National bans on the use of hazardous substances can come into conflict with the need of companies and institutions to carry out measurements or analyses by standard methods, i.e. methods on which agreement has been reached within European (CEN) or international standardization organizations (ISO). Because national legislation overrides standards the CEN and ISO standards that contain a requirement for measurement with mercury-containing instruments have not been implement-al as Swedish standards, since the current regulation of certain mercury-containing goods was introduced. SIS, the Swedish Standards Institute, has in such cases requested exemptions for the standards in Sweden. Corresponding problems will occur if a general ban should be introduced for analytical chemicals and reagents.
In the examination of exceptions and dispensations for regulated goods kemI has since the beginning of the 1990's primarily investigated, from case to case, whether there is a technically possible alternative to the desired function. Other special or exceptional reasons for exemption/dispensation, such as dependence on being able to carry out a measurement by standard methods, have been regarded as of secondary importance in such examinations. KemI has found reason to deviate from the stated principle only in a few cases where, to satisfy other legislation, the use of a particular standard method is prescribed, which, in its turn, prescribes or for technical reasons requires the use of a mercury-containing instrument.
Within the framework for the current ban on mercury in measuring instruments it has been claimed in a number of cases that it is necessary to carry out measurements with mercury thermometers in order to conform with various standard methods, especially methods from the USA (ASTM). Closer examination has shown that these methods do not always prescribe mercury thermometers but, rather, a particular accuracy and in particular traceability in the analysis. In ASTM methods, for example, the instrument is often specified in such a way that it will contain a thermometer pocket or holder that is designed for a specific mercury thermometer. In isolated cases, such as flash-point determination, the ASTM methods prescribe a certain size of bulb that arises from the shape of the mercury ball. In these situations, therefore, there are no actual technical obstacles to changing over to alternative techniques where they are available (Östman, 2004).
The analysis of EC law has shown that it is possible to extend the current national ban to areas within which a large number of standard methods occur, for example in chemical analyses. KemI considers that the principles that have been developed and the experience that has been obtained in the case of handling dispensations within the current ban should be a guide in the case of the general ban as well. The starting point should thus be to investigate case by case whether there is mandatory legislation and whether there are alternative methods that are technically comparable. These principles have therefore governed the structure of the impact assessments that have been carried out as part of the present commission.
Sweden is, together with a number of other countries in Europe, actively seeking the removal of mercury and mercury compounds from standards and some progress has been made. A national ban on mercury means that Swedish representatives can put forward proposals for amending standards in different standardization committees more forcefully. According to the Swedish Standards Institute's (SIS) reply to our questionnaire Swedish representatives have often highlighted problems with the use of, in particular, elementary mercury in measuring equipment, but up to now they have not found much sympathy for these views in standardization committees and in votes within the ISO and CEN.
All standards are reviewed every five years and there is then the possibility of making changes, for example exchanging undesirable substances or equipment for other alternatives. It is, however, possible to change a standard ahead of time by a supplement (amendment).
An analysis of the prerequisites under EC law for a national ban is set out in Chapter 4. The legal analysis has identified within which areas of use it is possible to introduce stricter national rules and this analysis provides the framework fro the investigation carried out. The impact assessments described in this chapter focus on the areas of use identified in the legal analysis and the areas of use which have not so far been regulated in Sweden or the EU:
The analyses throw light on the existence of alternatives to mercury in the above-mentioned uses and on whether these are available on the market or whether time is needed fro their development. In certain cases it has been difficult or impossible to obtain a comprehensive picture of uses and alternatives where the use is widespread throughout the Swedish economy. A complete and detailed study has not been possible in these cases during the short time available for this commission.
The impact assessment explores positive and negative effects for individual persons and the economy from environmental and economic points of view. To the extent that it has been possible and of interest, possible impacts on society have been analyzed in broad outline. The impacts have been analyzed from the point of view of various parameters. Some of these parameters are: the economy and competitiveness; environmental effects; health effects; safety aspects (technical/hygiene requirements); and research and education.
A special impact assessment has been carried out on the completed draft ordinance in accordance with the SimpLex Ordinance [1998:1820] on the effect of regulation on small enterprises. The SimpLex analysis is found in Chapter 8.
For each area of use there are conclusions and proposals for regulation, with possible exemptions. The exemptions are, in general, time-limited and the number of years indicated is based on the assumption that a general ban will come into force on 1 July 2005.
6.1.1 A short historical retrospection
Amalgam has been used as a tooth-filling material since the 1880s. A debate on the risks of leakage of mercury from the fillings began as early as the middle of the last century. In 1938 the Swedish parliament decided on free dental care for children and the expansion of public dental care by the county councils started. The predominant tooth-filling material was amalgam. [SOU 2003:53]
Both health and environment risks connected with the use of amalgam have been debated since the 1970s. Curing the 1980s a number of expert groups and investigations were set up and in 1991 the National Board of Health and Welfare investigated at the government's request the preconditions fro phasing out amalgam as a tooth-filling material. The investigation proposed a phasing-out process in which amalgam would cease to be used entirely by 1997. As a stage in this, an agreement was made between the state and county councils in 1995 that amalgam should be phased out from children's dentistry (Government decision 1995). [SOU 2003:53]
KemI was requested by the Government to evaluate by 1 July 1996, in consultation with the National Board of Health and Welfare, the phasing out of amalgam. In the investigation it was established, inter alia, that total phasing out by 1997 was not possible but that its use could be reduced further. The investigation showed that despite the 1995 agreement amalgam was still used for fillings when there were other alternatives and, remarkably, often for the repair of children's teeth [Kemikalieinspektionen, 1996]
To make amalgam more cost-neutral against other filling materials, Parliament decided in 1999 that no financial support should be given for amalgam filings via the national dental insurance.
6.1.2 Amalgam and dental materials
Dental materials are used to repair damaged teeth or to replace lost teeth. Desirable properties are that they shall be harmless to both dental-care personnel and patients, durable, able to withstand strong chewing loads, and aesthetically acceptable. Amalgam is an alloy of mercury and other metals. Dental amalgam contains silver, tin and copper in addition to mercury. About half of amalgam, by weight, is mercury [Kemikalieinspektionen, 1996]. There are no complete statics available from which to determine reliably how much amalgam is currently used. Estimates can be made from the quantities of amalgam products supplied to the Swedish market. Statistics on fillings from county councils and patient groups are another method used to estimate use.
Dental materials can be divided into materials used for direct and indirect techniques. In the case of direct techniques the material is introduced in a plastic state and hardens in the tooth, while in indirect techniques an impression is usually made which is used by a dental technician to make an inlay or crown. The most common filling materials nowadays are different types of composite. Other materials used are ceramics, glass ionomer cement and cast metal (principally gold alloys and titanium). Also used are combinations of materials, e.g. "compomers". There are also prefabricated ceramic cones, which are pressed into composite fillings to reduce shrinkage of the filling. There is constant research into the development of new materials. One example is hydrated ceramics, which form a body-compatible substance that is integrated chemically and biologically into the tissue. These are not yet on the market.
According to the Swedish Dental Trade Association, there are six distributors of amalgam in the Swedish market and two companies that manufacture such materials. According to the Association there are currently no Swedish manufacturers of alternative filling materials producing for the Swedish market. The number of companies that distribute or supply alternatives to dental amalgam on the Swedish market is around forty. (Svedberg, personal communication)
6.1.3 Are there alternatives to amalgam?
In Sweden amalgam has been replaced to a large extent by other filling materials during the last five to six years. The quantities of mercury sold for amalgam are estimated to have decreased from 890 kb in 1997 to about 100 kg in 2003 (see Annex 3), which, in itself, indicates that the need for amalgam is not as great as formerly. During the investigation it has become clear that what has caused this reduction is, inter alia, a high awareness of the environmental and health risks among both patients and dentists, access to and demand for other alternatives, the agreement between the state and the county councils to phase out use in children and young people, and the abolition of financial support for amalgam fillings from the national dental insurance service.
According to a survey carried out in 2002 by Statistics Sweden (SCB) for the Dental Material Investigation [SOU 2003:53] 64% of the dentists questioned say that they do not use amalgam, while 36% do. Asked whether they consider that there are currently satisfactory alternatives to amalgam 61% answered "yes" and 33% "No".
According to the National Board of Health and Welfare 2002 follow-up of the dental care of children and young people, the use of amalgam has decreased to about 0.1% of the total number of fillings (based on statistics from eight out of the total of 25 responsible authorities. Since 2003 the Board has tightened up its written advice that alternatives to amalgam must always be the first choice. Nevertheless if amalgam is considered the tooth's future importance for the biting function should be tested, since removal of the tooth can in certain cases be a better alternative than repairing it with amalgam. [Socialstyrelsen, 2002] The last follow-up survey for 2003 is based on data from 21 of 25 responsible authorities and shows that use has halved since 2002. Amalgam's share of fillings is stated to be only 0.05% of the total number of fillings in children and young people. A majority of the responsible authorities state that amalgam is no longer used at all in the case of children and young people [Socialstyrelsen, 2002].
The National Board of Health and Welfare has also followed up the use of amalgam in adult dental care within the Public Dental Service by means of a questionnaire sent to all the Service's County Dental Directors. The answers showed that the share of amalgam fillings was just under 3% of the total (2002) and it can no longer be regarded as the first choice as filling material [Socialstyrelsen, 2003]. The same year the Research Group for Community and Information Studies (FSI) carried out a questionnaire investigation for the Ministry of Health and Social Affairs and the Dental Material Investigation, which shows that around 18% of the patients questioned believe they had got amalgam fillings when they had had teeth repaired during the last two years [SOU 2003:53].
The results from these two investigations differ substantially. The time available for the present investigation has not permitted any clarification of which result is closer to the truth. The National Board of Health and Welfare follow-up of the use of amalgam within the Public Dental Service's adult dental care in 2003 [Socialstyrelsen, 2004] has however shown a further reduction of the share of amalgam fillings from just below 3% to 1.8% (data from 21 of 25 responsible authorities). According to the National Social Insurance Board (RFV) previous comparisons showed that the use of amalgam is similar in the Public Dental Service and in private dental care (Håkansson, personal communication). It therefore seems improbable that the use of amalgam in private dental care is currently significantly higher than in the Public Dental Service--enough for the total use to amount to 18%, as suggested by patients. From a rough estimate of the number of amalgam fillings calculated from the quantities of mercury sold for amalgam according to the Dental Trade Federation (about 100 kg) it appears that the figure of around 2% of the total number of fillings is too small and it should be around 5%[22].
