3 UNEP ChemControlGuide
3 UNEP ChemControlGuide
3 UNEP ChemControlGuide
UNEP GUIDANCE
Risk Reduction Tools for
Chemicals Control
EXECUTIVE SUMMARY
Tens of thousands of chemicals exist in commercial Key concepts of risk reduction in a chemicals
products and processes, many of which have control context include:
hazardous properties. Risk reduction measures aim to
protect human health and the environment from the • A preventive approach. This concept is
adverse effects of these hazardous chemicals. embodied in the “Precautionary Principle” (from
the 1992 Rio Declaration), which states that
The establishment and implementation of legal where there are threats of serious or irreversible
frameworks for industrial and consumer chemicals damage, lack of full scientific certainty shall not
is an aspect of sound chemicals management still be used as a reason for postponing cost-effective
lacking in many countries, especially in developing measures to prevent environmental degradation.
countries. In most countries, pesticides are covered in A preventive approach reduces costs and is the
separate legislation and are often subject to stringent most effective approach for protecting health and
requirements. The term “chemicals control” is used the environment.
to refer to the regulation of industrial and consumer
chemicals before or at the point when they are placed • Implementing GHS. Implementing the Globally
on the market in a country. In parallel to establishing Harmonized System of Classification and Labelling
the legal requirements, the related institutional of Chemicals (GHS) in national legislation is the
capacity needs to be established or improved. core element of integrating risk reduction into
daily operations with chemicals. These resources
Adopting chemicals control legislation and provide essential information on safe handling
establishing the related institutional capacity and risk reduction in the supply chain.
to manage chemicals at an early stage is a cost-
effective way of strengthening national chemicals • Clear roles and responsibilities. Legislation
management systems. The United Nations should clearly define roles and responsibilities
Environment Programme’s (UNEP) 2015 publication, for manufacturers and importers. These
Guidance on the Development of Legal and Institutional include gathering information on chemical
Infrastructures and Measures for Recovering Costs properties, hazards and risks; classifying and
of National Administration (LIRA Guidance), offers labelling chemicals in accordance with the
suggestions on ways to establish chemicals control GHS; disseminating information on hazardous
legislation and institutional capacity. properties of chemicals, including providing
Safety Data Sheets (SDSs) to professional
This guidance document aims to support technical users; complying with bans and restrictions;
government officials who are working to build and adopting safer substitutes for hazardous
government capacity for reducing the potential risk to chemicals when possible. Downstream users of
human health and the environment from chemicals. It chemicals should comply with risk management
supplements the suggestions in the LIRA Guidance, measures, choose the safest chemical, and handle
by further describing risk reduction tools for reducing the chemicals they use or dispose of in a safe way.
or eliminating these risks. It provides information Government should ensure that all actors in the
on the prioritization of chemicals for cost-efficient supply chain apply relevant risk management
risk reduction; the range of risk reduction tools for measures.
chemicals; and options for choosing appropriate risk
reduction tools.
All chemicals that have already been prioritized under Classification and labelling, bans, restrictions and
multilateral environmental agreements (MEAs) should authorization systems
be prioritized at the national level. Further prioritization
of chemicals for possible risk reduction measures can Implementing the GHS as a legal requirement for all
be based on additional existing lists of chemicals that chemicals is a core element of risk reduction. Chemical
pose severe and well documented risks. manufacturers and importers should be responsible
for gathering and communicating this information. Use
If prioritization decisions have already been made of the GHS ensures international harmonization of the
in another jurisdiction, it is cost efficient to use the classification and labelling of all types of chemicals.
information generated through those decision-making
processes. Many countries and organizations publish Official/harmonized classifications from other
preparatory work and lists of candidates for regulation countries or regions based on the GHS criteria should
on their websites. be used. These are peer-reviewed by expert groups
and therefore considered reliable.
Chemicals can be categorized and prioritized based
on their known or expected hazards. Hazard-based Bans and restrictions regulate access to chemicals
decision-making focuses on addressing the inherent that are too hazardous to remain freely and openly
hazards of chemicals through substitution or other available, or that a country does not have the national
approaches, rather than calculating an acceptable capacity to manage effectively. They can also help to
level of risk. promote the development and introduction of safer
alternatives that are technically and financially viable.
Chemicals can also be prioritized based on exposure. Bans and restrictions can exist at a variety of levels,
This includes identifying use patterns that may create including total bans, bans with specific exemptions, or
widespread exposure across a population, or intense bans or restrictions for a specific use of a chemical.
exposure for a subset of the population.
In an authorization or pre-market approval system, a
Risk evaluations that have been generated by other manufacturer or importer must have authorization,
countries or regions should be used whenever approval or a licence before placing a chemical on
possible. If another country has already assessed the market. While many countries have laws of this
or acted upon a chemical, information is likely to be kind for pesticides and pharmaceuticals, they are less
available on risk reduction measures that have been common for industrial and consumer chemicals as
adopted, as well as background information for these types of system tend to be resource-demanding
these measures. Countries should allow for the use both for the authorities and industry.
of data and evaluations from other jurisdictions, as
long as they comply with internationally recognized Additional approaches: Economic and informative
standards, such as guidelines from the Organization instruments
for Economic Co-operation and Development (OECD).
Economic instruments include taxes and fees that are
A variety of risk reduction resources are available for designed to shift markets towards safer chemicals.
government and industry employees wishing to find Economic instruments are not a good choice if the
information about chemicals. These include databases chemical poses an unacceptable risk to health or the
on chemical properties and information about safer environment. They can also be resource-demanding
alternatives. Many of these resources are publicly to administer. However, in some cases, well-designed
available; others are available for a subscription fee. economic instruments can be used to complement
These include: OECD Regulations and Restrictions; other instruments.
the eChemPortal; substances restricted under
Registration, Evaluation, Authorization and restriction
PREFACE
This document is part of a series of guidance documents that aim to complement the information provided in
UNEP’s 2015 publication, Guidance on the Development of Legal and Institutional Infrastructures and Measures for
Recovering Costs of National Administration (LIRA Guidance). More specifically, it provides further information on
risk reduction tools that are part of chemicals control legislation.
