Strategy for Chemical Safety for the interdepartmental implementation of the chemicals legislation

Federal Departement of Home Affairs FDHA, Federal Office of Public Health OFSP Federal Food Safety and Veterinary Office FSVO Federal Departement of the Environment, Transport, Energy and Communications DETEC, Federal Office for the Environment FOEN Federal Departement of Economic Affairs, Education and Research EAER, Federal Office for the Agriculture FOAG State Secretary for Economic Affairs SECO Strategy for Chemical Safety for the interdepartmental implementation of the chemicals legislation Strategy for Chemical Safety Imprint Strategy for Chemical Safety Bern, 30 October 2017 Contracting authority Steering Committee for chemicals and plant protection products Project Management Steffen Wengert, FOPH Martin Schiess, FOEN Kaspar Schmid, SECO External support Anna Vettori, Thomas von Stokar INFRAS, Binzstrasse 23, 8045 Zürich Tel. +41 44 205 95 95 Contributors to the preparation Harald Bentlage, FOEN Peter Bormann, FOAG Martine Bourqui, FOPH Heribert Bürgy, FOPH Pierre Favre, NAChem (FOPH) Olivier Felix, FOAG Dag Kappes, FOPH Lucia Klauser, FSVO Christoph Moor, FOEN Olivier Sanvido, SECO Josef Tremp, FOEN Strategy for Chemical Safety Content 1.1. Importance and risks of chemicals 5 1.2. Legal framework 5 1.3. International Context 7 2.1. Overview 8 2.2. Vision 9 2.3. Strategic Objectives 9 2.4. Strategic Measures 10 3.1. Targets and indicators 15 Annex I: Matrix of Objectives and Measures 18 Annex II: Organisation of the Federal Implementation of the Chemicals Legislation 19 Strategie Chemikaliensicherheit 4/24 Preamble Bearing in mind the results of the evaluation of the interdepartmental implementation of the chemi cals legislation carried out in 2013 the Federal Council mandated the federal authorities to prepare a common strategy. The present strategy expresses the common understanding of the federal authorities involved in the implementation of the chemicals legislation at the federal level in regard to chemical safety, and is intended to strengthen cooperation. It builds up trust externally as the objectives pursued are clearly demonstrated to stakeholders, other federal authorities and politicians. The strategy has been prepared by the five federal authorities (FOPH, FSVO, FOEN, FOAG and SECO) involved in the federal implementation of the chemicals legislation and will be put in place jointly. Federal Office of Public Health Pascal Strupler, Director Federal Food Safety and Veterinary Office Hans Wyss, Director Federal Office for the Environment Marc Chardonnens, Director Federal Office for Agriculture Bernard Lehmann, Director State Secretariat for Economic Affairs Boris Zürcher, Head of the Labour Directorate Strategy for Chemical Safety 5/24 Introduction 1.1. Importance and risks of chemicals Chemicals are part of our everyday life. They are contained inter alia in paints, medicinal products, cleaning agents, fertilisers, pesticides, but also in furniture, smartphones, heat pumps and many other objects in daily use. Chemical products and technologies enable innovations in all areas of life, for example fuel-efficient cars, energy-efficient houses or self-cleaning surfaces. Today, ca. 100 000 chemical substances are produced. The importance of chemicals is also confirmed by the worldwide annual production of chemicals which has multiplied in the last hundred years from 1 mil lion tonnes in 1930 to more than 400 million tonnes at present. The OECD1 continues to anticipate strong growth.2 The benefits of chemicals are manifold, but they also involve risks for the environ ment and human health.  Tox Info Suisse reports more than 10 000 domestic accidents per year involving chemical products. Moreover, chemicals are associated with allergies, cancer diseases, congenital de fects, diabetes, obesity and disorders in reproductive capacity and fertility. The OECD esti mates that each year chemicals cause 350 000 unintended premature deaths worldwide. In 2014 the SUVA recognised more than 17 000 cases of occupational illnesses attributed to chemicals (not including asbestos) and their harmful effects on human health.3 The related costs amount to more than 28 million CHF.  In the environment, damage due to chemicals also leads to considerable costs. In the Kölliken landfill site the remediation costs amounted to around 660 million CHF.4 Consequently, risks for the environment and health need to be minimised when chemicals are used. Chemicals management5 is of primary importance for this. 1.2. Legal framework Protection objectives The Federal Constitution empowers the Confederation to protect the health and the environment against damage from hazardous chemicals and in this regard to enact regulations relating to chemi cals.6 The following protection objectives arise from the Constitution:  The protection of human health,  Safety of professional users of chemicals,  The protection of the environment,  The protection of agricultural crops. The protection objectives are the subject of various federal acts that contain provisions relating to chemicals. In particular, these federal acts include the Chemicals Act (ChemA), the Environmental Protection Act (EPA), the Water Protection Act (WPA), the Foodstuffs Act (FoodA) and the Agricul ture Act (AgricA). Chemicals legislation The Swiss chemicals legislation includes at the ordinance level eight Federal Council ordinances that regulate the use of chemicals, and are primarily based on the abovementioned Acts. 1 All abbreviations used in the Strategy are described in more detail in the List of Abbreviations. 2 See OECD Environmental Outlook to 2050; http://www.oecd.org/env/indicators-modelling-outlooks/oecd-environmental-out look-1999155x.htm 3 https://www.unfallstatistik.ch/d/publik/unfstat/pdf/Ts16.pdf 4 http://www.smdk.ch/index.cfm?setcatlist=66&publication id=93&publication action=dsp publicationdetail&content=0801&par agraph=3 5 See Glossary. 