Exemption of lead oxides used in manufacture of piezo ceramic materials under Article 58(2) REACH

Transcription

1 Ref. Ares(2015) /11/2015 Exemptin f lead xides used in manufacture f piez ceramic materials under Article 58(2) REACH Shuld lead mnxide and lead tetrxide be the subject f an authrisatin, that authrisatin culd in any event be restricted t use f these substances in manufacture f piez ceramic materials and hence this is the scpe f the REACH Article 58(2) exemptin hereby requested. Article 58(2) f REACH allws t exempt frm the authrisatin requirement uses r categries f uses prvided that, n the basis f the existing specific Cmmunity legislatin impsing minimum requirements relating t the prtectin f human health r the envirnment fr the use f the substance, the risk is prperly cntrlled. The piece f legislatin has t define the measures t be implemented by the actrs and t be enfrced by authrities in a way that ensures the same minimum level f cntrl f risks thrughut the EU and that this level can be regarded as prper. Accrding t guidance issued by the Eurpean Chemicals Agency, legislatin impsing "minimum requirements" means that Member States may adpt mre stringent, but nt less stringent requirements when implementing the specific EU legislatin in questin. By cntrast, harmnizatin measures such as legislatin impsing EU-wide ccupatinal expsure limits amunt t maximum requirements; the Eurpean Chemicals Agency states in its guidance n Article 58(2) f REACH that where ccupatinal expsure limits exist, applicatins fr an exemptin under that prvisin is mre likely t succeed. The fllwing elements shall be cnsidered when deciding whether t include an exemptin f a use f a substance in its recmmendatin. (i) There is existing Cmmunity legislatin 1 addressing the use (r categries f use) that is prpsed t be exempted. Special attentin has t be paid t the definitin f use in the legislatin in questin cmpared t the REACH definitins. Furthermre, the reasns fr and effect f any exemptins frm the requirements set ut in the legislatin have t be assessed. (a) Existing lead specific Cmmunity legislatin exists fr this industrial use f lead mnxide and lead tetrxide in manufacturing f piez ceramic materials, as fllws: Cuncil Directive 98/24/EC n the prtectin f the health & safety f wrkers frm the risks related t chemical agents at wrk (CAD), as implemented by Directives 2000/39/EC, 2006/15/EC, 91/322/EC and 2009/161/EU establishing lists f indicative ccupatinal expsure limit values in implementatin f Directive 98/24/EC as amended 1 Only existing EU legislatin is relevant in the cntext t be assessed (nt natinal legislatin).

2 Cuncil Directive 92/85/EEC - Prtectin f pregnant/breast feeding wrkers Cuncil Directive 94/33/EC n the prtectin f yung peple at wrk The Industrial Emissins Directive 2010/75/EC replacing Directive 96/61/EC n Integrated Pllutin Preventin and Cntrl (IPPC) Cuncil Directive 2008/50/EC n ambient air quality and cleaner air fr Eurpe Cuncil Directive 2000/60/EC establishing a framewrk fr Cmmunity actin in the field f water plicy Cuncil Directive 98/83/EC n the quality f water intended fr human cnsumptin Cuncil Directive 2006/118/EC n the prtectin f grundwater against pllutin and deteriratin Cuncil Directive 86/278/EEC n the prtectin f the envirnment, and in particular sil, when sewage sludge is used in agriculture (ii) This Cmmunity legislatin prperly cntrls the risks t human health and/r the envirnment frm the use f the substance arising frm the intrinsic prperties f the substance that are specified in Annex XIV. Lead mnxide and lead tetrxide were identified as a Substance f Very High Cncern (SVHC) accrding t article 57 (c) as they are classified in Annex VI, part 3, Table 3.1 (the list f harmnised classificatin and labelling f hazardus substances) f Regulatin (EC) N 1272/2008 as Txic fr Reprductin, Categry 1A, [H360D ( May damage the unbrn child )], and were therefre included in the candidate list fr authrisatin n 19/12/2012, fllwing ECHA s decisin ED/169/2012. It is this intrinsic prperty that can result in their prpsal fr inclusin in Annex XIV. It is therefre imprtant t assess whether existing cmmunity legislatin already prperly cntrls risks t human health and the envirnment arising frm this intrinsic prperty. In ding s, ECHA has t cnduct a detailed assessment f the relevant legislatin s as t determine nt nly whether such legislatin exists but als whether it sets ut measures that already adequately cntrl the relevant risks. Such assessment must be cnducted by ECHA in cncret n a case-by-case basis. This analysis is described belw: a. Wrker health cntrls The health hazards f lead mnxide and lead tetrxide are well established and an EU wide harmnised classificatin exists thrugh an entry in Annex VI, part 3, Table 3.1 (the list f harmnised classificatin and labelling f hazardus substances) f Regulatin (EC) N 1272/2008. This triggers requirements fr specific packaging and labelling and thrugh REACH article 31 the prvisin f Safety Data Sheets t prvide dwnstream users (including wrkers) with infrmatin n hazards and risk management measures.

