kemikalieinspektionen.se

Guidance on national chemicals control

Risk reduction of chemicals

GU

IDAN

CE 2/18

The Swedish Chemicals Agency is supervisory authority under the Government. We work in Sweden, the EU and internationally to develop legislation and other incentives to promote good health and improved environment. We monitor compliance of applicable rules on chemical products, pesticides and substances in articles and carry out inspections. We review and authorise pesticides before they can be used. Our environmental quality objective is A Non-toxic Environment. © Swedish Chemicals Agency, 2018.

Article number: 511 293.

Preface Chemicals contribute in many ways to improving our standard of living, but some of them are hazardous and can have serious adverse effects on human health and the environment. It is therefore necessary to use different means to protect human health and the environment from adverse effects emanating from exposure to hazardous chemicals.

This Guidance, developed by the Swedish Chemicals Agency, is a complement to the UNEP Guidance on the Development of Legal and Institutional Infrastructures and Measures for Recovering Costs of National Administration (LIRA guidance). It supplements LIRA with further guidance related to risk reduction measures with regard to the control of chemicals placed on the market.

The Swedish Chemicals Agency has developed this Guidance document with the financial assistance of the Swedish International Development Cooperation Agency (Sida). The views herein shall not be taken to reflect the official opinion of Sida.

Content Preface............................................................................................................... 3

Content .............................................................................................................. 4

Summary ........................................................................................................... 6

Definitions and acronyms ................................................................................ 8

1. Introduction and scope ........................................................................ 9

2. Risk reduction of chemicals – a preventive approach .................... 11

3. Roles and responsibilities ................................................................. 12 3.1 The role of governments ............................................................................................... 14 3.2 The role of industry ....................................................................................................... 14

4. Risk reduction through general obligations on industry ................ 15 4.1 Dissemination of information in the supply chain .......................................................... 15 4.1.1 Implementation of GHS ................................................................................................. 18 4.2 General requirements on industry to assess and reduce risks ..................................... 18

5. Implementing international conventions and agreements .............. 20

6. Prioritisation of chemicals for introducing risk management measures by authorities .................................................................... 20

6.1 What substances should be prioritised? ....................................................................... 21 6.1.1 Prioritisation based solely on hazard ............................................................................ 21 6.1.2 Prioritisation based on potential risk ............................................................................. 22 6.2 Sources of information supporting prioritisation. ........................................................... 23

7. The role of the authority’s risk assessment ..................................... 24

8. Risk reduction instruments ............................................................... 25 8.1 Choice of instruments ................................................................................................... 26 8.1.1 Socio-economic considerations .................................................................................... 27 8.2 Administrative instruments ............................................................................................ 28 8.2.1 Classification and labelling and safety data sheets ...................................................... 28 8.2.2 Control of access to particularly hazardous chemicals and to chemicals posing

uncontrolled risks .......................................................................................................... 28 8.3 Economic policy instruments......................................................................................... 31 8.4 Informative instruments (and general information) ....................................................... 32 8.4.1 Broad awareness raising ............................................................................................... 33 8.4.2 Information from authorities aimed at solving a specific problem ................................. 35

9. Decision making ................................................................................. 37

Annex 1 – International Conventions and agreements ............................... 39 1. Strategic approach to International Chemicals Management ....................................... 39

2. Stockholm Convention .................................................................................................. 40 3. Rotterdam Convention .................................................................................................. 40 4. Minamata Convention ................................................................................................... 40 5. The Globally Harmonized System of Classification and Labelling of Chemicals -

GHS ............................................................................................................................... 41 6. The 2030 Agenda for Sustainable Development and the Sustainable Development

Goals ............................................................................................................................. 41

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Summary The aim of the present document is to give guidance to countries (governments and authorities) in their efforts to set up an efficient system for the sound management of chemicals with a special focus on legal and voluntary tools for risk reduction of chemical substances on their own or when used in mixtures or in articles.

The guidance focuses on preventive chemicals control, which means measures directed towards the placing of chemicals on the market. The risk management of chemicals covered here makes use of information on the properties of chemicals at an early point in their life cycle and thus contributes to preventing exposure to chemicals with adverse effects. Choosing a preventive approach saves not only human and natural resources, but will also often have financial benefits because the costs for preventing pollution are considerably less than the costs for remediation of a contaminated environment.

An important part of preventive chemicals control is to make chemicals risk management an integrated and natural part of the daily work within industry, including all companies that handle chemicals. It is central to develop legislation that allocates responsibilities to producers, importers, and users. The starting point is to ensure that information on the contents of the chemical substances and mixtures that are placed on the market is disseminated in the supply chain by those who place the substances and mixtures on the market. A fundamental means to provide for the dissemination of information needed for informed choices and safe handling to all actors in the supply chain is to make the requirements for classification and labelling according to the Globally Harmonized System (GHS) mandatory. Obligations placed on a few upstream actors will provide many downstream actors with the information they need to assess risks, make informed choices, and provide for safe handling. There could also be legal requirements for industry to perform risk assessments and to apply any risk-management measures needed to control the risk.

In some cases, general requirements in the legislation, including disseminating information according to GHS and taking necessary action as required, are not sufficient to handle specific chemicals due to the potential risks they pose. It will then be necessary for authorities to introduce measures towards those substances or groups of substances. Some measures are taken at the international level through international conventions and agreements. The implementation of international conventions and agreements, that the country is a party to, is a matter of high priority.

Besides the implementation of decisions taken internationally, there is a need to consider the prioritisation of chemicals that might be of concern on a national level and for which risk-management measures might be necessary. A systematic approach would build on the prioritisation of substances that, due to their known or assumed hazards and/or use patterns, are likely to give rise to risks that need to be eliminated or at least reduced to an acceptable level. For substances with inherent properties giving rise to very severe or irreversible effects, it can be sufficient to base a decision for risk reduction on the hazard assessment. This could, for example, be the case for substances that are persistent, bio-accumulating, and toxic (PBT) or that are very persistent and very bio-accumulating (vPvB), carcinogenic, mutagenic, or toxic to reproduction that meet the criteria for CMR category 1A or 1B according to the GHS (especially those without a non-threshold for effects), or that give rise to other severe and irreversible health effects.

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For other chemicals than those mentioned above, when considering the need for restricting or banning the use of such a chemical a risk assessment should normally be carried out. For such a risk assessment, it is necessary to have information both on the hazard of the substance (the inherent properties) and the potential exposure to the substance in the country because risk is a function of hazard and exposure.

When analysing the need for further risk reduction, much support for the selection of substances can be drawn from actions taken and priorities set in other countries. The hazard assessment of a specific substance does not need to be repeated because the inherent properties are always the same. There might, however, be a need to assess the national exposure to the substance because this might vary from country to country. The exposure parameter needs to be based on the available data, and the simplest method is to base it on the volume of the substance on the market. Not having detailed exposure data should not prevent authorities from making an estimate of the likelihood that the occurrence of the substance on the market might entail risks to the environment or to human health.

Precaution should be applied in risk management when there are threats of serious or irreversible damage to human health or the environment, which is in line with the Precautionary principle from the 1992 Rio Declaration. In this situation, the lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent damage.

When the result of a risk assessment shows that measures already taken by industry are not enough to reduce the risk and there is a need to further reduce the exposure to a chemical in the environment and in humans, it is necessary for the government and/or its authorities to introduce one or more risk reduction measures. There are a number of different instruments that can be used. Administrative risk reduction instruments cover bans and restrictions, authorisations, premarket approval systems, and the obligation to classify and label chemicals and to supply safety data sheets. Economic policy instruments include fees and taxes. Examples of informative instruments are targeted information on a specific problem, ecolabelling, dialogues with industry, voluntary commitments as well as tools for substitution and public procurement.

Which instrument to choose depends on the risks that need to be tackled and on the specific situation in individual cases. When the hazard is high, as mentioned above, measures might be taken without performing a full risk assessment. In such cases, the preferred risk reduction measure many times can be a total ban. Also, in other cases in which the risk from the chemicals is high, administrative risk reduction instruments might be the most appropriate. Economic instruments could be used e.g. for moderately hazardous substances where there is a need for a reduction in the use, but not a total phase-out, and the government wants to use market forces to find the areas where the reduction could be made with the lowest cost. An informative instrument is less compulsory than other types of risk reduction measures and aims to achieve a voluntary reduction of the use of a specific substance or group of substances. Informative instruments can be used as stand-alone measures if the risk from a specific substance or group of substances is comparably low but still needs to be reduced. When developing new legislation, a clear process – including possibilities for companies to engage in the process – makes it easier for companies to comply with the legislation. It is important that all requirements are fully understandable by the affected companies as well as by the enforcement authorities. Decisions regarding risk management usually have to be taken in several steps, and for each step it needs to be defined at what level and by whom a decision can be taken, and the legislation needs to give clear mandates to these decision-makers.

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Definitions and acronyms Chemical products are usually defined and understood as chemical substances and mixtures of chemical substances.

GHS uses the following definitions: Substance means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities derived from the process used, but excluding any solvent, which may be separated without affecting the stability of the substance or changing its composition

Mixture means a mixture or solution composed of two or more substances in which they do not react

Many chemical products are incorporated in finished products, or articles, during the production phase. Examples could be painted and lacquered furniture, polymers and metals in electric and electronic products, dyes in textiles, flame retardants and plasticizers in plastics etc. Articles may pose a risk due to their chemical contents. In some countries specific substances have been regulated in specific groups of articles, but in general they are to a large extent unregulated with regards to their chemical contents.

The following definition is used in the EU Reach regulation: Article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.

Acronym Explanation

CLP EU Regulation on Classification and Labelling of Substances and Mixtures (No. 1272/2008)

CMR Carcinogenic, Mutagenic and Toxic to the Reproductive system

ECHA European Chemicals Agency

EU European Union

GHS Globally Harmonized System of Classification and Labelling of Chemicals

ICCM International Conference on Chemicals Management (of SAICM)

IOMC The Inter-Organization Programme for the Sound Management of Chemicals

OECD Organisation for Economic Co-operation and Development

PBT Persistent, Bioaccumulative and Toxic

REACH EU Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (No. 1907/2006)

SAICM Strategic Approach to International Chemicals Management

SDS Safety Data Sheet

SVHC Substances of Very High Concern

UNEP United Nations Environment Programme

WHO World Health Organisation

vPvB very Persistent and very Bioaccumulative

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1. Introduction and scope Chemicals form an important part of our daily life, but they may also pose risks to health and environment depending on their intrinsic hazardous properties and how they are used. Hazardous chemicals can be present in products that are sold to professional users and to private consumers for use in everyday life. The use and subsequent dispersal of hazardous substances can jeopardise the long-term utilisation of land and water resources and make groundwater and fish, for example, unfit for human consumption. This in turn can have an adverse impact on the development of countries. People are exposed to chemicals at work, in their homes, and indirectly through the environment, which can lead to deaths or acute or long-term effects on health. Measures are taken to reduce such exposure in many countries, but there are wide differences today in the capacity of the world's countries to manage chemicals safely.