The approach suggested in the LIRA Guidance is referred to in this series as “chemicals control” and primarily
addresses regulation of industrial and consumer chemicals before or at the point when they are placed on the
market.
The series is composed of four documents with one document on the benefits of chemicals control and three
guidance documents:
By supporting the development of chemicals management frameworks at the national level, the LIRA Guidance
and these complementary documents contribute to the priorities developed in the context of the Strategic
Approach to International Chemicals Management (SAICM) and the Overall Orientation and Guidance (OOG)
document, as well as the implementation of the Basel, Rotterdam, Stockholm and Minamata Conventions, and
the Sustainable Development Goals under Agenda 2030.
This publication was developed by UNEP in the context of the Inter-Organization Programme for the Sound
Management of Chemicals (IOMC).
This document has been produced with financial assistance from Sweden through the Swedish International
Development Cooperation Agency (Sida), which was arranged by the Swedish Chemicals Agency, Keml. The
views herein do not necessarily reflect the official opinions of Sida or Keml.
CONTENTS
Executive Summary.................................................................................................................................................................................. 2
Preface.............................................................................................................................................................................................................5
Acknowledgements................................................................................................................................................................................. 7
1. Introduction..........................................................................................................................................................................................10
1.1 Background..........................................................................................................................................................................11
1.2 Scope and aim.....................................................................................................................................................................11
References.................................................................................................................................................................................................41
Endnotes......................................................................................................................................................................................................45
ACKNOWLEDGEMENTS
The development of this UNEP guidance document was coordinated by Maria Delvin and Pierre Quiblier, UNEP
Chemicals and Health Branch. Rachel Massey and Lindsey Pollard, Massachusetts Toxics Use Reduction Institute
(TURI), and Susan Kaplan (consultant) were contributing writers.
The development of this guidance benefited from input from an expert group that included participants from
governments, intergovernmental organizations, private sector organizations, non-governmental organizations
and academia.
Governments
Alison Kennedy, Manager, Department of Environment and Climate Change, Canada; Bojana Djordjevic, Head
of Unit, Ministry of Environmental Protection, Serbia; Cayssa Marcondes, Ministry of Environment, Brazil; Elize
Lourens, Deputy Director, Health and Hygiene, Department of Labour, South Africa; Fredrick Muyano, Principle
Inspector, Environmental Management Agency, Zambia; Helga Schrott, Senior Legal Adviser, Federal Ministry
of Agriculture, Forestry, Environment and Water Management, Austria; Ingela Andersson, Head of International
Unit, Swedish Chemicals Agency, Sweden; Juan Simonelli, National Ministry of Environment and Sustainable
Development, Argentina; Juergen Helbig, Principal Policy Officer, European Commission; Leticia Carvalho,
Chief of Environmental Quality Branch, Department of Environmental Quality in Industry Ministry of Environment
Brazil; Mangaka Mahlako, Deputy Director, Mfanuwenkosi Mathebula, Assistant Director, Hazardous Chemicals
Management, Department of Environmental Affairs, South Africa; Marthe D. Rahelimalala, Chief of Environmental
Pollution, Ministry of Environment, Ecology and Forest, Madagascar; Nguyen Thi Ha, Head of Division, Viet Nam
Chemicals Agency, Vietnam; Phengkhamla Phonvisai, Deputy Director General, Ministry of Natural Resources
and Environment, Lao PDR; Simone Irsfeld, Federal Ministry for the Environment, Nature Conservation, Building
and Nuclear Safety International Chemical Safety, Sustainable Chemistry, Germany; Szymon Domagalski, Senior
Specialist, Department for Dangerous Substances and Mixtures, Poland.
Intergovernmental organizations
Abdouraman Bary, Regional Subprogramme Coordinator, UN Environment (UNEP); Baogen Gu, Senior
Agricultural Officer, Food and Agriculture Organization (FAO); Carmen Bullon, Legal Officer, FAO, Haddy Guisse,
Associate Legal Officer, UNEP Hilda Van Der Veen, Chemicals and Waste Management Expert, United Nations
Development Programme (UNDP); Jacob Duer, Chief, Chemicals and Health Branch, UNEP; Jordi Pon, Regional
Chemicals and Waste Coordinator, UNEP; Jose de Mesa Programme Officer, UNEP; Juliette Voinov Kohler, Legal
and Policy Adviser, Head of the Legal and Governance Unit, Secretariat of the Basel, Rotterdam, and Stockholm
Conventions (BRS), UNEP; Kakuko Nagatani-Yoshida, Regional Subprogramme Coordinator for Chemicals and
Waste, UNEP; Kei Ohno Woodall, Programme Officer, BRS, UNEP; Kersten Gutschmidt, Technical Officer, Public
Health, Environmental and Social Determination of Health, World Health Organization (WHO); Lena Perenius,
consultant, Strategic Approach to International Chemicals Management (SAICM); Magaran Monzon Bagayoko,
Regional Adviser, WHO; Mijke Hertoghs, Regional Coordinator, UNEP; Nalini Sharma, Programme Officer,
Secretariat of the Special Programme, UNEP; Sylvie Poret, Principal Administrator, Organization for Economic
Co-operation and Development (OECD); Yvonne Ewang, Legal Officer, BRS,UNEP.
Private sector
Alan P. Kaufman, Senior Vice President, Technical Affairs, The Toy Association, Inc.; Beth Jensen, Senior Director
of Sustainable Business Innovation, Outdoor Industry Association; Catherine Lequime, ICCA representative,
Véronique Garny, Director, Product Stewardship, European Chemical Industry Council.
Baskut Tuncak, UN Special Rapporteur, OHCHR-UNOG; Beverley Thorpe, Clean Production Action; David
Azoulay, Environmental Health Program Director, Center for International Environmental Law, (CIEL); Goh
Choo Ta, Associate Professor, National University of Malaysia; Hanna-Andrea Rother, Head Associate Professor,
University of Cape Town; Ken Geiser, Professor Emeritus, University of Massachusetts Lowell; Linn Persson, Head
of Unit, Stockholm Environment Institute; Mengjiao Wang, Research Scientist, Greenpeace International; Olga
Speranskaya, Director, Chemical Safety Program, IPEN; Sabaa A. Khan, Senior Researcher, University Of Eastern
Finland; Taelo Letsela, Managing Director, Global Environmental Solutions.
