ENVIRONMENTAL PROTECTION N A T IO N A L P R O G R A M M E O N H A Z A R D O U S C H E M IC A L S THE FINNISH ENVIRONMENT 4en | 2017 National Programme on Hazardous Chemicals Interim review and revision 2017 MINISTRY OF THE ENVIRONMENT T H E F IN N IS H E N V IR O N M E N T 4 e n | 2 0 1 7 National Programme on Hazardous Chemicals Interim review and revision 2017 Ministry of the Environment, Helsinki 2018 The Finnish Environment 4en/2017 Ympäristöministeriö ISBN: 978-952-11-4739-5 (PDF) Cover photo: Risto Puranen / Vastavalo Layout: Government Administration Unit, Publications, Erja Kankala Helsinki 2018 Description sheet Published by Ministry of the Environment 2018 Authors Working group Title of publication National Programme on Hazardous Chemicals. Interim review and revision 2017 Series and publication number The Finnish Environment 4en/2017 Register number - Subject Environmental protection ISBN PDF 978-952-11-4799-9 ISSN (PDF) 1796-1637 Website address (URN) http://urn.fi/URN:ISBN:978-952-11-4799-9 Pages 84 Language English Keywords chemicals, environmental protection, health protection, occupational health and safety, risk management, chemicals control Abstract A review has been conducted on the implementation of the National Programme on Hazardous Chemicals and its recommendations have been revised. The programme was prepared in accordance with Prime Minister Vanhanen’s Government Programme in 2006 and it was supplemented in 2013 as required by Prime Minister Katainen’s Government Programme. The objective of the programme is to ensure that chemicals pose no significant environmental risks or human health hazards in Finland in 2020. With regard to the management of chemical risks the revision focused on changes in the operating environment. These include the circular economy, the 7th EU Environment Action Programme, the Agenda 2030 for Sustainable Development and Sustainable Development Goals, and the reform of the EU the legislation and policy on occupational health and safety. The matters considered also included how the programme can contribute to the sustainable use of biocides and application of the principles of sustainable chemistry, enhance the knowledge base on environmental microplastics, and better take into account the exposure to sensitizers. The recommendations for measures have been further specified and updated. More information is still needed on the exposure of the population and employees to chemicals and environmental load caused by hazardous chemicals. Matters to be taken into account in promoting the circular economy include the risks of hazardous substances contained in the materials and possibilities to use non-harmful alternatives instead of these. The new recommendations for measures are concerned with making sustainable chemistry better known, reducing exposure to sensitizers at workplaces, preparation of instructions for sustainable use of biocides, and taking international action to reduce plastic wastes in marine areas and the harmful substances contained in and bound to these. Publisher Ministry of the Environment Publication sales/ Distributed by Distribution by: julkaisut.valtioneuvosto.fi Publication sales: julkaisutilaukset.valtioneuvosto.fi http://julkaisut.valtioneuvosto.fi/ http://julkaisutilaukset.valtioneuvosto.fi/Etusivu Kuvailulehti Julkaisija Ympäristöministeriö 2018 Tekijät Työryhmä Julkaisun nimi Kansallinen vaarallisia kemikaaleja koskeva ohjelma. Väliarviointi ja tarkistus 2017 Julkaisusarjan nimi ja numero Suomen ympäristö 4en/2017 Diaari/hankenumero - Teema Ympäristönsuojelu ISBN PDF 978-952-11-4799-9 ISSN PDF 1796-1637 URN-osoite http://urn.fi/URN:ISBN:978-952-11-4799-9 Sivumäärä 84 Kieli englanti Asiasanat kemikaalit, ympäristönsuojelu, terveydensuojelu, työsuojelu, riskinhallinta, kemikaalivalvonta Tiivistelmä Kansallista vaarallisia kemikaaleja koskevan ohjelman toimeenpanoa on arvioitu ja sen suositukset on tarkistettu. Itse ohjelma on laadittu vuonna 2006 pääministeri Vanhasen hallitusohjelman mukaisesti ja sitä on täydennetty vuonna 2013 pääministeri Kataisen hallitusohjelman edellyttämällä tavalla. Kemikaaliohjelman tavoite on, että kemikaalit eivät aiheuta Suomessa merkittävää terveys- ja ympäristöhaittaa vuonna 2020. Tarkistuksessa kiinnitettiin kemikaaliriskien hallinnan näkökulmasta huomiota toimintaympäristön muutoksiin. Näiksi tunnistettiin kiertotalous, EU:n 7. ympäristöalan toimintaohjelma, Agenda 2030-toimintaohjelma ja kestävän kehityksen tavoitteet sekä EU:n työsuojelulainsäädännön ja -politiikan uudistaminen. Lisäksi pohdittiin, miten ohjelmalla voidaan edistää biosidien kestävää käyttöä ja kestävän kemian periaatteiden soveltamista, lisätä tietopohjaa ympäristön mikromuoveista sekä huomioida nykyistä paremmin altistuminen herkistäville aineille. Ohjelman toimenpidesuosituksia on täsmennetty ja ajanmukaistettu. Väestön ja työntekijöiden altistumisesta kemikaaleille sekä haitallisten aineiden ympäristökuormituksesta tarvitaan edelleen lisää tietoa. Kiertotaloutta edistettäessä tulee myös ottaa huomioon materiaalien sisältämien haitallisten aineiden riskit ja mahdollisuudet korvata ne haitattomilla vaihtoehdoilla. Uusina toimenpidesuosituksina esitetään kestävän kemian tunnetuksi tekemistä, herkistäville aineille altistumisen vähentämistä työpaikoilla, biosidien kestävän käytön ohjeiden laatimista sekä merten muovijätteiden ja niihin sisältyvien ja sitoutuvien haitallisten aineiden vähentämistä kansainvälisin toimin. Kustantaja Ympäristöministeriö Julkaisun myynti/ jakaja Sähköinen versio: julkaisut.valtioneuvosto.fi Julkaisumyynti: julkaisutilaukset.valtioneuvosto.fi http://julkaisut.valtioneuvosto.fi/ http://julkaisutilaukset.valtioneuvosto.fi/Etusivu Presentationsblad Utgivare Miljöministeriet 2018 Författare Arbetsgruppen Publikationens titel Nationella programmet för farliga kemikalier. Halvtidsutvärdering och revidering 2017 Publikationsseriens namn och nummer Miljön i Finland 4en/2017 Diarie-/ projektnummer - Tema Miljövård ISBN PDF 978-952-11-4799-9 ISSN PDF 1796-1637 URN-adress http://urn.fi/URN:ISBN:978-952-11-4799-9 Sidantal 84 Språk engelska Nyckelord kemikalier, miljövård, hälsoskydd, arbetarskydd, riskhantering, kemikalietillsyn Referat Verkställandet av det nationella programmet för farliga kemikalier har utvärderats och dess rekommendationer reviderats. Själva programmet har utarbetats 2006 i enlighet med statsminister Vanhanens regeringsprogram och har kompletterats 2013 på det sätt som statsminister Katainens regeringsprogram förutsatte. Kemikalieprogrammets mål är att kemikalier inte ska orsaka betydande hälso- och miljöolägenheter i Finland efter år 2020. I revideringen fäste man uppmärksamhet vid förändringar i verksamhetsmiljön vad gäller hanteringen av kemikalierisker. Som förändringar identifierade man cirkulär ekonomi, EU:s 7:e åtgärdsprogram för miljön, åtgärdsprogrammet Agenda 2030 och målen för hållbar utveckling samt reformen av EU:s arbetsmiljölagstifting och politik. Därtill funderade man på hur programmet kan främja hållbar användning av biocider och tillämpningen av principer för hållbar kemi, öka kunskapsbasen om mikroplaster i miljön och beakta exponering för allergiframkallande ämnen bättre än i nuläget. Programmets åtgärdsrekommendationer har preciserats och uppdaterats. Det behövs fortsättningsvis mer information om befolkningens och arbetstagarnas exponering för kemikalier och om miljöeffekterna av skadliga ämnen. När cirkulär ekonomi främjas ska man också beakta riskerna med de skadliga ämnen material innehåller och möjligheterna att ersätta dem med ofarliga alternativ. Som nya åtgärdsrekommendationer föreslår man mer information om hållbar kemi, minskad exponering för allergiframkallande ämnen på arbetsplatser, upprättande av anvisningar för hållbar användning av biocider samt minskning av plastavfallet i havet och de skadliga ämnen de innehåller och binder genom internationella åtgärder. Förläggare Miljöministeriet Beställningar/ distribution Elektronisk version: julkaisut.valtioneuvosto.fi Beställningar: julkaisutilaukset.valtioneuvosto.fi http://julkaisut.valtioneuvosto.fi/ http://julkaisutilaukset.valtioneuvosto.fi/Etusivu Contents 1 Introduction ................................................................................................................................................................. 9 2 Programme objectives ........................................................................................................................................ 14 3 Changes in the operating environment .............................................................................................. 16 3.1 The circular economy and chemicals........................................................................................................... 16 3.2 The European Union Seventh Environment Action Programme..................................... 18 3.3 The 2030 Agenda: Sustainable Development Goals and chemicals............................. 19 3.4 Safer and healthier work for all........................................................................................................................... 21 3.5 Other key changes........................................................................................................................................................... 22 3.6 Key authorities and research institutes in the field........................................................................ 24 3.7 Key sectoral legislation............................................................................................................................................... 30 4 Programme recommendations for action ......................................................................................... 43 5 Implementation and monitoring of the programme ............................................................. 74 6 Impact assessment of the recommendations for measures ............................................. 75 7 Summary ..................................................................................................................................................................... 77 Appendix 1: Abbreviations ......................................................................................................................................... 79 Appendix 2: Sustainable Development Goals and targets ............................................................ 