sou · GLB384d4 · 1998-01-01 00:00:00 — Ett tillsynsprojekt riktat mot importörer och tillverkare av bilvårdsprodukter genomfördes och resulterade i krav på förbättringar på märkning, varuinformationsblad, utbyteskrav på klorerade lösningsmedel m.m. BKL, bildades med målsättning att aktivt höja kunskapsnivån och engagemang för hälso- och miljöfrågor bland sina medlemmar. Projektet har följts upp genom inspektionsverksamhet 1990 och 1994. Bland resultaten kan nämnas att bl.a. klorerade lösningsmedel, kortkedjiga glykoletrar och fluorvätesyra ersatts i stor utsträckning. Avfettningsmedel till personbilsmarknaden har volymmässigt halverats sedan 89/90 och sammansättningen har ändrats så att totalvoly- men ingående lacknafta har minskat . Av- fettningsmedel baserade på vegetabiliska oljederivat har ökat liksom alkaliska produkter. Tensider har bytts ut mot mer lättnedbrytbara och nonyfenoletoxylater är i stort sett borta. Parallellt med dessa projekt har information i form av vägledning, information till lokala myndigheter, branschen och konsumenter intensifierats. Kriterierna för positiv miljömärkning av bilvårdsprodukter blev klara . Som ett stöd för det lokala tillsynsarbetet har inspektio- nen 1995 publicerat Råd & Tips - Bilkemikalier. I en första rapport om färgprodukter gjordes en genomgång av den kemiska sammansättningen av färger och hur olika komponenter påverkar miljön och användar- nas hälsa. Färger sprids i stora volymer och nästan allt utsläpp sker vid användningen. Det innebär att det är i användareledet som spridningen till miljön måste minska. Rapporten lämnar förslag till åtgärder för att minska risker med färger. Mot denna bakgrund har kemikalieinspektionen kontrol- lerat leverantörer av färg till konsument- och yrkesmåleri. Syftet var att påskynda leverantörernas arbete med att utveckla mindre farliga produkter och att minska använd- ningen av ämnen/ämnesgrupper i färger som innebär stora risker, bl.a. lösningsmedel som lacknafta, blyföreningar, alkylfenoletoxylater, klorparaffiner och vissa biocider som diklofluanid, diuron, folpet, karbendazim, klormetylisotiazo- linon/ metylisotiazolinon och klortalonil. Ett annat syfte med inspektionerna var att driva på utvecklingen av företagens rutiner för kemikaliekontroll och förbättring av produktinformationen. Kraven resulterade i förbättrade rutiner och en redovis- ning av arbetet med att minska riskerna med de utpekade ämnena/ämnesgrupperna genom att företagen preciserade sina avvecklings- och utvecklingsplaner. T.ex. utvecklas lösningsmedelsfria träoljor och färger med alternativa biocider. Den totala volymen använd lacknafta har varit och aromatnafta är fyra gånger så vanlig som alifatnafta. Både aromatisk lacknafta och alifatisk lacknafta ger samma bidrag till bildningen av marknära ozon och bör minska i användning. Med anledning av färgprojektet har inspektionen initierat en grupp med representanter från myndigheter och branschen för att utbyta information och följa upp de planerade avvecklingarna. Parallellt med dessa projekt har information i form av vägledning, information till lokala myndigheter, branschen och konsumenter intensifierats. Allmänheten informeras via broschyrer och massmedia. Arkitekter och byggentreprenör- er får riktad information. Som ett stöd för det lokala tillsynsarbetet har inspektio- nen 1996 publicerat Råd & Tips - Färghandel. Produktområdet tvätt- och rengöringsmedel har genomgått en betydande utveckling. I den utredning som Kemikalieinspektionen presenterade till regeringen föreslogs bl a att tillverkarna ökar andelen tensider som är biologiskt lättnedbrytbara, att tensiden DSDMAC med dålig nedbrytbarhet och giftighet mot vattenorganismer avvecklas i textilsköljmedel och att leverantörer inom två år ser till att maskindiskmedel och maskintvättsystem är klorfria till . Företagens utvecklingsarbete har inneburit att avveck- lingen av klorblekmedlen natriumhypoklorit och klorisocya- nurater i konsumentprodukter för maskindisk och maskintvätt är genomförd. Industri- och konsumentan- vändningen av DSDMAC i textilsköljmedel har upphört.Mer är av de tensider som används i produktgruppen är biologiskt lättnedbrybara. I en rapport från Kemikalieinspektionen redovisa- des en produktstudie av gummidäck. Det förbrukas ca däck i och gummimassa slits av på vägarna. Ett gummidäck består till av gummiblandning, resten är stål och textil. Den huvud- sakliga mjukgöraren i gummiblandningar för personbilsdäck är högaromatoljor som är ett oljeextrakt från raffinaderier. Dessa högaromatiska oljor utgör den största risken från hälso- och miljösynpunkt när gummidäck slits, liksom vid okontrollerad förbränning. De har hög inneboende farlighet (bl.a cancer och akvatisk toxicitet) och används i stor volym. Gummidäcksbranschen