Valuable input on a test version was provided by Xiomara Jiménez Soto, Ministry of Health of Costa Rica; Maria del
Mar Solano, Ministry of Environment and Energy, Costa Rica; and staff of the Technical Coordination Secretariat
for the Sound Management of Chemicals in Costa Rica.
INTRODUCTION
Chemicals are integral to modern life, and when there is the greatest opportunity
their sound management is a key aspect for prevention before adverse effects on
of sustainable development. Adoption human health and the environment occur.
and implementation of chemicals control It complements and supports other aspects
legislation is an aspect of sound chemicals of risk management activities, such as
management that many countries often worker protection, prevention of accidents, CHAPTER
1
lack. Risk reduction measures aim to protect transportation regulation and waste
human health and the environment from the disposal. For further information about
adverse effects of hazardous chemicals. the benefits of chemicals control, see the
document, Benefits of Chemicals Control, in
In this document, the term “chemicals this series.
control” is used to refer to the regulation of
industrial and consumer chemicals before As reported by the United Nations
or at the point when they are placed on Environment Programme (UNEP) in the
the market. This includes chemicals used Costs of Inaction report from 2013, the costs
in industrial processes; chemicals used in from the mismanagement of chemicals can
everyday life, such as cleaning products and be substantial.i Although many countries
paints; and chemicals in articles, such as have laws to regulate the release of
clothing, furniture and electrical appliances chemicals into the environment, to protect
(not including pesticides, pharmaceuticals, workers, and to authorize certain chemicals
cosmetic products or food additives). before marketing and use (pesticides,
Placing on the market means supplying pharmaceuticals and/or food additives),
or making available chemicals, whether in there are still many countries that lack
return for payment or free of charge. This regulation to control the manufacture and
includes imports. import of industrial and consumer chemicals
as they are placed on the market. Early action
Chemicals control can be addressed in on risk reduction is often cost efficient.
free-standing law or it can be built into a
broader chemicals management law or A chemical that has several uses may
other framework legislation related to the be subject to several different laws. In
protection of health and the environment. many countries, pesticides are covered
in separate legislation and normally have
Chemicals control focuses on defining more stringent requirements than chemicals
responsibilities for industry in implementing control for industrial or consumer chemicals.
knowledge-based measures as early as Guidance on pesticides is available from the
possible in the life cycle of chemicals, Food and Agriculture Organization of the
The key concepts of risk reduction include the environment. It complements and
a preventive approach. Core elements in supports other aspects of downstream risk
chemicals control include implementing management activities, such as worker
the GHS; developing and providing Safety protection, prevention of accidents,
Data Sheets (SDS); and identifying a clear transportation regulation and waste
division of responsibilities between industry disposal. While measures to address the CHAPTER
2
and government, with the main obligations widespread use of chemicals already on the
on manufacturers and importers. market are complicated and costly, early
action can offer greater efficiencies. The EU’s
Preventive approach. A preventive approach Registration, Evaluation and Authorization
is a key concept of chemicals control, as of Chemicals (REACH) regulation explicitly
it reduces costs and is the most effective cites the Precautionary Principle as a basis
approach for protecting health and for decision-making.viii
Precautionary Principle is an anticipatory approach that aims to protect human health and the environment
against the potential risks from human action. It marks a shift from post-damage to pre-damage control of risks.ix
An early definition of the Precautionary Principle is found in the Rio Declaration, adopted in 1992. It reads,
“[w]here there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used
as a reason for postponing cost-effective measures to prevent environmental degradation”.x Since then, the
principle has been expanded to encompass the protection of human health.
The principle has four central components: taking preventive action in the face of uncertainty; shifting the
burden of proof to the proponents of an activity; exploring a wide range of alternatives to potentially harmful
actions; and increasing public participation in decision-making.xi The principle is referred to in Article 1 of the
Stockholm Convention.
Polluter pays principle. The polluter pays principle specifies that the costs of addressing pollution from a
wide range of sources should be the responsibility of the industry creating the pollution. Principle 16 of the Rio
Declaration states that “[n]ational authorities should endeavour to promote the internalisation of environmental
costs and the use of economic instruments, taking into account the approach that the polluter should, in
principle, bear the cost of pollution with due regard to public interest and without distorting international trade
and investment”.xii
Extended producer responsibility “is a policy approach under which producers are given a significant
responsibility – financial and/or physical – for the treatment or disposal of post-consumer products. Assigning
such responsibility could, in principle, provide incentives to prevent wastes at the source, promote product
design for the environment and support the achievement of public recycling and materials management
goals”, according to the OECD.xiii A common example is a takeback programme for electronics, in which
electronics manufacturers are assigned responsibility for taking back used electronics and disposing of them
in an environmentally sound manner.
Implementing the GHS in national legislation • Make informed choices about chemicals
should be a priority, as it creates a system for in order to avoid hazards and risks.
chemical manufacturers and importers to Substitute chemicals for less hazardous
provide information about chemical hazards ones or apply an alternative technique,
and precautions. The GHS is a cornerstone of when possible (the Substitution Principle
knowledge-based risk reduction measures – described in greater detail below).
as it gives information about the properties
of chemicals and how to handle them safely. • Organize and assure the safe use of
This is further addressed in Section 4.1. chemicals and their storage, transport
and appropriate disposal.
Clear division of responsibilities between
industry and government. Chemicals control • For downstream/professional users of
legislation should make it clear that industry chemicals, comply with risk management
is responsible for its products. Given the measures, choose the safest chemical
large number of chemicals that exist in and handle the chemicals they use or
commerce, it is essential that the legislation dispose of in a safe way.
includes general provisions placing
responsibility on industry to ensure the The European Chemicals Agency provides
availability of health and safety information information for industry on assessing hazard
throughout the supply chain. Information and risk. It states that companies need to
sharing is crucial to ensure that downstream consider the following regulatory, scientific
users can safely handle chemicals and that and technical requirements:
consumers can make informed decisions.
