sou · H2B390 · 2015-01-01 00:00:00 — ligt att till en rimlig samhällsekonomisk kostnad fasa ut BPA från termopapper så fort lagstiftningsprocessen inom EU och medger samt från ytskikt i kontakt med livsmedel . Jag föreslår därför att regeringen formulerar mål för en sådan utfasning med detta tidsperspektiv. Därigenom får alla berörda aktörer en tydlig tidsram för arbetet med att fasa ut användningen av BPA. Utfasningen skulle främjas av en reglering inom EU. bör därför driva på för en sådan reglering i alla relevanta EU-organ. Om en EU-reglering inte kan förutses inom de när- maste åren, kan det finnas behov av en nationell reglering. Ifråga om BPA i ytskikt i kontakt med livsmedel bedömer jag att de åtgärder som behövs för att åstadkomma en utfasning bör utformas på ett sådant sätt att den utfasning som sker på eget initiativ inom livsmedels- och förpackningsmaterials- kedjan verkligen genomförs – och det inom hela handeln. Grunden för en eventuell reglering av BPA bör enligt min upp- fattning i första hand vara dess inneboende hormon- och repro- duktionsstörande egenskaper. Detta innebär att ett förbud mot BPA i ytskikt i kontakt med livsmedel, såsom lagstiftningen på området är utformad , bör införas i kemikalieförbudsförord- ningen. Ett förbud kan också införas i livsmedelsförordningen men måste då baseras på en riskanalys eftersom ett förbud i denna förordning inte enbart kan baseras på ämnets särskilt farliga inne- boende egenskaper. Konsekvensanalysen tyder på att det behövs en skälig omställ- ningsperiod och att ett eventuellt förbud bör kunna gälla från . Jag bedömer att detta datum är rimligt oavsett när ett beslut om förbud fattas. Det innebär att ett sent beslut leder till en kortare omställningstid för branschen. Eftersom det redan pågår en utfasning bör dock en kortare omställningsperiod i det fallet inte vara ett stort problem. Ett tidigt beslut kommer å andra sidan under alla omständigheter behöva en omställningsperiod ända och kommer således inte innebära ett snabbare genom- förande i praktiken. Däremot kan ett alltför tidigt beslut leda till vissa negativa kon- sekvenser. Om den pågående frivilliga utfasningen ersätts med en regeldriven, kan det medföra att de berörda företagen blir mindre motiverade att genomföra utfasningen så snabbt som möjligt. Där- med uppstår en risk att utfasningens tyngdpunkt förskjuts från början av omställningsperioden till slutet av densamma. Till detta kommer att så länge den frivilliga utfasningen löper väl skulle kommissionen kunna bedöma att ett tidigt förslag till nationellt förbud är oproportionerligt och/eller inte nödvändigt. Slutligen kan det finnas skäl för att avvakta utvecklingen och i ett senare skede välja livsmedelsvägen om t.ex. nytillkommet veten- skapligt underlag ändrar förutsättningarna för en riskbedömning som stöder ett nationellt förbud i livsmedelsförordningen. Oavsett vilken förordning eller väg som väljs för ett förbud måste räkna med att dras in i en överträdelseprocess med osäker utgång. Regeringen bör därför avvakta dels utvecklingen av utfasningen av BPA inom livsmedels- och förpackningsmaterialkedjan, dels Efsas utvärdering och den efterföljande EU-processen, innan den tar ställning till om det behövs ytterligare reglering på detta om- råde, och i så fall vilken typ av reglering som behövs. Av den orsaken föreslår jag att utfasningen av BPA i ytskikt som har kontakt med livsmedel utvärderas vid en kontrollstation . Om det visar sig att det finns en risk att målet om en utfasning inte nås och om de pågående EU- processerna inte leder till att kommissionen agerar för en reglering på EU-nivån, bör regeringen överväga nationella åtgärder inklusive regleringar enligt de alternativ som beskrivs i detta betänkande. Den huvudsakliga källan till exponering från livsmedel är, som framgår ovan, ytskikt i livsmedelsförpackningar av metall. Även kött och fisk kan dock innehålla sådana halter av BPA att de påverkar människors exponering. Källan till förekomsten är okänd och för att hantera exponeringen från dessa källor bör detta undersökas närmare. Ifråga om termopapper bör regeringen avvakta utgången av den pågående EU-processen. Om inte denna process leder till att Kom- missionen förbjuder ämnet enligt artikel 69 i Reach bör regeringen undersöka möjligheten att införa ett nationellt förbud i kemikalie- förbudsförordningen utifrån de förutsättningar som gäller då EU- processen slutförts. Ett förbud bör baseras på Kemikalieinspek- tionens förslag . Jag bedömer att det finns ett legitimt skyddsintresse och att en sådan åtgärd är proportionerlig samt icke diskriminerande. Farorna med BPA är väl dokumenterade och de samhällsekonomiska effekterna överkomliga. Dessutom kan re- ringen, om BPA