Delimitations

This chapter reports on the environmental factors as they exist in the form of chemicals, their sources, uses and regulations. It also describes the most prominent instruments, actors and strategies of the issue in Denmark.

Focus is directed towards the chemicals and their use pattern, where they are regulated by DEPA. This is particularly the marketed chemical substances and preparations as such, and where these chemicals come in direct contact with non-professional human users, e.g. household chemicals and consumer articles and goods.

Some areas where a considerable direct exposure to chemicals may take place are not regulated by DEPA. This includes the working environment, food and pharmaceuticals. Also, indirect effects associated with the individual’s consumption of tobacco, alcohol, drugs, general lifestyle or living conditions are excluded. A more detailed description of responsibilities of Danish authorities in regulation of health and environmental factors is given in chapter 2 and 3.

10.1.1 Chemical factors

This chapter deals with products, where the chemical substances were put in the original product intentionally or where they appear as contaminants from used raw materials. Therefore, the term ‘environmental factor’ is adjusted to ‘chemical factor’ since the exposure will be directly from the original source with no implication of environmental issues. The exposure from the environment is treated in each of the media chapters.

Distinction is made between chemical substances and preparations in the Danish Law on Chemical Substances and Products:

	Chemical substances are the natural elements and their inorganic or organic compounds as they are naturally or industrially produced.
	Chemical preparations which are mixtures of more substances (such as paints, detergents, cosmetics, etc.) are sometimes referred to as chemical products.
	In addition to chemical preparations as defined in the statutory order, numerous consumer products in the form of articles and goods (a few examples are toys, textiles, building and construction materials) may also lead to exposure covered by the regulation. Typical consumer products will be addressed separately in this chapter.

It is estimated that in the EU about 30,000 - 50,000 chemical substances are marketed, and approx. 2,700 are so-called ‘High Production Volume Chemicals’ (> 1,000 tons marketed per year) for which a certain amount of data on inherent properties must be available. Data for these substances and also the approximately 20,000 ‘Middle production Volume Substances’ (>10 tons, <1000 tons) are made available in the CD ROM database ‘International Uniform Chemical Information Database’ (IUCLID) developed by the European Chemicals Bureau (ECB 2000, IUCLID, Version 2).

Other substances are marketed in lesser amounts, some in very small quantities. Among these, there are substances of no obvious concern (e.g. common salts, carbohydrates) where the need for information is less crucial but also substances for which a targeted effort is required. For a vast number of the 100,000 chemicals little or close to nothing is known regarding their health and environmental properties.

Chemical properties/ harmful effects

The number of potential contact points between chemicals and humans are enormous. In order to identify the risk of chemical exposure, new and existing chemical substances must be classified with respect to human and environ-mental hazard based on available information on their inherent properties.

Only a limited number of the substances on the market (approx. 5,000) have been officially classified by the authorities and included in the list of dangerous substances (DEPA, 2000). However, producers and importers are obliged to evaluate the chemicals they produce and import. Furthermore to provisionally classify and label the chemicals they should meet the require-ments of the statutory order on classification, packaging, labelling, sale and storage of chemical substances and products.

Table 10.1
Examples of the chemical factors receiving most attention regarding possible human health effects in the regulation of chemical substances, chemical preparation and consumer articles and goods (DEPA 1996)⁸⁵.

10.1.2 Sources and exposure

Chemical substances

The chemical substances, preparations, articles and goods sold to professionals and laymen, are the source of numerous direct exposures of humans to chemical factors. A great number of different items are in retail and a considerable effort is directed into labelling the chemical substances with risk and safety phrases. The objective is to limit the anticipated exposures by restricting the use or prescribing the use of specific protective equipment.

Single substances like certain solvents, metals, oils, acids and bases (Example 1) are also marketed, sometimes giving rise to high exposures to the individual substance and subsequently their related adverse effects.

Example 1
Sources of chemicals

Chemical substances released or migrating from articles and goods is another source of exposure, which often requires detailed analysis in order to identify and quantify the actual exposure. This is especially the case when the chemical substances are a result of contamination of the raw material and not intentionally added to the products. Recent examples of such exposures are the findings of traces of tributyl tin in babies' napkins and asbestos in crayons.

Chemical preparations

The number of different chemical products (mixtures of substances e.g. paints, varnishes and detergents) are greater than the number of substances and may individually release health affecting environmental factors during their storage, use and disposal. A strategy for limiting exposure following the same path as for the chemical substances is followed.

Some specific substances have been identified as particularly hazardous: lead, cyanoacrylates, isocyanates, epoxy compounds, active chlorine and cadmium. Additional labelling is required for certain preparations containing these substances.