Generally, poor people are exposed significantly more often than others to hazardous substances. It is particularly serious when foetuses and children are exposed, as this can affect their development and in many ways impair their prospects in life. Control over chemicals and their use saves lives and is needed in order to achieve sustainable development.

During the last decades, international cooperation with the aim of improving the sound management of chemicals globally has taken place. This cooperation has resulted in some international conventions to eliminate or reduce the use of the most hazardous chemicals, including the Stockholm Convention on Persistent Organic Pollutants and the Minamata Convention on Mercury. The Strategic Approach to International Chemicals Management (SAICM), an international, non-legally binding agreement, is a policy framework to foster the sound management of chemicals. SAICM was developed by a multi-stakeholder and multi-sectoral Preparatory Committee and supports the achievement of the goal agreed upon at the 2002 Johannesburg World Summit on Sustainable Development through its overall objective:

Substance Mixture Article

For example, citric acid or pentachlorophenol

For example, a can containing paint

For example, a mobile phone or a T-shirt

Figure 1. A substance can be used as such, in a mixture or in an article.

The aim of the present document is to give guidance to countries (governments and authorities) in their efforts to set up an efficient system for the sound management of chemicals with special focus on legal and voluntary tools for risk reduction of chemicals.

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Thereby the guidance supports work in relation to SAICM for meeting the 20201 goal. The guidance is complementary to the UNEP LIRA guidance2 and adds to the IOMC Toolbox3.

A legal framework that defines roles and responsibilities for both industry and the government is a fundamental starting point and is a cornerstone for the sound management of chemicals and for achieving sustainable development.4 5

This guidance focuses on the control of chemical substances and mixtures as well as articles that contain chemicals when they are placed on the market. Placing chemicals on the market includes the production and import of chemicals and making them available to third parties for use in the supply chain, including use by the general public. It focuses on examples of different risk reduction measures and instruments – legal as well as voluntary – that might be introduced to reduce the risks from hazardous chemicals. Specific legislation on occupational health, industrial accidents, emissions from production, and waste also contributes to the overall risk reduction of chemicals, but this will only be mentioned briefly in this document. The document will not focus on types of chemicals that are normally covered by sector-specific legislation such as pesticides6, pharmaceuticals, and food additives.

Figure 2. Exposure to chemicals may occur through emissions from facilities to air and water. Workers may be exposed at the work place. These areas are normally covered by specific legislation on occupational health and emissions from production. Exposure can also occur from the products produced in or imported to a country. This guidance focus on substances placed on the market as such or used in mixtures or articles.

1 http://www.saicm.org/StrategicApproach/Towardsnbsp2020/tabid/5499/language/en-US/Default.aspx 2 UNEP Guidance On the Development of Legal and Institutional Infrastructures and Measures for Recovering Costs of National Administration for Sound Management of Chemicals (LIRA) https://www.unenvironment.org/resources/report/lira-guidance 3 The Inter-Organization Programme for the Sound Management of Chemicals, http://www.oecd.org/chemicalsafety/news-iomc-online-toolbox-may-2015.htm 4 UNEP Guidance On the Development of Legal and Institutional Infrastructures and Measures for Recovering Costs of National Administration for Sound Management of Chemicals (LIRA). See footnote 2. 5 See Swedish Chemicals Agency Guidance on Legislation for chemicals management (to be published) 6 See Swedish Chemicals Agency Guidance on Practical guidance on hazard assessment, risk assessment, and risk management of pesticides (to be published)

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Some important international goals and strategies for the sound management of chemicals

2020 goal In 2002, at the UN World Summit on Sustainable Development in Johannesburg, governments and all other relevant organisations agreed to renew as advanced in Agenda 21, to sound management of chemicals throughout their life cycle and of hazardous wastes for sustainable development as well as for the protection of human health and the environment, inter alia, “aiming to achieve, by 2020, that chemicals are used and produced in ways that lead to the minimization of significant adverse effects on human health and the environment”7.

Strategic Approach to International Chemicals Management, SAICM SAICM is a multiple stakeholder and multi-sectoral policy framework adopted in 2006 by the first International Conference on Chemicals Management, ICCM, to achieve the 2020 goal8.

Overall Orientation and Guidance for Achieving the 2020 Goal, OOG In order to define sound management of chemicals in concrete elements, the fourth ICCM in 2015 as a part of SAICM endorsed the OOG, with six core activity areas and 11 basic elements recognised as critical to attaining sound management of chemicals and waste. These include legal and institutional frameworks, industry participation and defined responsibilities across the product life cycle, and cost recovery policies and systems9. See also Annex 1.1 for the full text.

Sustainable Development Goals, SDGs Seventeen Sustainable Development Goals and 169 associated targets were adopted by the Heads of State and Government and High Representatives meeting at the United Nations Headquarters in 2015. Target 12.4 in principle reflects the 2020 goal: “By 2020, achieve the environmentally sound management of chemicals and all wastes throughout their life cycle, in accordance with agreed international frameworks, and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment”10.

2. Risk reduction of chemicals – a preventive approach

As described above, chemicals can have serious adverse effects on human health and the environment, which affects people’s quality of life and can lead to substantial costs for society. The reason/rationale for applying risk reduction measures is to protect human health and the environment from the adverse effects of hazardous chemicals as well as to gain financially because natural resources will be preserved and remain useable in the long run and because there will be reduced costs for health care. In addition, trade is promoted because a clear and consistent legal system for managing risks from chemicals allows countries to trust products from another country, and greater trade generates greater profits.

7 Johannesburg Plan of Implementation http://www.un-documents.net/jburgpln.htm) 8 See SAICM website. http://www.saicm.org/ 9 http://www.saicm.org/Portals/12/Documents/OOG%20document%20English.pdf 10 http://www.un.org/sustainabledevelopment/; http://www.un.org/sustainabledevelopment/sustainable-development-goals/

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While risk assessment to a large extent is based on science, subsequent risk-management measures are frequently influenced or steered by political considerations. Risk management is a decision making process that involves political, social, economic and technical factors as well as a relevant risk assessment 11.

The risk management of chemicals covered here makes use of information on the properties of chemicals at an early point in the life cycle of the chemicals and thus it contributes to preventing exposure to chemicals with adverse effects. Traditionally, pollution control often takes place as an end-of-pipe activity, but preventing pollution at the beginning of the supply chain offers an opportunity to achieve additional environmental and health benefits. The sooner action is taken to reduce adverse effects from chemicals, the cheaper it will be for society as well for industry because taking early action is much less complicated than to direct measures towards widespread uses. Choosing a preventive approach saves not only human and natural resources, but will also often have financial benefits.

For the vast majority of chemicals, it is sufficient to place general obligations on the actors in the supply chain to communicate and make use of the information conveyed in accordance with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), while for a number of chemicals more stringent risk reduction measures are needed.

Adopting a clear and transparent national chemicals policy supports the work of the government as well as that of industry and other stakeholders. Such a policy will contribute to clear and transparent information on what measures might be taken for chemicals and thus give industry guidance on what types of substances not to choose for production and use. In combination with relevant legislation, this will contribute to a level playing field for industry.

3. Roles and responsibilities To provide for the sound management of chemicals, national legislation is necessary. In the legislation there will be a number of tasks defined that someone needs to carry out. It is, therefore, important that the legislation clarifies the division of responsibilities between trade and industry on the one hand and the national administration on the other hand.

It is reasonable that the main responsibilities for managing risks with chemicals placed on the market should lie with the chemical producers and importers for the risks that might emerge from the chemicals they produce and import. It is, therefore, central to develop legislation that allocates responsibilities to companies in order to internalise most of the costs of chemicals management.

The approach to clearly identify the roles and responsibilities of different stakeholders, including governments and industry, is covered by six core activities and 11 basic elements as elaborated in the OOG (see full text in annex 2.1), which aims to identify approaches for all of SAICM’s stakeholders towards the achievement of the overall 2020 goal, including some

11 WHO: Terminology from the International Programme on Chemical Safety, WHO

”Prevention is better than cure” Bernardino Rammazzini (1633-1714)

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concrete elements to support the implementation of the Overarching Policy Strategy12 of SAICM.

The role of governments is to make industry assume their responsibility by issuing relevant legislation and recommendations as well as carrying out enforcement of the legislation, including, when necessary, banning or restricting the use of certain chemicals.

Table 1. Division of chemicals management activities relating to placement of chemicals on the market between producers/importers, downstream users, and national administrations. Examples of tasks are given.

Companies producing or importing chemicals

Downstream users of chemicals

National administration related to chemicals placed on the market

Adjusting production and/or importation to comply with bans and restrictions Gathering data on hazards Pre-marketing testing (if data are not already available) Assessing risks and take measures to reduce risk if necessary Updating the information base when required Classifying and labelling according to relevant legislation, preferably GHS Transferring of safety information in the supply chain, including labelling and safety data sheets Reporting according to existing obligations, for example, to the national chemicals registry or notifying the production or import

Adjusting the use and production to comply with bans and restrictions Taking into account the received and otherwise obtained information on hazards and safety measures of supplied chemicals when deciding which chemicals to use and how they will be used Transferring safety information in the supply chain for the whole life cycle of the chemical, including labelling and safety data sheets for chemical mixtures Reporting according to existing obligations, for example, to the national chemicals registry or notifying the production or import

Obtaining and keeping information on chemical producers/importers Requiring information on chemicals produced/used in the country Prioritising substances and assessing information from industry and other sources about the hazards and risks of those substances Issuing regulations, and guidelines, including:

a) legal requirements on classification and labelling

b) bans and restrictions on certain hazardous substances

c) authorizations of chemicals of high concern, e.g. pesticides Enforcing the legal requirements and taking measures to ensure compliance Having dialogues with industry Providing general information to various stakeholders in society Participating in international and regional communication and co-operation Co-operating with other authorities Charging fees for services provided

12 The Overarching Policy Strategy is one important part of SAICM http://www.saicm.org/About/SAICMOverview/tabid/5522/language/en-US/Default.aspx

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3.1 The role of governments The role of governments is to make industry, i.e. producers and importers, as well as downstream users, assume responsibility for the products they place on the market by issuing relevant legislation and recommendations as well as carrying out enforcement of such legislation. It is, therefore, central to develop legislation that allocates responsibilities to producers, importers, and users for ensuring informed choices and safe handling of chemicals.