Chemical manufacturers are best placed to • Gather information on uses and current
have or generate the necessary knowledge conditions of use from the supply chain.
about the hazards of the chemicals they Contact your industry association for best
produce. Importers should be responsible for practice in your sector.
obtaining the necessary safety information
from manufacturers. • Collect hazard data as requested by
REACH information requirements
Basic requirements for industry should triggered by the tonnage and uses of the
include: substance.
• Gather knowledge and, if necessary, • Assess the coverage and quality of the
generate new knowledge on chemical hazard information about the substance
properties, hazards and risks. available within the SIEF [Substance
Information Exchange Forum].
• Classify and label chemicals in
accordance with the GHS. • Define a strategy to fill in any resulting
data gaps (e.g. carrying out new studies,
• Disseminate information on the hazardous justifying missing information using
properties of chemicals and on safe scientifically solid read-across, data
handling procedures, including providing waivers, etc.).
SDSs to professional users.
• Agree classification and labelling within
• Supply additional information about the the SIEF (based on the hazard data).
products, when necessary, in order to
enable and facilitate the best choice of • Record all hazard data and classification
products for downstream users and to in the registration dossier.
ensure the safe handling of the products.
• If manufacturing or importing more than
• Ensure that no banned substances are 10 tons per year, carry out the chemical
produced, imported or placed on the safety assessment (CSA) and record it in a
market. chemical safety report (CSR).xiv
PRIORITIZATION OF
CHEMICALS FOR RISK
REDUCTION
The legislation should require industry to Protocol on Substances that Deplete the
take responsibility for reducing the risks Ozone Layer, parties have a responsibility
from the chemicals they produce, import to ban, phase out or restrict chemicals
and use. Implementation of the GHS requires that are recognized as high priority at
industry to classify and label their hazardous the international level. Adopting such
chemicals appropriately before placing requirements domestically is best done via CHAPTER
3
them on the market. Product and transport legislation that implements the provisions
labelling and SDSs provide information to in the MEA, including introducing bans
users about the hazards and how to handle or restrictions on the production and use
the chemicals in a safe way how to protect of a specific chemical. It is important to
oneself and the environment. For many remember that the legislation will probably
chemicals, provisions for communicating need to be updated as further progress or
information in the supply chain provide new decisions are made.
sufficient risk reduction. However, for
certain hazardous chemicals – for which 3.2 Further prioritization
disseminating information is not sufficient
for handling the risks to human health or Chemicals can be prioritized based on
the environment – the authorities should prioritization or regulation decisions
introduce more stringent risk reduction that have already been made in other
measures. There are several options for jurisdictions; the degree of hazard; levels
prioritizing such chemicals or groups of of exposure; or a risk evaluation process.
chemicals. Successful prioritization approaches often
employ more than one of these options.
3.1 Implementing Multilateral
Environmental Agreements As previously noted, legislation should
require industry to take responsibility for the
All chemicals that have already been chemicals they produce, import and use in
prioritized under multilateral environmental order to reduce the risks to human health
agreements (MEAs) should be prioritized at or the environment. However, in cases
the national level. Countries are responsible where such requirements in the legislation
for fulfilling their obligations under MEAs – including disseminating information
related to chemicals. For example, under in accordance with the GHS (see further
the Stockholm Convention on Persistent discussion on Page 17) and taking the
Organic Pollutants (POPs), the Minamata necessary precautions – are inadequate for
Convention on Mercury, or the Montreal managing risks from chemicals, authorities
should introduce more stringent measures and make use of information such as the
to address these substances or groups of list of Substances of Very High Concern
substances. (SVHCs) defined under REACH. Canada
has categorized all of the chemicals on the
While these substances might be identified Canadian market; see Canada’s Domestic
through cases of pollution and poisoning, Substances List.xv
it is advisable to try to identify potentially
problematic chemicals before any harm has Many countries publish preparatory work
occurred. and lists of candidates for regulation on
their websites. This information can be
Adopting a national chemicals policy valuable for other countries. It often includes
identifying the types of substances that useful background information on why a
should be prioritized for action could substance is a candidate for risk reduction.
support the work of government, as well as One example of such information is the
that of industry. Such policy contributes to REACH Candidate List of substances that
greater certainty for industry and provides could be subject to authorization within the
guidance on what kinds of substances EU.xvi On the European Chemicals Agency
should be avoided in order to reduce risks. (ECHA) website, information on chemicals
under consideration for harmonized
If there is a particularly high likelihood classification and labelling, and bans is
of exposure due to national conditions, accessible to countries outside the EU. The
this should be taken into account in the US Environmental Protection Agency (EPA)
prioritization process. Preferably, these also publishes information on substances
substances should be identified before any of concern. For example, US EPA’s 2014
harm (cases of poisoning or pollution) has update of the Toxic Substance Control Act
occurred. A systematic approach would (TSCA) Workplan for Chemical Assessments
build on the prioritization of substances that, is a valuable resource, providing an overview
due to their known or assumed hazards and/ of dozens of chemicals considered to be
or use patterns, are likely to give rise to risks priorities for assessment and action.xvii
that need to be eliminated.
The information available under the
3.2.1 Actions of other jurisdictions Rotterdam Convention can help a country
make a decision as to whether they wish
Actions taken and priorities set in other to take further action to restrict or ban a
countries can be an important and cost- chemical. For all parties to the Rotterdam
saving resource when making prioritization Convention, export of the listed chemicals
decisions. should be accompanied by information
about the chemical, including information
If prioritization decisions have already for classification and labelling. Such
been made in another jurisdiction, it is notifications give the importing country
cost-efficient to use the information already valuable information about the decisions
developed through that particular decision- of other countries to ban and restrict the
making process. There is no need to re- chemical, and give them an opportunity
assess hazard if a chemical has already to consider the need to introduce similar
been assessed. The inherent properties of measures.
chemicals are always the same, regardless
of the place, type of production and use. The Rotterdam Convention requires each
party to notify the Secretariat when it has
For example, within the US, a state will often adopted a final regulatory action to ban or
use the work already completed in other severely restrict a chemical;xviii this provides
states, to decide on which chemicals to information about chemicals that have
prioritize. This is more efficient than each been identified as priorities by individual
state creating a new list from first principles. countries. The EU has a Prior Informed
Internationally, countries can draw upon Consent (PIC) procedure governing exports
prioritization approaches in other countries,
from the EU of any substance that is banned manufacturers and importers to make
or severely restricted within the EU.xix This informed decisions about which chemicals
lengthy list, which has more than 180 to invest in, use and import, as well
chemicals, can also be a good resource for as decisions about possible chemical
any government interested in identifying substitutions.
high-priority chemicals for regulatory action.
