This chapter reviews Denmark’s chemicals management framework, with a particular focus on industrial chemicals. It analyses pressures from chemicals on health and the environment in Denmark and the country’s involvement in chemicals management at the regional and global levels. The Danish framework is part of the broader EU context, and a significant part of chemicals management is regulated at that level. This chapter does not focus on EU‑level polices, but highlights Danish contributions to implementation and complementary activities at the national level.
OECD Environmental Performance Reviews: Denmark 2019
OECD Environmental Performance Reviews
Chapter 5. Chemicals management
Abstract
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5.1. Introduction
The main drivers of Danish activity in the area of chemicals management include protection of the public (with a focus on consumers and vulnerable groups) and substitution of dangerous chemicals. They respond to major pressures for health and the environment from the use of chemicals in the country (e.g. reliance on imported goods, in particular products, along with low fertility and vulnerability of children and the elderly to chemical exposure). Synergy exists in the activities of the authorities, industry and society, and Denmark has a robust chemicals management framework. Some areas could benefit from further enhancement or improvement, as this chapter will show.
5.2. Pressures on health and the environment from chemicals
Denmark has a relatively small and export-oriented chemical industry. The number of hazardous installations has been relatively stable and the country faced few major accidents in the last decade. Denmark achieved significant emission reductions of greenhouse gases (GHGs), acidifying gases, air pollutants and heavy metals from industrial processes and product use. The country’s system of chemical monitoring in the environment supports identifying its priorities in relation to chemicals management and efforts to address pressures from chemicals on health and the environment. Despite this, pressures persist (e.g. from endocrine disrupters and pesticides).
5.2.1. Chemical production and use
In 2016, the Danish chemical industry accounted for about 1% of the EU market. It consisted of 245 chemical companies with 11 400 employees and total turnover of EUR 5.5 billion. Danish companies’ share of research and development within the EU chemical industry is higher at EUR 670 million or 3% (CEFIC, 2018[1]). Investment in the broad chemical sector (including pharmaceuticals, oil refining, rubber and plastic products and non-metallic mineral products) almost doubled in 2010 prices between 2007 and 2015. The chemical industry is largely export oriented: some 65% of production is exported and the broad chemical sector is the country’s second largest export sector, after machinery and transport equipment. The Danish share in beyond-EU exports placed it at ninth place in 2017. The value of sales of chemicals and pharmaceuticals increased between 2007 and 2018 by over 90%, with the pharmaceutical sector as the main driver (Figure 5.1). The import and export of chemicals have shown fairly stable growth (except in 2009). Denmark is a net exporter of some chemicals (e.g. organic chemicals, chemical materials and products) and a net importer of others (e.g. inorganic chemicals, primary plastics) (Denmark, 2018[2]; Eurostat, 2018[3]).
Data from the national product registry, which covers not only manufacturers but also users of chemicals, show that the number of companies issuing chemical product notifications, the number of substances and products and total tonnage in 2015 did not differ substantially from 2005 (Denmark, 2018[2]).
Sales of pesticides and biocides (in tonnes/year) generally decreased by about 12% between 2007 and 2016 due to actions by the authorities to limit their use. A tax on pesticides introduced in 2013 resulted in stockpiling of certain pesticides and lower-than-usual sales in the following years. The lower sales may not be indicative of lower use over the short term (Ørum and Holtze, 2017[4]; Denmark, 2018[2]).
Figure 5.1. A pharmaceuticals boom stimulated growth in the chemical sector
Chemical facilities are spread relatively evenly around the country, but concentrated near the biggest cities: Aalborg, Aarhus, Copenhagen, Esbjerg and Odense. However, relatively bigger facilities are overwhelmingly located in the greater Copenhagen area (EEA, 2018[5]; Denmark, 2018[2]).
5.2.2. A stable number of hazardous facilities and visible efforts in reducing emissions of chemicals
The number of Danish installations classified as hazardous under the applicable EU legislation has been relatively stable. There are about 120, of which some 45% are upper tier installations (more hazardous) and some 35% fuel storage facilities (above the EU average of 11%, but in line with national policy to secure fuel supplies). Denmark expands the scope of application of the EU rules to also cover smaller installations (i.e. chlorine and ammonia installations), so the total number of hazardous installations is almost 140. Information on hazardous establishments is publicly available via a dedicated website (Denmark, 2018[2]; EMA, 2017[6]).
Since 2005, Denmark has reported only two industrial accidents to the e-MARS chemical accident reporting database; they resulted in one casualty and damage to a marine habitat (Denmark, 2018[2]). The biggest accident in recent times, an explosion in a fireworks storage facility, took place in 2004. Post-accident action led to enhanced enforcement and amendment of national legislation. Moreover, Denmark proposed enhanced standardisation at the European level (French Ministry for Sustainable Development, 2009[7]; EMA, 2017[6]).
The relatively stable number of major hazardous installations and low number of accidents suggest that measures to prevent major chemical accidents work relatively well in Denmark. Moreover, the country has a co‑ordination forum for authorities to build on the experience of accidents, which is working on dedicated web pages to support experience sharing (Denmark, 2018[2]).
Reducing emissions of chemicals is a strategic goal included in relevant legal and policy frameworks in Denmark. The Environmental Protection Act and Act on Chemicals set the overall goal of reducing pollution caused by chemical production and use, while national action plans include implementation measures (MEF, 2017[8]; Government of Denmark et al., 2017[9]). Denmark reduced emissions of GHGs1 from industrial processes and product use by over 20% between 2005 and 2016. Significant reductions also occurred for acidifying gases, air pollutants and heavy metals2 in industrial processes and product use and in manufacturing industries and construction (Figure 5.2).
Figure 5.2. Emissions from industrial processes and product use are generally on the decline
5.2.3. Despite monitoring of chemicals, pressures on health and the environment are significant
Denmark has a system of monitoring chemicals in the environment that supports identification of the country’s priorities in relation to chemicals management. It includes a pollutant release and transfer register. Denmark has undertaken biomonitoring activities and co‑operates with other countries in this field. Monitoring and biomonitoring results (Box 5.1) are publicly available.
Box 5.1. Examples of chemical monitoring/biomonitoring results that have helped shape Danish chemicals management priorities
Studies showed that 40% of the male population had reduced semen quality; it is suspected that exposure to phthalates contributed to this result (EPA, 2013[10]).
A cohort study of non-persistent environmental chemicals suspected of endocrine‑disrupting properties concluded that nearly everyone in the population might be exposed to the monitored chemicals and that EU-wide restrictions had had a positive effect in Denmark. For instance, decreasing excretion of the phthalates DnBP and DEHP was observed following the introduction of restrictions on food contact materials and toys (Choi et al., 2015[11]; Denmark, 2018[2]; Frederiksen et al., 2014[12]). Increased public awareness contributed to decreased use.
DEMOCOPHES revealed that Danes were widely exposed to PCBs (mostly from food) and PFAS (used, for example, in food packaging, non-stick coatings and textile coatings) (Choi et al., 2015[11]; Mørck et al., 2015[13]; Denmark, 2018[2])
In the work of CEHOS, the effects of perinatal bisphenol A exposure on both male and female rat sexual development were identified at doses that could warrant a decrease in the tolerable daily intake of this substance (Bourguignon, Hutchinson and Slama, 2017[14]).
Danish biomonitoring results were included in the restriction proposal for four phthalates jointly issued in 2016 by Denmark and the European Chemicals Agency (ECHA) (Denmark, 2018[2]).
A 2012-15 initiative on better control of nanomaterials found, among other conclusions, that inhalation of nanomaterials might constitute a risk (Christensen et al., 2015[15]).
In 2015, the Danish Environmental Protection Agency (EPA) requested an evaluation of health hazards from exposure to PFAS. This led to establishment of limit values for 12 PFAS in soil, drinking water and groundwater, and to further monitoring and screening activities (OECD[16])
In 2016, pesticides and their metabolites were found in 34.3% of groundwater samples and in concentrations exceeding the quality standard of 0.1 ug/l in 8.6% of samples (reduced from 37.3% and 13.6%, respectively, in 2007). The data for 2017 showed a slight increase, but the data set differed significantly from previous years (GEUS, 2019[17]). This outcome led to actions at national level to expand the scope of monitoring.
Concentration of zinc in agricultural soils increased by 19% between 1998 and 2014 and some 25% of streams had zinc concentrations above the environmental quality standard. The situation is expected to worsen due to the elevated concentration of zinc in manure from pig farming (Jensen and Bak, 2018[18]).
National Allergy Research Centre research supported regulatory action on chromium in leather and methylisothiazolinone in cosmetics (Denmark, 2018[2]).