Treatment of patients with special needs
Amalgam continues to be used in the treatment of children and adults who are severely ill or suffering from grave physical and mental development disorders, the mentally ill, habitual criminals and people who are fearful of dentistry (Palmö, personal communication). These patients can for various reasons be hard to treat if they do not cooperate with dentistry staff to the extent necessary for dental treatment. In many cases this is therefore carried out under general anesthesia.
There are patients who for medical reasons cannot be anesthetized, e.g. people who are seriously ill or have a high risk of complications [Tandlåkarförbundet, 2004a]. Amalgam is used, exceptionally, for filling teeth if the patient requires protracted or extensive treatment and the dentist judges that treatment with amalgam will be quicker and less onerous for the patient than using alternative filling materials. In the case of very sick patients treatment with amalgam sometimes takes place in hospital wards and at the patient's home (Palmö, personal communication).
In the data submitted to KemI, treatment under general anesthesia has been highlighted by a number of the respondents as an area where amalgam will continue to be needed because of difficulties in making durable composite fillings under these treatment conditions. The reason given by the majority of them is that it is difficult to maintain adequate dryness when working under general anesthesia, as is necessary when repairing with composites. Another reason given is that it takes longer to carry out repairs with fillings materials other than amalgam. There are other respondents however that considers these problems can be handled, and that amalgam can be replaced by alternatives in every case.
Dental care under general anesthesia is performed principally by the hospital dental service but it also takes place at a few private clinics. The patients who need to be anesthetized often need extensive treatment, which must be completed during the maximum of three hours of general anaesthesia. Since general anesthesia can carry health risks, especially for patients who are already ill, attempts are made to minimize the number of episodes of general anesthesia and also their duration. According to the Swedish association of Hospital Dentists the number of people who fear dentistry has increased in recent years and a high proportion of them are refugees and middle-aged women who need extensive intervention (Palmö, personal communication). Treatment by psychologists and psychotherapists is used in some cases to reduce the fear. At clinics that specialize in this, it is estimated that around a third of the patients are helped so that they can undergo treatment while awake (Friedner, persona communication). Tranquilizers are also used in some cases.
In the case treatments under general anesthesia the patient is given oxygen and anesthetic through tubes (intubation), as far as possible through the nose. There are some patients fro whom this is difficult and intubation has to take place through the mouth, which means the working space for the dentist is more limited. This is the case, for example, with children and with adults where it is cramped and therefore there is increased risk of bleeding (Ekman and Palmö, personal communication). Sometimes there are other medical reasons for oral intubation. Irrespective of the intubation technique the throat must be blocked with gauze bandage, i.e. throat packing, to prevent material getting into the throat.
General anesthesia, in itself, causes the patient to have a reduced saliva secretion, corresponding to a sleep state. In addition to that, further measures are required to produce dryness in the mouth, which is conditional for making durable composite fillings. One alternative is to give medicine that prevent saliva production under anaesthesia and adrenalin-containing local anesthetics to reduce the risk of bleeding from the gums when the cavity to be repaired lies deep under the edge of the gum (deep under the gingival margin). Other alternatives to achieve dryness are suction, cotton rolls, rubber dams and astringents (medicines that have a contracting effect on the blood vessels).
There are clinics that never use amalgam. They mainly treat patients with dental fear, often with a very great need for dental treatment, under general anesthesia. They mainly use composite materials and the work takes about the same time as if the treatment had been carried out with amalgam (Friedner, personal communication). Plastic-reinforced glass ionomers are also used on surfaces that are not exposed to great stress, e.g. at the edges of gums. For patients who have difficulties in keeping their teeth clean it can be a good alternative for reducing the risk of secondary caries since glass ionomers release fluoride. Pure glass-ionomer cements are, however, not a good alternative in the case of treatments under general anesthesia since they last for a maximum of two to three years, after which the operation must be repeated (Olsson, personal communication). Bridges and crowns must sometimes be made, irrespective of access to amalgam, which means extra episodes under anesthetic for the patient.
What differentiates amalgam from other dental materials used in the direct technique is that it solidifies by itself within a few days and does not need to be hardened. When using amalgam the dentist can immediately start work on the next tooth while composites, for example, need to be hardened with the lamp after each layer is applied. There are modern curing lamps for hardening composite filings which, depending on the material and the thickness, harden a layer in 3 to 20 seconds. With only three seconds of hardening time there is however a risk that the filling is not hardened sufficiently if the lamp is not aimed optimally. This can lead to impairment of the mechanical properties of the filling [Umeå universitet, 2004].
According to the National Board of Health and Welfare (Ekman, personal communication) a well-made amalgam filling does not need to be polished but if it does it should be possible to do it without anesthetizing anesthetizing the patient again. Composite fillings can be polished directly after hardening but it is recommended that it should not be done for 24 hours [Kunskapscentrum för dentala material, 2004].
6.1.4 What would be the impacts of a ban?
Impacts on routine treatment
For normal dental care it is the judgment of KemI and the National Board of Health and Welfare that a ban on amalgam will not lead to any adverse effects on treatment. The analysis has shown that there are other filling materials on the market, which all in all replace the need for amalgam, and these are already used for 95-98% of all fillings.
Treatment of patients which special needs
The analysis has shown that there are possibilities for producing durable composite fillings under anesthetic. This is already practiced in certain clinics. A ban could however mean difficulties in treating sick patients if they take medicines that should not be combined with salivation-inhibiting drugs. Opinions about the extent of difficulties vary. According to the Specialist Clinic for Anaesthesia using suction, cotton-rolls or rubber dams should be sufficient to maintain dryness (Friedner, personal communication). According to the Swedish Dental Association and the Association of Hospital Dentists these mechanical methods are not sufficient in some cases. A ban on the use of amalgam would therefore mean that in the case of these patients teeth would need to be extracted instead of repaired, which is regarded as unethical. This applies for example in situations where repairs need to be made on teeth far back in the mouth, the cavities are located below the edge of the gum, and drainage cannot be achieved because of severe bleeding from an inflamed gum [Tandlåkarföbundet, 2004b]. Such situations can also arise when patients are not treated under general anesthesia. The Coordination Committee for the Swedish Disability Federation (HSO) considers that no exemption is needed for use in hospital dentistry since there are satisfactory replacement materials and there is no reason why these should not be used on their members [HSO, 2004].
For medical reasons some patients are intubated via the mouth instead of the nose. This means that the working space for the dentist is more limited, which makes the work more difficult. The Swedish Dental Association and the Association of Hospital Dentists maintain that it is necessary to use amalgam in these situations, while the Specialist Clinic for Anesthesia considers that the problems with oxygen tubes and the reduced space occur irrespective of whether amalgam or another filling material is used. In the case of children who are treated under general anesthesia and are intubated via the mouth filling materials other than amalgam are used to a large extent despite the limited space. But since the life of primary teeth is relatively short there is not the same requirement for the fillings to last as long as those in permanent teeth in adults (Ekman, personal communications).
According to the Association of Hospital Dentists the patients who need to be anesthetized, often need extensive treatment that must be completed during the maximum of three hours of general anesthesia differ between those who maintain that amalgam is absolutely necessary when many fillings have to be done and those who maintain that using alternative materials does not have to mean any significant needs, and impacts on the patient's health below.)
Impacts on health and the environment
Patient's health
All filling materials can give rise to hypersensitivity in susceptible persons. The Dental Material Investigation, [SOU 2003:53] observes that information about side effects from dental materials is inadequate and that their frequency is hard to establish, in part because of a lack of diagnostic methods. But since there are now so many materials to choose from the dentist can probably find the material that does not cause problems for the patient.Amalgam corrodes and can consequently expand and split the teeth. This has been studied and confirmed using electron microscopy and photography. The risks of such impacts on the patients and the subsequent need for extensive treatment would decrease if a ban were introduced. The fact that a smaller quantity of healthy tooth-tissue needs to be removed when making repairs with materials other than amalgam is also beneficial for the patient.
The Association of Hospital Dentists points out, however, the risk of an increased problem with caries for patients with poor or non-existent oral hygiene since , for example, a composite filling can give a gap between tooth and filling and cannot be made as smooth as an amalgam filling (Palmö, personal communication) which means that the risk of caries in connection with the filling is greater. According to the International Academy of Oral Medicine (IAOMT), however, there is no problem with gaps in the case of a correctly performed composite filling. While there is always a gap between an amalgam filling and the tooth the environment there does not permit the growth of bacteria [IAOMT, 2004].
For patients treated under anesthetic there are health risks, especially for those who are already ill, so that attempts are always made to minimize the use of general anesthesia and also its duration. The Swedish Dental Association and the Association of Hospital Dentists (Palmö, personal communication) fear that a ban on amalgam would mean an increase in the number of episodes of general anesthesia per patient because for reasons of time it would not be possible to carry out all the repairs at one time. This is rejected, however, by the Specialist Clinic for Anaesthesia (Friedner, personal communication), whose patients are also reported to have a very great need for dental treatment, comparable with hospital dental-service patients. The Clinic maintains that a ban on amalgam would not mean an increase in the time required for treatment and thus in the number of episodes of general anesthesia in the normal case (see the analysis for patients with special needs). For certain patients with an extremely great need for treatment, however, a ban may mean some extra use of general anesthesia. These patients may, however, also be in need of other forms of dental treatment, e.g. crown therapy, which also gives raise to extra episodes of general anesthesia irrespective of access to amalgam.
For seriously ill patients who are treated within the hospital dental service and who for medical reasons cannot e anesthetized, the effects of a ban could be that the treatment takes longer and is more stressful, according to the Association of Hospital Dentists (Palmö, personal communication).
Health of dental personnel
In the mid-1990s there was an increase in the number of cases of skin damage and allergies among dental-care staff as a result of an increased use of various acrylic resin based composites and bonding materials used to fix composite fillings to teeth. Dental staff has now to a large extent learned to handle these products and the manufacturers have modified the packaging to reduce the risks. Data from the Swedish Information System for Occupational Accidents and Work-Related Diseases (ISA), show that skin injuries related to unpolymerized acrylic-resin based materials used in dental treatment have decreased from thirty-eight cases in the peak year of 1997 to five cases in 2000. In 2001 eleven cases were reported [Arbetsmiljöverket, 2001]. During the period 1997-99 the Work Environment Authority carried out an extensive inspection and information program covering the Authority carried out an extensive inspection and information program covering the whole country. KemI inspected manufacturers and importers of dental filling materials because, inter alia, dentists had reported that it was difficult to get information about what alternative filling materials contain. One result from the inspections was that packaging, labeling and product information sheets were improved [Kemikalieinspektionen, 1997a].
