Professional Documents
Culture Documents
Table of Contents
08.05.2012
Executive Summary
India REACH
5-17
India RoHS
18-24
India CLP
26-34
Interview Summary
35
37
Appendices
A. Appendix Primary Research Contacts
B. Appendix Industry Associations
C. Appendix Comparison of RoHSs
D. References
39
40
41-49
50
08.05.2012
Methodology
Information collection in internet and databases
Interviews with governmental officials, industry experts
The reports outcome will be presented in a seminar
organized by Teknologiateollisuus
Project team:
Teknologiateollisuus ry
Ms. Pirjo Kaivos
Ms. Mia Nores-Korkeamki
Ms. Carina Wiik
Finpro study team members
Mr. Matti Rasimus, Finpro Finland (Project Owner),
matti.rasimus@finpro.fi
Eija Tynkkynen, Finpro Beijing, (Project Manager) ,
eija.tynkkynen@finpro.fi
Finpro India study team:
Rekha Salvi, Senior Consultant rekha.salvi@finpro.fi
Shriya Ramachandran, Marketing & Communications
Manager shriya.ramachandran@finpro.fi
Dinkar Krishnan, Analyst dinkar.krishnan@finpro.fi
www.finpro.fi/finpro-maailmalla/intia
Executive Summary
Regulations and legislations for Chemicals Management in India
not evolved to the level comparable to the levels of European regulations such REACH
Overall apathy in the industry towards regulations in Chemicals sector
REACH though companies exporting to Europe satisfy the requirements, no domestic regulations so far same as, or
equivalent to REACH
RoHS enacted since June, 2011
CLP planning regulations in line with GHS (draft regulation July, 2011)
The highly fragmented Indian chemicals industry is undergoing restructuring and consolidation phase
Export of Chemical through investments in Special Chemical Zones, PCPIR etc
Planned investment of about USD 33 billion
Medium Domestic
Companies
India REACH
Companies catering to the domestic market are bound by numerous local legislations that are not as stringent as
REACH
Hence this report attempts to understand the Indian Chemical industry holistically, and tries to find how the
REACH, RoHS and CLP legislations would relate to the domestic as well as export market in the future
08.05.2012
High
Oil Refinery,
Petrochemicals
Medium
Fertilisers, Chlor-Alkali
Low
Soda Ash
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Medium
Pesticides
Low
Bulk Drugs, Dyes &
Dye-intermediaries
Leather Industry:
Policy Framework:
Licensing requirements have been removed, except for hazardous chemicals and a few special drugs
100% FDI is allowed under the automatic route, for all chemicals except hazardous ones
Customs and Excise Duties: Peak customs rate of 7.5% on most chemicals, and excise duty of 16% on almost all chemicals
PCPIR (Petroleum, Chemicals and Petrochemicals Investment Regions) Policy: introduced to boost the development of
chemicals and petrochemicals in investment regions
USD 33 billion proposed investments
Includes SEZs, industrial parks, free trade and warehousing zones, export=oriented units or growth centres
08.05.2012
Exports
MSIHC Rules,
Petroleum Act & Rules
Explosives Act & Rules
SMPV Rules
Gas Cylinder Rules
Insecticides Act & Rules
Customs Act & Rules
ODS (R&C) Rules
Production
MSIHC Rules,
CA (EPPR) Rules,
PLI Act & Rules
Explosives Act & Rules
SMPV Rules
Gas Cylinder Rules
Factories Act & Rules
Insecticides Act & Rules
ODS (R&C) Rules
Petroleum Act & Rules
Recycling
Storage
MSIHC Rules,
CA (EPPR) Rules,
PLI Act & Rules
Explosives Act & Rules
SMPV Rules
Gas Cylinder Rules
Factories Act & Rules
Insecticides Act & Rules
ODS (R&C) Rules
Petroleum Act & Rules
Transportation
CA (EPPR) Rules,
PLI Act & Rules,
Petroleum Act & Rules
Factories Act & Rules
Explosives Act & Rules
Mines Act & Rules
Insecticides Act & Rules
Port Act & Rules
Dock Act & Rules
PFA Act & Rules
ODS (R&C) Rules
Use
08.05.2012
Disposal
EP Act & Rules
Air Act & Rules,
Water Act & Rules,
HW (M&H) Rules
Batteries Rules
Insecticides Act & Rules
Explosives Act & Rules
ODS (R & C) Rules
Environmental Management
The Air (Prevention & Control of Pollution)
Act, 1981 amended 1987
The Air (Prevention & Control of Pollution)
(Union Territories) Rules, 1983
The Water (Prevention & Control of
Pollution) Act, 1974, amended 1988
The Environment (Protection) Act, 1986
amended 1991
Environmental (Protection) Rules, 1986
(amended in 1999, 2001, 2002,
2002, 2002, 2003, 2004)
Hazardous Wastes (Management and
Handling) Rules, 1989 amended
2000 and 2003
EIA Notification, 1994
Ozone Depleting Substances (Regulation
and Control) Rules, 2000
Batteries (Management and Handling)
Rules, 2001.