A key tool to monitor chemicals in the Danish environment is the National Monitoring and Assessment Programme for the Aquatic and Terrestrial Environment (NOVANA), established in 2004. It analyses pollution sources, trends, policy actions and environmental pressures in various categories (surface water, sediment, biota, groundwater, air and point sources, wastewater and rainwater installations), in particular to support compliance with Danish and EU legislation and international conventions. Since its inception, the programme has been adapted to evolving EU policies (e.g. Natura 2000, river basin management plans, emission ceilings). In the current monitoring period, 2017‑21, it covers more than 250 substances in one or more categories and with varying monitoring frequency, e.g. 25 polycyclic aromatic hydrocarbons (PAHs), 13 per- and polyfluoroalkyl substances (PFAS), 20 metals, 17 polychlorinated biphenyls (PCBs), 8 plasticisers, 20 pharmaceuticals, and 66 pesticides and their metabolites. Denmark also monitors persistent organic pollutants (POPs) and heavy metal levels in the Arctic (EPA, AU and GEUS, 2017[19]; Denmark, 2018[2]).
As pesticide exposure remains a cause of concern, there are dedicated monitoring subprogrammes, including the National Groundwater Monitoring Programme and the Pesticide Leaching Assessment Programme. Denmark has also undertaken and supported efforts to address emerging issues of concern, such as the presence in the environment of antibiotics (antibiotic resistance was identified in 2017 as one of the country’s four key risk challenges) and micro plastic (EUSBSR, 2017[20]; Løkkegaard et al., 2017[21]; Denmark, 2018[2]; EMA, 2017[6]).
As the country relies for its drinking water on groundwater that is not chemically treated (it is subject only to aeration and sand filtration), particular focus on enhanced monitoring is needed in this area. A key concern is so-called legacy pesticides (and their metabolites), no longer authorised for use in Denmark but found in groundwater sources.
Denmark would benefit from further enhancement of pesticide and legacy pesticide monitoring in groundwater and under the Pesticide Leaching Assessment Programme. It should also consider supplementing its actions with surface water monitoring (relevant for biocides), in line with the recommendations of its national expert-based water panel. In January 2019, Denmark announced that pesticide monitoring in groundwater would be expanded (MEF, 2019[22]), which should be applauded. Denmark should also consider enhanced monitoring of emerging pollutants (e.g. pharmaceuticals in surface and groundwater) and heavy metals (e.g. zinc in soil and water).
Biomonitoring
Denmark does not have a long-term biomonitoring programme for environmental chemicals like those in, for instance, Germany and the USA.3 However, it is a one of the relatively few countries that have undertaken biomonitoring for non-occupationally exposed populations and it co‑operates with other countries in this field within the EU framework. Both public and private sources, but mainly the latter, finance this work.
Denmark collaborated with 16 other European countries in the DEMOCOPHES project (DEMOnstration of a study to COordinate and Perform Human biomonitoring on a European Scale) on exposure to bisphenol A, other phenols, parabens, cadmium, cotinine and phthalate metabolites in urine, POPs in blood and mercury in hair. It also funded supplementary actions to increase knowledge of exposure of its population to potential endocrine disrupting chemicals (Mørck et al., 2015[23]; Denmark, 2018[2]). And it currently participates in the EU flagship human biomonitoring project, HBM4EU. Launched in 2017, the project aims to harmonise exposure assessment methods based on biomonitoring data. In 2017, Denmark hosted a Nordic workshop to discuss priorities for the project (HBM4EU[24]; Knudsen and Hansen, 2017[25]). The Danish action plan on industrial chemicals (Section 5.3.1) includes biomonitoring in the context of endocrine disruptors.
An external evaluation of the Danish Centre for Endocrine Disrupting Substances (CEHOS) recommended in 2017 that the country should increase public investment in biomonitoring (Bourguignon, Hutchinson and Slama, 2017[14]). Denmark would benefit from enhanced biomonitoring, taking into account the trade-offs needed to balance it with predictive risk assessment to proactively identify chemicals that require regulatory action before a negative impact can be detected in humans or the environment. These actions should take into account a science/policy nexus, for instance supporting identification of the source of exposure or aligning the efforts with Denmark’s regulatory priorities (e.g. under the EU REACH Regulation).
Consumers and workers
To ensure a high level of protection of the public (particularly consumers and workers) from risk related to chemicals, Danish research centres, supported by public resources, are undertaking activities to monitor and prevent risk in relation to:
endocrine disruptors (CEHOS and the International Centre for Research and Research Training in Endocrine Disruption of Male Reproduction and Child Health)
allergies to chemicals (the National Allergy Research Centre)
the impact of chemicals on occupational health (Working Environment Research Fund) (Denmark, 2018[2]).
Pollutant release and transfer register
Danish companies have reported environmental information via so-called green accounts since 1995. In 2008, Denmark ratified the Kiev Protocol on Pollutant Release and Transfer Registers to the Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters. It was implemented through the 2006 EU Pollutant Release and Transfer Register (E‑PRTR) Regulation and national legislation. The EU/Danish PRTR covers 91 substances and some 65 economic activities. It includes 90 out of 126 chemicals from the OECD harmonised list of pollutants (OECD, 2014[26]). Danish reporting to the E‑PRTR started in 2007 and to the Kiev Protocol in 2010. PRTR data are complemented by estimating emissions for substances with diffuse sources. Since 2012, geographical mapping of emissions from Danish diffuse sources in the PRTR has been publicly available (AU, 2018[27]).
Companies report measured, calculated or estimated data annually to the PRTR, usually via a one-stop portal.4 The EPA provides technical support. Companies, local authorities and the EPA contribute to data quality assurance. No overall assessment of the submitted data has yet done; such an assessment could help authorities understand the completeness and relevance of the data (MEF, 2016[28]). PRTR data are available to the public via the national PRTR register or the E‑PRTR portal; national reports are subject to public consultation. Both registers offer a wide choice of search options (MEF, 2016[28]).
The scope of PRTR reporting was visibly reduced in the review period. Regulatory changes (modifying green account reporting in 2010 and abolishing it in 2015 in favour of a separate national regulatory framework for the PRTR) (EPA[29]) led to a reduction of the economic activities covered as well as strict application of E‑PRTR scope and thresholds. The number of companies reporting environmental information in the green accounts and the PRTR fell by 52% between 2007 and 2014; the number of Danish companies in the E‑PRTR dropped by 48% between 2007 and 2016 (Figure 5.3) (EEA, 2018[5]; EPA[30]). The number of chemical industry facilities reporting dropped almost by half (from 49 to 25), mostly following the 2015 abolition of green accounts (EEA, 2018[5]; EPA[30]).
Fewer reporting companies means less information available for the authorities and stakeholders (e.g. companies and general public). This can contribute to the reduced ability of Denmark’s PRTR system to provide comprehensive data on emissions that could support broader decision making.
Figure 5.3. The number of Danish companies reporting to the E-PRTR and national PRTR/green account programmes has fallen
5.3. Policy, regulatory and institutional frameworks
Denmark has a comprehensive policy and regulatory framework consisting of EU and national legal instruments, with national rules sometimes exceeding the EU rules’ scope. Denmark manages all enforcement activities on chemicals at the national level and co‑operates at the regional level in this field. Stakeholders are actively involved in chemicals management, and the use of economic analysis in decision making is on the rise.
EU membership had direct, comprehensive implications for the Danish legal system in the review period, for instance through introduction of the new EU horizontal legislation (applying to all chemicals not regulated by specific regimes) for industrial chemicals: the REACH Regulation and Classification, Labelling and Packaging (CLP) Regulation. However, the influence does not go just one way. Denmark has actively and rather successfully pursued its national objectives on chemicals both at the EU level and in a broader international context.
5.3.1. A comprehensive policy, legal and institutional framework is in place
Policies
Denmark has mainstreamed chemicals management into its national policy framework. Several high-level policy documents address chemicals management and reflect national objectives and pressures. They take into account policy documents adopted at the EU level, notably the Environmental Action Programmes (EAPs).
General chemicals management
At the national level, since 2005 Denmark has prepared and implemented strategic policy documents related to general chemicals management. They take the form of four-year action plans, currently called the Chemical Initiatives. Negotiations between the government and main political parties outside government precede adoption of these policy documents. This approach secures a broad commitment from the political level, along with medium-term resources, to prioritise chemicals management. The current action plan covers 2018‑21 (Box 5.2).