Dentists and dental nurses would reduce their exposure to amalgam if a ban were introduced. A ban would not appreciably increase the risks of allergies from acrylic-resin based materials since these are already used to a great extent.
A ban on amalgam would also reduce the exposure of teachers and students in dental schools, where teaching about using amalgam is carried out using dummies.
Environmental impacts
A ban on the use of amalgam would mean that the new supply of mercury for amalgam fillings would cease. In 2003 the dental supplies industry estimated sales of mercury for amalgam in Sweden at about 100 kg.
The presence of mercury in sewage sludge makes it more difficult to use sludge as an agricultural fertilizer and thus to close the cycle of nutrients between town and country. Investigations of metal flows in Stockholm have shown that amalgam is the largest single source of the mercury in the sludge. Almost half of this is mercury released from amalgam fillings, while they are in the mouth, and another large part comes from incomplete separation of amalgam from dental surgeries, including mercury in waste pipe sediment [Sörme and Lagerkvist, 2002; Sörme et al, 2003].
According to checks carried out by the Stockholm Water Company, there are deficiencies in the effectiveness of amalgam traps. In some cases they are installed incorrectly, blockages occur and they are often maintained inadequately. In a study carried out in 1998 one in four traps checked did not operate correctly, which could lead to increased discharges [Stockholm Vatten AB, 2000]. Estimates for Stockholm have shown that even if the traps' cleaning capacity were theoretically 95%-99% then the amount of mercury discharged would correspond to 2-11% of the total quantity of pollution [Sörme, 2003].
A ban on the use of amalgam would lead to the release of mercury from dental clinics falling and in the long term ceasing. Despite a ban, however amalgam will continue to be handled in dental surgeries for a number of years to come as old amalgam fillings are removed. Among the adult population 74% have amalgam in their mouths [SOU 2003:53]. The sewage treatment plants will also continue to be polluted with mercury from households since these filings will continue to leak mercury during their lives. In the long term, however, a ban will reduce this pollution as well.
Crematoria are one of the largest sources of air emissions of mercury in Sweden. The Swedish EPA calculated emissions from crematoria as 123 kg of mercury in 2001. In Sweden 70% of the dead are cremated and just over half of cremations take place with flu-gas scrubbing [Naturvårdsverket, 2004a]. In these cases a mercury-containing scrubbing product is produced which must be dealt with for final disposal.
In the use of amalgam were banned then in the long-term mercury emissions from crematoria would in principle cease. If more people underwent amalgam removal, mercury emissions from crematoria would fall more quickly and so would household discharges of mercury to sewage treatment plants and the risk of mercury release from dentist's surgery.
To summarize, a ban on amalgam would mean that one of the largest remaining areas of use of mercury would cease. The use of amalgam leads to atmospheric emissions of mercury, discharges to sewage treatment plants and clean-up products that must be processed fro final disposal. A ban is necessary to ensure that, in the long term, these releases of mercury into the environment cease.
Economic impacts
Dental clinics
According to the Swedish Federation of County Councils (FCC), the decisive factors for the costs of dental clinics and their pricing of dental treatments are premises rental, salaries, treatment time, etc. [Landstingsförbundet, 2004]. According to information from the Specialist Clinic for Anaesthesia (Friedner, personal communication), and the Biomedical Dental Centre, material costs for fillings contribute about 5-10% of the treatment costs, irrespective of the type of material (Olsson, personal communication). According to the report from the FCC, salary costs amount to almost three-quarters of the total costs of the National Dental Service [Landstingsförbundet, 2004].
The National Dental Service in Våsternorrland points out that the purchase costs for, inter alia, composite materials are higher than for amalgam and that an increased demand for alternatives has not meant a price reduction from the suppliers [Folktandvården i Våsternorrland, 2004].
For dental clinics that work with treatments under general anesthesia and do not already have an efficient lamp for light-curing of composite fillings, a ban on amalgam implies a capital cost for new equipment. KemI judges that costs for new equipment do not imply any adverse effects when the prices of new curing lamps lie in the range SEK 5,000 - 15,000 (544-1,633 EURO).
Patient costs
Since 1 January 1999 patient fees are no longer regulated by the Government, which means that prices can vary greatly between dentist. It is therefore difficult to obtain comparable information. Free pricing can be of greater importance for the patient's finances than the choice of filling material. Each county council determines the National Dental Service prices and they therefore vary between counties. Private care-givers determine their own prices.
The patient's reimbursement for dental care has not been adjusted since prices were decontrolled. Each change in the caregiver's charges has therefore impacted directly on patient charges. An exception is high-cost protection for patients aged 65 or over, which came into force on 1 July 2002. Up to 1 January 1999 the patient met the costs of all dental care up to SEK 1,300 (142 EURO). For costs above this, the dental insurance paid out a dental-care grant according to a fixed percentage depending on the amount.
Since 1999 the patient gets no reimbursement from the dental insurance for amalgam fillings. The result is that the costs to the patient for an amalgam filling are as much for a repair with composite, or even more. According to Uppsala County Council's 2004 price-list for general dental care the patient's fee for single-surface fillings with materials other than amalgam is SEK 484 (53 EURO) [Landstinget Uppsala lån, 2004]. According to the Public Dental Service 2004 prices for general dental care the price for single-surface fillings with amalgam varied between SEK 313 (53 EURO) and SEK 610 (66 EURO). The corresponding price-range for single-surface fillings with other materials was SEK 258 - 625 (39 - 68 EURO). From this, the price differences between materials do not seem to be so large: the price differences between county councils and private dental clinics are of greater importance.
Where larger repairs and crowns are concerned the patient's fee can, for example, vary between SEK 985 (107 EURO) and SEK 1,200 (131 EURO) for amalgam crowns. The corresponding fee for a composite crown can be SEK 950 - 1,462 (103 - 159 EURO) [Uppsala County Council, 2004]. The price depends partly on the difficulty but also on which surgery or region the treatment is carried out in. The Public Dental Service in Våsternorrland points out that treatment costs with, for example, composite materials in higher than for amalgam and the increased demand for alternatives has not meant any price-reduction from the suppliers. For the patient it is, according to these dentists, still cheaper to have an amalgam crown than, for example, a gold or porcelain crown [Folktandvården i Våsternorrland, 2004]. The National Social Insurance Board (RFV) states that the price of a gold or porcelain crown varies between about SEK 3,300 (359 EURO) and SEK 4,500 (490 EURO). On top of this is the cost of materials, which for gold is about SEK 400 (44 EURO) per crown. Where a pillar must be manufactured there is a further cost of about SEK 1,500 (163 EURO) (Håkansson, personal communication).
For patients with financial difficulties the impacts of a ban on amalgam can become apparent if the only alternative to a new gold or porcelain crown is to extract the tooth. In the National Board of Health and Welfare follow-up of the use of amalgam in the Public Dental Service in 2003, the dental-care trustees reported that it was often older patients who affected--people who had extensive amalgam repairs and regarded themselves as unable to afford crown therapy [Landstingsförbundet, 2004].
According to the RFV analysis of the price trend for dental care over the period 2000-2002, patients' costs have increased since the introduction of free pricing, and prices continue to rise [Landstingsförbundet, 2003]. According to the Board, the county councils raised patients' fees by 16-27% on average over the period May 2000 to December 2002, depending on the particular treatment. According to the Federation of County Councils, prices for public dental care over the country as a whole have increased by 59.8%. Amalgam fillings are among the items for which the price increased has been highest over the period 1998 to 2004. Between 2003 and 2004 the price of one-surface amalgam fillings rose by 12.1%. The corresponding increase for equivalent composite fillings was 2.8% [Landstingsförbundet, 2004].
According to the County Councils the price increase has been necessary to improve the working environment of dental personnel within the Public Dental Service. A further contributing factor is dentists' salaries, which have increased substantially over this period because of competition from abroad [Landstingsförbundet, 2004].
The board's investigation shows there are large differences between county councils. For private dental care patient fees have on average increased by 6-27% over the period October-December 2002, depending on the treatment. Patient fees for private care also differ between counties [Riksförsåkringsverket, 2003].
According to the RFV analysis, 60% of the people questioned say that they would not change dentists even if there were a cheaper dentist within a reasonable distance. According to the investigation it is not primarily the price that is critical for whether the patient continues to see the same dentist. More important considerations are confidence in the dentist and the service provided [Riksförsåkringsverket, 2003].
The choice of standards and materials affects the price. The patient can choose between the different filling-materials. The person providing the care has a great influence on the choice of material since the patient normally finds it hard to judge the need for and extent of treatment himself. According to an analysis by RFV about 78% of the respondents said that they let the dentist or dental hygienist do everything they suggested. Since oral health and the choice of treatment is an individual matter it was not possible in the study to give an opinion about the relationship between price and standard and about whether the price variations which occurred were reasonable or not [Riksförsåkringsverket, 2002].
KemI's judgment is that patient costs will not be affected adversely by a ban on amalgam. Decontrol of pricing in dentistry has already brought with it effects on patient costs and for the great majority of patients a ban will not entail any further impacts. For patients with financial difficulties the impacts can be significant if amalgam is not available and the choice is therefore between a new gold or porcelain crown and extraction of the tooth. It ought, however to be possible to limit such adverse effects within the framework of the dental insurance scheme and they should not prevent a ban on amalgam.
Swedish dental trade
According to information from Nordiska Dental AB, which manufactures and markets dental filling materials, an exemption for amalgam from the general ban on mercury is a prerequisite for the continued development of new products and their marketing in those markets where the company currently sells amalgam [Nordiska Dental, 2004].
The 2-5% of fillings that are currently provided using amalgam can almost entirely be replaced by other materials. KemI's judgment is that a ban on amalgam in Sweden would not imply any extensive adverse financial impacts on companies affected.
Research and Development
The analysis has shown that the commonest dental-filling materials today are composites and that these and other materials have to a large extent replaced the use of amalgam. Research and development are continuing to find even better materials. A ban on amalgam in Sweden would probably have no great effect on this development since the use of amalgam is already relatively marginal and the market for other materials would therefore not be affected very greatly.