Substances in consumer articles and goods

Many consumer products are not perceived as the possible source of chemical factors, but the chemicals are used in the production of consumer goods. They serve a purpose, as part of the structural material, the decoration or similar, or reside as a residual concentration or contamination of the produced goods. Examples, such as lead and cadmium in glazing and enamelware, plastisicers in cling film or flame retardants in electronic equipment, may be mentioned.

Indoor living conditions may be greatly affected by the choice of building materials because of the long-term exposure and the huge areas/amount of material. Volatile compounds receive special attention, since evaporation from walls and floors may lead to significant concentration in confined, not ventilated areas with large surfaces. One example is the assigned limit value for evaporation of formaldehyde from chipboards, another issue under much consideration presently is the emission of plastisicers from PVC flooring materials.

Evaporation of chemicals from construction materials is recognised as a major component in determining indoor climate. These materials include e.g. glues, fillers, foams and other polymer materials such as paints, lacquer and varnishes. Most of the exposure is by inhalation and the effects are related to volatile organic compounds used as solvents.

Other chemicals migrating from building and construction materials during use are increasingly in focus as sources of potential health effects. The use of acrylates and related monomers may lead to direct dermal exposure, but the release and subsequent indirect exposure from the environment of e.g. plasticisers migrating from PVC has recently also been addressed.

Cleaning products

Household cleaning products may contain hazardous chemicals such as corrosives, irritants and substances toxic to humans or the environment. The products may fall in many categories. The diversity is exemplified by a few products from the cleaning sector: Dishwashing, car wash, drain cleaner, wax, dry cleaning agents, engine wash, window cleaning, protective coatings, stain remover, speciality metal cleaning products, decalcifiers.

The chemicals used in cleaning products are mainly organic and a number of them are among the undesired substances: alkylphenolethoxylates, phthalates and many are solvents.

Cleaning products are used in large quantities and for some of these products high exposures can also be foreseen, especially substantial dermal exposure. Many cleaning products containing detergents are used in connection with warm water, which increases the risk of skin absorption and inhalation of aerosols and gasses. For a vulnerable group such as children a higher than average exposure must be anticipated from residues on floors and other surfaces, and from inhalation and contact to dust particles.

Cosmetics

Cosmetics are typically used directly on human skin and consequently a large dermal exposure is expected. Some are used near mucous membranes (e.g. eyes and mouth) which may increase absorption of the substances or repetitively on large skin surfaces e.g. lotion for babys/infants. Examples include lipstick, perfume, shampoo, make up, deodorants, sun tan lotion, and toothpaste.

Adverse effects have been attributed to some of the substances traditionally used in cosmetics in low concentration. In high concentrations, these substances show mutagenic, allergenic and reproductive toxicity, e.g. isopropyl alcohol, musk xylenes, DEHP.

Allergy is the most common adverse effect related to cosmetics often caused by preservatives and fragrances. A reason for concern is supported by the fact that the incidence of cosmetic allergy is increasing.

Toys

Infants and small children (< 3 years) represent a vulnerable group by themselves, but also requires special attention because they have high hand-to-mouth ratios and risk exposure via mucous membranes. Much effort is therefore directed towards evaluating migration of substances from the products under conditions mimicking the gastro-intestinal milieu and the substance’s oral toxicity.

The phthalates have been one of the target substances for restrictions recently, since the migration and risk of effects from these substances in flexible PVC were deemed unacceptable by the Danish authorities.

For a number of metals used for colouring in grease paint, paints and crayons limit values have been applied since it is estimated that both oral and dermal exposures can be expected.

Clothes/textiles

In clothes and other textiles a similar attention is given to migration of material components, production chemicals and residues of pesticides or preservatives. The main cause for attention is not the hazard associated with the substances themselves, but rather the fact that a close contact may take place between the material and a large part of skin surface for a relatively long time.

Pesticides

Exposure to pesticides (including biocides) is of particular interest because of the proven biological effects and the products therefore represent a high-risk area in terms of toxicity. Human exposure may take place during mixing of formulations and filling of equipment, and in the application process in the field. Especially the non-professional user may wear insufficient protective equipment or none at all and is therefore not protected against dermal exposure and inhalation (www.agrsci.dk)⁸⁶.

A higher than average risk level may also be attributed to children playing on pesticide treated lawns. Likewise, the treatment of kindergartens, playing rooms and buildings to combat e.g. insects and other pests may infer higher risk to children.

Biocides occur in many chemical products for preservation purposes, but biocides are also used in building and construction materials, fabrics and other materials to prevent the biological degradation processes.

10.1.3 Risk to human health

Relatively little is known about the actual health effects and the effects of the combined impact from different sources on public health related to the use of chemicals. In some areas, a certain level of knowledge is available. The acute effects of a number of chemicals are relatively well known from workplace and consumer exposure situations, accidents, and poisoning incidents, e.g. from reporting of acute toxicity to emergency sections at hospitals and to the poison control centre. Chemical pneumonia from drinking and aspiration of lamp oil is one such example. In relation to acute effects like toxic, harmful, irritant and corrosive effects, it is usually easy to establish a relation between the exposure to a given chemical and the actual effect, because the response follows immediately after the exposure.