Box 5.2. Danish Chemical Initiatives 2018-21
The 2018‑21 Chemical Initiatives, agreed by all parties in the Danish Parliament, build on previous plans and set the following priorities for national actions regarding chemicals:
credible information to consumers on chemicals (with particular attention to chemicals in products, vulnerable groups, and food and food packaging)
a level playing field for enterprises, particularly effective regulation of chemicals and good enforcement, with a particular focus on promotion of standard setting for Danish companies, better data quality, imported products, and support to SMEs
initiatives on five groups of chemicals of concern – substances that are carcinogenic, mutagenic or toxic for reproduction; chemicals affecting brain development; endocrine-disrupting chemicals; allergenic chemicals; and chemicals of high concern for the environment
research and knowledge building (in particular on endocrine disruptors).
The plan supports Denmark in meeting its obligations under the EU acquis on chemicals and the international agreements in this field.
Source: (Government of Denmark et al., 2017[9]).
Danish action plans on chemicals can serve as a best practice example. They have secured continuity and coherence of Danish priorities: focus on consumers, enforcement, implementation of EU legislation and support of international work. The priorities have been modified where activities did not yield the expected results. The action plans have reflected ongoing policy discussions (e.g. on endocrine disruptors or circular economy) and Danish reliance on imported products (e.g. focus on users of chemicals and imported products). They have also highlighted consumers’ right to know and encouraged stakeholder involvement. The level of detail of the action plans has been enhanced over the review period.
The Chemical Initiatives have served as a guide for Danish efforts in the European and global arenas and as vectors to promote Danish knowledge and expertise. They have been aligned with and supported policy developments at the EU level, e.g. the EU EAPs and the Conclusions of the Council of the European Union (Government of Denmark, 2005[31]; Government of Denmark, 2010[32]; Government of Denmark, 2013[33]; Government of Denmark et al., 2017[9]). The Chemical Initiatives respond to the interests of various stakeholders. For instance, in line with industry expectations, the current plan prioritises respecting growth and innovation when substituting hazardous chemicals (Danish industry, 2017[34]).
An area that might benefit from further improvement is chemicals’ role in Danish policy documents on occupational health and safety (OHS). The 2011‑20 OHS strategy only marginally addresses chemicals. This is surprising, given the important interface of EU industrial chemicals and OHS legislation, as well as the significant involvement of Danish OHS authorities in chemicals management in Denmark (Government of Denmark et al., 2011[35]). The 2019 political negotiations in Denmark on the strategy beyond 2020 offer an opportunity to improve this situation.
The first external evaluation of the Chemical Initiatives, in 2017, produced data that were not systematically gathered to evaluate the previous plans’ effectiveness. As EPA staff were directly involved in preparation of the evaluation methodology, it should be beneficial for future assessments. The results also gave a clear signal for policy makers that evaluation should be a standard procedure. Indicators to better track progress of the action plans should be further developed and their use improved.
Pesticides
The first pesticide action plan was introduced in 1986. All strategic documents of the last ten years in this area share the same overall objective: limiting the use of pesticides and (from 2013) minimising the pesticide load on the environment and health (Government of Denmark and the Danish Peoples’ Party, 2009[36]; ME, 2013[37]; MEF, 2017[38]).
The pesticide strategy for 2013-155 initiated a significant change in pesticide management, introducing a pesticide load indicator (PLI) based on the impact of individual pesticides on human health, nature and groundwater. This replaced a treatment frequency index, whose reduction targets had not been achieved. In addition, a differentiated tax based on the environmental and health burden, with the rate higher for pesticides with higher load, replaced a pesticide levy based on percentage of retail price (Box 5.3).
Box 5.3. Results of the 2013 pesticide load indicator reform are not yet fully known but appear promising
Pesticide load calculated on sales data (but not consumption) allowed Denmark to meet its goal of a 40% PLI reduction in 2016. Since the reform, pesticides with a greater load have largely been replaced with ones with a lower load (e.g. in cases of certain insecticides or growth regulators), which made it possible to meet the target on the most problematic substances in 2016. Moreover, the reform coincided with reclassification of chemical substances and mixtures in line with the EU CLP Regulation. In many cases, this led to stricter classification in relation to health hazards and heavier health loads.
The complete effects of the PLI reform on consumption were still not known in 2018, as farmers stockpiled pesticides ahead of the reform. The authorities need to monitor whether the reform negatively affects resistance to certain pesticides (e.g. antifungal resistance) due to, for instance, increased use of the least taxed pesticides. An action plan to address this, and to strengthen efforts to develop integrated pest management, will be implemented over 2019‑22. Results of a research project to analyse how the tax reform changed farmer behaviour are expected in 2019. Further discussion on the tariff changes is expected to follow in 2020.
Measures to compensate farmers and gain their support accompanied implementation of the reform. These included reducing the land value tax and using tax revenue to support organic farming and administrative services.
Source: (Pedersen, 2016[39]; MEF, 2017[38]; Holtze, Kühl and Hyldebrandt-Larsen, 2018[40]; Denmark, 2018[2]; MEF, 2019[22]; Böcker and Finger, 2016[41]).
The new tax has four components: basic tax, health tax (with rates differing by health hazard), environmental toxicity tax (with rates differing by species) and a tax covering persistence, bioaccumulation and leaching. The major goal of the strategy was reducing pesticide sales, based on PLI, by 40% to a level equivalent to a pesticide load of 1.96 (Figure 5.4). It also included a 40% reduction target for the health burden of the use of carcinogens and hormone disrupting substances (ME, 2013[37]).
The pesticide strategy for 2017-21 has four main areas: pesticide authorisation; targeted and reinforced inspection efforts (focused on distributors); a pesticide research programme; and information, advice and guidance. The strategy serves as the National Action Plan for Sustainable Pesticide Use (MEF, 2017[38]). In January 2019, a supplement to the strategy was agreed. It contained additional measures regarding reduction of the risk of pesticidal contamination of groundwater in well vicinity protection zones, addressed pesticide resistance and banned (as of 2020) the sale of concentrated pesticides to non‑authorised individuals. Additional measures and funding to strengthen monitoring of pesticides in groundwater were also agreed (MEF, 2019[22]).
Figure 5.4. A differentiated tax, introduced in 2013, helped reduce the pesticide load
Regulatory framework
The regulatory framework for chemicals management is comprehensive and addresses all relevant aspects. It consists of EU and national legal instruments.
In the last 13 years, the EU has substantially revised its legislation on industrial chemicals, in particular by adopting horizontal legislation, i.e. the REACH and CLP regulations. These rules have heavily influenced chemicals management in Denmark: on the one hand they imposed certain constraints (it was no longer possible to regulate some aspects of chemicals management at the national level), but on the other they provided new opportunities (e.g. making it possible to influence the EU-wide legal framework). There are also several EU regulations addressing more specific areas of chemicals management or groups of chemicals, such as those on cosmetics, detergents, and export and import of hazardous chemicals, POPs and mercury. In addition, EU directives addressing important areas of chemicals management include the Seveso Directive on major industrial accidents and the Industrial Emissions Directive.
At the national level, key Danish legal instruments related to chemicals management are the Act on Chemicals, the Environmental Protection Act and the Act on the Working Environment. They are the basis for executive orders issued to, among other things, transpose the relevant EU directives into the Danish legal framework or address areas of chemicals management that are beyond or outside of the scope of EU regulations and directives. For instance, the Danish regulatory framework requires companies to provide information on substances not covered by the REACH Regulation, e.g. produced or imported in amounts between 100 kg and 1 tonne (Denmark, 2018[2]). Pesticides and biocides are covered by both EU legislation (the Biocidal Products and Plant Protection Products regulations) and national rules (EC[42]; ECHA[43]).
In relation to prevention, preparedness and response to chemical accidents, Denmark expanded the scope of the applicable EU legislation to address smaller ammonia and chlorine installations as well. Denmark provides information on hazardous installations to other countries and exchanges information on accidents and near misses via the e‑MARS database. Provision of information on hazardous installations to the public is also regulated, as is public participation in decision making (Denmark, 2018[2]).
An ongoing process of removing administrative burdens in Denmark, exemplified by a focus on avoiding over-implementation of EU regulations, has had some impact on the regulatory framework. It led to a significant reduction of the scope of reporting under the Danish PRTR and green account programmes and the removal of certain taxes on chemicals (e.g. phthalates) (Denmark, 2018[2]). This process has not affected the ambitious and well-resourced multi-year national action plans on chemicals or the areas of chemicals management where the country is a standard setter.
Institutional arrangements
At the national level, the Ministry of Environment and Food (MEF) is responsible for environmental protection in general and oversees and co‑ordinates chemicals management, covering industrial chemicals, pesticides and biocides. MEF has a unit on chemicals and a unit on industrial regulation (MEF[44]). The EPA is responsible for implementation and enforcement of the vast majority of chemical legislation.
