Every day, both at home and at work, we are surrounded by products containing chemicals. Very many of the products we use are manufactured outside of Denmark. These include “chemicals-intensive” articles such as electronic equipment, plastic products and textiles. In order to protect people and the environment against the possible problems entailed in using hazardous chemicals, the challenges must be addressed internationally. There are also huge gaps in our knowledge about which chemicals are risky, how hazardous they are, and how and where they are used. Denmark will work to investigate and document chemicals of concern for future common regulation. The Danish Chemicals Initiatives 2014-2017 will therefore have sharp focus on collaboration with other countries and dialogue with authorities, enterprises and other stakeholders to ensure that initiatives have an impact.
REACH – joint efforts give better results
Despite having used tens of thousands of chemical substances for more than 50 years, we still lack knowledge about the harmful effects of chemicals. Therefore, REACH has made enterprises responsible for obtaining the knowledge necessary and for using chemical substances safely. REACH is the EU chemicals legislation which ensures uniform regulation across national borders and which is therefore crucial for securing both a high level of protection and uniform conditions for enterprises. Therefore the European collaboration on implementation of REACH is an important hub for Danish initiatives in the chemicals area.
REACH is the only legislation in either the EU or globally which generally requires data about the hazardous properties and use of chemical substances. REACH includes data requirements for tens of thousands of chemical substances on the market, and this makes it possible to regulate chemicals broadly in a large number of sectors and regulations, for example regarding hazardous waste, the aquatic environment, environmental approval of enterprises, and occupational safety and health.
Through regulation, and in close collaboration with enterprises and other stakeholders in the chemicals area, well reasoned and manageable requirements will be imposed in REACH on manufacturers and importers. In this context, Denmark will intervene actively, for example in hazard classification, proposed restrictions, inclusion in the Authorisation List, verification of registration information, and substance evaluations. Initiatives will help Danish enterprises to be among the world’s best at avoiding chemicals of concern and phasing out their use. This could create innovation and growth in Denmark.
REACH is pivotal for regulation of hazardous substances both globally and in the EU. REACH also helps other countries to manage chemicals properly and to establish green transition outside European borders. The principles of REACH are being extensively copied throughout the world. For example, both China and the US are currently examining the possibilities of introducing similar models. In the context of the environment and human health, this is good for Denmark, and for the competitiveness of Danish enterprises.
REACH is also opening up for opportunities to share the heavy work load involved in collecting knowledge, registration, classification and regulation for the chemicals area. Thus, REACH is ensuring efficient exploitation of the resources of enterprises and of the authorities. Denmark will continue to contribute to regular development of the information realised through implementation of REACH, when new knowledge is obtained about the effects of substances and when new methods of using chemicals are developed.
Denmark has been a benchmark in the debate on criteria for identification of endocrine disruptors, and in collaboration with the Nordic countries, the Netherlands, Germany and the UK, Denmark has called for introduction of more relevant test methods to demonstrate the endocrine disrupting effects of substances. In these Chemicals Initiatives 2014-2017 more than ever, Denmark will join forces and share the workload with other EU member states and the Nordic countries in order to achieve more influence in important areas.
Development and improvement of REACH instruments
Development of the Candidate List for phasing-out and substitution
The Candidate List (Kandidatlisten) includes substances of very high concern for health or the environment. For example, the List includes substances which can cause cancer, damage genes and the reproductive system, or injure the child during pregnancy (carcinogenic, mutagenic and toxic for reproduction (CMR) substances). The list also includes substances which are not degraded in the environment and which accumulate in people and in other organisms (PBT substances) or which are endocrine disrupting.
Inclusion of a substance on the Candidate List under REACH is the first step towards phasing-out in the EU. If a chemical substance is included on the List, the manufacturer and supplier must inform customers about the presence in the article, and in the long term authorisation will be required to use the substance at all. Today this already applies for many substances of very high concern.
Experience shows that in practice the Candidate List has great significance for enterprises in Denmark, the EU and globally; not least with regard to substitution.
