Annexes to COM(2004)240 - Implementation of the EC Strategy for dioxins, furans and polychlorinated Biphenyls (COM(2001) 593) - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
dossier | COM(2004)240 - Implementation of the EC Strategy for dioxins, furans and polychlorinated Biphenyls (COM(2001) 593). |
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document | COM(2004)240 ![]() |
date | April 13, 2004 |
2.3.4. Projects on the preparation of certified reference materials
The Institute for Reference Materials and Measurements (IRMM) at the JRC has developed a set of certified reference materials for PCBs in pork fat. The certified reference materials are intended as quality assurance tools, allowing laboratories involved in monitoring programmes to check the quality of the data they produce. This should eventually lead to an improved comparability of monitoring data regarding dioxins, furans and PCBs across Europe.
2.3.5. Development and validation of screening methods
There is a strong need for rapid screening methods for the detection of dioxins in food and feed that can be used to analyse a high number of samples, subjecting only positive samples to more expensive analyses applying high resolution mass spectrometry. In November 2003 the IRMM finalised a validation study of a cell line based screening method indicating that this type of methods needs further refinement.
2.3.6. RTD Framework Programmes
Spending on research involving dioxins and PCBs was increased significantly in the Fifth RTD Framework Programme (1998-2002), the total amount rising to 12 million euros [8]. The Quality of Life and Management of Living Resources Thematic Programme spent most of this amount sponsoring six projects [9]. These ongoing projects concentrate mostly on risk assessment of dioxins and PCBs, focusing on various endpoints such as cancer or fertility, also involving organisations from Eastern European countries. The Energy, Environment and Sustainable Development Programme has financed one project on the arctic food chain.
[8] http://europa.eu.int/comm/research/ endocrine/index_en.html for general information and an overview of all research projects and related activities.
[9] http://www.anemone-project.dk/ for the Anemone-Project investigating neurobehavioral endpoints and markers of neurotoxicant exposures, http://www.inuendo.dk/ for the Inuendo-project studying time to pregnancy and semen quality in Inuit and European population groups.
Under the Sixth Framework Programme (2002-2006), a Network of Excellence (CASCADE) is currently being negotiated with a budget of 14.4 million euros from Priority 5 on Food Quality and Safety. It focuses on durable integration of European research into the effects on human health (cardiovascular disease, various cancers, decline in fertility etc.) caused by chemical residues (including PCBs and dioxins) in the diet. Priority 5 is also co-financing a Specific Targeted Research Project called DEVNERTOX with a budget of 2.4 million euros focused on a variety of effects of mixtures of neurotoxic substances (PCBs and methylmercury) contaminating food. [10]
[10] See 7.
2.4. Communication to the public and awareness rising
A web site on dioxin exposure and health has been set up at http://europa.eu.int/comm/environment/ dioxin. It gives an overview of the issue and contains links to the most important documents (e.g. the Dioxin Strategy and the Environment and Health Strategy) and several studies and projects.
The Commission is preparing a workshop on raising awareness of bad practices, such as open burning of waste or the use of waste as combustion material. The competent authorities from the Acceding and Candidate Countries and the present Member States will be invited to attend.
2.5. Co-operation at international level
2.5.1. Ratification of international agreements
Two important international instruments have been adopted on persistent organic pollutants (POPs): the UNECE Protocol and the Stockholm Convention. The UNECE Protocol entered into force on 23 October 2003, but additional ratifications are needed before the global Stockholm Convention can enter into force. In order to comply with the EU commitment to ratify these instruments without delay, the Commission has proposed a regulation to give effect to their main provisions, which are not yet covered by Community legislation (see 2.8 - Regulation on POPs).
The international agreements aim at phasing out these dangerous substances by controlling their production, use, import, export, emissions and disposal. Some of the obligations of the Regulation proposed by the Commission are even stricter than the international agreements.
In the framework of the Stockholm Convention the Commission has been actively involved in expert groups that are drafting guidance on BAT (best available techniques) and BEP (best environmental practice) for the unintentional production of dioxins, furans and PCBs, and producing technical guidelines for environmentally sound management of waste containing these substances.