3 During the industrial use f lead mnxide and lead tetrxide in manufacturing f piez ceramic materials, the health risk assciated with lead expsure is prperly cntrlled by the specific requirements f three f the afrementined legislative acts: Cuncil Directive 98/24/EC n the prtectin f the health & safety f wrkers frm the risks related t chemical agents at wrk; Cuncil Directive 92/85/EEC Prtectin f pregnant/breast feeding wrkers; and Cuncil Directive 94/33/EC n the prtectin f yung peple at wrk. Mrever, the s called OSH Framewrk Directive (Cuncil Directive 89/391/EC) als cntains minimum safety and health requirements thrughut Eurpe that are applicable t wrkers emplyed in the manufacture f piez ceramic materials such as use f persnal prtective equipment (thrugh Directive 89/656). Cuncil Directive 98/24/EC n the prtectin f the health & safety f wrkers frm the risks related t chemical agents at wrk The Chemical Agents Directive (CAD) seeks t prtect wrkers frm the effects f chemical agents that are present at the wrkplace r as a result f any wrk "activity invlving chemical agents", which is defined as "any wrk in which chemical agents are used, r are intended t be used, in any prcess, including prductin, handling, strage, transprt r dispsal and treatment, r which result frm such wrk". This wuld include the industrial use f lead cmpunds in manufacturing f piez ceramic materials. The risks t the health f wrkers at wrk that is linked t ccupatinal expsure t lead are cntrlled (in particular) by the impsitin f a binding ccupatinal expsure limit f 0.15 mg/m 3 as specified in Annex 1 t the Directive and a binding bilgical limit value f 70 µg Pb/dL bld and health surveillance measures. Lead (and its inic cmpunds) remains the nly substance listed in the CAD fr which binding ccupatinal expsure and bilgical expsure limits are mandated. Article 10 f Directive 98/24/EC, indicates that where a binding bilgical limit value has been set fr a chemical, health surveillance is cmpulsry and emplyees shall be infrmed f this requirement befre being assigned t the task invlving risk r expsure t the hazardus chemical agent indicated (currently this is nly relevant t Lead and its inic cmpunds). These binding limits are clearly sufficient t adequately cntrl the risks frm the fur lead cmpunds used in manufacturing f piez ceramic materials; in fact, they even g beynd impsing minimum cmmunity wide standards n Member States by way f establishing harmnized ccupatinal expsure limits. Lking at thse measures in cncret reveals that regular expsure reprts and studies are cllected by several Member States authrities n a yearly basis [see UK HSE statistics at that shw that the industry fully cmplies with these expsure limits and that, as a result, any risks t wrkers health are already adequately cntrlled]. Mrever CAD als defines additinal measures t be implemented by the actrs and t be enfrced by authrities in a way that ensures the same minimum level f cntrl f risks presented by lead and lead cmpunds thrughut the EU. This is highlighted by the requirements utlined in Articles 4 t 11 and Annex II t the Directive, which impse psitive bligatins n the emplyer, t be assessed against measurable indicatrs. Fr instance Annex II specifies that bilgical mnitring f lead expsed

4 wrkers must include measuring bld lead levels using absrptin spectrscpy (r an equivalent methd), and detailed medical surveillance must be carried ut if expsure t lead in air is greater than mg/m 3 (8hr TWA) r if a bld lead level greater than 40 µg/dl is measured in individual wrkers. Thus mechanisms exist t identify and, if necessary, remve wrkers shuld risks frm lead expsure be such that ccupatinal ill-health culd result and befre any statutry limits are exceeded. In additin, Cmpany emplyee bld lead data cllected fr purpses f cnducting a chemical safety assessment as required by REACH Articles 10 & 14 has indicated that fr the piez ceramic materials manufacturing sectr f all the measured bld lead is belw the DNEL f 40 µg/dl. Cuncil Directive 92/85/EEC Prtectin f pregnant/breast feeding wrkers As lead