A profound knowledge of the combined pressure of chemicals to the health status in Denmark is not available, and obviously neither of chemicals as they occur in consumer products.

In general, it is difficult to establish firm scientific evidence for long-term effects like cancer, mutagenicity and reproductive toxicity in humans because of numerous confounding factors related to life-style which can be difficult to account for in epidemiological studies. Long-term effects develop over a long period (sometimes many years) and the exposure pattern becomes very complex in epidimiological studies making a causal relationship between exposure and effects very difficult to establish. There are however, some chemicals for which adequate data for this relationship has been generated both in animal experiments and from observations in humans, e.g. carcinogenic substances such as benzene, asbestos, chromium(VI)-compounds, ethyleneoxide, nickel compounds and vinyl chloride.

Pesticides are well investigated compared to other chemicals. Both acute and chronic effects are tested in animals and the results are extrapolated to humans. DEPA does not find it ethical to use tests on humans with regard to pesticide exposure.

In 1995, it was concluded by the Ministry of Environment and Energy that some chemical factors may influence the life expectancy in a negative direction, and perhaps does so in Denmark. A number of specific factors and effects are mentioned: Chemical carcinogens as such, radon in indoor air, ozone depleting substances increasing UV transmittance, lead and dioxins increasing neural dysfunction, and compounds with reproductive effects. A range of allergenic responses, including eczema and asthma, can also be coupled to exposure to chemical substances and products.

When it comes to long term exposure of the population, knowledge is more scarce, as it can be very difficult to relate the use of various chemicals to the incidence of cancer, reproductive toxicity, allergy and other effects. Again knowledge from workplace exposure and related effects provides some indication of a relation between e.g. the development of eczema, allergies and reduced tolerance to chemical substances, and the exposure of the population to chemicals.

Knowledge about the cancer incidences in the population is difficult to relate to the use of chemicals. This is because very little is known about the actual level of exposure to chemicals and also because a number of life style factors may influence the development of cancer. The impact on the state of health of combined exposure to chemicals and chemicals in combination to other environmental factors like e.g. noise is another area characterised by limited knowledge.

Lack of knowledge makes it therefore very important to identify exceptional exposure situations involving hazardous chemicals, high and repeated exposure and exposure of vulnerable groups like children and pregnant women. Realising this, DEPA has intensified its efforts to identify such specific exposure situation which will also form a background for the future protection of vulnerable groups.

This section focuses on the direct exposure to ’containerised’ substances and products in the human sphere. The main concerns for risk of health threatening exposure are the previously mentioned areas with

	Hazardous chemicals
	High exposure
	Vulnerable groups

The exposure to chemical factors related to chemical substances and preparations, articles and goods is by far the most direct exposure situation. In this area, however, indirect exposure takes place as well, e.g. in the form of pesticide residues in food or substances migrated from food packaging material.

The main overall distinction in exposure pattern is between the chemical substances, preparations and products used in the industry, incl. agriculture, and those used in the household sector. Typically, more hazardous chemicals are allowed to be used in the industrial sector because the users in the working environment have access to training and protective equipment. Especially, more CMR substances and products may be used (CMR is short for carcinogenic, mutagenic and reproductive harmful substances). However, occupational exposure of professionals is not covered here.

In a number of instances laymen also risk exposure to ‘professional’ products. These include the many uses by ‘do-it-your-self’ people using such products in building and construction, painting and decoration, washing, cleaning and rinsing of surfaces and items. It is therefore the products (the vehicles) rather than the sectors, which are in focus as the source of exposure for the non-professional user of such products. As for the consumer, a great number of items comprise the everyday sources of exposure and they are also coupled to the products – not the sectors. The exposure is therefore addressed via the products of use.

Children, as well as the unborn child, have in some cases appeared to be uniquely vulnerable to chemical substances because of their biological growth and development. Furthermore, children may be more heavily exposed than adults to certain chemicals and pollutants in the environment because children, on a body weight basis, breathe more air, drink more water, and eat more food than adults. Additionally, their behavioural patterns, such as play close to the ground and hand-to-mouth activities, can increase their relative exposure.

10.2 Level of protection

From the beginning, the primary objective of chemical regulation has been to protect humans from the adverse health effects from exposure to chemicals, also illustrated by the previous Danish Poison Act from 1961.