har insett att de högaromatiska oljorna bör bytas ut och utvecklingsarbetet för nya alternativ pågår. Regummering av däck för personbilar kan ske utan användning av högaromatiska oljor. Ett antal däcktillverkare testar nya däck utan tillsats av högaromatiska oljor. Syftet med flamskyddsmedelsprojektet var att analysera risken för hälsa och miljö förknippade med flamskyddsme- del samt att föreslå riskbegränsande åtgärder. Projektet har omfattat alla typer av flamskyddsmedel i bland annat plaster, textil och gummi. Flamskyddsmedel tillverkas inte i utan ämnena importeras som kemiska ämnen eller som ingrediens i plast- och gummicompound som bearbetas i varor. mängden flamskyddsmedel importeras i varor och kompo- nenter till varor som tillverkas utomlands. Därför har arbetet drivits internationellt för att påverka samman- sättningen för importerade varor. Arbetet bedrivs i flera internationella organ bl.a. där industrin har gjort ett åtagande som rör produktionen av polybromerade difenyletrar och polybromerade bifenyler. har också drivit frågan om bromerade flamskydds- medel inom och föreslagit en utfasning av de polybromerade bifenylerna. Nationellt verkar Kemikalieinspektionen för att de branscher som använder flamskyddsmedel ska vidta åtgärder genom att uppmärksamma dem på de negetiva effekter polybromerade bifenyletrar och bifenyler kan ha. Genom uppgifter från produktregistret har en viss minsk- ning av användning noterats. 10 An Outline of A paper prepared for Since the first Action Programme on the Environment of 1973 the EC has steadily developed an environmental policy. This is largely embodied in items of legislation in contrast with other policy areas e.g. for agriculture and for the regions, which is largely composed of financial instruments e.g. price setting and grants. EC environmental legislation now covers all the traditional fields that have been developed by the Member States e.g. pollution of air and water, disposal of waste, radioactivity, nature protection, noise, climate change, and hazardous substances (chemicals). In addition there are certain 'horizontal' subjects e.g. environmental impact assessment and freedom of access to information. It is also a requirement of the that 'environmental protection requirements must be integrated into the definition and implementation of other Community policies'. 262 An Outline of Policy There is extensive EC legislation to prevent pollution of air, of water, and concerning disposal of waste. It is a general characteristic of this legislation that each item relates to a narrow subject (e.g. incinerators, bathing water) and often sets numerical standards to be met by deadlines. Several environmental quality standards and emission standards have been set, often relating to specific chemical substances, in addition to procedures to be followed e.g. the need for authorisation, plans, consultation, and publication. There are also three principle 'framework' Directives i.e. implying that details will be provided in subsequent 'daughter' Directives, or dealt with by Member States themselves:- -Directive 76/464 relating to discharge of dangerous substances to water -Directive 84/360 relating to air pollution from industrial plants -Directive 75/442 relating to waste. The framework Directives on air and water will eventually be replaced by the newly adopted Directive 96/61 on integrated pollution prevention and control which requires certain industrial installations to be authorised so as to protect "the environment taken as a whole". Manufacturers and authorities will thus have to think about all emissions and impacts in the design of the whole plant ('clean technology') rather than relying on 'end-of-pipe' solutions dealing with air or water alone. From these pollution Directives lists of controlled chemicals emitted as waste to air, water and land can be drawn up including chemicals covered by the Declaration. An Outline of Policy 263 EC chemicals policy (i.e. concerned with the manufacture and use of chemicals rather than the emission of chemicals as waste) dominates national policy in all Member States more completely than other sectors of EC environmental policy for two reasons: -Chemicals policy directly affects traded products so that the EC became involved even before the first Action Programme on the Environment of 1973. The free movement of goods has been one of the underlying objectives of the EC long before it adopted an environmental policy. -Chemicals policy is relatively new and EC policy developed before Member States had established coherent policies of their own. In many respects it is original and is not modelled on pre-existing national schemes. 