6 Art. 74, Art. 104 para. 3 let. d, Art. 110 para. 1 let. a, Art. 118 para. 2 let. a. Cst. (https://www.admin.ch/opc/de/classified-com pilation/19995395/index.html) Strategy for Chemical Safety 6/24 Figure 1: Federal Council Ordinances in the Chemicals Legislation Chemicals in the scope of the chemicals legislation refer to chemical substances and their mixtures (preparations), including biocidal products (BP) for use against harmful organisms, and plant protec tion products (PPP) for use against diseases and pests as well as weeds in crops.7 Micro- or macro organisms that are incorporated in PPP and BP fall within the scope of the chemicals legislation and are therefore also implicitly subject to the present strategy. The provisions of the chemicals legislation are directed towards manufacturers, importers and trad ers, to professional and private users (agriculture, traders, non-professional users, etc.) of chemi cals as well as to manufacturers of articles.8 Chemicals that are considered to be foodstuffs, cosmetics, therapeutic products, feedstuffs, weap ons and ammunition or waste are largely or completely exempt from the chemicals legislation. These chemicals are regulated by specific legislations. There are other areas with provisions on chemicals which are likewise not subject to the chemicals legislation, but play an important role in the scope of the integral chemicals risk management. These include inter alia the regulatory areas soil pollution, water protection, air pollution control, transport of hazardous goods, accident preven tion, construction products and residues in foodstuffs. Implementing organisation The implementation tasks for the application and enforcement of the rules of the chemicals legisla tions are split between the Confederation and cantons.9  In particular, the Confederation is responsible for the verification of the manufacturers’ de clared classification of substances and preparations, the risk assessment of selected sub stances, the examination of notifications and applications for authorisation for substances, BPs and PPPs as well as for their confirmation or authorisation, the notification procedure for hazardous substances and preparations as well as for the international cooperation.  The cantons are responsible for the market surveillance. In regard to random sample checks the cantons monitor substances, preparations and articles as well as PPPs and BPs, which are present on the market, to ascertain their conformity with the chemicals legislation and compliance with the handling requirements. Essentially, six federal authorities are involved with the federal enforcement of the chemicals legisla tion: The Federal Office of Public Health (FOPH), the Federal Office for Agriculture (FOAG), the Federal Food Safety and Veterinary Office (FSVO), the Federal Office for the Environment (FOEN), the State Secretariat for Economic Affairs (SECO) and the Notification Authority for Chemicals (NA Chem). Annex II provides further details on the organisation for the federal enforcement of the chemicals legislation. 7 In other contexts the term “Chemicals” sometimes refers only to chemical substances and mixtures. 8 Articles include e.g. floor coverings and textiles. 9 See ChemA chapter 5: Implementation, Art. 31 ff. https://www.admin.ch/opc/de/classified-compilation/19995887/index.html Strategy for Chemical Safety 7/24 1.3. International Context Switzerland has ratified inter alia the following UN conventions in the field of chemical safety and transposed them into its legal system:  Stockholm Convention on Persistent Organic Pollutants (POP Convention),  Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemi cals and pesticides in international trade (PIC Convention),  Vienna Convention and Montreal Protocol on the protection of the ozone layer,  Minamata Convention on the protection of mankind and the environment from the negative ef fects of mercury (Mercury Convention),  Aarhus Convention of the United Nations Economic Commission for Europe (UN ECE) on the Access to Information, Public Participation in Decision-making and Access to Justice in Envi ronmental Matters and the PRTR Protocol on Pollutant Release and Transfer Registers. Moreover, Switzerland supports various UN resolutions that demand the worldwide introduction of the Globally Harmonized System (GHS) for the classification and labelling of chemicals, as well as careful management of chemicals (inter alia Strategic Approach to International Chemicals Manage ment (SAICM) 10 and Agenda 203010). As Switzerland is a member of the OECD the Council deci sions of the OECD are also binding for Switzerland. In view of the close economic ties between Switzerland and the EU the Swiss chemicals legislation has been harmonised in certain areas with the corresponding EU legislation (“autonomous adapta tion”). This is intended to avoid technical barriers to trade. In addition, harmonisation contributes to the further development of the level of protection for health and the environment in Switzerland. In the context of the bilateral agreement on the mutual recognition of conformity assessments (MRA) 10 Switzerland committed to adopt equivalent provisions to EU legislation for the authorisation of BPs and for the coordination of good laboratory practice (GLP) 10. The parties in these legal fields thereby receive a simplified mutual market access. At the same time Switzerland is involved in the preparation of Community regulatory decisions. 10 See Glossary. Strategy for Chemical Safety 8/24 2. Strategy for Chemical Safety 2.1. Overview The present strategy focusses on those aspects of chemical safety in Switzerland which fall under the regulatory area of the chemicals legislation. It is conceived as an interdepartmental strategy for the federal authorities FOEN, FOPH, FSVO, FOAG and SECO involved in the federal implementa tion of the chemicals legislation and thereby also creates a basis for any sectorial strategies of these federal authorities in the field of chemical safety. Figure 2: Strategy for Chemical Safety Strategy for Chemical Safety 9/24 2.2. Vision Vision of Chemical Safety  During their entire life cycle11 chemicals have no harmful effects on the environment and the hu man health.  If an impact in the environment is planned,12 the chemicals are to be used such that (as far as possible) no harmful side effects occur. 