Avis juridique important

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32001H0838

Commission Recommendation of 7 November 2001 on the results of the risk evaluation and the risk reduction strategies for the substances: acrylaldehyde; dimethyl sulphate; nonylphenol phenol, 4-nonyl-, branched; tert-butyl methyl ether (Text with EEA relevance.) (notified under document number C(2001) 3380)

Official Journal L 319 , 04/12/2001 P. 0030 - 0044

Commission Recommendationof 7 November 2001on the results of the risk evaluation and the risk reduction strategies for the substances: acrylaldehyde; dimethyl sulphate; nonylphenol phenol, 4-nonyl-, branched; tert-butyl methyl ether(notified under document number C(2001) 3380)(Text with EEA relevance)(2001/838/EC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(1) and in particular Article 11(2) thereof,Whereas:(1) Article 10 of the Regulation (EEC) No 793/93 established the procedure to be followed for the risk evaluation of the substances on the priority lists at the level of the Member States designated as rapporteur.(2) Commission Regulation (EC) No 1488/94(2) outlines the principles for the assessment of risks to man and the environment of existing substances in accordance with Regulation (EEC) No 793/93.(3) The Member State rapporteur after evaluating the risk of a given priority substance to man and the environment should suggest where appropriate a strategy for limiting the risk, including control measures and/or surveillance programmes.(4) Article 11 of Regulation (EEC) No 793/93 foresees that the results of the risk evaluation and the recommended strategy for limiting risks in respect to substances on the priority lists should be adopted at Community level in accordance with the procedure laid down in Article 15 and shall be published by the Commission.(5) Article 1 of Regulation (EEC) No 793/93 provides that that Regulation should apply without prejudice to Community legislation on the protection of consumers and on safety and protection of health of workers at work, in particular Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(3).(6) A first priority list identifying substances requiring attention has been adopted by Commission Regulation (EC) No 1179/94(4); this priority list provides, among other substances, for the evaluation of the following:- acrylaldehyde.(7) A second priority list identifying substances requiring attention has been adopted by Commission Regulation (EC) No 2268/95(5). This second priority list provides, among other substances, for the evaluation of the following:- dimethyl sulphate,- nonylphenol,- phenol, 4-nonyl-, branched.(8) A third priority list identifying substances requiring attention has been adopted by Commission Regulation (EC) No 143/97(6). This third priority list provides, among other substances, for the evaluation of the following:- tert-butyl methyl ether.(9) The rapporteur Member States have completed all the risk evaluation activities with regard to man and the environment for the above five substances(7) and, where appropriate, have suggested strategies for limiting the risks.(10) The results of the risk evaluation of the five substances and the recommended risk reduction strategies for the five substances should be adopted at the Community level.(11) In accordance with Article 11(3) of Regulation (EEC) No 793/93, the Commission will consider the results of the risk evaluation and the recommended strategy for limiting the risks, when proposing Community measures in the framework of Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(8) and in the framework of Directive 89/391/EEC as well as in the framework of other relevant existing Community instruments.(12) The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) has been consulted and has issued an opinion with respect to the risk assessment reports referred to in this recommendation.(13) The measures provided for in this recommendation are in accordance with the opinion of the Committee set up pursuant to Article 15 of Regulation (EEC) No 793/93,HEREBY RECOMMENDS:1. All sectors importing, producing, transporting, storing, formulating into a preparation or other processing, using, disposing or recovering the following substances:- acrylaldehydeCAS No 107-02-8EINECS No 203-453-4- dimethyl sulphateCAS No 77-78-1EINECS No 201-058-1- nonylphenolCAS No 25154-52-3EINECS No 246-672-0- phenol, 4-nonyl-, branchedCAS No 84852-15-3EINECS No 284-325-5- tert-butyl methyl etherCAS No 1634-04-4EINECS No 216-653-1should take into account the results of the risk evaluation as summarized in Section I (human health/environment) of Parts 1, 2, 3, 4 and 5 of the Annex to this recommendation and include them, where appropriate, in the safety data sheets(9). These results were formulated in the light of the opinions delivered by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE)(10).2. The risk reduction strategies described in Section II (strategy for limiting risks) of Parts 1, 2, 3, 4, 5 of the Annex to this recommendation should be implemented.Done at Brussels, 7 November 2001.For the CommissionMargot WallströmMember of the Commission(1) OJ L 84, 5.4.1993, p. 1.(2) OJ L 161, 29.6.1994, p. 3.(3) OJ L 183, 29.6.1989, p. 1.(4) OJ L 131, 26.5.1994, p. 3.(5) OJ L 231, 28.9.1995, p. 18.(6) OJ L 25, 28.1.1997, p. 13.(7) The comprehensive risk assessment reports as forwarded to the Commission by the Member States rapporteur are publicly available. Short summaries are also available. Both can be found on the internet site of the European Chemicals Bureau, Institute for Health and Consumer Protection of the Joint Research Centre in Ispra, Italy (http://ecb.ei.jrc.it/existing-chemicals/).(8) OJ L 262, 27.9.1976, p. 201.(9) In accordance with the provisions of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 196, 1.8.1967, p. 1), Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35), Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (14th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, OJ L 131, 5.5.1998, p. 11 and Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1).(10) The risk assessment reports were peer-reviewed by the CSTEE and its opinions were expressed at the 13th plenary meeting (Brussels, 4 February 2000), 15th plenary meeting (Brussels, 19 June 2000), 22nd plenary meeting (Brussels, 6 and 7 March 2001) and 23rd plenary meeting (Brussels, 24 April 2001). The CSTEE opinions can be found on the internet site: (http://europa.eu.int/comm/food/fs/sc/sct/outcome_en.html).ANNEXPART 1>TABLE>The risk assessment is based on current practices related to the life-cycle of the substance produced in or imported into the European Community as described in the risk assessment forwarded to the Commission by the Member State Rapporteur.The risk assessment has, based on the available information, determined that in the European Community the substance is only used as an intermediate for the manufacturing of a number of different substances (e.g. animal feed additives, biocides, pesticides, leather tanning agents, fragrances). Outside the European Community the substance is also used as an effective broad-spectrum biocide, tissue fixative, in etherification of food starch and production of colloidal metals. It was not possible to obtain information on the use of the total volume of substance produced in or imported into the European Community, therefore, some uses may exist which are not covered by this risk assessment.The risk assessment has identified other sources of exposure of the substance to man and the environment in particular releases of the substance from industrial combustion processes, automobile exhaust gases and tobacco smoke, which do not result from the life-cycle of the substance produced in or imported into the European Community. The assessment of the risks arising from these exposures is not part of this risk assessment. The risk assessment forwarded to the Commission by the Member State Rapporteur does however provide information that could be used to assess these risks.I. RISK ASSESSMENTA. HUMAN HEALTHThe conclusions of the assessment of the risks toWORKERSare1. that there is a need for specific measures to limit the risks. This conclusion is reached because of concerns for eye, nose and respiratory tract irritation as a consequence of single and repeated inhalation exposure arising from the production and processing of the substance;and:2. that, in addition to the conclusion given above, the risk assessment shows that there are uncertainties with regard to the possible genotoxic and carcinogenic effects of the substance locally at the exposure site after long-term exposure by inhalation to non-cytotoxic concentrations. However, at this moment no validated genotoxicity test exists to investigate this, and the relatively low exposure levels do not justify the request for a carcinogenicity study by inhalation.The conclusion of the assessment of the risks toCONSUMERSis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficientThe conclusion is reached, because the risk assessment shows that the substance is not used in products available for consumers.The conclusion of the assessment of the risks toHUMANS EXPOSED VIA THE ENVIRONMENTis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.The conclusion of the assessment of the risks toHUMAN HEALTH (physico-chemical properties)is that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.B. ENVIRONMENTThe conclusion of the assessment of the risks to theATMOSPHERE, AQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEMis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied.This conclusion is reached because:- the risk assessment shows that risks related to the environment spheres mentioned above are not expected. Risk reduction measures already being applied are considered sufficient.The conclusion of the assessment of the risks forMICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT,is that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied.This conclusion is reached because:- the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk reduction measures already being applied are considered sufficient.II. STRATEGY FOR LIMITING RISKSFor WORKERSThe legislation for workers' protection currently in force at Community level is generally considered to give an adequate framework to limit the risks of the substance to the extent needed.Within this framework it is recommended to develop at Community level occupational exposure limit values for the substance to subirritating levels. Until such time as occupational exposure limit values for the substance have been