The Poison Act applied to substances, which were not covered by other acts, e.g. the Pesticide Act. According to the poison act, substances were classified and categorised in one of the following categories: ‘strong poison’, ‘poison’, ‘harmful’, 'harmful organic solvent’, and ‘harmful gas’. Substances were not evaluated with regard to long-term effects. Criteria for long-term effects were introduced through an amendment to the European Substance Directive which was first issued in 1967 (EU, 1967). Much later, through the 12th adaptation to this directive, criteria for evaluation of environmental effects for substances were introduced.

The main tools used to define and administer the level of protection are risk assessment procedures and classification criteria for classification of chemical substances and preparations. In general, the classification of chemical substances forms the background for all downstream regulation.

For some specific chemical products, e.g. plant protection products and biocides, the level of protection is primarily built into pre-marketing approval schemes, as these products because of the way they are used may be particularly hazardous to the health. In the process of the approval by the authorities, a detailed risk assessment is performed and the need for specific restrictions attached to the use of the products is evaluated before these are put on the market. In the downstream regulation restrictions in marketing and use are either based on the classification of substances and preparations or on specific risk reduction measures. The latter resulting from risk assessment of the particular substances as part of the risk assessment procure for new and existing substances. For example substances classified as Very toxic or Toxic because of CMR effects cannot be sold to the general public. These measures also contribute to sustain a certain level of protection.

Vulnerable groups like children and pregnant women are often more at risk to exposure from chemical factors than the general public and are therefore also getting increasing attention in relation to regulatory development and the level of protection as such. As a result of this, DEPA is working to increase the level of protection in relation to certain uses of chemicals, e.g. with regard to toys and cosmetics. Another area of concern is exposure to endocrine disruptors, which are currently not addressed directly in the regulations. DEPA therefore finds it very important to improve this area in the regulations.

It is difficult in quantitative terms to define the level of protection in chemical regulation, as protection levels from different kinds of regulations in different areas can hardly be compared. Thus a protection level in more qualitative terms may be reflected in an overall view of which kind of regulations that have been issued.

Denmark has, in order to obtain a high level of protection of human health, prioritised bans and restriction of a number of problematic substances including heavy metals like cadmium, mercury and lead, ozone depleting substances, creosote, brominated flame retardants, phthalates and PVC. These restrictions are motivated by either the hazardous properties, the amount used, the method of use or the exposure of vulnerable groups.

The principles for setting health based quality criteria for specific chemicals in order to prevent health hazards in the human population caused by chemical substances as pollutants are discussed in relation to the various media (air, soil and drinking water) and are outlined in more detail in Appendix 1.

10.2.1 Pre-marketing approval

Plant protection products and a great variety of biocides are subject to pre-marketing approval schemes, which in a very direct manner contributes to the level of protection. In general these chemicals are considered to be particularly hazardous to health and are used in large quantities.

Pre-marketing approval implies that the responsible importer or manufacturer must submit a detailed dossier to the competent authority, DEPA. DEPA will then make an evaluation of the data in the dossier before an approval can be assigned. DEPA can also decide to restrict the approval if the forwarded dossier gives reasons for concern in relation to e.g. the planned use.

10.2.2 Classification and labelling of substances and preparations

The purpose of the classification and labelling system is to consider the hazards arising from normal handling and use of substances and preparations in the form they are placed on the market, i.e. to:

	identify all the inherent physico-chemical and toxicological properties and for substances also the environmental properties, which may involve a risk during normal handling and use, - and
	inform the general public about the hazards and adequate precautionary measures for handling and disposal in order to prevent accidents and harmful effects among the users.

Substances are categorised according to the identified properties in one or more categories of danger expressing physico-chemical, toxicological and environmental properties. Only classification with respect to human health is addressed in this section, i.e. classification based on toxicological properties.

The following danger categories are related to health:

	Very toxic
	Toxic
	Harmful
	Corrosive
	Irritant
	Sensitising
	Carcinogenic
	Mutagenic
	Toxic to reproduction

The classification into these nine danger categories is based on existing data and reflects the present level of knowledge and possibilities for testing the various endpoints. These criteria are continuously developed as more know-ledge is generated. DEPA has especially worked to promote more adequate criteria for neurotoxicity, immunotoxicity, reproductive toxicity and impact on the endocrine system. This is also to be better prepared for handling the endocrine disrupters in relation to the endpoints for this newly acknowledged effect.

For endocrine disruption⁸⁷, appropriate test methods have still not been developed for the various endpoints, and this effect is therefore not considered by the classification system. Also for some of the well-known effects like neurotoxicity and respiratory allergy, the test methods have been questioned and are still not fully developed.