Active Danish initiatives will ensure continued development of the Candidate List so that enterprises can use it to phase out the use of substances of very high concern. In this respect, Denmark will target work to ensure that the European Commission’s roadmap to include all relevant substances of very high concern on the Candidate List before 2020 is implemented.
Better quality registration data on chemicals for suppliers, consumers etc.
Manufacturers of chemical substances must register their use of chemical substances under REACH in order to document that they have investigated how hazardous the substances are, and that the chemical substances can be used without harming people and the environment.
However, a great many of the registrations from manufacturers are incomplete and do not contain all the data on the chemicals required. This is a problem for all enterprises using chemicals in their production. If enterprises do not receive adequate information about the hazards of chemicals, they cannot ensure that they are using these chemicals appropriately. Danish enterprises, and ultimately consumers, can therefore encounter difficulties if manufacturers do not live up to their responsibilities in REACH. Therefore it is vital to ensure better quality registration data under REACH by chemicals manufacturers.
Consistency and quality of basic hazard information of the chemicals, and the instructions on safe handling which registrants send down the supply chain, are important to ensure the information in REACH is reliable and useful.
In the future, categorisation of registrations according to quality, for example, may be a tool to achieve the quality assurance necessary for information registered under REACH.
The European Chemicals Agency (ECHA) is responsible for the practical administration of registrations, as well as verification that registrations meet the requirements, but Denmark can influence developments; firstly by working for simple guidelines for manufacturers when they register their chemicals and secondly by undertaking to evaluate selected substances.
Clear international regulation is beneficial for the health of citizens as well as the competitiveness of industry. This agreement ensures that we focus on exactly this, states Villum Christensen, Environment Spokesman for Liberal Alliance
Classification and labelling of hazardous chemicals
Common understanding of when chemicals are to be considered hazardous is a first step in work to regulate chemicals of concern. There is classification of hazardous chemicals under the CLP (EU Regulation on Classification, Labelling and Packaging) and the GHS (UN agreement on Globally Harmonized System of Classification and Labelling of Chemicals). Chemicals must be labelled according to their hazards. If a substance is designated a harmonised classification within the EU, depending on the specific hazard, there will be a number of consequences in REACH and in other EU directives and regulations. For example, if a substance is classified as being carcinogenic, this will trigger a number of bans and restrictions, including that it may no longer be sold to private consumers. Classification is thereby the first step in a number of decision-making processes. The criteria under the GHS for classification and labelling of hazardous substances are global and therefore they are a particularly important instrument for the Third World with regard to managing chemicals correctly.
Greater focus on inspection and supervision
Every year new or amended regulations for the chemicals area are issued by the EU. Therefore it is important to ensure compliance with both new and old regulations, including through inspection. Distortions in free competition will arise if law-abiding enterprises are put in a worse position because they comply with the rules.
Trade in chemicals crosses national borders and this places strong demands on EU collaboration on inspection and market surveillance. Today countries work together and exchange information to achieve a uniform approach to inspection and market surveillance. Among other things, authorities in various countries exchange knowledge about illegal chemicals, products and articles so that these can be stopped before they reach consumers.
Inspection in the chemicals area is also deeply integrated into other instruments to provide enterprises with support and guidance in complying with legislation.
The Danish EPA’s Chemical Inspection Service has been taking an active part in several European chemicals inspections networks for many years in order to increase focus on inspection and collaboration at European level. A forward-looking focus area is that Denmark is to contribute actively to common European inspection tools, for example ICSMS, the common European databank in which, in the future, inspection authorities throughout the EU will share information about illegal activities.
Furthermore, future inspection efforts in the Chemicals Initiatives 2014-2017 will bolster and develop the close collaboration across national borders within the following focus areas:
- Consumer products with children and young persons as their target group
EU regulation of consumer products such as toys, electronic equipment and cosmetics is often changed, and many of the articles on the Danish market are produced in countries outside the EU where standards are not necessarily very high. The new chemicals initiatives will therefore focus on these product areas, for example through inspections of containers in collaboration with Central Customs and Tax Administration and the Danish Safety Technology Authority (read more about the special efforts for children and young persons under “non-toxic products”).