mnxide and range lead/lead tetrxide are classified as Txic fr Reprductin, Categry 1A, [H360D ( May damage the unbrn child ) it is imprtant t evaluate whether this intrinsic prperty is adequately addressed by existing Cmmunity legislatin. Mrever, in the recent RAC pinin fr harmnised classificatin f lead metal it was cncluded that effects n r via lactatin (Lact. - H362 (R64)) shuld be cnsidered in a harmnised classificatin prpsal as a result f evidence in humans that under extreme cnditins levels f lead in breast milk culd exceed WHO guidelines. This pinin culd als be extraplated t ther lead cmpunds. Specific risks t the unbrn child and t infants that are breastfeeding are addressed by the requirements f Article 6 t Directive 92/85/EC that specifically lists lead and lead derivatives (in Annex II A and B) as substances fr which pregnant wrkers and wrkers breastfeeding are prhibited frm expsure if a risk assessment has indicated expsure wuld jepardise safety r health. In specifically listing lead and its cmpunds as substances impacted by the requirements set ut in Article 6 prhibiting expsure, we believe that this Directive als impses binding minimum standards fr prtectin f pregnant and breastfeeding wrkers t lead cmpund expsure that are applicable acrss the EU. Cuncil Directive 94/33/EC n the prtectin f yung peple at wrk It has been prpsed that the develping brain f yung peple is particularly sensitive t the effects f lead. It is therefre re-assuring that this element f risks t wrkers is als cvered by lng standing Cmmunity legislatin in the frm f Cuncil Directive 94/33/EC n the prtectin f yung peple at wrk. Article 7 (2) b ensures that Member States prhibit the emplyment f yung peple fr wrk invlving harmful expsure t agents which are txic, carcingenic, cause heritable genetic damage r harm t the unbrn child r which in any ther way affects human health. Lead and its cmpunds are specifically described in Annex t this Directive as agents fr which Article 7 (2) applies. b. Envirnmental cntrls Althugh the prpsal fr inclusin f lead mnxide and lead tetrxide in Annex XIV relates predminantly t health risks it is als relevant t reprt that manufacturing facilities using lead and

5 cmpunds are als cvered by existing Cmmunity legislatin ensuring that envirnmental releases are apprpriately managed. Ambient Air Quality Directive 2008/50/EC The Air Quality Directive requires that ambient air quality must be mnitred thrughut the territry f the Member States, wh must ensure that the levels f lead in ambient air d nt exceed the limit value f 0.5 µg/m 3. In ding s this legislatin can be seen t meet the requirement t specifically refer t lead cmpunds and set a minimum requirement fr cntrl f risk in establishing a limit value fr lead in Annex XI that Member States shall ensure ambient air des nt exceed. The Industrial Emissins Directive (IED) 2010/75/EC This Directive is a recast f six previus directives cncerning integrated pllutin preventin and cntrl (2008/1/EC12), waste incineratin (2000/76/EC), slvent emissins (1999/13/EC) and three cncerning waste frm the titanium dixide industry and sets ut t achieve a high level f prtectin fr the envirnment taken as a whle frm harmful effects f industrial activities. As frm January 2016 IED will als replace Directive 2001/80/EC n the limitatin f emissins f certain pllutants frm large cmbustin plants. The key prcesses in manufacturing piez ceramic materials are regulated directly by requirements f the IED. Permit cnditins and pllutant emissin limit values (ELVs) therein have t be set n the basis f the applicatin f best available techniques (BAT). Cmpetent Authrities shall set emissin limit values that ensure that, under nrmal perating cnditins, emissins d nt exceed the emissin levels assciated with the best available techniques as laid dwn in the decisins n BAT cnclusins. Binding EU-wide Assciated Emissin Limit Values (A-ELVs) have recently been established fr several industries manufacturing r using lead. Water Framewrk Directive (WFD) 2000/60/EC The WFD cmmits Eurpean Unin Member States t achieve gd qualitative