blivit klassificerat så att krite- rierna i artikel 68.2 uppfylls, lämna ett förslag till begränsning enligt denna artikel till kommissionen. Ännu en möjlighet som kan övervägas är att tillämpa produktsäkerhetsdirektivet. Det är mycket viktigt att exponeringen för farliga kemikalier såsom BPA minskar överlag och att offentliga aktörer genom exempelvis information och vid upphandling bidrar till detta. Sådana åtgärder, från central nivå, som är särskilt inriktade mot BPA skulle dock kunna leda till en snedvridning av myndigheternas arbete med att generellt minska riskerna från kemikalier. Jag lägger därför inga förslag ifråga om information eller märkning. är jag övertygad om att ett aktivt arbete med att minska användningen av farliga kemikalier inom offentlig verksamhet kan ge ett väsentligt bidrag till en minskning av exponeringen för BPA . Vidare bedömer jag att det inte är möjligt att fasa ut medicin- teknik som innehåller BPA innan fullgoda alternativ finns till- gängliga. Landstingen bör dock prioritera denna fråga. Jag föreslår att får i uppdrag att ta fram upphandlings- kriterier med avseende på kemikaliekrav vid upphandling av medicinteknik, liknande det uppdrag verket fått för upphandling till förskolor. För att skydda för tidigt födda barn som intensiv-vårdas är det också viktigt att andra källor till exponering minimeras. Jag konstaterar vidare att det behövs en större samordning mellan de institutionella systemen på kemikalie- respektive livsmedels- området. Dessa system verkar parallellt på delvis samma område, med varsin uppsättning av lagar, myndigheter och andra institu- tioner. Det är bl.a. önskvärt att möjligheten att fasa ut ämnen med särskilt farliga egenskaper på basis av deras inneboende egenskaper utsträcks till materiallagstiftningen inom livsmedelsområdet. Det finns olika sätt att åstadkomma detta. Liknande möjligheter finns i Reach, biocid- och växtskyddsmedelsförordningarna. bör utforma ett förslag om hur livsmedelslagstiftningen skulle kunna ändras på denna punkt och driva det i relevanta EU-organ. För att åstadkomma en ökad samstämmighet och effektivitet vid hante- ringen av farliga kemikalier i livsmedel behövs också utvecklade former för dialog, kunskapsutbyte och vid behov samordning. Slutligen är det angeläget att en utfasning av BPA inte leder till att denna kemikalie ersätts med ämnen som har eller kan befaras ha särskilt farliga egenskaper, t.ex. andra bisfenoler. 1 b Summary – how can a significant reduction in exposure to bisphenol A (BPA) be achieved? Proposals for targets and strategy I propose that the Government adopt the following targets and strategy to achieve a significant reduction in exposure to BPA: 1.By the beginning of 2020 BPA will generally no longer be present in coatings in contact with food. 2.A substantial reduction in BPA in coatings in contact with food will have occurred by 1 2017. At the same time, there will be a clear shift towards the phase-out that, under point 1, should have occurred by 2020. The basic principle will be that BPA is not substituted by other bisphenols or particularly hazardous substances. 3.The targets under points 1 and 2 are aimed at supporting and ensuring the phase-out initiated by the grocery trade and the food and packaging industries. If the target under point 2 is not met ahead of the checkpoint, the Government should consider a ban on BPA in coatings in contact with food. Regulation of BPA should be based primarily on its intrinsic properties of causing endocrine disruption and reproductive toxicity. On this basis, a ban can be incorporated into the (Handling, Import and Export Prohibitions) Ordinance (1998:944). A ban can also be incorporated into the Decree 2006:813, but such a ban cannot be based solely on particularly hazardous intrinsic properties. 4.The use of BPA in thermal paper should cease as soon as possible. The Government should, however, await the outcome of the ongoing EU process initiated by . If this does not lead to the Commission banning the substance under Article 69 of REACH, the Government should investigate the possibilities to incorporate a national ban into the Prohibition of Chemicals Ordinance based on the circumstances at the time when the EU process has been completed, taking the proposals from 2012 as the point of departure. In addition, if at this point BPA has been classified such that the criteria set forth in Article 68(2) are met, the Government can present a proposal to the Commission for restriction under this article. 