2.3. Strategic Objectives The strategic objectives substantiate the vision and demonstrate what the involved federal agencies want to achieve in regard to chemical safety in the period up to 2020. They represent a yardstick for measuring the success of the federal agencies’ activities. Table 1: Strategic Objectives No. Title Objective Z1 No data – no market Manufacturers dispose of the required data for all chemicals that are intended to be placed on the market in order to assess the risks to the environment and to human health, and in order to be able to provide information required for safe use. Z2 Risk assess ment and risk reduction Chemicals may be marketed only if the assessment demonstrates that no unac ceptable13 risks to human health and the environment result from the intended use. If necessary, the competent authorities shall take measures to reduce the risks aris ing from a chemical. Z3 Substitution Chemicals with risks to health or the environment shall be replaced by lower-risk al ternatives. Z4 Sustainable chemistry The fundamental principles of sustainable chemistry13 are respected in the manufac ture, use and waste management of products as well as in the development of new processes and products. Z5 State of knowledge Tests for the properties of chemicals and the assessment of their risks to health and to the environment are based on scientifically sound methods and strategies, which also refer to the 3R Principles13. Switzerland plays an active role internationally in order to further develop the relevant state of knowledge and continually adapts its chemicals legislation to it. Z6 International standards The international standards for the careful handling of chemicals are developed by participating in inter alia the United Nations Environmental Programme (NEP), in the WHO, the FAO, the ILO and the OECD. This enables Switzerland’s needs as a busi ness location to be taken into account. Switzerland is committed to these standards and is an advocate for their worldwide implementation, also in regard to the sustainability objectives 2030 defined by the United Nations13. Z7 Professional ex pertise and in formation of the controllers Anyone who manages chemicals,  has the knowledge that ensures safe handling,  is aware of the responsibility for safe handling and  receives the information required for this. Z8 Appropriate and efficient en forcement The competent authorities guarantee a proper and efficient enforcement of the chemicals legislation and encourage manufacturers, importers, traders and users to fulfil their obligations when handling chemicals. 11 Entire life cycle means that the effects of chemicals are to be taken into account from the raw material extraction, production, further processing, storage and transport up to the use and disposal in Switzerland and abroad. 12 The claim “no harmful side effects” relates to chemicals that are intended to achieve a change in the environment, e.g. pesti cides. The intended environmental impact is that the pests are eliminated. An impact on health is always a side effect; chemi cals never target health. 13 See Glossary Strategy for Chemical Safety 10/24 2.4. Strategic Measures The strategic measures are those activities with which the involved federal authorities want to achieve the set strategic objectives in the medium term. Strategic measures are those that are of crucial importance to achieve the objectives.14 The strategic measures for the timeline 2017–2020 are listed below in the Table (some measures have already been taken). Table 2: Strategic Measures Title Strategic Measures Objectives Involved federal authorities M1 Obligation to no tify Placing certain chemical substances on the market requires a notification.15 The federal authorities evaluate the documen tation submitted by the manufacturers and make non-confidential data available to the public. Z1 No data – no market Z2 Risk assessment and risk reduction Z8 Appropriate and effi cient enforcement FOEN, FOPH, SECO, NAChem M2 Modernising chemicals legis lation Placing on the market of substances that have not been registered in the EU, and synthetic nanomaterials, is subject to the notification requirement. Intermediates placed on the market and the use of syn thetic nanomaterials are subject to a re porting obligation. Z1 No data – no market Z2 Risk assessment and risk reduction Z8 Appropriate and effi cient enforcement FOEN, FOPH, SECO, NAChem M3 Authorisation procedures for PPPs and BPs Placing BPs and PPPs on the market re quires an authorisation. Application docu mentation is scientifically examined, inter alia in regard to health and environmental risks, and in regard to proof of efficacy. Authorisation decisions are temporary. Where necessary, restrictions on use are stipulated. For BPs and PPPs which con tain an active substance to be replaced (substitution candidates) the procedures for the comparative evaluation16 are used. Z2 Risk assessment and risk reduction Z1 No data – no market Z3 Substitution FOEN, FOPH, SECO, FOAG, FSVO, NAChem M4 Risk assess ment of selected chemicals The in-depth risk assessment of selected chemical substances with a high risk po tential is realised by taking into account of or by cooperating in international pro grammes of WHO, UNEP, OECD, EU etc. Z2 Risk assessment and risk reduction Z6 International stand ards FOPH, FOEN, FSVO M5 Restriction of certain sub stances As a consequence of Swiss risk assess ments the Confederation, in a mode of autonomous implementation of EU Regu lations and by the implementation of in ternational conventions, examines re strictions for certain chemicals and im poses them. Z2 Risk assessment and risk reduction Z6 International stand ards FOPH, FOEN, SECO, FOAG, FSVO 14 These measures generally tie up significant resources and last for several years. 