Participation in EU work on chemicals undertaken by the EU authorities has been enshrined in Danish policy documents since the enactment of the REACH, CLP and biocides regulations. It occurs at both the policy level (Council of the European Union) and the technical level, through ECHA and the European Commission (EC). MEF and EPA are the main participating authorities. For instance, EPA staff have worked on all of ECHA’s main bodies: the Member State Committee, the Committee for Risk Assessment, the Committee for Socio-economic Analysis, the Biocidal Products Committee and the Enforcement Forum and Management Board (of which Denmark has been a deputy chair since 2017), as well as several ECHA working groups (Denmark, 2018[2]).
Some chemicals management tasks are attributed to the Veterinary and Food Administration (VFA, monitoring food and feed for harmful chemical substances) and Agricultural Agency (AA, for fertilisers). Both are part of MEF. Important institutions not under MEF are the Working Environment Authority (WEA), which is part of the Ministry of Employment and is responsible for OHS; the Maritime Authority (MA); and customs. The Ministry of Health is involved on poisons and its research centres support the MEF/EPA work on chemicals. Finally, local authorities are responsible for certain tasks (Denmark, 2018[2]; EPA, 2015[45]). Those regarding chemical accidents are shared between the national Emergency Management Agency (EMA, under the Ministry of Defence), central and local environment authorities, and other authorities such as the police (Denmark, 2018[2]; EMA, 2017[46]).
The national institutional framework was modified in 2015 by merging the ministries responsible for environment and food (actions related to food were included for the first time in the 2018-21 Chemical Initiatives). In addition, the EPA is being relocated from Copenhagen to Odense, with some former EPA staff integrated into MEF.
As a majority of authorities responsible for chemicals are in the same ministry, co‑ordination mainly takes the form of ad hoc intra-institutional consultations (or inter‑institutional, for legislative procedures). Authorised access to registers and databases containing information on chemicals or installations (e.g. the Digital Environment Administration portal) supports information sharing among authorities. In some cases, the regulatory framework directly imposes co‑operation among authorities (e.g. on major accidents or the REACH Regulation) (Denmark, 2018[2]; MEF, 2016[47]).
Financing chemicals management, performance measurement and cost saving
Denmark has multi-year action plans on chemicals (including biocides) and pesticides that guarantee stability of midterm funding. The Chemical Initiatives budget, for example, increased from some EUR 8.5 million for 2006-09 to some EUR 28 million for 2018-21. Between 2006 and 2017, this financing was highest in 2012-13 when activities under REACH peaked in relation to consumer products and information on chemicals. (Denmark, 2018[2]; Government of Denmark, 2005[31]; Government of Denmark et al., 2017[9]). Many chemicals management actions are undertaken and financed at the EU level, where Denmark contributes by transferring a percentage of its gross national income to the EU budget.
For 2018, the EPA had a total budget of some EUR 24 million for chemicals management. The main sources of funding were, in descending order, the action plans on chemicals and pesticides (29% and 37%, respectively, or 66% in all), fees for biocides and pesticides (21%) and the general budget (Table 5.1). The budget for pesticides is slightly higher than for general chemicals management. The pesticide action plan also contributes resources to the AA and VFA, and the budgets of other Danish institutions help fund actions on chemicals management (Denmark, 2018[2]).
Table 5.1. The EPA’s 2018 budget for chemicals
(DKK million)
* This amount comes mainly from fees.
Note: The budget does not reflect the fact that in the organisational change some resources were moved to MEF but still allocated to chemicals.
Source: Country submission.
In 2018, the EPA had over 120 employees in chemicals management. Slightly more staff were involved in pesticide work (38%) than in general chemicals management (32%); some 17% worked in biocides and the rest in enforcement. Employees of other national authorities working on chemicals, management, particular in OHS (over ten persons), increase the number. Some work is outsourced: for instance, the EPA and VFA have a co‑operation agreement with Technical University of Denmark to provide scientific advice on toxicological assessments and scientific research on safety of chemicals for human health (Denmark, 2018[2]; EPA, 2015[45]).
The human and financial resources secured by Denmark for chemicals management are encouraging. They support actions at the national level as well as in the international context, particularly within the EU. They also show that this area is a priority for the country. However, the EPA relocation process has triggered a visible turnover in staff, which entails risk in relation to institutional memory and current or planned activities when, for instance, new staff need to be hired and trained.
For industrial chemicals, a cost‑recovery mechanism is essentially enshrined at the EU level, under the REACH and CLP regulations, rather than at the national level. Companies’ fees, for registration of chemicals and application for authorisation, support covering the cost of services delivered by ECHA and national authorities. Part of the fee revenue is transferred to national authorities for work on substance evaluation, restriction proposals and authorisation applications (ECHA, 2017[48]). This cost‑recovery mechanism may create challenges for the future, as it is likely to diminish after the last batch of REACH registrations in 2018. The EC stated in 2018 that implementing REACH required long-term financial and resource stability and greater national contributions in view of the diminishing fee income (EC, 2018[49]). As this could entail additional pressure on future Danish financial and human resources for chemicals management, it might be worth it to commence analyses on what form of enhanced contribution to ECHA’s work would be in line with Danish priorities.
In relation to pesticides and biocides, it is the national authorities that charge the fees. Denmark charges annual fees on each authorised product (pesticides and biocides) and each place of sale (pesticides), as well as fees every three years for inspection of spraying equipment. These fees constitute a significant part of the Danish authorities’ budget (Denmark, 2018[2]).
5.3.2. Compliance and enforcement need enhancement to meet Danish priorities on chemicals
Unlike many areas of chemicals management, where efforts are shared between the EU and its members, Denmark regulates and performs all enforcement activities in relation to chemicals management at the national level, including implementation of EU legislation. However, common EU efforts on REACH and CLP compliance are increasing. While the approach to inspections concerning industrial chemicals is generally risk-based, it is more systematic in regard to pesticides and chemical accidents.
The main Danish enforcement bodies are the Chemical Inspection Service (CIS, within the EPA), WEA and MA. CIS, with a staff of 17‑18 persons, is responsible for industrial chemicals (including in electronics and toys), pesticides, biocides and cosmetics. The WEA is responsible for information obligations in the supply chain and for downstream users and OHS in general (including at offshore installations). The MA is responsible for chemicals related to obligations on ships. Some enforcement tasks related to chemicals management (e.g. on food) are attributed to other MEF agencies or other public authorities, particularly municipalities and customs (Box 5.4) (Denmark, 2018[2]; Dupont, Pelsy and Oulès, 2016[50]).
Box 5.4. A project to protect children from harmful chemicals shows potential for further work sharing and co‑operation
As part of a broad initiative in 2013-16 to protect children from harmful chemicals, the EPA and customs conducted joint targeted border control actions. They built on an analysis of import volumes at various custom offices and used the relevant customs codes.
The results suggested that, while certain chemicals (e.g. heavy metals) can be effectively controlled at borders, compliance checks for most products in the retail chain can be just as effective if not more so. The main reason is that border controls do not prevent products from entering the market, as they are released following sampling, yet further actions (e.g. chemical analysis) may be needed to determine product compliance.
As the EPA plans to continue prioritising chemical import control and e-commerce, successful co‑operation with customs (to be expanded to other stakeholders through the Danish Chemicals Forum) is expected. However, the above-mentioned results indicate more resources for enforcement in the supply chain may be needed to meet Danish objectives.
Source: (Denmark, 2018[2]).
Both informal and formal co‑operation by enforcement authorities as well as joint inspections take place in Denmark. The enforcement authorities set their own inspection strategy. During the review period, some had a strategy that was not in line with the EU‑wide strategy adopted by ECHA’s Enforcement Forum (EPA, 2015[45]), but that situation was recently resolved (Denmark, 2018[2]).
The approach to inspections concerning industrial chemicals is risk based. In practice, this means complying companies can benefit from less frequent inspections, and enforcement focuses on certain geographical areas, particularly the capital region. Denmark makes its enforcement strategies publicly available. CIS focuses its activities on 15 to 18 targeted campaigns per year, plus response to complaints (some 400 per year). The WEA performs general inspections in which all aspects of OHS are checked (Denmark, 2018[2]; EPA, 2015[45]).
For pesticides, enforcement takes the form of systematic supervision of companies introducing products to the market. As there are fewer of them than of companies dealing with industrial chemicals, the effects of enforcement are more tangible. For instance, increased inspections in relation to sale of illegal pesticides led to a sharp decrease in infringements, from 30% in 2016 to 10% in 2017 (EPA, 2018[51]).
Denmark participates in EU-wide enforcement activities, particularly regarding downstream users or consumers, in line with its approach to chemicals management. It also co‑operates with other Nordic countries on inspections, with a focus on the EU legislation (EPA[52]; Kristiansen et al., 2018[53]).