5.Sweden should support and cooperate with other EU Member States and EU bodies promoting a phase-out of BPA. 6.Sweden should highlight the need for changes to relevant parts of EU food legislation in relevant EU bodies so that substances that migrate from packaging or in some other way end up in food through human handling can be regulated on the basis that they have particularly hazardous intrinsic properties. In addi- tion, should promote dialogue, knowledge exchange and, if necessary, coordination between the EUs food and chemicals agencies. 7.The Swedish Government should assign the Swedish Competi- tion Authority to develop procurement criteria for devices, with regard to chemicals. BPA – a much-discussed but indisputably hazardous substance BPA is a substance produced in very large quantities. It is used widely in society in many different areas and for a wide variety of articles and products. Its use is most widespread in the manufac- of plastics, principally polycarbonate and epoxy. The fact that low levels of BPA are encountered in almost all urine and blood samples from humans, despite rapid breakdown in the human body, suggests that we are continuously exposed to this substance. Although BPA is also short-lived in the environment, it has been found in water, sediments, sludge, air and aquatic animals as a result of continuous input. BPA is an endocrine disrupter and toxic to reproduction, and is thought to be potentially harmful to human health and the environment. Among other things, this substance has been linked to effects on the mammary glands and obesity, as well as affecting brain development and behaviour. Women of childbearing age, children and adolescents are considered to be particularly susceptible to endocrine-disrupting effects. There are, however, differing views on which effects are relevant to human health and at what levels these effects can occur. Food and beverages in metal packaging and thermal paper1 are the two largest sources of exposure to BPA. Cans and other food packaging made of metal are often coated with epoxy to prevent undesirable interaction between the metal and the food. Residues of BPA can leach (migrate) from the epoxy layer and consequently end up in the food. Thermal paper is coated with BPA that can detach and be transferred to fingers. devices containing BPA may be a key source of exposure for certain groups, in particular for premature infants. The substance has been investigated by several different agencies. In 2014 Food Safety Authority (EFSA) published a preliminary report in which it presented its assessment that the risk of harmful effects on health at present-day levels of exposure is low. At the same time, the French agency ANSES has identified a risk of effects on human health. (KemI) has also identified risks in the use of BPA in receipts and, in addition, in the use of two-component epoxy in the relining of tapwater pipes. Many researchers in the field share this concern that effects may occur even at low exposure levels. It has not been possible for the inquiry to take account of EFSAs final report, which will be published in January 2015 and may alter the conclusions drawn in the preliminary report. 1 Heat-sensitive paper used, for instance, in receipts and tickets. of introducing instruments, including further regulation of BPA A broad range of measures, from information campaigns to regulation, can be used to enable a phase-out of BPA in the main sources of exposure. With regard to information and, for example, requirements in public procurement, however, it is generally the case that BPA forms part of a wider complex of problems relating to hazardous substances in general. If human exposure is to be substantially reduced, it may become necessary to resort to regulation. The overriding question that then arises is whether it will be possible to regulate in the near future at EU level, which is always preferable, or whether should try to make use of the often limited options that exist for introducing national provisions. In the case of food packaging, there is also the issue of what legislation should be used for this purpose: food and materials legislation or chemicals legislation. An analysis follows here of how these issues can be addressed with regard to the two principal sources of exposure: BPA in thermal paper, and food and beverages in metal packaging. BPA in thermal paper At the time of presentation of this report, a process initiated by is under way to investigate whether BPA in thermal paper should be banned in the EU pursuant to Article 69 of the chemicals regulation REACH. If this proposal does not lead to an EU ban, there may be another option for EU regulation of BPA in thermal paper under Article 68(2) of REACH. This article provides scope to limit substances in consumer articles if they are classified in the hazard carcinogenicity, germ cell mutagenicity or repro- ductive