The Danish Profile on Management of Chemicals has been prepared in order to grant the application from "The Intergovernmental Forum on Chemicals Safety" (IFCS) and "Inter-Organization Programme for the Sound Management of Chemicals" (IOMC) to give a national description of the management of chemicals.

The reason for giving a profile on management of chemicals in the different countries is the increased use of chemical substances in both the industrial and developing countries. The large consumption of chemicals may be injurious to both the health and the environment, as the chemicals will come into contact with humans and sooner or later will be discharged to the environment.

The purpose of preparing the profile is to gain an overview of the management of chemicals in different fields of application in Denmark. In this profile it means the presence of chemicals in the environment, the working environment and food. The health aspects both to workers and to the public in general as a consequence of the use of chemicals in these areas are described.

The document is prepared in order to comply with the guidance document from the United Nations' Institute for Training and Research (UNITAR). However, the Danish document is chosen as a mini-profile, which means that some issues will not be prepared as detailed as the guidance document prescribes. Selected major issues of managing chemicals have been pointed out.

The Danish legislation and regulations concerning chemicals as well as the ministerial authorities and responsibilities have been selected as major issues in the Danish profile. The three major fields of application concerning the occurrence of chemicals in Denmark are the environment, the workers' health and safety, and foodstuffs.

Other issues are also of great interest in a national profile on management of chemicals. In this mini-profile, it is, however, decided that these areas are of lesser interest than the selected areas covered.

Chemicals and chemical compounds connected only with the following fields of application will not be described: pharmaceutical products for therapeutic use, radioisotopes and other radioactive substances and chemical goods, ready for trade and use. These issues are, however, strongly regulated by the European Union and the regulations are in force in Denmark.

Chemical accidents and acute chemical poisoning are two specific areas which are not included in this profile. However acute toxicological effects are included in the classification of chemicals.

This profile only represents the management of chemicals in Denmark. Greenland and the Faeroe Islands are not included, as special regulations are applied to these regions.

This document has been prepared in co-operation between three ministries and agencies. The participants were:

Anders Carlsen, Chemicals Division, Danish Environmental Protection Agency, (chairman)

Lea Frimann Hansen, Cleaner Technology and Products Division, Danish Environmental Protection Agency

Pernille Weile, Pesticides Division, Danish Environmental Protection Agency

Vagn H. Madsen, Directorate, the Danish Working Environment Services

Ib Knudsen, Institute of Toxicology, National Food Agency of Denmark

Anette Schnipper, Institute of Toxicology, National Food Agency of Denmark

Anne Abildgaard, COWI Consulting Engineers and Planners (secretary) .

The Danish Profile on Management of Chemicals is primarily prepared to gain an overview of the management of chemicals in the different fields of applications. Especially the management of chemicals present in the environment, the working environment and in food is described. Major focus concerning the chemicals is set on the Danish legislation. Denmark is a member state of the European Union (EU), which means that the EU plays an important role in the Danish legislation.

Denmark is a rather small country with 5 mill. inhabitants. The consumption of chemicals is about 8 mill. tonnes pr. year representing about 100,000 chemical products that include 20,000 chemical substances. The hazardous chemical waste forms 1% of the total amount of generated solid waste and is treated at special plants.

Priorities are set on the management of chemicals in the individual ministries related to the field of applications: environment, working environment and food. These priorities include health aspects such as average life expectancies, cancer, neurotoxicity, infertility, asthma and allergy. The environmental aspects with high priorities are the use of hazardous chemical substances, environmental harmful substances, pesticides and the generation of waste. For the working environment priorities also are set on harmful chemical substances and polluting processes to reduce the health effects. Food priorities concern the strengthening of food control system, safe use of food additives and the content of chemical pollutants in foodstuffs.

A description of the Danish legislation includes the major acts and statutory orders concerning the management of chemicals in the environment, the working environment and the food. The major environmental legislation is the Environmental Protection Act, which applies to all the activities affecting the environment. The Act on Chemical Substances and Products applies to the manufacture, storage, use and disposal. The working environment is regulated by the Working Environment Act which mainly applies to the employees, their health and safety at the workplace and both the planning and performance of the working environment. A brief description of the most relevant statutory orders for each are presented.

An overview of the relevant legislation of chemicals present in different areas such as the environmental air, occupational air, indoor air, soil, water areas and waste is brought. Also a description of the legislation for each stage of the life-cycle of the chemicals is made. Control procedures for the chemicals present in the environment, working environment and food are generally based upon high demands for internal control in the enterprises. The control procedures carried out by the authorities include inspections and the possibility to issue injunctions regarding lack of compliance with the legislation.

An overview of the relevant ministries and their responsibilities related to the chemicals is described. The ministerial authorities in the three ministries: Ministry of Environment and Energy, Ministry of Labour and Ministry of Food, Agriculture and Fisheries and the relevant divisions in each ministry are covered in chapter 6.

In chapter 7 references to the relevant data available in Denmark concerning the application of chemicals are presented. Also some research reports are mentioned.