It is estimated that more than 100,000 chemicals are available on the market13, but the number used in significant volumes are much fewer. The number of registered substances in the REACH system in volumes over one tonne/year was 21 551 at 31 May 2018, which was the final date of the 10-year period for registration of phase-in substances manufactured in and imported to the EU-market in such volumes.

Many of the substances used today have hazardous properties to a greater or a lesser degree and they are used in many different ways. It is not possible to have detailed legislation on the use of each and every one of these chemicals. General provisions laying responsibility on industry are therefore necessary.

For chemicals where unacceptable risks to human health or the environment might occur despite this general obligation, the government should be able to introduce bans, restrictions, and other risk-reducing measures. The government should, in order to be resource efficient, focus its regulatory work on chemicals posing the greatest risks.

Thus, the legislator should:

· Adopt a legislative framework clarifying the roles and responsibilities of government and authorities as well as those of industry.

· Adopt detailed legislation supporting the sound management of chemicals, e.g. how to implement GHS14.

· Introduce bans, restrictions, and other risk reduction measures for substances posing risks that are not adequately controlled by industry.

· Supervise and enforce the compliance of legislation.

3.2 The role of industry All actors in the supply chain shall apply relevant risk-management activities for the chemicals they produce, import, place on the market, and use. Hence, the main responsibilities for managing risks with chemicals placed on the market should lie with industry, i.e. producers and importers of chemicals, as well as with users for the risks that could emerge from the chemicals they produce, import, or use. They are the ones who develop and/or use the actual substance and should therefore be responsible for having the necessary knowledge. To achieve this, it is necessary to define clear roles and responsibilities for industry, including that industry shall always carry the responsibility for its products. Such basic requirements (should) include:

· To gather knowledge, and if necessary generate new knowledge on chemicals’ properties, hazards, and risks.

13 The Classification and Labelling Inventory at ECHA contained at the beginning of 2018 more than 135,000 substances. These include all substances subject to registration under REACH as well as all substances placed on the market that are classified as hazardous. https://echa.europa.eu/regulations/clp/cl-inventory 14 The Globally Harmonized System for Classification and Labelling. See chapter 4 and appendix 1 for further details.

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· To classify and label their chemicals in accordance with GHS15. · To disseminate information on hazardous properties of chemicals and on safe

handling procedures as well as to provide safety data sheets to professional users.

· To supply additional information about the products, when necessary, in order to enable and facilitate the best choice of products for downstream users and to ensure their safe handling of the products.

· To take necessary actions following the classification. · To make informed choices about chemicals in order to avoid hazards. · To substitute hazardous chemicals for less hazardous ones or to apply an

alternative technique when possible (the substitution principle)16 17 18. · To organise and assure the safe use of chemicals and their storage, transport,

and appropriate disposal. · Depending on which part in the supply chain a company operates,

responsibilities differ. The main obligations fall on the primary producers, while downstream users should choose the safest chemical for their purpose and should use the chemical in a safe way.

4. Risk reduction through general obligations on industry

Chemicals risk management should be an integrated and natural part of the daily work within industry, including all companies that handle chemicals. As mentioned above, it is central to develop legislation that allocates responsibilities to producers, importers, and users. The starting point is to ensure that information on the contents of the chemical substances and mixtures that are placed on the market is disseminated in the supply chain by those who place the substances and mixtures on the market. This enables all actors who receive the information to assess risks, make informed choices, and provide for safe handling. There could also be legal requirements on the role of industry on performing risk assessments and on applying the risk management measures needed to control the risk.

4.1 Dissemination of information in the supply chain A fundamental means to provide for the dissemination of information needed for informed choices and safe handling to all actors in the supply chain is to make the requirements for classification and labelling according to GHS mandatory. Furthermore, this system supports the use of standardised safety data sheets, which are a valuable source of information on the properties of chemicals and how to handle them.

The anticipated role of GHS is that knowledge on hazards and necessary precautions shall be gathered and conveyed by the chemicals producers and importers that are the primary actors 15 The Globally Harmonized System for Classification and Labelling. See chapter 4 for further details. 16 ECHA Strategy to promote substitution to safer chemicals through innovation January 2018; https://echa.europa.eu/documents/10162/13630/250118_substitution_strategy_en.pdf/bce91d57-9dfc-2a46-4afd-5998dbb88500; Substituting hazardous chemicals (ECHA website). https://echa.europa.eu/regulations/substituting-hazardous-chemicals 17 “The American way”, interview at ECHA website. https://echa.europa.eu/regulations/substituting-hazardous-chemicals/examples-from-real-life/the-american-way 18 OECD Substitution and Alternatives Assessment Toolbox. http://www.oecdsaatoolbox.org/

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making chemicals available for use along the supply chains. Producers of mixtures need to classify and label their products, based on the information that they receive from their suppliers. The information should follow the chemicals down the supply chain, see figure 2. Obligations placed on a few upstream actors will provide many downstream actors with the information they need to make safe choices and to handle chemicals safely.

Figure 3. Flow of information down the supply chain. The size of the block illustrates the number of companies in a schematic way.

As an example, the EU legislation implementing GHS, the CLP Regulation19 20, aims to ensure that the hazardous properties of chemicals are identified and clearly communicated to users through labelling (all users) and safety data sheets (professional users). The obligation to classify chemicals before making them available on the market is put on producers and importers of substances and mixtures.

The obligation for producers and importers to classify and label chemicals, as set out in GHS, is the primary means for handling the vast majority of chemicals and their accompanying risks. GHS gives information, via the labels and the safety data sheets, on the properties of the chemicals and how to handle them in a safe way. GHS should thus be considered as a cornerstone for risk reduction measures. The GHS pictograms are shown in figure 3.

19 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on Classification, Labelling and Packaging Of Substances And Mixtures. 20 Requirements for safety data sheets are implemented through the REACH regulation.

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Figure 4. Pictograms to be used when a substance or a mixture fulfils the criteria for different hazards as defined in GHS.

As mentioned, GHS also includes harmonised criteria for mixtures, but the system is not directly aimed for use with articles. Information on the occurrence of specific substances in an article can, however, be based on the classification of the substances according to GHS, e.g. this article might contain a substance that is a skin sensitizer. Within the framework of SAICM, a voluntary information system for Chemicals in Products (CiP) has been developed21.

The CiP system is used by companies to give information to downstream users, including final customers, on the content of specific chemicals in products and articles. An obligation for information on the presence of chemicals in articles could primarily address substances that are specifically important to be aware of, i.e. those with specific hazardous properties, and when there is a need to pay specific attention to how to handle the article during the use phase or when it becomes waste. This should be done in order not to contaminate the environment or to create a health risk for the consumer. Such information enables downstream users to influence the choice of chemicals and can force the producers to find substitutes for the most hazardous chemicals. This is also important for creating a circular economy22 where resources can be recycled in a safe way.

The merits behind focusing the law and consequently enforcement activities at the primary level would be:

· Relatively few producers and importers compared to retailers and users · Producers and importers generally have a better knowledge on their respective

products (and the contents) than their clients · Product information (label/SDS) should be produced by producers and

importers and distributed to retailers and users

21 http://www.saicm.org/EmergingPolicyIssues/Chemicalsnbsp;innbsp;Products/tabid/5473/language/en-US/Default.aspx 22 A circular economy is an economy where the value of products, materials and resources is maintained in the economy for as long as possible, and the generation of waste minimised. Definition from COM(2015) 614 final, Communication From The Commission To The European Parliament, The Council, The European Economic And Social Committee And The Committee Of The Regions -Closing the loop - An EU action plan for the Circular Economy

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4.1.1 Implementation of GHS GHS can be implemented in a couple of ways. It can be included in legislation as it is and with all details of criteria and all other technical details included or with some adaptations in accordance with the “Building block principle” as defined in the system. In such a case it is important to realise that the system is updated every second year and it is therefore necessary to be able to keep the legislation up to date in a quick and uncomplicated manner. Some countries have chosen another way to implement the system, such as through a general text in the legislation about the obligation to apply it and in addition referring to a national standard or the UN publication as such. This might be a better way of implementation if updating legislation according to the national legislative process and tradition is complicated and time-consuming and perhaps needs to be brought to the parliament for adoption.

When introducing GHS, it is not only necessary to provide an ample transitional period in order for industry to learn how the system works and to have time to implement it, but it is also advisable to have a later entry-into-force date for mixtures than for substances. Those who are obliged to classify and label mixtures need to have access to the classifications of all substances that are ingredients in the mixture in order to be able to classify the mixture. If they purchase the components of the mixture they produce, they need to get the information on the properties of the substances before they are able to classify their mixtures. This means that there needs to be quite a long time between the two entry-into-force dates in order for those who have to classify mixtures to get access to all the necessary data. As an example the EU CLP regulation implementing GHS required that all substances were classified and labelled according to the new system by 1 December 2010 and all mixtures by 1 June 2015. A similar adaptation time was used in Indonesia where GHS criteria had to be used for substances by 24 March 2010 and for mixtures by 31 December 2016.

Countries could also consider the need for a list of harmonised classifications of a number of substances. Such a list could contain the most hazardous chemicals and/or the most commonly used substances, if they are hazardous. Such classifications should then be obligatory for all companies that are placing them on the market. Because hazards depend on the intrinsic properties of a chemical and hence are always the same, official/harmonised classifications using the GHS criteria from other countries or regions could preferably be used as a starting point. These are normally peer-reviewed by expert groups and thus can be considered reliable. The advantages of having such a list are that it ensures that the whole market is using the same classification for the same substance and it facilitates small and medium-sized enterprises giving correct information to their downstream users. International trade is also facilitated by using the same official classification as in other countries or regions, which is an advantage for the national exporting industry. It is of course necessary to make sure that the list is updated regularly and kept up to date. One disadvantage with a national list is thus that additional administrative tasks will be put upon the government and thus draw from the normally scarce resources in the chemicals area of the country. Using other countries’ official lists will reduce such disadvantages.

4.2 General requirements on industry to assess and reduce risks The chemicals legislation could require producers or importers to perform risk assessments for the substances they produce or import and to take necessary measures to ascertain that the chemicals can be used in an acceptable way. If at some stage of the chemical’s life cycle the

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risk assessment shows that there is a risk23, companies could be required to apply necessary risk-management measures to control the risk and to supply relevant safety information to downstream users based on the assessment that has been carried out.