toxicity, category 1A or 1B. BPA is expected to be classified as toxic to reproduction, category 1B during the first half of 2016 and would consequently meet the criteria for restriction under Article 68(2). This type of restriction (under Article 68(2)), which is based on the intrinsic properties of the substances and the potential for exposure that exists, requires more extensive evidence than an ordinary EU restriction and can only be proposed by Commission. A may, however, contribute evidence and in so doing initiate work within the Commission. There is also an option at EU level to regulate BPA pursuant to the Safety Directive. can also incorporate a national ban into the (Handling, Import and Export Prohibitions) Ordinance (1998:944) (the Prohibition of Chemicals Ordinance). However, there has to be a legitimate protective interest and the measure is required to be proportionate and non-discriminatory. A proposal has been prepared for a ban and was submitted by KemI on behalf of the Government in 2012. In KemIs assessment receipts were not covered at the time of harmonised measures in the EU. However, this situation will have changed by the time the Commission has responded to the French proposals. Thus, if a national ban is introduced, will have to take account of the possibility of the Commission initiating an infringement procedure against it. The only BPA-specific EU rules existing at present in the area of food are the ban on use in the manufacturing of baby feeding bottles made of polycarbonate and a migration limit value for other food plastics. There are no special rules for coatings from which BPA in foods primarily originates. This area can, however, be regulated under Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food, known as the Materials Regulation. Regulation pursuant to this Regulation necessitates showing that BPA exposure is so high that there is a risk of consumers being harmed. As described above, EFSA is currently investigating the risk of harmful effects of BPA on human health. EFSAs assessment will provide the basis for action by the Commission, among others. If, having studied the assessment and the reactions and measures it gives rise to, the Government finds it likely that it will take some time before EU regulation of BPA in coatings in contact with food comes into being, the Government can incorporate a national ban into the Decree. There is no harmonised regulation in this area today. However, in the same way as with regard to a national ban on BPA in thermal paper, there has to be a legitimate protective interest and the measure is required to be proportionate and non-discriminatory. There is already a provision in Section 6(b) of the Food Decree that BPA may not be used in varnishes and coatings in packaging containing such foods as are specifically intended for children between the ages of 0 and 3 years. There are also similar bans in , and , based on national risk appraisals and citing the precautionary principle. In addition, has banned all use of BPA in all materials that come into direct contact with food from 1 January 2015. notes in its risk assessment that use of BPA in materials in contact with food may pose unacceptable risks to human health. If were to extend the ban to all uses of coatings in contact with food, it would have to carry out its own risk assessment. is the Swedish authority that out national risk assessments under food legislation. For obvious reasons, EFSAs risk assessments will weigh heavily in this context. In addition, there is a possibility of restricting BPA in food under chemicals legislation. This regulates the chemicals as such. Regulation under chemicals legislation, like regulation in food legislation, is based on risk assessment of substances. However, there is an important difference compared with food legislation. As regulation under food legislation always necessitates risk assess- ment, there is provision in REACH and Swedish chemicals legisla- tion to, in certain cases, regulate substances on the basis of their intrinsic properties, if these are particularly hazardous. REACH provides several options for restricting BPA in foods, in particular those described above for thermal paper. can promote such regulation in relevant EU bodies but must anticipate encountering resistance and the possibility of implementation taking some time. At the same time, it is possible to incorporate a national ban on BPA in coatings in contact with food into the Swedish Prohibition of Chemicals Ordinance. KemI has come to the conclusion in several cases (for example BPA in receipts and BPA in two-component epoxy used in relining) that it is possible to regulate chemicals at national