The country carries out systematic appraisal of measures applied by operators of Seveso installations.6 Almost all Danish upper tier installations have an external emergency plan prepared by the authorities (police and municipalities), which is above the EU average. However, testing of these plans has been an issue since 2003: it only took place for some 50% of installations due to an unclear division of responsibility. In 2018 the EPA published updated guidance material to aid authorities in addressing this issue (EC, 2017[54]; Amec Foster Wheeler, 2017[55]; EPA, 2018[56]).
Denmark has a dual system of penalties for non-compliance with chemical legislation. Heavy fines (proportional to income and applicable to legal persons) or a criminal sanction can be applied, but in practice, the authorities focus on preventive and educational actions. The most common enforcement tool is a warning; legal proceedings are rarely initiated (Denmark, 2018[2]; Rass-Masson, Blainey and Pelsy, 2010[57]; Dupont, Pelsy and Oulès, 2016[50]).
There are fewer inspections concerning industrial chemicals than in comparable EU countries (Dupont, Pelsy and Oulès, 2016[50]), which may be linked to potential differences in the scope of inspections and could become an issue in the long term. The results of recent enforcement campaigns related to chemical products (e.g. 80% of inspected hazardous mixtures sold online did not meet hazard information and labelling requirements) show that there is room for compliance improvement.
Additional efforts may be required in the future, in particular to cope with a priority area for Denmark: chemicals in products. Moreover, coherent and mutually supportive activities of all countries implementing the REACH and CLP regulations may be necessary, so Denmark could benefit from increased involvement in EU-wide activities. Beyond the EU context, product supply chains are becoming increasingly global, so global action will be needed. Danish stakeholders support enhanced enforcement (Danish industry, 2017[34]).
5.3.3. Exemplary public participation and involvement in chemicals management
Denmark actively involves stakeholders in chemicals management. Hence it is no surprise that Danes have the EU’s highest level of trust in national authorities (Eurostat, 2018[58]). They also top the EU rankings for understanding and use of safety information on chemicals (e.g. safety instructions, warning symbols, labels). They consider themselves well informed about the risk posed by chemicals and feel that chemical safety has improved in last 10 to 15 years (EC, 2011[59]; EC, 2013[60]; EC, 2014[61]; EC, 2017[62]).
At the national level, Danish stakeholders can take part in the public consultation mechanism employed during legislative discussions. A Special Government Committee for the Environment, open to all organisations with an interest in environmental matters, is consulted on the Danish position in the EU and other international forums, and non government organisations (NGOs) are occasionally included in Danish delegations to international negotiation meetings (Denmark, 2018[2]). Improved, formalised dialogue with the industry has been an inherent part of the Chemical Initiatives. The creation of the Danish Chemicals Forum in 2014 strengthened stakeholder engagement in the chemicals area. The forum groups representatives from public authorities, industry, labour, NGOs and academia and focuses on dialogue, co‑operation, knowledge and dissemination of information on chemicals management (Sørensen et al., 2017[63]). Stakeholder bodies are also in place for biocides (the Biocide Panel) and pesticides (the Pesticide Dialogue Forum). All meet a few times a year. MEF also meets regularly with stakeholders from the Danish cosmetic and toy sectors. Dedicated chemical events for stakeholders include Chemistry Day, organised annually since 2005; the 2018 edition focused on sustainable chemistry in the future (Denmark, 2018[2]).
The public has access to non‑confidential information on chemicals and has been the target of a vast number of initiatives, heavily supported by communication activities. The current Chemical Initiatives highlight the strategic importance of ensuring that consumers receive honest information about risks related to chemicals (whether in substances, products or food) so they can make informed choices.
To increase awareness about hazardous chemicals and chemical exposure in the general population, and contribute to EU and OECD work, the EPA has undertaken information campaigns on chemicals in consumer products. Particular attention has been paid to vulnerable groups such as children. Another example is correct pesticide use. The EPA has published an exemplary amount of information on chemicals for consumers, including, since 2001, over 160 studies on everyday products such as toys, furniture, clothing and sport equipment. It has prepared educational material for school-age children. Since 2013, it has run a Facebook account called Hverdagskemi (Everyday Chemicals) to advise on safe use of chemicals (Denmark, 2018[2]). In September 2018, a website on chemicals in consumer products and food, bridging information from the EPA and VFA, was launched (EPA, 2018[64]). Stakeholders are often involved in these activities.
Many other awareness-raising activities are directed towards supporting industry compliance with regulatory measures (EPA, 2015[45]). Thematic national and international workshops have been organised to promote knowledge sharing on chemicals of particular interest for Denmark, such as endocrine-disrupting chemicals (EDCs) (OECD, 2010[65]; EPA[66]). Danish authorities support NGO work related to chemicals management and co‑ordinate activities with them to build synergy (Government of Denmark et al., 2017[9]). For instance, the EPA and Danish Consumer Council launched a smartphone application to give consumers information on hazardous substances in products (Box 5.5) The same NGO launched THINK Chemicals, an initiative to test consumer products (e.g. earphones, diapers, cosmetics, chewing gum, cleansing tissues), in co‑ordination with the EPA (Danish Consumer Council[67]).
Box 5.5. Denmark is at the forefront of best practices stimulating public involvement in chemicals management
In 2014, the EPA and Danish Consumer Council launched a mobile app called Tjek Kemien (Check Chemicals) enabling consumers to scan products for information on whether they contain substances of very high concern (SVHCs) under the REACH Regulation. It increased consumers’ awareness of their right to information on hazardous chemicals in everyday products. This experience and that of Germany, which launched a similar app, led to discussions on developing such an app at the EU level. It is being developed under the AskREACH project funded by the EU’s LIFE Programme, with Danish stakeholder participation). It is expected to be launched in 2019.
Sources: (Sørensen et al., 2017[63]; ECHA, 2015[68]; Chemical Watch, 2017[69]; Chemical Watch, 2018[70]; LIFE AskREACH, 2018[71]).
5.3.3. Increasing the use of economic analysis in decision making
Economic analysis in relation to decision making (including chemicals management) is built into the legislative framework at both the EU and national levels. At the national level, due to the growing importance of the horizontal EU legislation on chemicals, economic analysis has been increasingly used, particularly to influence EU‑wide decisions and policies (e.g. in the work of ECHA technical committees). It was also influenced by studies showing the pressures from chemicals on Danish society.
For instance, a high prevalence of male reproductive disorders, in comparison with neighbouring Finland, and a decline in the onset of puberty in girls have been observed in Denmark, with EDCs being identified as a potential factor (Krysiak-Baltyn et al., 2010[72]; Mouritsen et al., 2010[73]). It has been estimated that exposure to EDCs in Denmark leads to total yearly health and economic costs of more than EUR 2 billion (some 1.3% of GDP, which is above the EU average) (Trasande et al., 2016[74]). There are also statistically significant healthcare costs and productivity losses for adults with contact dermatitis. The socio‑economic costs of contact allergies have been estimated at EUR 2.4 billion per year (Saetterstrøm, Olsen and Johansen, 2014[75]; Sørensen et al., 2017[63])
Denmark has begun evaluating the effects of its action plans on industrial chemicals. The 2017 ex post evaluation of the 2014-17 Chemical Initiatives, for example, assessed their qualitative and quantitative impact by identifying the overall goals and later establishing effect chains7 for each of the 14 actions. In effect chains, inputs, activities, outputs and effects are combined to explain how and why a given planned activity should lead to the desired effect. The analysis by external consultants and the EPA suggested, among other things, that the environmental and health benefits of the actions over the long term (50 years) would outweigh the costs in all scenarios, with benefits ranging from EUR 27 million to EUR 1.2 billion. An ex ante analysis of the 2018-21 Chemical Initiatives, mainly establishing the framework for a future ex post evaluation, followed in 2018. It recognised the use of the effect chains developed in principle for the ex ante evaluations (Denmark, 2018[2]; Sørensen et al., 2017[63]).
Other public authorities in Denmark that have employed economic analysis in their work include the VFA, which in 2013 produced economic impact assessment tools for its staff to support cost-benefit analysis of its policy measures, and the EPA, which used economic analysis to estimate the pesticide tax’s impact on agricultural producers (Sørensen et al., 2017[63]; Holtze, Kühl and Hyldebrandt-Larsen, 2018[40]).
5.4. International forums and regional settings
Denmark has long been at the forefront of global and regional discussions on chemicals management and has prioritised international co‑operation in national strategic documents.
5.4.1. Multilateral environmental agreements and international organisations
Denmark actively participates in the multilateral environmental agreements (MEAs) and non-binding initiatives on chemicals, and contributes to international organisations’ work. It is a party to all relevant chemical MEAs (e.g. the Minamata Convention on mercury, the Rotterdam Convention on prior informed consent, the Stockholm Convention on persistent organic pollutants) and to regional agreements in the UNECE framework, including the Helsinki Convention on transboundary effects of industrial accidents and the Kiev PRTR protocol. Danish implementation is usually through laws transposing the applicable EU legislation (Denmark, 2018[2]).