15 Pursuant to Art. 9 in connection with Art. 4 ChemA, https://www.admin.ch/opc/de/classified-compilation/19995887/index.html 16 See Glossary Strategy for Chemical Safety 11/24 Title Strategic Measures Objectives Involved federal authorities M6 GHS implemen tation GHS is implemented in Switzerland, tak ing into account the CLP Regulation of the EU and any future amendments. Z2 Risk assessment and risk reduction Z6 International stand ards FOPH, FOEN, SECO, FOAG, FSVO, NAChem M7 Cooperation with the EU The federal authorities perform the func tions resulting from the existing MRA in the fields BP and GLP. They deepen the technical cooperation (participation in expert bodies etc.) with the EU Commission, the European Chemicals Agency (ECHA) and the Euro pean Food Safety Authority (EFSA). The formal cooperation is extended, e.g. by a cooperation agreement with ECHA or through an agreement on the mutual recognition of authorisations for PPPs. Z2 Risk assessment and risk reduction Z5 State of knowledge Z8 Appropriate and effi cient enforcement FOEN, FOPH, FOAG, FSVO, SECO, NAChem M8 Authorisation procedures for SHVC Chemical substances of very high con cern (SHVC) are, as in the EU, subject to an authorisation procedure in order to promote the development of lower risk al ternatives. Z3 Substitution Z2 Risk assessment and risk reduction Z4 Sustainable chemis try FOEN, FOPH, SECO, NAChem M9 Promoting sus tainable chemis try Projects and initiatives are promoted es pecially by:  Networking the research institutes ac tive in this field and the federal author ities.  Financial and content-related support of the Global Chemical Leasing Pro gramme of UNIDO.  Promotion of a Best Practice for as sessing chemical substitutes and al ternatives.  Creation of an incentive system for the Safe-by-Design approach in the inno vation phase.17  Substitution of SVHC (see M8).  Supporting training and consultancy for a sustainable use. Z4 Sustainable chemis try Z3 Substitution Z2 Risk assessment and risk reduction FOPH, FOEN M10 WG endocrine active sub stances A Working Group (WG) “Endocrine active substances” steps up the cooperation in this field and ensures that the relevant activities by the federal agencies are co ordinated. Z2 Risk assessment and risk reduction Z5 State of knowledge Z6 International stand ards Z7 Professional exper tise and information of the controllers Z3 Substitution FOEN, FOPH, FSVO, SECO, FOAG, Swissme dic M11 Action plan PPP The action plan of the Federal Council on Risk Reduction and Sustainable Use of PPPs contains ca. 50 specific measures in the following areas for action: All objectives FOAG, FSVO, FOEN, SECO, FOPH 17 In the framework of the Research and Innovation promotion by the Confederation, e.g. in the field of nanomaterials. Strategy for Chemical Safety 12/24 Title Strategic Measures Objectives Involved federal authorities  Existing risks are specifically reduced.  Independently of the risk, the potential for reducing the use of PPPs and their emission levels is used.  New possibilities are developed in or der to reduce the uses of PPPs and their emission levels.  An improved understanding of the ef fects and sustainable use of PPPs. M12 Action Plan Syn thetic Nano materials The action plan Synthetic Nanomaterials of the Federal Council contains a cata logue of measures in order to fill in meth odological and legal gaps in the field of nanomaterials. All objectives FOEN, FOPH, FOAG, SECO, FSVO, NAChem M13 Support for SCAHT and Ecotox Centre The strategic monitoring group of the Confederation for the Swiss Centre for Applied Human Toxicology (SCAHT) and the advisory group for the Ecotox Centre shall encourage these two Centres to support the involved federal authorities in the implementation of the Chemicals strategy. Z5 State of knowledge Z6 International stand ards Z2 Risk assessment and risk reduction FOEN, FOPH, SECO, FSVO, FOAG, Swiss medic M14 Development of risk evaluation methodologies Harmonised alternative test methods as well as new assessment approaches shall be developed for the risk evaluation of chemicals. Development shall be real ised by cooperating in particular with SCAHT, Ecotox Centre, Agroscope and the planned 3R Competence Centre as well as with the OECD, with the Euro pean Union Reference Laboratory for al ternatives to animal testing (EURL ECVAM), with ECHA and EFSA. Z5 State of knowledge Z6 International stand ards Z2 Risk assessment and risk reduction FOPH, FOEN, FOAG, SECO, FSVO M15 Impact of chemi cals policy The involved federal authorities shall identify and describe indicators enabling to estimate the impact of the Swiss Chemicals Policy on the environment and health. Ongoing activities and initiatives of WHO, UNEP, OECD and the EU shall be supported, when possible, by Swiss projects and activities (see M16–18). Z5 State of knowledge Z2 Risk assessment and risk reduction Z6 International stand ards FOEN, FOPH, SECO, FOAG, FSVO M16 Influence of chemicals on diseases Knowledge about relationships between certain diseases and exposure to chemi cals shall be deepened. Ongoing work and initiatives of WHO shall be supported (see M15, M17). Z5 State of knowledge Z2 Risk assessment and risk reduction FOPH, SECO M17 National HBM study The setup of a national Human biomoni toring Study (HBM Study) that inter alia contains a collection of health data and human biological samples. This should enable relationships between exposure to chemicals, nutrient deficiencies and be haviours and the occurrence of illnesses to be investigated. The project is inte grated into the HBM Research project of the EU (HBM4EU). Z5 State of knowledge Z2 Risk assessment and risk reduction FOPH, FSVO, SECO Strategy for Chemical Safety 13/24 Title Strategic Measures Objectives Involved federal authorities M18 Environmental Specimen Bank The federal authorities shall carry out a feasibility study for the creation of an En vironmental specimen bank, while taking into account existing monitoring pro grammes. Z5 State of knowledge Z2 Risk assessment and risk reduction FOEN, FOAG M19 Identifying new risks The federal authorities draw up suitable procedures in order to swiftly identify chemical-related risks to the environment and health (e.g. using expert hearings, systematic screening of scientific litera ture, indications from other countries, findings from their own observations). Z5 State of knowledge Z2 Risk assessment and risk reduction Z6 International stand ards FOPH, FOEN, SECO, FOAG, FSVO M20 Information and advising The federal authorities inform, support and advise in particular manufacturers, downstream users, the general public and the enforcement authorities. Z7 Professional exper tise and information of the controllers Z8 Appropriate and effi cient enforcement Z2 Risk assessment and risk reduction NAChem, FOPH, FOEN, SECO, FOAG, FSVO M21 Information on environmental figures The federal authorities inform the public of the emissions of pollutants in air, water and land as well as of waste transfers. Z6 International Stand ards Z8 Appropriate and effi cient enforcement FOEN M22 Education Aspects of chemical safety and sustaina ble use are promoted in schools (compul sory primary and secondary schools), in vocational education, higher professional education and in professional further edu cation, in particular by:  Supporting the teachers with teaching materials/modules on chemical safety which are oriented towards the Swiss curriculums Lehrplan 21 (discipline NPS Nature, People, Society; compe tence area NPS 3) and Plan d’Études Romand.  