial units, industry-associations, professional bodies, and members
of the Bureau and members of its technical committees may submit proposals to the Bureau for
establishing a standard or for revising, amending, or cancelling an established standard by making
such request in writing.

b) The work of formulation of standards on any specific subject shall be undertaken when the
Division Council concerned is satisfied because of its own deliberations or on investigation
and consultation with concerned interests that the necessity for standardization has been
established.

c) When the subject has been so investigated and the need established, the Division Council
concerned shall assign the task of formulating the standard to an appropriate Technical Committee
or shall appoint a new Technical Committee for the purpose.

d) When request for establishing a standard for any specific subject has not been accepted after its due
consideration, the proposer is informed of the decision.

e) A draft standard prepared and duly approved by a Committee is issued in draft form and widely
circulated for a period of not less than one month amongst the various interests concerned for
critical review and suggestions for improvement. The wide circulation may be waived if so decided
by the Sectional Committee where the matter is urgent or non-controversial.

f) The appropriate Technical Committee thereafter finalizes the draft standard giving due
consideration to the comments that may be received. The draft standard after it has been approved
by the Sectional Committee and submitted to the Chairman of the Division Council concerned
for adoption on its behalf.

8
https://www.bis.gov.in
18

g) All established standards are reviewed periodically, at least once in five years, to determine the
need for revision or withdrawal. Standards which in the opinion of the Sectional Committee
need no revision or amendment are reaffirmed by the Sectional Committee.

Special attention is given to multidisciplinary areas such as energy conservation, environmental

protection, rural development, and safety. The Sectional Committee of BIS examines the
adoption of ISO/IEC standards wherever available and required. The BIS is engaged in
formulation of Indian Standards for the following sectors through a Division Council for each
sector:

» Chemicals
» Civil Engineering
» Electronics and Information Technology
» Electro Technical
» Food & Agriculture
» Mechanical Engineering
» Management and Systems
» Medical Equipment and Hospital
Planning
» Metallurgical Engineering
» Petroleum Coal & Related Products
» Production & General Engineering
» Transport Engineering
» Textiles
» Water Resources

Standards Development Process

Draft issued for Division council

wide circulation approves
adoption
of standard
02 04
06
Division council
decides upon
development 05 07
01 of standard
03
Technical New
committee standard
Proposal for Technical is issued
finalises
development of new committee
standard
standard from either drafts
• companies or industry standard
associations.
• Government
• consumer organisations, or
• members of technical
committees

Figure 2 – Standards Development Process

 19

Standards related to machinery safety

The BIS has various technical committees, most relevant for this study are the Mechanical
Engineering Department MED 40 Safety of Machinery, Electrotechnical Department ETD 44
Safety of Machinery- Electrotechnical Aspects, and Chemical Department CHD 8 Occupational
Safety and Health.

A more recent committee under Mechanical Engineering Department, MED 40: Safety of
Machinery has been established and mirrors the International Organization for Standardization’s
ISO/TC 199 Safety of Machinery. The BIS committee has finalized 32 Indian Standards (under
print) which are an adoption of the corresponding ISO standard.

Published Standards

IS No. & Year Title

IS 16806 (Part 6):2018 Safety of machinery - Evaluation of the emission of airborne

ISO 29042-6:2010 hazardous substances - Part 6: Test bench method for the
measurement of the separation efficiency by mass of air
cleaning systems with ducted outlet
IS 16806 (Part 7):2018 Safety of machinery - Evaluation of the emission of airborne
ISO 29042-7:2010 hazardous substances - Part 7: Test bench method for the
measurement of the pollutant concentration parameter
IS 16912:2018 Safety of machinery - Lubricants with incidental product
ISO 21469:2006 contact - Hygiene requirements
Table 1 – List of Published Indian Standards (Non-electrotechnical)

Draft Standards under Wide Circulation:

Standards formulation
ISO Standards Under New Committee Description
MED 40 in India (doc no)1
Safety of Machinery Minimum gaps to avoid
ISO 13854:2017 MED 40 (13240)
crushing of parts of the human body

Finalized Draft Indian Standards under Print

Standards
formulation
ISO Standards Under New Committee Description
MED 40 in India
(doc no)2
Safety of machinery - General principles for
ISO 12100:2010 MED 40 (11995)
design - Risk assessment and risk reduction
Safety of machinery - Safety-related parts of
ISO 13849-1:2015 MED 40 (11996) control systems - Part 1: General principles for
design
ISO 13849- Safety of machinery - Safety-related parts of
MED 40 (11997)
2:2012 control systems - Part 2: Validation
Safety of machinery - Emergency stop function -
ISO 13850:2015 MED 40 (11998)
Principles for design
Safety of machinery - Two-hand control devices -
ISO 13851:2002 MED 40 (11999)
Functional aspects and design principles