The future strategy on the regulation of chemicals in Denmark among other priorities includes increased attention towards the assessment of products concerning the influence on the environment and the health and the presentation of lists on undesirable chemical substances in products. As to the working environment the exposure to carcinogenic substances, injuries among children and illnesses and severe syndromes caused by poor indoor air climate are considered important.

Denmark is a small country with a total area of 43,000 km2 lying in the northern part of Europe. The country is surrounded by sea except for a short terrestrial border (70 km) to Germany. Denmark has the environmental responsibility of a total area of 100,000 km2 of the surrounding sea.

62% of the land area is used for agricultural purposes. 12% of the area is forest area. The forest area is increasing, the overall strategy is to double the forest area within the next 80 to 100 years. The urban area and the summer cottage zones occupy 5% of the total area.

About 5 million people live in Denmark. The average population density is 120 habitants pr. km2. The education level of the population is such, that 15% of the 15 -69 years old have completed a higher education level, 30% have completed a basic vocational school and 41% of the 15 - 69 years old have completed a general basic education level (9 years - primary and lower level secondary education).

48% of the gross domestic product (GPD) is generated by the private service sector, 25% is generated by the manufacturing industry, raw materials extraction and building and construction sector, 23% by the public sector and 3.7% by the agricultural sector.

Denmark is a member of the European Union. The European Commission can represent its members in international negotiations when it is within the competence of the Commission, which means the EU plays a prominent role in the solution of the environmental problems within the boundaries of the Union.

About 100,000 chemical products are marketed in Denmark which involve the use of more than 20,000 chemical substances. The most significant issues for the use of chemicals are the iron and metal industry, the chemical industry and the repairs/service sector.

According to the Danish Environmental Protection Agency ("Denmark's Nature and Environment Policy 1995") the total annual consumption of chemical products is about 8 million tonnes.

In table 3.1 the consumption of different categories of chemicals is presented. The data presented is based on "Statistic Yearbook, Statistics Denmark, 1996".

Table 3.1 Consumption of Chemical Products

1 The number in the parenthesis represents the amount of the active ingredients

The import of inorganic chemicals and organic chemicals are available from the statistics on foreign trade from Statistics Denmark.

The production of hazardous waste in 1995 in Denmark is presented in table 3.2. The data is based on "Statistics of Waste 1995", Danish Environmental Protection Agency.

The amount of treated hazardous chemical waste at the chemical treatment plant Kommunekemi A/S in 1995 is presented in table 3.3. The data presented is based on "Statistic Yearbook, Statistics Denmark, 1996" and "Statistics of Waste 1995", Danish Environmental Protection Agency.

1 Statistical Yearbook 1996, Statistics Denmark.

The managing of chemicals in Denmark is carried out by different authorities. Focus is on the environment, the public health and the worker's health and safety. Each of the relevant authorities has its own set of priorities regarding chemicals contributing to the different areas.

The overall management of chemicals in Denmark can be described as following the structural elements shown below:

This means that the first step is to classify a given chemical substance or chemical product. This is then followed by a risk assessment of the chemicals. The third step is to consider whether a reduction of a discovered risk is necessary, for example by restriction of use or banned use. The fourth step will then be the setting of limit values regarding the emissions to air, water, soil and food. Special regulations and requirements regarding the working environment will then be set.

As a member state of the European Union, the EU action programmes for the environment, health and workers' health and safety provides considerable input for the Danish priorities concerning chemicals.

Environment
The priorities related to the overall environmental aspects are described in "Denmark's Nature and Environment Policy 1995" from the Ministry of Environment and Energy. The current policy statement was prepared in 1995, covering the period 1995 to 1999. The statement is related to exposures to water, air and soil, and waste management. For pesticides the statement was already set down in 1986.

The priority health aspects concern: average life expectancy, cancer (skin, lung, breast, testicular and leukaemia), neurotoxicity, infertility, asthma, allergy and hypersensitivity and endocrine disrupters.

Major priorities concerning health aspects and the use of chemicals are: chemicals in products, traffic pollution, emissions from industry, polluted sites, groundwater and indoor air quality. One of the major environmental concerns regarding the environment in Denmark is the quality of the groundwater. The discharge of nitrogen and pesticides represents a threat towards the generally high quality of the groundwater and is therefore in focus. The content of heavy metals, especially cadmium in sewage sludge, is also in focus. The cadmium content in fertilisers was regulated previously. Another major environmental problem is air pollution caused by increased traffic.

Some major actions related to chemicals are:

• reduced production and use of hazardous chemical substances and products
• reduced use of environmental harmful substances
• substitution of hazardous chemical products to less hazardous
• substitution of ozone depleting substances and organic solvents
• reduction of emissions of VOC's (volatile organic compounds)
• reduction in the use of pesticides
• banned use of specific pesticides hazardous to the health and the environment
• reduction in nitrogen leaching from agricultural land (50% reduction before 2000)
• minimized production of (hazardous) waste and improved source sorting
• reuse of waste and especially sewage waste

The reduction in use of pesticides was planned in 1986. The objective of the plan is to halve the level of pesticides before 1997 as compared to the average of the period 1981-1985.