and quantitative status f all water bdies (including marine waters up t ne nautical mile frm shre) by The strategy fr achieving this invlves the identificatin f pririty substances amngst thse that pse a significant risk t, r via, the aquatic envirnment at Eurpean Unin level. The Water Framewrk Directive fresees in its articles 16 and 17 tw crucial Daughter Directives, n quality f grundwater and n quality f surface waters. The Pririty Substances Directive (2008/105/EC) lists lead and its cmpunds and lays dwn assciated Envirnmental Quality Standards (EQS) that Member States shuld take int accunt fr the first time in river basin management plans cvering the perid 2015 t Inclusin f a lead EQS in the Pririty Substances Directive meets in ur pinin the REACH article 58(2) requirement t specifically mentin the substance and establish a Eurpe wide standard. (iii) This Cmmunity legislatin impses minimum requirements 2 fr the cntrl f risks f the use. Attentin shuld be paid as t whether and hw the risks related t the life-cycle 2 There needs t be binding and enfrceable minimum requirements in place fr the substance(s) used. Legislatin impsing minimum requirements means that: - The Member States may establish mre stringent but nt less stringent requirements when implementing the specific EU legislatin in questin.

6 stages resulting frm the uses in questin (i.e. service-life f articles and waste stage(s), as relevant) are cvered by the legislatin. Frm the analysis made abve it wuld appear that the existing wrkplace legislatin fr lead impses specific minimum requirements fr the cntrl f health risks f the industrial use f the lead mnxide and lead tetrxide used in f piez ceramic materials manufacturing. Whilst nt directly applicable t the intrinsic hazards fr which inclusin in Annex XIV is being cnsidered (i.e. reprductive txicity) it is als evident that existing envirnmental legislatin cntains elements intended t prperly cntrl the risks t human health and/r the envirnment resulting frm release f lead frm f piez ceramic materials manufacturing facilities. We therefre cnclude that the scpe f authrisatin wuld be limited t the Industrial use f the substances as intermediate stages in the piez ceramic materials manufacturing prcess itself-nt the use phase f the piez ceramic materials. Ntwithstanding this being the case we wuld like t highlight that irrespective f this situatin there is existing EU legislatin cvering the marketing and end f life phases f lead-based batteries that are highlighted belw: Cuncil Directive 2000/53/EC n End-f-Life Vehicles The End f Life Vehicle Directive was adpted in September 2000 with the aim f reducing waste frm end f life cars as well as at the imprvement in envirnmental perfrmance f all the ecnmic peratrs invlved in the lifecycle f vehicles by ensuring that the cnstituent parts f a car can be recycled. As a key cmpnent in the functining f a car with exemptins. The general restrictin fr lead is > 0,1 % per weight and hmgeneus material with the fllwing exemptins: 10(a): Electrical and electrnic cmpnents which cntain lead in a glass r ceramic, in a glass r ceramic matrix cmpund, in a glass-ceramic material, r in a glass-ceramic matrix cmpund. This exemptin des nt cver the use f lead in: glass in bulbs and glaze f spark plugs, dielectric ceramic materials f cmpnents listed under 10(b), 10(c) and 10(d). a list f applicatin can be fund in fllwing reprt (p 184ff): df/_en_1.0_&a=d 10(b): Lead in PZT based dielectric ceramic materials f capacitrs being part f integrated circuits r discrete semicnductrs 10(c):Lead in dielectric ceramic materials f capacitrs with a rated vltage f less than 125 V AC r 250 V DC 10(d): Lead in the dielectric ceramic materials f capacitrs cmpensating the temperature-related deviatins f sensrs in ultrasnic snar systems Other Lead-Specific EU Legislatin - The piece f legislatin has t define the measures t be implemented by the actrs and t be enfrced by authrities in a way that ensures the same minimum level f cntrl f risks thrughut the EU and that this level can be regarded as apprpriate.