83 9 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 1 Introduction Finland adopted the National Programme on Hazardous Chemicals in 2006 with a view to ensuring that chemicals cause no significant harm to human health and the environment in Finland in 2020. This objective is in line with one of the goals agreed at the 2002 Johan- nesburg World Summit on Sustainable Development and the United Nations (UN) Strate- gic Approach to International Chemicals Management (SAICM) adopted in 2006. The programme has assessed the harm caused by chemicals to consumers, public health, occupational health and the environment throughout their life cycles. The programme aims to promote and develop chemical risk management, particularly in those sectors and functions of society that have so far received less attention. The groups of substances ad- dressed include industrial and consumer chemicals (substances and mixtures), plant pro- tection products, fertilisers, feed and food additives and contaminants, biocides, medicinal products and veterinary medicinal products, cosmetics, chemicals in products (articles), and harmful substances generated in industrial and combustion processes. The key programme objectives include: • achieving the objectives laid down in the EU Regulations on chemicals (REACH and CLP) effectively and making use of new information obtained in the process; • gathering information on and monitoring exposure to hazardous substances; • developing chemical risk assessment and risk management among industrial and other operators; • reducing chemical risks posed by products; • contributing to the reduction of the adverse effects of chemicals at an international level. The scope defined for the programme does not include environmental or health risks aris- ing from viable microbes or genetically modified organisms (GMOs), nor those posed by intentional misuse of chemicals. Chemicals affecting climate change, acidification and eu- trophication are not discussed, because their risks are covered in other programmes; nor 10 THE FINNISH ENVIRONMENT 4EN/2017 are chemical accidents and transport operations covered. Furthermore, the programme does not explore health risks due to smoking, regardless of the fact that environmental tobacco smoke contains several carcinogenic and other hazardous chemicals, as these are governed by separate legislation. In addition, this second revision took note of the fact that Finland’s 2011 National Action Plan on the Sustainable Use of Plant Protection Prod- ucts is implementing the objectives of the National Programme on Hazardous Chemicals with regard to plant protection products. The first interim review of the National Chemicals Programme was conducted in 2012. At the time, the review looked into the progress made through the original measures in terms of achieving the international goal of minimising the health and environmental risks of chemicals by 2020. In keeping with an objective set out in Prime Minister Katainen’s Government Programme of 22 June 2011, the review also assessed the need for further ac- tion to address newly emerging topics, such as nanomaterials, endocrine-disrupting sub- stances, and the combined effects of chemicals. As part of the first interim review and revision, it was decided that the Ministry of the Envi- ronment and the Ministry of Social Affairs and Health would get together in 2016 to assess the need and methods for a new interim review on the status of implementation of the programme’s recommendations. The two ministries recognised the need to review wheth- er the current measures would be sufficient in order to achieve the international goals and to consider any possible further action due to changes in the operating environment. The Ministry of the Environment set up a working group to carry out an interim review and re- vision of the National Programme on Hazardous Chemicals between 1 October 2016 and 31 January 2017. The working group was assigned to review whether the measures set out in the programme were sufficient to achieve its objective and to submit a proposal for re- vising the programme, considering the changes in the operating environment. Before the working group began its work, the following aspects were identified as changes in the op- erating environment: i) the circular economy; ii) the EU Seventh Environment Action Pro- gramme; and iii) the 2030 Agenda for Sustainable Development and the Sustainable De- velopment Goals. A further change in the operating environment raised during the con- sultation process involved the European Union’s new policies for modernisation of occu- pational safety and health legislation. While drafting its proposal, the working group was also expected to explore how the programme could contribute to the sustainable use of biocides and application of the principles of sustainable chemistry. Based on these assess- ments and reviews, the working group put forward a proposal for the interim review and revision of the programme, which was sent out for a consultation process on 23 February 2017. Opinions on the proposal were submitted by 28 parties, which were mostly satisfied with the proposal. The opinions included some suggestions for technical revisions, which have been taken into account. A few opinions called for more emphatic recommenda- tions for measures than proposed, considering that the programme should be strategic 11 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 and goal-oriented, while not making any specific proposals for changes. Furthermore, a few opinions highlighted the significance of chemical exposure through pharmaceutical waste, foodstuffs and imported goods. Raising the topic of sustainable chemistry was also supported. Some opinions called for a more active role in the European Union and at an international level to restrict the most harmful substances, etc. Several opinions stressed the need to take the circular economy into account and to review legislation governing the topic. Working group members The working group was chaired by Director General Tuula Varis from the Ministry of the Environment, with Director Jari Keinänen from the Ministry of Social Affairs and Health as deputy chair. The working group consisted of the following members: Ministerial Advisers Hanna Korhonen and Sirkku Saarikoski, Ministry of Social Affairs and Health; Laura Holkko, Senior Adviser, Ministry of Economic Affairs and Employment; Tove Jern, Senior Agricul- tural Officer, Ministry of Agriculture and Forestry; Ministerial Advisers Pirkko Kivelä and Ari Kangas, Ministry of the Environment; Heads of Unit Annette Ekman and Paula Haapasola, Finnish Safety and Chemical Agency (Tukes); Jukka Mehtonen, Senior Expert, Finnish En- vironment Institute; Hannu Kiviranta, Research Professor, National Institute for Health and Welfare (THL); Tiina Santonen, Senior Specialist, Finnish Institute of Occupational Health; Irina Simola, Adviser, Confederation of Finnish Industries (EK); Eliisa Irpola, Senior Advisor, Chemical Industry Federation of Finland; Kari Mäkelä, Work Environment Officer, TEAM Industrial Union; Terhi Kuljukka-Rabb, Chemicals Specialist, Association of Finnish Techni- cal Traders; Jenni Vainioranta, Expert on Sustainable Consumption, Consumers’ Union of Finland; and Jari Huhtala, Chemical Adviser and Specialist, Finnish Association for Nature Conservation. The deputy members were as follows: Senior Inspectors Jussi Poutanen and Kirsi Kyrkkö, Ministry of Social Affairs and Health; Pirjo Salminen, Ministerial Adviser, Minis- try of Agriculture and Forestry; Tarja-Riitta Blauberg, Ministerial Adviser, and Kaisa Kauko, Senior Engineer, Ministry of the Environment; Heads of Unit Marilla Lahtinen and Kaija Kal- lio-Mannila, Finnish Safety and Chemical Agency (Tukes); Noora Perkola, Chemist, Finnish Environment Institute; Tapani Tuomi, Senior Specialist, Finnish Institute of Occupational Health; Juha Pyötsiä, Director, Chemical Industry Federation of Finland; Markku Aaltovirta, Collective Bargaining Officer, TEAM Industrial Union; Marja Ola, Environmental Manager, Association of Finnish Technical Traders; Sari Karjomaa, Director-General, Finnish Cosmet- ic, Toiletry and Detergent Association; and Pertti Sundqvist, Expert, Finnish Association for Nature Conservation. The working group’s workshop was also attended by the following specialists: Ministerial Advisers Taina Nikula, Eeva Nurmi and Ulla-Riitta Soveri, Ministry of the Environment; Johanna Salomaa-Valkamo, Director of Communications, Finnish Safety and Chemical Agency (Tukes); and Helvi Heinonen-Tanski, DSc (Agr. & For.), Finnish Associ- ation for Nature Conservation. Ministerial Adviser Laura Niskanen from the Ministry of the Environment functioned as the working group’s secretary. 12 THE FINNISH ENVIRONMENT 4EN/2017 Work implementation The working group prepared an interim review on the implementation of the National Programme on Hazardous Chemicals between 2013 and 2016, complete with a proposal for a revised version of the programme. The interim review is available on the website of the Ministry of the Environment. The working group focused on reviewing the implemen- tation of the recommended measures aiming to achieve the programme’s intended im- pacts between 2013 and 2016, while also identifying development and reform needs relat- ing to the recommendations. The group also analysed key changes that had taken place in the operating environment since the previous interim review and revision process, iden- tifying needs for new recommendations for measures and actions. In its work, the group confined itself to the scope of application outlined in the original programme, while also taking note of the fact that the National Action Plan on the Sustainable Use of Plant Pro- tection Products is implementing the objectives of the Chemicals Programme with regard to plant protection products. The group launched its work by reviewing the implementation of the recommended measures from 2013 to 2016, following the programme’s first interim review and revision. Drawing on the annual monitoring efforts carried out by Finland’s Advisory Committee on Chemicals (KENK), the parties represented in the working group collected the outcomes of implementation of the recommended measures and made proposals for further action to ensure their implementation by 2020. Furthermore, based on the outcomes, the work- ing group assessed the progress of implementation using the following four-step scale: i) green = recommended measure completed; ii) yellow = implementation of recommended measure ongoing and proceeding on schedule; iii) blue = implementation of recommend- ed measure continuing and under control; iv) red = implementation of recommended measure not started or not on schedule. The working group convened four times. In addition, a workshop was organised i) to as- sess whether the programme’s recommendations for measures and the subsequently pro- posed further actions would suffice to achieve the objectives by 2020, while also propos- ing new further actions as required for impact areas 1–4; ii) to deliberate and propose new recommendations for measures, considering changes in the operating environment and analysing how the programme could contribute to the sustainable use of biocides and ap- plication of the principles of sustainable chemistry; and iii) to discuss the cross-cutting role of communications in support of the programme. The workshop was attended by both members and their deputies, as well as the above-mentioned specialists. The workshop was led by Research Engineer Pia Rotko from the Finnish Environment Institute, while working group members facilitated the work carried out in smaller groups. The working group assessed the proposals made in the workshop for revising the pro- gramme, while also analysing the objectives, responsibilities and impacts of the recom- 13 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 mendations for measures. The group aimed to further specify the previous recommenda- tions for measures which were still found to be relevant and require continued implemen- tation. Some recommendations for measures were removed from the revised proposal, because they were assessed to be complete in the interim review or could no longer be implemented for resource-related or other reasons. Completely new recommendations for measures were identified in some impact areas. The analysis paid special attention to the changes identified in the operating environment and to the ways in which the programme could contribute to the sustainable use of biocides and application of the principles of sustainable chemistry, while also considering exposure to sensitisers. 14 THE FINNISH ENVIRONMENT 4EN/2017 2 Programme objectives The objective of the 2006 National Programme on Hazardous Chemicals is to ensure that chemicals cause no significant harm to human health and the environment in Finland in 2020. In keeping with the original version of the National Programme on Hazardous Chem- icals, as adopted in 2006, the programme still places emphasis on the general principles of the EU chemicals policy, a high level of protection of human health and the environment, and the wellbeing of present and future generations. It starts from the precautionary prin- ciple that risk reduction measures must be taken if scientific results indicate that a chemi- cal may cause harmful effects, even if there remains some scientific uncertainty on the sig- nificance and nature of such harm. A further premise is to promote substitution of harmful substances with less harmful ones, should suitable alternatives be available. The impact areas and intended impacts specified for the programme in 2012 remained unchanged. The programme’s impact areas and their intended impacts are as follows: 1) Achieving the objectives laid down in the REACH and CLP Regulations and making use of new information The obligations imposed by the EU’s REACH and CLP Regulations concerning the registration, evaluation, authorisation and restriction of chemicals, as well as the classification, labelling and packaging of chemicals will have been effectively implemented, including the achievement of the objectives set by these Regulations for ensuring a high level of protection of human health and the environment, as well as the widespread application of information obtained through implementing these Regulations. 