For chemicals whose inherent properties
can cause severe or irreversible effects,
Box 2. The Rotterdam Convention focuses on hazard information should be sufficient
information exchange and currently includes 50 for risk reduction decisions. This would
chemicals that are subject to the PIC procedure.
These chemicals have been identified by the
apply, for example, to chemicals that are
international community as presenting a severe persistent, bioaccumulative and toxic (PBT)
hazard to human health or the environment, and or very persistent and very bioaccumulative
are already banned or restricted in many parts of the (vPvB); carcinogenic, mutagenic or toxic to
world. For these substances, a decision guidance
document is available, which contains valuable
reproduction (CMR), meeting the criteria for
background information on the substances and the GHS CMR category 1A or 1B (especially
their properties.xx those without a non-threshold for effects); or
associated with other severe and irreversible
health effects.
Costa Rica developed Guidelines for Prioritization of Industrial Chemicals in 2018. The guidelines were
developed as part of the country’s commitments to the process of accession to the OECD. The prioritization
of chemical products is the first step in a new process for assessing the safety of existing chemical products.
The guidelines provide a methodology for prioritization: a relative value will be obtained for each chemical,
based on a set of criteria, which will then be used to determine if that product requires a subsequent risk
assessment. The selected criteria for the evaluation are:
• Import/production volumes
• Potential harm to human health and the environment
• Persistence in the environment (biodegradability)
• Listed in international agreements
• Reported emergencies
• Potential risk of damage, whether physical, health or environment-related (aquatic environment and/or
ozone layer) as established in the GHS
Following an initial “screening”, a list of candidate chemicals will be generated for risk analysis; based on the
results, a set of preventive and corrective actions will be developed.
Source: Jordi Pon and Costa Rica workgroup, personal communication, 2018
Criteria for prioritization of chemicals in Costa Rica; from “Report on Costa Rica’s Industrial
Chemicals Management Programme”.
Source: Jordi Pon and Costa Rica workgroup, 2018
3.2.4 Data and information supporting measures that have been adopted, as well
prioritization as the background for these measures.
Information is also often available on
ECHA maintains information on as many additional concerns that are still under
as 135,000 chemicals. These include consideration. All of this information can be
all substances subject to registration useful for a country in its initial assessments
under REACH, as well as all substances of a chemical. In all cases, it is essential to
placed on the market that are classified make use of existing data sources rather
as hazardous.xxii Under REACH, chemicals than reinvent the wheel.
must be registered if they are placed on the
EU market at a volume above 1 ton/year.1 Countries should make use of data and
The Toxic Substances Control Act provides evaluations in other jurisdictions, as long
information on reporting requirements in as they comply with recognized standards,
the United States.2 such as guidelines from the OECD. Data
on chemical properties is shared through
Manufacturers and importers are responsible various platforms, such as the OECD
for gathering and conveying knowledge on eChemPortal and the ECHA databases.
hazards and necessary precautions. The Existing GHS classifications are another
costs of testing and assessing chemicals for important source of information. Database
hazardous properties will vary. Importers can resources that are available internationally
obtain this information primarily by requiring include databases of chemical hazard
it from their suppliers in other countries. information; regulatory information; and
This can include ecotoxicological and ingredients in consumer products. Section
toxicological data. Within the EU, sharing of 3.2.5 and Annex 2 provide information on a
data and of testing costs among companies number of such resources.
is formalized and is a legal obligation.
4
Implementing the GHS and SDSs as a chemicals to which one might be exposed.
legal requirement for all chemicals is a Chemical manufacturers and importers
core element of risk reduction. Hazard are required to gather and communicate
assessments, and classification and accurate information, and ensure the flow
labelling should be done in accordance of this information through supply chains.
with the GHS because it is internationally Use of the GHS ensures international
recognized and the most widely used harmonization of classification and labelling
standard. Both manufacturers and importers of all types of chemicals. It also facilitates
should be held accountable for establishing international trade in chemical substances
and maintaining appropriate systems for and products containing chemicals,
classification and labelling, and SDSs. including facilitating access to markets in
compliance with international requirements.
GHS applies to chemical substances and
mixtures of chemical substances that meet
the harmonized criteria for physical, health
or environmental hazards under the GHS.