Recommendations for the revision or new development of educational ordi nances and educational curricula for vocational basic education and of ex amination regulations and guidelines in the higher vocational training.  Defining the requirements for obtain ing special licences for the use and of expertise for the delivery of certain chemicals. Z7 Professional exper tise and information of the controllers Z2 Risk assessment and risk reduction Z4 Sustainable chemis try FOEN, FOPH, SECO, FOAG, FSVO Strategy for Chemical Safety 14/24 Title Strategic Measures Objectives Involved federal authorities M23 International chemicals pol icy The federal authorities collaborate on in ternational programmes and regulations (e.g. with SAICM, UNEP, UNECE, WHO, OECD). Z6 International stand ards FOPH, FOEN, FSVO, SECO M24 Good laboratory practice The federal authorities coordinate and harmonise GLP-relevant aspects in na tional and international fields and ensure the monitoring of certain GLP test facili ties. The principle of mutual acceptance of data (MAD) 18 in the context of the OECD is supported. Z6 International stand ards Z8 Appropriate and effi cient enforcement FOPH, FOEN, Swissmedic, NA Chem M25 Market surveil lance Controls are carried out in order to moni tor the actions of the parties, and to en sure the legality of the actions. In particu lar, the compliance with self-regulation, notification obligations, registration obli gations and authorisation requirements are controlled. Z8 Appropriate and effi cient enforcement Z1 No data – no market Z2 Risk assessment and risk reduction Z7 Professional exper tise and information of the controllers FOEN, FOPH, FOAG, SECO, NAChem M26 Improving the enforcement Enforcement of the chemicals legislation is evaluated and if needed, adapted, also in regard to the utilisation of synergies from international collaboration. Z8 Appropriate and effi cient enforcement Z2 Risk assessment and risk reduction Z4 Sustainable chemis try FOPH, FOEN, SECO, FOAG, FSVO, NAChem M27 IT support in im plementation IT instruments will be developed and em ployed which are compatible with the de velopment of international (e.g. IUCLID, R4BP) and national Standards (e.g. Chemicals Product Register). An e-ad ministration will be developed for the pro cessing and should contribute to an in creased efficiency. Z8 Appropriate and effi cient enforcement Z2 Risk assessment and risk reduction NAChem, FOPH, FOEN, SECO, FOAG, FSVO M28 Reporting obli gation for chemi cals Manufacturers are obliged to report the most important information on their chemical substances and preparations to the National Product Register. This regis ter serves in particular in an advisory ca pacity for the information centre for poi soning emergencies (Tox Info Suisse). Z8 Appropriate and effi cient enforcement Z2 Risk assessment and risk reduction NAChem, FOPH, FOEN, SECO, FOAG M29 Stakeholder groups A regular exchange takes place with the most important stakeholder groups (inter alia cantonal enforcement authorities, un ions, industrial and trade associations as well as consumer protection and environ mental associations). Z7 Professional exper tise and information of the controllers Z8 Appropriate and effi cient enforcement Z2 Risk assessment and risk reduction Z3 Substitution Z4 Sustainable chemis try FOEN, FOPH, FOAG, FSVO, SECO, NAChem 18 See Glossary Strategy for Chemical Safety 15/24 3. Implementation A regular report on the implementation of the chemicals legislation must be submitted to the Federal Council.19 These reports shall also take into account the status of achievement of the objectives. The chemicals and PPP steering committee20 is responsible for the implementation of the Chemical Safety Strategy. When implementing the measures other federal strategies have to be taken into ac count. Any conflict of objectives has to be solved by balancing of interests. 3.1. Targets and indicators With regard to the implementation of the strategy the strategic objectives are made operational with target values, and indicators are assigned to each target value. This enables the achievement of the intended medium-term objectives to be measurable and verifiable. Table 3: Target values for the period 2017–2020 No . Strategic target Target(s) 2017–2020 Indicators Z1 No data – no market The intrinsic properties for all chemicals (as such and in articles) used in Switzerland are known. The chemicals (as such) are correspondingly classified and labelled, and the manufacturers di vulge the relevant safety information in the safety data sheets to the professional or commercial us ers. Results of controls A notification requirement is introduced for sub stances that are placed on the market in amounts of ≥ 1 tonne/year and not registered in the EU. Qualitative (met, partially met, not met) The notification requirement for substances that are placed on the market in amounts of ≥ 1 tonne/year is extended to synthetic nanomateri als. Qualitative (met, partially met, not met) All substances, which require notification, as well as PPPs and BPs have been legally placed on the Swiss market (also applies to Z2). Results of controls Z2 Risk assessment and risk reduc tion Only those chemicals that have been assessed with regard to their risks to the human health and the environment are placed on the Swiss market. Necessary risk reduction measures have been put in place. Manufacturers fulfil the self-regulation obligations. Results of controls The placing on the market and the use of sub stances with inacceptable risks for the environ ment and health are adequately restricted. Qualitative (met, partially met, not met) Compare the Swiss regula tions with EU law (inter alia REACH21 Annex XVII) and international agreements Switzerland participates in international pro grammes and initiatives for the risk assessment of certain chemical substances. Qualitative (met, partially met, not met) In the Swiss chemicals legislation the criteria for identifying endocrine disrupters are defined. They Qualitative (met, partially met, not met) 19 Reporting for 2013-2016 is currently under preparation; the next reporting period will cover 2017-2020. 