2) Exposure data and monitoring Adequate information, covering emissions and exposure to substances hazardous to human health and the environment will have been made available for risk assessment 15 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 and risk management purposes, as well as for assessing the impact of the measures taken. 3) Chemical risk assessment and risk management among industrial s and other operators Operators will have adequate information on chemical risk management, including appropriate practices put in place, and such information is used to ensure a high level of protection of human health and the environment, irrespective of the size of the enterprise or unit. Workplaces will have a good command of risk assessment, which is also put into action. 4) Reducing chemical risks posed by products and preparations Adequate information will have been made available on chemicals contained in products and preparations, and the risks posed by these will be controlled throughout their life cycles. 5) International influencing Finland will have actively contributed to the goal of minimising the most significant harmful effects of chemicals on a global scale by 2020, in order to achieve the targets set in the Johannesburg Plan of Action. Finland will be an active participant in international collaboration on chemical risk management and exchange of information. 16 THE FINNISH ENVIRONMENT 4EN/2017 3 Changes in the operating environment The second interim review and revision of the National Programme on Hazardous Chem- icals explored the need for any further action due to changes in the operating environ- ment. This chapter provides a general outline of the key changes in the operating environ- ment from the perspective of chemicals management that the working group considered. At the beginning of its work, the changes identified in the operating environment includ- ed the circular economy, the EU Seventh Environment Action Programme, and the 2030 Agenda for Sustainable Development and its Sustainable Development Goals. In addition, the sections covering the key changes in government organisations and legislation have been updated. As part of drafting the original 2006 National Chemicals Programme, the national bases for drawing up the programme were thoroughly analysed. From its own perspective, the pro- gramme described Finland’s national characteristics and current status, chemical use and manufacturing, steering methods aimed at reducing chemical risks and key authorities, the then-draft REACH Regulation, international cooperation, operators’ voluntary actions, oth- er parties involved in reducing chemical risks, research, and harmful chemicals covered in other programmes. In addition, extensive studies on the chemicals management situation in Finland were conducted to provide some background for drafting the programme. The 2012 interim review and revision of the programme only described the key changes in gov- ernment organisations and legislation since the adoption of the Chemicals Programme. 3.1 The circular economy and chemicals In a circular economy, resources are retained in the economy even when a product has reached the end of its life. The aim is to design and manufacture products from the start in such a way that they can be used and recycled for as long as possible. Transition to a circu- lar economy requires changes throughout value chains, ranging from product design to new business and marketing models and consumer behaviour. The circular economy en- tails a multi-sector and profound transformation in operating methods. One of the objec- 17 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 tives specified in Prime Minister Sipilä’s Government Programme is to elevate Finland as a pioneer in a circular economy by 2025. Published in the autumn of 2016, the ‘Leading the cycle – Finnish road map to a circular economy 2016–2025’ is a plan jointly prepared by the Finnish Innovation Fund Sitra, the relevant ministries and a wide variety of other stake- holders to respond to the opportunities offered by the circular economy. The European Commission Communication of December 2015 on the circular econo- my contains an extensive action plan and proposals to amend six Directives in the waste sector. The implementation of this Circular Economy Package was mainly scheduled for 2016–2017. The Circular Economy Action Plan explores actions to be taken at EU level in order to work towards a circular economy. It contains measures to close material cycles and address different stages of product life cycles from production and consumption to waste management and secondary raw materials markets. With regard to production processes, the Commission will establish the European Re- source Efficiency Excellence Centre with a view to helping small and medium-sized en- terprises (SMEs) to benefit from the business opportunities of increased resource effi- ciency. Examples of actions in this area include facilitating substitution of chemicals of concern and SME access to innovative technologies. In the waste sector, the Commission will launch work on EU-wide quality standards for secondary raw materials. Moreover, the rules to determine when a secondary raw material should no longer be legally considered as ‘waste’ will be established by clarifying existing rules on ‘end-of-waste’. The aim is to pro- vide operators with more certainty and a level playing field. The promotion of non-toxic material cycles1 and better tracking of chemicals of concern in products will facilitate recycling and improve the uptake of secondary raw materials. The Commission will assess the interaction of different pieces of legislation on waste, products and chemicals to address the presence of substances of concern, limit unnecessary bur- den for recyclers and facilitate the traceability and risk management of chemicals in the re- cycling process. The results of this work will feed into the future EU strategy for a non-toxic environment. The analysis of legislative interfaces aims to facilitate substitution of chemicals of concern in products; to improve identification of such chemicals in products; to promote non-tox- ic material cycles; to facilitate the risk management of chemicals in recycling processes; to facilitate recycling, reduce unnecessary burden for recyclers and enhance the uptake of 1 ‘Non-toxic material cycles’ is a concept used in the Circular Economy Package to refer to material cycles that do not contain harmful chemicals to such an extent that they could be regarded as being of concern for health or the environment. The Commission is yet to come up with a more precise definition of the concept, but it is mainly con- sidered to refer to persistent organic pollutants (POPs) and substances of very high concern (SVHCs). 18 THE FINNISH ENVIRONMENT 4EN/2017 secondary raw materials; to facilitate the cross-border circulation of secondary raw mate- rials across Europe; and to create a foundation for the future EU strategy for a non-toxic environment. 3.2 The European Union Seventh Environment Action Programme The European Union Seventh Environment Action Programme (7th EAP), entitled ‘Living well, within the limits of our planet’, will guide the EU environment policy up until 2020. The relevant EU institutions and Member States are jointly responsible for implementing the Action Programme and achieving its priority objectives. The European Parliament and Council adopted the Decision (1386/2013) on the current Action Programme on 20 No- vember 2013. The priority objectives of the Action Programme are as follows: 1. to protect, conserve and enhance the Union’s natural capital; 2. to turn the Union into a resource-efficient, green and competitive low- carbon economy; 3. to safeguard the Union’s citizens from environment-related pressures and risks to health and wellbeing; 4. to maximise the benefits of Union environment legislation by improving implementation; 5. to improve the knowledge and evidence base for Union environment policy; 6. to secure investment for environment and climate policy and address environmental externalities; 7. to improve environmental integration and policy coherence; 8. to enhance the sustainability of the Union’s cities; 9. to increase the Union’s effectiveness in addressing international environmental and climate-related challenges. The third EAP priority objective concerns challenges relating to human health and wellbe- ing and reduction of risks to these posed by pollution, chemicals and climate change. The Action Programme also sets out a long-term vision for a non-toxic environment. It sug- gests that efforts need to be stepped up to ensure that, by 2020, all relevant substances of very high concern (SVHCs), including substances with endocrine-disrupting properties, are placed on the REACH candidate list of substances of very high concern for authorisation. 19 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 The Action Programme also includes a commitment to developing a Union strategy for a non-toxic environment by 2018. The aim is to promote non-toxic material cycles, innova- tion and the development of sustainable substitutes, including non-chemical solutions. The strategy’s horizontal measures intend to ensure: 1. the safety of manufactured nanomaterials and materials with similar properties; 2. the minimisation of exposure to endocrine disruptors; 3. appropriate regulatory approaches to address combination effects of chemicals; and 4. the minimisation of exposure to chemicals in products, including, inter alia, imported products, with a view to promoting non-toxic material cycles and reducing indoor exposure to harmful substances. The European Commission has begun efforts to draft the strategy. Background studies and actions will be prepared in the following themes by the spring of 2017: i) the most vulner- able population groups; ii) substitution of chemicals and grouping of substances; iii) de- velopment of non-toxic substances; iv) very persistent chemicals; v) chemicals in products and material cycles; vi) policy measures, innovations and competitiveness; and vii) an early warning system. 