adopted at Community level, exposure in the workplace should be reduced as low as technically feasible because of possible local carcinogenic effects.PART 2>TABLE>The risk assessment is based on current practices related to the life-cycle of the substance produced in or imported into the European Community as described in the comprehensive risk assessment forwarded to the Commission by the Member State Rapporteur.The risk assessment has, based on the available information, determined that in the European Community the substance is mainly used as an intermediate and methylating agent in production of many organic chemicals (dyes, perfumes, pharmaceuticals). Other uses reported are as a sulphating agent in the manufacturing of various products (e.g. dyes, fabric softeners). It was not possible to obtain information on the use of the total volume of substance produced in or imported into the European Community, therefore, some uses may exist which are not covered by this risk assessment.The risk assessment has identified other sources of exposure of this substance to man and the environment. In particular releases of the substance from combustion of sulphur containing fossil fuels and formation in the atmosphere as a reaction product of sulphur dioxide and organic compounds, which does not result from the life-cycle of the substance produced in or imported into the European Community. The assessment of the risks arising from these exposures is not part of this risk assessment. The risk assessment forwarded to the Commission by the Member State Rapporteur does however provide information which could be used to assess these risks.This substance has not been tested for all aspects of reproductive toxicity and consequently the risk assessment does not evaluate in full the risks to any population of this endpoint. This test has not been required, as the substance has been identified as a non-threshold carcinogen.I. RISK ASSESSMENTA. HUMAN HEALTHThe conclusions of the assessment of the risks forWORKERSare that there is a need for specific measures to limit the risks. This conclusion is reached because of:- concerns for risks for respiratory tract irritation, mutagenicity and carcinogenicity as a consequence of inhalation exposure arising from production, processing and use of the substance,- concerns for the pregnant population for adverse health effects as a consequence of repeated inhalation exposure arising from the use of the substance as an intermediate.The conclusion of the assessment of the risks forCONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENTis that the risk assessment shows that risks cannot be excluded at any exposure, as the substance is identified as a non-threshold carcinogen. However the risks covered by this risk assessment are not of a magnitude, that immediate action is deemed necessary. Risk reduction measures already being applied are considered sufficient to impose pressure in reducing and controlling exposure to the substance.The conclusion of the assessment of the risks toHUMAN HEALTH (physico-chemical properties)is that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.B. ENVIRONMENTThe conclusion of the assessment of the risks to theATMOSPHERE, AQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEMis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk reduction measures already being applied are considered sufficient.The conclusion of the assessment of the risks forMICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANTis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk reduction measures already being applied are considered sufficient.II. STRATEGY FOR LIMITING RISKSFor WORKERS:The legislation for workers' protection currently in force at Community level is generally considered to give an adequate framework to limit the risks of the substance to the extent needed.Within this framework it is recommended:- to develop at Community level occupational exposure limit values for the substance.PART 3>TABLE>The risk assessment is based on current practices related to the life-cycle of the substance produced in or imported into the European Community as described in the comprehensive risk assessment forwarded to the Commission by the Member State Rapporteur.The risk assessment has, based on the available information, determined that in the European Community the substance is mainly used as an intermediate in the production of nonylphenol ethoxylates (e.g. in detergents and paints) and in the production of resins, plastics and stabilisers in the polymer industry. Other uses include the manufacture of phenolic oximes for use outside the EU in the metal extraction industry and in some speciality paints.I. RISK ASSESSMENTA. HUMAN HEALTHThe conclusion of the assessment of the risks toWORKERS, CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENTis that there is a need for further information and/or testing. This conclusion is reached because there is a need for better information to adequately characterise the risks for human health.This conclusion is reached while evaluation of the available data submitted in accordance with the relevant provisions of Regulation (EEC) No 793/93 is underway(1).B. ENVIRONMENTThe conclusion of the assessment of the risks to theATMOSPHEREis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk reduction measures already being applied are considered sufficient.The conclusions of the assessment of the risks to theAQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEM are:1. that there is need for further information and/or testing. This conclusion is reached because of:- concerns for effects on the aquatic spheres including sediment.The information and/or test requirements are:- further toxicity testing on sediment organisms.However, the implementation of the strategy for limiting risks for the environment in Section II Part 3 of the Annex will eliminate the need for further information requirements.and2. that there is a need for specific measures to limit the risks. This conclusion is reached because of:- concerns for effects on local and regional aquatic environmental spheres including sediment as a consequence of exposure arising from nonylphenol production(2), production of phenolic oximes, phenol/formaldehyde resins(3), epoxy resins(4) and other plastic stabilisers, nonylphenol ethoxylate production, formulation and use,- concerns for effects for terrestrial spheres as a consequence of exposure arising from the production, formulation and uses of nonylphenol ethoxylates in veterinary medicines, captive use by the chemical industry, electrical engineering, industrial and institutional cleaning, in leather processing, metal extraction, in the photographic, pulp and paper, polymer and textile industry, in paint manufacture and in civil and mechanical engineering,- concerns for effects on secondary poisoning to fish and earthworm predators as a consequence of exposure arising from nonylphenol ethoxylate production and formulation, and the use of nonylphenol ethoxylates in industrial and institutional cleaning, the electrical engineering industry, the paints, lacquers and varnish industry, civil engineering, leather processing, metal extraction, the pulp, paper and board industry, and in textile processing.The conclusion of the assessment of the risks forMICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANTis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk reduction measures already being applied are considered sufficient.II. STRATEGY FOR LIMITING RISKSFor the ENVIRONMENT:Marketing and use restrictions should be considered at Community level to protect the environment from the use of nonylphenol/nonylphenol ethoxylates (NP/NPEs) in particular in:- industrial, institutional and domestic cleaning,- textiles processing,- leather processing,- agriculture (biocidal products, in particular use in teat dips),- metal working,- pulp and paper industry,- cosmetics including shampoos and other personal care products.Further work is necessary to establish those uses for which derogations can be justified.In addition to the above, and recognising development of new Community procedures, additional measures for nonylphenol and nonylphenol ethoxylates should be considered including pollution prevention measures(5) at Community level, as appropriate, for the following sectors:- production of nonylphenol and nonylphenol ethoxylates;- use of nonylphenol ethoxylates in the synthesis of other chemicals (captive use);- use of nonylphenol ethoxylates in emulsion polymerisation in particular use in acrylic esters used for specialist coatings, adhesives and fibre bonding;- production of phenol/formaldehyde resins using nonylphenol;- production of other plastic stabilisers using nonylphenol.The results achieved through marketing and use restrictions and pollution control measures should be monitored and if necessary additional measures should be considered. In particular, consideration should be given to other Community instruments(6) to ensure control of environmental concentrations of nonylphenol and nonylphenol ethoxylates via the objectives as set-out in those instruments. These measures should be applied to the above sectors and those listed below:- formulation (in sectors where nonylphenol/nonylphenol etoxylates use will continue);- civil and mechanical engineering including the manufacture of wall construction materials, road surface materials and also in the cleaning of metals;- additives in lubricating oil and in the blending of fuel additive packages;- electronics/electrical engineering in particular use in fluxes in the manufacture of painted circuit boards, in dyes to identify cracks in printed circuit boards and as a component of chemical baths used in the etching of circuit boards;- the photographic industry (small and large scale) in particular use in products intended for home use by amateur photographers, for photo developers who develop film for amateur photographers, some professional products and also use in x-ray film;- production of phenolic oximes/epoxy resins;- the preparation of paint resin and also as a paint mixture stabiliser.The need for further marketing and use restrictions should be considered at Community level if the measures taken in these sectors are shown to be inadequate.For possible use in biocides as an active substance, within the legislative framework currently in force at Community level for biocidal products, it is recommended that due consideration be taken of the results of the risk assessment.For use in pesticides as an active substance, within the legislative framework