Specific Chemical
Category/Container
08.05.2012
10
India has not adopted REACH legislation yet, for its domestic market. However, all exporters of chemicals to EU region are required to comply with
REACH and hence, the government supports chemical industry in the compliance requirements of the companies
Ministry of Commerce supports the REACH-compliance needs of Indian Chemical companies through CHEMEXCIL REACH-Help desk. Chemexcil is
Basic Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council
Confederation of Indian Industry (CII) along with SSS Europe also provides REACH Support through their Help desk, for Indian companies
REACH directly applies to the European manufacturer and importer of chemicals and chemical containing products and requires them to demonstrate the
safety of their products put into the European markets by submitting detailed information on the intrinsic and toxicological properties of the products to the
central chemical agency (ECHA)
Therefore, it is but natural that the EU importer shall ask his Indian supplier to furnish the required information and this is how the Indian exporters get
implicated within REACH
If the Indian exporters wish to continue uninterrupted trade with the EU, they shall have to collect all the information, as required within REACH for
submitting to the ECHA
It is important to note that submission of information to ECHA cannot be done by the Indian exporters
It can either be done by the European importer provided he is willing to act as the registrant or if he refuses to take this responsibility and in certain
cases, if the Indian exporter does not wish to share proprietary information relating to his products, he shall have to appoint an only representative
The only representative is the only legal entity authorized to pre-register on behalf of the Indian exporter
11
REACH
Europe
India
Status
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12
08.05.2012
13
SSS, who supports the Help desk in India, based upon its assessment process can provide a certificate of SVHC free article
and in case article contains SVHC then it can facilitate the compliance process as required with REACH and then issue a
certificate of REACH compliance article, that can be then issued to various buyers
SSS certified products and chemicals are presently being acknowledged and accepted by over 2000 EU buyers
SVHC have posed new challenges to article suppliers. Here articles suppliers mean non-EU article exporters, EU importers and
manufacturers of articles.
Under REACH, an article is defined as an object which during production is given a special shape, surface or design, which
determines its function to a greater degree that does its chemical composition. e.g. automobile, garments, tires, plastics
products, electrical products, handicraft, toys, electronics. Thus, the limitation on SVHCs set out in the REACH regulation, has a
broad scope, affecting lots of industries.