3.3 The 2030 Agenda: Sustainable Development Goals and chemicals The global 2030 Agenda for Sustainable Development (the ‘2030 Agenda’) will guide pro- gress in sustainable development up until 2030. The aim is to eradicate extreme poverty and achieve sustainable development in all of its dimensions. Adopted at the UN Sustain- able Development Summit in September 2015, the Agenda and its Sustainable Develop- ment Goals (SDGs) entered into force at the beginning of 2016. The 2030 Agenda forms an integrated whole with the 2015 Addis Ababa Action Agenda, focusing on financing for development and support for implementation. The new Sustainable Development Goals build on the UN Millennium Development Goals. However, the Sustainable Development Goals differ from the Millennium Development Goals in that they are universal, concerning all UN Member States, rather than just developing countries. The 2030 Agenda contains 17 Sustainable Development Goals, which are specified by 169 targets (see Appendix 2). All the Goals are linked to each other; no one Goal can be achieved without the other. The cross-cutting idea of the 2030 Agenda is the interdepend- ence of global challenges and the comprehensive nature of the solutions adopted. Conse- quently, the Agenda emphasises that promoting sustainable development calls for broad 20 THE FINNISH ENVIRONMENT 4EN/2017 commitment from various stakeholders and new forms of cooperation and partnerships between the public sector, civil society, industry and citizens. Sustainable management of chemicals and waste is key to the implementation of the 2030 Agenda. Chemicals and waste are directly linked to the Sustainable Development Goals concerning sustainable consumption and production, health and wellbeing, and clean water and sanitation. Moreover, sustainable management of chemicals and waste is essential to many other Goals (incl. those concerning climate and biodiversity), supporting their implementation. The UN Strategic Approach to International Chemicals Management (SAICM) is expected to assume an active role in implementing the SDGs, which would ena- ble better access to financing and tapping into the expertise of various UN organisations. The progress made in implementation of the 2030 Agenda and the SDGs is being mon- itored and reviewed at international, regional and national levels. The UN High-Level Political Forum on Sustainable Development (HLPF) plays a key role in monitoring at the international level. Global indicators are being developed for monitoring the implemen- tation of the Goals and targets in a process led by the UN Statistical Commission. In 2016, its expert group published a proposal for over 200 indicators, which will be supplemented over the years. In addition, complementary national indicators are also required due to the general nature of the international indicators. Finland is committed to implementing the 2030 Agenda and its Sustainable Development Goals. The Finnish government has submitted to Parliament a report on its plans to imple- ment the UN Sustainable Development Agenda. Its aim is a carbon-neutral, resource-wise and competent Finland where non-discrimination and equality is secured by 2030. The National Programme on Hazardous Chemicals is carrying out the Goals with regard to sus- tainable chemicals management. Chemicals are directly referred to in targets 3.9, 6.3 and 12.4. Furthermore, chemical risk management supports the achievement of several other Goals (see Appendix 2). Goal 3. Ensure healthy lives and promote wellbeing for all at all ages 3.9 By 2030, substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination. Goal 6. Ensure availability and sustainable management of water and sanitation for all 6.3 By 2030, improve water quality by reducing pollution, eliminating dumping and minimising release of hazardous chemicals and materials, halving the proportion of untreated wastewater and substantially increasing recycling and safe reuse globally. 21 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 Goal 12. Ensure sustainable consumption and production patterns 12.4 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 minimise their adverse impacts on human health and the environment. 3.4 Safer and healthier work for all The EU occupational safety and health policy is contributing to the objective of improving the safety and health of workers in the EU. The Commission conducted a detailed ex-post evaluation of the EU occupational safety and health acquis, which comprised Framework Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work and 23 related Directives. As a result of the evalua- tion, outdated rules will be updated while also refocusing efforts on ensuring better and broader protection and compliance in other respects. Following its evaluation, the Commission adopted Communication COM(2017) 12 final, outlining its view on the modernisation of the EU occupational safety and health legisla- tion and policy in the years to come. All measures will be carried out in cooperation with the Member States and social partners. Efforts will be made to find effective ways to address new risks. Legislative proposals to set or revise binding limit values for carcinogenic substances will be used to step up the fight against occupational cancer. Likewise, efforts will be made to revise existing or establish further occupational indicative exposure limit values and biological limit values in 2017 and 2018. In order to achieve effective implementation of legislation, the European Agency for Safe- ty and Health at Work will stage a Healthy Workplaces Campaign on dangerous substances in 2018–2019, which will be carried out at the national level. In addition to the occupational safety and health Directives, dangerous chemicals used at work are regulated within the EU by virtue of the REACH Regulation. The Commission has undertaken to remove any uncertainties and overlaps between the occupational safety and health Directives regulating chemical agents and the REACH Regulation governing dangerous chemicals and to agree on a common approach in 2017. The theme of safer and healthier work for all will also be promoted through non-legislative measures. Based on the HazChem@Work study, a database on occupational exposure for 22 THE FINNISH ENVIRONMENT 4EN/2017 some hazardous chemicals is being established to centrally pool data on occupational ex- posure to priority dangerous chemicals within the European Union. The European Human Biomonitoring Initiative aims to pool EU-wide biomonitoring data on exposure of the pop- ulation and workers. There are plans to relaunch data collection on European Occupational Diseases Statistics. The Commission also aims to help industry, in particular micro-enterprises and SMEs, com- ply with occupational safety and health legislation. Comprehensive efforts to develop workplace procedures and cooperation and workers’ wellbeing at work are an effective way to boost productivity and innovation in business- es. In its own occupational safety and health policy guidelines, Finland has pointed out that simply eliminating risks is not enough on its own; it is also necessary to promote good concrete solutions. The National Chemicals Programme contributes to responding to these needs. 3.5 Other key changes Sustainable chemistry helps to enhance the sustainable use of natural resources when developing chemicals and chemical services and to promote the design, manufacturing and use of chemicals that are safer for human health and the environment. ‘Sustainable chemistry’ refers to safer, more efficient and more environmentally friendly design, manu- facturing and use of chemicals and processes. Putting sustainable chemistry innovations into use calls for cooperation between industry, public authorities and the scientific com- munity. An example of chemical services and a new type of business model is chemical leasing, where profit is generated by providing services relating to the use of chemicals in- stead of selling large amounts of chemicals. At the same time, this increases the efficiency of chemical use, reduces exposure risk and improves the financial and environmental per- formance of businesses and their access to new markets. Industry could put the abundant chemical data produced under the REACH Regulation to broader use in order to identify the risks posed by the chemicals that they are using and manufacturing, to develop solu- tions in keeping with sustainable chemistry, and to assess the recyclability of materials and products. Sustainable chemistry can contribute to achieving Finland’s bioeconomy and cir- cular economy objectives. Furthermore, Finland’s sustainable chemistry expertise provides a good springboard for building a stronger brand and promoting exports. This calls for close public-private cooperation and adequate investment in research and development in the field of sustainable chemistry. 23 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 The National Communications Plan for Dangerous Chemicals 2014–2020 was drawn up in 2013 in broad cooperation between various public authorities. As part of the pre- vious revision of the Chemicals Programme, the working group set up for this purpose proposed that the key parties draw up an action plan for communicating about chemical risks by the end of 2013. The plan creates guidelines for communications carried out in cooperation between the authorities, outlining the main target groups, key messages and principles, and means and channels of communication. The primary goal is to ensure that consumers use chemicals safely and to increase people’s awareness of chemicals, while al- so helping SMEs, in particular, deal with their statutory duties effectively. The plan takes the key recommendations for measures set out in the Chemicals Programme into account from the perspective of communications and, like the Chemicals Programme, it extends to 2020. The plan’s objectives and contents will be updated, while a chemicals-related communi- cations network set up to implement the plan will draw up annual action plans for chemi- cals communications. The theme of chemicals communications defined for 2016–2017 was construction chemicals. http://www.tukes.fi/en/Branches/Chemicals-biocides-plant-protection-products/The-Na- tional-Communications-Plan-for-Dangerous-Chemicals-20142020/ With regard to digitalisation, the KemiDigi project for digital chemical data management coordinated by Tukes is building a national chemical data repository, enabling enterpris- es to deal with their chemicals-related obligations through a single centralised service. The authorities can then access each operator’s information through their own service view in a format suited to their own purposes. The aim is to enter data into the electronic system only once, allowing industrial operators and authorities to make use of the same service. This reduces the need for both industry and authorities to maintain their own registers. The usability of chemical data will improve, as will its validity and reliability. Companies’ up-to- date chemical data and extracts will serve a wide variety of purposes, such as fire and res- cue operations, supervision of the storage and use of dangerous chemicals, process safety, chemicals safety work, environmental protection, worker protection, consumer safety, and research activities. The service also allows the authorities to provide operators with guid- ance and counselling. In keeping with one of the recommendations for measures set out in the Chemicals Pro- gramme, international influencing efforts were addressed in 2014 by drawing up Finland’s strategic framework for international chemicals management in consultation with various stakeholders, with a view to achieving the best possible impact in terms of chem- icals management. According to this framework, moving forward, Finland will increase high-level influencing efforts in international processes concerning chemicals. Finland has solid expertise in chemical risk management, and it wants to further consolidate this expertise profile. In order to develop international chemicals management, Finland will 24 THE FINNISH ENVIRONMENT 4EN/2017 continue to work towards promoting interaction between the Strategic Approach to Inter- national Chemicals Management (SAICM) and international chemicals agreements. Other key aspects include supporting action, strengthening institutions and increasing educa- tion in developing countries. Further objectives cover paying attention to geographical conditions, developing risk assessment and management, as well as highlighting signifi- cant topical issues relating to chemicals. The strategic framework also calls for national dia- logue and cooperation between administrative authorities, the scientific community and the private sector in international chemical issues. Moving forward, various Finnish parties aim to work towards promoting the objectives in keeping with the framework. 