3.2 Standards for and the Internal Market The fact that chemicals are traded products (or incorporated into traded products, or emitted when traded products are used, e.g. fuel, cars) creates an exception to the general rule of EC environmental policy that Member States may introduce more stringent measures than laid down in EC legislation. This general rule, set out in Article 130t of the Treaty, only applies to legislation adopted under the environmental Articles 130r and s. It does not apply to legislation relating to the internal market adopted under Article 100a unless an exception is made. This complicated subject will be discussed in a subsequent paper, but the underlying reason can briefly be explained as follows. If country A adopts more stringent standards for a 264 An Outline of Policy manufacturing process than contained in EC legislation, then country A will benefit from an improved environment, and if it suffers an economic disadvantage because of increased production costs that is its own choice. If however country A adopts more stringent standards for a traded product than EC standards, then country B manufacturing to EC standards will be unable to export to country A without incurring the extra costs of having to manufacture to two sets of standards. Country B is therefore disadvantaged and the internal market is fragmented. The Commission is bound by the Treaty to preserve the integrity of the internal market, and will tend to view any proposed national standards that are higher than the EC standard with suspicion since it might be an attempt to protect domestic interests. Indeed many technical standards were simply disguised trade barriers. There are some exceptions to the rule that Member States may not set more stringent standards, but the EC has yet fully to confront the fact that its reluctance to allow higher national standards may inhibit innovation. 3.3Testing new chemicals before marketing The Directive that gave Policy its reputation for innovation is Directive 79/831 known as the 'sixth amendment' (now replaced by 92/32 - the 'seventh amendment'). This requires the manufacturer of a new chemical to submit a notification with the results of tests to evaluate possible harmful effects, and an assessment of the results, to a competent authority which then passes the results to the Commission and in turn to the authorities in other Member States. If no objections are raised within 60 days the manufacturer then has assured access to the whole EC market. The Directive is thus an embodiment of the precautionary or preventative approaches to environmental policy, while at the same time serving the purposes of the internal market. It can be assumed that some harmful An Outline of Policy 265 chemicals will not have been developed to the point of production (without the authorities necessarily knowing) because of the scheme. No had a similar scheme before 1979 (and did not have one before joining the EC). Part of the success of the Directive comes from its adoption before conflicting national rules developed. It was welcomed by chemical industry because it strengthened the EC's hand when negotiating with the as the US Toxic Substances Control Act 1976 came to be implemented. The scheme is dependent on mutual trust between authorities in different countries, since most countries accept without question the views of the country of notification. The notification submitted to the competent authority must include: -a technical dossier of information relating to testing and studies -a declaration concerning potential unfavourable effects in terms of the various foreseeable uses -the proposed classification and labelling -proposals for recommended precautions for safe use (if necessary the EC can adopt restrictions on marketing of use - see 3.6 below). General principles for the assessment of risks of new substances are laid down in Directive 93/67 which draws a distinction between 'hazard' and 'risk'. 'Hazard' is a property intrinsic to a substance e.g. its toxicity. 'Risk' relates to the likelihood of harm and so depends on likely exposure. The test methods laid down are based on those recognised or recommended by competent international bodies (in particular). An defines the 'base set' of information required with every notification. Another defines two further levels or steps (hence the term step sequence testing). The first additional level (level 1) beyond the base set must be considered once 100 per year or 500 in all of a substance have 266 An Outline of Policy been marketed, but competent authorities may already require these tests at one tenth this amount. Level 2 is reached when 1000 per year are marketed (or 5000 total) and then a further programme of tests must be drawn up by the competent authority. These tests concern primarily long term health and environmental effects (e.g. toxicity to aquatic species) and their predictive ability and cost increase with each level. A 'new' substance is a substance not listed in EINECS (European Inventory of Substances) as having been on the market before . 