2
These are temporary document numbers and once printed they will be aligned to corresponding ISO standards.
20

Standards formulation
Under New Committee
ISO Standards Description
MED 40 in India
(doc no)2
Safety of machinery -- Minimum gaps to avoid
ISO 13854:2017 MED 40 (12000)
crushing of parts of the human body
Safety of machinery -- Positioning of safeguards
ISO 13855:2010 MED 40 (12001) with respect to the approach speeds of parts of
the human body
Safety of machinery -- Pressure-sensitive
protective devices -- Part 1: General principles
ISO 13856-1:2013 MED 40 (12002)
for design and testing of pressure-sensitive mats
and pressure-sensitive floors
Safety of machinery -- Pressure-sensitive
protective devices -- Part 2: General principles
ISO 13856-2:2013 MED 40 (12003)
for design and testing of pressure-sensitive edges
and pressure-sensitive bars
Safety of machinery -- Pressure-sensitive
ISO 13856- protective devices -- Part 3: General principles
MED 40 (12004)
3:2013 for design and testing of pressure-sensitive
bumpers, plates, wires and similar devices
Safety of machinery -- Safety distances to
ISO 13857:2008 MED 40 (12005) prevent hazard zones being reached by upper and
lower limbs
Safety of machinery -- Interlocking devices
ISO 14119:2013 MED 40 (12007) associated with guards -- Principles for design
and selection
Safety of machinery -- Guards -- General
ISO 14120:2015 MED 40 (12008) requirements for the design and construction of
fixed and movable guards
Safety of machinery -- Permanent means of
ISO 14122-1:2016 MED 40 (12009) access to machinery -- Part 1: Choice of fixed
means and general requirements of access
Safety of machinery -- Permanent means of
ISO 14122-2:2016 MED 40 (12010) access to machinery -- Part 2: Working platforms
and walkways
Safety of machinery — Permanent means of
ISO 14122-3:2016 MED 40 (12011) access to machinery — Part 3: Stairs, stepladders
and guard-rails
Safety of machinery -- Permanent means of
ISO 14122-4:2016 MED 40 (12012)
access to machinery -- Part 4: Fixed ladders
Safety of machinery -- Reduction of risks to
health resulting from hazardous substances
ISO 14123-1:2015 MED 40 (12013)
emitted by machinery -- Part 1: Principles and
specifications for machinery manufacturers
Safety of machinery -- Reduction of risks to
health resulting from hazardous substances
ISO 14123-2:2015 MED 40 (12014)
emitted by machinery -- Part 2: Methodology
leading to verification procedures
Safety of machinery -- Hygiene requirements for
ISO 14159:2002 MED 40 (12015)
the design of machinery
 21

Standards formulation
Under New Committee
ISO Standards Description
MED 40 in India
(doc no)2
Safety of machinery - Fire prevention and fire
ISO 19353:2015 MED 40 (12016)
protection
Safety of machinery - Evaluation of the emission
ISO 29042-1:2008 MED 40 (12018) of airborne hazardous substances -- Part 1:
Selection of test methods
Safety of machinery - Evaluation of the emission
ISO 29042- of airborne hazardous substances - Part 2: Tracer
MED 40 (12019)
2:2009 gas method for the measurement of the emission
rate of a given pollutant
Safety of machinery - Evaluation of the emission
ISO 29042- of airborne hazardous substances - Part 3:
MED 40 (12020)
3:2009 Test bench method for the measurement of the
emission rate of a given pollutant
Safety of machinery - Evaluation of the emission
ISO 29042- of airborne hazardous substances - Part 4: Tracer
MED 40 (12021)
4:2009 method for the measurement of the capture
efficiency of an exhaust system
Safety of machinery - Evaluation of the emission
of airborne hazardous substances - Part 5:
ISO 29042-
MED 40 (12022) Test bench method for the measurement of the
5:2010
separation efficiency by mass of air cleaning
systems with unducted outlet
Safety of machinery - Evaluation of the emission
ISO 29042- of airborne hazardous substances - Part 8: Room
MED 40 (12025)
8:2011 method for the measurement of the pollutant
concentration parameter
Safety of machinery - Evaluation of the emission
ISO 29042-
MED 40 (12026) of airborne hazardous substances - Part 9:
9:2011
Decontamination index
Safety of machinery - Prevention of unexpected
ISO 14118:2017 MED 40 (12407)
start-up

Table 2 - List of Draft Indian Standards (Non-electrotechnical)

Along similar lines, the Electrotechnical Department of BIS has a technical committee, ETD 44
Safety of Machinery- Electrotechnical Aspects which is a mirror committee of IEC/TC 44. The
BIS technical committee has published 8 Indian Standards, and 7 standards are under various
stages of processing. These standards are the adoption of the corresponding IEC standard.

Standards Published:

Standard No. & Year Description

Safety of Machinery – Functional Safety of Safety – related

IS 16501:2017
Electrical Electronic and Programmable Electronic Control
IEC 62061:2005
Systems
Safety of Machinery – Electro – Sensitive Protective Equipment
IS 16502 (Part 2):2017
Part 2 Particular Requirements for Equipment Using Active
IEC 61496 – 2:2013
Opto-Electronic Protective Devices AOPDs
22

IS 16503 (Part 1):2017 Safety of machinery -Indication Marking and Actuation -

IEC 61310-1:2007 Part 1 Requirements for Visual Acoustic and Tactile Signals
IS 16503 (Part 2):2017 Safety of machinery -Indication Marking and Actuation -
IEC 61310-2:2007 Part 2 Requirements for Marking
IS 16503 (Part 3):2017 Safety of machinery - Indication Marking and Actuation -
IEC 61310-3:2007 Part 2 Requirements for the Location and Operation of Actuators
IS 16504 (Part 1):2017 Safety of machinery – Electrical Equipment of Machines Part 1
IEC 60204-1:2008 General requirements
IS 16504 (Part 32):2017 Safety of Machinery Electrical Equipment of Machines Part 32
IEC 60204- 32:2008 Requirements for Hoisting Machines
IS 16594 (Part 1): 2017 Safety of Machinery – Electro – Sensitive Protective Part 1
IEC 614961:2012 General Requirements and Tests
IS 16936:2018 Safety of Machinery - Guidelines for use of communication
IEC TR 62513:2008 systems in safety related applications
Electrical equipment of machine tools Part 1 Electrical
IS 1356 ( Part 1):1972
Equipment of machines for General Use
Table 3 – List of Indian Standards (Electrotechnial)