20 See Annex II 21 See Glossary Strategy for Chemical Safety 16/24 No . Strategic target Target(s) 2017–2020 Indicators are harmonised with the EU. The criteria serve as the basis for risk management decisions. The sales restrictions for chemicals take into ac count the findings from current cases of poison ing. Qualitative (met, partially met, not met) Measures have been adopted for risk reduction when chemicals are correctly used and against their unintended use. Qualitative (met, partially met, not met) Z3 Substitution Substances of very high concern (SVHC) are sub stituted (also applies to Z4). Qualitative (met, partially met, not met) Compare the Swiss regula tions with REACH Annex XIV Procedures for comparative evaluation are used for BPs and PPPs, which contain an active sub stance to be replaced (substitution candidates). Qualitative (met, partially met, not met) Z4 Sustainable chemistry The principles of sustainable chemistry are taken into account in research, development, production and application. Qualitative (met, partially met, not met) The aspect of chemical safety is increasingly con sidered in funded innovation projects (e.g. from Innosuisse22 in the field of nanotechnology or from UNIDO in the field of chemical leasing). Quantitative: Proportion of the funded projects with modules for chemical safety Assistance in CHF for such projects Networking between stakeholders in commerce and industry, science and with the authorities serves the transfer of knowledge and enables a coordinated support of sustainable processes and applications. Qualitative (met, partially met, not met) Z5 State of knowledge Research to clarify mechanisms of action of sub stances is supported (Adverse Outcome Path ways AOP). Qualitative/Quantitative: Number of proposals intro duced into the OECD work ing groups Switzerland participates in the Test Guideline Pro gramme of the OECD in the development of test ing guidelines that are based on alternative and animal-friendly methods. Qualitative/Quantitative: WNT project (co-)chaired by Switzerland Participation of Switzerland in commenting on new/re vised testing guidelines First proposals for indicators for the evaluation of the effects of chemicals management on health and the environment are put forward. Qualitative (met, partially met, not met) The chemicals legislation is based on the current state of knowledge. Qualitative (met, partially met, not met) Switzerland participates in scientific committees for the further development of knowledge in the field of safety and sustainable use of chemicals. Qualitative: Projects at na tional and international level, in which Switzerland participates or which are (co-)financed by Switzer land 22 https://www.kti.admin.ch/kti/de/home/ueber-uns/Innosuisse.html Strategy for Chemical Safety 17/24 No . Strategic target Target(s) 2017–2020 Indicators A national cohort (see M17) has been launched regarding a national human biomonitoring pro gramme. Qualitative (met, partially met, not met) Z6 International Standards Switzerland contributes to international resolu tions, conventions, guidelines etc. in the field of chemicals and also campaigns internationally for their implementation. All the UN conventions and resolutions ratified by Switzerland as well as OECD Council decisions which relate to chemi cals legislation are adopted into Swiss law and implemented. The SAICM guidelines for the pru dent risk management of chemicals are observed. Qualitative (met, partially met, not met) Z7 Professional ex pertise and infor mation of the controllers The manufacturers of chemicals meet their self regulation obligations23 (see target Z1 and Z2). Results of controls Non-confidential data from the notification dossier for chemical substances are accessible to the public. Qualitative (met, partially met, not met) Professional and industrial users, who are active in the fields of bathing water disinfection, pest control, use of plant and wood protection products as well as in handling coolants, have the required special licences and training. Results of controls All dealers who supply certain hazardous chemi cals (see Annex 5 ChemO) have the required technical expertise. They inform the recipients on the correct handling. Results of controls The basic elements for the safe handling of chem icals are included in the education ordinance and educational curricula. This also relates to the vo cational basic education in professional catego ries, which need the handling of chemicals that are generally prohibited for adolescents. Quantitative: number of ed ucational curricula that meet the requirement Qualitative (met, partially met, not met) Z8 Appropriate and efficient enforce ment The pre- and post-market implementation of the chemicals legislation is evaluated in regard to its efficiency. Possible measures for optimising the procedures and cooperation (within the Confeder ation and between the Confederation and the can tons) have been introduced. Qualitative (met, partially met, not met) The chemicals legislative requirements for com panies and their products are checked by the competent authorities by means of spot checks. Results of the spot checks Switzerland participates in international priority projects to control companies and products. Qualitative (met, partially met, not met) 23 See Glossary Strategie Chemikaliensicherheit 18/24 Annex Annex I: Matrix of Objectives and Measures In the following table, the measures applicable to each objective are shown. Dark coloured measures provide a major contribution, lightly coloured measures provide a complimentary contribu tion to the achievement of the objective. Table 4: Matrix of Objectives and Measures Z1 Z2 Z3 Z4 Z5 Z6 Z7 Z8 N o d a ta – n o m a rk e t R is k a s s e s s m e n t a n d ri s k r e d u c ti o n S u b s