2.5.2. Rapid screening methods
A joint EC/WHO initiative was set up in November 2001 with the aim of organising a workshop to review and scientifically evaluate rapid screening methods for dioxins and related compounds, and to identify research needs in this area. An inventory of all available methods will be made. This inventory will include a detailed description of the different screening methods and address the strengths and weaknesses of each method and the applicability and limitations of the methodology.
2.6. Best Available Techniques reference documents
Since the adoption of the Strategy, the Commission has continued to organise an exchange of information on BATs in various sectors. The recently finalised documents include information on dioxin-related prevention and control measures in large-volume organic chemicals production, manufacture of other chemicals, mineral oil refining and production of textiles. There is also a recent document on the monitoring of releases, including dioxin emissions. Relevant documents under preparation cover foundries, large combustion plants, waste incineration, other waste treatment, and disposal of animal by-products.
In order to get a better view of the current knowledge and available information on emissions of dioxins from foundries and their abatement, a workshop was organised by the foundry industry in September 2003. The workshop showed that it is not possible to identify the single controlling factors in the reformation of dioxins. This makes it difficult to identify appropriate preventive measures that can guarantee low emission levels. Moreover, there is very little industrial experience with secondary control measures.
2.7. Integrated dioxin and PCB monitoring in the Baltic region
The long-term monitoring objectives of the Strategy are being addressed through the preparation of a pilot project on integrated dioxin and PCB monitoring in the Baltic area in the framework of the European Environment and Health Strategy [11] and the Marine Strategy [12].
[11] COM(2003) 338 final.
[12] COM(2002) 539 final.
The Commission will examine the possibility of linking current environment, fish and human health monitoring data and programmes for dioxins and PCBs in the Baltic Area and will identify ways of developing integrated environment and health monitoring. This will provide the information needed to assess the link between the release of these substances into the environment, their transport through different environmental compartments, their accumulation in the environment, the ecosystem and food, and their effects on health. The integrated information will be used as a basis for further policy development.
In September 2003 a technical working group on dioxin and PCB monitoring in the Baltic area was established. The working group has prepared a baseline report including an overview of existing dioxin and PCB monitoring programmes in the Baltic countries, the problems and shortcomings of existing monitoring systems, and requirements for integrated environment and health monitoring of dioxins and PCBs. In a second stage, by the end of March 2004, the working group will establish options for action and recommendations for the Commission's Environment and Health Action Plan 2004-2010. The results from the pilot project will be used to develop a "European integrated environment and health monitoring and response system" that will be extended to other substances.
2.8. Regulation on persistent organic pollutants
On 12 June 2003 the Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on persistent organic pollutants and amending Directives 79/117/EEC and 96/59/EC [13]. The proposal aims at implementing the obligations of the Stockholm Convention and the UNECE Protocol on POPs. Several control measures on dioxins, furans and PCBs are included.
[13] COM(2003) 333 final.
The proposal obliges Member States to develop and maintain release inventories and National Action Plans designed to identify, characterise and reduce the releases of these substances, as laid down in the Stockholm Convention. Both the release inventories and the National Action Plans are regarded as essential tools for the cost-effective and continuing reduction of the release of by-product POPs.
The proposal also lays down stringent rules on waste containing or consisting of POP substances, including dioxins and furans. As a general rule, POPs waste should be disposed of without delay in such a way that POP content is destroyed or irreversibly transformed into substances which do not exhibit POP characteristics.
Furthermore, it is proposed that the Commission and the Member States, in close co-operation, establish appropriate programmes and mechanisms, consistent with the state of the art, for the continuous provision of comparable monitoring data on the presence of dioxins, furans and PCBs in the environment. This obligation goes beyond the provisions of the international agreements, but it is based on the Dioxin Strategy. Taking into account the current lack of data on environmental levels and trends for dioxins, furans and PCBs, and the need to evaluate the effectiveness of control measures, a specific provision on monitoring is considered necessary. However, it is essential to have the measurement and monitoring tools required for those activities.
Lastly it is proposed that Member States provide the Commission with summary information on release inventories and the presence of dioxins, furans and PCBs in the environment every three years.