3.6 Key authorities and research institutes in the field The general steering, monitoring and development of activities in accordance with the Chemicals Act2 and the highest management and control of the supervision of compli- ance with the Act and the provisions issued under the Act are the responsibility of the Ministry of Social Affairs and Health as concerns the prevention of physical hazards and harm caused by chemicals to human health and the Ministry of the Environment as con- cerns the prevention of hazards and harm caused by chemicals to the environment. In addition to the duties laid down in the Chemicals Act, the Ministry of Social Affairs and Health is responsible for legislation governing cosmetic products and medicines, which is also harmonised under EU legislation. In particular, there are clear links between the EU cosmetics and chemicals legislation, which require nationally coordinated implementation. Furthermore, the Ministry of Social Affairs and Health is responsible for occupational safety and health legislation. In addition to the duties laid down in the Chemicals Act, the Ministry of the Environment is responsible for environmental protection, waste, water protection, and land use and building legislation, which has links to chemicals legislation. The Ministry of Economic Affairs and Employment is responsible for the Act concerning the safe handling and storage of dangerous chemicals and explosives3, also known as the Chemicals Safety Act, among others. 2 Kemikaalilaki (599/2013) 3 Laki vaarallisten kemikaalien ja räjähteiden käsittelyn turvallisuudesta (390/2005) 25 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 The Ministry of Agriculture and Forestry is responsible for the Plant Protection Act4, the Food Act5, the Fertiliser Product Act6 and the Feed Act7, among others. The Finnish Safety and Chemicals Agency (Tukes) began operations on 1 January 2011 under the guidance of several ministries. Its administrative steering and supervision falls within the purview of the Ministry of Economic Affairs and Employment (TEM). In addition, Tukes is collaboratively steered by the TEM, the Ministry of Transport and Communications (LVM), the Ministry of Agriculture and Forestry (MMM), the Ministry of the Interior (SM), the Ministry of Social Affairs and Health (STM) and the Ministry of the Environment (YM) with- in their respective sectors. With a staff of more than 200 people, Tukes is currently an agen- cy that oversees and promotes technical safety and conformity in a variety of branches as well as performing consumer and chemicals safety duties. As a result of its recent organisational reform, Tukes was also tasked with official duties relating to surveillance of industrial and consumer chemicals, biocides and plant protec- tion products, as well as maintenance of the Chemical Products Register. In other words, the official duties relating to chemical products surveillance previously assigned to the Finnish Food Safety Authority Evira, the National Supervisory Authority for Welfare and Health (Valvira) and the Finnish Environment Institute (SYKE) were gathered within a single agency, which covers the health and environmental effects of different groups of chemi- cals. At present, Tukes is the competent national authority responsible for chemical prod- ucts surveillance. It is also an important partner of the Helsinki-based European Chemicals Agency (ECHA), in particular regarding the implementation of the European Union’s REACH and CLP Regulations. Furthermore, Tukes is the supervisory authority under the Consumer Protection Act8, which entered into force on 1 January 2012. This Act also applies to sur- veillance of toys. Tukes is also the National Contact Point for the EU Rapid Alert System for dangerous non-food products (RAPEX). These organisational changes made it possible to enhance Finland’s national chemicals administration and monitoring of compliance with legislation. Tukes also acts as the market surveillance authority for construction products. Market surveillance is targeted at construction products to be CE-marked under the Con- struction Products Regulation (EU) No 305/2011, construction products within the scope of the Act on the Type Approval of Certain Construction Products9, and other construction products to be permanently affixed to a construction object where the product may have a bearing on the fulfilment of the construction project’s essential technical requirements. 4 Laki kasvinsuojeluaineista (1563/2011) 5 Elintarvikelaki (23/2006) 6 Lannoitevalmistelaki (539/2006) 7 Rehulaki (86/2008) 8 Kuluttajaturvallisuuslaki (920/2011) 9 Laki eräiden rakennustuotteiden tuotehyväksynnästä (954/2012) 26 THE FINNISH ENVIRONMENT 4EN/2017 Tukes is also the key licensing authority under the Chemicals Safety Act, responsible for large-scale establishments and for supervision of explosives. Local rescue authorities su- pervise compliance with the Chemicals Safety Act with regard to small-scale industrial han- dling and storage of chemicals, as well as release of fireworks for private consumption, etc. The Finnish Environment Institute (SYKE) focuses its work in the field of chemicals and harmful substances on research, environmental monitoring and related analytics and as- sessments. SYKE carries out chemicals-related expert work on waste, product and produc- tion management, life-cycle analyses and contaminated areas, etc. Its chemicals-related official and expert duties are related to international environmental agreements, including the Stockholm Convention on Persistent Organic Pollutants (the ‘Stockholm POPs Conven- tion’) and the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (the ‘Rotterdam PIC Convention’). SYKE is part of the Finnish Partnership for Research on Natural Resources and the Envi- ronment (Lynet), which has operated since 2008 and also includes the Natural Resources Institute Finland (Luke), the Finnish Meteorological Institute (IL), the Finnish Food Safety Au- thority Evira, VTT Technical Research Centre of Finland Ltd, the Geological Survey of Finland (GTK), and the National Land Survey of Finland (MML). With the exception of the last-men- tioned one, all Lynet partners are involved in operations relating to chemicals and harmful substances. Within the framework of the Lynet partnership, SYKE contributes to environ- mental monitoring and residue level reports, while also partnering with other research insti- tutes in studies on the presence and effects of contaminants on wildlife and ecosystems. The Natural Resources Institute Finland (Luke) is a research and expert organisation operating in the administrative sector of the Ministry of Agriculture and Forestry. It was es- tablished on 1 January 2015 by merging MTT Agrifood Research Finland, the Finnish Forest Research Institute (Metla), the Finnish Game and Fisheries Research Institute (RKTL), and the Information Centre of the Ministry of Agriculture and Forestry (Tike). Luke is responsi- ble for testing the efficacy and usability of plant protection products and certain biocides used in plant production in different applications. Luke is also involved in the implemen- tation of the National Action Plan on the Sustainable Use of Plant Protection Products by contributing to research and development in the field of integrated plant protection and by participating in counselling and training users of plant protection products. Under Pesti- cide Statistics Regulation (EC) No 1185/2009, Luke has a statutory duty to collect informa- tion on the agricultural use of plant protection products once every five years. Luke also cooperates closely with Tukes in issues relating to the safe use of plant protection products. The Finnish Food Safety Authority Evira ensures food safety and quality as well as plant and animal health through research and monitoring. While duties relating to plant protec- tion products were reassigned to Tukes, Evira is still discharging chemicals-related duties 27 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 focusing on controlling pesticide residues, food contaminants, feedstuffs and fertilisers, use of veterinary medicinal products, and residues of veterinary medicinal products and contaminants in animal-based foodstuffs. The National Institute for Health and Welfare (THL) is an independent expert agency operating within the administrative sector of the Ministry of Social Affairs and Health. THL serves central and local government decision-makers, parties operating in the social wel- fare and health sector, organisations, the research community and the public. Its aim is to promote the Finnish population’s health and wellbeing. Its Department of Health Security consists of units providing decision-makers with information on key risks to environmental health and assessing the efficacy of various alternative prevention methods. Finnish Customs controls chemical imports, as well as exports and imports of danger- ous chemicals. Customs plays a role in surveillance of consumer goods, such as toys and cosmetics, also including chemicals contained in these. In addition, the role of Customs in surveillance operations has been influenced by the Accreditation and Market Surveillance Regulation (EC) No 765/2008 (the ‘NLF Regulation’), one of the instruments included in the New Legislative Framework (NLF) that entered into force on 1 January 2010. The NLF Regu- lation aims to prevent the entry into the market of any products that are non-compliant or dangerous to health, safety or the environment. Examples of other restrictions supervised by Finnish Customs include import controls of medicinal, veterinary medicinal and feed products in cooperation with Evira. The Finnish Institute of Occupational Health (TTL) supports workplaces, occupation- al health service units and public authorities in chemical risk management at workplaces through research and expert services. The National Supervisory Authority for Welfare and Health (Valvira) is the central environmental health authority, contributing to management of the living environment’s health risks through guidance and supervision, among other things. Valvira’s supervisory duties cover adverse health effects caused by waste, health issues relating to domestic wa- ter, swimming pool water and beaches, as well as indoor air problems. These have links to chemicals safety. The Consortium of Expert Institutions on Health and Welfare (SOTERKO) compris- es the following partners: the National Institute for Health and Welfare (THL), the Finnish Institute of Occupational Health (TTL), the Radiation and Nuclear Safety Authority (STUK), the Finnish Meteorological Institute (IL), the Finnish Environment Institute (SYKE), the Finn- ish Food Safety Authority Evira, VTT Technical Research Centre of Finland Ltd, and VATT In- stitute for Economic Research. The consortium promotes the quality and efficiency of the partners’ R&D activities by building cooperation between the parties by means of expert 28 THE FINNISH ENVIRONMENT 4EN/2017 networks, R&D programmes and cooperation in individual projects or other functions. The consortium’s risk management programme aims to improve the population’s health and wellbeing by increasing awareness of various risks relating to working and living environ- ments. The consortium aims to enhance the social impact of health and welfare research, increase know-how in the healthcare and social welfare sector, improve productivity, and consolidate international competitiveness. A further objective is to support the provision of healthcare and social welfare services and professional practices in the sector with the aid of R&D, expert services and innovation. Finland has responded to increasing serious chemicals-related threats by establishing the Centre of Excellence for Serious Chemical Threats (COSK) in 2004. Its on-call duties are shared by the National Institute for Health and Welfare (THL) and the Finnish Institute of Occupational Health (TTL), and its steering group has representatives from all administra- tive sectors and expert bodies relevant to chemicals safety. The Finnish Medicines Agency Fimea started operations in November 2009 as its prede- cessor, the National