Furthermore, GHS provides information that is supportive and valuable for complying with legislation that might already exist in areas such as occupational health, industrial emissions, preventing industrial accidents, and handling hazardous waste, see figure 5. The regulation of the transport of hazardous chemicals uses the same symbols for the same type of hazard, but the transport sector also has the need for further pictograms and the final pictograms differ in colour.

Figure 5. Classification and labelling of substances and mixtures provides safety information to support other legislation areas. Sometimes, legislation in these areas can explicitly refer to relevant GHS criteria, and if so it needs to be regularly updated in line with the GHS amendments. Legislation can also address specific substances (see chapter 8). However, in most cases, the legislation on emissions and

23 Swedish Chemicals Agency, Guidance on Hazard Assessment and Risk Assessment of Chemicals – an introduction, (to be published)

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the legislation concerning workers’ protection are not so detailed in relation to single chemicals but use parameters that are more general. In any case, making use of the information provided by GHS as far as possible is advisable because this facilitates and supports the managing of chemicals and the fulfilment of the obligations for industry in various pieces of legislation either on a specific or on a more general level.

5. Implementing international conventions and agreements

During the last decades, international cooperation in restricting or banning the production and use of the most hazardous chemicals has taken place, and for a small number of substances that are transported across international boundaries, international conventions on how to handle such chemicals have been developed. For countries that have signed and ratified24 conventions, it is an obligation to implement the agreed-upon decisions in their legislation. It has to be taken into account that even if the first, basic requirements have been implemented, the legislation might need to be continuously updated due to progress that is made and new decisions that are taken as part of the convention. The implementation needs to be carried out in a manner that is coherent with the aim of the agreement, such as introducing bans or restrictions on the production and use of a specific chemical, as well as coherent with each country’s own constitution, legal framework, and tradition. Examples of such international agreements are the Stockholm Convention on Persistent Organic Pollutants, the Minamata Convention on Mercury, and the Montreal Protocol on Substances that Deplete the Ozone Layer. For more information, see annex 1.

6. Prioritisation of chemicals for introducing risk management measures by authorities

In addition to the obligations of implementing a convention following its ratification, it is necessary for a country to consider the need for introducing further risk reduction measures for other chemicals not covered by the conventions but that nevertheless pose risks to human health or the environment on the national level.

As pointed out above, it is essential that basic legislation requires industry to take responsibility for the chemicals they produce, import, and use in order to reduce the risks to human health or the environment. However, in case such requirements in the legislation, including disseminating information according to GHS (see chapter 4) and taking necessary action as required, are not sufficient to handle specific chemicals due to the potential risks emanating from them, it will be necessary for authorities to introduce measures towards those substances or groups of substances. These substances might be identified through actual cases of pollution and poisoning, but it is advisable to try to identify potentially problematic chemicals before any harm has occurred. A systematic approach would build on the prioritization of substances that, due to their known or assumed hazards and/or use patterns, are likely to give rise to risks that need to be eliminated or at least reduced to an acceptable level.

24 Ratification means signing or giving formal consent to a treaty, contract, or agreement making it formally valid. In many countries, this requires the adoption of a legal act by the parliament.

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Adopting a national chemicals policy pointing to the types of substances that should be prioritised for action could support the subsequent legislative work of the government. Such a policy contributes to transparency, clarity, and certainty for industry and thus makes it clear what kinds of substances are likely to be banned or restricted in order to reduce risks. A policy could be based on the classification criteria in GHS, as far as is possible, and possibly in combination with other priority criteria and factors. This means that chemicals meeting chosen specific criteria could be subject to, or be candidates for, certain risk-management measures.

6.1 What substances should be prioritised?

6.1.1 Prioritisation based solely on hazard For substances with inherent properties giving rise to very severe or irreversible effects, it can be sufficient to base a decision for risk reduction on the hazard assessment. This could be, for example, the case for substances that are:

· persistent, bio-accumulating, and toxic (PBT) or very persistent and very bio-accumulating (vPvB),

· carcinogenic, mutagenic, or toxic to reproduction meeting the criteria for CMR category 1A or 1B (especially those without a non-threshold for effects) according to GHS, or

· giving rise to other severe and irreversible health effects.

Such an approach is in line with the SAICM objectives for risk reduction in its Overarching Policy Strategy which states that chemicals or chemical uses that pose an unreasonable or otherwise unmanageable risk to human health and the environment based on a science-based risk assessment and taking into account the costs and benefits as well as the availability of safer substitutes and their efficacy should no longer be produced or used. Examples of groups of chemicals, mentioned by SAICM, that might be prioritised for such assessment are PBTs; vPvBs, chemicals that are carcinogens and mutagens or that adversely affect, among other things, the reproductive, endocrine, or nervous system; mercury; and other chemicals of global concern.

Substances that are vPvB accumulate in the environment and are resistant to degradation. The levels might therefore increase in biota over time however small the emissions are. Experience has also shown that quite a few substances with such properties have later, when more scientific data have become available, turned out to be toxic, but at such a point it is impossible to eliminate the substance from the environment and reduce the risk associated with it. Substances that are carcinogenic, mutagenic, or toxic to reproduction are another group that might be prioritised only based on hazard because these have very severe effects and it cannot be presupposed that all possible users can handle these substances safely enough to protect themselves and others from being exposed.

As an example, the EU REACH legislation defines chemicals that have inherently very severe and/or irreversible properties. These are chemicals meeting the criteria for CMR category 1A or 1B according to GHS and includes chemicals that are PBTs or vPvBs25 and those that due to other severe and irreversible health effects give rise to an equivalent level of concern, as

25 Defined in the REACH legislation because GHS lacks criteria for persistence and bioaccumulation

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substances of very high concern (SVHC). The substances identified according to these criteria are published on the so-called Candidate list26. This list contains substances that are candidates for authorisation (substance and company specific) for use within the EU. If authorisation is not granted for the use of a substance, its use will prohibited.

The way that the ECHA PBT Expert group explains the concerns of the PBT/vPvB substances is: “Substances that persist for long periods of time in the environment and have a high potential to accumulate in biota are of specific concern since their long-term effects are rarely predictable. After entering the environment once, the exposure to these substances is very difficult to reverse by the cessation of emission. Protection of pristine remote areas from PBT/vPvB substances is particularly difficult as these substances do not degrade near emission sources but may be gradually transported into remote areas. For PBT/vPvB substances a "safe" concentration in the environment cannot be established using the methods currently available. A particular concern with vPvB substances is that even if no adverse effects can be demonstrated in laboratory testing, long-term effects might be possible since high but unpredictable levels may be reached in humans or the environment over extended time periods”27.

6.1.2 Prioritisation based on potential risk Even if a general obligation is put on industry to act upon its own risk assessments, there are cases where the authorities need to prioritise substances that are assessed by industry for possible further action. This is, for example, necessary if there are a great number of producers and importers and/or users because it is not reasonable for a single company to assess and consider the total exposure from all different sources. In some instances, it might also be necessary to consider restricting a group of substances when the structures of the different substances in the group are very similar to each other and one can expect that the mode of action and the end-point for effects will be the same. As in the previous case, such consideration needs to be taken by the authorities because the substances might be produced and imported by many different companies.

For other chemicals than those covered by 6.1.1, and when considering the need for restricting or banning the use of a chemical, a risk assessment should normally be carried out. When performing a risk assessment, it is necessary to have information both on the hazard of the substance (the inherent properties) and the potential exposure to the substance in the country because risk is a function of hazard and exposure. These parameters therefore also form the basis for the prioritisation.

In some cases, a country might have national experience that a substance has given rise to, or is suspected to give rise to, adverse effects in humans or pollution of the environment. In other cases, data on the occurrence of the substance in the country are well known and give rise to concern due to the chemical’s inherent properties.

In all these cases, the following information should be taken into account when setting the priorities:

· Degree of severe inherent properties · Exposure

• Volume of the substance produced and/or used, including import as a proxy for potential exposure, and/or

26 See ECHA website: https://echa.europa.eu/candidate-list-table 27 https://echa.europa.eu/pbt-expert-group

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• Use pattern (e.g. whether the product is likely to be used by a vulnerable part of the population such as children, pregnant women, illiterate persons, etc.), and/or

• Wide-spread and/or well-known exposure from, for example, monitoring studies or surveillance projects (this includes if there is a large number of producers and/or users or if the chemical is available to the general public)

The exposure parameter needs to be based on available data, and the simplest method is to base it on the volume of the substance on the market. If more refined data exist, this information should be added or used instead. Not having detailed exposure data should not prevent authorities from making an estimate of the likelihood that the occurrence of the substance on the market might entail risks to the environment or human health.

Prioritisation is normally a stepwise procedure. A broader group of substance might be prioritised based on basic information. For these, more refined data are searched for, and when more detailed data become available the prioritisation is gradually improved to finally target the substances with the greatest potential risks.

6.2 Sources of information supporting prioritisation. When analysing the need for restricting chemicals, much support for the selection of substances can be drawn from actions taken and priorities set in other countries. Thus experiences from other countries’ work and decisions in the area of restricting the production and use of specific chemicals can serve as a gateway or a reason for authorities in the country to look into the need to take action in the national arena. Taking advantage as far as possible, not only of other countries’ prioritisations, but also assessments of chemicals prioritised for action, is valuable and resource saving. Not only is information on the risk reduction measures in force, and the background to them, made available on websites etc. by countries or organisations, but there is also information on priorities, considerations, and proposals for further measures linked to specific substances. Such information will be useful for countries that need to decide how to proceed in reducing the risks from different substances.

The assessment of the inherent properties of a specific substance (hazard assessment) does not need to be repeated because these properties are always the same. There might, however, be a need to assess the national exposure to the substance because this influences the extent of the risk to be considered. If, after investigation into the occurrence, there is no indication that the substance is produced or imported or used in any kind of product in the country, the need for prioritising it for action for the time being is small (even if other countries have seen problems with it), especially if resources are limited.

An important step in getting information on substances regulated in other countries is to use information from the Rotterdam Convention. Annex III to the convention lists substances, including pesticides and industrial chemicals that are banned or severely restricted in at least two of the five UN regions. For all substances listed in Annex III, a Decision Guidance Document is available that contains valuable background information on the substance and its properties. Information on further national restrictions can be found through information28 sent to the Rotterdam Convention Secretariat because parties to the convention have an obligation to inform the secretariat about their national or regional bans and severe restrictions on chemicals that are not (yet) covered by any international conventions or agreements even though they have the potential to create problems in the national arena.