Training of dentists
Nowadays, students in the country's dental schools are first taught about other materials for oral reconstruction. Teaching about amalgam forms only a small part of the training of dental students and is mostly theoretical. A ban on the use of amalgam would according to the dental schools mean that training would be affected adversely. Swedish dental students would not be able to learn practically how to carry out amalgam fillings, which could affect their opportunities to seek work abroad and to have their qualifications approved in other countries. Each year about 10% of students make their way abroad after completing training in Sweden.
For students who train as dentists the cost of further training so that they can also carry out amalgam fillings could be an extra expense if the want to work abroad.
6.1.5 Conclusion
Although the use of amalgam has decreased considerably during the last few years, just over 100 kg of mercury is still used in dentistry each year according to the Swedish Dental Trade Association. This is mercury that ends up in the natural environment in one way or another. Using amalgam requires emission control measures to prevent releases of mercury. These measures produce hazardous waste that has to be finally disposed of. Even though emissions control is used, mercury will contaminate the sewage sludge and emit to the air from crematoria.
There are therefore strong reasons from an environmental point of view to prohibit the use of amalgam. From the health point of view there is every reason to apply a precautionary approach. There are other tooth-filling materials available on the market. These meet existing needs and could replace the whole remaining use of amalgam within ordinary dental care for children and adults.
There are different views, however, as to whether other filling materials on the market can replace amalgam in all the treatment situations that occur in hospital dentistry. The judgment of the National Board of Health and Welfare is that there is no justification for any exemptions for amalgam in the case of children and young people. But there may be a few situations where for special medical reasons the use of amalgam on adult patients in hospitals is the only alternative to extracting the tooth, which in some cases may be regarded as unethical. It is unclear how large this use is today but it is estimated that it is at most 20% of the use of amalgam, corresponding to about 20 kg of mercury per annum. A three-year exemption from the general ban is judged to be a reasonable time.
A special obligation for the dentist performing the treatment to keep records is necessary in order to get a better knowledge base concerning the need for and extent of amalgam use before future follow-ups of its use in hospital dentistry. It cannot be regarded as reasonable to use amalgam on hospital wards or in the course of home visits where there is no adequate equipment to protect health and the environment since there are other filling materials which can be used in acute situations.
In KemI's judgment costs for patients will not be affected adversely by a ban on amalgam. The decontrol of pricing within dentistry has already brought about effects on patient costs and for the great majority of patients a ban will not mean any further impacts. For patients with financial difficulties the impacts may be significant if the choice is between making a new gold or porcelain crown and extracting the tooth. It ought however to be possible to limit such adverse effects within the framework of the dental insurance scheme and they should not prevent a ban on amalgam.
The 2.5% of fillings that are currently carried out using amalgam can be replaced almost totally by other materials. KemI judges that a ban on amalgam in Sweden should not mean any extensive adverse financial impacts for the companies concerned.
Because the use of amalgam is to cease in Sweden it cannot be regarded as reasonable to grant a general exemption for the use of amalgam in the training of dentists. Sweden is working for corresponding restrictions on amalgam within the EU and internationally. If there is found to be exceptional problems for the about 10% of students who find their way abroad the dental schools will be able to apply for a dispensation to provide further training.
6.1.6 Proposal
Dental amalgam should be covered by a general national ban.
KemI and the National Board of Health and Welfare consider, however, that dental amalgam should be exempted from the general ban until 31 December 2008 for use within hospital dentistry on adult patients where for special medical reasons other methods of treatment cannot be used with a sufficiently good result. Treatment with amalgam should only take place in dental clinics.
KemI and the National Board of health and Welfare further consider that a special obligation should be introduced for the dentist performing the treatment to keep records. The reasons why other relevant methods of treatment could not be used should be stated in every case. A follow-up of the use of dental amalgam should be carried out one year after the ban comes into force.
6.2 Analytical chemicals and reagents
KemI estimates that the quantities of mercury compounds used in the form of analytical chemicals in Sweden in 2003 correspond to about 53 kg of mercury (see Annex 3).
Most of the mercury compounds used as analytical chemicals are classified as very toxic (see Para 3.4) and are therefore extremely dangerous products according to KIFS 1998:8, Chapter 8. Companies that distribute products that are extremely dangerous must have authorization from the county administrative board. The chemicals may only be transferred to a person who will use them professionally[23].
The impact assessment for analytical chemicals and reagents is based principally on about 40 questionnaire responses from accredited laboratories, industry organizations, individual companies in different industries, and suppliers of analytical chemicals, public authorities, hospitals and universities. Two consultation meetings have also been held. The industries represented are dyestuff and pigments, sewage treatment plants, foodstuffs, medicinal products, medical diagnostics, the steel and non-ferrous metal industries, forest products and specialist chemicals. The focus in the impact assessment in on the industries whose responses indicated problems. In Sweden there are about 230 laboratories accredited for chemical analysis and about 110 for medical analysis according to SWEDAC, the Swedish Board for Accreditation and Conformity ASsessment (SWEDAC's web site). The accredited are in some cases commercial laboratories which sell analytical services and in some cases commercial laboratories which sell analytical services and in other part of a company which manufactures and/or sells products of some type. The commercial analytical laboratories may be part of concerns with operations in several locations throughout the country, each of which is accredited. In addition there are believed to be a number of laboratories that are not accredited. For this reason, among others, it has been difficult to establish how many potential areas use and users of mercury and mercury compounds for analysis there are in Sweden.
6.2.1 Impacts on the environment and health
The use of mercury compounds as analytical chemicals represents a relatively large part of the current use of mercury and can cause substantial adverse impacts on the environment and health. When analyses are carried out in open systems there is a risk that the people who handle the chemicals are exposed to mercury. A certain amount of mercury risks ending up in the sewer system, even if there are internal water-treatment systems. The use of mercury compounds as analytical chemicals can thus make it difficult to use sewage sludge as an agricultural fertilizer.
In the case of analysis in both open and closed systems (e.g. vials) waste of various kinds arises--the sample analyzed, the reagent solution used and the reference solution to which final disposal. A ban on the use of mercury as an analytical chemical would reduce direct occupational exposure and direct and indirect discharges to the natural environment as well as decreasing the quantities of mercury-containing waste.
6.2.2 Mercury analysis
Mercury analysis is needed in many situations. Within the environmental field there are methods for the determination of mercury in the air, water, soil, sewage sludge and waste. Mercury levels are also measured in blood, hair and saliva. In many branches of industry there is a need to carry out determinations of mercury levels in, for example, foodstuffs, steel and medicinal products.
Are there alternatives to mercury?
There are no alternatives to using mercury or mercury compounds when analyzing for mercury. To be able to analyze for mercury and mercury compounds access is needed to reference solutions with known concentrations of mercury compounds.
What would be the impacts of a ban?
A ban would mean that measuring and reporting mercury levels would be impossible. This would affect both national and international monitoring programs could therefore not be carried out and reports to, for example, international conventions could no longer be compiled. Furthermore, food and medicinal-product companies could no longer ensure that their products meet the limits laid down.
Conclusion
A general exemption for analysis for mercury and mercury compounds is required. It is not possible to time-limit the exemption because mercury will always need to be monitored as regards its occurrence and residue levels. A ban would mean that it would be impossible to carry out the measurement and reporting of mercury levels.
Proposal
KemI considers that the use of mercury in analysis for mercury should be exempted for the general ban with no time limit.
6.2.3 Chemical Oxygen Demand (COD)
Chemical Oxygen Demand (COD) is a measure of the theoretical oxygen consumption of a water sample. The organic matter in the sample is oxidized chemically with potassium dichromate, CODCr9 or potassium permanganate, CODMn9 to calculate how much oxygen is needed to break down the organic matter. When analyzing COD using potassium dichromate as the oxidizing agent, mercuric sulphate is added to precipitate chloride ions, which otherwise interfere with the analysis and make the value measured too high.
According to the standard method (SS 02 81 42) COD is analyzed using a wet-chemical method and 400 mg of mercuric sulphate is added to precipitate chloride ions. There are also commercial vials that are used in a standard ISO method [ISO 15705]. The analysis is carried out in a closed tube containing a very small quantity of mercuric sulphate(about 40 mg). Vials without mercuric sulphate can also be purchased. All the questionnaires returned stated that the vial method for COD is used.
The quantities of mercury compounds in analytical chemicals are estimated by KemI to have been equivalent to about 53 kg of mercury in 2003, see Annex 3. Use for COD analyses in vials represents about 14 kg or just over 25% COD analyses are therefore the single largest application for mercury compounds within chemical analysis, which it was possible to identify in the investigation.
Background
It has been discussed whether COD can be replaced by another parameter, total organic carbon (TOC). Since the 1970s the Swedish Environmental Protection Agency (SEPA) has been working to reduce the use of COD analyses in Sweden and measure TOC instead [Naturvårdsverket, 2004b]. The last time the question was investigated was in 1999 in collaboration between KemI and SEPA. Then, too, it was recorded that COD was the largest single application of mercury in chemical analysis. Work on a voluntary reduction in the use of mercury-containing analytical chemicals and reagents was regarded as having gone too slowly and a ban was seen as the only practicable method for bringing about a reduction (see Para 2.3).
Many industries measure COD in their process water and in water discharged from their plants, e.g. pulp and paper mills, effluent treatment plants, the chemical process industry and the food industry. Activities that require authorization under the Swedish Environmental Code have conditions imposed as to what they may discharge into the receiving body of water. The conditions can be set as COD, BOD7 (biochemical oxygen consumption, 7 days) or both. A few of the enterprises concerned have a parameter TOC in their discharge conditions [Naturvårdsverket, 2004b].
Are there alternatives to mercury?
Three alternative to COD using mercuric sulphate emerged from the investigation--COD without the addition of mercuric sulphate, TOC and BOD. It is possible to measure COD without adding mercuric sulphate if the sample does not contain too many chloride ions. There are commercially available COD vials without mercuric sulphate which, according to the manufacturer, can be used in the range 100-1000 mg/l of COD if the chloride content does not exceed half the COD value, Benito and Morrison (2203) have developed a mercury-free COD method using silver nitrate instead of mercuric sulphate. the method has mainly been tested on municipal effluent. Since the method is new and relatively untested it is hard to judge whether it constitutes a real alternative to COD using mercuric sulphate.