A. Finalised and under Print

Standards formulation
Under New Committee Description
ETD 44 in India (doc no)
IECTS 61496-4-3 2015 Safety of Machinery - Electro-
sensitive protective equipment - Requirements for
ETD 44 (10918) equipment using vision based protective devices VBPD
Additional requirements when using stereo vision
techniques VBPDST

B. Draft Standards under Wide Circulation Stage

Standards formulation
Under New Committee Description
ETD 44 in India (doc no)
Safety of machinery Electrical equipment of machines Part 1
ETD 44 (12365)
General requirements first revision
Safety of machinery Electrical equipment of machines Part 11
ETD 44 (12384) Requirements for HV equipment for voltages above 1000 V or
1500 V DC and not exceeding 36 kV
Safety of machinery Electrical equipment of machines Part 31
ETD 44 (12385) Particular safety and EMC requirements for sewing machines
units and systems
Safety of machinery Electrical equipment of machines Part 33
ETD 44 (12386)
Requirements for semiconductor fabrication equipment
Safety of machinery Electrical equipment of machines Part 34
ETD 44 (12387)
Requirements for machine tools
Table 4 – List of Draft Indian Standard (Electrotechnical)

The technical committee CHD 8 of Chemical Department, BIS is responsible for formulating
standards on occupational health and safety such as ISO 18001 and others.
 Ministry of Heavy Industries & Public Enterprises 23

MINISTRY OF HEAVY INDUSTRIES &

PUBLIC ENTERPRISES
The third pillar of the Indian regulatory framework is the Ministry of Heavy Industries
& Public Enterprises (MHI & PE) which introduced the National Capital Goods Policy in
2016. This policy defines the minimum acceptable safety, environment, and performance
requirements for machinery in India.

The Department of Heavy Industry of the MHI&PE is responsible for promoting the
engineering industry, like machine tools, heavy electrical, industrial machinery, and the
auto industry in India10. The Ministry also looks after the machine building industry
and caters to the requirements of equipment for basic industries such as steel, non-ferrous
metals, power, fertilizers, refineries, petrochemicals, shipping, paper, cement, sugar and
others.

In India, imports contribute around 45% of capital goods demand and domestic capacity
utilisation across its sub-sectors is only around 60-70 percent.11

India is a importer across capital goods sub-sectors

India Imports & Exports, 2014-15 (Rs. ‘000 Cr)

60.0
56.0 Import

50.0
Exports

40.0 35.4

30.0

20.0
12.9 12.1
10.0 7.7 7.4 7.8
6.4 5.5 5.3
2.5 2.1 3.3 2.9 2.6 1.1
1.3 0.3 1.4 0.7
0.0
Heavy Process Earthmoving Textile Printing Food Machine Die, Moulds Metallurgical Plastic
electrical Plant & Mining Machinery Machinery Processing Tools and Machinery Machinery
equipment equipment Machinery machinery Press Tools
Source: Data from sub-sector Industry Associations, DGCIS
Figure 3 – India Imports and Exports

6. National Capital Goods Policy, 2016

The National Capital Goods Policy 2016 foresees increasing exports from the current 27
percent of production to 40 percent.12 The policy also aims to facilitate improvement
in technology depth across sub-sectors, increase skill availability, ensure mandatory
standards and promote growth and capacity building of micro, small and medium
enterprises (MSMEs). Key features include:

10
https://dhi.nic.in/UserView/index?mid=1369
11
Capital goods, as shown on Figure 3 includes heavy electrical equipment, process plant equipment, earthmoving and mining machinery, printing machinery, food
processing machinery, dies, moulds and press tools, textile machinery, machine tools, plastic machinery, and metallurgical machinery.
12
https://dhi.nic.in/writereaddata/Content/Capital%20Goods%20Policy%20Final.pdf
24

» The introduction of minimum safety requirements - to develop a policy document

ensuring that requirements are at par with global benchmarks.
» Definitions of minimum acceptable safety, environment and performance
requirements for machinery.
» The policy also calls for mandatory standardisation, which includes defining the
minimum for acceptable standards and the adoption of IOS norms.
» Significant enhancement to the capacity, capability and infrastructure of the
standards, testing and certification schemes.13

The framework for this policy is in development stage and is yet to incorporate legislations.
13
 Legal Fields In The European Union And Transposition In Germany 25

LEGAL FIELDS IN THE EUROPEAN UNION AND

TRANSPOSITION IN GERMANY
At the European level, both regulations and directives shape policy. The European Commission
(EC) requires EU Member States to achieve certain objectives by EU Directives, that have to be
transposed into national law and EU Regulations that become directly valid.14

The directives are transposed by the Member States into national laws. The connection between
standardization and legislation in the EU is assured by the “New Legislative Framework”. This
principle, introduced in 1985, promotes the coherence and consistency of mandatory health
and safety legislation supported by voluntary harmonised standards. The German legislative
framework is characterised by the transposition of all European Directives without modification
of the regulated issues. The directives are implemented literally on the national level.

Technical standards substantiate the more general requirements for product safety, reflects the
state of the art and product conformity of European Directives into more practical specifications
for a safe product design. These standards are developed by the European standardisation
organisations CEN, CENELEC, and ETSI. Combined with the publication of the reference
of harmonized European standards in the Official Journal under a European Directive, these
standards are an important pillar for proving the safety of products even though the application
of the standards is voluntary. The comprehensive application of harmonized standards is an
elementary trigger for the so-called presumption of conformity.