Because of the problems with testing for chronic brain damage, it has been difficult to reach agreements in EU about how to evaluate and classify many organic solvents with regard to neurotoxicity in the past. Many organic solvents were only classified with regard to flammability in EU, and Denmark has used the safeguard clause in several situations in order to introduce a classification reflecting the neurotoxic potential as expressed through the risk phrase R48/20 (Danger of serious damage to health by prolonged exposure through inhalation). Recently, two additional risk phrases have been introduced to cover typical solvent-related health hazards, namely R66 (Repeated exposure may cause skin dryness or cracking) and R67 (Vapours may cause drowsiness and dizziness).

The criteria for classification do not focus on sensitive subgroups, e.g. children. However, a number of R- and S-phrases are specifically related to the protection of children and/or pregnant women.

As classification is based on the inherent properties of the substance or preparation in the form it is marketed, it does not take the actual use situation and the exposure into consideration. For example whether the chemicals are intended to be heated during use, diluted, sprayed or processed in any other way.

The classification of a substance / preparation comprises the relevant danger categories and the related risk phrases. Risk phrases express the type and degree of danger from the different routes of exposure. In the classification system there are in addition some risk phrases, which can be assigned to substances classified for other effects. These phrases cover accumulation in the human body and danger to breast-feeding children. The classification system includes currently 65 individual risk phrases of which 33 are directly related to health hazards.

Examples of danger categories and related risk phrases:

Labelling serves the purpose of communicating the potential hazard through danger symbols, risk and safety phrases and other required information on the label.

The use situation is considered by labelling the substances and preparations with safety phrases expressing adequate precautionary measures in relation to handling and disposal of the chemicals. Safety phrases, some of which are obligatory, are assigned based on the classification of the substance/preparation and a defined set of criteria. Preparations which are intended to be applied by spraying must be assigned with specific safety phrases warning about the exposure (S23⁸⁸) and giving advise on protective measures (S38⁸⁹ or S51⁹⁰), as the application is expected to give rise to a considerable exposure.

The health related danger symbols and indications of danger are shown in Figure 10.1 in order of their degree of danger.

Figure 10.1
Health related danger symbols

Very toxic

Toxic

Corrosive

Harmful

Irritant

The labelling rules also includes some requirements for child-resistant fastenings and tactile danger warnings for certain hazardous chemicals aiming to protect vulnerable groups like children and blind people against exposure from the chemicals.

The classification and labelling rules and the ranking of the chemicals in different classes according to their degree of danger form the basis of a large number of administrative rules with regard to restrictions in marketing and use and further priority setting in much of the downstream regulation. Only a small proportion of the substances already on the market are classified in the regulations, a fact which may be a concern in relation to the level of protection. In order to compensate for this problem, DEPA supports the use of group classification of chemical substances and QSAR as methods to evaluate the substances in order to raise the level of protection. DEPA has therefore recently issued a draft guidance list for self-classification of dangerous substances. The list contains 20,624 substances, which have been classified with regard to acute toxicity from ingestion, allergy from skin contact, mutagenicity, carcinogenicity or dangers to the aquatic environment. The substances have been identified among 47,000 substances using QSAR (Quantitative Structure-Activity Relationship) computer modelling. A final list is expected to be issued in 2001.

10.2.3 Risk assessment of chemical substances

Risk assessment of chemical substances forms the basis of the risk reduction strategies and thereby the level of protection. Lack of data is, however, one of the challenges when securing a sufficient level of protection of human health from exposure to chemicals. Only a limited number of the chemicals which are already on the market have been adequately investigated and even fewer have been through the risk assessment procedure.

The risk assessment process, in relation to both human health and the environment, entails a sequence of actions: effect assessment (hazard identification and dose (concentration) - response (effects) assessment), exposure assessment (estimation of the concentrations/doses to which human populations or environmental compartments are or may be exposed), and risk characterisation (estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental compartment due to actual or predicted exposure to a substance).

The risk characterisation is then carried out separately for three subgroups of the population: workers, consumers, and man exposed indirectly via the environment. In the risk characterisation for consumers and man exposed indirectly via the environment, the interspecies variation is taken into account when considering the margin of safety (the ratio between the No Observed Adverse Effect Level (NOAEL) or Lowest Observed Adverse Effect Level (LOAEL) and the estimated exposure).

The principle of general risk assessment of chemicals is to evaluate the inherent properties (the hazards) of the chemical and to make a risk
assessment taking account the most probable exposure of man and environment, with special reference to protect workers, consumers and other persons ex-posed via drinking water, food, soil or other parts of the environment. Most often exposure data are not available for all of these groups and therefore standard scenarios reflecting realistic worst case situations are used and also modelled in computer models. In this respect, the Danish and other product data from product registers like the Danish can be an important source of information about the actual use of many chemicals in the workplaces, but in general the exposure assessments are subject to some uncertainty. For some substances (e.g. phthalates), children have been considered as a specific subgroup of consumers as they may be exposed to these substances in a way which is not considered relevant for adults. Furthermore they may be more susceptible to the exposure of specific chemicals e.g. endocrine disrupters.

