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.