100,000 substances are listed. List of Substances (ELINCS) should be updated annually. EINECS and ELINCS are available on . By 1993 over 2,300 notifications had been made, the proportion by country being as follows: 3.4Classification and packaging and labelling The 'sixth' and 'seventh' amendment Directives 79/831 and 92/32 are amendments to a much older Directive 67/548 which concerned only classification, packaging and labelling of dangerous substances. The original Directive was adopted before EC environmental policy began. It was based on recommendations of driven by the need to avoid conflicting national rules in Member States. As now amended, substances are to be classified on the basis of their intrinsic properties according to 15 danger categories, one of which is 'dangerous for the environment'. The list of classified substances is updated periodically and together with EINECS and ELINCS it is An Outline of Policy 267 also available on . A separate Directive 88/379 deals with classification and labelling of dangerous preparations i.e. mixtures or solutions of two or more substances. It is to be consolidated with the Directives on classification and labelling of pesticides (see 3.7 below). The new consolidating Directive has been made necessary by the new category 'dangerous for the environment'. at Ispra, undertakes scientific and technical work arising out of the 'seventh' amendment and other EC chemicals legislation. The US Toxic Substances Control Act 1976 applies to both 'new' and 'existing' chemicals. In the EC the scheme for 'existing' chemicals i.e. those listed in EINECS, developed more slowly and was only agreed 14 years after the scheme for 'new' chemicals. It is still too young for its success to be evaluated. Regulation 793/93 requires manufacturers or importers who make or import more than certain quantities of existing substances (including pesticides) to send the Commission existing data relevant for an evaluation of risk. This data is used to draw up priority lists of substances which need to be examined in more detail. These are then assessed to see whether they pose a particular risk for man or the environment, the work being divided between the Member States. If necessary the Commission can then propose restrictions on marketing and use (see 3.6 below). Manufacturers who produce or import more than 10 per year are to submit data to the Commission on a computer software package (HEDSET). All readily available data on physico-chemical, toxicological and eco-toxicological properties are to be submitted. The Commission consolidates the submissions, and together with national lists of priority substances, uses it to draw up priority lists for detailed assessment. The lists are to be adopted by a 268 An Outline of Policy Committee including representatives of Member States. The factors to be taken into account in drawing up the priority lists are: effects, exposure, lack of data on effects, work already carried out in other international fora, other EC legislation and/or programmes relating to dangerous substances. Special attention is paid to substances which may be carcinogenic or have other chronic effects. Each substance on the priority list is then allocated to a which designates a rapporteur to carry out the assessment. Within six months of publication of the priority list manufacturers/importers of listed substances are to submit to the rapporteur all available information relevant for risk assessment. If any of the 'base set' of data (see 3.3 above) are not available for a priority substance, the manufacturers/importers must carry out the necessary testing and report to the rapporteur within 12 months. The rapporteur is to evaluate the information and decide whether the manufacturer/importer is to be required to supply further information or carry out further testing. decides whether the request for further information is to be imposed and the time limits. The rapporteur evaluates the risk of the substance and can suggest a strategy for limiting risks including control measures and/or surveillance programmes. Where restrictions on marketing or use are recommended, the rapporteur must submit an analysis of the advantages and drawbacks of the substance and of the availability of replacement substances. Risks are to be assessed on the basis of principles set out in Regulation 1488/94 which makes the same distinction between 'hazard' and 'risk' as is made when assessing