EU Machinery Legislation

The regulatory framework for the European Union and Germany on machinery safety is divided
into two complementary areas of responsibility. The first component addresses the manufacturer’s
liability for a safe machine and the second component addresses the employer’s liability for a safe
workplace. The European machinery legislation has a balanced approach with common directives
for manufacturers and social directives for the users. One of the main legislations governing the
harmonisation of essential health and safety requirements for machinery at the European Union
level is the Machinery Directive 2006/42/EC, which:
» promotes the free movement of machinery within the Single Market, and
» guarantees a high level of protection for EU workers and citizens.15

The Machinery Directive only applies to products that are to be placed on the European Union
market for the first time.16

Manufacturer Employer

Common Directives Documentation by Social Directives

(MD, EMC, ATEX, Physical Agent, RoHS, WEEE, etc.) (Work equipment, Workplace,
Manufacturer ATEX etc.)

Essential Requirements of
applicable Directives  EU Declaration Minimum Required
 CE Marking conditions
Conformity Assessment Procedure  Instructions

Procedure according Art. 13 of the MD

Partially Completed National Technical Rules
Machinery (PCM)
Harmonised EN Standards  Separate Declaration of
Incorporation
National Law  Assembly Instructions National Law

Figure 4 - EU
Product Safety Act OSHA Act
Machinery
Legislation
http://www.marketing.rockwellautomation.com/safety-solutions/sv/MachineSafety/LegislationAndStandards/LegislationAndStandards
14

https://ec.europa.eu/growth/sectors/mechanical-engineering/machinery_en
15

https://ec.europa.eu/growth/sectors/mechanical-engineering/machinery_en
16
26

System of Standards for Machinery Safety

European countries and economic operators, like manufacturers, often take the initiative
The CE Marking in proposing the standards and establishing them as ISO/IEC international standards. The
is a mark of International Electrotechnical Commission (IEC) prepares international standards for all
compliance with electrical and related technologies, and the International Organization for Standardization (ISO)
the European prepares international standards for all technologies other than electrical and related technologies
Commission’s (machinery and management).
directives.
The mark on Europe’s EN Standards are prepared by the European Committee for Standardization and the
a product European Committee for Electrotechnical standards CEN/CENELEC.17 IEC/ISO international
indicates that it standards are implemented without duplicating the efforts of various agreements. Member
complies with countries of the WTO/TBT Agreements ensure the adoption of international standards as own
the required level national standards.18
of protection in
all relevant EC Structure of Standards Related to Machinery Safety
directives.
Machinery safety standards in Europe are clearly defined in three sections:
Type-A standards (basic safety standards) giving basic concepts, principles for design and general
aspects that can be applied to machinery.

Type-B standards (generic safety standards) dealing with one safety aspect or one type of
safeguard that can be used across a wide range of machinery:
» Type-B1 standards on particular safety aspects (e.g., safety distances, surface temperature,
noise)
» Type-B2 standards on safeguarding devices (e.g., two-hand controls, interlocking devices,
pressure-sensitive devices, guards)
Type-C standards (machinery safety standards) dealing with detailed safety requirements for a
particular machine or group of machines.
Type-A standards provide a general overview of hazard identification and Type-B standards
provide typical requirements addressing conventional application of safety aspects or devices, while
Type-C standards probe deeper into the respective details as they apply to a specific industry or
machine group.

Structure of Standards Related to Machinery Safety19

Type Category ISO IEC

Safety requirements for specific ISO 16092
Type C -
machinery ISO 10218
ISO 4413, ISO 4414, ISO 13849
Generic Safety Standards IEC 60204
ISO 13854, ISO 13857, ISO 13855
Type B (applied to different type of IEC 61496
ISO 14118, ISO 14120, ISO 14119
machinery) IEC 61508
ISO 13856, ISO 13851
Basic Safety Standards that
Type A ISO 12100 -
can be applied to all machinery
Table 5 – Standards related to machinery safety

CE Marking
The CE Marking is a mark of compliance with the European harmonised
legislation. The marking of a product indicates that it complies with the
requirements of all relevant EU legislation. CE labelled machines can be
imported and transferred within the EU without restrictions. National

For more information, see: https://www.cencenelec.eu/

17

http://www.omron-ap.co.in/service_support/technical_guide/safety_component/safety_requirements.asp
18

This list is not exhaustive, and the complete list can be found at https://ec.europa.eu/growth/single-market/european-standards/
19

harmonised-standards/machinery_en
 27

authorities in Europe carry out market surveillance to prevent the market from unsafe products.
The manufacturer has to prove the compliance with all applicable provisions of the CE marking
with a comprehensive technical file, the documentation of the conformity assessment procedure.

The next diagram shows the process flow for conformity assessment. Usually the path on the far
left applies with full responsibility for product safety according to the requirements of Annex
I of the Machinery Directive by the manufacturer. A compilation of the restricted number of
machines named in Annex IV of the European Machinery Directive is filed in the annex.

Key elements of CE marking:

The product must first show conformity with all relevant directives. The marking must be affixed to the machine
and should be clearly visible, legible and indelible. The marking must be affixed in the immediate vicinity of the
name of the manufacturer or representative. The CE mark on a machine attests market surveillance authorities
and operators the full compliance with the safety requirements of the Machinery Directive’s Annex I.
Special assessment procedures according Annex IV of the Machinery Directive only exist for a few types of
machines. These machines also need an assessment by a notified body and the number of the notified body must
be added to the CE mark.