28 http://www.pic.int/Implementation/PICCircular/tabid/1168/language/en-US/Default.aspx; see annex V.

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Some background information is also available for these substances. Such notifications give the importing country and others valuable information about the occurrence and use of a substance as well as the decisions of other countries to ban and restrict the substance, and it gives them an opportunity to consider the need to introduce similar measures in their country.

Another source of information is of course the GHS classifications. Examples of substances to look into could be CMR substances or substances with other serious hazardous properties, even if they are not part of annex III to the Rotterdam Convention.

It is often a long process before a country introduces a restriction on the use of a substance that poses risks to the environment or human health. Many countries publish preparatory work and candidates for risk reduction on their websites, and such information can also be of value for other countries. Such information quite often not only contains lists of substances, but also valuable background information on why a substance is a candidate for risk reduction. One example of such information is the REACH Candidate list29 of substances that might be subject to authorisation within the EU. On the ECHA website, information on substances being discussed for harmonised classification and labelling and bans is also accessible for countries outside the EU. The US EPA website30 also publishes information on the assessments of substances that are of concern.

Information on volumes and use areas of a candidate for restriction can be obtained from the chemicals register, if available in the country, or by other means, e.g. surveys or questionnaires. Guidance on how to get an overview of use areas for different chemicals is described in the guidance on Access to information on primary suppliers and chemicals on the market31.

Finally, it is necessary for the government to weigh all of the above-mentioned information in relation to each other before a decision is taken as to whether the chemical is to be prioritised for further action or not. How much weight each factor should be given needs to be decided nationally.

7. The role of the authority’s risk assessment Having legal structures where inherent properties giving rise to very severe or irreversible effects is enough for decisions on restrictions and bans enables countries to base a decision for risk reduction on hazard assessments32. This could be the case for substances that are PBTs or vPvBs, as well as chemicals that are carcinogenic, mutagenic, or toxic to reproduction or that have other severe and irreversible health effects.

For other chemicals, a risk assessment should normally be carried out when considering the need for restricting or banning the use of a chemical. When performing a risk assessment, it is necessary to have information both on the hazard of the substance (the inherent properties) and the potential exposure to the substance in the country because risk is a function of hazard and exposure. Unless the chemical undergoing risk assessment is uniquely produced in the country, risk assessments from other countries could be used to a large extent. Normally, the

29 ECHA website https://echa.europa.eu/candidate-list-table 30 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca 31 Swedish Chemicals Agency Guidance on Access to information on primary suppliers and chemicals on the market, (to be published) 32 Swedish Chemicals Agency, Guidance on Hazard Assessment and Risk Assessment of Chemicals – an introduction, (to be published)

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first step when carrying out a risk assessment of a substance is to assess the inherent properties of the substance – to make the hazard assessment. The inherent properties of any substance are always the same and hence all such available hazard data and assessments from other countries, organisations, and science should be used as the basis for the risk assessment. The exposure of the environment and the population to a substance might, however, vary from country to country. In some cases, especially when it concerns hazardous chemicals entering the country as a constituent in a product that is also used in other countries, it might be relevant to use full risk assessments that are internationally available in order to save resources and time. On the other hand, if it is clear that the use pattern or the volume of the substance differs significantly from these parameters in a country where a risk assessment has already been made, it might be necessary to undertake a national risk assessment taking into account the exposure in the country33.

Precaution should be applied in risk management when there are threats of serious or irreversible damage to human health or the environment. In this situation, the lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent damage.

8. Risk reduction instruments When the result of a risk assessment shows that measures already taken by industry are not enough to reduce the risk and there is a need to further reduce the exposure to a chemical in the environment and in humans, it is necessary for the government and/or its authorities to introduce one or more risk reduction measures. There are a number of different instruments that can be used. When the hazard is high, as mentioned above, measures might be taken without doing a full risk assessment. In such cases, the preferred risk reduction measure many times can be a total ban. A total ban might, for example, be relevant for substances that are very persistent and very bioaccumulating, vPvBs, or substances that are carcinogenic, mutagenic, or toxic to reproduction, CMRs, especially in products intended for use by the general public.

When considering how to most effectively reduce the exposure and hence the risk of a chemical, it is necessary to look into where the highest exposure occurs and what is giving rise to this exposure. Issues to consider are if the sources are emissions from production facilities or if emissions as well, or even primarily, are occurring during the use and waste stages in the chemical’s life cycle. Further, based on this, it is important to assess if there are

33 Swedish Chemicals Agency, Guidance on Hazard Assessment and Risk Assessment of Chemicals – an introduction, (to be published)

The Precautionary principle Rio Declaration 1992

Principle 15

“Where 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.”

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only a few sources or many. Such considerations indicate whether there is a need to take measures on the placing the chemical on the market or if it is more efficient to reduce risk by placing demands on, for example, emission reduction from a specific facility.

If the exposure to the environment and/or humans emanates from a point source, the most efficient way to reduce the risk might thus be to take action at the point source. This means that safer handling of the chemical in the production line or the elimination of releases into the air and water at production plants could be an efficient and economical way to reduce the risk. The same approach can be applied to reduce occupational health risks by introducing emission restrictions in the workplace. Detailed guidance on how to apply risk reduction instruments to eliminate or reduce point sources is, for example, available through EU34, OECD35, and other organisations and includes how to use Best Available Techniques (BAT) and Best Environmental Practices (BEP). This might be sufficient, especially if the chemical is used by a very limited number of companies and is only intended for industrial use and is not present in the products they produce. Examples of such chemicals could be intermediates or chemicals used to support production, such as lubricants or cleaning agents. These areas are not further covered in this paper where the focus is on reducing the use of the substance as such, in mixtures, or in other types of articles in production and import where the use is more widespread.

Because there is a very large number of chemicals on the market, many of which have hazardous properties to a greater or a lesser degree and which are used in many different ways, it is necessary to be able to choose from a palette of alternative risk reduction measures in order to apply the most suitable or relevant risk reduction instrument for a specific chemical or a specific use of a chemical. Measures for restricting the production and use can entail a total phase-out or reduction of specific uses of the substances and can be legally binding or voluntarily applied by industry, downstream users, and retailers in order to reduce risks from the chemical.

In this chapter, different risk reduction instruments leading to changes in production and use of substances that pose risks will be described. Some of these instruments have to be clearly spelled out in the legislation in the country, while others are more of a voluntary nature. Their advantages and disadvantages will be discussed.

8.1 Choice of instruments When considering the introduction of any kind of risk reduction measures for a chemical, it is advisable to work in a structured way and to start by identifying the problem. Examples of questions that then need to be answered include:

WHAT risk reduction is to be achieved? WHO needs to take action in order to reduce the risk? HOW might the risk be managed? WHEN should a specific instrument be used in relation to the use of other instruments?

The process starts with prioritisation followed by hazard and/or risk assessment for selected chemicals (see chapters 6 and 7).

34 See e.g. EU on BAT and BEP http://eippcb.jrc.ec.europa.eu/about/more_information.html 35 See OECD on BAT etc.http://www.oecd.org/chemicalsafety/risk-management/best-available-techniques.htm

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The next step in the process should be to identify the most appropriate risk reduction instruments. In this process, industry, downstream users, and other stakeholders should be invited to contribute. The latter group might be other authorities or different non-governmental organisations (NGOs), including environmental and consumer representatives. Downstream users play an important role because they can have other perspectives than the producers/importers when it comes to introducing safer alternatives. The waste sector is another important stakeholder because waste containing hazardous substances has to be treated in a special way. Reducing the use of hazardous substances makes it easier to handle waste in an adequate way. It is essential to have good contacts with relevant industry groups in order to increase their understanding for the need to introduce risk reduction measures and to get a broad picture as a basis for assessing the most effective instrument to achieve the aim of the measures.

Factors to take into account for the choice of the most appropriate risk reduction instrument are:

· Degree of hazard and risk

· Efficiency

· Sustainability over time

· Costs and benefits for different actors, socioeconomic consequences

· Administrative burden

To achieve the expected result, i.e. that the risk to human health and the environment from the chemical is eliminated or reduced, there is a need for comparing different instruments with each other. The introduction of an administrative (legal) measure such as a total ban or a restriction for certain uses is one option. Another way forward is to investigate whether economic policy instruments such as taxes or fees alone or in combination with other instruments would serve the purpose to reduce the risk. Still another way forward would be to assess whether an informative instrument, such as dialogues between authorities and industry, might be sufficient to reduce the risks to the required extent.

8.1.1 Socio-economic considerations In the process of choosing policy instruments to reduce the risk from the production, import, and use of a chemical, it is helpful to carry out an assessment of the socio-economic impacts of different options. Such an assessment is facilitated by having good contacts with different stakeholders, including relevant industries, in order for them to be able to investigate the effects on their industry sector and to inform the authorities. Information can also be gathered from other sources and actors. Furthermore, information on actual consequences in other countries could be used.

Such an analysis for different options facilitates choosing the instrument that is most cost-effective, that is, is connected with the lowest costs for different actors (including the government) but at the same time reduces the risk to a sufficient extent. Even though the cost for one type of industry might be a disadvantage, it should not prevent the introduction of the measures if considered relevant and important for the protection of human health and the environment. It should also be taken into account that introducing a risk reduction instrument can be a disadvantage for one company and at the same time an advantage for another company (e.g. a company that provides alternative solutions). These aspects should be taken into account when considering the most relevant choice of instrument, and if all other

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requirements for an efficient instrument are fulfilled, then the one with the most advantages for society as a whole should be chosen.

Methods for carrying out quite extensive impact assessments have been collected by the OECD36. These methods are aimed at all different levels of regulation and are thus quite complicated in nature.

8.2 Administrative instruments

8.2.1 Classification and labelling and safety data sheets As mentioned before, a cornerstone for risk management measures is to make GHS mandatory for all substances and mixtures. Because this is fundamental in placing general obligations on industry, this instrument has already been dealt with in chapter 4.

8.2.2 Control of access to particularly hazardous chemicals and to chemicals posing uncontrolled risks

Certain substances can be considered too hazardous or give rise to too great of a risk to be freely and openly available to use. There are some different instruments to control access to such substances, all of which are aiming at more or less far-reaching limitations on the production, placing on the market, or use of the substance as such, in mixtures, or in articles.