currently in force at Community level for plant protection products(7), national authorities when granting authorisation decisions and in particular in cases where significant environmental impact is already experienced at local level should take into due consideration the results of the risk assessment. In such cases encouragement should be given to the development and use of alternatives to nonylphenol and nonylphenol ethoxylates.For the use as an adjuvant/co-formulant(8) in pesticide and biocidal products national authorities when granting authorisation decisions and in particular in cases where significant environmental impact is already experienced at local level should take into due consideration the results of the risk assessment. Encouragement should be given to the development and use of alternatives to nonylphenol and nonylphenol ethoxylates and the adoption of other measures aimed at modifying consumer behaviour.Furthermore, information should be disseminated to all interested parties in the Community to ensure protection of the environment.For the possible uses of nonylphenol and nonylphenol ethoxylates in veterinary medicinal products, within the legislative framework currently in force at Community level for veterinary medicinal products, it is recommended to holders of marketing authorisations for products containing the substances that they should substitute them with less harmful alternatives.For the use of sludge containing nonylphenol and nonylphenol ethoxylates, within the legislative framework currently in force at Community level for sludge management, it is recommended that consideration be given to the development of provisions on concentration limit values for nonylphenol and nonylphenol ethoxylates when sludge is spread on land.The measures identified to protect the environment will also reduce human exposure.PART 4>TABLE>The risk assessment is based on current practices related to the life-cycle of the substance produced in or imported into the European Community as described in the risk assessment forwarded to the Commission by the Member State Rapporteur.The risk assessment has, based on the available information, determined that in the European Community the substance is mainly used as an intermediate in the production of nonylphenol ethoxylates e.g. in detergents and paints and in the production of resins, plastics and stabilisers in the polymer industry. Other uses include the manufacture of phenolic oximes for use outside the EU in the metal extraction industry and in some specialty paints.I. RISK ASSESSMENTA. HUMAN HEALTHThe conclusion of the assessment of the risks toWORKERS, CONSUMERS, HUMANS EXPOSED VIA THE ENVIRONMENTis that there is a need for further information and/or testing. This conclusion is reached because there is a need for better information to adequately characterise the risks for human health.This conclusion is reached while evaluation of the available data submitted in accordance with the relevant provisions of Regulation (EEC) No 793/93 is underway(9).B. ENVIRONMENTThe conclusion of the assessment of the risks to theATMOSPHEREis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk reduction measures already being applied are considered sufficient.The conclusions of the assessment of the risks to theAQUATIC ECOSYSTEM and TERRESTRIAL ECOSYSTEM are:1. that there is need for further information and/or testing. This conclusion is reached because of:- concerns for effects on the aquatic spheres including sediment.The information and/or test requirements are:- further toxicity testing on sediment organisms.However, the implementation of the strategy for limiting risks for the environment in Section II Part 4 of the Annex will eliminate the need for further information requirements;and2. that there is a need for specific measures to limit the risks. This conclusion is reached because of:- concerns for effects on local and regional aquatic environmental spheres including sediment as a consequence of exposure arising from nonylphenol production(10), production of phenolic oximes(11), phenol/formaldehyde resins, epoxy resins(12) and other plastic stabilisers, nonylphenol ethoxylate production, formulation and use,- concerns for effects for terrestrial spheres as a consequence of exposure arising from the production, formulation and uses of nonylphenol ethoxylates in veterinary medicines, captive use by the chemical industry, electrical engineering, industrial and institutional cleaning, in leather processing, metal extraction, in the photographic, pulp and paper, polymer and textile industry, in paint manufacture and in civil and mechanical engineering,- concerns for effects on secondary poisoning to fish and earthworm predators as a consequence of exposure arising from nonylphenol ethoxylate production and formulation, and the use of nonylphenol ethoxylates in industrial and institutional cleaning, the electrical engineering industry, the paints, lacquers and varnish industry, civil engineering, leather processing, metal extraction, the pulp, paper and board industry, and in textile processing.The conclusion of the assessment of the risks forMICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANTis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks related to the environmental spheres mentioned above are not expected. Risk reduction measures already being applied are considered sufficient.II. STRATEGY FOR LIMITING RISKSfor the ENVIRONMENT:Marketing and use restrictions should be considered at Community level to protect the environment from the use of nonylphenol/nonylphenol ethoxylates (NP/NPEs) in particular in:- industrial, institutional and domestic cleaning,- textiles processing,- leather processing,- agriculture (biocidal products, in particular use in teat dips),- metal working,- pulp and paper industry,- cosmetics including shampoos and other personal care products.Further work is necessary to establish those uses for which derogations can be justified.In addition to the above, and recognising development of new Community procedures, additional measures for nonylphenol and nonylphenol ethoxylates should be considered including pollution prevention measures(13) at Community level, as appropriate, for the following sectors:- production of nonylphenol and nonylphenol ethoxylates;- use of nonylphenol ethoxylates in the synthesis of other chemicals (captive use);- use of nonylphenol ethoxylates in emulsion polymerisation in particular use in acrylic esters used for specialist coatings, adhesives and fibre bonding;- production of phenol/formaldehyde resins using nonylphenol;- production of other plastic stabilisers using nonylphenol.The results achieved through marketing and use restrictions and pollution control measures should be monitored and if necessary additional measures should be considered. In particular, consideration should be given to other Community instruments(14) to ensure control of environmental concentrations of nonylphenol and nonylphenol ethoxylates via the objectives as set-out in those instruments. These measures should be applied to the above sectors and those listed below:- formulation (in sectors where nonylphenol/nonylphenol etoxylates use will continue);- civil and mechanical engineering including the manufacture of wall construction materials, road surface materials and also in the cleaning of metals;- additives in lubricating oil and in the blending of fuel additive packages;- electronics/electrical engineering in particular use in fluxes in the manufacture of painted circuit boards, in dyes to identify cracks in printed circuit boards and as a component of chemical baths used in the etching of circuit boards;- the photographic industry (small and large scale) in particular use in products intended for home use by amateur photographers, for photo developers who develop film for amateur photographers, some professional products and also use in X-ray film;- production of phenolic oximes/epoxy resins;- the preparation of paint resin and also as a paint mixture stabiliser.The need for further marketing and use restrictions should be considered at Community level if the measures taken in these sectors are shown to be inadequate.For possible uses in biocides as an active substance, within the legislative framework currently in force at Community level for biocidal products, it is recommended that due consideration be taken of the results of the risk assessment.For use in pesticides as an active substance, within the legislative framework currently in force at Community level for plant protection products(15), national authorities when granting authorisation decisions and in particular in cases where significant environmental impact is already experienced at local level should take into due consideration the results of the risk assessment. In such cases encouragement should be given to the development and use of alternatives to nonylphenol and nonylphenol ethoxylates.For the use as an adjuvant/co-formulant(16) in pesticide and biocidal products national authorities when granting authorisation decisions and in particular in cases where significant environmental impact is already experienced at local level should take into due consideration the results of the risk assessment. Encouragement should be given to the development and use of alternatives to nonylphenol and nonylphenol ethoxylates and the adoption of other measures aimed at modifying consumer behaviour.Furthermore, information should be disseminated to all interested parties in the Community to ensure protection of the environment.For the possible use of nonylphenol and nonylphenol ethoxylates in veterinary medicinal products, within the legislative framework currently in force at Community level for veterinary medicinal products, it is recommended to holders of marketing authorisations for products containing the substances that they should substitute them with less harmful alternatives.For the use of sludge containing nonylphenol and nonylphenol ethoxylates, within the legislative framework currently in force at Community level for sludge management, it is recommended that consideration be given to the development of provisions on concentration limit values for nonylphenol and nonylphenol ethoxylates when sludge is spread on land.The measures identified to protect the environment will also reduce human exposure.PART 5>TABLE>The risk assessment is based on current practices related to the life-cycle of this substance produced in or imported into the European Community as described in the Comprehensive Risk Assessment forwarded to the Commission