7 Lead and lead cmpunds als have an additinal plethra f existing EU legislatin t mitigate residual risks and drive substitutin in prducts where technically and ecnmically feasible. In the interests f brevity these are nt further discussed in this dcument but add t the weight f evidence that REACH authrisatin fr use f lead xides in manufacturing f piez ceramic materials wuld nt be an apprpriate regulatry actin in terms f prprtinality. There is an existing Directive 2011/65/EC n the restrictin f the use f certain hazardus substances in electrical and electrnic equipment (RHS) and Directive 2002/96/EC n waste electrical and electrnic equipment (WEEE). Under RHS there is a general restrictin fr lead > 0,1 % per weight and hmgeneus material with the fllwing exemptins: 7(c)-I: Electrical and electrnic cmpnents cntaining lead in a glass r ceramic ther than dielectric ceramic in capacitrs, e.g. piezelectrnic devices, r in a glass r ceramic matrix cmpund 7(c)-II: Lead in dielectric ceramic in capacitrs fr a rated vltage f 125 V AC r 250 V DC r higher Furthermre, the Directive 2002/96/EC n waste electrical and electrnic equipment (WEEE) prmtes f the cllectin and recycling cntributed effectively t reducing hazardus substances such as lead cntained in new EEE. A cmprehensive list f lead specific prduct legislatin is included in Appendix A Summary & Cnclusin The use f lead mnxide and lead tetrxide fr f piez ceramic material manufacture shuld be granted a REACH Article 58 (2) exemptin n the fllwing grunds: Existing Cmmunity legislatin already addresses the use categries t be exempted. The existing legislatin prvides binding and enfrceable minimum requirements fr the cntrl f risks frm industrial use f lead mnxide and lead tetrxide in f piez ceramic materials manufacturing. In having a binding ccupatinal expsure and bilgical limit fr lead, supprted by additinal measures such as medical surveillance, Cuncil Directive 98/24/EC ensures that harmnized, EU wide standards perate (althugh Member States can establish mre stringent but nt less stringent requirements). Existing Natinal statistics and expsure data gathered by Industry t supprt develpment f REACH chemical safety reprts and vluntary sectr wide vluntary bld lead reductin targets shws the effectiveness f the measures already in place under existing Cmmunity legislatin such that it prperly cntrls risk t human health frm the use f the substances arising frm their intrinsic prperties specified in Annex XIV. The existing legislatin cvers the risks related t the lifecycle stages resulting frm the use f the substances in piez ceramic material manufture and this is further supprted by

8 additinal legislatin. Appendix 1 Existing and Prpsed Lead Specific EU Legislative Acts Mixtures, articles and cnsumer prducts cntaining lead (and cmpunds) are regulated thrugh several EU directives with regard t their risk t human health. EU regulatins Directive 76/768/EC n csmetics Directive 98/83/EC n quality f water intended fr human cnsumptin Legal requirements List f substances that csmetic prducts must nt cntain (including lead and its cmpunds) Member States must ensure that all apprpriate measures are taken t reduce the cncentratin f lead in drinking water in cmpliance with parametric value f 10 µg/l Directive 98/70/EC n petrl prhibitin f leaded gasline (except aircraft) lead cntent < g/l Annex XVII f REACH: restrictin f the use f certain hazardus substances Directive 2011/65/EU n the restrictin f the use f certain hazardus substances in electrical and electrnic equipment (RHS) (including 2006 ATP) and Directive 2002/96/EC n waste electrical and electrnic equipment (WEEE) Direct restrictin f lead carbnates and sulphates in preparatins intended t be used as paints substances