8.2.2.1 Bans and restrictions Banning the production/import and use of a chemical or restricting its use in certain applications can be introduced at all stages of the chemical’s lifecycle. The most far-reaching measure is of course to ban all production, import, and use of a substance, including in mixtures and articles. This type of ban is relevant to introduce when the hazard or the risk from the substance is high and especially if there are a number of sources giving rise to the risk. The efficiency and sustainability of this type of ban is normally good as long as the legislation is enforced.

When banning or restricting the use of a chemical nationally, it has to be remembered to include the same measure for import of the substance as such, in mixtures, and in articles. The import could otherwise reduce the efficiency of the measure and give rise to continued health and environmental problems caused by the chemical. It would also create uneven conditions for producers and importers.

Substances with inherent properties giving rise to very severe or irreversible effects could be banned based on the hazard assessment of their inherent properties, as mentioned in section 6.1. This could be done for specific substances. Another risk reduction measure can be to introduce more general restrictions on the use of substances based on the classification of the substance meeting specific GHS criteria, e.g. CMR substances, because it could not be considered acceptable to expose the general public or the environment to these kinds of substances. Such restrictions can be introduced for products that are intended for consumer use such as paints and household chemicals. Inherent properties such as persistence and bioaccumulation can also be a reason for introducing a general ban on substances having such serious properties.

36 http://www.oecd.org/gov/regulatory-policy/ria.htm

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Further, in cases where risk assessments have been carried out and these have shown that risk reduction is necessary, different levels of bans and restrictions can be introduced. In some cases a total ban is necessary. In other cases it might be sufficient to ban the use of the chemical in specific areas where the use gives rise to, for example, pollution of the environment but the chemical can still be used in other applications without causing an unacceptable risk. There might also be a need to allow a specific use of a substance that is essential to society and for which there are no alternatives yet. This can be done by introducing exemptions that can vary in their extent. Introducing this possibility can, in certain cases, create a greater acceptance of the ban. Examples of how to partly ban a substance are:

1. The ban covers only specific uses of the chemical, which means that all other uses are permitted.

2. A ban with general exemptions for specific areas that are specified in the legislation.

3. A ban with a possibility to issue exemptions on a case-by-case basis, following applications from industry, for a specific use that fulfils criteria specified in the legislation.

The first case, from the points above, is useful if the risk is reduced to an acceptable extent with a ban for a specific use or uses. In the second and third case, the aim is eventually to achieve a phase-out of the substance, but some specific uses are essential for society and no substitutes are available yet. These types of bans give already from their introduction a clear signal that the goal is to eliminate the use of the substance. Criteria for the third case need to be specified in the legislation. Such criteria could be that the use is of critical importance for society as a whole or an important subset of it and there is no possibility – for different reasons and for the time being – to substitute the substance with a less hazardous alternative. Such exemptions can be time-limited and can be combined with an obligation to investigate, within a certain time frame, alternatives to the substance in question. This type of system can, however, be quite resource demanding and can create a heavy administrative burden on the part of the government that is granting exemptions for use. This type of exemption is in its construction similar to authorisations or a premarket approval system of the use, which in a way also allows the use on a case-by-case basis.

In some countries, additional legislation for specific products, e.g. for toys and cosmetics, have been introduced in addition to the general chemicals legislation. Such legislation might cover several different aspects of the product, not only in relation to its chemical content but, as in the toy example, the size of toy’s parts to avoid choking in small children. In relation to chemicals, product legislation often uses the GHS criteria as a basis for banning or restricting the use of substances. The EU legislation on toys and cosmetics, for example, includes a ban on the use of substances meeting the GHS criteria for CMR classification categories 1A and 1B and in some cases also those meeting the criteria for category 2. .

The advantages of introducing a ban that reduces or even eliminates the risk to environment and health is that it is clear and equal to all actors in the supply chain and is easy to communicate, it is normally sustainable, and it does not require high administrative costs to maintain, other than for its enforcement. A disadvantage is that it might need quite a long time before being fully effective.

If a partial ban is enough for achieving the needed reduction in exposure to eliminate the risk, it is an advantage to design such a limited ban because the cost to industry as a whole will be smaller. On the other hand, with a partial ban new areas of use that are not specifically

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mentioned in the ban might be introduced. Therefore, it is necessary to regularly monitor the use of the substance in order to be able to assess the effects of new use areas and take action against them if needed.

A system that allows for exemptions is more administratively resource demanding than the others and might need even more resources for effective enforcement.

Generally, there is also a need to consider what kind of action will be taken by industry when a substance is banned or severely restricted. There could be a risk that the substance will be replaced by a substance with similar properties such as a related salt of a metal belonging to the same group of substances. In such cases, it might be advisable to consider the need to introduce the same ban or restriction for the whole group of substances in order to avoid the use of a substitute that does not give any advantages from a health or environmental perspective.

8.2.2.2 Authorisation or premarket approval systems A premarket approval system is not common for chemicals in general (industrial and consumer chemicals) but can be used in certain cases. On the other hand, such a system is generally used for specific chemicals such as pesticides, food additives, and pharmaceuticals. This type of system might also be useful for some hazardous industrial and consumer chemicals for which the use should be limited to the greatest possible extent, for example, the authorisation system for substances of very high concern (SVHC) in the EU REACH legislation.37 The ultimate aim is, however, that all such substances shall eventually be substituted. The reason for introducing such a system is that the use of the substances in these groups needs to be restricted because of the risks related to them, sometimes in combination with very widespread use. In such a system, industry has to prove that there is a need for these substances and that they can be used in a safe way. Each use of a substance needs a specific authorisation, which is normally time-limited. This could also be a way to encourage companies to substitute such hazardous substances with less hazardous ones. At the same time, the system is complicated and resource demanding both for the authorities and industry. Hence, such a system can only be recommended for a very limited number of substances meeting very specific criteria. Such criteria could identify substances that either have very severe hazardous properties or could cause long-term problems if spread in society or the environment.

An advantage of an authorisation system is that a high level of safety and risk reduction can be achieved. It gives clear signals to industry on which substances that preferably should be avoided. On the other hand, it is very resource demanding. To be efficient and sustainable, it requires a long time engagement by personnel who are quite competent in relevant areas.

8.2.2.3 Transparent processes and enforcement requirements When drafting new legislation it is essential to ensure that requirements are fully understandable for trade and industry. The duties of affected companies must be made clear, so that both the regulated companies and the government can readily identify what constitutes compliance. It is best when the regulated companies not only understand what the requirements are and how to comply with them, but also the reasons for the requirements.

37 The REACH Legislation: Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH): Title VII Authorisation

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Knowing the reason for requirements can help develop both the capacity and the willingness to comply.

A clear process for the development of new legislation including e.g. possibilities for companies to engage in the process and relevant transition periods prior to entry into force makes it easier for companies to comply with the legislation.

Requirements can also be phased in over a period of time, with some simpler or more critical rules becoming effective earlier than others. The more industry and government can engage in a dialogue when new requirements are being worked out, the better compliance can be expected once the regulations enter into force.

Figure 6. General scheme presenting the legislative process

All administrative (legal) instruments need to be accompanied by efficient and effective enforcement and sanctions if the legal requirements are not fulfilled. The goal with enforcement is to ensure compliance with legislation. Without enforcement, even the strictest bans are of little or no value thus .enforcement is a prerequisite for efficiency and effectiveness. Therefore, enforcement is one of the most important instruments to actually reduce risks from hazardous substances because

Any country introducing new legal requirements in different areas will need to consider how this law shall be controlled. Provisions for an inspection system should therefore be established in legislation and effectively implemented.

8.3 Economic policy instruments In addition to common administrative instruments, economic policy instruments or incentives can complement these in a number of areas. The instruments could consist of taxes and fees as well as different forms of subsidies.

An economic policy instrument could be taxes or fees that have to be paid for the use of a specific substance that is considered to create health or environmental problems. The application of taxes and fees as economic policy instruments must be based on legislation in the same way as administrative risk reduction instruments. They also need the same basis for decisions, such as hazard and/or risk assessments and socio-economic considerations. In addition, they require a system for collection of the taxes and/or fees as well as a system for control and enforcement.

An economic policy instrument could also be designed to cover a broader group of chemicals according to well-defined criteria. Such an economic policy instrument could be differentiated with respect to the toxic or hazardous properties of the substances in the group. Differentiated fees based on different properties could create incentives to seek out less harmful alternatives.

It is normally not useful to introduce economic policy instruments if the area is already well regulated, in which case an economic policy instrument would have little effect, and not if the

Legislation proposal Remittance Adoption Transition

periodEntry into

forceEnforce-

ment

No enforcement = No law

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undesirable chemical is highly hazardous to health or the environment. It should not be possible to pay for the right to spread a substance that is highly hazardous. In addition, an economic policy instrument is not suitable if the undesirable substance occurs sporadically.

However, economic policy instruments might usefully complement other instruments in a number of cases, e.g. for moderately hazardous substances where there is a need for a reduction in the use, but not a total phase-out, and the government wants to use market forces to find the areas where the reduction could be made with the lowest cost. When there are good opportunities to increase the market share of alternatives that are better from the point of view of health and/or the environment, economic policy instruments are also a suitable complement. Environmental economic instruments consequently drive substitution and innovation and favour environmentally sound alternatives, with the result that these reach the market more quickly and/or increase their market shares to a greater extent than if such instruments were not used.

A drawback of economic policy instruments is that the administrative burden increases, and hence the costs, due to the additional administration of such instruments, both for the authorities and for industry. It is necessary that a system for collection of taxes or fees is available in the country, otherwise it will be very difficult to ensure the efficiency of the instrument. This means that it is important to assess the accompanying administrative costs before an economic policy instrument is introduced. It is also important to ensure that compliance can be monitored and that enforcement is possible.

8.4 Informative instruments (and general information) An informative instrument as a risk reduction measure is less compulsory than other types of risk reduction measures and aims to achieve a voluntary reduction of the use of a specific substance or group of substances. Informative instruments can be used as stand-alone measures if the risk from a specific substance or group of substances is comparably low but still needs to be reduced. Benefits for society could still be gained and the costs to industry would not be too high because ample time could be taken for reducing the use of the substance in question thus making it possible to find or develop suitable alternatives. A drawback with informative instruments is that the outcome is less certain than with administrative measures. For the risk reduction to be sustainable, it is also necessary to make sure that the activities are followed-up continuously over a longer period of time. If not followed up, or complemented by introducing an administrative instrument at a later stage, the effects of these kinds of instruments might not be very sustainable.

An informative instrument can be appropriate:

· to encourage the reduction of use and the substitution of a substance or a group of substances with unwanted properties causing a moderate risk to human health and/or the environment.