COD can also be determined using potassium permanganate as the oxidizing agent: in this case mercuric sulphate is not added. This analysis is often designated CODMn or permanganate number and is suitable for measurements on water with a low content of organic matter, such as lake water, since the detection limit is lower than for COD with potassium dichromate [Naturvårdsverket, 2004b].
TOC gives a measure of the quantity of organically bound carbon in the sample, both dissolved and in form of particles. The analysis is sensitive to particles in the sample and the sample can then be filtered before analysis. If filtration is carried out before analysis of TOC only the fraction of the organic matter dissolved in the water is measured. This analysis is often called Dissolved Organic Carbon (DOC) [Naturvårdsverket, 2004b].
Biochemical oxygen demand (BOD) is an analytical method that measures the quantity of oxygen consumed biochemically under controlled conditions in a specified time. In the case of 20oC and 7 days the method is designated BOD7. BOD7 gives a measure of the fraction of easily degradable organic matter. The drawback to BOD7 is that it takes a comparatively long time, 7 days, before the results are obtained [Naturvårdsverket, 2004b].
It is possible to make correlations between COD and TOC by measuring the parameters in parallel over a period. Many investigations have been made of the correlation between COD and TOC [Naturvårdsverket, 2004b]. These show that a good correlation is often found. It is then possible to establish a factor for converting TOC values to COD when COD must be reported. There are also cases that show a very poor correlation so that no correlation factor can be established. There are examples of enterprises which have authorization conditions the idea of which is to investigate the correlation between COD and TOC in order later to switch to TOC after consultation with the body issuing the authorization [Naturvårdsverket, 2004b].
There are about 60 pulp and paper mills in Sweden that are members of the industry organization Skogsindustrierna. About a quarter of the mills are positive about using TOC instead of COD and some of them are considering going over to TOC. Some have tested the mercury-free COD method but for the majority it does not work because of interference from chloride ions. The correlation between COD and TOC is in many cases not satisfactory and must be established for each sub-flow in the process. Around two-thirds of the pulp and paper mills consider that they need to retain COD analysis using mercury (Haglind, personal communication).
The Waste Water Directive [91/271/EEC][24] states that COD must be measured but not that the method using mercuric sulphate must be used. According tot he Directive it is possible to replace the stated analytical methods with alternatives if it can be shown that they are as good. Germany has already got a national exception from measuring COD but has still not introduced TOC into its regulations. It is however possible to calculate the COD value from the TOC value and in most cases where a conversion factor cannot be established the enterprise can have its conditions reconsidered by a body issuing the authorization [Naturvårdsverket, 2004b].
Measurements of COD in urban waste water are made to control the treatment processes, to monitor discharges and to characterize the waste water. Some sewage treatment plants have begun to move away from COD. From 1 April 2004 Stockholm Water Company will start to measure TOC instead of COD (Lindblom, personal communications). Other sewage treatment plants are investigating the possibility of moving away from COD analysis, among them Malmö and Örebro (Lind, personal communication). Characterization of waste water is carried out in order to see the effect of industrial waste water in the urban waste water. In this characterization it can be difficult to replace COD; it is possible that TOC, for example, can be used for this as well but further investigations would be needed to demonstrate the possibility (Lind, personal communication).
A small number of questionnaires were returned by companies engaged in the production of dyes and pigments and of specialist chemicals. These currently use COD for measurements on the process streams and for discharge monitoring. The companies have carried out or have plans under way to replace COD with TOC and their returned questionnaires will show that in certain cases there are possibilities of switching to TOC. It is hard to draw any general conclusions from such limited data but it appears possible to switch to TOC after investigating the correlation between COD and TOC.
In the food industry it is planned to investigate alternatives to COD during 2004. The amount of information in the questionnaire responses is small, however, so it is hard to draw any general conclusions about the possibilities for moving away from COD.
To summarize, it appears that extensive work is going on among the companies surveyed which is aimed at replacing COD with alternatives, principally TOC. A switch from COD to TOC requires a certain amount of investigation of the correlation between the two parameters and, if possible, the establishment of a conversion factor if COD is to be calculated from a TOC value.
What would be the impacts of a ban?
Commercial impacts
The analysis of the commercial impacts of a ban deals with five different types of company, i.e. suppliers of analytical chemicals, suppliers of alternative analytical instruments (TOC), users of analytical chemicals in their own laboratories, users who send samples to outside laboratories, and those outside laboratories themselves.
An obvious impact of a ban would be that sales of mercuric sulphate and commercial vials containing it would fall while sales of TOC instruments would rise. The suppliers of analytical chemicals have not indicated that the reduced sales would lead to any significant financial loss. As far as KemI can judge, the (Swedish) market for chemicals for COD analysis contributes only a minor share of their revenues. On the other hand it is KemI's judgment that the positive impacts on manufacturers of TOC instruments would also be marginal, since the Swedish market will continue to be small from a European and international perspective.
For smaller companies, which already send their samples to outside laboratories, a national ban implies no change, since the cost of an outside TOC analysis is comparable with COD[25]. The analysis of commercial impacts can therefore be restricted to users with their own laboratories and laboratory companies.
The costs the companies can incur are primarily the capital costs of the TOC instrument itself. There are in addition the costs of switching over, e.g. training/recruiting staff and establishing the correlation with COD. These costs fall largely on the user.
A switch to an alternative methodology means a capital cost for a TOC instrument, for example, of about SEK 400,000 (43,541 EURO). This may be regarded by the laboratory, depending on its size and turnover, as far too high a cost.
In a number of the questionnaire responses it was stated that the capital costs for TOC would be an obstacle to switching from COD. The responses give no clear picture of how many users have already switched to alternative methods. Some have already switched while others express an intention to do so.
According to the questionnaire responses, when the TOC method is in operation it can be a quick, simple and economical method to use in large laboratories that have experience of instruments and which analyze at least 1000 samples per annum. KemI judges that the same applies to larger companies performing their own analyses.
The possibility of purchasing their own equipment for TOC analyses can be more limited for smaller laboratories and companies. SEPA, however, considers that the commercial impacts on individual companies as a result of reduced use of COD analyses using added mercury should be limited. This is because the cost of carrying out COD analyses at an authorized laboratory is about the same as for TOlC analyses [Naturvårdsverket, 2004b].
An important difference between COD analysis using mercuric sulphate and TOC is that no hazardous waste is formed in the case of the TOC analysis. Over and above the cost of purchasing analytical chemicals, dealing with the waste is a significant item in the case of COD analysis [26].
To summarize, it is the judgment of KemI that the cost of switching to TOC instruments will in the long term be compensated for by the lower running costs and elimination of the costs of dealing with hazardous waste.
Impacts on discharge monitoring and process control
For companies which use COD analysis for monitoring the water they discharge and for process control the financial impacts can be adverse in the short term if the capital cost of TOC instruments is regarded as too high in relation to the business's turnover. An alternative, which remains for smaller companies that may be affected by this, is to employ outside laboratories. However, according to the suppliers of mercury-containing COD vials this can mean that the control of, for example, water-treatment processes and manufacturing processes is made more difficult since it takes longer to get the results. This in turn could mean adverse effects on the environment. The companies affected have not, however, quantified these possible effects. SEPA has not identified any such impacts in its survey of COD analysis [Naturvårdsverket, 2004b].
Impacts on national and international reporting of mercury levels
One adverse consequence could be that the national compilation of data on discharges from individual enterprises, industries and regions that are currently obtained using COD analyses is made more difficult. A national ban could also create impacts on ongoing work on comparisons of discharges indifferent countries. Currently COD values are used in such comparisons. It is however possible to calculate the COD value from a TOC value when a correlation factor has been established.
The impacts from a national ban on mercury would be that certain international standards (for more information on standards see Chapter 5: Standard methods) and Swedish rules such as SEPA's regulations concerning the treatment of urban waste water [SNFS 1994:7] would need to be altered or modified. SEPA is currently carrying out a review of SNFS 1994:7 but does not intend to change the requirement for COD analysis at the present time [Naturvårdsverket, 2004b].
Conclusion
The conclusion is that from a technical point of view there are in most cases alternatives to the analysis of COD using mercuric sulphate. A study of the questionnaire responses shows that a switch to alternatives to COD is under way in many enterprises while in others the development has not got as far. KemI notes that for larger laboratories and enterprises responsible for discharging water a switch to TOC can be positive from many aspects. On the other hand switching from COD to other alternatives produces temporary adverse impacts in the form of costs for investment and development work, especially for smaller enterprises.
To ensure that the switch to alternative methods can occur in commercially acceptable ways even for smaller enterprises it is necessary to have a time-limited exception from the general ban. KemI judges that a three-year transitional period from the date when the ordinance and regulation come into force is adequate for replacing COD with an alternative method of analysis.
Proposal
Mercury compounds for COD analysis should be covered by a general national ban.
KemI considers, however, that mercury compounds for COD analysis should be granted a time-limited exemption for a ban and be allowed to be marketed until 31 December 2007 and used until 31 December 2008.
6.2.4 Foodstuff analyses
Mercury analyses are carried out in the foodstuff sector and most of the methods are standardized. There are limits for mercury in, among other things, fish, baby food made from fish products [SLVFS 1993:36], drinking water [SLVFS 2001:30] and chemicals used for purifying drinking water. Mercury analysis is dealt with in Para 6.2.2.
There are also analyses that involve reagents containing mercury compounds. An example is the determination of Pseudomonas aeruginosa where Nessler's reagent is used for confirmation. Nessler's reagent contains potassium tetraiodomercurate corresponding to 0.5-0.7% of elementary mercury. The method is a European standard [EN SS 12789], which is in the process of becoming an ISO standard. The standard is incorporated in the Drinking Water Directive [98/83/EC] that has been embodied in Swedish legislation via the National Food Administration's (NFA) Drinking Water Regulation [SLVFS 2001:30]. The analysis has to be carried out only on drinking water sold in containers, but not on mineral water which is regulated by a different directive. Since the standard has only just come into use it is difficult to know how much use of Nessler's reagent this gives rise to.
Are there alternatives to mercury?
According to the NFA, when the standard for Pseudomonas aeruginosa was produced, Sweden raised the problem of the use of Nessler's reagent but did not receive support for developing any alternative. There is currently no alternative to Nessler's reagent in this case.
What would be the impacts of a ban?
The determination of Pseudomonas aeruginosa could not be carried out and therefore the requirements of the Drinking Water Directive could not be met.
Conclusions
The use of mercury compounds in analytical methods should be eliminated in the long term where that is possible. A time-limited exemption would provide the possibility of developing alternatives to Nessler's reagent. KemI judges that a period of three years from the date on which the ordinance and regulation come into force is a reasonable transitional period.