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14
Outlook
The implications on the export of articles shall be two-fold:
Manufacturers and exporters of articles shall have to look for alternative safer chemicals; which would amount to
incorporating major changes in their product profile
The search for safer substitutes that are not readily available will involve a lot of R&D, trials and expense
These implications are further compounded by the fact that the SVHC list shall keep increasing with time. It is eventually
expected to contain 500 to 600 substances
In the case of India-REACH, exporters have to appoint an OR (Only Representative) in the destination country to undertake
both the registration formalities as well as legal liability on behalf of the exporter
08.05.2012
15
CHEMEXCIL, the Chemicals & Cosmetics Export Promotion Council, has set up a REACH help desk and a web portal to
provide the latest updates to exporters. In order to provide professional assistance, CHEMEXCIL has appointed Sustainability
Support Services, (Europe) AB. Sweden, (SSS) to represent its member-exporters in European Union as Only
Representative
This arrangement has helped over 700 Indian companies go through the pre-registration and registration deadlines
Through a MoU with SSS, the CII Standards and Conformity Assessment Task Force has decided to launch a nation-wide
capacity building programme across various export sectors (leather, garments, auto components, etc) to strengthen the supply
chain in meeting REACH and other similar regulations
As a first step, experts from the European Chemical Agency (the nodal organization for REACH) have been invited as key
speakers in two back to back symposiums on REACH Regulations and their impact on Indian industry, in Delhi and Mumbai
The symposiums, being organized jointly by CII and the Union Ministry of Chemicals and Fertilizers, will be the first face-toface interaction of ECHA officials with Indian industry and other stakeholders
This will be followed by extended outreach programmes targeting impacted sectors over the next year. As deadlines are fast
approaching, the symposiums would provide an ideal forum to obtain clarifications and enhance understanding on coverage
as well as compliance issues
08.05.2012
16
India RoHS
RoHS (Restriction of Hazardous Substance) legislation was previously enacted in the European Union, Japan, China, Korea,
and California. WEEE (Waste Electrical and Electronic Equipment) legislation was enacted in the EU, Korea, 25 US states,
and five Canadian provinces
India has long been plagued by the problem of backyard recycling. India's new legislation is an attempt to address that
problem
India is now on the list, and its new legislation laid by the Ministry of Environment and Forests, Government of India (covering
both RoHS and WEEE requirements) is known as the E-Waste (Management and Handling) Rules, 2011. India's WEEE
requirements will take effect in May 2012, and its RoHS requirements two years later
(Http://moef.nic.in/downloads/rules-and-regulations/1035e_eng.pdf )
This treats WEEE and RoHS identically in terms of scope, exclusions etc, and there is a considerable similarity with the EU
WEEE and RoHS legislation, although these are treated as totally separate legislation in the EU. The requirements are
similar to the EU's requirements
The new waste rule will significantly change the way electronic waste is handled in India. Producers, collection centers,
dismantlers, and recyclers, to remain operating, will have to apply for a government-issued "Grant of Authorization" by July
31, 2012. Onsite storage of electronic waste will be limited to 180 days
The new RoHS rule will limit the amount of hazardous substances present in electronic products produced and imported in
India ( source CII Reach Help desk and CPCB GUIDELINES FOR ENVIRONMENTALLY SOUND MANAGEMENT OF EWASTE Report)
08.05.2012
18
Use
Electrical and electronics industry in solder, lead-acid batteries, electronic components, cable sheathing and in the
glass of cathode-ray tubes
electronic equipment, car batteries, and pigments, electroplated coatings, special solders, electric contacts, relays
and switched, PVC stabiliser etc
While some forms of chromium are non-toxic, Chromium VI can produce toxic effects. Found in passivation
coatings on metals and in corrosion resistant paints
These are flame retardants found in electronic and electrical appliances. They have been found in indoor dust and
air through evaporation from plastics
These are also flame retardants found in electronic and electrical appliances. Combustion of printed wiring boards
release toxic emissions
India - Environment Regulation Industry Chemicals Report 2012
19
Finpro ry
08.05.2012
Legislation
Legislation
Adopted
EU RoHS:
February 13th, 2003
EU RoHS II (recast): July 1st, 2011
Legislation
Entered into force
EU RoHS:
July 1st, 2006
EU RoHS II (recast): January 2nd, 2013
Legal
Responsibility
Producers
Consumers
Collection Centres
Dismantlers
Recyclers
Producers
Distributors
Business end users
Treatment facilities for WEEE
Exporters of WEEE
Business Size
Affected
Does not apply to Micro & Small Enterprises as defined under the
Micro, Small and Medium Enterprises Act, 2006 (See Table A in
slide no: 23)
In Scope
Current:
1.Large household appliances
2.Small household appliances
3.IT and telecommunications equipment
4.Consumer equipment
5.Lighting equipment, (including electric light bulbs and household
luminaries)
6.Electrical and electronic tools (with the exception of large-scale
stationary industrial tools)
7.Toys, leisure and sports equipment
10. Automatic dispensers
Following the pending recast:
8. Medical devices (with the exception of all implanted and
infected products)
9. Monitoring and control instruments
11. Anything else not covered in categories 1-10
08.05.2012
20
EU RoHS
Out of Scope
a)
b)
c)
Currently:
a)Military & National Security
b)Electricity not primary power source
c)Primary function does not need electricity
d)Part of another type of equipment that is out of scope
e)Batteries
Following the pending recast:
a)Military equipment
b)Equipment designed to be sent into space
c)Part of another type of equipment that is out of scope
d)Large-scale stationary industrial tools
e)Large-scale fixed installations
f)Transport
g)Non-road mobile machinery for professional use
h)Active implantable medical devices
i)Photovoltaic panels
j)R&D equipment for B2B only
Enforcement
Not specified
Penalties
Not Specified
WEEE/RoHS:
Fines and costs, plus imprisonment in some EU States. The size of
fines varies considerably between EU Member States.