by the Member State Rapporteur.The risk assessment has, based on the available information, determined that in the European Community the substance is mainly used as a fuel-additive in petrol. Other uses are in chemical and pharmaceutical industry and laboratories.I. RISK ASSESSMENTA. HUMAN HEALTHThe conclusion of the assessment of the risks toWORKERSis that there is a need for specific measures to limit the risks. This conclusion is reached because of:- concerns for repeated dose local skin effects as a consequence of exposure arising from maintenance operations and automotive repair.The conclusion of the assessment of the risks toCONSUMERSis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.The conclusion of the assessment of the risks toHUMANS EXPOSED VIA THE ENVIRONMENTis that there is a need for specific measures to limit the risks. This conclusion is reached because of:- concerns for the potability of drinking water in respect of taste and odour as a consequence of exposure arising from leaking underground storage tanks and spillage from overfilling of the storage tanks.The conclusion of the assessment of the risks toHUMAN HEALTH (physico-chemical properties)is that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.B. ENVIRONMENTThe conclusion of the assessment of the risks to theAQUATIC ECOSYSTEM are:1. there is a need for further information and/or testing. This conclusion is reached because:- there is a need for better information to adequately characterise the risks to the aquatic eco-system regarding the emission of the substance to surface water.The information and/or test requirements are:- a tiered testing strategy for the investigation of the avoidance behaviour of fish and possibly wildlife related to water contaminated with the substance;and2. there is a need for specific measures to limit the risks. The conclusion is reached because of:- concerns for the aquatic eco-system as a consequence of exposure arising from releases to surface water from terminal site storage tank bottom waters.The conclusion of the assessment of the risks toGROUNDWATERis that there is a need for specific measures to limit the risks. The conclusion is reached because of:- concerns for the potability of groundwater in respect of taste and odour as a consequence of exposure arising from leaking underground storage tanks and spillage from overfilling of the storage tanks.The conclusion of the assessment of the risks toATMOSPHERE and TERRESTRIAL ECOSYSTEMis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.The conclusion of the assessment of the risks toMICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANTis that there is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion is reached because:- the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.II. STRATEGY FOR LIMITING RISKSFor WORKERS:The legislation for workers' protection currently in force at Community level is generally considered to give an adequate framework to limit the risks of the substance to the extent needed.Furthermore, and without prejudice to Community legislation in force in the area(17), it is recommended to investigate how to improve the design of fuel filter position in cars and fuel pumps so to facilitate maintenance and repair work while aiming at minimum skin exposure to petrol. It is therefore suggested to pursue discussions with relevant organisations of industry branches in this respect.For HUMANS EXPOSED VIA THE ENVIRONMENT:It is considered that measures, presented below, aiming at protection of groundwater will contribute to preventing the contamination of drinking water.For the ENVIRONMENT:The prevention of all anthropogenic inputs, including MTBE, to groundwater is a key objective of current Community legislation(18). It is recommended therefore that monitoring programmes be undertaken, where appropriate, in order to permit the early detection of groundwater contaminated by MTBE.It is further recommended that the best available techniques be widely applied for the construction and operation of petrol underground storage and distribution facilities at service stations. In this regard Member States should consider mandatory requirements especially for all service stations in groundwater recharge areas. Furthermore, it is recommended that harmonised technical standards for the construction and operation of the storage tanks be developed at a European level by the European Committee for Standardisation (CEN). Potential past release sites, located on critical areas, should be investigated and, where necessary, remediated.Furthermore, exchange of information on these programmes and their results should be promoted.It is also recommended that MTBE containing bottom waters of above-ground storage tanks be controlled by plant permits(19) or national rules.To facilitate the permitting (as well as any fixing of national rules) these issues are included in the ongoing work to develop guidance on "Best Available Techniques" (BAT)(20).It is recommended that Member States carefully monitor the implementation of BAT in this respect and report any important developments in BAT to the Commission in the framework of the exchange of information on BAT.(1) The need for further information and/or testing applies to one scenario only. The full conclusions of the human health risk assessment will be published in a subsequent Commission recommendation.(2) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels. The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes and domestic and industrial emulsion paints.(3) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels. The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes and domestic and industrial emulsion paints.(4) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels. The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes and domestic and industrial emulsion paints.(5) Work currently underway at Community level in the framework of Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (OJ L 257, 10.10.1996, p. 26) in developing BAT Reference Documents (BREFs) that cover various chemical processes may be particularly significant in this respect. Further information on the matter can be obtained consulting the European IPPC Bureau website: http://eippcb.jrc.es.(6) 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) introduces provisions for pollution reduction measures at Community level. Based on the list of priority substances in Annex X of the Directive, the Commission will propose quality standards and emission controls, including emission limit values two years after adoption of the list. For certain "priority hazardous substances" amongst the priority substances, the emission controls shall aim at the cessation or phase-out of discharges, emissions and losses within 20 years. Nonylphenols are included as a "priority hazardous substance" in the first list of priority substances which has been proposed by the Commission in February 2000 (COM (2000) 47 final (OJ C 177 E, 27.6.2000, p. 74) as amended by COM (2001) 17 final of 16 January 2001). The first list of priority substances including nonylphenols was adopted on 11 June 2001 by the Council thus allowing the measures under Directive 2000/60/EC to be used as an additional instrument to reduce risks to or via the aquatic environment.(7) In the framework of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991) it is foreseen that nonylphenol and nonylphenol ethoxylates as active substances in pesticides will be withdrawn from the market as from July 2003.(8) For the time being this use is not subject to Community evaluation in the framework of 91/414/EEC.(9) The need for further information and/or testing applies to one scenario only. The full conclusions of the human health risk assessment will be published in a subsequent Commission recommendation.(10) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels. The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes and domestic and industrial emulsion paints.(11) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels. The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes and domestic and industrial emulsion paints.(12) For these uses risks to the aquatic environment only occur because of the contribution of background concentrations to local levels. The same applies to the use of nonylphenol ethoxylates in agricultural pesticide formulations, small scale photographic processes and domestic and industrial emulsion paints.(13) Work currently underway at Community level in the framework of Directive 96/61/EC in developing BAT Reference Documents (BREFs) that cover various chemical processes may be particularly significant in this respect. Further information on the matter can be obtained consulting the European IPPC Bureau website: http://eippcb.jrc.es(14) Directive 2000/60/EC introduces provisions for pollution reduction measures at Community level. Based on the list of priority substances in Annex X of the Directive, the Commission will propose quality standards and emission controls, including emission limit values two years after adoption of the list. For certain "priority hazardous substances" amongst the priority substances, the emission controls shall aim at the cessation or phase-out of discharges, emissions and losses within 20 years. Nonylphenols are included as a "priority hazardous substance" in the first list of priority substances which has been proposed by the Commission in February 2000 (COM (2000) 47 final, OJ C 177 E, 27.6.2000, p. 74; as amended by COM (2001) 17 final of 16 January 2001). The first list of priority substances including nonylphenols was adopted on 11 June 2001 by the Council thus allowing the measures under Directive 2000/60/EC to be used as an additional instrument to reduce risks to or via the aquatic environment.(15) In the framework of Directive 91/414/EEC it is foreseen that nonylphenol and nonylphenol ethoxylates as active substances in pesticides will be withdrawn from the market as from July 2003.(16) For the time being this use is not subject to Community evaluation in the framework of Directive 91/414/EEC.(17) Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to measures to be taken against air pollution by gases from positive-ignition engines of motor vehicles (OJ L 76, 6.4.1970, p. 1).(18) Directive 2000/60/EC.(19) Plant permits issued under Directive 96/61/EC.(20) Work currently underway at Community level in the framework of Directive 96/61/EC in developing BAT Reference Documents (BREFs) that cover MTBE production and handling, including design and management of storage modes.