ti tu ti o n S u s ta in a b le c h e m is tr y S ta te o f k n o w le d g e In te rn a ti o n a l S ta n d a rd s P ro fe s s io n a l e x p e rt is e a n d i n fo rm a ti o n o f th e c o n tr o ll e rs A p p ro p ri a te a n d e ff i c ie n t e n fo rc e m e n t M1 Obligation to notify M2 Modernising chemicals legislation M3 Authorisation procedures for PPPs and BPs M4 Risk assessment of selected chemicals M5 Restriction of certain chemicals M6 GHS implementation M7 Cooperation with the EU M8 Authorisation procedures for SHVC M9 Promoting sustainable chemistry M10 WG endocrine active substances M11 Action plan PPP M12 Action Plan Synthetic Nanomaterials: M13 Support by SCAHT and EcoTox Centre M14 Development of risk assessment methodologies M15 Impact of the chemicals policy M16 Influence of chemicals on diseases M17 National HBM study M18 Environmental specimen bank M19 Identifying new risks M20 Information and advising M21 Information on environmental indicators M22 Education M23 International chemicals policy M24 Good laboratory practice M25 Market surveillance M26 Optimisation of the enforcement M27 IT support for the implementation M28 Reporting obligation for chemicals M29 Interest groups Strategie Chemikaliensicherheit 19/24 Annex II: Organisation of the Federal Implementation of the Chemi cals Legislation Essentially, six federal authorities are involved in the federal implementation of the chemicals legis lation:  Federal Office for the Environment (FOEN) for the interests of environmental protection and indirect health protection;  Federal Office of Public Health (FOPH) for the interests of health protection;  Federal Food Safety and Veterinary Office (FSVO) for the interests of food safety;  Federal Office for Agriculture (FOAG) for specific interests in plant protection products;  State Secretariat for Economic Affairs (SECO) for the interests of the protection of workers;  Common Notification Authority for Chemicals (NAChem) of FOEN, FOPH and SECO, as the central authority for the notification and authorisation for industry. The inter-agency implementation organisation can be described schematically as follows: Figure 3: Federal Implementation of the Chemicals Legislation The Steering Committee Chemicals and Plant Protection Products consists of the Directors of FOEN, FOPH, FSVO, FOAG and SECO. The activities of the steering committee in the framework of the chemicals implementation include:  Defining and reviewing the strategy (see chapter 3),  Managing the Notification Authority for Chemicals (NAChem) and the Authorisation Body for PPPs of the FOAG (AB),  Managing the associated interdepartmental procedures. The Coordination Committee Chemicals is composed of the Heads of the specialist departments, the specialist fields and the departments of the FOPH, the FOEN and SECO as well as of NAChem. The Heads of the specialist departments of the FOAG and FSVO have observer status. The activi ties of the Coordination Committee are:  Supervision of the NAChem (controlling: achievement of objectives, budget, strategy), report ing to the Steering Committee, de-escalation of disputes between the involved federal authori ties.  Organisational coordination of the interdepartmental implementation procedures (notification, registration, authorisation) that are handled by the NAChem. Strategie Chemikaliensicherheit 20/24  Coordination of additional activities of the involved federal authorities in connection with the implementation of the chemicals legislation, in particular coordinating strategies in the chemi cals implementation, technical and legal coordination of the chemicals legislation. The Common Notification Authority for Chemicals (NAChem) of FOPH, FOEN and SECO, is the central authority for the notification and authorisation for industry. NAChem processes all notifica tions of existing hazardous substances and preparations as well as applications for registrations of new substances and for biocidal product authorisations. The Coordination Committee PPP consists of the Heads and the Coordinators of the specialist de partments of the FOAG, the FOEN, the FSVO and SECO as well as of the AB. The specialist de partment of the FOPH has observer status. The activities of the Coordination Committee PPP are limited to the coordination of specialised and strategic questions in connection with the implementa tion of the Plant Protection Products Ordinance (PlantPPO). The Approval Body PPP of the FOAG (AB) is the central implementation organ for the approval of PPPs. It handles the applications from companies for the approval of PPPs. In the involved federal authorities the specialist departments or specialist disciplines are responsible as the Assessment Authorities (AA) for handling the applications from the relevant specific spe cialist perspective. Strategie Chemikaliensicherheit 21/24 Glossary 3R Principles The application of the principles of the 3Rs – Replacement, Reduction and Refinement – is intended to limit animal testing to the absolute min imum and to distress the animals as little as possible. Replace means replacing animal testing with alternative methods, Reduce means fewer animal tests, and Refinement means that the stress on the tested ani mal is reduced. Agenda 2030 The Agenda 2030 for sustainable development contains 17 objectives (Sustainable Development Goals, SDGs) on various topics such as overcoming extreme poverty and hunger, education, health, water etc. Implications for chemical safety result from inter alia Objective 2 Sus tainable Agriculture, and from Objective 3 Healthy life for all people. Biocidal products Chemicals for use against harmful organisms. Chemicals Management Processes, standards and framework conditions which allow social ben efits to be realised from the use of chemicals, without any negative ef fects to the environment or to human health. CLP Regulation Regulation (EC) No 1272/2008 on classification, labelling and packag ing of substances and mixtures. The EU introduced the GHS with the CLP Regulation. Comparative Assessment The concept of comparative assessment provides that active sub stances (in the case of PPP or BP), which although fulfilling all legal re quirements, nevertheless have certain unfavourable properties for health and the environment, are