RoHS Exemptions
(i)
(ii)
Compliance
Approach
08.05.2012
Batteries
Radio Active Waste
Micro & Small Enterprises as defined under the Micro, Small &
Enterprises Development Act, 2006
Finpro ry
21
Micro
Small
Business Area
Investment
Manufacturing
Approx<35K
Services
Approx <14K
Manufacturing
Services
Manufacturing
Services
INR 20 50 million
Medium
08.05.2012
22
Sl. No.
E-Waste Categories
(For Schedule II and III, please go to the hyperlink given in Slide 19)
08.05.2012
23
The complexity of e-waste flows within India and inadequate record-keeping (maintenance of registry) make an
estimation of the quantities and composition of e-waste within India, making enforcement of legislation difficult
The draft rule does not specify how it will ensure that informal recyclers reduce their operations to dismantling and
collection activities. Furthermore, the underlying incentives that can result in the informal sector being able to outbid the
formal sector remain unaddressed
A lack of awareness of the hazards of improper e-waste disposal, at the consumer-level, collector-level or recycler-level
or disposer-level
Inadequate monitoring and enforcement mechanisms
Outlook
Many electronic companies are willing to comply with the requirements
It is expected that Indian companies will be more open to complying with RoHS than REACH
The various regulations that are at various stages of enactment and implementation tries to achieve the broader
objectives similar to EU and the US regulations. Considering all the challenges mentioned above, it will be a tough task
for the government and regulatory bodies to achieve full adherence and compliance
08.05.2012
24
India CLP
India is expected to publish by mid-2012 rules governing the labelling of hazardous chemicals, in line with the UN GHS
requirements
The draft rules were released in July, 2011 for comments from interested groups. Ministry of Environment and Forests is now
working on the final document (Rule called as Hazardous Substances (Classification, Packaging and Labelling) Rules, 2011;
draft notification dated 8th July, 2011. http://moef.nic.in/downloads/rules-and-regulations/SO523_E_new.pdf)
Indias approach would be to implement new rules that are entirely in agreement with the UN or partially fulfil the UN mandate
India currently uses a combination of lists and laws to classify chemicals and govern their storage and handling
For example, one current law is the Manufacture, Storage and Transport of Hazardous Chemical Rules of 1989 whose rules
do not conform to GHS. But efforts are to be made to radically revise these rules to avoid conflict and confusion with the new
GHS rules that would be introduced
Some of the salient points of Indias new HS (CPL) rules are:
Responsibilities in the supply chain to be prescribed
All dangerous goods will have to have a UN number and proper shipping name according to their assigned hazard
classification and composition
Suitable labelling and packaging will have to be used, along with updated safety data sheets
People engaged in the handling, storage and transport of dangerous goods will have to be trained
The consultation of the draft law has received a great deal of technical specifications, including how inflammable liquids and
mixtures of gases must be dealt with and more detailed definitions of what constitutes a toxic dose and how to determine
levels of flammability
08.05.2012
26
27
Other Legislations
The Hazardous Wastes (Management & Handling) Rules 1989
Motor Vehicles Act - 1988 & Rules thereunder ( Safety in transportation of Hazardous substances)
The petroleum and Explosive Act - 1984 & Rules ( Safety in handling of Petroleum and Petrochemical including bulk storages)
Factories Act -1948 ( Safety In Manufacturing Activity)
The Emergency Planning , Preparedness & Response For Chemical Accidents Rules-1995
The Public Liability Insurance Act & Rules- 1991 ( Payment Of Compensation To The Outsiders In Respect Of Major Incidents
In Factories)
08.05.2012
28
Sl.
