EUROPEAN COMMISSION Brussels, 28.10.2021 SWD(2021) 300 final COMMISSION STAFF WORKING DOCUMENT



IMPACT ASSESSMENT REPORT

Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Annexes IV and V to Regulation (EU) 2019/1021 of the European Parliament and of the Council on persistent organic pollutants {COM(2021) 656 final} - {SEC(2021) 379 final} - {SWD(2021) 299 final} - {SWD(2021) 301 final}



Table of contents 1. Introduction: Political and legal context 1.1. Main elements of the impact assessment 1.2. Policy context 1.3. Legal context 1.3.1. International context – the Stockholm Convention 1.3.2. International context – The Basel Convention 1.3.3. Regulation (EU) 2019/1021 on Persistent Organic Pollutants 1.3.4. Other relevant EU legislation 1.3.5. Enforcement: 1.4. Economic context 1.5. Public context 2. Problem definition 2.1. What are the problems? 2.1.1. Pollution by POPs 2.1.2. POPs can be present in recycled materials 2.1.3. We are immersed in a climate emergency 2.2. What are the problem drivers? 2.2.1. Some waste contains POPs

2.2.2. The POPs Regulation contains no limit values or these are inadequate 2.2.3. There are insufficient means for sorting and decontaminating POP waste 2.2.4. Deficiencies in the interaction between the legislation on chemicals, products and waste 2.3. How will the problem evolve? 2.4. Who is affected and how? 3. Why should the EU act? 3.1. Legal basis 3.2. Subsidiarity: Necessity of EU action 3.3. Subsidiarity: Added value of EU action 4. Objectives: What is to be achieved? 4.1. General objectives 4.2. Specific objectives 4.3. Hierarchy of objectives 5. What are the available policy options? 5.1. What is the baseline from which options are assessed? 5.2. Methodology to set the limit values 5.2.1. Setting the limit values 5.2.2. The precautionary principle and the principle of proportionality 5.3. Policy options 5.3.1. Description of the policy options

5.3.2. Summary of policy options – Annex IV 5.3.3. Annex V values 5.4. Options discarded at an early stage 6. Impacts of the policy options and how they compare 6.1. Polybrominated diphenylethers (PBDEs) 6.1.1. What are they and why are they a problem? 6.1.2. Baseline 6.1.3. Impacts of the policy options 6.1.4. Conclusion on preferred policy option 6.2. Hexabromocyclododecane (HBCDD) 6.2.1. What is it and why is it a problem? 6.2.2. Baseline 6.2.3. Impacts of the policy options 6.2.4. Conclusion on preferred policy option 6.3. Dioxins and furans (PCDD/Fs) 6.3.1. What are they and why are they a problem? 6.3.2. Baseline 6.3.3. Impacts of the policy options 6.3.4. Conclusion on preferred policy option 6.4. Dioxin-like PCBs

6.4.1. What are they and why are they a problem? 6.4.2. Baseline 6.4.3. Impacts of the policy options 6.4.4. Conclusion on preferred policy option 6.5. Short-chain chlorinated paraffins (SCCPs) 6.5.1. What are they and why are they a problem? 6.5.2. Baseline 6.5.3. Impacts of the policy options 6.5.4. Conclusion on preferred policy option 6.6. Perfluorooctanoic acid (PFOA), its salts and PFOA related compounds 6.6.1. What are they and why are they a problem? 6.6.2. Baseline 6.6.3. Impacts of the policy options 6.6.4. Conclusion on preferred policy option 6.7. Perfluorohexane sulfonic acid, its salts and related compounds (PFHxS) 6.7.1. What are they and why are they a problem? 6.7.2. Baseline 6.7.3. Impacts of the policy options 6.7.4. Conclusion on preferred policy option 6.8. Pentachlorophenol and its salts and esters (PCP)

6.8.1. What are they and why are they a problem? 6.8.2. Baseline 6.8.3. Impacts of the policy options 6.8.4. Conclusion on preferred policy option 6.9. Dicofol 6.9.1. What is it and why is it a problem? 6.9.2. Baseline 6.9.3. Impacts of the policy options 6.9.4. Conclusion on preferred policy option 7. How do the options compare? 8. Preferred option 8.1. Summary of preferred options (for all substances) 8.2. Regulatory burden and simplification 8.3. Future proofing 8.4. International competitiveness 8.5. REFIT (simplification and improved efficiency) 9. How will actual impacts be monitored and evaluated?