GHS uses the following definitions:
In the US, the GHS focuses on the right of Table 1. Additional GHS classification
workers to information about chemicals in resources that link users to the public GHS
their workplace, which is required as part classification lists for individual countries
of the US Occupational Safety and Health
Administration’s Hazard Communication European https://echa.europa.eu/information-on-
Standard. Union chemicals/cl-inventory-database
Australia http://hcis.safeworkaustralia.gov.au/Hazard-
Costa Rica provides an example of a country ousChemical
that, in introducing the GHS, adapted and Japan www.safe.nite.go.jp/english/ghs_index.html
improved on existing national labelling Republic http://ncis.nier.go.kr/en/main.do
systems. In Costa Rica, existing regulations of Korea
required SDSs that generally followed the Malaysia http://www.dosh.gov.my/index.php/en/legis-
GHS guidelines. In June 2017, the Costa lation/codes-of-practice/chemical-manage-
Rican Government published a requirement ment
for labelling in accordance with the GHS New https://www.epa.govt.nz/database-search/
“for workplace and supplier chemicals”, Zealand chemical-classification-and-information-data-
providing a five-year transition period base-ccid/
(until December 2022) for compliance.xxxiii
In November 2017, the government
published a requirement that, in order to be
registered, hazardous chemicals must have
a GHS-compliant Safety Data Sheet; again,
transitional periods are provided for renewal Box 7. Additional resources for GHS
of registrations. implementation: Web pages
A key resource for checking existing GHS GreenScreen List Translator, through Pharos:
www.pharosproject.net
classifications is the ECHA Classification
and Labelling Inventory, which offers a Toxplanet: https://toxplanet.com/
free, up-to-date list of substances classified
by the EU.xxxiv This resource shows both eChemPortal: https://www.echemportal.org/
echemportal/index.action
harmonized and non-harmonized GHS
classifications developed within the EU. For UNITAR – in partnership with the International
non-EU classifications, a useful resource Labour Organization and Inter-Organization
is Pharos, an independent subscription- Programme for the Sound Management of
Chemicals – guidance on GHS implementation:
based chemical database aggregated http://www.unitar.org/cwm/ghs
from numerous lists generated by various
countries for chemicals of concern. If a National Institute of Technology and Evaluation
subscription to Pharos is not available, it – Support Tools for Implementation of GHS:
http://www.safe.nite.go.jp/english/ghs/ghsrefs.
is also possible to use the websites listed
html
in Table 1 to view GHS classifications for
countries outside of the EU.
There are some subscription-based database services that can help governments to gain quick access to
other countries’ GHS classifications, among other information. One such resource is the GreenScreen List
Translator available through Pharos, a US-based non-governmental organization. The Massachusetts Toxics
Use Reduction Institute has compiled a guide covering a wide range of databases, including both publicly
available and subscription-based services. Toxplanet, a subscription-based service, is a useful source for both
toxicological and regulatory information from many countries. The Chemical Hazard and Alternatives Toolbox
(ChemHAT) provides publicly available information in an easy-to-read format. The OECD’s eChemPortal
provides information on the properties of chemicals, including physical chemical properties, ecotoxicity,
environmental fate and behaviour, and toxicity. UNITAR’s guidance on GHS implementation describes how
countries can assess their capacity for implementing the GHS, engage stakeholders in capacity-building, and
develop a national GHS implementation strategy.
Addressing challenges to GHS adoption. The capacity to implement the GHS requires
UNITAR notes: “The current global situation resources for developing legislation and
is a patchwork of sometimes conflicting guidance, technical knowledge, and funds
and diverse national and international for implementation costs and staff time.
requirements…The GHS was created to A study published in November 2017xxxvi
harmonize the different or lacking hazard found that, as of April 2017, 50 countries
classification and communication systems had fully implemented the GHS; 15 had
within a country and between countries and partially implemented it; and 128 had not.
regions”.xxxv Broad implementation of the It also found that most countries that have
GHS across countries will lead to information implemented the GHS have a higher gross
being more consistently communicated via domestic product per capita than those that
labels and SDSs – with benefits for human have not. Full implementation was most
health, the environment and business. It common in Europe and parts of Asia. One
is also essential to adopt best practices for country in Latin America, Ecuador, had fully
confidentiality, with provisions that health implemented the GHS, as had two in Africa:
and safety information in SDSs be exempt. Zambia and Mauritius. Among the 15 that
had partially implemented the GHS, most
SDSs come from suppliers, and the had implemented the system for workplaces
information they contain must be correct. It only – not for the consumer and agriculture
is critical that information included in labels sectors.
is easy to understand for all users; labelling
requirements must be tailored to the target
audience, as well as use internationally
recognized pictograms.
Source: Stockholm Environment Institute Policy Brief, “Reducing chemical risks in low-income
countries: strategies for improved coverage of basic chemicals-management legislation”,
2018.xxxvii xxxviii
The study also finds that regulatory capacity, a circular economy4 in which waste and
as measured by government effectiveness pollution are reduced and resources can be
indicators, is positively associated with recycled in a safe way.
GHS implementation – highlighting the
importance of capacity to formulate 4.2 Bans and restrictions
and introduce legislation. Additional
influences may include EU membership Bans and restrictions regulate access to
or the aspiration to join other international chemicals that are too hazardous to remain
organizations or agreements. freely and openly available, or which a
country does not have the national capacity
In the case of Zambia, “it seems that to manage effectively. According to the
sustained capacity-building and donor LIRA Guidance,5 bans and restrictions
support for the GHS implementation have “set forth a schedule, or list, of specific
served as a factor of importance. Zambia has compounds which are considered to cause
received support from UNITAR under the unacceptable risk to human health and/or
SAICM Quick Start Programme (QSP)” and the environment. While bans strictly prohibit
from other donors, according to the study. the production, sale and/or use of the
“Indeed, the need for capacity-building substance, restrictions limit the availability
and awareness-raising for successful GHS of the chemicals to specific uses/condition”.
implementation in low-income countries They may apply to the manufacture, import
has been long standing on the agenda of and/or use of a chemical. They may apply to
international collaboration…”xxxix Similarly, a substance as such or to a substance in a
Viet Nam’s chemicals management efforts mixture or in an article.
have been supported by several donors
and organizations; the outcome was the Bans and restrictions can exist at a variety
establishment of the Viet Nam Chemicals of levels, including total bans, bans with
Agency. This support is likely to have specific exemptions, or bans or restrictions
influenced GHS implementation through for a specific use of a chemical. In some
parallel institutional strengthening and cases, a ban or restriction may cover just
broad chemicals management capacity- the manufacture and use of a chemical in
building efforts. the country, while in other cases it may also
apply to imported products or articles. An
Chemicals in Products Programme. The example is the EU’s ban on nonylphenol
GHS system is designed for classification ethoxylates (NPEs), a group of chemicals
and labelling of individual chemicals and mainly used as cleaning agents, but also
chemical mixtures. The system does not added to plastics and rubbers, pesticides,
provide information on the occurrence of pharmaceuticals, cosmetics, paints and
specific chemicals in an article (e.g. toys, coatings, agro-chemicals and chemicals
electronics, clothes).3xl To address this used in paper making.xlii However, they
gap, a voluntary information programme remained present in the environment as
called Chemicals in Products (CiP) has been many imported products, such as textiles,
developed within the framework of SAICM. continued to include the substance, which
It aims to identify chemicals in articles/ could be emitted during washing.xliii This
products and the means for improving the triggered the need to ban or restrict their
sharing of this information through the presence in articles as well.
supply chain, including with recyclers/waste
managers.xli Bans or restrictions can also help to promote
the development and introduction of
This voluntary programme is intended for safer alternatives that are technically and
use by companies, to provide information financially viable. Substantial innovation
to downstream users, including final often occurs during the phase-out period.
customers, on the content of specific It is often useful to involve stakeholders
chemicals in products and articles. This when designing a ban, increasing the
information is also important for creating likelihood that it will be designed in a way
that facilitates compliance.