- REACH registration by enterprises
It has proved to be difficult for enterprises further down the supply chain to meet the regulations in REACH on being able to document safe use of their products, as in many cases registration by chemicals manufacturers does not live up to the requirements and because adequate information on safe use is not being communicated down through the supply chain. Therefore inspection of whether manufacturers and importers of chemicals have made registrations according to the regulations will continue.
- EU regulations on “household poisons” (the biocide rules)
The Biocidal Products Regulation entails that the number of biocidal products subject to authorisation from 2013 up to 2025 will gradually be increased from about 300 to about 2000. Therefore there will be a need to expand inspection in this area.
- Cross-sectoral enforcement and inspection with focus on several legislative areas (e.g. chemicals and waste)
Cross-sectoral inspection will ensure focus on chemicals of concern and recycling in a closed cycle. For example, this may include inspection of exports of refrigerators and electronics waste, for which both chemicals regulations and waste regulations are relevant.
In the area of chemicals we are dependant on technical kowledge. Therefore, it is important to involve the stakeholders in order to fully exploit the knowledge within the area. And then I am personally pleased, that the international work and the cooperation with other countries has a high priority, states Henrik Høegh, Environmental Spokesman for The Liberal Party of Denmark
Identification and prediction of environment and health hazards of chemicals
Thousands of chemical substances have yet to be tested for their hazardous properties, and it would be costly, time-consuming and entail many tests on animals if all the substances were to be tested for all relevant effects. This applies not least for the large number of chemical substances which today are used only in small amounts, but which in the future could perhaps replace known substances of concern. Therefore, there is a need for other methods to identify the hazards of chemical substances which have not yet been tested.
For more than ten years now, the Danish EPA has been working with the National Food Institute on developing and using QSAR computer models, among other things to predict the toxicity and environmental fate of chemical substances. The models provide increased knowledge about the properties of thousands of chemical substances and therefore they could identify potentially hazardous substances. This means that the models are important tools in prioritising substances which should be evaluated in more detail and possibly be made subject to stricter regulation.
The objective under the Chemicals Action Plan 2010-1013 was very much to develop QSAR tools. In these Chemicals Initiatives 2014-2017, on the other hand, the primary objective is use of the tools. Targeted studies will be carried out to identify possible substances of concern (e.g. endocrine disruptors). It should be possible to use the results of these studies directly in work by the authorities to identify and regulate substances of concern, including as input for the EU list of potential substances of concern to be investigated more closely (the CoRAP list).
The models will also be a tool for enterprises to identify problematic effects at an early stage in development work; to avoid hazardous new product types; and to consider substitution of chemicals of concern in existing products.
Influence of new EU regulation of household poisons (biocides) and information for enterprises
Household poisons (biocides) include mosquito repellent, disinfectants, rat poison, wood preservation agents, etc. They are chemical products designed to kill and therefore they must not be placed on the market in the EU unless they have been approved. In 2013 the existing EU regulation for the area was replaced by a Regulation on the making available on the market of biocidal products, and this tightens the rules for EU authorisation of biocidal products. The primary objective of the new Regulation is to ensure that products available on the market are both effective and that they impact the environment and health as little as possible. Denmark wants to influence EU work on authorisation of biocidal products, and will work for rapid risk assessment and to have substances of very high concern phased out if there are practicable alternatives.
In addition, the Danish EPA will prepare Danish enterprises for the new, stricter regulations. This will require huge efforts and a close dialogue with the enterprises. The Biocides Panel is a new collaboration between the Danish EPA and a number of stakeholders representing industry, professional users, environmental stakeholders and consumers. The Panel is to promote dialogue, as well as contribute knowledge and expertise for regulation and information work. The Panel will be involved in ongoing sector-specific information campaigns by the Danish EPA on biocides.
In 2015, the European Commission will issue a paper on sustainable use of biocidal products. The paper will supplement the rules on authorisation of biocidal products. Sustainable use is about reducing the impacts of household poisons, including through product design (e.g. windows which require less treatment with wood protectors), training requirements for professional users, and targeted information for consumers and professional users about alternative methods.