Among non-binding global initiatives on chemicals, Denmark has implemented the Globally Harmonized System of Classification and Labelling via the CLP and REACH regulation ( the latter in relation to safety data sheets). It is active in the Strategic Approach to International Chemicals Management (SAICM), including involvement in and support for the SAICM Beyond 2020 process (EPA, 2018[76]).
Denmark has provided both in-kind and financial support to the work of international organisations involved in chemicals management, particularly in areas aligned with its national priorities, such as EDCs. Over the review period, Denmark continued to be one of the top 15 contributors to the Environment Fund of UN Environment (Denmark, 2018[2]; UN Environment, 2018[77]; Urho et al., 2019[78]). Finally, Denmark contributes to the OECD work on chemicals: it chaired the Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology in 2015‑17, and continues its participation in that body and its working parties and groups.
5.4.2. Regional and bilateral co‑operation
Although co‑operation within the EU (see Sections 5.5 and 5.6 for Denmark’s contribution to chemicals management at the EU level) has become more important for Denmark, in line with the evolution of regional legislation on chemicals, it has not completely replaced other modes of regional involvement. They continue to exist, as do bilateral initiatives.
Nordic co‑operation
Important regional co‑operation on chemicals takes place within the Nordic Council of Ministers, an inter‑governmental co‑operation forum comprising Denmark, Finland, Iceland, Norway, Sweden, the Faroe Islands, Greenland and the Ǻland Islands (Norden[79]). The main vector for co‑operation on chemicals is the Nordic Chemical Group, whose overarching goal is “sustainable development based on high-level health and environmental protection for both the present and future generations” (Norden[80]).
For over 30 years, the group has co‑ordinated members’ activities to support national efforts on chemicals management. Its 2019‑24 priorities include supporting substitution of hazardous chemicals; strengthening EU regulations on grouping of hazardous substances; co‑operating on supervision of chemicals in articles, in recycling and in e‑commerce; and paying special attention to the presence and impact of chemicals in northern regions and the Arctic (NCM, 2018[81]).
Arctic region
The Arctic Council is a co‑operation forum comprising Canada, Denmark, Finland, Iceland, Norway, the Russian Federation, Sweden and the United States, along with Arctic indigenous communities and other inhabitants. Of particular importance for chemicals management are its:
Arctic Contaminants Action Program
Arctic Monitoring and Assessment Programme (AMAP)
Emergency Prevention, Preparedness and Response Working Group (AC[82]; Denmark, 2018[2]).
Denmark is very active in the work concerning the region (for instance, in AMAP), particularly due to its ties with the Faroe Islands and Greenland (Box 5.6).
Box 5.6. Continuing co‑operation in the Arctic is important
The Kingdom of Denmark consists of Denmark and the territories of the Faroe Islands and Greenland. The territories face serious environmental challenges. For instance, Denmark’s 2017 National Risk Profile identifies increased activity in the Arctic region as one of four challenges for the kingdom and calls for greater commitment to maintain effective civilian preparedness throughout the realm.
A common policy document of Denmark and the territories, Strategy for the Arctic 2011-20, underlines the importance of monitoring the Arctic environment and protecting it from such hazardous substances as POPs and mercury. It also highlights focusing on national implementation of international environmental agreements and on prevention of accidents involving chemicals. Denmark and its territories co‑operate on chemicals management, for instance through long-term monitoring of POPs and heavy metals in Greenland and related human health effects in Greenland and the Faroes. About half of Danish funding for research and monitoring in the Arctic is devoted to chemicals. The results support Danish activity at the EU level (e.g. under the REACH Regulation) and internationally (e.g. under the MEAs).
Sources: (Prime Minister's Office[83]; Denmark, 2018[2]; Governments of Denmark, Greenland and the Faroe Islands, 2011[84]; EMA, 2017[6]).
North-east Atlantic Ocean
Denmark co‑operates with 14 European countries and the EU within the OSPAR Commission under the OSPAR Convention.8 The goal of co‑operation on chemicals is to prevent pollution by reducing discharges, emissions and losses of hazardous substances. The Hazardous Substances & Eutrophication Committee implements OSPAR’s Hazardous Substances Strategy, for instance via assessments of substances of concern for the maritime environment, regional data collection and co‑ordinated monitoring. This work complements and supports the work of the EU and international organisations (OSPAR Hazardous Substances & Eutrophication Committee, 2018[85]).
Baltic Sea
Denmark co‑operates on chemicals in the Baltic Marine Environment Protection Commission, HELCOM,9 whose aim is to protect the Baltic Sea marine environment from all pollution sources. On chemicals, the main goal is for the Baltic to be undisturbed by hazardous substances (HELCOM[86]). The work includes co‑operation on environmental monitoring and reduction of inputs of hazardous substances to the Baltic Sea. Denmark led the project on risk of oil and hazardous substance spills in the Baltic Sea and is a lead country for developing the core indicators for “PAH and their metabolites” and “TBT and imposex” (HELCOM, 2015[87]; Denmark, 2018[2]). In 2018, Denmark signed a regional declaration whose commitments included jointly re‑examining the effectiveness of measures and recommendations for legacy pollutants, identifying the scale of problems of contaminants of emerging concern, identifying and assessing further hazardous substances and contaminants from offshore sources, and developing appropriate mitigation measures (HELCOM, 2018[88]).
Bilateral co‑operation
In 2014, EPA signed a bilateral agreement with the Swedish Chemicals Agency on co‑operation in the EU context, e.g. on chemicals in consumer products and on EDCs. It aims to support information exchange and experience sharing (Denmark, 2018[2]).
5.5. Systematic investigation of chemicals
Since 2007, the REACH Regulation has set the framework for systematic investigation of industrial chemicals at the national and European levels. Denmark actively contributes to priority setting and assessment processes at the EU level and to identification of chemicals of concern.
5.5.1. Gathering, exchanging and protecting information on chemicals
Several chemical inventories at the EU level contain information provided by Danish companies. Examples include the database of substances registered under the REACH Regulation, the ECHA classification and labelling database (C&L Inventory), and databases on biocides and pesticides. Non-confidential information from these is publicly available, while the confidential part is accessible to authorised EU and national authorities (ECHA[89]).
Denmark complements the EU inventories with its own databases. The Danish Product Registry, run jointly by the WEA and EPA, covers low-volume hazardous substances (of which between 100 kg and 1 000 kg is manufactured or imported per year) and mixtures (more than 100 kg produced or imported per year) placed on the market for professional use; biocides not yet covered by the authorisation system; and offshore chemicals. The registry contains information on about 38 000 registered products (WEA[90]). The Danish Nanoproduct Register (whose data are accessible only to the Danish authorities) gathers information on mixtures and articles containing nanomaterials (EPA[91]). Denmark also has a database of chemicals in consumer products (EPA[92]); a database of pesticides and biocides, including information on cancelled, rejected or expired authorisations (EPA[93]); and a database of advisory self-classifications (EPA[94]).
Exchange and protection of chemical data
Several mechanisms enable the exchange of various types of information on chemicals between Denmark, other countries and regional and international bodies. They serve mainly to facilitate work at the EU level (e.g. confidential information is exchanged between ECHA, national authorities and industry) (Denmark, 2018[2]). In addition to EU data-sharing mechanisms, Denmark exchanges non-confidential information on chemical products with other Nordic countries and provides information to international bodies, for instance through reporting under MEAs, SAICM and AMAP (Denmark, 2018[2]).
Confidentiality provisions are part of the national and EU legal framework. For instance, information in the Danish Product Registry is protected to ensure that companies can only gain access to their own confidential information (Denmark, 2018[2]).
5.5.2. Involvement in assessment of chemicals
Priority setting and assessment
Priority setting for industrial chemicals is in principle done at the EU level but in practice is a joint effort of the EU and national authorities. The Community rolling action plan (CoRAP) lists prioritised substances for evaluation. ECHA and the national authorities identify substances that could be included in CoRAP and subsequently evaluated by the national authorities (ECHA, 2018[95]; ECHA, 2018[96]). The EU legislation directly applicable to Denmark lays out a process for hazard, exposure and risk assessment of industrial chemicals, as well its timeline. Box 5.7 provides an example of the approach to chemical assessment in a non-EU OECD country: Australia.
