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List of Undesirable Substances 2004

1 Selection criteria

In relation to the previous editions of the LOUS, a number of significant changes have taken place as to the criteria forming the basis for selection of substances for the LOUS.

1.1 Future EU regulatory framework for chemicals and the sustainability strategy

As a completely new initiative, the Danish EPA has chosen that the principles and criteria included in the prioritisation of the particularly dangerous substances under the authorisation system in the future EU regulatory framework for chemicals and in the Danish government's sustainability strategy http://www.mst.dk/udgiv/Publications/2002/87-7972-279-2/html/default_eng.htmDenmark's National Strategy for Sustainable Development are to be reflected on the LOUS. This means that a number of substances appear on the LOUS for the first time. Moreover, several substances, which were previously on the LOUS, have been removed because they no longer meet the selection criteria.

Although the substances are now selected on the basis of new criteria, the more technical method of selection remains the same. Some substances are selected in a purely systematic manner because they possess clearly undesirable properties, while other substances are selected because there is a political wish to have them replaced.

In the systematic analysis, substances are selected automatically if they meet some clear and defined criteria, eg. problematic classifications, because they are under suspicion for being PBT/vPvB (Persistent, Bioaccumulative, Toxic/very Persistent, very Bioaccumulative) or endocrine-disrupting.

Using the other method - so-called supplementary selection - the substances not caught in the systematic selection, but which still have a number of undesirable effects, will be added to the LOUS. This could be substances that constitute a particular problem for drinking water or in the waste stream.

In the following paragraphs, the individual steps of the selection procedure are described in detail.

1.2 Systematic selection of substances for the List of Undesirable Substances

The first step of the systematic selection of substances for the LOUS is to clarify the properties regarded as most problematic.

1.2.1 Determination of problematic properties

In October 2003, the European Commission presented a proposal for a revision of the EU chemicals legislation, REACH. The proposal consolidates more than 40 individual legal acts in one single regulatory framework in order to create an overview of the chemicals that European consumers risk contact with. The proposal also includes a description of which substances are regarded by the EU as being so problematic that, in future, approval will be required for specific use.

The goal of the Danish EPA is for the principles reflected in the so-called authorisation system in the new EU regulatory framework to also be reflected in the way substances are selected for the LOUS. Therefore, the definitions of the very problematic substances referred to in the future EU regulatory framework for chemicals will also play an important role in the selection of substances for the LOUS.

Another cornerstone in the policy on chemicals in Denmark is the government's strategy Denmark's National Strategy for Sustainable Development from 2002. In this Strategy, the paragraph about chemicals states the following: "Chemicals used in society must not have any undesirable impact, such as carcinogenic effects, reproduction toxicity, mutagenicity or effects on vulnerable ecosystems. By 2020, no products or goods on the market may contain chemicals that have highly problematic effects on health and the environment." In order to be able to meet this objective, it is necessary already now to reduce the use of very problematic substances. Therefore, the Danish EPA has incorporated the principles of the objectives regarding chemicals in the Strategy for Sustainable Development into the way substances are selected for the LOUS.

In the following paragraphs, the criteria applied by the Danish EPA to identify substances with undesirable effects will be described.

1.2.1.1 The List of Dangerous Substances

The List of Dangerous Substances [2] contains a list of the substances that, in the EU, have been evaluated and classified as to their physiochemical properties, the danger they pose to human health and their environmental effects. For each substance on the list, which includes approx. 7,000 substances/substance groups, the danger classification is stated, including risk phrases that briefly identify the inherent dangerous properties of the substances.

On the basis of the List of Dangerous Substances, the Danish EPA has chosen to concentrate on the substances that could cause very serious and long-term damage. In other words, substances which may cause chronic damage to human health or which may impact future generations. Precisely these substances are among those that the EU has indicated as particularly problematic in the new regulatory framework for chemicals and which will be subject to an authorisation system.

More specifically, this means that substances classified for the so-called CMR effects in categories 1 and 2 (carcinogens, mutagens, reproduction toxins) are subject to authorisation for specific application before they can be used. Therefore, the substances are candidates for the LOUS.