Avis juridique important

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51999SC1302

99/669/EC, Euratom: Commission Recommendation of 15 September 1999 on a classification system for solid radioactive waste (SEC(1999) 1302 final)

Official Journal L 265 , 13/10/1999 P. 0037 - 0045

COMMISSION RECOMMENDATIONof 15 September 1999on a classification system for solid radioactive waste(SEC(1999) 1302 final)(1999/669/EC, Euratom)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community, and in particular Article 155 thereof, having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 124 thereof,(1) Whereas under Article 174 of the Treaty establishing the European Community calls for promoting measures at international level to preserve, protect and improve the quality of the environment;(2) Whereas Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment(1) requires under Article 7 that "Member States shall take the necessary steps to provide general information to the public on the state of the environment by such means as the periodic publication of descriptive reports";(3) Whereas Council Resolution 92/C 158/02 of 15 June 1992 on the renewal of the Community plan of action in the field of radioactive waste(2) under point 1 "Continuous analysis of the situation" of the Annex, requires that the Commission will periodically provide the Council with an analysis of the situation and prospects in the field of radioactive waste management in the Member States, with special reference to safety and environmental protection requirements and the requirements of nuclear programmes and activities involving radioisotopes. The Commission will also keep the European Parliament informed of this analysis;(4) Whereas the Community action plan in the field of radioactive waste(3) calls for, "Concerted action on the safe management of radioactive waste" which should make it possible to "approximate national practices and regulations in the field of safety of disposal, with particular reference to the different waste categories";(5) Whereas the Committee of the Regions under Article 11 of Resolution 98/C 251/06 on nuclear safety and local/regional democracy(4) "considers that many of the issues relating to the consideration of proposals for disposal of radioactive waste are complex and not subject to widespread public understanding and for this reason believes that it is crucial to ensure access to all relevant information to the public, to involve local and regional authorities, and the public in decision-making and to seek public confidence in the principles that govern the safety of repositories and in waste management programmes",HEREBY RECOMMENDS:on the base of the explanatory statements provided in the Annex;that the Member States and their nuclear industry adopt a common classification system of radioactive waste for national and international communication purposes as well as to facilitate information management in this field;that this classification system should be used for providing information concerning solid radioactive waste to the public, the national and international institutions and the non-governmental organisations. It would not replace technical criteria where required for specific safety considerations such as licensing of facilities or other operations;that this classification system could be used by Member States. During the period to 1 January 2002 it could be used in parallel with existing national systems;the proposed classification is summarised as follows:1. Transition radioactive wasteType of radioactive waste (mainly from medical origin) which will decay within the period of temporary storage and may then be suitable for management outside of the regulatory control system subject to compliance with clearance levels.2. Low and intermediate level waste (LILW)In LILW the concentration of radionuclides is such that generation of thermal power during its disposal is sufficiently low. These acceptable thermal power values are site-specific following safety assessments.2.1. Short-lived waste (LILW-SL)This category includes radioactive waste with nuclides half-life less than or equal to those of Cs137 and Sr90 (around 30 years) with a restricted alpha long-lived radionuclide concentration (limitation of long-lived alpha emitting radio-nuclides to 4000 Bq/g in individual waste packages and to an overall average of 400 Bq/g in the total waste volume).2.2. Long-lived waste (LILW-LL)Long-lived radionuclides and alpha emitters whose concentration exceeds the limits for short-lived waste.3. High level wasteWaste with such a concentration of radionuclides that generation of thermal power shall be considered during its storage and disposal (The thermal power generation level is site-specific and this waste is mainly forthcoming from treatment/conditioning of sent nuclear fuel).This Recommendation is addressed to the Member States.Done at Brussels, 15 September 1999.For the CommissionRitt BJERREGAARDMember of the Commission(1) OJ L 158, 23.6.1990, p. 56.(2) OJ C 158, 25.6.1992, p. 3.(3) OJ C 158, 25.6.1992, p. 3.(4) OJ C 251, 10.8.1998, p. 34.ANNEX1. IntroductionRadioactive waste comprises a great variety of materials, with different physical, chemical and radioactive characteristics. This diversity results in widely different potential hazards.The classification systems for radioactive waste in use across the European Union vary widely in approach and application. Some are used purely for communication purposes, while others are dictated by the disposal route.Member States' radioactive waste classification systems are based on activity concentration, total activity, waste source or disposal route.One of the main differences is between countries which have nuclear power generation and those that do not. In addition the borderlines between the categories are not always easily quantifiable and hence can vary widely from one country to another.Differences in radioactive waste classifications may make cooperation between Member States difficult within the framework of the single market and the free movement of goods and services. For instance in the optimisation of disposal facilities and in return of wastes following treatment and/or conditioning, a common language defining the different radioactive waste categories could be very useful.A European Union classification system should also be useful for providing comparative information concerning solid radioactive waste to the public, the national and international institutions and the non-governmental organisations.This explanatory statement outlines the reasons and need for harmonisation, discussses the requirements and describes the proposed classification system.2. BackgroundThe Community action plan in the field of radioactive waste(1) calls for "concerted action on the safe management of radioactive waste" which should make it possible:1. develop a common approach and work towards harmonisation at Community level on radioactive waste management strategies and practices wherever possible,2. approximate national practices and regulations in the field of safety of disposal, with particular reference to the different waste categories,3. draw up recommendations regarding safety assessment in the storage of radioactive waste and establish the relevant criteria,4. to achieve, generally speaking, an equivalent and satisfactory degree of protection at the highest practical safety level for workers, members of the public and the environment.In general terms, as a consequence of industrial, research and medical activities, residual materials containing radionuclides are produced. Following potential segregation, reuse in the nuclear industry and treatment, there are, in principle, two categories of such materials left. The main distinction between the two categories is established as follows:>TABLE>Material of category 1 can be released by national authorities provided they comply with clearance levels established using the basic criteria laid down in Annex 1 of Directive 96/29/Euratom(2). National authorities shall take into account technical guidance provided by the Community. It should be noted however that there is as yet no common basis for the harmonisation of category 1.Only category 2 materials are regarded as "radioactive waste", and this recommendation is only concerned with the latter. Two basic management alternatives can be defined:1. storage for a limited period of time until they can be either assigned to category 1 or disposed;2. disposal following well-established routes (surface or near-surface disposal, or deep disposal).In general, the factors considered most relevant to the definition of radioactive waste classification systems as well as management procedures are: type of radionuclides, total activity, activity concentration, half-life, dose rate, heat generation and other physical/chemical properties.International bodies, national authorities and waste operators have established radioactive waste classification systems in their sectors of competence or responsibility (waste treatment, transport, waste disposal, communication within international scientific community and with the public, etc.), grouping in the same category wastes with similar characteristics and hazards, with a view to facilitate management and thereby improve safety.Most national needs of the Member States are adequately covered by the national classifications they have developed (see Section 4, "Current position"). However, since these systems have been developed independently and for different purposes, they can vary significantly, some being based on activity concentration, others on source or disposal route.The use by all countries of the international IAEA classification of radioactive waste packages is a suitable base to develop a common classification system for the Member States of the European Union. Definition of a reference classification system may provide useful guidance for specific countries in developing their own management strategies, whilst at the same time facilitating general and commercial communications. Concerning safety, however, while such a reference classification system may be useful for generic and basic considerations, it cannot replace specific safety assessments performed for specific management purposes, including the selection of disposal routes.3. The purpose of a European Union waste classification system.A classification system's primary purpose is to improve communication and facilitate information management by providing a good descriptive tool enabling holdings of radioactive waste within the Community to be described to politicians and the public in a standard and easily understood manner.A more difficult issue is the relationship between the classification system and the way in which waste itself is handled and eventually disposed of in practice. Therefore the Commission services shared the view that the classification system should be indicative (qualitative) rather than prescriptive.The key consideration is that any such qualitative classification system could never pre-empt the role of national regulatory authorities in the control of handling and disposal of radioactive waste at specific sites. The detailed safety assessments which they employ in light of their own specific management and regulatory arrangements and capabilities require much more detailed information concerning the individual waste streams than a classification system can provide. The different current waste classification systems used in practice within the Member States rarely feature in the wording of national legislation or regulatory procedures.The divergence of current plans for final radioactive waste disposal within individual Member States also complicates the linkage of waste classification to eventual disposal routes. Some Member States have firm plans for both deep and surface disposal facilities for different types of waste. Other are likely to opt for only one of these types of facility, and some are undecided.Some Member States believe that a suitably constructed classification system could provide basic guidance as to how radioactive waste management, in particular disposal, could be better structured in general terms. For example in those Member States where both surface and deep underground disposal options were available it might give some indication of the groups of waste streams which would go to each type of disposal site.In light of the current diversity of national waste classification systems, a European Community classification system could be used initially in parallel with existing national systems until 1 January 2002. It would also need to be capable of dealing with all current and anticipated future waste streams in order to allow comprehensive reporting of holdings. It will serve regulatory purposes and improve communication to the public, for example on free access to environmental information (Directive 90/313/EEC).4. Current positionThe classification systems used in the Member States and the central and east European countries who have applied for membership of the EU have been described by the EU(3). This EC report gives extensive information on the individual countries classification systems.The classification systems can be briefly described as follows.4.1. EU Member StatesBelgiumRadioactive waste is classified separately in Belgium according to whether it is unconditioned or conditioned. The categorisation of unconditioned waste depends on the physical state, the nature of the emitters, the level of activity concentration and the applicable treatment. These characteristics are summarised by a three position alphanumeric. Conditioned waste is defined according to the disposal route and split into three categories, A, B and C. The classification is based on suitability for surface or deep disposal and on the heat generating capacity of the conditioned waste. An additional type of waste is currently being considered, this is radium contaminated waste. No other changes to the classification system are expected.DenmarkDisposal of radioactive waste has not been considered in Denmark to date, hence only storage is taken into account in the classification system. The system is based mainly on the origin of the waste and to some extent on measurement and sorting. On arrival at the storage facility the waste is classified according to external radiation, after treatment the waste units are stored in either the low level waste or low intermediate level waste storage facility according to dose rate and fissile content. Spent sealed sources are stored at Risoe National Laboratory. No revisions are expected to the classification system.FinlandRadioactive waste is firstly classified into two main types of waste, radioisotope waste and nuclear waste. Radioisotope waste comes from hospitals, research institutes and industry, whereas nuclear waste results from nuclear power plants and from a research reactor. Radioisotope waste is further classified according to its activity concentration into cleared waste or laboratory waste. Nuclear waste is split into three categories according to its origin and intended disposal route, high level spent fuel, low and intermediate level waste from NPP operation and low and intermediate level waste from decommissioning NPPs. The low and intermediate level waste is then classified further into cleared waste, low level waste and intermediate level waste according to activity concentration. No changes to the classification system are expected.FranceIn the nuclear industry, waste is divided between conventional waste and nuclear waste according to its geographical and functional origin (zoning of the installations). For nuclear waste the classification system is a matrix linking the toxicity of the waste to the disposal routes. Two parameters are distinguished for defining the toxicity of the waste: lifetime of the main radionuclides (under or over 30 years) and