Box 5.7. Assessment of industrial chemicals: The Australian perspective
Australia introduced the Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework in 2012 to accelerate assessment of industrial chemicals and complement the work done in the Priority Existing Chemicals (PECs) process. This science- and risk-based framework is used to identify and rapidly assess existing chemicals of concern. It is also used to enhance risk management of industrial chemicals by increasing the flow of chemical safety information to industry, risk management bodies and the public. IMAP has extensively used assessments performed abroad, particularly in Canada, the United States and the EU.
The number of industrial chemicals on the national inventory considered in the IMAP framework is significantly greater than the number considered in the PEC process: more than 12 000 chemicals were assessed between 2012 and 2018. The framework reduced the gap of unassessed chemicals from 92% to 61%. It has been used to identify environmental contaminants of emerging concern and has raised awareness of the need for risk reduction strategies for high concern chemicals.
The accelerated rate of assessment of industrial chemicals achieved using the IMAP framework relies on a tiered approach in which chemicals are assessed at a level corresponding to their potential risk to human health or the environment. In 2016, the assessment focus shifted from identification of concerns (IMAP stage 1) to de‑prioritisation (IMAP stage 2) (see Chapter 5 of the 2019 OECD Environmental Performance Review of Australia for further information). The human health and environmental assessments are often conducted separately, which allows resources to be efficiently allocated to addressing areas of concern.
Under IMAP, chemicals are frequently assessed in groups, using OECD principles for building chemical categories, and a weight-of-evidence approach is used to consider relevant, reliable data from domestic and international sources. A comprehensive Quantitative Structure-Activity Relationship strategy, including custom-built tools, was established to support decision making. A significant investment was made in developing chemical informatics software that enables rapid assessment and maximises the use and reuse of the large amounts of quality-assured regulatory information generated in assessments.
Once the Australian National Industrial Chemicals Notification and Assessment Scheme reform enters into force, it is expected to replace both the PECs process and the IMAP framework with a new legislative tool.
Source: (Australia, 2019[97]; OECD, 2019[98]).
Denmark has actively contributed to priority setting and assessment processes at the EU level (Figure 5.5). Danish priorities for selecting chemicals are set in a multi-year action plan on chemicals and have been relatively stable over the last decade. The current Chemical Initiatives prioritise actions in relation to carcinogenic, mutagenic or toxic for reproduction (CMR) substances; chemicals affecting brain development; EDCs; allergenic chemicals; and chemicals of high concern to the environment (Government of Denmark et al., 2017[9]).
Denmark has been especially active in estimating properties of chemicals from their molecular structure using results of SAR or QSAR modelling, known collectively as (Q)SARs. The National Food Institute at the Technical University of Denmark, supported by the EPA, NCM and ECHA, launched a publicly available (Q)SAR database with estimates from more than 200 (Q)SARs and (Q)SAR predictions for more than 600 000 chemical substances. It is part of the OECD QSAR Toolbox (NFI[99]).
The country has been involved in investigating chemicals outside the EU framework, for instance under the Helsinki and OSPAR conventions. It has actively participated in development of the OECD test methods for EDCs (e.g. it led the development and adoption of a test for endocrine-disrupting effects in fish and updates on test methods for screening of reproductive effects and for developmental toxicity), and worked within the OECD to prepare guidance for authorities and industry on the use of the test methods for EDC assessment (EPA[66]).
Figure 5.5. Denmark is an active player in evaluation of chemicals at the EU level
Pesticides and biocides
The EU legislation on pesticides and biocides includes specific pre-marketing requirements and timelines. In principle, national authorities must authorise a product before it is placed on the market. There were about 650 authorised pesticides in Denmark in 2016 and some 350 authorised biocidal products in 2018 (Denmark, 2018[2]; ECHA[89]). Over 2008-17, Denmark evaluated 26 biocide active substances/product type combinations and 13 pesticide active substances (with co-responsibility for evaluation of further 14), with the final decision taken at the EU level. The validity of authorisation for an active substance in pesticides and biocides, and for a biocidal product, is typically no more than ten years. The validity of a pesticide product authorisation is linked to the active substance authorisation (ECHA, 2018[100]; Denmark, 2018[2]).
For pesticides, Denmark is responsible for hazard, exposure and risk assessment of products, based on information provided by the applicant. The EPA accepts the use of assessments performed in other countries, with limitations (e.g. adoption of Danish requirements on leaching to groundwater). Denmark collaborates on assessments with other countries in a so-called northern zone,10 but the final decision is taken by national authorities (Northern zone, 2018[101]). For biocides, Danish authorities evaluate products under application for EU-wide authorisation and co‑operate with other countries for product evaluation if an applicant seeks mutual recognition in multiple jurisdictions (ECHA, 2018[102]).
Testing requirements
For industrial chemicals, pesticides and biocides, the applicable EU legislation sets out testing requirements. The OECD Test Guidelines also apply. The EU legislation requires application of the OECD Principles of Good Laboratory Practice (GLP). Good Experimental Practice (GEP) applies for field trials on plant protection products. The Danish Accreditation Fund is responsible for GLP compliance and the EPA (with support from Aarhus University) for GEP compliance. For chemicals used offshore, the testing requirements follow the OSPAR Convention (Denmark, 2018[2]).
5.5.3. Contribution to identification of chemicals of concern
Denmark has long worked actively on identification of chemicals of concern. In recent years, the tendency has been to focus actions on supporting EU-wide activities.
As early as 1998, Denmark established a List of Undesirable Substances (LOUS). It was not legally binding, but guided the industry on what should be substituted. The latest version (2009) included 40 substances or groups of substances selected in line with EPA criteria (based on hazardous properties identified, for instance, by computer models). Over 2012-15, Denmark reviewed all the substances and groups of substances, in co‑operation with stakeholders, with a budget of some EUR 6.4 million. The LOUS has not been updated, as its criteria largely overlap with those of the REACH SVHC.
Selection of substances for the LOUS allowed Danish authorities to create a 2009 list of effects, including 19 500 substances that fulfilled the LOUS criteria but whose use had not been assessed in Denmark (EPA, 2010[103]). The selection of chemicals for both lists was supported by the Danish work on (Q)SARs, prioritised in all Danish action plans on chemicals.
In line with national priorities, Denmark made significant efforts to identify potential EDCs and address combined effects of chemicals and nanomaterials (Box 5.8). Over 2013-15, the EPA carried out initiatives targeted at children, using the results as the basis for evaluation of total exposure of children (including those unborn) to more than 60 selected substances that were hormone disruptive, suspected of being hormone disruptive or posed neurotoxic and related risks (Larsen et al., 2017[104]).
Box 5.8. Top priorities for Denmark: Endocrine disruptors and nanomaterials
Denmark has assessed several potential EDCs and undertaken studies on the exposure of children to EDCs. It included potential EDCs on LOUS and ranked EDCs high on its environmental agenda during its 2010 presidency of the Nordic Council of Ministers and 2012 presidency of the Council of the European Union. In 2011, Denmark proposed EDC criteria for the REACH and plant protection product regulations and later pushed for their adoption. It also participated in the development of relevant OECD test methods and guidance documents. Denmark supported preparation of the 2018 UN Environment report on global EDC-related initiatives. Also in 2018, the government asked CEHOS to perform annual screenings of hazardous chemicals to support addressing EDCs at the EU level. In the context of EDCs, Denmark pushed for action to address phthalates at the national level (a holistic strategy adopted for 2013‑15, a new set of compliance initiatives agreed in 2017) and the EU level.
On nanomaterials, Denmark has undertaken projects aiming at investigating, and generating new knowledge on, the presence of nanomaterials in products on the Danish market and assessing possible associated risk to consumers and the environment. About 30 reports are available.
Source: (Danish Chemicals Forum, 2015[105]; UN Environment/IPCP, 2017[106]; Denmark, 2018[2]; CEHOS, 2018[107]; Christensen et al., 2015[15]).
Regarding industrial chemicals, Denmark has actively supported identification of potential SVHCs at the EU level. It has been among the most active countries in this area, submitting ten dossiers between 2010 and 2018 (ECHA[89]). On pesticides and biocides, the EPA Pesticide Research Programme, in place since 1987, generates information that supports the regulatory measures for these chemicals. The National Allergy Research Centre, established in 2001, played an important role in providing documentation on human exposure to allergens, relevant for the EU‑wide restrictions on the use of chromium in leather goods (2015) and the prohibition of methylisothiazolinone in leave-on cosmetics (2017). The Working Environment Research Fund, established in 2003, aims to strengthen research and development in occupational safety and health (Denmark, 2018[2]).
Pollution caused by pharmaceuticals is an emerging environmental problem. At the regional level, Denmark co‑operates in the HELCOM collaboration platform on pharmaceuticals (EUSBSR, 2017[20]). Efforts at the national level have focused on pharmaceuticals in wastewater treatments plants, especially from hospital discharges (Denmark, 2018[2]).