Labour
The priority concerns related to chemicals in the working environment are described in the Danish Working Environment Act, annual reports from the Ministry of Labour and "Working Environment in Focus" from the Danish Working Environment Service. Fatal accidents, cancerogenic substances, children at work and indoor air climate are in focus. Priorities besides these 4 major issues are:

However, mere compliance with the Occupational Exposure Limit's is not sufficient, a full assessment must be carried out and exposure kept as low as possible.

Food
The priority concerns related to chemicals in foodstuffs are set by the Ministry of Food, Agriculture and Fisheries and are described in the annual report from the National Food Agency. Issues in focus are:

The improved assessment of chemicals for example concerns the chemicals (drugs) capable of introducing antibiotic resistant microorganisms in the food chain.

Special attention is given to investigate possible effects on human health from chemicals used in packaging materials and from chemicals with hormone-like effects.

As mentioned in the previous chapter different ministries deal with managing chemicals. The overall legislation related to the environment is set by the Ministry of Environment and Energy. The workers health and safety regulations are set by the Ministry of Labour. The legislation related to the health of the general public (food) is set by the Ministry of Food, Agriculture and Fisheries. Some of the regulations set in one ministry can however affect other ministries. This will be presented in the following chapter.

The main elements of the Danish legislation system on chemicals consists of:

Most of the Danish legislation concerning chemical products is founded in regulation set by the European Union and adopted in the Danish legislation. For some issues the Danish legislation is more strict than the EU regulation prescribes. Separate Danish legislation is made for issues not covered by the EU regulations.

The use of taxes is also included as regulatory element. Taxes are imposed on chlorinated solvents, pesticides, fertilisers and on SO₂ -emissions.

Besides the above mentioned elements also non-regulatory elements are used. This includes incentives to the industry to reduce the consumption of chemicals by negotiations with the relevant parties. Examples are agreements on reduction in use of PVC-based products, reduction in emission of VOC´s from the industry and reduction in use of plant protection products.

Another non-regulatory aspect is the use of subsidies to encourage the industry to introduce cleaner technology. Research and development projects are also financed by the Ministry of Environment and Energy in order to develop new cleaner technologies and recycling methods.

This act is an overall frame act which applies to all activities affecting the environment. The main purpose of this act is to contribute to safeguarding nature and environment, and ensure a sustainable development.

The major issues of this act in relation to chemicals are:

In the administration of the act it is set down, that special consideration shall be given to preventive measures in the form of cleaner technology. The act prescribes the use of the least polluting technology in process, design, use and operate activities. The use of resources, the amount of pollution and waste must in general be minimised for any person both public and private.

The act allows the Minister of Environment and Energy to lay down rules for emissions (limit values), pollutants (limit values) and disposal of waste.

A number of statutory orders concerning environmental protection have been issued. Some major orders will be mentioned here.

Import and export of chemical waste
The order includes rules for supervision and control of shipment of waste within, into and out of the EU. The statutory order contains lists of the different waste fractions and their labelling, e.g. green, orange and red.

Disposal, planning and registration of waste.
The order includes definitions and rules for waste and hazardous waste.

Limit values for exposure of hazardous chemical substances into watercourses, lakes or the sea
The order includes a list of substances which are not allowed to be discharged into the water environment. Permission for the discharge of chemicals into the water environment must be notified to the local councils.

Quality of drinking water
The order includes a list of limit values for impurities and chemical substances in drinking water. Limit values for each pesticide and the total content of pesticides are included.

This act applies to the manufacture, storage, use and disposal of chemical substances and products.

The act covers: chemical substances, naturally occurring or manufactured by industry. Chemicals included or released from goods are not included. The major issues of the act are:

The act prescribes the notification on import, sale and use of specified chemicals and products. Rules also can be set on the composition of chemical products and the content of impurities to prevent hazards to health and environment.

A number of statutory orders are issued at the Ministry of Environment and Energy covering chemical substances and products. The most important are described below:

Classification, packaging, labelling, sale and storage of chemical substances and products.
The aim of the order is to protect man and the environment from the adverse effects of chemicals by hazard communication and rules on safety handling. A set of rules covering the classification, packaging, labelling, sale and storage are stated. This includes the classification criteria for health hazards and environmental effects of each chemical substance. The labelling must inform about hazardous substances and products and show the prescribed hazard symbols. This order does not apply to pharmaceutical products, food, animal foodstuffs, cosmetics and pesticides.

Notification of new chemical substances.
New chemicals are defined as chemicals which are not included in the EINECS list (European Inventory of Existing Commercial Chemical Substances) prepared by the European Commission. The notification must include a description of the environmental effects and health effects as well as proposal of classification based on laboratory investigations.

List of hazardous chemical substances.
The list includes chemicals to be labelled as mentioned in the statutory order on classification. The list is not complete, which means that chemical substances which are not included in the list must be classified by the importer or manufacturer according to the order on classification.