activity content (very low, low, intermediate and high). On this basis the classification system presents eight categories of waste, each linked to one or more management pathways. Some of the pathways are still under study.GermanyThe radioactive waste classification system for Germany is related to the disposal site. Classifications are established by the operator as a result of site specific safety assessments taking into account the legally binding acts, ordinances and regulations. Quantitative requirements are then set for the specific repository particularly including a system of waste form groups, waste container classes and radio-nuclide specific activity limitations. No basic changes to the classification system are expected.GreeceThere is no official classification system for radioactive waste in Greece, as the only radioactive waste produced is from research institutes, hospitals and industry. However, users must have a license, issued by the Regulatory Authorities, if they wish to perform activities that generate radioactive waste.The radio-protection regulation is currently undergoing modification which could have an effect on the classification system.IrelandAs there are no nuclear power plants or fuel-cycle facilities in Ireland radioactive waste is classified simply by half life and then according to whether it is a sealed or unsealed source. No modifications to the existing system are foreseen.ItalyThe basis of the classification system for conditioned waste in Italy is the disposal route. Radioactive waste is classified into three categories, according to the radio-isotopic characteristics and activity concentrations. Category I waste is that which decays in a few months to below clearance levels, the remaining waste is classified according to half-life and activity content into Category II and III. Category II is further divided into two subcategories dependent on their conditioning requirements prior to final disposal.The only changes envisaged are to "Technical guide No 26" which will be revised to incorporate technical requirements for HLW, vitrified waste and ILW (non-heat generating).NetherlandsNo decision has been taken as yet on the disposal route for radioactive waste therefore the classification system concentrates on the treatment and conditioning of radioactive waste without foreclosing on any disposal option. There are three categories of radioactive waste, each of which has a number of sub-categories. Category 1 includes all low and intermediate level waste below a set dose rate and is subdivided according to the origin, radionuclide content and half-life. Categories 2 and 3 waste are classified depending on heat production and then subdivided according to origin and type of waste respectively. No modifications to the existing system are foreseen.PortugalThe classification of radioactive waste is defined according to disposal route. There are three categories, short-lived low level waste (from research, medicine and industry, also includes beta/gamma spent sealed sources with half-life less than 30 years, conditioned via separate routes), Alpha waste (mainly radium and americium spent sealed sources) and uranium mining and milling waste. No modifications to the existing system are foreseen.SpainThe Spanish classification system has two waste categories based on the disposal option planned or applied to them, these are low and intermediate level waste which is suitable for near surface disposal and all other waste. In addition to this, specific criteria are set for individual disposal sites; these are requirements relating to the properties of the waste package, the conditioning, and specific radio-nuclides as well as for the site as a whole.No modifications to the existing system are foreseen, although clarification may be needed in the wording used to describe the management of spent fuel, currently HLW, as a result of the recent Vienna Conventions on the safe management of spent fuel.SwedenRadioactive waste is divided into nuclear and non-nuclear waste, for example waste arising from hospitals and research institutions. Some low level nuclear waste is disposed of in shallow surface repositories, according to criteria on activity concentration and total activity. Nuclear waste which is not cleared or disposed of in shallow surface repositories is classed into three disposal routes. These are rock repository for operational waste (operational), rock repository for decommissioning waste (planned) and a repository for spent fuel and other long lived wastes (planned). Non-nuclear waste which cannot be cleared is conditioned and then disposed of with nuclear waste, or stored awaiting construction of planned facilities. No changes to the classification system are expected.United KingdomThe United Kingdom has four broad categories of radioactive waste, classified according to the heat generating capacity and the activity content of the waste. The four categories are very low level waste, low level waste, intermediate level waste and high level waste.A 1995 policy review indicated that there was a possible need for revisions to the waste classification system in light of EU deliberations. Any change to the system could be phased in with implementation of the new Euratom basic safety standards.4.2. Central and east European CountriesBulgariaBulgaria has three categories of radioactive waste classified according to the equivalent dose rate of gamma emission at a distance of 0,1 m from the surface or the value of specifc alpha or beta activity. Institutional waste and spent sealed sources are classified under the scheme above.Czech RepublicThe Czech Republic does not have a classification system which is specified in the regulations. However the regulations require waste generators to establish their own classification system, according to their system of treatment and conditioning and the technology used and with respect to criteria set by the State Office for Nuclear Safety. For national communication purposes the categories low and intermediate level waste, high level waste and spent fuel are used, although these are not defined.EstoniaEstonia is in the process of changing the radioactive waste classification system and the new regulation is expected to be in place by the end of 1998. Until that time Estonia continues to use the old USSR classification system (SPORO-85). SPORO-85 sets clearance limits for radioactive waste based on specific activity and surface contamination. Radioactive waste is then divided into three groups, items, biological waste and spent radiation sources. These groups are then subdivided into three groups according to dose rate.HungaryHungary's waste categorisation system is based on the source of the waste and activity concentration. The three categories are low level waste, intermediate level waste and high level waste, depending on the activity concentration or the surface dose rate of the radioactive waste.LatviaThe Latvian authorities are in the process of drafting new regulations on radioactive waste management. The new system will be based on disposal routes with waste categorised according to half-life and activity content. Existing waste can be put into three categories, waste disposed of in old vaults, waste stored in new vaults and spent sealed sources held in interim storage.PolandIn Poland limits are given for establishing whether waste is considered to be radioactive waste or not, once this has been established the radioactive waste is classified according to radio-nuclide content (beta/gamma or alpha) and closed radiation sources. Beta/gamma waste is then further grouped into low, intermediate and high level waste according to activity concentration. Additional criteria are given for individual packages for storage and disposal.RomaniaRadioactive waste is placed in three categories, high, intermediate and low level waste in Romania according to the specific activity or the surface dose rate. Solid low level waste is then further categorised into combustible, non-combustible or special waste. Combustible waste is sub-categorised into biodegradable and non-biodegradable and non-combustible waste according to whether it can be compacted or not. Uranium mining and milling waste is classified separately according to its physical characteristics and activity concentration. The current radioactive waste management system is to be reviewed in the near future and a classification system based on the IAEA system and EC recommendations is envisaged.Slovak RepublicThere is no formal classification system as yet in the Slovak Republic. A qualitative system is widely used which has low, intermediate and high level waste categories, however there are no specific limits for the categories. The current system is based mainly on the source of the radioactive waste but a revision of the system is under way and the new system is likely to be based on the disposal route.SloveniaSlovenia has three categories of radioactive waste: low level waste, intermediate level waste and high level waste. These are based on the source of the waste with limits set on the specific activity. The categories of low and intermediate level waste are subdivided into waste with alpha emitters and those with beta/gamma emitters. There is work ongoing on a classification system based on the IAEA system with the inclusion of the exemption approach.5. Commission's proposed classification systemRadioactive waste management systems should be established according to the characteristics and properties of the waste, and its potential to cause harm to humans and/or impact on the environment. Acceptance criteria for radioactive waste in a disposal facility are derived from (and supported by) safety assessments that have to consider the specific conditions relevant to the case (regulatory requirements, repository concept, assessment context, etc.). These conditions are even more important when trying to define acceptance criteria for near-surface facilities. They include the disposal concept, the type and role of engineered and natural barriers, the type and period of institutional control assumed to exist, and the scenarios to be considered in the assessments.Any radioactive waste classification system based on disposal, for general use, can only be qualitative (indicative), unless important features of the safety assessment can be fixed in advance with a great degree of realism and credibility.Such an indicative system provides a qualitative description of the individual waste categories. In this case, most of the general characteristics of the radioactive waste are used as criteria for the classification. Nevertheless numerical values to characterise broad bands or "orders of magnitude" for some key properties are also helpful.The European Commission classification system is based on the IAEA classification scheme(4) with some changes to take into account the views and practical experiences of European national experts. For instance the IAEA recommended limit of heat generation in LILW radioactive waste (2 kW/m3), was not retained. The experts could not find any foundation for such a value and commonly accepted that this value is only related to site-specific safety analysis. This classification system deals only with materials which contain or are contaminated by radionuclides and for which no further use is foreseen (Council Directive 92/3/Euratom(5)).The classification scheme is intended for use with solid waste only, however it should be noted that some liquid waste could be covered by the proposed transition waste category (mainly hospital and medical radioactive waste).The classification system could be used initially in parallel with national systems until 1 January 2002. National technical classification criteria should not be replaced as they are based on specific safety considerations such as licensing of facilities or other operations. It should be noted that no simple classification scheme can address all the issues associated with its use, these would need to be dealt with in separate, more detailed, guidance. However, it should be made clear that a well described and supported, but basically qualitative waste classification scheme still provides a lot of useful information to facilitate information management on radioactive waste and improve communication actions at European level.The following paragraphs describe the proposed classification system based on radioactivity content, duration and thermal power generated.5.1. Transition radioactive wasteType of radioactive waste (mainly from medical origin) which will decay within the period of temporary storage and may then be suitable for management outside of the regulatory control system subject to compliance with clearance levels. It is suggested to use five years as the maximum duration, beyond this period of five years the waste should be regarded as low and intermediate level waste. The clearance levels are values established by national competent authorities and expressed in terms of activity concentration and/or activity, at or below which radioactive substances or materials containing radioactive substances arising from any practice subject, to the requirement of reporting or authorisation may be released from the requirements of Directive 96/29 Euratom. These levels shall follow the basic criteria used in Annex 1 to the Euratom basic safety standards to Council Directive 96/29/Euratom and shall take into account any other technical guidance provided by the European Community.5.2. Low and intermediate level waste (LILW)In LILW the concentration of radionuclides is such that generation of thermal power during its disposal is sufficiently low. These acceptable thermal power values are site-specific following safety assessments.5.2.1. Short-lived waste (LILW-SL)This category includes radioactive waste with nuclides within half-life less than or equal to those of Cs137 and Sr90 (around 30 years) with a restricted alpha long-lived radionuclide concentration (limitation of long-lived alpha emitting radionuclides to 4000 Bq/g in individual waste packages and to an overall average of 400 Bq/g in the total waste volume).5.2.2. Long-lived waste (LILW-LL)Long-lived radionuclides and alpha emitters whose concentration exceeds the limits for short-lived waste.5.3. High level wasteWaste with such a concentration of radionuclides that generation of thermal power shall be considered during its storage and disposal (The thermal power generation level is site-specific and this waste is mainly forthcoming from treatment/conditioning of spent nuclear fuel).6. ConclusionsThe Commission recommends the Member States and their industry to adopt the proposed classification system for national and international communication purposes.This classification system should be used for providing information concerning solid radioactive waste to the public, the national and international institutions and the non-governmental organisations.The Commission recommends the use of this classification system by Member States. During the period to 1 January 2002 it could be used in parallel with existing national systems.Therefore it seems useful that the Commission addresses a recommendation to the Member States for a classification system for solid radioactive waste.(1) Council Resolution of 15 June 1992 on the renewal of the Community plan of action in the field of radioactive waste (OJ C 158, 25.6.1992, p. 2).(2) Council Directive Euratom 96/29 of 13 May 1996 laying down basic safety standards for the health protection of the general public and workers against the danger of ionising radiation (OJ L 159, of 29.6.1996, p. 1).(3) Radioactive waste categories. Current Position (98) in the EU Member States and in the Baltic and central European countries. 1998 EUR-OP Luxembourg EUR 18324.(4) IAEA Safety Series No 111-G-1.1 Classification of radioactive waste, A safety guide. Vienna 1994.(5) OJ L 35, 12.2.1992, p. 24.