Agency for Medicines, was closed down. Fimea is in charge of the safe- ty of medicinal products for human and veterinary use. The Centres for Economic Development, Transport and the Environment (ELY Centres) contribute to regional development by dealing with the central government’s implemen- tation and development duties in their respective regions. Their Environment and Natural Resources Departments promote environmental protection. In addition to general promo- tion of environmental protection, ELY Centres have permit and supervisory duties under the Environmental Protection Act10, the Water Act11 and the Waste Act12, as well as supervisory duties under the Chemicals Act. By way of example, ELY Centres process notifications of con- taminated soil. ELY Centres supervise adherence to the environmental and water permits granted by Regional State Administrative Agencies (AVIs) and ensure that public interest is taken into account in environmental and water issues. They also supervise the use and trade of plant protection products. In their capacity as oil spill response authorities, ELY Centres work to prevent and combat environmental pollution and damage. They also act as contact authorities in impact assessments carried out in accordance with the Act on Environmental Impact Assessment Procedures13 and issue opinions in environmental impact assessments of plans and programmes. Their Economic Development, Employment, Competence and Culture Departments promote matters relating to business, the labour force and employ- ment, as well as competence and culture. In addition, the Southeast Finland ELY Centre 10 Ympäristönsuojelulaki (527/2014) 11 Vesilaki (587/2011) 12 Jätelaki (646/2011 13 Laki ympäristövaikutusten arviointimenettelystä (252/2017) 29 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 specialises in chemical issues, and its tasks include providing the other ELY Centres with ad- vice on chemicals control. There are six Regional State Administrative Agencies in Finland, promoting implemen- tation of basic rights and legal protection, access to basic public services, environmental protection, environmental sustainability, public safety, and safe and healthy living and working environments in the regions. They make decisions on licences and permits pursu- ant to the Environmental Protection Act and the Water Act, which used to be handled by former Regional Environment Centres and Environmental Permit Authorities. Compliance with occupational safety and health legislation is supervised by five AVI Occu- pational Safety and Health Divisions. In addition to provisions on working conditions, their supervisory duties cover legislation governing working hours and, to a certain extent, other terms and conditions of employment, as well as non-discrimination in the world of work. Each employer is responsible for ensuring that the working environment does not endanger the health of their employees. For this purpose, employers are required to iden- tify and assess workplace hazards and manage risks, with occupational healthcare services acting as their expert assistants. In their supervisory duties, the occupational safety and health inspectors of the Occupational Safety and Health Administration assess the ade- quacy of employers’ actions and the compliance of the measures that they have carried out. Cooperation between employers and occupational healthcare services aims to pre- vent and deter workplace health hazards and problems due to chemical agents. The Occu- pational Safety and Health Administration supports this work through its operations. Workplace risk assessments concerning chemical agents and chemicals aim to ensure that the extent and nature of exposure of all employees is known, so as to prevent any health-endangering exposure by means of risk management. The order of risk manage- ment measures proceeds from a general to an individual level, such that plans for work- place procedures to reduce and eliminate exposure and structural protection measures to combat risk at source, including minimising the number of employees exposed, are in place, whenever possible, before providing employees with personal protective equip- ment. Estimating the number of workplace safety and health risks relating to chemical agents is based on existing information as well as other exposure data, such as the results of occupational hygiene and biological exposure measurements. Managing risks posed by chemical agents also involves training and guiding employees in their safe use, appropri- ate package labelling and safety data sheets of chemicals, and use of personal protective equipment as required. As part of its supervision of workplace conditions, the Occupation- al Safety and Health Administration supervises risk assessment and management of chem- ical agents. Its duties also cover various supervisory projects and extensive cooperation with stakeholders. 30 THE FINNISH ENVIRONMENT 4EN/2017 There is an ongoing regional government reform based on the policy concerning the re- form of regional administration outlined by the Government in April 2016. The allocation of responsibilities in the new structure will be examined once the reform has entered into force. As in the past, this second revision of the programme refers to the Regional State Administrative Agencies and ELY Centres as the parties responsible for certain recommen- dations for measures, but they will be replaced with the Government Agency for Permits and Supervision as of 1 January 2019. There are also supervisory authorities operating at a local level in areas such as environ- mental protection and food control. In addition, the police supervise the use of explosives, among other things. 3.7 Key sectoral legislation Chemicals are regulated by several different statutes. The following sections outline the most significant amendments to legislation made since the original National Programme on Hazardous Chemicals was adopted. Chemicals legislation The current Chemicals Act14 (599/2013) entered into force in 2013. This law is quite a limit- ed supervision act, because provisions on operators’ obligations are mostly laid down by European Union Regulations. The Chemicals Act includes provisions on supervisory au- thorities and their tasks, rights and responsibilities. The law consolidated chemicals market surveillance duties by reassigning the existing duties from local authorities to the Finnish Safety and Chemicals Agency (Tukes). The occupational safety and health authority’s du- ties, in turn, focus on supervision of the conditions of chemical use and the obligations of employers. The regional Centres for Economic Development, Transport and the Environ- ment (ELY Centres) and municipal environmental protection authorities are still involved in supervising the conditions of chemical use. The Finnish Environment Institute (SYKE) oversees compliance with certain EU Regulations and international agreements. Fulfil- ment of import and export conditions and compliance with good laboratory practice are supervised by Finnish Customs and the Finnish Medicines Agency Fimea, respectively. In addition to supervisory duties, the Chemicals Act includes the necessary substantive pro- visions on the duties of operators, registries of the Finnish Safety and Chemicals Agency, the retail trade of chemicals, language requirements for safety data sheets, marketing, na- 14 Kemikaalilaki (599/2013) 31 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 tional authorisation of biocidal products, and non-disclosure. The Act also includes provi- sions on administrative means available to supervisory authorities, other duties of author- ities, as well as penalties resulting from violation of the obligations imposed on operators. Furthermore, the Act lays down the national provisions required under the EU Regulations concerning biocidal products, persistent organic pollutants, and the export and import of hazardous chemicals. The REACH Regulation The ‘REACH Regulation’ refers to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH stands for Registration, Evaluation, Authorisation and restriction of CHemicals). The Regulation entered into force on 1 June 2007, replacing about 40 different European Union acts. The Regulation is a piece of legislation directly binding on the Mem- ber States. The Regulation aims to ensure a high level of protection of human health and the environment; enhance the competitiveness of the European Union’s chemicals indus- try; promote the development of alternative methods to animal testing for the assessment of hazards of substances; and ensure the free movement of goods in the EU’s internal mar- ket. The Regulation imposes an obligation on operators to register the substances they manufacture and import with the European Chemicals Agency (ECHA). Furthermore, the Regulation lays down provisions on substance evaluation, an authorisation procedure for the most hazardous substances, and restrictions on the manufacture, placing on the mar- ket and use of chemicals. The Regulation also includes provisions concerning safety data sheets, information in the supply chain, and risk management guidelines. The Commission is currently preparing its second review on the functioning of the REACH Regulation as re- quired in the Regulation. The Commission is expected to publish the results of the review by 1 June 2017.15 The CLP Regulation The ‘CLP Regulation’ refers to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on the classification, labelling and packaging of substances and mix- tures (CLP stands for Classification, Labelling and Packaging). The Regulation entered into force on 20 January 2009. The CLP Regulation replaces the previous EU acts concerning the classification, labelling and packaging of chemicals. The CLP Regulation implements within the European Union the Globally Harmonised System (GHS) of Classification and Labelling of Chemicals, which was adopted under the auspices of the UN. The CLP Reg- 15 The 2nd REACH review (COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Commission General Report on the operation of REACH and review of certain elements Conclusions and Actions) was published 8 March 2018. 32 THE FINNISH ENVIRONMENT 4EN/2017 ulation covers both the key parts of the GHS and some parts of the superseded legisla- tion concerning the classification and labelling of chemicals, which were not harmonised under the UN. The GHS is being updated and developed on a continuous basis, and any changes will be introduced into the CLP Regulation. The Biocidal Products Regulation The ‘Biocidal Products Regulation’ refers to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products. ‘Making available on the market’ means any supply for distribution or use in the course of a commercial activity, whether in return for payment or free of charge. In Finland, provisions governing biocides are included in chemicals legislation. Biocidal products are authorised separately in each Member State, whereas the active substanc- es contained in such products are authorised at EU level. The Commission keeps the lists of authorised and prohibited active substances up to date. The list of products authorised in Finland in accordance with the Biocidal Products Directive and Regulation is available at Tukes. Under the national legislation in force in Finland, national authorisation must be sought for products intended for preservation of wood, slimicides used in the pulp and paper industries, insecticides and insect repellents, and anti-fouling products intended for treatment of vessels, prior to placing these on the Finnish market. The Detergent Regulation Regulation (EC) No 648/2004 of the European Parliament and of the Council on detergents contains provisions on biodegradability of surfactants in detergents, restrictions and bans on such substances, the labelling of detergents, and the information that manufacturers must hold at the disposal of the competent authorities and medical personnel. The Reg- ulation aims to safeguard