classified as CMR may nt be sld t the public (lead cmpunds are Repr. Cat 1 and lead hydrgen arsenate in Carc. Cat 1) substances restricted in a waste management perspective articles cncerned: electric light bulbs, luminaires, husehlds appliances, IT, telecmmunicatins and ffice equipment, hme equipment: tv, audi-visual equipment, lighting equipment, electrical and electrnic tls (such as watches), tys, leisure and sprts equipment and autmatic dispensers substances < 0.1% by weight in hmgeneus material electrnic mdules and used in quartz and watches (2006 ATP): maximum f 37% f lead in slder allys prmtin f the cllectin and recycling f such equipment Directive 2009/48/EC n tys ttal prhibitin f certain substances r preparatins in tys except thse which are essential t their functining. In this case, they are submitted t a maximum cncentratin defined fr each

9 substance individually Biavailability resulting frm the use f tys < 0.7 µg/day (EN 71-3) lead migratin limit frm tys = 90 mg/kg (EN 71-3) lead migratin limit = 13.5 mg/kg dry, brittle, pwder-like r pliable ty material lead migratin limit = 3.4 mg/kg liquid r sticky ty material lead migratin limit = 160mg/kg scraped-ff ty material Directive 84/500/EEC n ceramics articles intended t cme int cntacts with fdstuffs Directive 2005/31/EC.maximum permitted quantity f lead which can be extracted using standard methds is 0.8 mg/dm² fr articles which cannt be filled r which can be filled but nt deep (25mm), 1.5 mg/l fr cking ware and strage vessels which can be filled by mre than 3 litres and 4.0 mg/l fr ther articles (+50% f these threshlds tlerated) Amends Cuncil Directive 84/500/EEC as regards a declaratin f cmpliance and perfrmance criteria f the analytical methd fr ceramic articles intended t cme int cntact with fdstuffs Sectin 4.2 establishes quantificatin limits fr lead, which are set at < 0.2 mg/l. Regulatin (EC) N 1935/2004 n materials and articles intended t cme int cntact with fd and repealing Directives 80/590/EEC and 89/109/EEC Directive 2001/95/EC n General Prduct Safety 17 typlgies f materials and bjects destined t becme int cntact with fdstuffs are described. nly safe prducts fr cnsumers are placed n the market (cnceptin and/r infrmatin) infrmatin system (RAPEX) Directive 94/62/EC n packaging Cmmissin Regulatin 466/2001 n cntaminants in fdstuffs Directive 98/83/EC n quality f water intended fr human requirements n the design f packaging and packaging waste special article 11 n SVHC (including lead): cncentratin level in packaging and packaging cmpnents < 100 ppm (mg/kg) lead level in milk, meat, fish, shellfish, cereals, vegetables, fruits, berries, ils, fats, fruit juice and wine must be between 0.02 mg/kg by wet weight (cw s milk) and 1.5 mg/kg w.w. (mussels) lead cntent < 10 µg/l in water fr human cnsumptin

10 cnsumptin Directive 88/344/EEC n extractin slvents in fdstuffs Directive 88/388/EEC n flavurings fr use in fdstuffs and t surce materials fr their prductin Directive 69/493/EEG n crystal glass residues f slvents used in fd industry lead cntent in extractin slvents < 1 mg/kg lead cntent in flavurings < 10 mg/kg prescriptin f the use f lead in crystal glass >30% f cntent f lead in full crystal glass cat. 1 [24%, 30%[ f cntent f lead in full crystal glass cat. 2 Cmmissin regulatin (EU) N 836/2012 f 18 September 2012 amending Annex XVII t Regulatin (EC) N 1907/2006 f the Eurpean Parliament and f the Cuncil n the Registratin, Evaluatin, Authrisatin and Restrictin f Chemicals (REACH) as regards lead REACH Restrictin prpsal fr lead in cnsumer articles Quality f Petrl and Diesel Fuels Directive 2003/17/EC Cuncil Directive 1999/45/EC n the classificatin, packaging and labelling f dangerus preparatins Cuncil Directive 91/689/EEC n hazardus waste