A comprehensive list of Annex IV products is listed in the following section. Compliance

evaluation based on the machinery directive

Partly completed
Machinery
machinery referred to in
Product referred to in Article 1 (1) - (a) to (f)
Article 1 (1) - (g)

Technical File -
Annex VII A Relevant technical
Instructions documentation Annex
VII B Assembly
Category of machinery Category of machinery instructions Annex VI
not in Annex IV in Annex IV

Fully designed to Not fully

harmonised standards designed to harmonised
that cover all standards that cover
applicable EHSRs all applicable EHSRs*

Assessment Full quality EC type-examination Colour code:

of conformity with assurance Annex IX
internal checks on Annex X + Internal checks on
manufacture manufacture Product
Annex VIII Annex VIII 3 category

Documents
EC Declaration of Conformity Declaration
Annex II 1 A of Incorporation
Annex II 1 B Procedure

CE marking Annex 16 Declaration -

Annex III marking
* Harmonised standards are not available, the harmonised standards do not cover all the applicable EHSRs or the harmonised standards
are not applied or are only partially applied.

Figure 5 – Compliance evaluation based on Machinery Directive

28

Annex IV of the Machinery Directive

Categories of machinery to which one of the procedures referred to in Article 12(3) and (4) must
be applied:

1. Circular saws (single or multi-blade) for working with wood and material with similar
physical characteristics or for working with meat and material with similar physical
characteristics, of the following types:
a. Sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with
manual feed of the work-piece or with a demountable power feed;
b. Sawing machinery with fixed blade(s) during cutting, having a manually operated
reciprocating saw-bench or carriage;
c. Sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed
device for the work pieces, with manual loading and/or unloading;
d. Sawing machinery with movable blade(s) during cutting, having mechanical movement
of the blade, with manual loading and/or unloading.
2. Hand-fed surface planning machinery for woodworking.
3. Thicknesses for one-side dressing having a built-in mechanical feed device, with manual
loading and/or unloading for woodworking.
4. Band-saws with manual loading and/or unloading for working with wood and material with
similar physical characteristics or for working with meat and material with similar physical
characteristics, of the following types:
a. Sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-
movement bed or support for the work piece;
b. Sawing machinery with blade(s) assembled on a carriage with reciprocating motion.
5. Combined machinery of the types referred to in points 1 to 4 and in point 7 for working
with wood and material with similar physical characteristics.
6. Hand-fed tenoning machinery with several tool holders for woodworking.
7. Hand-fed vertical spindle moulding machinery for working with wood and material with
similar physical characteristics.
8. Portable chainsaws for woodworking.
9. Presses, including press-brakes, for the cold working of metals, with manual loading and/
or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed
exceeding 30 mm/s.
10. Injection or compression plastics-moulding machinery with manual loading or unloading.
11. Injection or compression rubber-moulding machinery with manual loading or unloading.
12. Machinery for underground working of the following types:
a. Locomotives and brake-vans;
b. Hydraulic-powered roof supports.
13. Manually loaded trucks for the collection of household refuse incorporating a compression
mechanism.
14. Removable mechanical transmission devices including their guards.
15. Guards for removable mechanical transmission devices.
16. Vehicle servicing lifts.
17. Devices for the lifting of persons or of persons and goods involving a hazard of falling from a
vertical height of more than three metres.
18. Portable cartridge-operated fixing and other impact machinery.
19. Protective devices designed to detect the presence of persons.
20. Power-operated interlocking movable guards designed to be used as safeguards in machinery
referred to in points 9, 10 and 11.
21. Logic units to ensure safety functions.
22. Roll-over protective structures (ROPS).
23. Falling-object protective structures (FOPS).
 Comparison of European Union and Indian Systems 29

COMPARISON OF EUROPEAN UNION AND INDIAN

SYSTEMS
A comparison of the EU and Indian systems for machinery safety has been made above. Below, a
summary of the four key aspects of the regulatory frameworks, including standards, conformity
assessment and enforcement is shown.

Category European Union/ Germany India Conclusion

Both EU and Indian

Safety obligations are
systems are at
primarily directed towards
different levels of
The framework is based occupational health and safety
maturity in terms of
on well-established requirements prescribed in
regulatory framework.
Regulatory machinery directive and the Indian Factories Act,
As India is in the
Framework work equipment directive and the New Capital Goods
process of setting
to ensure machinery and Policy and development of
up its system, the
workers safety. Indian Standards by BIS. The
EU system could be
importance of machinery safety
used as a reference
is recognized and evolving.
framework.

a) The German Institute a) India is also participating

Increased machinery
for standardisation, DIN member ISO/TC 199. In India
safety by adopting
holds the secretariat MED 40 mirrors this and India
current International
of ISO/TC 199 Safety of has adopted 32 ISO standards
Standards.
machinery as National Standards
India should adopt
Standards Internationally
b) Germany is a b) For Electrical safety aspects
harmonised standards.
participating member at IEC/TC 44 India is an
A classification of
in the electrical safety observing member. India also
these standards based
aspects group at IEC/TC has a mirror committee and
on their scope is
44 Safety of Machinery: has adopted 8 IEC standards as
required.
Electrotechnical Aspects National Standards.

The EU has a
comprehensive compliance
framework with
compliance marks on
There is an absence
products which fulfil EC In India, there is no compliance
Conformity of compliance
directives. Safety aspects marking system or market
Assessment framework and market
are ensured -even at the surveillance system.
surveillance in India.
commissioning stage,
and during the product
lifecycle through market
surveillance.

The implementation of Indian

Member States follow the Factories Act is done by the There is a lack
same directives which state governments through of uniformity in
Enforcement brings uniformity in their own rules based on the implementation of
implementation and ease act. This causes enforcement existing rules across
of compliance. variation and results in the states in India.
increased cost of compliance.