title: Recommendation for a Council opinion in accordance with the third paragraph of Article 5 of Council Regulation (EC) No 1466/97 of 7 July 1997 on the updated stability programme of Italy, 2002-2006

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title: Council Recommendation of 10 July 2012 on the National Reform Programme 2012 of the United Kingdom and delivering a Council opinion on the Convergence Programme of the United Kingdom, 2012-2017

text:
               24.7.2012

               EN

               Official Journal of the European Union

               C 219/91

         COUNCIL RECOMMENDATION
   of 10 July 2012
   on the National Reform Programme 2012 of the United Kingdom and delivering a Council opinion on the Convergence Programme of the United Kingdom, 2012-2017
   2012/C 219/27
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 121(2) and 148(4) thereof,
   Having regard to Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies (1), and in particular Article 9(2) thereof,
   Having regard to Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances (2), and in particular Article 6(1) thereof,
   Having regard to the recommendation of the European Commission,
   Having regard to the conclusions of the European Council,
   Having regard to the opinion of the Employment Committee,
   After consulting the Economic and Financial Committee,
   Whereas:

               (1)

               On 26 March 2010, the European Council agreed to the Commission’s proposal to launch a new strategy for jobs and growth, Europe 2020, based on enhanced coordination of economic policies, which focuses on the key areas where action is needed to boost Europe’s potential for sustainable growth and competitiveness.

               (2)

               On 13 July 2010, the Council adopted a recommendation on the broad guidelines for the economic policies of the Member States and the Union (2010 to 2014) and, on 21 October 2010, adopted a decision on guidelines for the employment policies of the Member States (3), which together form the ‘integrated guidelines’. Member States were invited to take the integrated guidelines into account in their national economic and employment policies.

               (3)

               On 12 July 2011, the Council adopted a recommendation (4) on the UK’s National Reform Programme for 2011 and delivered its opinion on the UK’s updated Convergence Programme for 2011-2014.

               (4)

               On 23 November 2011, the Commission adopted the second Annual Growth Survey, marking the start of the second European Semester of ex ante and integrated policy coordination, which is anchored in the Europe 2020 strategy. On 14 February 2012, the Commission, on the basis of Regulation (EU) No 1176/2011, adopted the Alert Mechanism Report, in which it identified the UK as one of the Member States for which an in-depth review would be carried out.

               (5)

               On 1 December 2011, the Council adopted conclusions calling on the Social Protection Committee, in cooperation with the Employment and other Committees, to present its views on actions recommended within the Europe 2020 policy cycle. These views form part of the opinion of the Employment Committee.

               (6)

               The European Parliament has been duly involved in the European Semester, in accordance with Regulation (EC) No 1466/97, and, on 15 February 2012, adopted a resolution on employment and social aspects in the Annual Growth Survey 2012 and a resolution on the contribution to the Annual Growth Survey 2012.

               (7)

               On 2 March 2012, the European Council endorsed the priorities for ensuring financial stability, fiscal consolidation and action to foster growth. It underscored the need to pursue differentiated, growth-friendly fiscal consolidation, to restore normal lending conditions to the economy, to promote growth and competitiveness, to tackle unemployment and the social consequences of the crisis, and to modernise public administration.

               (8)

               On 30 April 2012, the UK submitted its Convergence Programme covering the period 2011-12 to 2016-17 and its National Reform Programme for 2012. In order to take account of their interlinkages, the two Programmes have been assessed at the same time. The Commission has also assessed, in an in-depth review under Article 5 of Regulation (EU) No 1176/2011, whether the UK is affected by macroeconomic imbalances. The Commission concluded in its in-depth review that the UK is experiencing an internal imbalance, although not an excessive one.

               (9)

               Pursuant to paragraph 4 of the Protocol (No 15) on certain provisions relating to the United Kingdom of Great Britain and Northern Ireland, the obligation in Article 126(1) of the Treaty on the Functioning of the European Union to avoid excessive general government deficits does not apply to the UK unless it adopts the euro. Paragraph 5 of the Protocol provides that the UK is to endeavour to avoid an excessive government deficit. On 8 July 2008 the Council decided, in accordance with Article 104(6) of the Treaty establishing the European Community, that an excessive deficit exists in the UK.

               (10)

               Based on the assessment of the Convergence Programme pursuant to Regulation (EC) No 1466/97, the Council is of the opinion that the macroeconomic scenario underpinning the budgetary projections in the Programme is plausible. The objective of the budgetary strategy outlined in the Convergence Programme is to implement the necessary fiscal consolidation to achieve the Government’s fiscal targets on net debt and cyclically-adjusted current balance. The Convergence Programme does not include a medium-term budgetary objective as foreseen by the Stability and Growth Pact. According to programme projections, the deadline to correct the excessive deficit set by the Council in its recommendation of 2 December 2009 is expected to be missed by one year. The government deficit in 2014-15, the deadline set by the Council, is estimated at 4,4 % of GDP, implying, based on the (recalculated) structural balance (5), an average fiscal effort of 1,25 % of GDP between 2010-11 and 2014-15 which is below the 1¾ % effort set out in the Council recommendation under the excessive deficit procedure (EDP). Although the Government has not deviated from its fiscal consolidation strategy which initially, based on previous macroeconomic projections, appeared sufficient to comply with EDP targets, the fiscal performance and outlook have been affected by a deterioration of economic growth prospects. Revenue measures have been significantly front-loaded in the adjustment path of the fiscal consolidation. Almost 40 % of the total annual fiscal consolidation planned for the 2010-11 to 2014-15 period has been achieved by the end of 2011-12, including 30 % of the spending cuts and two thirds of the net tax increases. The potential revenue contribution from an increased efficiency of the tax system, stemming from a review of the VAT rate structure, remains relatively underexploited.
               According to the Convergence Programme, the general government deficit is expected to be 8,3 % of GDP in 2011-12, 5,9 % of GDP in 2012-13, 6,0 % of GDP in 2013-14, 4,4 % of GDP in 2014-15, 2,9 % of GDP in 2015-16 and 1,2 % of GDP in 2016-17. These estimates are somewhat lower than those given in the Commission services 2012 spring forecast, namely, a deficit of 6,1 % of GDP in 2012-13 (which would be 7,9 % without an upcoming one-off pension fund transfer) and 6,5 % of GDP in 2013-14. The differences stem from a lower growth forecast and amendments made by Eurostat to UK data. Some adjustments were made to the Government’s fiscal plans in the 2011 Autumn Statement to prioritise growth-enhancing expenditure, but public sector investment is still set to fall sharply by 2014-15. Government debt, forecast at 94,7 % in 2013-14, is expected to peak in 2014-15.