No.
1
2
3
4
5
6
7
8
9
10
11
12
Chemicals
Schedule
1
Schedule
2
Schedule
3
Toxic
Flammable
Flammable gases
Highly flammable liquids
Flammable liquids
Explosive
Corrosive
Oxidizing
Reactive
Gasses compressed
Infectious substances
Radioactive substance
Y
Y
Y
Y
Y
-
Y
Y
Y
Y
Y
Y
-
Y
Y
Y
Y
Y
Y
Y
08.05.2012
1.
2.
3.
4.
5.
6.
29
CLASS-1 : EXPLOSIVES
e.g. TNT, Symbol-Exploding bomb with orange background
flame
cylinder
with
with
red
green
08.05.2012
30
08.05.2012
31
CLASS-7:RADIOACTIVE SUBSTANCES
e.g. Uranium, Radium
CLASS-8 :CORROSIVE
e.g. Hydrochloric Acid, Sulphuric acid, Caustic Soda
Sl. No.
08.05.2012
Degree of
Toxicity
Oral Toxicity
LD 50 (mg/kg)
Dermal
Toxicity LD 50
(mg/kg)
Inhalation
Toxicity LC 50
(mg/l)
Extremely
Toxic
<5
<40
<0.5
Highly Toxic
>5 50
>40 2000
>0.5 2.0
Toxic
>50 200
>200 1000
>2 10
32
08.05.2012
33
Interview Summary
Conclusions
Recommendations
Interview Summary
Some quotes
The major concerns and thrust areas of environmental pollution, at present, are hazardous waste handling, its storage and
disposal and minimisation of volatile organic compounds, besides ensuring proper operation and maintenance of pollution
control devices.
Various ministries are involved in implementation of respective Acts and Rules related to chemicals management. It is,
therefore, necessary to have more inter-ministerial commissions and coordination mechanisms.
Suppliers in unorganized sector have little knowledge of REACH. Unlike mass manufacturers like China, testing per
consignment for fashion garments is much more difficult and costly. India specialises in fashion garments, with lot of value
additions and embellishments. Compliance requires testing of these embellishments also.
A manufacturer supplying small lots of such products to EU will incur very high testing charges. REACH regulations will have a
long lasting implication on the Indian apparel industry.
There is a recommendation to, in future, merge all related regulations for having uniform standards. India is contemplating
REACH specific to India. But so far it has not been enacted. Small and medium companies in the sector are completely
unaware of REACH and such regulations. They are also sceptical of the high costs involved, as they operate on very low
margins already
The REACH and CLP market in China is much more matured than in India, as China is hosts a large number of European
businesses. India has seen an increase over the last few years in the awareness and sensitivity towards product related
environmental issues.