The Commission proposal was forwarded to the European Parliament and the Council in June 2003, together with the proposals for Council Decisions on ratification of the Stockholm Convention and the UNECE Protocol on POPs.
2.9. Other progress
2.9.1. "Preparatory actions in the field of dioxins and PCBs"
To obtain more specific information on dioxin and PCB sources and levels the Commission financed the study "Preparatory actions in the field of dioxins and PCBs" [14]. The final study report covers all EU Member States and was published in April 2002. A main focus of the project was the sampling and analysis of feed and food across Europe. It provides a systematic overview of dioxin and PCB contamination levels for different environmental compartments, feed and food, and closes existing data gaps in particular for dioxin-like PCBs. It also gives an overview of sources, pathways and human exposure.
[14] See 6.
2.9.2. Different open uses of PCBs and PCTs in products and determination of best available techniques for the disposal of PCBs
An ongoing study is designed to identify products containing PCBs/PCTs in open uses, together with applications, typical uses and further useful information. However, identification is hampered by the long period that has elapsed since use was stopped, the confidentiality of the preparations and the variety of applications.
2.9.3. Emission limit values
In its conclusions on the Dioxin Strategy the Council draws the attention to the possibilities provided by Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (IPPC) [15]. That Directive provides that EU-wide emission limit values for dioxins should be established if the need is identified. In its Communication on implementation of the Directive [16] the Commission makes the general point that limit values restrict the possibility for national authorities to make pragmatic and environmentally justified trade-off decisions with regard to local circumstances. EU-wide limit values should therefore only be introduced if they are strictly necessary.
[15] OJ L 25, 10.10.1996, p. 26.
[16] On the Road to Sustainable Production - Progress in implementing Council Directive 96/61/EC concerning integrated pollution prevention and control (COM(2003) 354 final).
The metal industry remains a major source of dioxin emissions. For this sector the Communication suggests as a first stage mandatory monitoring requirements as an alternative to emission limit values. This could be an effective regulatory tool since the lack of data on emissions in this sector is currently a serious impediment to appropriate measures being taken. The Commission has started preparatory work on this initiative.
In the autumn of 2003, the Commission received from Member States new information on representative emission limit values for dioxins and dioxin-like substances, which are applied in their country.
2.9.4. Water
For implementation of the Water Framework Directive [17], and in particular Article 16 on strategies against water pollution, a first list of priority substances has been drawn up [18]. Progress is currently under way on defining environmental quality standards for the aquatic environment and establishing controls on emissions, discharges and losses of substances.
[17] Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy. OJ L 327, 22.12.2000, p. 1.
[18] Decision No 2455/2001/EC of the European Parliament and of the Council of 20 November 2001 establishing the list of priority substances in the field of water policy and amending Directive 2000/60/EC. OJ L 331, 15.12.2001, p. 1.
PCBs, dioxins and furans were not included in the initial list of priority substances, on the grounds that they were considered to be historic pollutants and that existing marketing and use restrictions under Directive 76/769/EEC would give sufficient protection [19]. However, two ongoing studies undertaken to support the development of environmental quality standards and emission controls initially included these substances.
[19] European Commission. "Study on the Prioritisation of substances dangerous to the aquatic environment", June 1999. ISBN 92-828-7981-X. Available at
According to article 16(4) of the Water Framework Directive, the list of priority substances has to be revised every four years. If new monitoring data on dioxins and PCBs reveal that there are still risks of exposure to or via the aquatic environment in EU Member States, including the Acceding and Candidate Countries and/or that there are still significant point or diffuse sources connected with the aquatic environment where emission controls are insufficient, the inclusion of these substances on the list of priority substances for Community level action could be considered. The first review is due to start in 2004. As regards other main pollutants of concern each individual Member State is required under the Water Framework Directive to establish quality standards and emission controls for any substance that is identified as significant in that Member State. A first report on pressures and impacts is due in 2004 according to Article 5 of the Directive, and this report is expected to give an indication of which substances are relevant. PCBs, dioxins and furans could be identified in that process.