The EU risk assessment procedure for existing substances listed on EINECS⁹¹, applies in principle to more than 100,000 substances, but in practice the 141 priority substances has been selected among the 2,700 substances produced in the highest volumes (above 1000 tons). Only very few substances have been processed through the risk assessment procedure until now. It is not the idea to assess all the substances on EINECS, partly because it is impossible to manage, but also because a considerable number of the substances most likely are not on the market today. Other methods to be used for the assessments have been discussed, e.g. the previously mentioned substance groups evaluations and use of Quantitative Structure-Activity Relationships (QSAR).

10.2.4 Restrictions in use

Rules concerning restrictions in use or actual bans of substances hazardous to health or environment can either be based on decisions taken in international fora or they can be based solely on national decisions.

Denmark has given priority to bans and restrictions of a number of substances including heavy metals like cadmium, mercury and lead, ozone depleting substances, creosote, brominated flame retardants, phthalates and PVC. These restrictions are motivated by either the hazardous properties, the amount used, the method of use or the exposure of vulnerable groups.

10.2.5 Precautionary principle

The precautionary principle is a principle that opens up for regulatory action on the basis of suspicions for harmful consequences rather than waiting for cases or a full scientific evidence. In the context of this report, the use of the precautionary principle may be relevant for the aim of protecting vulnerable groups in the population against potential hazardous exposures for which the harmful consequences are not fully understood.

The precautionary principle has been incorporated in a series of international treaties (e.g., the EU Amsterdam Treaty from 1998) and declarations. In many of these, the principle has been connected mainly to hazardous chemical substances, but there are also examples of broader approaches to environ-mental issues.

In Danish legislation the precautionary principle is not explicitly mentioned, but it is often reflected in the introductory comments to various environmental acts, the central ones being the Environmental Protection Act, the Chemical Substance and Product Act, the Marine Environment Act, and the Gene Technology Act.

Both in Denmark and abroad, there has been increasing focus on the precautionary principle in recent years. In line with the increasing complexity of environmental issues, politicians, enterprises, and authorities are expected to allow this doubt to benefit the health or the environment.

However, a uniform and internationally agreed interpretation of the precautionary principle does not exist. Denmark has argued that the principle should be undertaken in cases where potentially adverse effects are of concern, but scientific evidence is unavailable due to lack of data. Finally, the precautionary principle is mentioned in the final conclusions from the Nice summit. Here the Council states that under international law, the Community and the Member States are entitled to establish the level of protection they consider appropriate in risk management. Further, that they may take the appropriate measures under the precautionary principle and that it is not always possible to determine in advance the level of protection appropriate to all situations.

10.2.6 Protection of vulnerable groups

In 1998, the Ministry of Environment and Energy participated in a conference on children and chemicals together with several other ministries. Each ministry presented a status report on how the protection of children and pregnant women is incorporated in its work. The overall impression from the discussions was that children and pregnant women should generally be recognised as special risk groups with respect to effects from exposure to chemical substances. As a consequence, a project was initiated by DEPA titled "Children and the unborn child: exposure and susceptibility to chemical substances – an evaluation". The aim of the project was to elaborate a detailed review and update the knowledge on the exposure and vulnerability of humans to chemical substances during the embryonic, foetal and postnatal periods. The report is intended to form the scientific basis for future regulatory work of the DEPA in the protection of children and the unborn child to environmental chemical substances and it also gives some recommendations for this work.

The regulation of chemical substances is generally based on the present knowledge regarding adverse health effects and risks related to the use of the substances. However, the available data on a specific chemical substance is seldom sufficient to evaluate whether children or the unborn child should be considered more vulnerable than adults. Concerning specific end-points such as fertility and teratogenicity, data exist only for 20 to 30% of the 2,700 high production volume chemicals, and for thousands of chemicals produced in smaller quantities, this percentage is expected to be considerably lower. Furthermore, for most chemical substances, limited data are available concerning exposure of children as well as of adults.

From a regulatory point of view, different approaches can be applied in order to protect children, including the unborn child, from adverse health effects resulting from exposure to environmental chemical substances. One regulatory approach is to improve the risk assessment of chemical substances by including a requirement for data specifically relevant for the protection of children, including the unborn child. Another approach is to pay more attention to children and pregnant women in the risk management process.

10.3 Regulation and strategy

10.3.1 The Danish strategy

Regulation of chemicals is under the auspices of the Ministry of Environment and Energy. In the 1980s and 1990s, Denmark strengthened efforts in the field of chemicals. In 1999, the Danish government presented a new strategy on chemicals, for the period up to 2002, aiming at strengthening international co-operation, making the chemical industry more responsible, strengthening national regulation and enforcement and increasing public access to information (DEPA, 2000).