Some of the priority actions proposed for India are,
prepare Indian chemical inventory (none exists today),
improve co-ordination at central government level amongst ministries,
create laboratory infrastructure,
augment human resources (-- Comments from industry experts)
08.05.2012
35
Identified that the chemical sector in India requires to go a long way towards REACH and CLP regulations
RoHS regulations have been enacted. However, full scale implementation and compliance is expected to
face stiff challenges from the industry
Large number of small and medium companies in the sector makes data gathering difficult one of the
key reasons why implementation of such comprehensive regulations have been difficult in India
Some of the administrative hurdles of the regulations many ministries such as Ministry of Commerce
and Industry, Ministry of Chemicals and Fertilizers, Ministry of Environment & Forests, Ministry of Finance
etc, deliberating on the hierarchy and decision-making authority on chemicals management in India
India has its own set of legislations and regulations which are getting evolved. Many government agencies
such as the Pollution Control Boards (Central and state level) are enforcing many of these regulations in a
strict manner now
It needs to be seen how the many regulations will evolve into a comprehensive legislation similar to
REACH
It is advised to closely monitor the regulatory developments in India on continuous basis, to gain more
understanding of how the various regulations (such as REACH, RoHS etc) are enacted and implemented
08.05.2012
36
Appendices
08.05.2012
38
39
1(a)
1(b)
1(c)
1(d)
Description
In Europe
EU-RoHS Recast
Limited to 5 mg
No Timescale specified
Limited to 5 mg
No Timescale specified
Limited to 7 mg
No timescale specified
1(e)
1(f)
2(a)
08.05.2012
40
Appendix C (Contd.)
Exempti
on Nr
Description
In Europe
2(a)(1)
2(a)(2)
2(a)(3)
2(a)(4)
2(a)(5)
2(b)
2(b)(1)
2(b)(2)
Limited to 4 mg
No timescale specified
Limited to 3 mg
No timescale specified
EU-RoHS Recast
Limited to 3.5 mg
No timescale specified
No weight reduction to
3.5 mg specified
No timescale specified
No weight reduction to
5 mg specified
No timescale specified
No expiry date
specified
No expiry date
specified
Expires on 13 April,
2012
Expires on 13 April,
2016
41
Appendix C (Contd.)
Exemptio
n Nr
Description
In Europe
3(a)
3(b)
3(c)
4(a)
4(b)
4(b)-I
4(b)-II
4(b)-III
P > 405 W
08.05.2012
Limited to 3.5 mg
No timescale
specified
Limited to 5 mg
No timescale
specified
Limited to 13 mg
No timescale
specified
No weight limit
No timescale
specified
Dec 2011
specified
Finpro ry
EU-RoHS Recast
42
Appendix C (Contd.)
Exemptio
n Nr
4(c)
Description
In Europe
4(c)-I
4(c)-II
4(c)-III
P > 405 W
4(d)
5(a)
5(b)
6(a)
6(b)
6(c)
7(a)
Limited to 25 mg
No timescale
specified
Limited to 30 mg
No timescale
specified
Limited to 40 mg
No timescale
specified
No timescale
specified
EU-RoHS Recast
Expires on 13th
April, 2015
43
Appendix C (Contd.)
Exemptio
n Nr
7(b)
7(c)-I
7(c)-II
Description
In Europe
7(c)-III
No expiry date
7(c)-IV
8(a)
EU-RoHS Recast
08.05.2012
No expiry date
Appendix C (Contd.)
Exemptio
n Nr
8(b)
9
9(b)
10
Description
In Europe
EU-RoHS Recast
11(a)
11(b)
12
13(a)
13(b)
08.05.2012
No Expiry Date
No expiry date
No conditions for
use
No conditions for
use
45
Appendix C (Contd.)
Exemptio
n Nr
Description
14
15
16
17
18(a)
18(b)
19
20
21
In Europe
No expiry date
No conditions for
use
No expiry date
No expiry date
No expiry date
No expiry date
EU-RoHS Recast
46
Appendix C (Contd.)
Exemptio
n Nr
22
23
24
25
Description
In Europe
No conditions for
use
No expiry date
27
Expired on 24 Sept
2011
No expiry date
28
29
31
26
30
EU-RoHS Recast
No definition in India
WEEE/RoHS to
which to refer
47
Appendix C (Contd.)
Exemptio
n Nr
32
33
34
35
36
37
38
39
40
Description
In Europe
EU-RoHS Recast
Lead oxide in seal frit used for making window assemblies for
Argon and Krypton laser tubes
Lead in solders for the soldering to thin copper wires or 100m
diameter and less in power transformers
Lead in cermet-based trimmer potentiometer elements
08.05.2012
No expiry date
No expiry date
Approved by Council
16 May 2011, not yet in
force, will expire on 31
Dec 2013
48
Appendix D
References
08.05.2012
49