Moreover, the Danish EPA has decided that substances under suspicion for having the same effects (CMR-category-3 substances); substances posing a risk of serious damage to human health by prolonged exposure; and substances that are extremely toxic to aquatic organisms and that may, at the same time, cause undesirable long-term effects in the aquatic environment are so problematic that they are also candidates for the LOUS.

All in all, this means that substances classified as having one or more of the following properties are candidates for the LOUS:

R33 Danger of cumulative effects

R39 Danger of very serious irreversible effects

R40 Limited evidence of carcinogenic effects

R42 May cause sensitization by inhalation

R45 May cause cancer

R46 May cause heritable genetic damage

R48 Serious damage to health by prolonged exposure

R49 May cause cancer by inhalation

R50/53 Very toxic to aquatic organisms, may cause long-term

adverse effects in the aquatic environment

R58 May cause long-term adverse effects in the environment

R59 Dangerous for the ozone layer

R60 May impair fertility

R61 May cause harm to the unborn child

R62 Possible risk of impaired fertility

R63 Possible risk of harm to the unborn child

R64 May cause harm to breastfed babies

R68 Possible risks of irreversible effects

For a number of substances on the List of Dangerous Substances, the CMR effect is attached to possible constituents (including impurities and, for example, the content of benzene, 1,3-butadiene, DMSO extract) in the complex compound on the list. This means that the substances are only to be classified for CMR effects if they contain these constituents. These substances all have one or more of the comment codes P, M, N, L, K or J on the list and thus indicate that it is not the entire complex compound listed that has CMR effects, but rather the impurities or specific constituents of the compound.

Previous studies carried out by the Danish Product Register have, however, shown that the substances used in Denmark do not contain these impurities/constituents and should therefore not be classified for CMR effects. Therefore, the Danish EPA has chosen not to include the substances with CMR effects that can be solely attributed to these impurities/constituents.

Substances used for motor fuel and combustion have not been included on the list although they may have problematic classifications. This type of application is not undesirable. The same method applies to oil derivatives which are included on the list. This undesirable application does not apply when they appear as a natural part of petrol and oil products, but merely when they are applied in other connections.

In the 29th adaptation of the EU Directive on Dangerous Substances (Directive 67/548/EEC), new classifications for a number of substances have been adopted [3]. Where relevant, the new classification is listed under the individual substances in Appendix A.

1.2.1.2 The Danish EPA's Advisory List for Self-classification of Dangerous Substances [4]

Lack of data for chemical substances is a great problem in connection with eg. evaluation of dangerous properties of chemicals. The Danish EPA estimates that sufficient test results from experiments on animals etc. are lacking for up to 90 per cent of the just over 100,000 substance entries in the EU's inventory of existing substances (EINECS).

Manufacturers/importers are obliged to assess whether the substances placed on the market are dangerous on the basis of existing knowledge on the substances. Experience shows that lack of data for chemical substances makes it extremely difficult to meet this obligation in a qualified manner. In a few cases, this may mean that today danger labels on products do no contain information about those dangerous properties of substances that have not been studied.

Therefore, the draft of the new EU regulatory framework for chemicals contains a requirement for new studies, and in this connection more extensive use of computer models for evaluation of the dangerous properties of substances will be made possible.

The Danish EPA has prepared an Advisory List for Self-classification of Dangerous Substances, which was made using QSAR models (Quantitative Structure Activity Relationships). The models can predict the dangerous properties of chemical substances on the basis of information about the substances' structure and physiochemical properties and comparison with other substances that have known dangerous properties. The accuracy of the models used is approximately 70-85 per cent. This means, that for some of the evaluated chemical substances - approximately 20 per cent - the model predictions will overestimate or underestimate the danger of the chemical substances (false positives/false negatives).

The Danish EPA has used the QSAR models on approx. 47,000 organic substances from EINECS with an unambiguous structure. On the list for self-classification, advisory classifications for 20,624 substances have been indicated for the following properties:

  • Acute oral toxicity
  • Sensitization by skin contact
  • Mutagenicity
  • Carcinogenicity
  • Danger to the aquatic environment

Substances on the Advisory List for Self-classification of Dangerous Substances with one or more of the problematic classifications indicated in paragraph 1.2.1.1 have been selected as possible candidates for the LOUS.