Proposal
Mercury compounds for foodstuff analysis should be covered by a general national ban.
KemI considers, however, that mercury compounds for foodstuff analysis should be granted a time-limited exemption from the ban and covered by the exemption for other analysis (Para 6.2.8).
6.2.5 Analysis in the medicinal products sector
In the medicinal products sector there are special standardized analytical methods for products, raw materials, etc. In two EC Directives (2001/82/EC and 2001/83/EC) there are requirements that substances used as medicinal products in the European market shall meet the requirements of the European Pharmacopoeia, which means that they must be analyzed by the methods described there. The European Pharmacopoeia is incorporated continuously into Swedish law via statutory orders made by the Medical Products Agency (MPA) concerning the coming into force of Swedish standards for medicinal products.
MPA has counted up how many analytical methods in the European Pharmacopoeia involve the use of mercury compounds as reagents. The total is around thirty. They relate mainly to the determination of the mercury content of various medicinal products and raw materials, but mercury compounds are also used in other types of analysis.
Are there alternatives to mercury?
MPA is working to eliminate analytical methods in the European Pharmacopoeia which involve the use of mercury compounds. Since 1999 a number of methods have been replaced by mercury-free alternatives, mainly titrimetric methods in which mercury acetate is used as a reagent.
What would be the impacts of a ban?
Swedish medicinal-product companies would not be able to use analytical methods in the European Pharmacopoeia and could therefore not satisfy the Medicinal Products Directive.
A positive effect, however, is that a national ban on mercury will mean that Swedish representatives can propose changes to standards in the European Pharmacopoeia with greater force.
Conclusions
Analyses of mercury according to methods in pharmacopoeias will be needed even in the future. It is not possible to time-limit the exemption since mercury is an element which will always need to be monitored as regards its occurrence and residue levels. Therefore mercury analysis should be exempted from the general ban (see Para 6.2.2).
In the long term the use of mercury compounds in other analytical methods should be eliminated where possible. A transitional period is needed to develop alternative methods without mercury. The Medical Products Agency (MPA) judges that it can take up to seven years to develop a new analytical method and introduce it into the European Pharmacopoeia. A period of seven years from the date when the ordinance and regulation come into force would therefore be reasonable.
Proposal
Mercury compounds for analyses in the medicinal products sector should be covered by a general national ban.
KemI considers, however, that mercury compounds for use in analyses in accordance with international standard methods in the medicinal products sector should be granted a time-limited exemption from the ban and be allowed to be marketed until 31 December 2011 and used until 31 December 2012.
6.2.6 Analyses for medical diagnosis
For a certain medical diagnoses analyses are currently required in which mercury and mercury compounds cannot be replaced. Some examples have been included in the survey questionnaires but there may be many more diagnoses that involve mercury or mercury compounds. The analyses described below are not covered by the In Vitro Diagnostic Directive [98/79/EC].
The Porphyria Centre at the Karolinska University Hospital, Huddinge, uses sodium amalgam for enzyme analyses in the investigation of prophyrias. Porphyrias are a group of inherited diseases which arise from a lack of some of the enzymes which participate in the synthesis of haem, which forms part of haemoglobin. The analyses are necessary to make a correct diagnosis. The Porphyria Centre is the only clinic in Sweden that carries out these analyses and the annual consumption of sodium amalgam is about 25 g. Extensive work has been carried out for two years to replace enzyme diagnostics by detecting instead the genetic defect (JAF: Defective gene?) that produces the disease. This has not be successful and the clinic currently sees no alternative to the use of sodium amalgam.
At the same clinic the enzyme ALAD (5-aminolaevulinic acid hydratase) is analyzed in the case of very rare investigations of porphyria caused by a lack of this enzyme and when there is a suspicion of blood poisoning. The analysis uses mercuric chloride--about 30 g per annum. There are no alternative methods of analysis. However, the number of ALAD analyses has decreased because they are no longer carried out routinely in the investigation of porphyria.
The centre for Inherited Metabolic Diseases at the Karolinska University Hospital is currently investigating whether screening for Type I tyrosinaemia should be carried out on all new-born babies along with the PKU test. Tyrosinaemia is a group of rare metabolic diseases in children. The PKU test analyses specific enzymes and hormones to detect certain serious inherited diseases, including phenylketonuria (PKU). Expansion of the analyses in the PKU test would mean that an analysis using mercuric chloride would be used and consume about 60 g of mercuric chloride per annum for all the new-born babies in Sweden.
Are there alternatives to mercury?
For the diagnoses described above there are currently no alternatives. A certain amount of development work has already been carried out and in KemI's judgment more time is needed to develop alternative methods without mercury compounds.
What would be the impacts of a ban?
Patients with some diagnoses would not be properly investigated because the laboratory results would not be available. The impacts would be adverse for both patient and medical staff if a diagnosis could no longer be made. If mercury were banned certain diseases and conditions could no longer be investigated.
Conclusions
At the present time there are no alternatives to certain analyses used in medicinal diagnostics. In the event of a ban mercury patients would not, in the case of certain diagnoses, be investigated because the laboratory results would not be available. A transitional period is required to develop alternatives.In KemI's judgment a period of three years from the date on which the ordinance and regulation come into force is a reasonable transitional period.
Proposal
Mercury compounds for analyses in medicinal diagnostics should be covered by a general national ban.
KemI considers, however, that mercury and mercury compounds for use in analysis and research and development in medicinal diagnostics should be granted a time-limited exemption from the ban and be allowed to be marketed until 31 December 2007 and used until 31 December 2008.
6.2.7 Other analytical uses
The area of use for analytical chemicals reported above are those which it has been possible to identify within the scope of the present investigation. There are probably a number of other smaller areas of use which have not yet been identified and for which it has not been possible to carry out an impact assessment. Despite this KemI judges that there are reasons to introduce a further time-limited exemption for three years for analyses other than those specified in the impact assessment. The greatest advantage would be that suppliers of analytical chemicals, users with their own laboratories and independent laboratories will in general have to observe only one final date for selling or using the chemicals irrespective of the mercury compound and the area of use. It could also reduce the number of applications for dispensations made to KemI. Finally, monitoring would be facilitated at all levels.
Proposals
Mercury compounds for analyses, other than those specified above in the impact assessment, should be covered by a general ban.
KemI considers, however, that mercury compounds for use in analyses other than those specified above in the impact assessment should be granted a time-limited exception from the ban and be allowed to be marketed until 31 December 2007 and used until 31 December 2008.
6.3 Disinfection and medial equipment
The preservative thiomersal, an organic mercury compound (merthiolat, CAS No 54-64-8) is used to disinfect certain medical equipment used, for example, in the case of transfusions and dialysis. This is sophisticated equipment which is used rarely and is only to be found in a few hospitals in the country, mainly university hospitals. The Clinic for Transfusion Medicine at the Karolinska University Hospital states that 29 g of thiomersal was used in 2003 in the case of transfusion equipment. For dialysis equipment a further 40 g was used.
6.3.1 Are there alternatives to mercury?
The manufacturers of the equipment approve only thiomersal as a disinfectant for various reasons. In some cases on manufacturer no longer guarantees the safety of the product if alternative disinfectants are used. Another manufacturer claims that no other preservative keeps the equipment disinfected for as long as necessary. Attempts have been made to replace thiomersal but this has not been successful since the manufacturers oppose it (Vass, personal communication). This also means a further cost for health care since the used thiomersal solutions are treated as hazardous waste.
6.3.2 What would be the impacts of a ban?
The health services would not guarantee patient safety when equipment is used where preservatives are needed because the manufacturer does not guarantee that the equipment will operate correctly.
6.3.3 Conclusions
There are currently no alternatives to thiomersal for disinfecting certain transfusion and dialysis equipment. In order to influence the manufacturers to develop alternatives a time-limited exemption is needed.
6.3.4 Proposal
Mercury compounds for disinfection of transfusion and dialysis equipment should be covered by a general ban.
KemI considers, however, that thiomersal for disinfecting transfusion and dialysis equipment should be granted a time-limited exemption from the ban and be allowed to be marketed until 31 December 2007 and used until 31 December 2008.
Research in the academic world and as part of commercial R&D efforts often leads to the development of new products. KemI considers that it is important that new applications of mercury and mercury compounds should not come into use and that new products containing mercury should not be put on the market. A general ban on the handling of mercury would counter such a new supply of mercury to society.
As part of research, various analyses of mercury and mercury compounds need to be carried out. The exemption proposed for the use of mercury compounds (see above, Paras 6.2.2-6.2.7) should satisfy many of the needs of R&D. But mercury compounds have areas of use other than as analytical chemicals. Below are some examples that have emerged from our investigation:
Organic and inorganic mercury compounds are used as catalysts in synthetic organic chemistry, principally for research purposes. For example, mercury oxide or mercury acetate can be added in small amounts to make a chemical reaction go faster. Generally a synthesis route is followed which is published in the international literature and alternative routes are not practicable.
In certain research studies on membrane proteins mercuric chloride is used to inhibit transport through the membrane. Alternatives are available (e.g. cytochalasin, CAS No 14930-96-02).
In protein structure research using X-ray crystallography heavy metals are used to derivatise the proteins. Mercury, platinum and lead can all be used but mercury is used most. In Sweden this type of research is carried out by around 10 research groups in universities and research institutes and in research-oriented companies such as medicinal products companies. The Institute for Molecular Biology at the Swedish Agricultural University states that they annually use about 50 mg of mercury compounds for this purpose.
6.4.1 Are there alternatives to mercury?
In certain cases there may be alternatives to mercury and mercury compounds. According to our information alternatives are available, for example, for certain uses in membrane-protein research.
Time is needed to develop alternatives in those fields where there is currently no alternatives to mercury compounds.
6.4.2 What would be the impacts of a ban?
A general ban on the use of mercury will counter the possibility that mercury and mercury compounds will find new applications in R&D activity, which will have a positive affect on the phasing out of mercury.
Of a ban on the use of mercury in research is introduced in Sweden the impacts on academic values could be substantial. New research results could fail to be accepted if they are based on methods that are not scientifically well-based. This could have effects on what research could be carried out in Sweden in future. A possible impact is that doctoral candidates would be forced to go abroad to take their degree.