               (11)

               The run-up to the crisis saw the housing market overheat, with house price-to-income ratios reaching historic highs in the context of a growing housing supply shortage, leading to the accumulation of high levels of mortgage debt. According to the Commission’s in-depth review, high household debt constitutes an internal imbalance in the UK economy. Due to a high share of variable interest rate mortgages, household finances are vulnerable to interest rates rises, with a potentially destabilising knock-on effect on the economy as a whole via the financial sector. A sustained and significant fall in household debt is only likely if house prices fall relative to disposable income; however, if nominal house prices were to fall rapidly it would risk pushing many households into negative equity. Residential construction remains at record lows, due both to a restrictive planning system and cyclical weakness, and wider housing market activity is also still muted. In November 2011, the Government published its housing strategy for England, which aims to facilitate an increase in residential construction, but significant uncertainty remains about the net impact of the new system on housing development. Also, the housing strategy did not mention the issue of property taxation: the UK system combines a regressive recurring tax (council tax) with a progressive transaction tax (the Stamp Duty Land Tax (SDLT)), which may play a role in cyclical developments in budget revenues and financial stability. Some adjustments were made to SDLT rates in the 2012 Budget, but only minor changes have been made in this field overall.

               (12)

               The UK has growing challenges with respect to unemployment and labour market participation. Unemployment in the UK currently stands at 8,4 %. Youth unemployment is much higher, at 22,2 %, and more than 38 % of the unemployed in the UK are under 25 years of age. Furthermore, 17,7 % of young people (16-24 year olds) are not in employment, education or training. Private sector employment has been growing modestly, but not enough to offset reductions in public sector employment and the growth of the workforce. The UK has an oversupply of low-skilled workers, for whom demand is falling, and a shortage of workers with high-quality vocational and technical skills that are particularly needed by goods producing and exporting sectors in which the UK’s performance is relatively weak. The main focus in vocational education and training (VET) policy is on basic skills and level 2 qualifications, while the economy increasingly demands more advanced VET qualifications. The UK also continues to have a relatively high number of adults with very poor basic literacy and numeracy skills, who are not well placed to benefit from vocational training. Early school-leaving has increased by 3,3 percentage points since 2005 and, at 14,9 %, is above the EU average; continued support for low-income families is crucial to prevent young people from dropping out of school.

               (13)

               The Government has a welfare reform agenda to help more people get into work, while supporting the most vulnerable. The Universal Credit, which aims to simplify the benefit system, has not yet been implemented. The Government must take measures to ensure that the positive impact of new policies on employment and incomes will not be offset by declining amounts available for benefits, which would risk increasing poverty, particularly for families with children. One independent estimate forecasts that, in 2020-21, absolute child poverty will reach its highest level since 2001-02 and that the Government will miss targets for reducing child poverty set down in the Child Poverty Act. The Government needs to take steps to ensure that there is sufficient access to childcare, in particular for low earners. Any cuts to support for childcare would risk exacerbating the problem.

               (14)

               Financing conditions remain tight, particularly for small and medium-sized enterprises (SMEs) and net lending to the corporate sector was negative in 2011. Survey evidence shows that a significant number of SMEs are credit constrained, while there are also potential challenges on the demand side. Additionally, access to non-bank lending remains largely restricted to bigger firms, and competition in the banking industry is limited. Notwithstanding the steps taken by the authorities to improve the situation, the Breedon taskforce on alternative debt markets has estimated a substantial ongoing financing gap over the next five years, especially for SMEs.

               (15)

               The UK has a challenge to improve its energy and transport infrastructure, which is linked to laying the foundations for long-term growth and competitiveness, and to addressing the causes of the UK’s lack of external competitiveness in manufacturing sectors. The UK needs substantial investment to upgrade its electricity generation capacity, given the need to replace a large part of the existing generating capacity, which will close over the next decade, and the need to meet the renewable energy obligation and tighter carbon emissions standards. The UK’s transport sector faces shortcomings in the capacity and quality of its networks, which could work against the Government’s aim of rebalancing the UK economy towards investment and exports. As part of the Government’s fiscal consolidation strategy, public sector net investment will fall sharply by 2014-15, which risks exacerbating existing pressures on transport infrastructure unless alternative funding sources can be secured.

               (16)

               In the context of the European Semester, the Commission has carried out a comprehensive analysis of the UK’s economic policy. It has assessed the Convergence Programme and National Reform Programme, and presented an in-depth review. It has taken into account not only their relevance for sustainable fiscal and socioeconomic policy in the UK, but also their compliance with EU rules and guidance, given the need to reinforce the overall economic governance of the Union by providing EU-level input into future national decisions. Its recommendations under the European Semester are reflected in recommendations (1) to (6) below.

               (17)

               In the light of this assessment, the Council has examined the Convergence Programme, and its opinion (6) is reflected in particular in recommendation (1) below.

               (18)

               In the light of the results of the Commission’s in-depth review under Article 5 of Regulation (EU) No 1176/2011 and this assessment, the Council has examined the National Reform Programme and the Convergence Programme. Its recommendation under Article 6 of Regulation (EU) No 1176/2011 is reflected in particular in recommendations (2), (3) and (6) below,

         HEREBY RECOMMENDS that the United Kingdom take action within the period 2012-2013 to:

               1.

               Fully implement the budgetary strategy for the financial year 2012-13 and beyond, supported by sufficiently specified measures, to ensure a timely correction of the excessive deficit in a sustainable manner and the achievement of the structural adjustment effort specified in the Council recommendations under the EDP and to set the high public debt ratio on a sustained downward path. Subject to reinforcing the budgetary strategy for the financial year 2013-14 and beyond, prioritise growth-enhancing expenditure to avoid the risk that a further weakening of the medium-term outlook for growth will negatively impact on the long-term sustainability of public finances.

               2.

               Address the destabilising impact of high and volatile house prices and high household debt by implementing a comprehensive housing reform programme to increase housing supply and alleviate problems of affordability and the need for state subsidisation of housing. Pursue further reforms to the housing market, including the mortgage and rental markets, financial regulation and property taxation to prevent excessive volatility and distortions in the housing market.

               3.

               Continue to improve the employability of young people, in particular those not in education, employment or training, including by using the Youth Contract. Ensure that apprenticeship schemes are taken up by more young people, have a sufficient focus on advanced and higher-level skills, and involve more small and medium-sized businesses. Take measures to reduce the high proportion of young people aged 18-24 with very poor basic skills.

               4.

               Step up measures to facilitate the labour market integration of people from jobless households. Ensure that planned welfare reforms do not translate into increased child poverty. Fully implement measures aiming to facilitate access to childcare services.

               5.

               Further improve the availability of bank and non-bank financing to the private sector, in particular to SMEs. Support competition within the banking sector, in particular through measures to reduce barriers to entry, increase transparency and facilitate switching between banks as recommended by the Independent Commission on Banking and explore ways to improve access to venture and risk capital and other forms of non-bank lending.

               6.

               Pursue a long-term strategy for improving the capacity and quality of the UK’s network infrastructure, including measures to address pressures in transport and energy networks by promoting more efficient and robust planning and decision-making processes, and harnessing appropriate public or private financing arrangements.

      Done at Brussels, 10 July 2012.

            For the Council

            The President

         V. SHIARLY

      (1)  OJ L 209, 2.8.1997, p. 1.

      (2)  OJ L 306, 23.11.2011, p. 25.

      (3)  Maintained for 2012 by Council Decision 2012/238/EU of 26 April 2012 on guidelines for the employment policies of the Member States (OJ L 119, 4.5.2012, p. 47).

      (4)  OJ C 217, 23.7.2011, p. 12.

      (5)  Cyclically-adjusted balance net of one-off and temporary measures, recalculated by the Commission services on the basis of the information provided in the Programme, using the commonly agreed methodology.

      (6)  Under Article 9(2) of Regulation (EC) No 1466/97.