Denmark will set its fingerprint on EU work; firstly to achieve ambitious regulations which reduce exposures of people and the environment to hazardous substances, and secondly to contribute to development of innovative Danish solutions in the area. The Biocides Panel will be involved in preparations of strategy work on sustainable use of household poisons.
Danish knowledge about endocrine disruptors to be used to influence EU regulation
There are still huge gaps in our knowledge about which chemicals are risky, how hazardous they are, and how and where they are used. Denmark will work to investigate and document chemicals of concern for future common regulation.
Danish knowledge about endocrine disruptors to be used to influence EU regulation
Endocrine disruptors are suspected of being able to harm humans and the environment at relatively low doses and concentrations. Therefore, initiatives regarding endocrine disruptors are very important. The WHO/UNEP 2013 status report on current knowledge about endocrine disruptors mentions increasing concerns about the serious effects of these substances on health and the environment.
Years of Danish efforts relating to endocrine disruptors and their combination effects have led to focus on the area within the EU and internationally, and new legislation is underway. The knowledge obtained over the past 10-15 years will now be translated into specific regulation to restrict exposures to endocrine disruptors. Work in the EU on developing criteria for endocrine disruptors is entering a decisive and critical phase. Denmark will work to ensure that endocrine disruptors are identified and assessed uniformly across relevant legislation. Denmark will also strive to send a Danish national expert to the European Commission to contribute to this work. This will contribute to developing Union legislation in this area that can effectively manage the challenge of endocrine disruptors.
Denmark will contribute with scientific documentation which supports work on regulation of endocrine disruptors. For example, this includes the issue of whether safe limit values for endocrine disruptors can be set, or the issue of identifying the best methods to assess the substances. This knowledge will be brought into the negotiations on endocrine disruptors under REACH, legislation for plant protection products and biocidal products, as well as other relevant legislation for cosmetics and toys, for example.
We still lack knowledge about combination effects, for example, and about the relationship between endocrine disruptors and incidences of diabetes, obesity, and cardiovascular diseases, effects on brain development, and effects on the female reproductive system in both humans and animals. Therefore, the Centre on Endocrine Disruptors will continue and help Danish researchers being at the forefront in the area, and the good collaboration in Denmark between researchers and the authorities will enable early preventive initiatives.
Collaboration across ministries on endocrine disruptors will also be fully exploited to place greater focus on these substances in the health, food, and occupational safety and health areas. This will ensure that Danish initiatives regarding endocrine disruptors are coordinated across ministries.
It is particularly important to me, that we have found means to continue the work within the area of endocrine disruptors. This is an area where Denmark has been taking the lead and we shall continue this work in order to get these substances away from the citizens, states Jørn Dohrmann, Environment Spokesman for The Danish People’s Party
Danish mapping of substances on the List of Undesirable Substances (LOUS) will form the basis for input to future initiatives
The Danish EPA is performing extensive mapping of all 40 substances and groups of substances on the List of Undesirable Substances (LOUS). LOUS is a signal list for Danish enterprises of substances which they should consider reducing their use of. The list includes Bisphenol-A, PFOA and PFOS compounds as well as certain phthalates. The substance mapping will generate more knowledge, for example about production, use, disposal and recycling of the substances, and it will generate greater understanding of the degree to which humans and the environment are exposed to the substances as well as the effects of this.
The mapping of the substances in LOUS will form the basis for future considerations in the area, for example on the need for further regulation and information, substitution/phasing-out, classification and labelling, as well as waste management.
The knowledge collected in the LOUS mapping will be used actively nationally, in the EU and globally. In the EU in particular, knowledge from the work on LOUS will be used as direct input for future regulation of the 40 LOUS substances and substance groups, if there is a need.
Danish knowledge on nanotechnology will contribute to developing a common EU solution
Nanotechnology involves growth potential and it is an intelligent proposition for how we can use fewer resources in production and consumption. However, we do not know enough about how nanotechnology can be used safely. The establishment of a new database of nanoproducts will provide an opportunity to collect structured knowledge about where the nanomaterials are found and how consumers are potentially being exposed to them.
The basis for Danish initiatives is collaboration with a number of other active countries in the EU such as France. Danish initiatives will propel developments towards a common EU solution. These efforts are being coordinated with the Danish Centre for Nano Safety.