the free movement of detergents in the internal market while, at the same time, ensuring a high degree of protection of the environment and human health. The Detergent Regulation repealed previous Directives restricting the placing on the market and use of detergents containing slowly biodegradable substances. Regulation (EU) No 259/2012 amending the Detergent Regulation limited the phosphorous content in laundry and dishwasher detergents. The POP Regulation Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants, also known as the ‘POP Regulation’, aims to reduce, minimise and even- tually eliminate releases of certain persistent organic pollutants (POPs). The POP Regula- tion implemented within the European Union the Stockholm Convention and the Aarhus Protocol on Persistent Organic Pollutants to the Convention of the UN Economic Commis- 33 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 sion for Europe (UNECE) on Long-Range Transboundary Air Pollution. The Annexes to the Regulation have been amended several times to correspond to amendments made to the Convention and its Protocol. The PIC Regulation The Rotterdam Convention lays down provisions on the prior informed consent proce- dure for certain hazardous chemicals and pesticides in international trade, also known as the ‘PIC procedure’ (for Prior Informed Consent). The Convention Parties undertake not to export chemicals covered by the Convention to countries that have banned such imports. The Parties also undertake to notify the country of destination of any exports of chem- icals that are banned or severely restricted at a national level. Provisions on the imple- mentation of the Convention within the European Union are laid down in Regulation (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of hazardous chemicals (the ‘PIC Regulation’). Annex I to the Regulation lists the chemicals that are currently subject to the procedure. An up-to-date list of chemicals in- cluded in Annex I is available on the website of the European Chemicals Agency (ECHA). Mercury Regulation In December 2016, the EU Member States agreed on a Regulation to reduce the environ- mental and health effects of mercury. The provisions included in the Mercury Regulation are necessary for the European Union and its Member States to accede to the Minama- ta Convention on Mercury, signed in October 2013. Due to enter into force at the begin- ning of 2018, the new Regulation is based on Mercury Export Ban Regulation (EC) No 1102/2008. The new EU Mercury Regulation covers the entire life cycle of mercury from extraction of ore to disposal of mercury waste. The Regulation includes provisions on the export, import and manufacturing of mercury and mercury-added products and on the use of mercury in certain manufacturing processes, in artisanal and small-scale gold min- ing and in dental amalgam. Furthermore, the Regulation revises obligations concerning the storage and treatment of mercury waste, while also requiring exchange of information concerning sites contaminated by mercury. In order to enter into force, the Regulation still needs to be formally adopted by the Council and Parliament, which is expected to take place in early 2017. The measures arising from the Proposal for the Regulation will remain relatively small in Finland, where mercury is not used to any significant extent. Cosmetics legislation Legislation concerning cosmetic products has been harmonised across the European Un- ion. Cosmetics are regulated by the EU Cosmetics Regulation (EC) No 1223/2009. Similar to 34 THE FINNISH ENVIRONMENT 4EN/2017 the Chemicals Act, Finland’s national Act on Cosmetic Products16 is a limited supervision act, mainly laying down provisions on the powers of national authorities. The manufac- turer/importer (‘responsible person’) of a cosmetic product must produce a safety report specified in the Cosmetics Regulation, in order to demonstrate that the cosmetic product does not present a danger to consumer health under reasonably foreseeable conditions of use. The Regulation also defines the ways in which consumers should be informed of the proper use of the product and its ingredients. The raw ingredients of cosmetic products fall within the scope of application of the REACH and CLP Regulations. Under the Con- sumer Protection Act17, service providers using cosmetic products as part of their servic- es (such as hairdressers) are responsible for the safety of the services that they are selling (such as hair dyeing). The environmental effects of cosmetic products and their ingredi- ents fall within the scope of application of, not cosmetics legislation, but chemicals legis- lation. Consequently, it is possible to specify limitations on cosmetic products under the REACH Regulation if the chemicals used as ingredients in cosmetics constitute an unac- ceptable risk to the environment. Plant protection legislation A new Act on Plant Protection Products18 entered into force at the beginning of 2012. The Act aims to ensure the proper and sustainable use of plant protection products and im- plements Directive 2009/128/EC of the European Parliament and of the Council establish- ing a framework for Community action to achieve the sustainable use of pesticides (the ‘Framework Directive’). In addition, the Act includes national provisions on competent au- thorities, supervision, administrative enforcement measures and sanctions, and fees and appeals to complement Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (the ‘Plant Protection Products Regulation’). The Framework Directive is based on the 2006 Commission Communication entitled ‘A Thematic Strategy on the Sustainable Use of Pesticides’. The measures proposed in the Thematic Strategy were intended to be included in part in new acts and in part in existing acts. In addition to the above-mentioned Framework Directive and the Plant Protection Products Regulation, the new acts include Regulation (EC) No 1185/2009 of the European Parliament and of the Council concerning statistics on pesticides (the ‘Pesticide Statistics Regulation’). The Machinery Directive was amended with regard to application equipment used for plant protection products by Directive 2009/127/EC of the European Parliament 16 Laki kosmeettisista valmisteista (492/2013) 17 Kuluttajaturvallisuuslaki (920/2011) 18 Laki kasvinsuojeluaineista (1563/2011) 35 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 and of the Council amending Directive 2006/42/EC with regard to machinery for pesticide application. The Framework Directive establishes a framework for the sustainable use of pesticides by reducing the risks to human health and the environment resulting from the use of pesti- cides and by promoting the use of integrated pest management and alternative pest con- trol measures. Each Member State is required to prepare a National Action Plan (NAP) on the sustainable use of plant protection products, aimed at setting quantitative objectives, targets, measures, timetables and indicators to reduce risks and impacts of pesticide use on human health and the environment. Finland’s National Action Plan was prepared by a working group operating under the Ministry of Agriculture and Forestry. The implemen- tation of the National Action Plan on the Sustainable Use of Plant Protection Products has been assigned to Tukes in cooperation with other parties operating in the field. Occupational safety and health legislation Key provisions concerning chemical agents are included in the Occupational Safety and Health Act19 and the Government Decree on Chemical Agents at Work20 issued by virtue of the Act. Other statutes relating to safe management of chemical agents include the De- cree of the Ministry of Social Affairs and Health on Concentrations Known to be Harmful21 , the Government Decree on the Prevention of Work-Related Cancer Risks22, the Decision of the Ministry of Labour concerning factors that cause a risk of cancer23 , the Government Decree concerning agents causing a risk to reproductive health at work and preventing the risk24, and Act concerning the register for workers at risk of exposure to carcinogenic substances and processes25 . Chemical agents at work are also governed by other Govern- ment Decrees and Decisions. Supervision of occupational safety and health is regulated by a supervision act, i.e. the Act on Occupational Safety and Health Enforcement and Cooper- ation on Occupational Safety and Health at Workplaces.26 19 Työturvallisuuslaki (738/2002) 20 Valtioneuvoston asetus kemiallisista tekijöistä työssä (715/2001) 21 Sosiaali- ja terveysministeriön asetus haitallisiksi tunnetuista pitoisuuksista (1214/2016) 22 Valtioneuvoston asetus työhän liittyvän syöpävaaran torjunnasta (716/2000) 23 Työministeriön päätös syöpäsairauden vaaraa aiheuttavista tekijöistä (838/1993) 24 Valtioneuvoston asetus lisääntymisterveydelle työssä vaaraa aiheuttavista tekijöistä ja vaaran torjunnasta (603/2015) 25 Laki syöpäsairauden vaaraa aiheuttaville aineille ja menetelmille ammatissaan altistuvien rekisteristä (717/2001) 26 Laki työsuojelun valvonnasta ja työpaikan työsuojeluyhteistoiminnasta (44/2006) 36 THE FINNISH ENVIRONMENT 4EN/2017 Key statutes relating to occupational healthcare cooperation at workplaces include the Occupational Health Care Act27 and the Government Decree concerning medical examina- tions in work that presents a special risk of illness.28 Environmental legislation The Environmental Protection Act29 was completely reformed in 2014. It is a general act aiming to prevent the pollution of the environment and to repair and reduce damage caused by pollution; to safeguard a healthy, pleasant, ecologically diverse and sustainable environment; to prevent the generation and the harmful effects of waste; to improve and integrate assessment of the impact of activities that pollute the environment; to improve citizens’ opportunities to influence decisions concerning the environment; to promote sustainable use of natural resources; and to combat climate change and otherwise sup- port sustainable development. Its key instrument consists of permit and notification pro- cedures used to ensure an acceptable level of functions posing risks to the environment and the minimisation of pollution loads. The key environmental objectives relating to improving the status of waters and seas have been set in the Water Framework Directive (2000/60/EC) and in the Marine Strate- gy Framework Directive (2008/56/EC), which were implemented in Finland by the Act on the Organisation of River Basin Management and the Marine Strategy30. The part of the Water Framework Directive concerning priority substances was implemented nationally by issuing the Government Decree on Substances Dangerous and Harmful to the Aquat- ic Environment31. Regulation relating to priority substances is developing constantly, and the Commission proposes new lists of environmental quality standards at regular inter- vals. The Government Decree on the Assessment of Soil Contamination and Remedia- tion Needs32, in turn, specified the criteria for assessment and outlined the threshold and guideline values of harmful substances used in support of assessment. Further provisions on soil pollution prohibition and responsibilities for the assessment of soil contamination and remediation needs and for the remediation of contaminated soil are laid down in the Environmental Protection Act. Waste legislation aims to prevent the hazard and harm to human health and the environ- ment caused by waste and waste management, to reduce the amount and harmfulness of 27 Työterveyshuoltolaki (1383/2001) 28 Valtioneuvoston asetus terveystarkastuksista erityistä sairastumisen vaaraa aiheuttavissa töissä (1485/2001) 29 Ympäristönsuojelulaki (527/2014) 30 Laki vesienhoidon ja merenhoidon järjestämisestä (1299/2004) 31 Valtioneuvoston asetus vesiympäristölle vaarallisista ja haitallisista aineista (1022/2006) 32 Valtioneuvoston asetus maaperän pilaantuneisuuden ja puhdistustarpeen arvioinnista (214/2007) 37 