Table 6 - EU-India System Comparison

30 Industry Challenges

INDUSTRY CHALLENGES
Machinery safety, in the traditional Indian context, is addressed from an occupational safety
Machinery safety, standpoint. More recently, there has been a shift in viewing machinery safety as an integral part
in the traditional of product safety. The current challenges faced by the industry can be categorized into four areas:
Indian context, is » central and state level regulations,
addressed from » standardization in machinery safety,
an occupational » compliance, and
safety standpoint. » awareness and capacity building.
More recently,
there has been a A survey conducted as part of this study indicated that European manufacturers are most
shift in viewing concerned with the lack of a robust machinery safety regulation in India.20 The Indian Factories
machinery safety Act, 1948, allows each state to formulate its own rules, which results in differing interstate
as an integral provisions. As industry operates across various states, compliance is difficult and expensive. The
part of product scope of the Dangerous Machinery Act (2007) was limited to agricultural machinery identified by
safety. the Central Government, excluding industrial machines from its jurisdiction. Only in 2016 did
the National Capital Goods Policy create a formal strategy from the Indian Central Government
that emphasised industrial machinery safety – before then only labour safety policies existed.
The Indian
Factories Act, Because of varying state regulations, and uncertainty about which acts apply for machinery, it is
1948, allows each difficult for the industry to identify which criteria are applicable and how to apply standards. This
state to formulate affects their adoption. A comprehensive roadmap, including the classification of standards, and an
its own rules, awareness raising campaign for users, would improve this situation.
which results Currently, there are no tests or documentary requirements (audits) for new or existing machines
in differing in India. Conformity assessment is a key requirement for compliance and it needs to be addressed.
interstate
provisions. Another challenge is ensuring general safety across industries and outlining specific safety
requirements for high-risk sectors, like:
» packaging machines,
» press machines,
» loaders,
» people handling machines (like lifts),
» material handling machines (i.e. earth moving machines), and
» industrial robots.
The European solution for these cases envisages several possibilities:
» either the application of the MD with clear limits of application, which is always well
established according to provision of Article 3 of the MD,
» a clear assignment to another directive, and
» a combination of different directives with the aim of applying the directive under which the
safety requirements are best regulated, like regulated by the provisions of Art. 3 of the MD.
New manufacturing technologies such as Industry 4.0 and the use of Internet of Things (IoT)
could play a role in enhancing machinery safety –perhaps using new ways of tracking processes
and machine performance. The present regulations do not adequately reflect the technological
The culture of advancements made in manufacturing processes.
safety and the The culture of safety and the corresponding low perception of safety in the industry, along with
low perception reluctance due to the perceived cost of safety installations and equipment, needs to be shifted.
of safety in The awareness about the value addition brought by safety features and its impact on reducing
the industry, downtime and enhancing productivity at large is limited. A comprehensive awareness raising
along with campaign paired with capacity building is needed. To achieve this incentives and recognition
reluctance due for those installing and maintaining safe machines is an option. This would involve the industry
to the perceived more and support them for taking the initial steps to develop a safety culture.
cost of safety
installations and All the above factors have a cost bearing on the final selling price of the machine – which then
equipment, needs loses price competitiveness to local competition in the market.
to be shifted.
20
For more information on the survey see the participate and respondent profile lists in the annex.
 Recommendations 31

RECOMMENDATIONS
Based on the expert exchanges conducted while preparing this study and international good
practices, the following are recommendations to strengthen machinery safety requirements in
India:

Regulatory Framework: Introduce regulations for machinery safety considering emerging

interconnected manufacturing and review the existing regulations for machinery and
workers safety to reduce variations at the state level. The examination of the basic
requirements for machine safety from Annex I of the European Machinery Directive
2006/42/EC could be a logical step.

Manufacturing in India is undergoing changes with programmes such as Make in India. These
changes will also bring in interconnected manufacturing technologies such as Industry 4.0 and
require a more structured approach for machinery safety and regulatory framework. The adoption
of standards from ISO and IEC will support a smooth coexistence of different industrial stages
of development; a key factor for the upcoming industrial development of India. In addition to
mandates for safety features in the design of machines, and during their placement in the factory,
these regulations could include:

» essential requirements and/or standards

» conformity assessment procedures
» market surveillance procedures
» penalties for non-compliance, and
» incentives for compliance

In India, where small machine manufacturers and users co-exist with large manufacturers and
users, a step-wise approach is recommendable to implement these regulations. Accident prone
machines, like press machines, packaging machines, industrial robots and steel rolling mills,
should be included in the initial steps.

Present variations in state regulations pose difficulty for industry operating across states, and
requires additional resources for compliance. It is therefore proposed to re-examine these
provisions to reduce the variation between the states.

Until these or similar provisions are in place, a guideline document based on good practices
and standards would be beneficial for the industry. This guideline should provide step by step A guideline
guidance, and be able to answer basic questions of the industry as to which standards are document based
applicable for them, which aspects should they consider for hazard reducing processes like on good practices
risk assessment, and how to apply and implement safety solutions. The guideline can act as a and standards
preparatory step towards regulations and could be adopted by the industry on a voluntary basis would be
until regulations are in place. In the long run, a better awareness for machinery safety can be beneficial for the
achieved in the country. A governmental organisation for market surveillance should be created industry.
for managing and controlling the aspects of product compliance in the market.