The prhibitin f the placing n the market and use f lead and its cmpunds in metallic and nn-metallic parts f jewellery articles, if the lead cncentratin is equal t r greater than 0.05% by weight f the individual part, unless it can be demnstrated that the rate f lead released des nt exceed the limit f 0.05 μg/cm 2 /h (0.05 μg/g/h). In March 2013, ECHA launched a public cnsultatin n the fllwing restrictin prpsal frm Sweden: Lead and its cmpunds shall nt be ( ) used in articles ( ), which are supplied t the general public and which can be placed in the muth by children, if the cncentratin f lead ( ) is equal t r greater than 0.05% by weight. Limit values f g Pb/L gasline, amends Cuncil Directive 98/70/EC, which itself amended Cuncil Directive 85/210 EEC All preparatins cntaining dangerus substance classified under directive 67/548/EEC abve a certain threshld have t be classified accrdingly. Labels f packages f paints and varnishes cntaining Pb in quantities exceeding 0.15% (expressed as weight f metal) f the ttal weight f the preparatin must cntain warnings Sets ut requirements fr management f waste cntaining Pb abve a certain level (ther hazardus waste t

11 Cuncil Directive 76/769/EEC n restrictins n the marketing and use f certain dangerus substances and preparatins Cuncil Directive 67/548/EEC n the classificatin, packaging and labelling f dangerus substances Prhibited use f Pb sulphates and Pb carbnates in paints (with minr exceptins). Directive was amended by Cuncil Directive 89/677/EEC which banned the use f all Pb based paint in residential applicatins Classifies sme Pb cmpunds in categries depending n their epidemilgical and envirnmental effects In additin, there is a number f internatinal initiatives and agreements which will have affected emissins t the envirnment, the results f which are still be realised in terms f changes in envirnmental cncentratins. These include: OSPAR Cnventin fr the Prtectin f the Marine Envirnment f the Nrth East Atlantic; UNECE Cnventin n Lng-Range Transbundary Air Pllutin (CLRTAP); Basel Cnventin n the Transbundary Mvements f Hazardus Wastes and their Dispsal; and Helsinki Cnventin n the Prtectin f the Marine Envirnment f the Baltic Sea Area. OSPAR The OSPAR Cnventin was initiated t prtect the marine envirnment f the Nrth-East Atlantic. As part f the Cnventin, a number f strategies have been develped t address the main threats t this envirnment. These include the Hazardus Substances Strategy which is intended t prevent pllutin f maritime areas by n-ging reductins in the release f hazardus substances; its ultimate aim is t achieve near backgrund levels fr thse substances which ccur naturally (e.g. Pb, mercury) r clse t zer fr anthrpgenically-generated substances. As part f this strategy, BAT requirements fr varius industrial prcesses that result in Pb emissins were published (e.g. OSPAR Recmmendatin 98/1 cncerning Best Available Techniques and Best Envirnmental Practice fr the primary nn-ferrus metal industry). It shuld be nted that much f the reprting requirements under OSPAR have nw ceased as they have been surpassed by the IPPC directive BREFs. CLRTAP The Cnventin n Lng-Range Transbundary Air Pllutin (CLRTAP) was signed in 1979 and entered int frce in As the first reginal envirnmental cnventin, CLRTAP has been instrumental in the reductin f key harmful pllutants in bth Eurpe and Nrth America. The Cnventin has been extended by eight Prtcls (including the Aarhus Prtcl, which is summarised belw), fcused upn setting strict reductin targets fr releases f pllutin fr the prtectin f human and envirnmental health. Each f these Prtcls targets pllutants such as