DEPA has issued strategies and actions plans in e.g. the following areas:

	Brominated flame retardants
	Phthalates in flexible PVC
	Ozone depleting substances
	Pesticides
	Heavy metals

Information about the action plans are available at DEPA's homepage: http://www.mst.dk/activi/01000000.htm.

10.3.2 Objectives and principles

Objectives

The primary objective of the chemicals regulation is to prevent health hazards and environmental damage caused by the use of chemicals and to promote the use of cleaner technology through the administration of the Act on Chemical Substances and Products.

In DEPA's strategy for intensified efforts in the field of chemicals, the main objectives are presented as follows:

	the consumption of problematic chemicals shall be reduced
	the control shall be strengthened, manufacturers responsibility increased and the consumers access to information improved
	the EU risk assessment procedure shall be made more coherent, simplified, efficient and faster
	the Danish efforts to secure a chemicals regulation at a global level should be strengthened.

Principles

Chemical regulation in Denmark rests in general on the following principles and instruments:

	Notification and approval of chemical substances and preparations
	Evaluation, classification and risk assessment of chemicals
	Bans or restrictions
	Substitution of dangerous chemicals with less dangerous ones
	Use of cleaner technology and products
	Inspection and penalties
	Information and campaigns
	Voluntary agreements
	Green guidelines for purchasing
	Taxes and fees
	Subsidies

10.3.3 Legislation on chemical substances and products

Danish regulation in the chemical area is, as mentioned, strongly related to the European Union legislation, which in this area is mainly based on totally harmonised directives. Classification and labelling, notification of new chemicals, use restrictions, and hazard and risk assessment are all areas where full harmonisation applies. In some of the directives the so-called ’safeguard clause’ exists which makes it possible for the Member States to implement provisional rules, which are stricter than the rules of the EU. Denmark has on some occasions used this clause, e.g. in relation to classification of certain organic solvents.

Denmark has also issued more strict regulations in areas, covered by minimum regulation in the EU. This regards for instance ozone depleting substances.

In addition to the regulation based on EU directives, Denmark has maintained and issued specific national regulation in areas not addressed by EU regulation, e.g. in relation to mercury, lead and restrictions of substances which are allowed in aerosol containers. Another example is the permit system whereby a consumer must obtain permission from the police to buy toxic substances.

10.3.4 Legislative background

Existing Community legislation on environmental and human health aspects of chemicals is based on a three-stage approach. It includes a hazard identification stage, in which a substance’s inherent capacity to cause adverse effects on human health and the environment is identified, on the basis of the intrinsic properties of a substance. The second stage consists of risk assessment, which is based on an assessment of the hazard combined with an assessment of exposure to the chemical substance. The third and final stage is one of risk management, in which strategies for the management of the risks are developed. This approach is reflected in the EU regulation.

The main EU Directives on chemicals governing Danish regulations are shown in Appendix 6.

National legislation and implementation

The Act on Chemical Substances and Products

The main act regulating chemicals is the Act on Chemical Substances and Products. This act was issued in 1979 and has been amended and revised several times, latest in 2000. The act covers all chemical substances and products and is intended to prevent health hazards and environmental damage caused by the use of chemical substances. It also aims at promoting the use of cleaner technology through the administration of the Act. The Act shall ensure that the dangers presented by substances sold in this country are highlighted, and that sale and use of chemical substances and products known or believed to be hazardous to health are regulated.

As a general rule, the Act does not regulate the content of chemicals in common products and goods, however in certain sections of the act, goods are included. Exposure of humans to chemicals diffusely leaching from consumer goods is only covered by specific regulations. Described in a simplified way, one could say that the environmental regulation in particular regulates environmental conditions involved with production, while the chemical regulation contributes with rules aimed at the later stages in the life cycle of the chemicals, e.g. distribution, use and as waste. (DEPA, 1996).

Text box 10.1
Objectives and Scope of the Act on Chemical Substances and Products

A number of statutory orders have been issued pursuant to ACSP, banning or restricting the use of a number of substances, e.g. heavy metals and ozone depleting substances.

Classification and labelling

Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (the Substances Directive), is an important single market directive that seeks to ensure the operation of the European single market in chemicals and to provide high standards of human health and environmental protection.

In Denmark, the Statutory Order on classification, packaging, labelling, sale and storage of chemical substances and preparations (no. 734 of 31 July 2000) implements the relevant EU Directives into national legislation. The Statutory Order provides the regulations for evaluating the inherent properties of a chemical substance or preparation in relation to hazard identification and assessment in line with the requirements in the Substance Directive described in 10.2 and Appendix 5.