Regulation on the evaluation and control of the risks of existing substances.
The Regulation is applied to the evaluation of the risks of existing substances to man, including workers and consumers and to the environment, in order to ensure management of these risks.

Pesticides.
These categories of chemicals require an approval before import, sale and use are allowed.

Banned pesticides
The order includes a list of banned pesticides and plant protection products.

Training for commercial uses of pesticides
The order sets down regulation for training and certification of commercial users of plant protection products. Only certified commercial users are allowed to use plant protection products.

Cosmetic products
The order is applied to chemicals or preparations for exterior use on human bodies, teeth and mucous membranes of the mouth. A list of prohibited chemicals for use in cosmetics is presented in annex 2 in the statutory order. Chemicals which may only be used to certain restrictions are listed in annex 3. Permitted chemicals for use as dye, conservation and UV-filters in the cosmetic products are listed in annex 4, 5 and 6 in the statutory order.

Safety rules for toys and products which by appearances can be confused with foodstuffs.
The order includes rules for approval, labelling and limit values for the content of specific chemical substances as well as prohibition of the use of chemical substances in toys with adverse health effects to children.

Prohibiting the use of certain ozone depleting substances.
The order prescribes a prohibition of the use, production, export and sale of chlorofluorocarbons, tetrachloromethane, trichloroethane, halons, hydro-bromofluorocarbons, hydrochlorofluorocarbons and methyl bromide.

Limiting the use of certain hazardous chemical substances and products for special purposes.
The order implements EC directives on restrictions on the marketing and use of certain hazardous substances and preparations.

The aim of the act is to contribute to the creation of:

The act is applied to the employees and only to some extent to the employer, his family, military persons, the air services, the fishing industry and the maritime industry. The act is applied to both the planning and the performance of the work.

The employer is overall responsible to the workers health and safety. The act prescribes the statutory duty of the enterprises to establish an Internal Safety Organisation with representatives from the employees. The Internal Safety Organisation initiates solutions to health and safety problems in co-operation with the employer. The employees are allowed to put forward confidential complaints about health and safety aspects to the Working Environmental Services.

Statutory Orders

In connection with the act a number of statutory orders are prepared. The statutory orders prescribes more specific measures such as the handling of substances and products, arrangement of work places and the work with labelled products (e.g. paints, varnishes, adhesives and organic solvents). A brief description of the main statutory orders in relation to chemicals is presented.

Substances and products
The order prescribes rules for:

The order is applied to the use and work with substances within trade and industry.

Products containing volatile substances or organic solvents
The order is applied to the work with substances included in the List of Occupational Exposure Limits as organic solvents or volatile compounds. The order prescribes safety data sheets for products containing solvents and labelling of hazardous substances when the amount exceeds 0,5 weight %.

The order also applies to the production of foods and medical drugs but not to the import and use of these substances.

Products containing carcinogenic substances
The order is applied to the work with substances and products containing carcinogenic substances. Carcinogenic substances are generally not allowed if a less hazardous product can be used. The order includes rules for the working environment such as encapsulation of the processes, ventilation requirements and working clothes as well as accessible safety data sheets. The order includes a list of carcinogenic substances and products.

Epoxy and isocyanates
The order prescribes rules for notification of the work with products containing epoxy or isocyanates as well as safety rules and requirements for the working environment.

List of Occupational Exposure Limits
The limits are founded in the statutory order on substances and products. The limit values are threshold values. However, mere compliance with the OEL's is not sufficient, exposure must be kept as low as possible.

Asbestos
The order states a ban against the import, sale and use of asbestos containing products. However the use of asbestos is authorised for a few specific cases, e.g. brake linings in some heavy duty vehicles.

The act concerns food, beverages, stimulants and other products meant for human consuming and transport of food. The act is applied to the sale, storage, production, packaging and transport of food. The act describes the following areas concerning chemicals in contact with and within food:

The enforcement of the act is carried out by the Ministry of Food, Agriculture and Fisheries in co-operation with the National Food Agency, the Food Inspection Units, the Regional Laboratories, the counties and the local authorities.

A number of statutory orders concerning chemicals in food are issued. The orders mentioned here each describes the means of control of the area they cover.

Additives for foodstuffs
This prescribes the use of additives for foodstuffs, dyes for labelling and labelling of additives. In the order it is also described that the National Food Agency generates the list of approved food additives (the Positive List).

Maximum levels for certain metals in foodstuffs
The order includes a list of maximum levels for lead, cadmium, mercury and tin.

Maximum residue levels for pesticides in foodstuffs
This order prescribes a list of the maximum levels of residues of pesticides in food and specified types of food.

Flavourings for use in foodstuffs
This order describes definitions and labelling of flavours. A list of maximum levels for certain compounds originating from natural occurring flavours is included.

A list of approved flavours is not yet agreed upon as it is the case for other food additives (the list of approved food additives, the Positive List).

Materials and articles intended to come into contact with foodstuffs
Description of the conditions under which the materials and articles have to be manufactured and how they should be labelled. Special considerations are described for cellulose products, PVC and ceramics. Lists of approved raw materials and additives for plastics are also found in this statutory order.