6.4.3 Conclusions
KemI considers that it is important that new applications of mercury and mercury compounds should not come into use and that new products containing mercury should not be put on the market. The use of mercury compounds in R&D should therefore in the long term be replaced where possible. To avoid drastic impacts on research that is currently in progress, a transitional period is required for the development of alternative methods. In KemI's judgment a period of three years from the date on which the ordinance and regulation come into force is a reasonable transitional period. After that it will be possible to apply for an exemption if there are exceptional reasons to use mercury.
6.4.4 Proposal
Mercury compounds for use in R&D should be covered by a general national ban.
KemI considers, however, that mercury compounds for R&D in industry and universities should be granted a time-limited exemption from the ban and be allowed to be marketed until 31 December 2007 and used until 31 December 2008.
In proposition 1997/98: 145 the government took the view that the use of mercury in the chlor-alkali industry could continue until 2010. Sweden has also undertaken in international agreements (North Sea Conference and Oslo and Paris Conventions) that mercury-based methods used in the manufacture of chlorine and caustic soda will be phased out by 2010 [OSPAR decision 1990/3]. The Swedish Environmental Protection Agency (SEPA) previously identified a need for special legislation to phase out mercury-based methods in the chlor-alkali industry by 2010.
Through the IPPC Directive (Integrated Pollution Prevention and Control Directive, 96/61/EC) a BREF (Best Available Techniques, BAT, Reference Document) has been produced in which processes using mercury are not regarded as being the best available technique (BAT). A strict interpretation of the IPPC Directive implies that BAT will be introduced in October 2007. The licensing authorities in each Member State have to take account of the local circumstances and precondition in their assessment of what the BAT is in each individual case. Therefore there will be a gradual phasing out of mercury cells in different Member STates.
In Sweden there are two chlor-alkali plants that use mercury cells. Eka Chemicals AB in Bohus, owned by Akzo Nobel, has a factory dating from 1969 with a capacity of 100,000 tons of chlorine gas per annum. Hydro Polymers AB in Stenungsund, owned by Norsk Hydro, has a factory dating from 1969 with a capacity of 120,000 tons of chlorine gas per annum.
Hydro Ploymers AB is going to phase out mercury cells by 2010 (minuted, inter alia, Eka Chemicals AB has stated that chlor-alkali production in Bohus will be discontinued before 2010 for market reasons [Eka Chemicals AB, 2004].
The total quantity of metallic mercury in use in the chlor-alkali industry in Sweden is about 400 tons. In 2002 the companies reported emissions to air of about 38 kg of mercury, to water about 1.6 kg, and residual amounts of about 3.4 kg in products. During the last few years the mercury supplied to the plants has come from recovered mercury (mainly from SAKAB) and from the companies' own stocks (Jorlöv and Andersson, personal communication).
6.5.1 Are there alternatives to mercury?
There are three different processes for chlor-alkali production. Two processes: the mercury method and the diaphragm technique date from the end of the 19th century while the third process: membrane technique was developed on an industrial scale in the 1970s. Membrane cells release less hazardous substances and are more energy-efficient than the older techniques.
6.5.2 What would be the impacts of a ban?
Since mercury-based chlor-alkali production must be phased out in accordance with the IPPC Directive a national ban in accordance with previous international commitments will not involve any further major impacts.
6.5.3 Conclusion
A strict interpretation of the IPPC Directive implies that the best available method, i.e. the membrane technique, must be introduced in October 2007. Since 1990 the companies affected have been aware of Sweden's commitment to phase out the mercury method by 2010. Thus, there have been good opportunities for these companies to plan and carry out a switch to alternative production techniques.
Both plants are 25 years old and use outmoded technology. If the companies intend to continue with chlor-alkali production a change of process would probably take place for economic reasons before too long, irrespective of the legal requirements.
A national ban on the use of mercury in the chlor-alkali industry from 2010 will produce no greater further impacts for the companies affected beyond those which follow from the IPPC Directive. KemI sees good reasons to adhere to the date of 2010 laid down by the government to ensure an end to the use of mercury in the chlor-alkali industry.
6.5.4 Proposal
The use of mercury in the chlor-alkali industry should be covered by a general national ban.
kemI considers, however, that mercury for chlor-alkali production should be granted a time-limited exemption from the ban and be allowed to be marketed and used until 31 December 2009.
6.6.1 Are there alternatives to mercury?
According to the Cosmetics Directive it is not permitted to place cosmetic products on the market if they contain mercury or mercury compounds. The Directive, however, contains exemptions that mean that phenylmercury eye make-up subject to maximum mercury content of 0.007%.
Phenylmercury salts and thiomersal are added as preservatives in eye products to minimize the risk of microbiological contamination and the spread of eye infections. There are, however, many other acceptable preservatives, e.g. methyl paraben and propyl paraben, which are used in eye make-up products for removing make-up. In the judgment of the Medical Products Agency (MPA) there is no eye make-up or product for removing make-up on the Swedish market which contains mercury (Guzikowski, personal communication).
6.6.2 What would be the impacts of a ban?
A ban on the use of mercury compounds in cosmetics would presumably not create any economic or practical impacts for industry since the available alternatives are already in use.
The consumers and the environment should not be affected either to any significant extent since the eye make-up and products for removing eye make-up which are on the Swedish market are already free from mercury.
6.6.3 Conclusion
There is no need to use mercury compounds in cosmetics since there are acceptable alternatives, which are considerably less harmful from environmental and health points of view. Using mercury in cosmetics means that mercury is spread via waste water to the sewage treatment plant and also into the solid-waste stream when packaging containing cosmetics residues is discarded. Even if the concentration is low this use contributes to an unnecessary spread of mercury.
6.6.4 Proposal
Mercury compounds in cosmetics should be covered by the general national ban.
Equipment for various purposes can incorporate mercury-containing instruments such as thermometers and barometers, and electrical components such as relays, conductors, switches and circuit-breakers. These utilize mercury's special properties such as its high electrical conductivity, liquid state at room temperature, high density, and no problems with oxidation of the surface since it disappears rapidly when new mercury is dripped on it. Furthermore liquid mercury does not wet normally absorbent materials such as paper.
Under current legislation it is forbidden to manufacture or sell mercury-containing measuring instruments and certain electrical components (see Annex 1 and 2). These goods may be imported from other EU countries but not from countries outside the EU. On the other hand this ban does not apply to equipment that contains such substances. In practice it has been possible to replace the instruments and electrical components concerned in most cases.
It is difficult to judge the effects of a general ban since it covers all goods, i.e. not just the instruments but also the equipment that contain the instruments. Currently such equipment can be imported from other EU countries and third countries.
Swedish suppliers of equipment are therefore treated unfairly compared with foreign suppliers. A general ban would mean that equipment that contains mercury could not be manufactured, sold, or imported from other EU countries and third countries. This means that Swedish industry could compete on equal terms with a foreign equipment suppliers.
It is not uncommon that incomplete information is provided about the composition of goods imported from other countries. The importer is then unaware that the goods contain mercury. Even if the goods are stated to contain mercury it can be difficult to identify the amount, which makes it difficult to check whether the ban is being observed. Despite these problems a ban on mercury is important since it gives a clear signal that the substance is undesirable and a general ban will presumably force the pace of development of alternative techniques.
Directive 2002/95/EC restricts the use of mercury and other hazardous substances in electrical and electronic equipment. The equipment covered by the Directive is regulated at EU level and not via national regulations. Lighting equipment is an example of an area regulated in the Directive. Information about the Directive can be found in the Legal Analysis (Annex 4).
Large quantities of mercury are stored in various types of instruments in society. New supplies of the substance occur in those areas which are not currently regulated, e.g. via new equipment. As regards equipment, the largest use probably takes place in professional use. Mercury in such equipment is presumably most often dealt with legally in the waste stream but there is still a risk of the substance spreading in the working environment to the natural environment during manufacture and via the waste stream.
The basis of the equipment investigation consists of the report from the consultant study, which was carried out within the framework of the commission (Östman, 2004), the questionnaire responses submitted to KemI, and oral information from industry representatives. It emerges from these sources that the use of mercury in instruments has in many cases been replaced by other techniques. Below follows a description of the instruments that are banned and equipment that contains them.
6.7.1 Thermometers
Are there alternatives to mercury?
Mercury-containing thermometers have been banned since 1991 and only a few applications for exemptions for specific applications have been submitted since then. Sales have gradually decreased and were very low in 2003. Generally speaking there are currently no obstacles to measuring temperatures using other techniques.
A large number of mercury thermometers are fitted with autoclaves, and warming cabinets used in laboratories and in health care. When the thermometers have been broken or no longer register correctly, the equipment has been modified to allow the installation of, for example, a thermocouple, or the thermometer has been replaced with a more modern digital temperature-measuring device. These two techniques offer certain advantages as regards automation and the collection/recording of data. There are probably still several thousand mercury thermometers in autoclaves, and warming cabinets, which will be replaced as they are become unserviceable.
In universities and colleges there are a few hundred pieces of equipment which are used to determine density and melting/boiling points. This equipment can be used until the mercury thermometers are no longer serviceable. Then they must be rebuilt or replaced.
Our specific use of thermometers is in flash-point determination. This type of measurement is used in the oil industry and by companies providing analytical services. Flash-point measurement is regulated by Directive 67/548/EEC, which indirectly requires mercury thermometers be used (see discussion Chapter 5). Therefore these thermometers have an exemption from the current ban.
What would be the impacts of a ban?
Changing the temperature-measuring technique or replacing the equipment can initially have financial impacts on the organizations concerned. The capital costs of new, more modern equipment are often higher than for traditional equipment. This is not because the instrument in the equipment is mercury-free but because the equipment in its totality is more sophisticated than is needed for their particular application.
Flash-point determination is regulated by Directive 67/548/EEC, as mentioned before. According to the Directive the use of a special mercury-containing thermometer is an indirect requirement. The exemption for this thermometer expired on 31 December 2003. and therefore needs to be renewed.
Conclusion
Alternative techniques exist for most measurements and it seems as though thermometers in equipment have gradually been replaced by new techniques. A general ban therefore seems unlikely to produce any drastic consequences except possibly for smaller organizations providing analytical services for which it is not financially worthwhile to exchange old equipment for equipment with is now mercury-free. The equipment used for flash-point determination has a mercury thermometer which is designed for this purpose. The exemption for thermometers for flash-point determination in accordance with Directive 67/548/EEC expired on 31 December 2003 and it ought to be renewed, since the use of mercury-containing thermometers is controlled by the Directive.