Identification and evaluation of chemicals of concern were high on the agenda in Denmark during the review period. Multi-year action plans provided stability of funding. However, additional effort may be needed to sustain Denmark’s standard-setting role in this area. The amount of work is rising (e.g. on analysing submitted data quality) and the transfer of fees from the EU level to support national activities started to diminish in 2016. The increasing amount of data (e.g. from research and implementation of legislation), combined with the increasing digitalisation of regulations and tools, will also require additional resources and capacity to better manage and use the information.
5.6. Risk management
Denmark applies a broad mix of instruments to risk management of chemicals. Regulatory, voluntary and other tools are adopted at the EU or national level. Denmark supports substitution of hazardous substances.
Danish environmental legislation incorporates the polluter-pays principle. The main legal instrument on chemicals, the Act on Chemicals, supplements this principle by making it possible for authorities to carry out chemical tests at industry’s expense if the latter does not do it upon request. The Environmental Protection Act requires industry to take precautions to avoid or minimise pollution and, failing that, to address its consequences. Certain fees collected by national and EU authorities help finance relevant measures by Denmark (EPA, 2017[108]; MEF, 2017[109]).
5.6.1. Use of risk management approaches
Regarding industrial chemicals, risk reduction provisions correspond to the authorisation and restriction stages of the REACH Regulation and harmonised classification and labelling under the CLP Regulation. Denmark has actively contributed to the relevant EU processes where possible (Figure 5.6), although initiative is reserved for the Commission in some areas. The timeline for application of risk management measures is usually enshrined in the applicable EU legislation. However, if a risk is of a national character, national measures can be applied, with no set timelines (Denmark, 2018[2]).
National regulations apply in areas not fully covered by EU or international legal frameworks. For instance, Denmark is one of the few countries with restrictions on the use of lead in gun ammunition (it applies a total ban, including outside wetlands) and fishing sinkers (ECHA, 2018[110]). The national restriction on importing or selling products containing lead is stricter than that of the EU (Fråne et al., 2018[111]).
For plant protection products and biocides, risk mitigation measures are identified during the authorisation process. Denmark applies additional measures in certain areas (e.g. voluntary agreements on pesticide use in public areas, thresholds for use on golf courses, training for professional users and distributors). For biocides, specific authorisation is required to use rodenticides with anticoagulants or to fumigate for pests. Danish rules on evaluation and approval of biocidal insecticides include provisions to protect bees and other non-target insects (Denmark, 2018[2]; MEF, 2017[8]).
Denmark has used taxes to reduce exposure to certain hazardous chemicals, but the PVC tax was recently abolished after a political agreement on easing the administrative burden on companies, and the phthalate tax was rescinded due to an agreement on an EU‑wide restriction (Denmark, 2018[2]).
Figure 5.6. Denmark actively contributes to risk management of chemicals at the EU level
The area of occupational work and safety features national legislation and guidelines, combined with monitoring, research and stakeholder collaboration on safe work. It includes considerable flexibility in adopting national risk management measures related to CMR substances. In the last ten years, Denmark has adopted occupational guidelines for 17 substances, most of which had to be implemented within three to five years (Denmark, 2018[2]).
The unintentional poisoning mortality rate dropped between 2006 and 2016 from 5.4 to 3.8 per 100 000 people (SD, 2018[112]). Poison centres support safe use of chemicals, as well as preventive and curative measures, by providing medical advice to the public and doctors on emergencies related to exposure to chemicals. The information is provided to both the EPA and, for mixtures in professional use, the WEA (ECHA[113])
Labelling programmes in Denmark include official ones (e.g. the EU eco-label and Nordic Swan) and private ones (e.g. the Blue Wreath and Allergy Certified). All support risk reduction by limiting the use of hazardous chemicals and promoting substitution by less hazardous alternatives.
5.6.2. Promoting substitution of hazardous chemicals
Substitution of hazardous chemicals is enshrined in EU and Danish legislation and policy documents and in international agreements such as the OSPAR Convention (Denmark, 2018[2]). Danish OHS rules require replacing hazardous substances with less hazardous ones, even if the effects of the former are insignificant (Camboni, 2017[114]).
The LOUS has long supported substitution by informing industry about substances whose use should be reduced or terminated. The 2014-17 Chemical Initiatives included a partnership between industry and academia to support substitution of certain chemicals of concern (Danish Chemicals Forum, 2015[105]; Denmark, 2018[2]; Kemi i Kredsløb, 2018[115]). A new innovation centre on substitution of hazardous chemicals follows up on that initiative under the 2018-21 Chemical Initiatives. An eco-innovation subsidy programme, under the 2015‑18 MEF Environmental Technology Development and Demonstration Programme, supported research on substitution (MEF[116]). The Pesticide Research Program supports reduction of pesticide use (including biocides) and research on their negative effects on human health and the environment. Since 2016, the Chemical Initiatives have supported substitution with less harmful biocides (e.g. by subsidising their authorisation under a simplified procedure) (Denmark, 2018[2]). The Centre for Catalysis and Sustainable Chemistry at Technical University of Denmark is working on chemistry innovation and on improvement to known processes in areas such as renewable chemicals and sustainable production of chemicals (Centre for Catalysis and Sustainable Chemistry, 2017[117]).
Recommendations on chemicals management
Develop innovative tools to help decision making
Further expand risk-based monitoring of chemicals. For instance, enhance monitoring of legacy pesticides and their metabolites in groundwater and approved pesticides under the Pesticide Leaching Assessment Programme, and consider supplementing it with surface-water monitoring (relevant for biocides). Consider enhanced monitoring of emerging pollutants (e.g. pharmaceuticals in surface water and groundwater) and heavy metals (e.g. zinc in soil and water).
Strengthen biomonitoring to provide better evidence of people’s actual exposure to endocrine-disrupting chemicals and possible effects on human health to support policy making in this area; address trade-offs between monitoring and proactive identification of chemicals requiring regulatory action, taking into account the science-policy nexus (e.g. identification of exposure source).
Make assessment of the Chemical Initiatives’ effects a standard procedure and consider further development such as increasing the use of indicators to track implementation progress.
Make better use of PRTR data (e.g. for tracking trends in releases or benchmarking among companies).
Implement and influence EU legislation
Continue identifying national priority areas for strengthened chemicals management and performing an active role at the EU level in identifying chemicals of concern (including the need for substitutes) and assessment of chemicals, including predictive risk assessment (e.g. in relation to endocrine-disrupting chemicals and quantitative structure-activity relationships) and risk management.
Assess implications of the coming reduction in REACH registration fees on activities that the fees are intended to support in Denmark.
Strengthen efforts at the national and international levels on compliance assurance for high-risk chemicals in products (including imports and e-commerce), for instance through enhanced co‑operation with customs.
Assess the effectiveness of new measures to strengthen emergency response for the most hazardous facilities (covered by the EU Seveso III Directive).
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Notes
← 1. Carbon dioxide, methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons and sulphur hexafluoride.
← 2. Acidifying gases: sulphur dioxide, nitrogen oxides, ammonia. Air pollutants: non‑methane volatile organic compounds, carbon monoxide, polycyclic aromatic hydrocarbons, particulate matter. Heavy metals: lead, cadmium, mercury.
← 3. The German Environmental Survey for Children and the US National Health and Nutrition Examination Survey.
← 4. www.virk.dk. In certain cases the data is collected by the EPA and added to the national PRTR, e.g. on emissions from farms (from the Central Husbandry Register or Fertiliser and Livestock Reporting Body), from wastewater treatment plants (from NOVANA) and from aquaculture (from the aquaculture database). The EPA conducts a manual review of the data (MEF, 2016[28]).
← 5. Later extended to 2016.
← 6. The inspection programme addresses the establishment’s production and risk conditions, the surrounding area and factors relevant for individual establishments (Amec Foster Wheeler, 2017[55]).
← 7. For each effect chain, inputs, activities, outputs and effects are listed. The effect chains were prepared by the EPA, validated by external experts and submitted to industry consultation. The resulting knowledge led to qualitative and, where possible, quantitative analyses of effects (Sørensen et al., 2017[63]).
← 8. The Convention for the Protection of the Marine Environment of the North-East Atlantic. The parties are Belgium, Denmark, the European Union, Finland, France, Germany, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom (OSPAR Commission[118]).
← 9. The Convention on the Protection of the Marine Environment of the Baltic Sea Area. The parties are Denmark, Estonia, the European Union, Finland, Germany, Latvia, Lithuania, Poland, Russia and Sweden (HELCOM[119]).
← 10. The zone covers Denmark, Estonia, Finland, Latvia, Lithuania, Norway and Sweden (European Parliament and Council of the EU, 2012[120]).