Standards and Conformity Assessment: Develop a roadmap for implementing standards

and conformity assessment procedures

Standards on machinery safety are broadly classified as generic standards and sector specific
standards. In the European Union, standards are classified as Type A (basic safety standards),
Type B (generic safety standards) and Type C (safety standards for specific machinery) based on
their specific scope. This internationally recognized classification (see ISO 12100) makes the
selection of standards easy for the user; and is also in line with the EU directives.
32

A machinery safety standards roadmap for India along with a guideline document would support
the implementation of the available standards in the future. A framework based on ISO 12100
(IS 11995) and ISO/TR 22100-1 as applied in the EU could be used as a reference model for
classification of standards formulated by the various sectional committees of BIS. Furthermore,
the orientation of Indian standards towards international standards to the maximum possible
extent will enhance the competitiveness of the Indian industry and its trade prospects. Along with
this, the promotion of standards related to occupational health and safety management systems
such as recently published ISO 45001: 2018 Occupational health and safety management systems -
Requirements with guidance for use will also be beneficial for India.21

Conformity assessment is one of the key elements in the enforcement of regulations. Introducing
a legal conformity assessment procedure in India would offer more confidence in product safety
and wider acceptance among users. A legally secured marking of compliant machinery would
provide additional support in this area. The conformity assessment for new machines should
always be based on the most state-of-the-art standards.

Workplace safety is the combination of both safe machines and additional organisational efforts,
like education and the use of personal protective equipment. During a machine’s life-span its
operating safety needs to be verified on a regular basis. In order to keep workplace safety current,
it is in many cases useful to increase the organisational efforts first, as technological retrofitting
may exceed reasonable financial frameworks without significant safety increases. Once this
relationship shifts, a larger technological retrofitting is necessary.

However, the conformity assessment should not cover only manufactured or imported new
machines but also second-hand imported machines, existing machines and partially completed
machines. This would also require developing a pool of qualified auditors to ensure compliance on
such a large scale.

To facilitate trade and reduce technical barriers to trade, mutual recognition of test results and
certification arrangements could also be explored.

Awareness and Training: Create awareness among the stakeholders

Machinery safety is not considered a strategic enabler of sustainable economic growth. It is often
only seen as a requirement of legal compliance. The need of the hour is to create awareness among
all stakeholders such as managers, machine manufacturers, users, and workers about machinery
safety so that a safety culture may be promoted through adopting international good practices.

The need of the hour: Creating awareness about machinery saftey, promoting and building a
The need of the culture of safety through adoption of international good practices.
hour: Creating
awareness about The first step would be to work together with regulators to sensitise industry management on the
machinery saftey, long-term detrimental effects of unsafe machines and precautions that can be taken to mitigate
promoting and these effects. Such sensitisation initiatives would cover awareness of regulations and standards,
building a culture and would highlight the importance of machinery safety at different stages of designing,
of safety through installation and operation including documenting the near misses, risk assessment, and auditing.
adoption of Industry associations can play an important role in developing such a culture.
international good
practices. The second step would be to develop training programs for workers at operational level as part
of a life cycle approach, which incorporates safety at every stage of the implementation of a
process or product, also taking into consideration future manufacturing technologies such as
Industry 4.0. Systematic training programs in industrial institutes would ensure that the working
population of tomorrow is aware of their responsibilities to meet required safety precautions, and
along with this contribute to a safe work environment.

https://www.iso.org/standard/63787.html
21
 References 33

REFERENCES
Cen and Cenelec.
https://www.cencenelec.eu/Pages/default.aspx (accessed September 12, 2018)

Dangerous Machines (Regulation) Rules, 2007.

http://niohenvis.nic.in/statistics/LEG_OSH/Dangerous Machines (Regulation) Rules, 2007.pdf
(accessed September 9, 2018)

Dnaindia.
http://www.dnaindia.com/india/report-1660-lives-lost-between-2013-and-2016-in-factory-
machine-related-accidents-2557391 (accessed September 9, 2018)

Factories Act.
https://labour.gov.in/sites/default/files/TheFactoriesAct1948.pdf (accessed September 9, 2018)

Indiastat.
https://www.indiastat.com/crimeandlaw/6/accidents/35/industrialaccidents/18115/stats.aspx
(accessed September 9, 2018)

National Capital Goods Policy, Building India of Tomorrow.

http://dhi.nic.in/writereaddata/Content/NationalCapitalGoodsPolicy2016.pdf. (accessed
September 9, 2018)

Natlex, India, The Factories Act.

https://www.ilo.org/dyn/natlex/docs/WEBTEXT/32063/64873/E87IND01.htm (accessed
September 9, 2018)

Open Government India Data.

https://data.gov.in/catalog/industrial-injuries-factories (accessed September 9, 2018)

Pilz.
https://www.pilz.com/en-IN/services/consulting-and-engineering (accessed September 9, 2018)
New Machinery, Health Safety Executive. http://www.hse.gov.uk/work-equipment-machinery/
new-machinery.htm (accessed September 9, 2018)

TC 44 Safety of Machinery -Electrotechnical Aspects.

http://www.iec.ch/dyn/www/f?p=103:7:0::::FSP_ORG_ID,FSP_LANG_ID:1302,25 (accessed
September 9, 2018)

Rockwell Automation.
https://www.rockwellautomation.com/en_IN/news/blog/detail.page?pagetitle=OEMs-Can-Use-
Machine-Safety-as-a-Differentiator&content_type=bl%E2%80%A6 (accessed September 9, 2018)

Safety Components, Omron.

http://www.omron-ap.co.in/service_support/technical_guide/safety_component/safety_
requirements.asp (accessed September 9, 2018)

Statutes.
http://dgfasli.nic.in/statutes1.htm (accessed September 9, 2018)

Standards catalogue ISO/TC 199.

https://www.iso.org/committee/54604/x/catalogue/p/1/u/1/w/0/d/0 (accessed September 9, 2018)
34

Methodology

The objectives of this study were categorised into two parts; the methodology, stakeholders and
source of information were planned accordingly.