· to speed up the elimination of a specific substance or a group of substances before a ban or a restriction is adopted and/or enters into force.

· to inform industry at an early stage on substances that might need measures due to the emerging weight of the evidence.

Informative instruments are, however, not suitable as stand-alone measures when there is a severe risk or when target groups are difficult to reach.

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When planning to develop and publish information about chemicals, it is important to carefully consider what the aim of the information is and with this is mind to define the target audience for the specific information. Information developed by the authorities for the different target groups, including professionals, producers, downstream users, and the general public, needs to be developed with the specific target group in mind because their needs will differ to a great extent.

As a basis for informative instruments, there needs to be a general awareness of the hazards that chemicals can pose. This also facilitates the introduction of other instruments. Therefore, general awareness will briefly be dealt with in this chapter.

Information on administrative and economic instruments is often needed. However, this is a measure to support the implementation of these instruments, and such information is not an instrument in itself. Many authorities have, for example, developed websites with information on existing legislation that is relevant for a company that is producing, importing, or using chemicals. They might also provide information through helpdesks, seminars, and printed material. This kind of information on the existence of other instruments will not be covered further in this chapter.

8.4.1 Broad awareness raising The authorities can support broad awareness-raising in general about chemicals and their effects and how to handle them, for example, in school curricula and through general information material, websites, etc. Broad awareness raising serves as a platform for all other risk reduction instruments because general knowledge about chemicals and their potential effects is necessary to achieve the intended effects of the instruments.

Many countries and organisations have developed websites and/or printed information material to inform the public in general about chemicals and their risks. When needed, information material, including press releases, is issued for specific issues of concern.

In figure 7 a few examples of information material and campaigns that are available on different websites are shown.

To a certain extent, non-governmental organisations can also play an important role in addition to the authorities in meeting these demands from consumers. In order to ensure that coming generations of adults have a good knowledge of sustainable safe handling of chemicals, education programmes can be developed to be included in the school curricula, which would make a long-term contribution to sustainable consumption.

Well-informed consumers can put pressure on national as well as local politicians to issue legislation with the aim of reducing the use of hazardous chemicals and reaching a less toxic everyday environment.

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Figure 7. Clockwise: Hanna’s house, information for teaching schoolchildren about hazardous chemicals38. Chemicals in Children's Everyday Lives, practical tips to all who care for children39. The European Chemicals Agency not only has information aimed at industry, but also at consumers40 to inform them about the use of chemicals and their possible risks, the Keep Sweden Tidy Foundation is another example of how to work with schools41. See also further examples at Chemicals in the everyday environment42 .

38 http://www.miljodirektoratet.no/en/News1/2015/School-children-in-the-Nordic-countries-are-taught-about-hazardous-chemicals-in-Hannas-House/ 39 https://www.kemi.se/global/broschyrer/chemicals-in-childrens-everyday-lives.pdf 40 https://echa.europa.eu/chemicals-in-our-life 41 http://www.hsr.se/sites/default/files/content_media/com_u_report_lagupplost.pdf 42 https://www.kemi.se/en/guidance-for/consumers/chemicals-in-the-everyday-environment

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8.4.2 Information from authorities aimed at solving a specific problem

8.4.2.1 Steering the marketing of the products

8.4.2.1.1 Dialogues with industry An important objective of dialogues between authorities and industry is to increase awareness and knowledge about the risks of using hazardous substances as such, in mixtures, or in articles and to encourage continuous substitution of hazardous chemicals with less hazardous alternatives whenever possible. Further, the dialogues can be used to speed up the phase-out of especially hazardous substances. Dialogues between the authorities and industry is long-term work. Initially, contact needs to be to established and trust needs to be built, and it is important to allow all actors to exchange views on difficulties and possibilities. Dialogues also give the participating authorities a better understanding of the conditions faced by different industries. A good dialogue hopefully gives rise to continued work within industry towards reducing risks from the use of hazardous substances without the involvement of authorities on any detailed level in the future.

A practical approach in carrying out dialogues might be to concentrate on a specific group of articles, such as toys, textiles, or electronics, because they might contain a number of chemicals that need to be reduced, and to carry out the dialogues with the sectors of industry that are producers and importers of these type of products. It is also useful to involve the sector-specific organisations in such dialogues because they can help reach a broader group of companies. An important goal of the dialogues should be to increase the company’s awareness and knowledge about the specific risks from the chemicals in these groups of articles.

Many years can pass from identification of a chemical’s risk to health and the environment until changes are made in legislation and these changes have entered into force. Industry-sector dialogues can be useful to speed up the elimination of a specific substance or group of substances before a ban or a restriction is adopted and/or enters into force. Dialogues with prioritised industry sectors can also be very useful for reducing the use of a specific substance or group of substances with unwanted properties causing a moderate risk to human health and/or the environment.

A basic requirement in the legislation should be that companies are responsible for ensuring that their products do not harm people or the environment, and one can argue that even though the legislation does not contain detailed rules for all substances or has not yet entered into force for a specific substance, it is an obligation for industry to avoid using hazardous substances when better alternatives are available.

In many cases, it is possible to see faster results with these kinds of informative instruments than with a ban or a restriction. However, one disadvantage might be that the results of such dialogues do not last over time. This should not discourage the government or other authorities from carrying out such activities, especially if they are combined with other more long-lasting measures such as introducing a legally based restriction at a later stage.

8.4.2.1.2 Voluntary commitment In some cases, discussions and dialogues with industry might result in a voluntary commitment from industry to substitute a hazardous substance with a less hazardous alternative substance or an alternative technique. This needs to be followed up in order to verify that such actions are actually taken.

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It is not recommended that the authorities commit to doing something in return in response to the industry’s commitment (i.e. to enter into a mutual agreement). This is legally complicated, and in some countries it is not even legally possible for authorities to sign a commitment as a response to an industrial commitment.

8.4.2.1.3 Tools for substitution Authorities can support choices of chemicals by providing information on which chemicals might have unwanted properties and could become candidates for substitution. An example of a website with a support tool for industry actors to go beyond the detailed legislation when choosing chemicals is the Swedish Chemicals Agency’s web-based tool PRIO that can help such actors in reducing the health and environmental risks from chemical substances43.

The aim of PRIO is to help industry in the assessment of health and environmental risks from chemical substances so that people who work as environmental managers, purchasers, and product developers can identify the need for risk reduction. In order to achieve this goal, PRIO provides a guide for decision-making that can help in setting risk reduction priorities.

8.4.2.2 Steering consumption Steering consumption towards reduced use of a specific substance, group of substances, or products when a specific problem has been identified can be achieved through some tools that are presented in this section.

8.4.2.2.1 Public procurement One example of an instrument that can provide great opportunities is chemical requirements in public procurement. Public tenders can be an important instrument in reducing the risks in hospitals, schools, and other public places. Municipalities and others who put out calls for tenders should be able to set well-founded requirements in relation to chemicals in their tenders. To support them in this, the central authorities can provide criteria and guidance. Such criteria could, for example, contain requirements that substances or mixtures meeting specific GHS criteria cannot be used for the purpose that the tender covers. One way to reduce risks from hazardous substances that can be used in public procurement is to ask for eco-labelled articles and services, or products with equivalent documentation. Demands in tenders for public procurements might also contribute to the production of less hazardous products in other parts of the market. The possibility to set these kinds of requirements might vary depending on the legislation in each country. For example, since 2014 it has been possible for EU authorities to set specific environment-related criteria in public procurement according to the EU Procurement Directive44.

8.4.2.2.2 Targeted information for a specific problem Information pamphlets, websites, press releases, and other similar material can be used as a steering instrument when there is a wish to reduce risks from a specific substance or a group of substances. Doing this can contribute to a reduction in the use of the substance as it can affect the demand from downstream users as well as the general public. Being aware of a problem might trigger questions on the availability of alternatives and the avoidance of buying products containing specific substances. In such a way, this might trigger substitution as well.

43 https://www.kemi.se/en/prio-start 44 http://ec.europa.eu/growth/single-market/public-procurement_en

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As for producers and importers of chemicals, authorities can support choices of chemicals by giving information to downstream users on which types of chemicals have unwanted properties and should be candidates for substitution. It is valuable to inform downstream users of the need or the desirability to substitute a specific type of substance for one that is less hazardous because they many times can choose between different alternatives and can put pressure on their suppliers to provide alternatives.

Information directly to the consumers on substances as such or when used in mixtures and articles aimed for the general public can lead to well-informed, strong consumer groups that refuse to buy products that contain specific hazardous chemicals. Their behaviour will put pressure on downstream users and through them also the primary suppliers to substitute such chemicals with less hazardous ones. Specific, targeted information from authorities on a specific problem aimed at private consumers is an informative steering instrument where the expected result is a substitution of the targeted substance.

The aim could also be to inform about the chemicals’ effects and properties and how to use and handle them. Consumers in many countries are increasingly asking for information and support to enable them to make safe choices, for example, with regard to hazardous substances in products and articles.

On a general level, authorities play an important role in giving correct and un-biased information to the general public and public organisations on chemicals in the everyday environment so that they can make informed choices and can handle chemicals, especially hazardous chemicals and chemical-containing articles, in a safe manner. This also includes how to deal with chemical-containing waste. However, more detailed information on how to handle a specific chemical needs to be supplied by the producer or the one placing the chemical or the article containing the chemical on the market through correct labelling and safety information.

8.4.2.2.3 Ecolabelling Ecolabelling has become a useful tool for governments in encouraging sound environmental practices and for businesses in identifying and establishing domestic and sometimes international markets for their environmentally preferable products. Commitment to clear objectives has been critical to the success of ecolabelling programmes around the world. The systems are voluntary third party programmes based on multiple criteria that award a license that authorises the use of ecolabels on products. These labels indicate overall environmental preferability within a specific product category for which specific criteria based on lifecycle considerations have been developed. In relation to chemicals, strict requirements for their use should, when relevant, be set that go beyond the legal requirements. The requirements for ecolabels need to be clear, unambiguous, and objectively verifiable in order to ensure transparency and fair competition in the procurement processes for the benefit of the suppliers. For examples, see the EU Ecolabel programme45 and the German Blue Angel.