1.2.1.3 The EU list of possible PBT substances and vPvB substances

In the draft EU regulatory framework for chemicals, not only CMR substances in categories 1 and 2 are subject to authorisation before use. The so-called PBT substances (persistent, bioaccumulative and toxic substances) and vPvB substances (very persistent and very bioaccumulative substances) are also subject to such authorisation. These substances are regarded as being so problematic that they may only be used under controlled conditions, ie. when authorisation for their use has been obtained.

Exactly because substances with PBT/vPvB properties have long-term effects and may cause damage to future generations, they are also included in the Danish Strategy for Sustainable Development.

In the European Commission's proposal [5] for a new regulatory framework for chemicals, criteria for PBT/vPvB substances have been defined. In this connection, the EU has prepared a working document with the substances that are currently regarded as having PBT or vPvB properties. A short description of the criteria deciding whether a substance has PBT or vPvB properties can be found in Appendix C.

The Danish EPA decided that all substances listed on the EU candidate list as PBT substances/vPvB substances are to be included on the LOUS when they are used in volumes of more than one tonne per year in Denmark. In this way, we ensure increased focus on the substances that constitute a special problem.

However, it is important to emphasise that the work on finding new PBT/vPvB substances or on clearing suspected PBT/vPvB substances is carried out on an ongoing basis and will take several years. This means that the PBT/vPvB substances on the LOUS are all substances that currently fall under the EU criteria. Since the work on identifying these substances is an ongoing process, studies of the properties of the substances may mean that a substance, which in 2003 was regarded as a PBT/vPvB substance, will not necessarily be regarded in the same way in 2005, because new knowledge has removed the suspicion - just as the opposite may happen.

1.2.1.4 The EU list of substances with documented endocrine-disrupting effects that have been prioritised for further testing.

Endocrine disrupters classified for CMR effects in categories 1 and 2 are covered by the authorisation system in REACH. Other substances with endocrine-disrupting effects may be included after a special evaluation of the substance. This is because there are no existing internationally accepted testing methods to determine whether a substance has endocrine-disrupting properties, and there are thus no fully standardised criteria to classify all endocrine-disrupting effects.

Currently, the EU work on prioritising substances for further testing when commonly recognised testing methods have been developed has resulted in a list of 66 substances for which documentation for endocrine-disrupting effects exists. The list is dynamic. As more and more knowledge is gathered in the area, substances may be added to and removed from the list.

So far, the Danish Parliament's Environment and Regional Planning Committee has, however, decided that all substances on the EU list of substances with documented endocrine-disrupting effects which are not already prohibited in Denmark should be included on the LOUS. All 66 substances are included in Appendix B; the substances not already regulated through bans or through an authorisation system are also included in Appendix A, except substances solely used as pesticides. Substances used both as pesticides as well as for other purposes have been included, because the use for purposes other than those authorised is undesirable.

1.2.1.5 Priority substances in relation to the Water Framework Directive

The selected substances on the LOUS have been compared with the substances covered by EC Decision 2455/2001/EC of 20 November 2001 establishing the list of priority substances in the field of water policy and amending Directive 2000/60/EC (Water Framework Directive). 33 substances/substance groups have been prioritised on the basis of the discharge into and occurrence in the aquatic environment as well as those of their properties possibly harmful to human health and the environment. This designation distinguished between "priority substances" and "priority hazardous substances" which are the potentially most harmful substances. It applies to all priority substances, including the dangerous ones, that a progressive reduction of additions (ie. discharges, emission and losses) of the substances to the aquatic environment with a view to meeting the qualitative objectives for the aquatic environment by 2015. In addition, by 2020 (after one generation), additions of priority hazardous substances to the aquatic environment must be cessated.

A large part of these substances is either covered by pesticide and biocide regulation or other regulation. The remaining substances which are, at the same time, applied above the tonnage limits in Denmark (see 1.2.3.2) are included on the LOUS. If a substance is one of the priority substances or priority hazardous substances in the Water Framework Directive, this will appear in Appendix A.