Denmark has issued a statutory order on the List of dangerous substances which implements Annex I to the Substance Directive. For white spirit (CAS-no. 8052-41-3) and solvent naphtha (CAS-no. 64742-88-7) Denmark has used the safeguard clause and implemented a more strict national classification including the risk-phrase R48/20 (Danger of serious damage to health by prolonged exposure by inhalation). The latest revision of the list (no. 733 of 31 July 2000) implements the 26th adaptation to the Substance Directive. Another national feature is the "Ae" code assigned to certain substances in the list. Substances with this code must not be used in spray canisters (aerosol containers) unless other legislation lays down special provisions hereon. The Statutory Order no. 1042 of 17 December 1997, on restriction of the sale and use of certain dangerous chemical substances and products for specific purposes includes a provision that spray canisters must not contain substances classified as "very toxic" or "toxic" and these substances are therefore also assigned the "Ae" code in the list.

As described in section 10.2.2, DEPA has recently issued a draft guidance list for self-classification of dangerous substances comprising 20,624 substances, which have been identified using QSAR. The accuracy of the predicted classifications varies from approximately 70 to 85%. The list is not intended to be mandatory, but exclusively to be a guidance list in case no other documentation is available.

Notification of new substances

A new chemical substance is a substance, which is not listed in EINECS as being on the European market in the period 1 January 1971 and 18 September 1981. Substances notified in the period from 18 September 1981 are listed on ELINCS (European List of Notified Chemical Substances), a list of approximately 400 substances.

New chemical substances must be notified with DEPA. Any manufacturer or importer of a new chemical substance shall, prior to sale, submit notification of the substance to the Danish Environmental Protection Agency. The detailed notification file must include, inter alia, a description of the intrinsic physio-chemical, toxicological, and eco-toxicological properties of the substance. The larger the amount of substance placed on the market, the more data must be submitted to the authorities. The notifier may also provide a preliminary risk assessment to support the succeeding risk assessment procedure carried out by DEPA.

The following chemical substances exclusively imported or sold in the following products ready for use are excluded from the notification requirement:

1. Medicinal products for human or veterinary uses.
2. Foodstuffs.
3. Animal feeding stuff.
4. Radioactive substances as defined by Directive 80/836/EEC⁹².
5. Mixtures of substances in the form of waste.
6. Pesticides to be authorized under Part 7 of the Act.
7. Cosmetic products.

Between September 1981 and September 2000 less than 10 substances have been notified in Denmark, where only limited production of basic chemicals takes place.

Restrictions in marketing and use

The ongoing amendments regarding the main EC Restrictions Directive (76/769/EEC) are either implemented through individual orders or through the Danish statutory order no. 1042 of 17 December 1997 on restrictions on the marketing and use of certain dangerous substances and preparations for specific purposes, latest amended 22 April 2000. The order also covers national provisions. Moreover, Denmark has issued strictly national provisions restricting certain other chemical substances and products.

Examples of amendments regarding the main EC Restrictions Directive (76/769/EEC) implemented by individual orders, include:

	Ban against import of certain Nickel-containing products (94/27/EEC)
	Ban against sale, import and manufacture of Cadmium containing products (91/338/EEC)
	Order on PCB, PCT and substitutes (85/467/EEC)
	Order on restriction in sale and use of pentachlorophenol (91/173/EEC)

Examples of amendments regarding the main EC Restrictions Directive (76/769/EEC) implemented by the Danish statutory order no. 1042 of 17 December 1997, include:

Benzene: This substance is not permitted in toys or parts of toys as placed on the market where the concentration of benzene in the free state is in excess of 5 mg/kg of the weight of the toy or part of the toy. Benzene must not be used in concentrations equal to or greater than 0.1 % by mass in substances or preparations placed on the market (82/806/EEC).

Arsenic: Arsenic compounds may not be used for antifouling, preservation of wood, or for the treatment of industrial waters irrespective of their use (89/677/EEC).

Mercury: Mercury compounds may not be used for antifouling, preservation of wood, impregnation of heavy textiles, or for the treatment of industrial waters irrespective of their use (89/677/EEC).

Chloroform, tetrachloromethane, 1,1,2-trichloroethane, 1,1,2,2-tetrachloroethane, 1,1,1,2-tetrachloroethane, pentachloroethane, 1,2-dichloroethyleneor 1,1,1-trichloroethane: These substances, or products containing them, in concentration of more than 0.1 % w/w must not be placed on the market for sale to the general public and/or in diffusive applications such as in surface cleaning and cleaning of fabrics. Preparations with a higher content must be labelled "For industrial installations only" (96/55/EEC).

Denmark has in addition to the substances mentioned here restricted or banned a number of other substances, e.g. ozone depleting substances, and 'Ae'-substances as well as 'very toxic' and 'toxic' substances in consumer products. In some cases, stricter rules are applied compared to the EU requirements, e.g. in relation to asbestos, PCP, cadmium and creosote (DEPA, 1999).