2.9.5. Soil
Soil contamination is one of three priority threats that will be addressed in a Communication from the Commission to be adopted by mid-2004 in the framework of the Thematic Strategy on Soil Protection [20]. Several actions are planned to improve soil protection and working groups have been set up. The full scope of the work has not yet been established, but some of these initiatives may tackle the monitoring and reduction of PCBs and dioxins in the soil and the treatment of contaminated sediments.
[20] COM(2002) 179 final.
2.9.6. Emission factors
The JRC has initiated the setting up of an Emission Factors Database, where one of the main goals will be to develop and make widely available country-/region-specific emission factors for dioxins and furans.
3. Progress achieved with the actions for feed and food
3.1. Integrated approach
The Strategy describes an integrated approach to legislation on feedingstuffs and foodstuffs to reduce the presence of dioxins and PCBs throughout the food chain. This integrated approach consists of three pillars:
- The establishment of strict but feasible maximum levels of dioxins in feed and food taking into account the results obtained in lowering the presence of dioxins in the environment.
- The establishment of action levels to trigger action when levels of dioxin in feed or food are found clearly above background level. These action levels have an early warning function.
- The establishment of target levels to be achieved over time so as to bring the exposure of the majority of the European population within the limits recommended by the Scientific Committee.
3.1.1. First pillar: maximum levels
Maximum levels for dioxins in feed and food have been established at a strict but feasible level in order to discard the unacceptably highly contaminated products.
Council Regulation (EC) No 2375/2001 of 29 November 2001 amending Commission Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in foodstuffs [21] establishes maximum levels for meat and meat products, fish and fishery products, milk and milk products, hen eggs and egg products, and oils and fats. The data available at that time did not allow maximum levels to be laid down for different categories of fish and fishery products. In the near future different levels are to be set for the various categories.
[21] OJ L 32, 6.12.2001, p. 5.
Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed, [22] as amended by Commission Directive 2003/57/EC of 17 June 2003, [23] establishes maximum levels for dioxins in feed materials of plant origin, minerals, binders, animal fat, and other products of animal origin, fish oil, fish meal, and compound feedingstuffs, including fish feed.
[22] OJ L140, 30.5.2002, p. 10.
[23] OJ L 151, 19.6.2003, p. 38.
From a toxicological point of view, maximum levels for dioxins should also include dioxin-like PCBs. However, as data on the occurrence of dioxin-like PCBs is still limited, an active approach is being pursued to obtain this data and to build up a reliable database in order to allow revision of the limits for dioxins in feed and food before 31 December 2004 to include dioxin-like PCBs in accordance with toxicological evaluation.
Furthermore, the maximum levels for dioxins and dioxin-like PCBs are to be further reviewed by 31 December 2006 at the latest with the aim of setting substantially stricter maximum levels, in line with the lowering of dioxin emissions to the environment.
3.1.2. Second pillar: action levels
There must be permanent monitoring of the presence of dioxins and PCBs in feed and food across the EU. Whenever there is an abnormal increase in the levels of these compounds, sources and/or pathways of contamination have to be identified. In order to determine what constitutes an abnormally increased level, action levels are set to prompt competent authorities and operators to identify sources and pathways of contamination and to take measures to eliminate them.
Action levels for foodstuffs, feed materials and feedingstuffs were set by Commission Recommendation 2002/201/EC of 4 March 2002 on the reduction of the presence of dioxins, furans and PCBs in feedingstuffs and foodstuffs. [24]
[24] OJ L 67, 9.3.2002, p. 69.
Under the Recommendation, the Member States, in proportion to their production, use and consumption of feed materials, feedingstuffs and foodstuffs, are to carry out random monitoring of the presence of dioxins and dioxin-like PCBs in feed materials, feedingstuffs and foodstuffs, including fish and fishery products. This monitoring has to be carried out, and results reported, in accordance with the specific guidelines and frequency established by a Commission Recommendation on the monitoring of background levels of dioxins and dioxin-like PCBs in foodstuffs and feedingstuffs.
The Recommendation 2002/201/EC provides that Member States will transmit every year a report by 31 December for foodstuffs and by 1 April for feedingstuffs on their findings, the results of their investigations and the measures taken to reduce or eliminate the source of contamination. In case the information is of immediate relevance for the other Member States the information has to be transmitted immediately. This report will be for the first time provided for the controls performed in the year 2003.