to be declared as “candidates for sub stitution”. Plant protection products and biocidal products with such sub stitution candidates may only be authorised for use when no economic and feasible alternatives exist that are significantly safer for humans and the environment. GHS Global harmonised system for the classification and labelling of chemi cals GLP Good Laboratory Practice regulates the implementation of safety checks for chemical products. MAD The OECD decision on the mutual acceptance of data (MAD) stipulates that data obtained from tests on chemicals in an OECD Member State according to the OECD testing guidelines and to the OECD basic princi ples of Good Laboratory Practice are accepted in other Member States for the purposes of the protection of human health and of the environ ment. MRA Agreement between the EU and Switzerland on the mutual recognition of conformity assessments. Plant protection product Chemicals used to combat diseases, pests and weeds in crops. REACH REACH stands for Registration, Evaluation, Authorisation and Re striction of Chemicals and regulates the handling of chemicals in the EU. SAICM The global chemicals strategy SAICM (Strategic Approach to Interna tional Chemicals Management) is a framework agreement which aims to promote the sustainable management of chemicals. Self-regulation The responsibility and liability for correctly placing the majority of chemi cal products on the market lies entirely with the relevant manufacturers. The principle of self-regulation applies. In the context of self-regulation the manufacturer must ensure that its products do not harm human Strategie Chemikaliensicherheit 22/24 health or the environment. In particular, the manufacturer must classify, package and label the products based on their properties, and compile exposure scenarios and a safety data sheet (see also Art. 5 ChemA, Art. 5 ChemO). Sustainable chemistry The endeavour when handling chemical substances in industry and la boratory, when manufacturing and using chemical substances and products, to protect the environment and its resources, in that fewer en vironmentally harmful chemical compounds are employed. At the same time the compounds used should be wholly returned again into the ma terial cycle and processes with a low energy consumption should be ap plied. Unacceptable risk The decisive issue of risk management is whether the acceptance of the risk can be justified and the risk in this sense is “reasonable”. In chemicals management this decision is mainly supported by the exist ence of scientifically founded effect thresholds, below which harm to health or damages to the environment are not expected. An unaccepta ble risk results from the use of a substance and if thereby an exposure occurs which exceeds the effect threshold. This simple concept of the “qualitative evidence” of risk differs from the “quantitative risk assess ment” or “risk-benefit analysis” which are used in other technical fields and also in chemicals management when threshold values cannot be derived (e.g. frequently for CMR substances). , Strategie Chemikaliensicherheit 23/24 Abbreviations AA Assessment Authorities AB Authorisation Body for PPPs AgricA Federal Act on Agriculture (Agriculture Act) AOP Adverse Outcome Pathways BP Biocidal products ChemA Federal Act on Protection against Dangerous Substances and Prepara tions (Chemicals Act) ChemFO Ordinance on Fees for the Federal Enforcement of the Chemicals Legisla tion (Chemicals Fees Ordinance) ChemO Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance) ChemPICO Ordinance on the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Chemicals in International Trade (PIC Ordi nance) CHF Swiss Francs CLP Classification, labelling and packaging24 DETEC Federal Department of the Environment, Transport, Energy and Communi cations ECHA European Chemicals Agency ECVAM European Centre for the Validation of Alternative Methods FDHA Federal Department of Home Affairs EFSA European Food Safety Authority EPA Federal Act on the Protection of the Environment (Environmental Protec tion Act) EU European Union EURL-ECVAM European Union Reference Laboratory for alternatives to animal testing FOEN Federal Office for the Environment FoodA Federal Act on Foodstuffs and Utility Articles (Foodstuffs Act) FOPH Federal Office of Public Health FOAG Federal Office for Agriculture FSVO Federal Food Safety and Veterinary Office GHS Globally Harmonized System of Classification and Labelling of Chemicals24 GLP Good Laboratory Practice24 ILO International Labour Organization IUCLID International Uniform Chemical Information Database MRA Mutual Recognition Agreement24 NAChem Notification Authority for Chemicals OBP Ordinance on the Placing on the Market and Handling of Biocidal Products (Ordinance on Biocidal Products) OECD Organisation for Economic Cooperation and Development OGLP Ordinance on Good Laboratory Practice ORRChem Ordinance on Risk Reduction related to the Use of certain particularly dan gerous Substances, Preparations and Articles (Ordinance on Chemical Risk Reduction) PIC Rotterdam Convention on the Prior Informed Consent PlantPPO Ordinance on the Placing on the Market of Plant Protection Products (Plant Protection Products Ordinance) POP Persistent organic pollutants PPP Plant protection product PRTR Pollutant Release and Transfer Register 24 See also Glossary Strategie Chemikaliensicherheit 24/24 PRTRO Ordinance on the Register relating to Pollutant Release and the Transfer of Waste and of Pollutants in Waste Water (PRTR Ordinance) R4BP Register for Biocidal Products REACH Registration, Evaluation, Authorisation and Restrictions of Chemicals24 SAICM Strategic Approach to International Chemicals Management24 SCAHT Swiss Centre for Applied Human Toxicology SECO State Secretariat for Economic Affairs SVHC Substances of Very High Concern TBA Federal Act on Technical Barriers to Trade UN United Nations UNECE United Nations Economic Commission for Europe UNEP United Nations Environment Programme UNIDO United Nations Industrial Development Organization WG Working group WHO World Health Organization WNT Working Group of National Coordinators of the OECD Test Guidelines Pro gramme WPA Federal Act on the Protection of Water against Pollution (Water Protection Act)