1.2.2 Selection criteria no longer used

In relation to the most recent LOUS (2000), a number of selection criteria are no longer used. The Danish EPA have, as can be seen in this LOUS, emphasised particularly problematic substances.

Criteria no longer used in the systematic selection are primarily risk phrases (R phrases) pertaining to classification for acute toxicity and skin allergy.

Chemical substances and products such as paints and cleaning products classified as toxic and very toxic may not be sold to non-professional consumers.

Professional use in industry is regulated by other legislation with regulations stipulating either substitution, encapsulation or personal protective equipment. Use may also be regulated in another manner so that employees are not exposed to health hazards, just as regulations take account of discharges and emissions into the environment.

Development and occurrence of allergies are subject to individual conditions. In the working environment, where the greatest exposure to individual substances occurs, people handle allergenic substances in the same way as acutely toxic substances that are regulated by other legislation. Exposure to potentially allergenic substances through consumer products is an individual problem. Therefore, it is important to provide information about potentially allergenic substances directly on the products so that consumers have a choice to avoid substances that are problematic for them.

Since the new labelling regulations for cosmetics regarding certain allergenic perfume ingredients have not yet entered into force, a number of known allergenic perfume ingredients have been placed on the LOUS. Moreover, particularly problematic allergenic substances have been selected. These include substances that cause allergies by inhalation as well as substances that cause allergies upon skin contact, but where the current labelling regulations are not sufficient to ensure that consumers avoid contact with the substances in finished products.

As part of strengthened efforts in relation to chemical substances in consumer products, the Ministry of the Environment has also established the National Allergy Research Centre. The Centre was established in cooperation with the dermatology and respiratory wards at the Copenhagen County University Hospital in Gentofte and the dermatology ward at the Odense University Hospital.

The National Allergy Research Centre is situated at the Copenhagen County University Hospital in Gentofte and takes care of tasks pertaining to research, monitoring, information and prevention of allergies to chemical substances in consumer products.

Classification on the basis of environmental hazards with R51/53 and R52/53 are no longer used as selection criteria. This is based on a wish to focus on the most problematic substances. Focus has been on PBT/vPvB substances, but in addition to this, the most environmentally problematic substances have been included, ie. the substances classified as N;R50/53 or the substances appearing on the advisory list with the designation N;R50/53. These substances may be easily degradable, but since they are most toxic to the aquatic environment, work should also focus on substituting these substances with less problematic substances.

Labelling with "R53: May cause long-term adverse effects in the aquatic environment" does not necessarily mean that the substances are difficult to degrade (persistent). Therefore, the specific application of the substances will determine whether they are problematic for the aquatic environment.

Despite the changes in selection criteria, it remains relevant to substitute allergenic, acutely toxic substances and substances with problematic properties according to the aquatic environment if the specific application indicates that there may be a risk. However, a prioritisation has been made with this list so that substances with particularly problematic and long-term effects come in focus. This is also reflected by the fact that the tonnage limits have been reduced for the particularly problematic substances.

As a further insurance in relation to the criteria no longer being used, a study has been made as to which substances on the List of Dangerous Substances are classified on the basis of environmental hazards with N;R51/53 and where the use in Denmark exceeds the tonnage limit of 100 tonnes. This concerns 6 substances. None of these six substances have been deemed particularly problematic or persistent and thus do not appear on the LOUS 2004.

Criteria no longer used appear in Appendix E.

1.2.3 Identification of substances with problematic properties

The next step after identifying substances with problematic properties is to study whether these substances are used in Denmark and the volumes and purposes of such use.

1.2.3.1 Extracts from the Danish Product Register

If they are used for commercial purposes in Denmark, dangerous chemical substances must be reported to the Danish Product Register. Manufacturers and importers are obliged to update this information when changes occur. The Danish Product Register is an important source for an overview of the chemical substances used in Denmark.

The Danish Product Register has studied whether substances with problematic properties from the List of Dangerous Substances and the Advisory List for Self-classification of Dangerous Substances are actually used in Denmark. Moreover, the Danish Product Register has studied the use of PBT/vPvB substances and endocrine-disrupting substances.