Proposal
Equipment which contains mercury should be covered by a general national ban.
KemI considers, however, that mercury-containing equipment for flash-point determination in accordance with Directive 67/548/EEC should be granted a time-limited exemption from a ban and be allowed to be marketed until 31 December 2010.
6.7.2 Relays
Are there alternatives to mercury?
In relays a powerful electric current is turned on or off by the action of a less-powerful one. Small relays are found in printed circuit cards. Larger relays are to be found in, for example, stairwell lighting, signal systems, machinery and elevator controls, and traffic lights. Relays are a large group of products which have gradually been replaced by other electronics. The driving forces for this have been developments in the electronics sector, increased pressure to phase out mercury, and increased awareness of the latent waste-situation.
What would be the impacts of a ban?
It appears that equipment consisting of mercury-containing relays is currently being replaced by alternative technology, and in case of Banverket, Vattenfall, Svensk Energi and Svenska Kraftnåt (see glossary for explanations), no mercury-containing components or equipment is installed when the old items are scrapped. Based on this information KemI judges that a ban will have no effects on this type of equipment.
Conclusion
A ban on equipment that contains mercury relays would probably have small, if any, impacts since there currently seem to be alternative techniques.
Proposal
Equipment using mercury-containing relays should be covered by a general national ban.
6.7.3 Electrical conductors, switches and circuit breakers
Are there alternatives to mercury?
Mercury-containing conductors, switches and circuit breakers use mercury in liquid form. The making or breaking of the electrical circuit is achieved in these cases by a mechanical action. The technique is old and has been used in thermostats, tilting switches, gas-operated relays and pressure switches, in which a change in position makes or breaks an electrical circuit. Common applications have been as level regulators for pumps and tanks. The function could also be to close a circuit when a cover is opened, for example the lid of a car boot. In the majority of applications there are established alternative techniques and practically no exemptions have been applied for since 1998.
There is an exemption until 31 December 2005 for electrical switches as spare parts for personal motion alarms which emit a radio signal indicating that the person is immobile if no change in position takes place within a certain period. These alarms are used in certain types of employment such as driving underground trains. According to information from Nordic Alarm AB an alarm of this type which does not use mercury and which has been tested with good results will come on the market in 2004 (Johnsson, personal communication). It has not been possible to quantify imports of these alarms as part of our commission. KemI judges, however, that only a few companies are involved.
For tracking devices for wildlife there are still no satisfactory alternatives, according to Scan Craft Data AB (Boxström, personal communication), and therefore Swedish companies have sought and been granted dispensations to manufacture and sell them. An alternative where the mercury has been replaced by a gold-plated ball has been tested but with poor results. The ball gets stuck in the device because of mechanical jolts and corrosion by the humid environment, and has therefore given false signals. Mercury-containing transmitters are moreover small and lighter than others and can therefore be used for migratory birds.
Mercury is used in ignitrons or mercury-arc rectifiers whose function is to convert alternating electrical current to direct current. There are alternative technologies.
What would be the impacts of a ban?
For conductors, switches and circuit breakers there are in most cases alternative technologies, and very few applications for exemptions have been submitted since 1998. No drastic impacts are therefore expected from a general ban.
Current personal motion alarms contain electrical switches using mercury. A mercury-free version will become available in the near future according to oral information from a Swedish manufacturer. Assuming the new alternative functions well, Keml's judgment is that a general ban will not mean adverse impacts such as increased risks for the categories of people who use these alarms.
It appears however that there are still no workable alternatives in the case of tracking devices for wildlife despite efforts to develop such. A general ban would make it impossible to carry out research where tracking devices are needed.
Conclusion
For most of the uses there are alternative techniques. An exemption from a general ban is however required for tracking devices for use in wildlife research. KemI expects that efforts will continue to be made to find alternative techniques.
Proposal
Equipment comprising electrical conductors, switches and circuit breakers which contain mercury should be covered by a general ban.
KemI considers, however, that tracking devices for use in wildlife research should be granted a time-limited exemption from the ban and be allowed to be marketed until 31 December 2008.
6.7.4 Continuous current transfer
Are there alternatives to mercury?
In many situations the transfer of electrical current from a shaft to a rotating part takes place using mercury, e.g. in contactors for cranes and packaging machines. After the review within the government commission 1998 the American manufacturer developed alternative techniques but Swedish customers prefer the mercury technique. The alternative technique seems, however, to be good enough to be able to replace the use of mercury.
Ventilation ducting and cans are manufactured using seam-welding machines. The technique used is a special application of current transfer. A wheel conducts an electric current through the material at the same time as a welding rod is fed in. The wheel rolls along the material and the current is transferred from the shaft to the circumference of the wheel since it is filled with mercury. Two manufacturers, in Italy and Switzerland, dominate the world market. Just below half the machines are of Italian manufacture. The technique is slightly different for straight and curved seams. The Swiss manufacturer has developed a mercury-free technique for straight seams but the corresponding development for curved seams has proved difficult.
The Italian manufacturer has not regarded the Swedish market as sufficiently interesting to consider investing in development.
There are about 100 seam-welding machines in Sweden (Hörnfeldt, personal communication). the mercury in the wheel oxidizes and its replaced after 2-5 years. The quantity in the wheel is on average about 60 g so the total quantity of all the machines is probably about 10 kg. The turnover of mercury is of the order of 5 kg per annum.
More than half the products manufactured using seam welding are exported.
Seam-welding machines have a life of at least 30 years so replacement of the existing machines will take many years. It is possible to rebuild the Swiss straight-seam machines but for machines for welding curved seams, which make up about half the total, there is currently no alternative technique. It is therefore unreasonable to expect that a mercury-free technique will be available within a few years.
What would be the impacts of a ban?
For contractors in general it appears that adequately good alternatives are available and therefore a general ban would not mean drastic impacts on suppliers or users.
The situation is different for seam-welding machines. A new Swiss seam-welding machine for straight seams, with the possibility of employing an alternative technique, costs almost SEK 2 million (217,704 EURO) while modifying an older machine costs about SEK 100,000 (10,885 EURO). Only small and medium-sized enterprises manufacture ventilation ducting, and buying alternative equipment is almost unthinkable. A gradual rebuilding of the Swiss machines is a possibility for moving away from the use of mercury in the case of straight seams. Of the Swiss seam-welding machines, which make up 60% of the total, over half have been rebuilt to be mercury-free, according to the Association of Swedish Engineering Industries (VI).
For manufacturers of ventilation equipment and cans a ban would mean that existing equipment would need to be replaced or modified if that has not already been done. The ASEI states that a possible impact of a national ban would be that the manufacture of ventilation equipment moves abroad, costing 700 jobs. The ventilation systems would then be imported.
Conclusion
Over half the Swiss seam-welding machines have already been modified and KemI expects more to be modified. For straight seams it thus seems that the trend is in the desired direction. But several more years will probably be needed to modify all the existing machines.
Curved-seam machines are a greater problem since no alternative technique has yet been found. More time is needed for development here and KemI expects that efforts will be made to find alternatives in this case as well.
It is therefore currently necessary to grant exemptions for seam-welding machines, but for different periods for the two types because the development of alternative techniques is at different stages. The exemption would mean that there would be no change as regards the manufacture of ventilation systems and the number of jobs.
The exemption should have the same duration as was proposed by KemI in 1999: straight-seam welding until 31 December 2010 and curved-seam welding until 31 December 2014. The proposal was regarded positively by the industry in 1999. KemI assumes that efforts will be made to find alternative techniques for both types of seam.
Proposal
Equipment containing mercury for continuous current transfer should be covered by a general national ban.
KemI considers, however, that seam-welding wheels as spare parts and metallic mercury for refilling them should be granted a time-limited exemption from the ban and should be allowed to be marketed for the welding of straight seams until 31 December 2010 and for the welding of curved seams until 31 December 2014.
6.7.5 Barometers and manometers
Are there alternatives to mercury?
In barometers and manometers a mercury column provides a counter to a pressure, so that the height of the column indicates the pressure measured. This technique has been used for, and other applications, measuring atmospheric pressure, blood pressure and differential pressure. In measuring differential pressure, a restriction in a flow of water o gas is registered and from this the size of the flow can be calculated. Mercury columns can be used for pressure and flow measurements both in the domestic and service sectors and in industry and the public sector. A mercury column can be connected directly to a pointer or to a pen recorder to transmit pressure, temperature, levels in tanks, etc. The column can also be coupled mechanically to a control unit that controls levels within a set range. In most cases mechanically to control unit that controls levels within a set range. In most cases there are alternatives to barometers and manometers in the form of electronic techniques and very few dispensations have been given since 1998.
A special form of pressure measurement occurs in industry in the case of polyethylene manufacture where a precision measurement is made at high temperature. The polyethylene product is evaluated by the pressure measurement, which is therefore a quality-assurance parameter. Alternatives have been tested over many years but none of them has given the required result.
What would the impacts of a ban?
In this area of application mercury-based equipment has already been replaced to a large extent. This means that the financial impacts on the companies affected should be marginal.
Special types of pressure measurement, such as precision measurement, would however be made impossible by a general ban. The only alternative would be to send samples of polyethylene products abroad to have them evaluated, which would mean a delay to production.
Conclusion
It would be possible to extend the current ban without significant impacts since there are alternative techniques in most cases. For special pressure-measurement: in polyethylene manufacture, where alternative techniques are still lacking there will be an opportunity for companies affected to apply for an exemption if the ban would create drastic impacts.
Proposal
Barometers and manometers that contain mercury should be covered by a general national ban.
6.7.6 Gyroscopes
Are there alternatives to mercury?
Gyroscopes, used for example for navigating small craft, appear to have been replaced by GPS (global Positioning System). Navigation by GPS makes use of satellites.
What would be the impacts of a ban?
Based on information form the Swedish Armed Forces and a supplier of navigational instruments to the Armed Forces KemI judges that a ban would not have any impacts on manufacturers, suppliers or users.
Conclusion
Since modern techniques are available mercury-containing gyroscopes are not needed.
Proposal
Gyroscopes which contain mercury should be covered by a general national ban.
6.8 Summary of proposals for exemptions
In the impact assessments KemI has identified that analysis of mercury ought to be exempted from the ban with no time limit.
The following users are judged to be in need of time-limited exemptions from a general national ban on mercury:
For other areas of application KemI has not identified any need for exemptions and they should be covered by a general ban when it comes into force.