Over the next few years, Denmark will be actively involved in ensuring that REACH and other relevant EU directives and regulations can work better on this point, for example by changing and specifying a number of documentation requirements for nanomaterials.
Denmark will influence the global chemical agenda
Chemicals pollute through the air and water, and across national borders, as well as through articles which increasingly come from countries outside the EU. The number and use of chemicals is increasing drastically; not least in the Third World. A large proportion of the articles on the Danish market are therefore produced outside the EU. This also applies for “chemicals-intensive” articles such as electronic equipment, plastic products and textiles. Therefore, focus must continue on the global chemicals agenda. Denmark will take part in relevant fora to share knowledge, gain influence and promote key Danish issues.
The Convention on Mercury was adopted in October 2013 and it is a good example of the success that can be achieved when Denmark uses international collaboration to achieve results which not only benefit Denmark itself, but also the entire world. Mercury is extremely toxic and can spread over long distances in the air and sea. It does not degrade, and therefore it accumulates in animals and humans. Mercury can cause serious deformities in the foetus, and retard intelligence in children and adults. The Convention includes bans on the use of mercury in specific products and processes, control procedures for emissions by industry, and waste management. The global agreement is also helping Danish enterprises, as Danish technology can be used to combat mercury pollution.
In general, a vital task is to ensure implementation and development of the existing chemicals conventions, including by promoting early global ratification and implementation of the Convention on Mercury. Therefore, in the years to come, and among other things through the common European collaboration under the global chemicals conventions, Denmark will work to ensure that European enterprises do not suffer poorer competitive conditions and that there are no undesirable impacts on health and the environment.
In global chemicals work under UNEP, Denmark will work for early action when new chemicals issues arise. Amongst other things, this will be as an integrated part of work on sustainable development. For example, the forthcoming global sustainability targets for 2030 should contribute to developments in which fewer harmful chemicals are used in production and consumption. In order to encourage action globally, focus will be on the economic costs of not reducing the chemicals footprint and the economic advantages of doing so. The OECD has an important role in this context with regard to developing and supplying innovative tools and methods.
Denmark will also work to strengthen the Strategic Approach to International Chemicals Management (SAICM) strategy, as well as the initiatives under the strategy The goal of the global SAICM strategy is to ensure achievement of the 2020 target that chemicals are produced and used in ways that minimise significant adverse impacts on the environment and human health. As 2020 is rapidly approaching, in the next four years Denmark will work to strengthen SAICM, including in particular with regard to efforts to support key Danish issues such as chemicals in products and endocrine disruptors.
Collaboration between the authorities, sector organisations and other stakeholders will be continued and further enhanced in the Chemicals Initiatives 2014-2017. This broad involvement of stakeholders is a great advantage, for example in SAICM, where there is even more intensive work to obligate industry to take more responsibility. Dialogue with sectors, NGOs and enterprises is important prior to global negotiations, as this can strengthen Danish influence and contribute to more collaboration on achieving the best possible regulation.
Close cooperation with other countries is necessary in order for Denmark to carry the torch in the EU. At the same time it is important for me that the efforts within the EU ensures equal conditions for Danish and European companies, states Vivi Kier, Environment Spokesman for the Conservative Peoples Party
Protection of the Arctic through monitoring and global agreements
Pollution is global and some substances are transported by sea and air currents to the Arctic, where they accumulate in the food chain. Knowledge about which substances that end up in the Arctic and their potential effects is important; both in assessing environment and health impacts, and in investigating which new substances should be regulated globally. The Stockholm Convention on persistent organic pollutants (POPs) is a good example of how global agreement on regulation to phase out toxic substances can work.
Together with the other countries in the Arctic Council, Denmark will contribute to monitoring pollution in Greenland and the rest of the Arctic, for example pollution with mercury, POPs and other substances with POP-like properties. Denmark will continue work to monitor the presence of existing and new substances of concern in the Arctic and to ensure that they are part of the international agenda when relevant. In future, work on PBT substances under REACH will be coupled with monitoring data from the Arctic collaboration programme.
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