Maximum residue levels of veterinary drugs in foodstuffs of animal origin are described in an European Commission regulation. Denmark has implemented the EC regulation to national law.

Legislation that is not covered by the above mentioned acts and statutory orders are:

The Danish Building Code has a specific paragraph on indoor climate regulations stating a healthy indoor air climate in buildings. Rules concerning formaldehyde content in building components are mentioned as well as regulations on mineral fibre boards for interior use.

The following table 5.1 is meant as an overview of the legislation covering the presence of chemicals in different areas: products and goods, air, waste, soil, groundwater and drinking water.

A number of statutory orders founded in the above mentioned acts in more detail regulates the chemicals present in different area.

The ministries are responsible for the administration, preparation of new acts and statutory orders as well as guidelines. A major part of the administration and the enforcement of the legislation is, however, assigned to the regional and local administrative bodies. Examples of administrative responsibilities at each level - central, regional and local are given below.

The central administration carries out the approval of pesticides and certain chemical products. At central level the approval of additives for foodstuffs (the Positive List) is carried out as well. At the central level rules and guidelines for enterprises concerning workers' health and safety also takes place. Authorisation of foodstuff enterprises is issued by the Ministry of Food, Agriculture and Fisheries. At this level also complaints concerning county or municipal authority activities are processed.

At the regional level (counties) the overall environmental planning and authorisation takes place. The counties are responsible for issuing consents and assuring supervision to more complex enterprises. This also means enterprises with more environment harmful activities. Another area is the responsibility for contaminated sites which also has been assigned to the counties.

Regional inspectorates concerning workers' health and safety as situated in each county in order to issue improvement notices and give guidance on problem solving. Approval of boilers and containers for export are also carried out at regional level.

At the local level (municipalities) building permissions and authorisation of the major part of enterprises are carried out. The municipalities also have administrative responsibilities within the foodstuff area. Retail business including sale or treatment of food and wholesale business requires approval by the local council before commencement.

In the following section an overview of legal instruments that regulate each stage of chemicals in the life cycle is presented. The life cycle stages that are considered are:

Import
Legislation on chemicals are laid down in a number of EC-directives and Denmark has implemented these regulations to national law. Guidelines and principles agreed in UNEP and FAO concerning chemicals are also a part of the Danish legislation. Besides these the Danish legislation includes specific rules for certain chemical products.

According to the Act on Chemical Substances and Products the importers in general are responsible of the correct classification and labelling. They must document the name of ingredients and percentage of weight of ingredients classified as hazardous or regulated otherwise. Products containing hazardous chemicals must be notified at the Product Register according to the statutory order on substances and products. Data on the composition of the products must be submitted to the Product Register by importer, manufacturers, agents and their international suppliers.

Hazardous chemicals stated in the List of Hazardous Chemical Substances should be classified and labelled in accordance with the order. Other substances and products must be classified by the importer or the manufacturer.

It is not legal to import, sale and use pesticides in Denmark without a national approval according to Chemical Substances and Products Act. Approvals are based upon a health and environmental assessment and have a time limit of 10 years at most.

The flow chart shown in table 5.2 represents the procedure for import and labelling of chemical substances and products.

Export
Certain hazardous chemicals have during the years been banned or severely restricted in the European Union according to a directive concerning plant protection products and a directive concerning industrial and consumer chemicals. 30 active substances for plant protection products and about 10 industrial chemicals are now adopted in the directive concerning the export and import of certain hazardous chemicals. An export notification is required for these chemicals.

The EC regulation also adopts the UNEP/FAO voluntary PIC-procedure (Prior Informed Consent) and makes it a legally binding instrument for the EU-member states. The "Prior Informed Consent" (PIC) is the principle that a chemical which is banned or severely restricted in order to protect human health or the environment should not be shipped internationally contrary to the decision of the importing country. The voluntary PIC-procedure today includes 17 chemicals.

Production
This stage of the life cycle is regulated by both the Environmental Protection Act, Act on Chemical Substances and Products and the Danish Working Environment Act. The chemicals used in the processes, emissions to the air, water and waste are regulated by the Environmental Protection Act. The Act on Chemicals states the use of cleaner technology to reduce or eliminate the use of hazardous chemicals. Guideline values for emissions to air and water are prepared by the Ministry of Environment and Energy. List of approved additives for foodstuffs is available at the Ministry of Food, Agriculture and Fisheries.

The amount of waste is regulated on voluntary basis by ensuring a high degree of reuse. Taxes are also used to initiate the reuse. Hazardous waste must be treated at chemical treatment plants.

The working environment for any production is regulated by a number of statutory orders from the Ministry of Labour. This also includes occupational health limits and guidelines.

Distribution/Marketing
The marketing of chemical substances is included in the Act on Chemical Substances and Products and the Statutory order on Substances and Products.

Transport
The transport of hazardous chemicals and goods are regulated by the Act on transportation of hazardous goods.

Use
The use of chemicals at workplaces (employees) are regulated by the Danish Working Environment. The use of chemicals in household products is regulated by the Act on Chemical Substances and Products and the statutory orders covering specific issues such as cleaning agents, toys and cosmetics.