3.1.3. Third pillar: target levels
Target levels are the levels to be achieved in food and feed whereby it can be reasonably assumed that the dietary exposure of a large majority of the European population will be within the tolerable weekly intake for dioxins and dioxin-like PCBs. These target values will be set by 31 December 2004 in the light of more accurate information on the impact of environmental measures on the reduction of the presence of dioxins and dioxin-like PCBs in different feedingstuffs and foodstuffs, including fish and fishery products. Target levels will act as the driving force for the measures required to further reduce emissions into the environment.
3.2. Specific issues
3.2.1. Progress on dioxin-like PCBs
Although it is recognised that from a toxicological point of view any levels should apply to dioxins, furans and dioxin-like PCBs, for the time being maximum levels have been set only for dioxins and furans. These maximum levels are laid down for food in Section 5 of Annex I of Commission Regulation (EC) 466/2001 and for feed in the Annex to Directive 2002/32. The Commission is committed to reviewing them for the first time by 31 December 2004, in particular with a view to including dioxin-like PCBs. To this effect, the Commission has been collecting monitoring data from Member States following the guidelines laid down in a Commission Recommendation on the monitoring of background levels of dioxins and dioxin-like PCBs in foodstuffs and feedingstuffs. Additional data has also been submitted to the Commission by Member States from national surveys and targeted monitoring outside the recommended monitoring strategy. The data collected will allow the Commission to start discussions with the competent authorities of the Member States on feasible maximum levels of dioxins, furans and dioxin-like PCBs, before the end of 2004.
3.2.2. Maximum limit for free-range and semi-intensive eggs
As there have been cases of high dioxin levels in free-range eggs, it was considered appropriate when the maximum levels were adopted to allow a transitional period for free-range and semi-intensive eggs before the maximum levels apply. The legislation provides that free-range and semi-intensive eggs must comply with the maximum level laid down as from 1 January 2005.
3.2.3. Derogation for fish from the Baltic Sea region sold in Finland and Sweden
By way of derogation, Sweden and Finland are authorised for a transitional period up to 31 December 2006 to place on the market fish from the Baltic intended for consumption in their territory which have dioxin levels higher than those set in the legislation. In return for this derogation, Finland and Sweden have to undertake intensive monitoring of the levels of dioxins and PCBs in fish from the Baltic. This intensive monitoring provides important information on factors like the importance of the age of fish on dioxin levels and the distribution of dioxins in different parts of the fish. The Accession Treaty, concluded in Copenhagen in December 2002, foresees for Estonia the possibility of derogation for fish from the Baltic under the same conditions as Finland and Sweden.
3.2.4. Target to reduce human exposure
Under the legislation, the maximum levels are to be reviewed within a defined period of time with the objective of reducing them. An overall reduction of at least 25% in human exposure to dioxins is to be achieved by 2006. To this effect, the Commission is continuing to work with Member States to collect data to allow the calculation of human exposure through diet to dioxins, furans and dioxin-like PCBs.
3.2.5. Progress on non-dioxin-like PCBs
At the beginning of 2002 the Commission asked the Scientific Committee for Food to provide a scientific opinion on the risks to consumers of dietary exposure to non-dioxin-like PCBs. Given the complexity of the issue the Commission, the WHO, and the US Environmental Protection Agency agreed to combine forces to avoid duplication of effort in performing risk assessments on non-dioxin-like PCBs. Since the European Food Safety Authority (EFSA) became operational in May 2003, it has responsibility for addressing the request of a scientific opinion on this issue, through its Panel of Experts on Contaminants. The Commission renewed its request for a scientific opinion on non-dioxin-like PCBs in November 2003 especially in view of including the assessment of the potential risks for animal and public health of the presence of non-dioxin-like PCBs in feedingstuffs. The Panel has set up a specific working group to assess non-dioxin-like PCBs, which will operate in parallel but co-ordinated with the international working group. A scientific opinion has to be delivered by the end of 2004.
The Commission has in the meantime discussed with the Member States the need to set provisional maximum limits for non-dioxin-like PCBs until the risk assessment has been completed. The Member States expressed the opinion that the setting of maximum limits without a risk assessment would be premature, so the discussions will be resumed once the risk assessment becomes available from EFSA.