3 “Article” is defined in the EU REACH regulation as an object that is given a special shape, surface or design during production which determines its
function to a greater degree than does its chemical composition.
4 A circular economy is an economy where the value of products, materials and resources is maintained for as long as possible, and the generation of
waste minimized. Definition from COM (2015) 614 final, Communication from the Commission to the European Parliament. ‘Closing the loop – An EU
action plan for the Circular Economy’
5 UNEP, LIRA Guidance, section 4.4.3
ADDITIONAL RISK
REDUCTION TOOLS
In addition to the main administrative risk administrative costs, both for the authorities
reduction instruments described above, a and for industry, and compare them to other
government may decide to use additional options before considering the introduction
approaches. These options may include of an economic instrument.
economic instruments and informative
instruments, or tools to influence business Economic instruments are not a good choice CHAPTER
5
or consumer behaviour, including chemical if the chemical poses an unacceptable risk
requirements in public tenders and support to health or the environment. It should not
for substitution for safer alternatives. be possible to pay for the right to use or
release a substance that is highly hazardous.
5.1 Economic instruments
However, economic instruments that
An economic instrument can consist of are correctly designed might usefully
taxes or fees that must be paid for the use complement other instruments – for example,
of a specific substance that is considered to where there is a need for a reduction in the
create health or environmental problems. use of moderately hazardous substances,
To promote the use of less hazardous but a total phase-out is not needed. In such
substances, different forms of subsidies cases, market forces may be harnessed
can be considered. Taxes and fees as to help reduce use while keeping costs
economic policy instruments must be low. Economic instruments can be used
based on legislation in the same way as the to accelerate a process of substitution and
traditional risk reduction instruments. They innovation, and to support safer alternatives,
also need the same basis for decisions and helping them to reach the market or increase
socioeconomic considerations, as well as a their market share. For example, a tax or fee
system for control and enforcement. There on the use of a chemical of particular concern
needs to be a pre-existing system for the can help to encourage substitution for safer
collection of taxes and fees in the country; alternatives. Differentiated fees based on
otherwise it will be difficult to establish an different properties could create incentives
efficient economic instrument. to seek out less harmful alternatives.
However, these potential advantages can
In general, economic instruments are be undermined by increased administrative
not an important element of chemicals burden.
control in developed countries as they
can be resource-demanding to establish When there are good opportunities to
and maintain effectively. Therefore, it is increase the market share of alternatives –
important to assess the accompanying that are less harmful in terms of health and/
For example, in Germany, the Blue Angel other risk-reduction instruments because
ecolabelling system evaluates products in general awareness about chemicals
relation to health, climate, water and resource and their potential effects provides the
goals.liv The EU ecolabel regulation specifies basis for achieving the intended effects
criteria to be used in the EU ecolabelling of the instruments. Many countries and
system.8 The US Environmental Protection organizations have developed websites
Agency has ecolabelling programmes and/or printed material to inform the general
including ENERGY STAR™, WaterSense® public about chemicals and their risks. When
and Safer Choice, which identify products needed, informational material, including
that meet certain benchmarks for energy press releases, is issued for specific issues of
efficiency, water efficiency and green concern.
chemistry. Examples of non-government
ecolabelling programmes are EcoLogo Targeted information for a specific problem.
and Green Seal, which are used to identify Information pamphlets, websites, press
more environmentally preferable cleaning releases and other similar material can be
products. used to educate the public about chemical
hazards. This can contribute to a reduction in
Ecolabelling has become a useful tool the use of harmful substances, as it can affect
for governments to encourage sound the demand from downstream users as well
environmental practices, and for businesses as the general public. Greater awareness
to identify and establish domestic and, of a problem might trigger questions on
sometimes, international markets for their the availability of alternatives and how to
environmentally preferable products. avoid buying products containing specific
The requirements for ecolabels need to substances. In this way, public awareness
be clear, unambiguous and objectively might trigger substitution as well.
verifiable in order to ensure transparency
and fair competition for the suppliers in the It is valuable to inform downstream users of
procurement processes. It is important to the need or the desirability to substitute a
understand the criteria used for a particular specific type of substance for one that is less
ecolabel, as it is possible that a product that hazardous; in this way they can put pressure
is deemed environmentally friendly could on their suppliers to provide alternatives.
still pose a risk to human health.
Well-informed consumers can put pressure
5.2.3 Awareness-raising on national and local politicians to issue
legislation that aims to reduce the use of
General awareness-raising. Authorities play hazardous chemicals and create a less
a role in providing accurate and unbiased toxic local environment. Depending on
information to the general public and public the resources available to the authority,
organizations on chemicals in the everyday information provided directly to consumers
environment. Detailed information on how to by government authorities or non-
handle a specific chemical in a safe manner governmental organizations regarding
and to enable people to make informed particular substances, or the substances
choices needs to be supplied by the used in mixtures and articles, can be
manufacturer or importer. Civil society also considered. Such efforts can lead to well-
has an important role to play in generating, informed, stronger consumer groups that
using and disseminating information about refuse to buy products that contain specific
chemicals. hazardous chemicals. Their behaviour
can put pressure on downstream users
The authorities can support general and, through them, the primary suppliers,
awareness-raising about chemicals and to substitute such chemicals with less
their effects, and how to handle them – for hazardous ones. Targeted information from
example, in school curricula and through authorities aimed at private consumers
general information material, websites, about a specific problem is an effective
etc. Broad awareness-raising supports all
chemicals that have been identified as SVHCs, specific group of articles, such as toys, textiles
based on the criteria defined within REACH. It or electronics that might contain a number
also serves as a tool for companies and others to of chemicals that need to be reduced. It is
identify which chemicals to start moving away also useful to involve, if available, sector-
from before they are classified as SVHCs and
placed on the Candidate List. The SIN List is specific organizations because they can
developed by ChemSec (International Chemical reach a broader group of companies.