Objective 1: Regulatory Framework

• To analyse the regulatory framework in India relevant to the

machinery safety
Sub-Objectives • To evaluate the effectiveness of regulation implementation
• To identify and map aspects of machinery safety not yet
covered in India but already addressed in the European Union
A combination of secondary research and primary interviews
Methodology
of stakeholders
• Technical services: Conformity assessment/ compliance / audit
Stakeholders focus: and risk assessment agencies
primary interview • Safety automation companies
• Indian machinery - Original Equipment Manufacturer (OEM)
• Websites of Bureau of Indian Standards (BIS), Ministry of
Labour & Employment (MoL&E), Directorate General Factory
Advices & Service Institutes (DGFASLI)
Information sources
• Technical presentation of OEM and critical safety components
suppliers
• One to one interaction with industry experts

Objective 2: Challenges faced by Industry

To evaluate the experiences and challenges faced by of the

Sub-Objectives stakeholders such as Industry, certification agencies and safety
solution providers

A combination of secondary research and primary interviews of

Methodology
stakeholders

Information sources Report of Industry Roundtable organized by GPQI

Table 7 – Overview of Objectives and Methodology

Respondent profile

Sr. No. Respondent Category Number of Respondents

1 Machine Manufacturers 11

2 Government of India 01

3 National Standards Body of India 01

4 Associations 01

5 Automation & Safety Control Provider 05

6 Consultant/ Conformity Assessment Agencies 03

Total 22

Table 8 - Respondents Profile

 35

List of respondents

Company Name Representative

BIS National Standards Body of India
DGFASLI GOI - Policy Maker
Pilz Automation & Safety Controls
Schmersal Automation & Safety Controls
Mac Consultant/Certifying agency
Nord Industrial Machines/components
Lenze Automation & Safety Controls
Premium Transmission Industrial Machines/components
Bosch Industrial Machines/components
Sandvik Mining Industrial Machines/components
Gudel Industrial Machines/components
BfW Association for machine tools
Ace Micromatic Industrial Machines/components
Thyssen Krupp Industrial Machines/components
Grind Master Industrial Machines/components
Festo Automation & Safety Controls
ATS Conveyor Industrial Machines/components
Buhler Industrial Machines/components
Hassia Packaging Packaging machines
SICK Consultant/Certifying agency
Rockwell Automation & Safety Controls
TÜV Rheinland Consultant/Certifying agency
Table 9 – Respondents List
36 Questionnaire

QUESTIONNAIRE
This questionnaire was used as a guideline for the interactions with experts and stakeholder
during the research phase of this study.

Machine Manufacturer: Evaluating Machinery Safety Standards & Regulations

1. How often are you required to export a machinery to European Nations?

2. What essential criterion is required to meet the machine safety standards & regulations
prevailing in European nations?
3. What challenges/trade barriers you face pertaining to machine safety design standards, codes,
specifications & regulations when exporting in European Nations/Germany?
4. What are the present machine safety standards in India & how different are they in
comparison to machine safety standards & regulation in European Nations?
5. Which aspects of machinery safety are not yet covered in India compared to Europe?
6. What are the gaps in standards & Regulation adopted in India in comparison to those
implemented in Europe/Germany?
7. What suggestions/changes do you recommend for bridging the gap and reduce trade barriers?

User Segment: Evaluating Machine Safety Standards & Regulations in India

1. How often are you required to import a machinery from European Nations?
2. How critical is machine & human safety during the operation of machine?
3. What precautions do you take to ensure machine & human safety?
4. What challenges/barriers you face pertaining to machine safety design standards, codes,
specifications & regulations in India?
5. What are the present machine safety standards applicable for you? Do you find that machine
is overdesigned in terms of machine safety standards in India?
6. Which aspects of machinery safety are not yet covered in India compared to Europe?
7. What are the gaps in standards & Regulation adopted in India in comparison to those
implemented in Europe/Germany?
8. What suggestions/changes do you recommend in Indian standards and regulations to bridge
the gap?.
Machinery and worker safety matter. Unsafe machines pose huge risks, affect workers, their
families, the environment, and damage company reputations, while safe machines contribute
to efficient production processes and are a key pillar of a robust economy. Machine related
accidents take the lives of 2.3 million workers around the world each year. Accidents and work-
related diseases cost the global economy three trillion US dollars annually. More and more the
ethical obligation of providing safe machines and safe work places is being linked to sustainable
economic development in India and other emerging economies.

The Make in India initiative opens opportunities for the machinery industry. By boosting
manufacturing and skill development, India aims to become a global manufacturing and design
hub. This increases the demand for high-quality machines, manufacturing components, and
technologies based on advanced automation and interconnectedness (Industry 4.0). Policy
changes are already taking place as Indian factories modernise. The 2016 National Capital
Goods Policy brings about mandatory minimum safety as well as environment and performance
standards for machinery, while a Technical Committee at the Bureau of Indian Standards
develops machinery standards.

This publication, created within the framework of the Indo-German Working Group on Quality
Infrastructure, recognises these dynamics and is of interest for regulators, managers and industry
associations alike. It is based on the well-acknowledged insight that machinery safety requires
comprehensive regulations and elaborated conformity assessment procedures. The study depicts
the regulatory framework and challenges identified by the industry. It also compares machinery
directives in India and the European Union, and identifies cooperation opportunities between
Germany and India. Recommendations include measures to strengthen regulations, processes
for classification of standards, conformity assessment for both new and used machines, and
promoting awareness raising among users and decision makers.

Making Safe Machines a Standard in India

Insights and Recommendations from
Comparing Regulations in India and Germany | Knowledge Series 2
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