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 waste, to promote the sustainable use of natural resources, to ensure functioning waste management, and to prevent littering. The previous Waste Act33 and key waste manage- ment decrees were reformed between 2011 and 2016, while a wide-ranging comprehen- sive reform of waste legislation mostly entered into force on 1 January 2012. The reform was based on the 2008 Waste Framework Directive (2008/98/EC), which is currently being reformed again. The new Waste Act34 imposed more stringent obligations concerning hazardous waste and linked the classification of hazardous waste to the CLP Regulation. To make it easier to interpret the definition of ‘waste’, it also includes criteria for by-prod- ucts and ‘no longer waste’. Provisions on the latter may be issued by type of waste through Commission Regulations, etc. When waste stops being waste, it is subject to the provisions of chemicals legislation, among other provisions. At present, producer responsibility cov- ers recycled paper, packaging, electrical and electronic equipment, vehicles and tyres, as well as batteries and accumulators. The Restriction of Hazardous Substances Directive 2011/65/EU (the ‘RoHS Directive’) re- stricts the use of certain hazardous substances in electrical and electronic equipment. The purpose of the Directive is to protect human health and the environment and to reduce the negative impact of waste. It also aims to contribute to the environmentally sound recovery and disposal of waste electrical and electronic equipment. After the transition- al periods, the Directive’s requirements will apply to any electrical and electronic equip- ment that is not specifically excluded from its scope of application. The requirements cover equipment such as household appliances, IT and telecommunications equipment, consumer electronics, lighting equipment, electrical and electronic tools, toys, leisure and sports equipment, and automatic dispensers. Finland transposed the Directive into nation- al law in June 2013 by publishing the Act on Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment35 and Decree 419/2013 of the Ministry of the Environment, laying down further provisions on restrictions on use and certain ex- ceptions. Commission Delegated Directive (EU) 2015/863, published in 2015, also restricts the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in electrical and electronic equipment placed on the mar- ket. The Directive was transposed into national law by Decree 419/2013 of the Ministry of the Environment. 33 Jätelaki (1072/1993) 34 Jätelaki (646/2011) 35 Laki vaarallisten aineiden käytön rajoittamisesta sähkö- ja elektroniikkalaitteissa (387/2013) 38 THE FINNISH ENVIRONMENT 4EN/2017 The requirements of the Battery Directive (2006/66/EC) apply to batteries and accumulators placed on the EU market, including those incorporated into electrical and electronic equip- ment, vehicles and other products. The Directive sets out requirements concerning the la- belling of batteries and accumulators and restriction of the use of hazardous substances. It also specifies the responsibilities applicable to producers of batteries and accumulators for the waste management of their products, i.e. producer responsibility. Finland has imple- mented the Directive by the Government Decree concerning batteries and accumulators.36 Chemicals safety legislation The Act concerning the safe handling and storage of dangerous chemicals and explo- sives37, hereinafter referred to as the ‘Chemicals Safety Act’, is a general act governing the safe handling of dangerous chemicals and explosives. Its wide scope of application has several links to other pieces of legislation promoting chemicals safety, such as the EU chemicals legislation and national occupational safety and health, environmental protec- tion, and land use and building legislation. The purpose of the Act is to prevent and deter personal, environmental and property damage arising from the manufacture, use, transfer, storage and any other handling of dangerous chemicals and explosives, and to promote public safety and security. The Chemicals Safety Act and the Decrees issued by virtue of the Act implement certain EU acts, including the Seveso III Directive (2012/18/EU), speci- fying obligations to prevent major accidents and minimise their effects within and outside establishments where chemicals are present. The obligations apply to establishments han- dling chemicals causing physical, health and environmental hazards. Consumer protection legislation The purpose of the Consumer Protection Act38 is to prevent health and property hazards. According to the Act, operators must ensure that consumer goods or services do not en- danger health or property with due diligence and professionalism required under the circumstances. The Act does not include provisions regarding liability for damages. Other aspects falling outside the scope of consumer protection legislation include environmen- tal damage, potential customer dissatisfaction with goods or services, and quality issues to the extent that they do not also pertain to product safety. The Consumer Protection Act is a general act, which is not, as a general rule, applicable when the safety of certain consumer goods or services is provided elsewhere in law. How- ever, if the provisions concerning safety laid down in such special legislation do not cover 36 Valtioneuvoston asetus paristoista ja akuista (520/2014) 37 Laki vaarallisten kemikaalien ja räjähteiden käsittelyn turvallisuudesta (390/2005) 38 Kuluttajaturvallisuuslaki (920/2011) 39 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 all safety issues, or if it does not require at least the same level of safety, or if its adminis- trative enforcement measures are not as comprehensive as those specified in a general act, the general act may be applied to the safety aspects of consumer goods and services, where an adequate level of safety is not provided by such special legislation. Consumer protection legislation is also linked to the Act on Notifying the European Com- mission of Information Relating to the Market Surveillance of Certain Products Presenting a Risk39, laying down provisions on the notification obligations set out in the European Accreditation and Market Surveillance Regulation (the ‘NLF Regulation’) and in the General Product Safety Directive (2001/95/EC). The Consumer Protection Act also applies to surveillance of toys. The safety of toys is also governed by the Act on the Safety of Toys40 and subordinate statutes issued by virtue of the Act. Food legislation The Food Act41 lays down provisions on the general requirements concerning food and on the organisation of controls. Its scope of application essentially includes all the food pro- duction, processing and distribution stages, with the exception of a private household’s primary production or handling of food for its own use. Certain maximum levels have been set for contaminants in foodstuffs, which are con- trolled by public authorities. Provisions on the maximum levels of certain contaminants in foodstuffs are laid down in Commission Regulation (EC) No 1881/2006. Provisions on the maximum residue levels of pesticides in or on food and feed of plant and animal origin are included in Commission Regulation (EC) No 396/2005. ‘Contaminants’ refers to substances other than food ingredients or additives, including residues of plant protection products used in plant production and residues of medicinal products used in the treatment of dis- eases in food-producing animals, etc. The presence of contaminants such as heavy metals or polychlorinated biphenyls (PCBs) in foodstuffs may be due to environmental pollution. Spoilage of foodstuffs or their ingredients may result in the formation of mycotoxins. Con- taminants such as polycyclic aromatic hydrocarbons (PAHs) may also be generated during food manufacturing processes. Food contaminants are controlled by virtue of the Food Act. 39 Laki eräiden riskin aiheuttavien tuotteiden markkinavalvontaan liittyvien tietojen ilmoittamisesta Euroopan ko- missiolle (1197/2009) 40 Laki lelujen turvallisuudesta (1154/2011) 41 Elintarvikelaki (23/2006) 40 THE FINNISH ENVIRONMENT 4EN/2017 In addition, any materials and articles intended to come into contact with food are con- trolled by virtue of the Food Act. Provisions on materials and articles intended to come into contact with food are laid down in European Parliament and Council Regulation (EC) No 1935/2004. All business operators are also subject to Commission Regulation (EC) No 2023/2006 on good manufacturing practice, which requires all operators to have in place documented quality assurance and quality control systems and records relevant to com- pliance and safety of the finished material or article. Provisions on plastic materials and articles intended to come into contact with food were reformed by Commission Regula- tion (EU) No 10/2011, while the heavy metal requirements concerning ceramic articles are being reformed at EU level. Medicines legislation Provisions on the safety and use of medicinal products for human and veterinary use are included in the Medicines Act42. Its most recent amendments involved further specification of provisions concerning pharmacy services, contract manufacturing of medicinal prod- ucts, delivery of pharmaceuticals from pharmaceutical plants, support provided for associ- ations and patient organisations by parties involved in pharmaceutical marketing, etc. Fertiliser product legislation The objective of the Fertiliser Product Act43 is, with the aim to ensure the quality of plant protection, foodstuffs and the environment, to promote the supply of safe fertiliser prod- ucts that are of good quality and suitable for plant production and utilisation of by-prod- ucts suitable for use as such. This Act also applies to the Fertiliser Regulation (EC) No 2003/2003, which currently only covers inorganic fertilisers and some liming material and does not set any maximum levels for harmful substances. The European Union has launched a comprehensive reform of its fertiliser legislation to incorporate all categories of fertilising products into the scope of such legislation, while also introducing safety re- quirements for these. Feed legislation The objective of the Feed Act44 is to ensure the quality, safety and traceability of feeds and provision of appropriate information on feeds in order to safeguard the health of animals and good quality of foods of animal origin. More detailed provisions on feed business op- 42 Lääkelaki (395/1987) 43 Lannoitevalmistelaki (539/2006) 44 Rehulaki (86/2008) 41 THE FINNISH ENVIRONMENT 4EN/2017 NATIONAL PROGRAMME ON HAZARDOUS CHEMICALS- INTERIM REVIEW AND REVISION 2017 erations have been given by virtue of the Feed Act in various Decrees of the Ministry of Agriculture and Forestry. As feed legislation has been harmonised to a large extent within the European Union, the relevant EU Regulations are applied as such without transposi- tion into national law. Provisions on feed additives are laid down in European Parliament and Council Regula- tion (EC) No 1831/2003. Feed additives are intentionally added to feed and they may be chemical compounds, substances, preparations, enzymes or micro-organisms. Only those additives approved in the European Union may be placed on the EU market, used and pro- cessed. The presence of undesirable substances and products in feed has been restricted by setting limit values for their levels. Provisions on such maximum levels are included in Commission implementing acts amending Annex I to Directive 2002/32/EC of the Europe- an Parliament and of the Council on undesirable substances in animal feed. Undesirable substances and products include heavy metals and certain other inorganic substances, my- cotoxins, residues of plant protection products, organic environmental toxins (such as diox- ins), and botanical impurities (such as toxic plants and seeds and their processing deriva- tives). Both additives and unde