new chemicals (see 3.3 above). Tests on animals are to be avoided. The rapporteur forwards its conclusions to the Commission and the recommended strategy can be adopted by the committee and published. The first two priority lists were published in 1994 and 1995 and contained 42 and 36 substances respectively. The first strategy to be proposed to limit risk will possibly relate to short chain chlorinated An Outline of Policy 269 paraffins used in cutting oils. The allocation of priority substances among the Member States can be a sensitive matter and the process of evaluation is not necessarily value free. Thus if chemical X is manufactured in country A, and the rapporteur is country B, in which an alternative chemical Y is manufactured, there may be an incentive for country B to recommend restrictions on chemical X to increase the market for chemical Y. 3.6Restrictions on marketing and use Only rarely has the manufacture of a substance been banned in the EC, examples being ozone depleting substances banned by the EC Regulations that implement the Protocol. Instead restrictions on marketing and use of substances can be imposed under Directive 76/769. That Directive was adopted as a result of a draft French law introduced to implement the 1973 decision to restrict PCBs but the which lists the restricted substances also included PCTs and monomer vinyl chloride. Extra substances can be added by adopting daughter Directives adding to the annex which now includes e.g. asbestos, leaded paints, anti-fouling paints, pentachlorophenol (PCP), cadmium, fire retardants, carcinogens, mutagens, creosote, and chlorinated compounds. There have been numerous controversies relating to the Directive. One concerns the decision of to maintain its existing laws which were more stringent than Directive 91/173 restricting PCP. The Commission granted a derogation not to apply the exemption that allowed the use of PCP in treatment. challenged this in the Court of on the grounds that the Commission had failed to assess 's argument that its stricter measures were justified. The Court (Case C41/93) annulled the derogation solely on procedural grounds and the Commission then issued a new derogation accompanied by a justification. This was the first case 270 An Outline of Policy before the Court on the use of Article 100a(4) - the 'environmental guarantee'. Another controversy surrounded a proposal made in 1991 for a Directive covering the marketing of 7 PBB ethers some of which are present in commercial flame retardants. This would effectively have banned all currently used PBBEs which are typically a co-formulation of different PBBE compounds. Several Member States were concerned that the proposal ignored the comparative risks and benefits of PBBE, and potential alternatives. Parliament declined to give an opinion on the proposal until the Commission published a related proposal on furniture flammability, and in 1995 the Commission withdrew its proposal. Discussions on PBBEs, is now taking place under the scheme for existing chemicals (see 3.5 above). EC pesticides legislation is in the process of evolution and is only briefly described here. Directive 78/631 concerns labelling and Directive 79/117 places restrictions on use. Several other Directives set levels on residues in food. Directive 91/414 concerning approval of pesticides will eventually replace Directive 79/117 concerning restrictions on use. Directive 91/414 seeks to harmonise the pesticides registration schemes of Member States by eventually replacing them with an EC approval scheme. National approval schemes will still be required for products not covered by the Directives. The Directive provides for the compilation of an EC authorised list of ingredients. Member States will remain responsible for the authorisation of pesticide products, but a number of EC principles must be respected including the principle of mutual recognition of pesticide product authorisations granted by Member States, although certain exceptions are permitted. The principle exception arises when a can establish that agricultural, plant health or environmental An Outline of Policy 271 conditions in its own territory are not comparable to those in the granting authorisations. A separate Directive 94/43 laid down 'uniform principles for evaluation and authorisation of plant protection products' but was annulled by the Court of as a result of a case brought by Parliament. The Commission will have to propose a new Directive. The Parliament argued that Directive 94/43 amended Directive 91/414 without Parliament being consulted and would have effects on the quality of groundwater. A Directive on biocidal products (i.e. non agricultural pesticides) is expected to be adopted shortly.