Secretariat) in collaboration with scientists and
technical experts, as well as an NGO advisory In some cases, discussions and dialogue
committee of leading environmental, health
and consumer organizations. The list is based with industry might result in a voluntary
on publicly available information from existing commitment from industry to substitute a
databases and scientific studies, as well as hazardous substance with a less hazardous
new research. The SIN List is implemented in alternative substance or an alternative
procurement requirements all over the world.
Health, environmental and consumer NGOs technique. However, it is important to follow
are using the SIN List as a tool for prioritizing up on these discussions, to verify that any
individual chemicals or groups of chemicals as proposed actions are actually taken and
part of their campaigns for safer products and continue over time.
stronger chemicals regulations.
specific chemicals in products and articles chemical or product. Such information can
that users should be aware of – for example, enable/influence downstream users’ choice
when there is a need for proper handling of chemicals and encourage producers to
during the use and/or disposal of the substitute for less hazardous chemicals.
CHOOSING RISK
REDUCTION TOOLS
Factors to take into account in choosing the choice of instrument should be described
most appropriate risk reduction instrument in a way that can be easily understood by
may include the type of hazard and the both decision makers and stakeholders.
level of risk; actors using the chemical; Industry, downstream users, other
efficiency and sustainability over time; and authorities and NGOs should be invited to
the administrative burden and costs. contribute to the process. When it comes to CHAPTER
6
introducing safer alternatives, downstream
Decision-making normally begins with users can provide important perspectives.
collecting information about the problem, The recycling and waste sector is also an
identifying risk reduction goals, and important stakeholder, as reducing the use
choosing a risk reduction option. When of hazardous chemicals can facilitate waste
phase-out of a substance such as mercury management. In general, risk reduction tools
has been identified internationally, national are most effective if a range of stakeholders
efforts should focus on applying risk representing different groups within the
reduction measures. sector are involved in their development.
A clear process for involvement in the
National legislation must be clear about development of the legislation and adoption
the level at which a decision to reduce the of risk reduction measures – as well as
risks from chemicals should be taken. In transition periods before they take effect –
some cases, an agency or other authority facilitates compliance.
is mandated to make these decisions in
regulations, often referred to as secondary In developing approaches to risk reduction,
legislation; while in other cases, the decision it is essential to maximize transparency.
rests at the level of the legislature. For example, any assumptions involved in
developing a risk reduction measure must
The rationale behind the decision to be clearly specified.
introduce risk-reduction measures and the
Some basic assessment of the regulatory Many countries have a large informal sector
socioeconomic impact may be needed. It that uses and sells chemicals. In assessing
is often sufficient to identify the industry the need to regulate a chemical, it is
sectors that are likely to be affected by the important to assess its marketing and use in
ban or restriction. Effective communication both the informal and formal sector. When
with the relevant industries helps to a hazardous chemical is marketed or used
facilitate an assessment. If the chemical predominantly in the informal sector it may
has already been successfully banned or be difficult or impossible to control exposure
restricted in other parts of the world, making due to a lack of engineering controls,
use of information about other countries’ personal protective equipment and training
socioeconomic experiences can help save on correct handling. In this instance, bans
resources.lxi 10 and restrictions on supplying the chemical
may be suitable.
A transition period prior to entry into force
helps to ensure that stakeholders have time If the risk from a specific substance or group
to understand the requirements and come of substances is relatively low but the use
into compliance. still needs to be reduced, an economic
or informative instrument could be more
In choosing a risk reduction tool, it is appropriate – either on its own or combined
important to consider the administrative with other measures.
burden and costs over time for both the
government and the industry. Any country Hierarchy of Controls
introducing new legal requirements will
need to consider how the law will be The concept of a “hierarchy of controls” is
enforced. Any instruments that are chosen used frequently in the occupational health
require administrative capacity; and for and safety field. The hierarchy of controls
legal instruments, capacity for effective makes clear that the most effective way
enforcement is a prerequisite. For more to protect against harm from hazardous
information, see Enforcement of Chemicals chemicals is to eliminate chemicals of
Control Legislation: Guidance Document. concern. Substitution for a safer alternative
is the next most effective approach. The
The effectiveness of different risk reduction least effective approach, which should be
instruments needs to be compared and used when no other options are available,
evaluated in the national context. The is to rely on personal protective equipment
implementation of the GHS is a very (PPE). Adopting and implementing
effective measure for reducing the risks chemicals control legislation helps to make
from any hazardous substances handled in clear which chemicals need to be eliminated
the workplace and/or used by consumers. or substituted. It also ensures that accurate
For highly hazardous chemicals, bans or information flows through the supply chain
restrictions are often the appropriate tool. when there is a need for measures lower
Substitution for safer alternatives or methods down the hierarchy (engineering controls,
is then a high priority. In cases where there administrative controls and PPE). A diagram
are suspicions of severe adverse effects of the hierarchy of controls is shown below.
from a substance, but full scientific evidence
is lacking, precaution should be applied.
10 Regulatory Impact Analysis (RIA) is a systematic approach often used by OECD countries. For more information, see: OECD, Regulatory Impact
Analysis, www.oecd.org/gov/regulatory-policy/ria.htm. However, this approach can be administratively and technically challenging.
Source: US Center for Disease Control and Prevention (CDC), National Institute for
Occupational Safety and Health (NIOSH). 2016. “Hierarchy of Controls”. Viewed at
https://www.cdc.gov/niosh/topics/hierarchy/, February 2018.
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