4. Summary
The first two years of the ten-year Community Strategy for reducing the presence of dioxins, furans and PCBs in the environment, feed and food have been spent on a number of implementation activities, with priority given to those stressed in the Council Conclusions.
The activities include in particular projects aimed at improving knowledge of the current situation in the Acceding and Candidate Countries with the secondary objective of strengthening capacity in these countries, for example by establishing networks and training experts. Through these projects it has been found that small but numerous diffuse sources, mainly in the residential sector have a considerably greater potential for dioxin emissions than in the EU. This is due to the widespread use of solid fuels, and possibly to the co-incineration and open burning of waste. These activities will probably be recognised in the future as dominant dioxin sources in the Acceding and Candidate Countries.
In its conclusions the Council underlines the importance of the Stockholm Convention and the UNECE Protocol on POPs. These agreements have been signed by the European Community but not yet ratified. They aim to eliminate certain POPs, inter alia dioxins, furans and PCBs. To enable ratification the Commission has proposed a Regulation on persistent organic pollutants to implement the obligations of the two international instruments.
With the long-term objective of developing an integrated approach to the monitoring of the environment, food and human health, a pilot project on integrated environment and health monitoring of dioxin and PCBs in the Baltic region will be launched. A working group has been set up to assess the current monitoring situation and to give recommendations.
Other implementation activities include continuing work on best available techniques reference documents and research on for example dioxin risk assessment and dioxins in waste.
On feed and food the Commission has already undertaken several initiatives like establishing maximum levels and action levels for dioxins and furans in feed and food, and setting up feed and food monitoring programmes. Before the end of 2004, dioxin-like PCBs are to be included and target levels set. By the end of 2006, the maximum levels for dioxins, furans and dioxin-like PCBs are to be significantly reduced. A risk assessment on non-dioxin-like PCBs addressing the potential risks of these substances in feed and food for animal and public health is expected to become available by the end of 2004. On the basis of this assessment, the Commission will consider the appropriateness of measures to reduce the presence of non-dioxin-like PCBs in feed and food.
A workshop to evaluate the scientific information contained in the inventory on rapid screening methods for dioxins and related compounds, and to identify the research needs, was organised in December 2003.
5. Next steps
The year 2004 will be dedicated to the continuation of the ongoing Acceding and Candidate Countries projects. The final report on the project "Environmental levels and human exposure in the Acceding and Candidate Countries" is due in February 2004 and the final report on the project "Dioxin Emissions in Acceding and Candidate Countries" is due by the end of that year. Research into the contribution of solid fuel burning to dioxin emissions started by the end of 2003 and will continue in 2004.
A workshop is being planned for 2004 to prepare an awareness rising campaign on bad practices, like the open burning of waste and the use of waste as a combustion material. Competent authorities from the Acceding and Candidate Countries and from the present Member States will be invited to participate.
To fill remaining gaps new project proposals are now being evaluated, including in particular the third stage of the project on human exposure to dioxins in recycled waste and a programme on long-term monitoring using selected indicators elaborated by the JRC.
The technical working group on integrated environment and health monitoring of dioxin and PCBs in the Baltic area will deliver its final results by the end of March 2004 in the form of options for action and recommendations for the Commission's Environment and Health Action Plan 2004-2010.
As regards the metal production and processing sector, which has been identified as a major source of dioxin emissions, a project is being prepared to supply background information for a possible Commission proposal laying down EU requirements for emission monitoring.
Depending on new data becoming available on the extent of pollution of the aquatic environment and current sources of pollution, the Commission might propose including dioxins and PCBs, in order that they be more closely monitored, in the list of priority substances under the Water Framework Directive if EU level relevance is established.
In 2004, the current maximum levels and action levels for dioxins and furans in feed and food will be reviewed to include dioxin-like PCBs. A risk assessment on the potential risks for animal and public health of the presence of non-dioxin-like PCBs in feed and food is currently ongoing and is expected to be completed by the end of 2004. Measures to reduce the presence of non-dioxin-like PCBs will be considered afterwards, in the light of this assessment.