Food additives for use in households must only be sold for this purpose if they are on the specified list in the Positive List from the National Food Agency. Special regulations are implemented by the Ministry of Food, Agriculture and Fisheries for the use of cleaning and disinfectant agents in the food industry and by retail business.

Disposal
The disposal of hazardous chemical waste is regulated by the Environmental Act and Statutory Order on Disposal, Planning and Registration of Waste. Furthermore the use of cleaner technology, taxes on waste and the initiation of reuse serve as regulating factors.

The enforcement of the legislation stated by the ministries depends on which ministry the legislation concerns. Generally the enterprises have the duty to comply with the existing legislation whether it concerns the environment, the public health or the workers' health and safety. The compliance with the legislation includes the duty to establish internal control procedures to ensure the compliance with the legislation. The enterprises also have the duty to inform on pollution, accidents and other aspects concerning the environment, public health and workers health and safety to relevant authority, either at county or municipal level.

The enforcement of the environmental legislation is carried out at either central, regional or local level.

At central level (Ministry, Agency) the Chemical Inspection Service is situated. The Chemical Inspection Service carries out inspections concerning all the different chemical regulations in Denmark. The CIS both control the import, production and trading of chemical substances and products and the products themselves. The CIS is responsible for inspection of importers, producers and traders in Denmark concerning chemical substances and products, storage, sale and use. The CIS is also responsible for the control of chemicals in toys. Campaign areas are pointed out each year. In 1995 the control of nickel content in jewels was carried out and also inspections of importers and producers of cleaning agents and traders of cosmetics took place.

At the regional level (counties) inspections of recipients, waste deposits, groundwater and enterprises are carried out. The county is also the environmental authority in relation to municipal sewage treatment plants and responsible for landfills, county water supply sources and ochre.

At the local level (municipalities) environmental control of the agricultural sector is carried out. Also inspections in the field of the major part of industrial enterprises are included. The control of chemical products for retail use and storage is also carried out.

Warnings and prohibition notices can be given to the enterprises to improve the environmental performances. If the prohibition notices are not observed, a recommendation of police prosecution is brought.

The employer is the overall responsible for the workers' health and safety.

The enforcement of the workers' health and safety legislation is controlled by the Regional Inspectorate placed in each county. The Regional Inspectorate carries out control visits to the enterprises. Control visits and inspections are carried out for both central and selected campaign areas each year as well as regional selected enterprises.

The inspections include both control of the internal control systems and spot tests of the working environment.

Warnings and prohibition notices can be given to the enterprises to improve the workers' health and safety. If the prohibition notices are not observed, a recommendation of police prosecution is brought.

At central level campaign areas can be decided.

The food control system includes a demand for internal control procedures of the manufacturers of foodstuffs.

The central level (Ministry or Agencies) carries out control of the municipal Food Control Units. The agencies also survey the content of contaminants in foodstuffs such as cereals, meat, dairy products and vegetables. Surveillance of the intake of foodstuffs is also part of the control system.

At the local level (municipalities) the control of foodstuffs is carried out by the Food Inspection Units. The Food Inspection Units carry out inspections of both manufacturers and retail businesses. The Food Inspection Units take out samples to be analysed at regional laboratories. The analyses include the content of residues of pesticides, veterinary drugs and pollutants in foodstuffs.

Warnings and prohibition notices can be given to the manufacturers and retail businesses in order to comply with the legislation. If the prohibition notices are not observed, a recommendation of police prosecution is brought.

The ministries are responsible for different categories of chemical and different categories of use of chemicals. A general overview of the relevant ministries and responsibilities in each stage of the life cycle of the chemical substances is presented in table 6.1

A more detailed description of responsibilities for the different ministries and agencies is presented in table 6.2. The administration of the regulations is generally placed in the responsible ministry. The ministry can delegate the administration to an agency, regional authorities (counties) or local authorities (municipalities). In table 6.2 it is also stipulated who in practise is responsible for different the administration of the acts.

The administration and preparing of new statutory orders and amendments are delegated to the Danish Environmental Agency. The divisions most relevant in this aspect are:

Chemicals Division takes care of the administration of the relevant acts and orders concerning this issue. The regulation and administration of new chemical substances is part of the mandates as well as priority settings for hazardous chemical substances. The regulations concerning the classification and labelling of chemical substances and products takes place in this division as well as the regulations concerning toys and cosmetics. Risk assessments of existing chemicals are also carried out in this division. Another area is the setting of quality criteria for drinking water and for soil to prevent negative health and environmental effects. The control of chemicals including the control of the products is also carried out by this division. This division is also responsible for the setting of air quality criteria (C-values).

Pesticides Division administrates the approval of pesticides. The priority setting of pesticides including the suggestions of pesticides to be banned is part of the mandates. It also includes the preparing of action plans concerning the consumption of pesticides in different areas. For the agricultural area, as an example the action plan is prepared in dialogue with the Ministry of Food, Agriculture and Fisheries. The import/export of certain hazardous chemicals according to the PIC-procedure is controlled by this division.