level if their use is not already regulated at EU level. However, once again, there has to be a legitimate protective interest and the measure is required to be proportionate and non-discriminatory. KemIs conclusions ought to also be applicable to the use of coatings in contact with food. must, however, anticipate the possibility of its view being questioned, and a national ban may therefore lead to an infringe- ment procedure that is time-consuming and demanding on resources, with an uncertain outcome. Consequences of a phase-out of BPA in thermal paper and in coatings in contact with food The phase-out of BPA in food contact materials may cause costs, particularly for companies in the food-chain. The most significant costs are most likely associated to the qualification processes for BPA-free coatings in food packaging of metal. A limited number of food products in certain product categories are estimated to be concerned. The companies adjustment costs partly depend on the time line for the ban to enter into force, as well as on possible derogations and exemptions. If the ban is implemented in too short notice and with no derogations, some companies will not be able to adapt their products and will have to withdraw them from sale. This may have an effect on supply, competition and prices for consumers. Adverse effects may be avoided if companies in the food chain are given sufficient time for adaptation. A possible national ban should therefore not enter into force until 2020. The greatest part of the phase-out should thereby be carried out in due time. Part of my remit is to present proposals regarding how a significant reduction in exposure to BPA, particularly for children, adoles- cents and women of child-bearing age, can be achieved in a way that is effective from the point of view of both risk reduction and costs. To achieve this, measures should focus on the largest sources of exposure, which are thermal paper and BPA in metal food packaging. This is also the basic principle in the terms of reference for the inquiry. I have found that a phase-out of BPA in these sectors is already under way to a varying degree, largely on a On the basis of the impact assessment in this inquiry, I consider it possible to phase out BPA from thermal paper at reasonable cost to public finances as soon as the legislative process in the EU and permits, and from coatings in contact with food by 2020. I therefore propose that the Government formulate targets for such a phase-out with this time perspective. As a result all stakeholders would have a clear time frame for work aimed at phasing out the use of BPA. The phase-out would be assisted by regulation in the EU. should therefore urge such regulation in all relevant EU bodies. If EU regulation cannot be anticipated in the next few years, there may be a need for national regulation. With regard to BPA in coatings in contact with food, I consider that the measures needed to achieve a phase-out by 2020 should be formulated in such a way that the phase-out taking place today in the food and packaging material chains on their own initiative is actually implemented, and that this happens throughout the trade. The basis for any regulation of BPA should, in my view, primarily be its intrinsic properties of endocrine disruption and reproductive toxicity. This means that a ban on BPA in coatings in contact with food, such as the legislation in this area is formulated at present, should be incorporated into the Prohibition of Chemicals Ordinance. A ban can also be incorporated into the Decree according to article 5 of Regulation (EG) no 1935/2004, but particularly hazardous intrinsic properties alone cannot serve as the basis for such a ban. The impact assessment suggests that there is a need for a reasonable changeover period, and that any ban should apply from 1 January 2020, regardless of when it is adopted. If the ban is introduced in the near future, the voluntary phase- out now in progress will be replaced by a regulatory phase-out, which might mean that the parties concerned become less motivated to implement a rapid phase-out. This a risk of the emphasis of the phase-out being shifted from the start of the phase-out period to the end. If the voluntary phase-out goes well, the risk of a ban being regarded as disproportionate in an EU review also increases. Finally, there may be reasons for to await the development; if new scientific evidence is published, the conditions for a risk assessment may be changed. This could potentially support a national ban in the Food Ordinance. Regard- less of which ordinance is chosen for a ban, must anticipate being involved in an infringement procedure with an uncertain outcome.