1.2.3.2 Tonnage limits

CMR substances in categories 1 and 2 and PBT substances/vPvB substances used in volumes of more than one tonne per year in Denmark have been included on the LOUS. According to the draft EU regulatory framework for chemicals, these substances can only be used in future if they have been approved for a particular application.

Other substances with problematic properties will be included on the LOUS if they are used in volumes of more than 100 tonnes per year in Denmark. This includes substances with CMR effects in category 3, substances that may have cumulative effects, or substances that are particularly dangerous to the environment.

Tonnage limits mean that problematic substances that were previously used in large volumes, but today are only used in very small volumes, will no longer appear on the LOUS. Therefore, it is important to ensure that these substances are not taken into use again in Denmark. The substances will still appear from the List of Effects, and if consumption increases again, they will return to the LOUS.

There are no tonnage limits for substances selected according to supplementary criteria or because of suspicion of endocrine-disrupting effects.

1.2.3.3 Deselection of candidates for the LOUS

Although a chemical substance immediately meets all the criteria for being included on the LOUS as regards both problematic properties and consumption, there may be matters that result in the substance not being included on the LOUS.

For example, substances that are only used as biocides and pesticides have been eliminated, since they are already regulated under an authorisation system. However, biocides and pesticides that are also being used for other purposes have been included on the LOUS. Also substances, which are only used in connection with the synthesis of other chemicals or in the pharmaceutical industry, have been deselected as have substances only used as laboratory chemicals. These substances are deemed to pose a slight risk to human health and the environment or they are subject to other study or control schemes.

Substances that are formed in various industrial processes have not been included on the list, since it only includes substances actually used as chemical substances. This means that substances like dioxins and furans have not been included on the list since they are not used directly. However, the substances are still prioritised politically through the existing Danish Dioxin Action Plan (only available in Danish) which works for a continued minimisation of dioxin discharges and for more knowledge about unidentified dioxin sources.

1.3 Supplementary systematic selection of substances for the LOUS

1.3.1 The systematic selection has certain limitations

In connection with the efforts so far to minimise to the greatest extent possible the adverse effects on human health and the environment from chemical substances, some substances/substance groups have previously been identified as problematic due to their effects on the environment and health. These may include substances constituting a particular problem eg. in the waste stream or to groundwater.

A number of substances in focus today have not been identified in the systematic selection due to various selection-technical reasons. This may be because:

  • the relevant substances have not yet been classified and have thus not been "caught" by the computer models.
  • the relevant substance or substance group does not have a known identity number.
  • the substances in question are certain pure metals/metal compounds that do not appear on the List of Dangerous Substances , since they have not been classified as particularly dangerous, or because they cannot be identified using computer-based selection methods .

1.3.2 Supplementary selection criteria

In order to ensure that the LOUS represents all the substances that the Danish EPA believes to be problematic for human health and/or the environment, a more pragmatic selection of substances has been carried out as a supplement to the systematic selection. This selection was carried out on the basis of the following five criteria:

1.3.2.1 Substances being phased out

Substances being phased out due to their environment- or health-related properties, but for which no time limits have been set in certain areas of use, as no technically and financially feasible alternatives have yet been found for these areas; or substances where restrictions on use are being or have been decided in the EU.

1.3.2.2 Substances with only partial restrictions on use

Substances that are only subject to partial restrictions on use, although other uses are also considered to be a cause for concern with regard to human health or the environment.

1.3.2.3 Substances that are problematic in waste streams

Substances that make the use of the residual products of waste streams (flue-gas cleaning products, slag, sludge and compost) problematic.

1.3.2.4 Substances that are prioritised politically

Substances covered by political phase-out goals.

1.3.2.5 Substances that are problematic with respect to groundwater.

Substances considered problematic with respect to groundwater.

Footnotes

[2] Statutory Order no. 439 of 3 June 2002: Statutory Order on the list of dangerous substances.

[3] Directive 2004/73/EC of 30 April 2004

[4] Environmental Project No. 635, 2001. Report on the Advisory List for Self-classification of Dangerous Substances.

[5] Proposal for a regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants}, which has been published by the European Commission on the website: http://europa.eu.int/eur-lex/en/com/pdf/2003/com2003_0644en.html.

 

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Version 1.0 December 2004, © Danish Environmental Protection Agency