9. Decision making There are a number of different decision that need to be made in the process of introducing instruments in order to eliminate or reduce the risk from hazardous chemical substances. The legislation has to be clear, explicit, and consistent in terms of at what level and by whom a

45 http://ec.europa.eu/environment/ecolabel/the-ecolabel-scheme.html and https://www.blauer-engel.de/en, http://www.nordic-ecolabel.org/the-nordic-swan-ecolabel/

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decision can be taken, and it must give clear mandates to those. Decisions usually have to be taken in several steps, and for each of them the appropriate level needs to be defined. Examples of such decisions are the following:

· Decision on the general policy for the risk management of chemicals · Decision on basic legislation, including defined roles and responsibilities

and mandatory requirements for using GHS · Decision on choice of chemicals for hazard and/or risk assessment, based

on · Decision on whether or not to continue with the development of proposals

for risk reduction based on the hazard/risk assessment · Decision on risk reduction measures

In some countries there might be one authority that is delegated to prepare and propose measures, while the final decision is taken at a more senior level, i.e. at the ministerial level or even by the legislative body, which can be the parliament. A proposal for measures to be taken could emanate from the delegated body or might come as an assignment from the decision makers.

The delegated body should in this case carry out the assessment of the risk of the chemical as well as assess the impact of the proposed measures and prepare the decision for adoption by the deciding body. It should also be clear in the legislation or in the policy from the legislator or the government (if this is not the same body) how the process is to be carried out, i.e. how the decisions needed for the different steps are to be made and which considerations they should be based on.

When legal instruments, including mandatory economic policy instruments, are adopted, this normally requires decisions at more senior levels than other instruments such as different types of informative instruments, e.g. dialogues with industry. The reasons behind the decision to introduce risk reduction measures and the choice of instrument should be described in a way that is understandable to both decision makers and stakeholders. In a case where there are suspicions of severe adverse effects caused by a substance but full scientific evidence is lacking, it should be considered to apply the precautionary principle for the decision on risk reduction. To what extent the Precautionary Principle should be applied should also be based on political decisions and should be documented in relevant legislation.

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Annex 1 – International Conventions and agreements

1. Strategic approach to International Chemicals Management Adopted by the International Conference on Chemicals Management (ICCM) on 6 February 2006 in Dubai, United Arab Emirates, the Strategic Approach to International Chemicals Management (SAICM) is a policy framework and hence not legally binding, to foster the sound management of chemicals.

SAICM was developed by a multi-stakeholder and multi-sectoral Preparatory Committee and supports the achievement of the goal agreed at the 2002 Johannesburg World Summit on Sustainable Development of ensuring that, by the year 2020, chemicals are produced and used in ways that minimize significant adverse impacts on the environment and human health.

SAICM comprises the Dubai Declaration on International Chemicals Management, expressing high-level political commitment to SAICM, and an Overarching Policy Strategy which sets out its scope, needs, objectives, financial considerations underlying principles and approaches and implementation and review arrangements. Objectives are grouped under five themes: risk reduction; knowledge and information; governance; capacity-building and technical cooperation; and illegal international traffic.

In the intersessional period between ICCM 3 and ICCM 4 stakeholders have discussed and recommended what need to be in place in a country to enable it to fulfil the 2020 goal in time. These recommendations are presented in a document outlining an Overall Orientation and Guidance to identify approaches for all SAICM’S stakeholders towards the achievement of the overall objective by 2020 including some concrete elements to support the implementation of the Overarching Policy Strategy. This recommendation was adopted at ICCM4 taking place 27 September - 3 October 2015.

This guidance contains a set of 11 basic elements that have been recognised as critical at the national and regional levels to the attainment of sound chemicals management they are:

• Legal frameworks that address the life cycle of chemicals and waste; • National, sub-regional and regional enforcement and compliance mechanisms; • Implementation of relevant international conventions; • Strong institutional frameworks and coordination mechanisms among relevant

stakeholders; • Collection and systems for the sharing of data and information among all relevant

stakeholders using a life-cycle approach; • Industry participation and responsibility, including cost recovery policies and systems as

well as the incorporation of sound chemicals management into corporate policies and practices;

• Implementation of the Globally Harmonized System of Classification and Labelling of Chemicals;

• Inclusion of chemicals in national budgeting, processes and development plans; • Chemical risk assessment through use of best practices; • Strengthened capacity to deal with chemicals accidents, including poisonings; • Monitoring and assessing the impacts of chemicals on health and the environment.

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2. Stockholm Convention The Stockholm Convention on Persistent Organic Pollutants was adopted by the Conference of Plenipotentiaries on 22 May 2001 in Stockholm, Sweden. The Convention entered into force on 17 May 2004. It is a global treaty to protect human health and the environment from chemicals that remain intact in the environment for long periods, become widely distributed geographically, accumulate in the fatty tissue of humans and wildlife, and have harmful impacts on human health or on the environment.

In response to this global problem, the Stockholm Convention, requires its parties to take measures to eliminate or reduce the release of POPs into the environment. Such measures include:

• Prohibition and/or elimination of the production and use, as well as the import and export, of the intentionally produced POPs that are listed in Annex A to the Convention;

• Restriction of the production and use, as well as the import and export, of the intentionally produced POPs that are listed in Annex B to the Convention;

• Reduction or elimination releases from unintentionally produced POPs that are listed in Annex C to the Convention;

• Ensuring that stockpiles and wastes consisting of, containing or contaminated with POPs are managed safely and in an environmentally sound manner;

• Targeting additional POPs.

3. Rotterdam Convention The text of the Rotterdam Convention was adopted on 10 September 1998 by a Conference of Plenipotentiaries in Rotterdam, the Netherlands. The Convention entered into force on 24 February 2004. The Convention covers pesticides and industrial chemicals that have been banned or severely restricted for health or environmental reasons by Parties and which have been notified by Parties for inclusion in the PIC procedure.

The Convention promotes the exchange of information on a very broad range of chemicals. It does so through:

• the requirement for a Party to inform other Parties of each national ban or severe restriction of a chemical;

• transition to inform other Parties that it is experiencing problems caused by a severely hazardous pesticide formulation under conditions of use in its territory;

• the requirement for a Party that plans to export a chemical that is banned or severely restricted for use within its territory, to inform the importing Party that such export will take place, before the first shipment and annually thereafter and hence give the importing country a possibility to deny the import via the so called Prior Informed Consent procedure.

4. Minamata Convention The Minamata Convention on Mercury is a global treaty to protect human health and the environment from the adverse effects of mercury. The major highlights of the Convention on Mercury include a ban on new mercury mines, the phase-out of existing ones, control measures on air emissions, and the international regulation of the informal sector for artisanal and small-scale gold mining. It also includes regulating the use of mercury in certain products such as measuring devices and cosmetics.

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5. The Globally Harmonized System of Classification and Labelling of Chemicals - GHS

The GHS system which was first adopted in 2002 provides a (non-legally binding) system for countries for classification a labelling of chemicals, substances as well as mixtures. It was agreed by the participating countries and stakeholders at the World Summit for Sustainable Development in the Johannesburg Plan of Implementation 2002 that it should be implemented by 2008. The purpose of the GHS is: • To enhance the protection of human health and the environment by providing an

internationally comprehensible system for hazard communication, • To provide a recognized framework for countries without an existing system • To reduce the need for testing and evaluation of chemicals; and • To facilitate international trade in chemicals whose hazards have been properly assessed

and identified on an n international basis. GHS is not intended to harmonise risk assessment procedures or risk management decisions but gives a sound basis for other pieces of legislation and according to the classification of a substance, measures can be warranted that reduce or eliminate the risk emanating for using the chemicals in questions.

6. The 2030 Agenda for Sustainable Development and the Sustainable Development Goals

In “Transforming our world: the 2030 Agenda for Sustainable Development”, UN Member States re-confirmed to

“reduce the negative impacts of urban activities and of chemicals which are hazardous for human health and the environment, including through the environmentally sound management and safe use of chemicals, the reduction and recycling of waste and the more efficient use of water and energy”.

This Agenda is a plan of action for people, planet and prosperity with 17 Sustainable Development Goals (SDGs) and 169 targets. It recognises that eradicating poverty in all its forms and dimensions, including extreme poverty, is the greatest global challenge and an indispensable requirement for sustainable development. All countries and all stakeholders, acting in collaborative partnership, will implement this plan.

The 17 Sustainable Development Goals and its 169 targets demonstrate the scale and ambition of this new universal Agenda. They seek to build on the earlier Millennium Development Goals and complete what these did not achieve. They are integrated and indivisible and balance the three dimensions of sustainable development: the economic, social and environmental.

However, there are eight goals and sixteen targets in Agenda 2030 that have a clear relation to chemicals: safe food and sustainable agriculture (goal 2), good health (goal 3), clean water (goal 6), safe working environments (goal 8), sustainable consumption and production patterns (goal 12), as well as protection of ecosystems and biodiversity (goals 14 and 15).

Governments have the primary responsibility for follow-up and review, at the national, regional and global levels, in relation to the progress made in implementing the Goals and targets over the coming fifteen years. To support accountability to our citizens, there will be a systematic follow-up and review at the various levels, as set out in this Agenda and the Addis Ababa Action Agenda. 230 indicators have been developed to assist the follow-up and review at the various levels.

The 17 SDGs takes into account all three dimensions of sustainable development, the economic, social and environmental dimension.

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Explanation of goals:

1. End poverty in all its forms everywhere. 2. End hunger, achieve food security and improved nutrition and promote sustainable agriculture. 3. Ensure healthy lives and promote wellbeing for all at all ages. 4. Ensure inclusive and equitable quality education and promote lifelong learning opportunities for all. 5. Achieve gender equality and empower all women and girls. 6. Ensure availability and sustainable management of water and sanitation for all. 7. Ensure access to affordable, reliable, sustainable and modern energy for all. 8. Promote sustained, inclusive and sustainable economic growth, full and productive employment

and decent work for all. 9. Build resilient infrastructure, promote inclusive and sustainable industrialization and foster

innovation. 10. Reduce inequality within and among countries. 11. Make cities and human settlements inclusive, safe, resilient and sustainable. 12. Ensure sustainable consumption and production patterns. 13. Take urgent action to combat climate change and its impacts* 14. Conserve and sustainably use the oceans, seas and marine resources for sustainable

development. 15. Protect, restore and promote sustain able use of terrestrial ecosystems sustainably manage

forests, combat desertification, and halt and reverse land degradation and halt biodiversity loss. 16. Promote peaceful and inclusive societies for sustainable development, provide access to justice

for all and build effective, accountable and inclusive institutions at all levels. 17. Strengthen the means of implementation and revitalize the Global Partnership for Sustainable

Development.

Swedish Chemicals Agency Box 2, SE-172 13 Sundbyberg +46 8 519 41 100

Visitors’ and delivery address: Esplanaden 3A, Sundbyberg

kemi@kemi.se www.kemikalieinspektionen.se