Cleaner Technology and Products Division promulgates statutory orders of limiting or banning the use of chemical substance in any products and statutory orders on products except for medical drugs, foodstuffs, toys and cosmetics. Furthermore environmental labelling of products and technical end economic co-ordination of activities in the field of cleaner technology are a part of the division.

The Danish Working Environment Service assists in the administration and preparing of new statutory orders and amendments. The Working Environment Service is divided into 2 divisions:

The Directorate drafts rules and guidelines for enterprises and assists the Ministry of Labour with the preparation of legislation. The Directorate is also responsible for information activities including general information, training, library function and documentation. The Directorate is also responsible for the administration of the approval of safety data sheets and the preparation of campaigns to control the working environment in selected trades. The Directorate records all reported occupational accidents and diseases. This Register is used to identify the priority areas when the campaign areas are pointed out. The directorate administrates the Danish Product Registers, which receives information on chemical substances and products from importers, producers, suppliers and authorities.

The Regional Inspectorates carry out control visits to the enterprises to inspect the health and safety conditions for the employees. There are 12 regional inspectorates which are situated in each county.

The Institute of Occupational Health is responsible for research and development activities including techniques for measurements in the working environment. The Institute is an independent research institute under the Ministry of Labour.

The Danish Working Environment Service gathers documentation concerning health and safety aspects. The documentation system consists of the 3 elements: research, registry of occupational injuries and the Register of Product.

The National Food Agency comprises four administrative divisions and two scientific institutes. The institutes represent the specialist scientific knowledge which forms the basis for the Agency's administration of the Food Act.

The Agency's four administrative divisions handle specific cases falling within the scope of the Danish Food Act, and in so far as they relate to food also cases covered by the Environment Act. The divisions draft proposals for food notices and instructions, assist in framing EC directives and regulations, and participate in other international collaboration activities concerning foods.

In close consultation with the Agency's scientific institutes, the administrative divisions advise the Ministry of Food, Agriculture and Fisheries and other public authorities, a function which includes coordination and guidance of the municipal food inspection units.

The Institute of Food Chemistry and Nutrition operates an extensive monitoring system for contents of nutrients and contaminants in foods, and maintains a data bank containing details of food composition. Surveys are carried out to uncover the Danish populations dietary habits.

The Institute acts as reference laboratory for the municipal food inspection units, and conducts performance checks on food laboratories.

The Institute of Toxicology advises the National Food Agency on the health risks from chemical substances in foods, such as food additives, contaminants and pesticides.

The Institute of Toxicology also advises the Danish Environmental Protection Agency (Ministry of Environment and Energy) on

The scientific basis for the advisory work is the performance of independent toxicological research using experimental animals and in vitro test systems on chemical substances and dietary components.

Besides available international data on assessment of chemicals a number of Danish lists, registers and databases of chemicals are available. Furthermore research reports and reviews within the field of the occurrence and application of chemicals exist.

At the Danish Environmental Protection Agency both lists of certain chemicals are available as well as environmental reviews and reports. Some major registers and report will be mentioned. Most of the mentioned literature will be available only in Danish language.

List of Hazardous Chemical Substances is public available. It is published as a statutory order. It includes CAS no., EINECS no., classification, labelling and remarks about specific rules. It is revised every second year.

List of approved pesticides in Denmark. The list is revised once a year in a paper version and every third month in a diskette version.

List of undesirable chemical substances is published in a discussion paper from the Danish EPA concerning chemicals (December 1996). The list includes about 100 chemical substances and groups of substances which in general is undesirable, but not banned. Each chemical substance is mentioned by CAS no., occurrence in goods, the reasons for selection is stated, effects on health and/or environment and existing regulations concerning the chemical.

Environmental Review on C-values. The review is a survey of existing limit values for emissions to the air of a number of chemical substances. The review is founded in a guidance document concerning air polluting substances from enterprises. The review also includes data sheets for a number of chemicals in the list of C-values. The data sheets describe physical characteristics, occurrence and use, environmental and health effects.

A number of research reports are available at the Danish Environmental Protection Agency. A few examples of these research report are mentioned here:

Environmental Reports on Quality Criteria for Soil and Groundwater (1996). One report which include toxicological quality criteria for soil and drinking water. Another report includes ecotoxicological quality criteria for soil. Also data sheets for the included chemicals are shown.

Environmental Report on assessment of DEHP and other Phatalates (1996). The report is available in English.

Environmental Report on assessment of health effects of air pollution from traffic. The report is in progress.

Environmental Report on Male Reproductive Health and Environmental Chemicals with Oestrogen effects (1995) . The report includes toxicological evaluations of pesticides and environmental chemicals. (available in English)

Both registrations of injuries and products containing chemicals take place at the Danish Working Environment Services. Also a number of research reports concerning workers health and safety aspects are available. Some major registers, lists and report are mentioned.

The Registry of Occupational Injuries. Information about occupational injuries are recorded. The recording system will be introduced in the other EU member states.