12 sulphur, nitrgen xide, persistent rganic pllutants, vlatile rganic cmpunds, ammnia, and txic heavy metals (including Pb). The CLRTAP requires Cntracting Parties t develp the best plicies and strategies including air quality management systems and, as part f these, cntrl measures cmpatible with balanced develpment, in particular by using the best available technlgy which is ecnmically feasible and lw and nn-waste technlgy, in particular relatin t new r rebuilt installatins. As mentined, the CLRTAP has been extended by eight specific prtcls, ne f which, the Aarhus Prtcl, relates t heavy metals. The Prtcl, adpted in 1998 and entered int frce n the 29th December 2003, targets heavy metals, in particular cadmium, Pb and mercury. The main bjective f the Prtcl is t cntrl emissins f heavy metals caused by anthrpgenic activities that are subject t lng-range transbundary atmspheric transprt and are likely t have significant adverse effects n human health r the envirnment. One f the basic bligatins requires Parties t reduce emissins belw 1990 levels (r an alternative year between 1985 and 1995). The Prtcl aims t cut emissins frm industrial surces (e.g. irn and steel industry, nn-ferrus metal industry), cmbustin prcesses (pwer generatin, rad transprt) and waste incineratin. Parties are required t implement emissin standards fr these pllutants fr statinary surces, based n the best available technlgies suggested in the prtcl. In additin, parties undertake t phase ut the use f leaded petrl and t intrduce measures designed t lwer heavy metal emissins frm ther prducts. Under the prtcl, parties are t develp strategies, plicies and prgrams, withut undue delay, t discharge their bligatins under the prtcl. A range f measures are suggested fr this purpse, including ecnmic instruments, gvernment/industry cvenants and vluntary agreements, mre efficient use f resurces, use f less plluting surces, develpment f a less plluting transprt system, phasing ut certain plluting industrial prcesses and develping cleaner prcesses. Parties are free t adpt mre stringent measures than thse required by the prtcl. As fr ther prtcls, the heavy metals prtcl prmtes technlgy exchange and ther frms f c-peratin between the parties. Parties must reprt peridically t the Executive Bdy n measures taken t implement the prtcl, with cmpliance verseen by the Implementatin Cmmittee (Sands 2003). As f 15 Nvember 2011, 31 f the 36 signatries had ratified the prtcl t at least sme extent. Basel Cnventin Under the Basel Cnventin, Member Parties must reprt data n the generatin and mvement f hazardus wastes (including thse cntaining Pb). Twards this end, an annual questinnaire is sent t Member States requesting infrmatin n the generatin, exprt and imprt f the varius hazardus wastes cvered by the Cnventin. It is the respnsibility f the designated respnsible natinal Agencies ( fcal pints ) t submit the required infrmatin t the Secretariat. This infrmatin is reviewed and cmpiled by the Secretariat and presented as an annual reprt that rutinely includes statistical tables and graphic representatins f data. Helsinki Cnventin

13 The mst recent Helsinki Cnventin (gverned by HELCOM) fr the Prtectin f the Marine Envirnment f the Baltic Sea Area entered int frce n the 17 January 2000 and cvers the whle f the Baltic Sea area, including inland waters as well as the water f the sea itself and seabed. Pb is included under Appendix 3 f HELCOM recmmendatin 19/5, which establishes a list f selected substances fr immediate pririty actin under the Cnventin. With specific relevance t industry, HELCOM recmmendatin 25/3 (adpted 2nd March, 2004), aims t reduce emissins and discharges frm industry by effective use f the Best Available Technique (BAT) fr the identified hazardus substances, and cntains a number f specific prvisins fr Pb (e.g. fr the waste incineratin and glass industry).