The Danish Product Register Data Base . The Danish Product Register is a governmental data base for information concerning substances, materials and products used in Denmark. The data base is established by the Ministry of Environment and Energy and the Ministry of Labour. The data base is not public available. Information about specific chemical products are partly available.

List of Occupational Exposure Limits. The list is public available. It includes a list of the existing occupational exposure limits as well as a list of cancerogenic chemical substances in the working environment.

SUBTEC is a PC-based database, which is public available. It is meant for substitution purposes in product development processes. The system includes both technical and health criteria for chemical substances.

VOC-base is also a PC-based database. It includes a list of odour and mucous irritation threshold values for a number of volatile organic compounds. This database is meant for indoor air evaluation of products emitting VOC´s.

A number of research project reports on workers health and safety aspects are available at the Directorate.

A programme on food monitoring of nutrients and contaminants in Denmark was established in 1983 at the National Food Agency. Analyses of contaminants are performed by the regional laboratories, and the data are compiled by the National Food Agency. Reports are published on the results of dietary survey and on the findings of pesticide residues in Danish food.

All the lists mentioned below are given in the Statutory Orders described in section 5.2.4:

A list of maximum levels for certain compounds originating from natural occurring flavours.

A list of maximum residue levels for pesticides in food.

A list of maximum levels for lead, cadmium, mercury and tin.

In the Statutory Order on additives for use in food it is described that the National Food Agency generates the list of approved food additives (the Positive List).

Scientific papers with toxicological research data and risk evaluations are published in peer reviewed scientific journals and in national and international reports.

This section provides an overview of the institutions responsible for surveying the different areas relevant to this document.

The National Environmental Research Institute is responsible for the monitoring of activities such as the quality of drinking water, groundwater and marine water.

The Pesticides Division of the Danish Environmental Protection Agency collects data on the import, export and trade of pesticides. An annual report presents the collected data.

The Waste Division at the Danish EPA collects data on waste production, disposal procedures and import/export of waste. An annual report is available.

Besides these areas surveillance of discharges of environmentally harmful substances to air and water is carried out. The collected data among others includes the emission of CO₂, SO₂, NO^x, NH₃, CH₄, heavy metals and VOC's to the air as well as discharge of fertilizers to the water. The consumption of chemical substances in the industry is also surveyed.

Environment
Besides the priorities given in chapter 4, the future strategy from the Ministry of Environment and Energy is stated in 2 discussion papers: "Status and Perspectives in the Chemicals Field", December 1996 and "A Strengthened Product-oriented Environmental Policy", December 1996.

In the discussion paper on the Danish EPA's work on chemical substances it is proposed that Denmark works actively for a high level of protection in decisions taken by international forums. Nationally promotion and reduction of the use of environmentally hazardous substances are proposed and as a mean to realize this strategy the discussion paper includes a list of about 100 undesirable chemical substances or group of substances, the emission of which over a period are to be reduced.

Also speeding up the classification of chemicals and risk assessments is proposed. The strategy is proposed carried out by involving relevant parties, e.g. environment aware consumers and purchasers. An extension of the obligations for manufacturers and importers to declare the contents of their products is also proposed.

The future management of chemicals includes the priority setting of 20 - 40 chemicals from the list of undesirable chemicals. These chemicals will be investigated further in order to set up restrictions in use or banned use.

New statutory orders are being prepared for the use of nonyl phenol compounds in detergents, lead, arsenic (impregnated wood) and an action plan for the use of phthalates is under preparation.

The object of the product oriented policy is to initiate further development of assessments of the products in all parts of the product life cycle. The product-oriented environmental policy is described as a process, including the elements: setting of objectives and targets, analyses of frames and terms, recommendation for achievement, implementation of achievement and evaluation of achievement.

The instruments to achieve the environmental targets are advising and information for developers, producers and dealers to change their attitudes towards a cleaner production and less use of chemical substances and products harmful to the environment and health. Three areas are selected for pilot projects. The three product areas are textiles, electronic products and transport of goods.

The instrument also includes the above mentioned list of undesirable chemicals and the request to substitution where these substances are included in the products.

In the area of pesticides the future strategy is to eliminate the most harmful substances of the active ingredients and minimise the consumption of pesticides. By 1. January 1997, 19 harmful substances have already been prohibited.

For the marine environment a new set of strategies is being prepared.

Labour
The Minister of Labour, represented by the Danish Working Environment Service in 1996 has prepared an action programme for the working environment stating "A Clean Environment in 2005". The following issues regarding chemicals will be of priority concern:

Other aspects which are of great concern are general exposure to chemicals and chemicals toxic to reproduction.

In connection with the priority concerned chemicals, focus are set on some business lines covering the different issues of the priority concerns. The lines related to carcinogenic chemicals are:

For the other priority issues, other business lines will be in focus.

Food
In the present action programme (1996-97) the National Food Agency has increased the efforts regarding pesticide residues, veterinary drug residues and food additives, especially chemically defined flavouring substances. These actions do include surveillance, control and risk assessments regarding individual compounds as well as potential combination effects..