Glossary

Term or acronym Meaning or definition C&D Construction & Demolition CoP Conference of the Parties DecaBDE Decabromodiphenyl ether dl-PCB Dioxin-like polychlorinated biphenyl ECHA European Chemicals Agency EEE Electrical and Electronic Equipment EGD European Green Deal ELV End of Life Vehicles EPS Expanded polystyrene EU European Union HBCDD Hexabromocyclododecane HCBD Hexachlorobutadiene HIPS High-impact polystyrene LPCL Low POP concentration limits MPCL Maximum POP concentration limits MSWI Municipal Solid Waste Incineration MS Member States NDL Non-dioxin like (PCBs) PBT Persistent, Bioaccumulative & Toxic PCBs polychlorinated biphenyls PCDD Polychlorinated dibenzodioxins PCDF Polychlorinated dibenzofurans PCP Pentachlorophenol PFHxS Perfluorohexane sulfonic acid PFOA Perfluorooctamoic acid (Pentadecafluorooctanoic acid) POP Persistent Organic Pollutant POPs Regulation Regulation (EU) 2019/1021 SCCPs Short-chain chlorinated paraffins TEF Toxic equivalency factor TEQ Total dioxin toxic equivalence UNECE United Nations Economic Commission for Europe UTC Unintentional Trace Contaminant level vPvB very Persistent and very Bioaccumulative WEEE Waste Electrical and Electronic Equipment WHO World Health Organisation



1.Introduction: Political and legal context Persistent Organic Pollutants (POPs) are chemicals that persist in the environment, bio-accumulate and pose a risk of causing significant adverse effects to human health or the environment. If released, these pollutants are transported across international boundaries far from their sources and even accumulate in regions where they have never been used or produced. POPs pose a threat to the environment and to human health all over the globe, with the Arctic, Baltic and the Alpine regions being examples of EU sinks of POPs. At the EU level, significant progress has been made towards the elimination of POPs. Manufacture and use of all POP chemicals is prohibited with some minor exemptions, limited in time, after which they are phased-out. A main challenge for the EU is to eliminate POPs and remaining stockpiles from the waste cycle as these still represent a major emission source. This impact assessment deals with POPs in waste and with their potential presence as legacy substances. More specifically it covers the threshold values set in Annexes IV and V of the POPs Regulation. These values determine how the waste is to be treated, including whether it can be recycled, or whether it should be destroyed or irreversibly transformed. This impact assessment does not cover any other aspects of the POPs Regulation nor specifically addresses contamination of environmental compartments (e.g soil, water, air) by POP substances. As indicated in the EU Chemicals Strategy for Sustainability certain chemicals, including some POPs, can cause cancer, affect the immune, respiratory, endocrine, reproductive and cardiovascular systems, weaken human resilience and capacity to respond to vaccines and increase vulnerability to disease. By way of example, findings in a recent report by the Nordic Council of Ministers indicate that the annual health-related costs associated to certain perfluorinated substances known collectively as PFAS is estimated to be 52 – 84 billion EUR per year for all EEA countries. Another study providing overall estimates of the cost of illness related to negative effects of exposure to endocrine disruptors on human male reproduction in the Nordic countries, concluded on costs estimates ranging from 59 – 1,200 million EUR per year, extrapolated to the EU28. The European Green Deal (EGD) puts forward the objective of achieving climate neutrality in Europe by the year 2050 and to implement a new Circular Economy Action Plan (CEAP) to stimulate the development of lead markets for climate neutral and circular products in the EU and beyond. Focus is placed on resource-intensive sectors such as textiles, construction, electronics and plastics. As also announced in the EGD and subsequently laid out in its Communication on a Zero Pollution Action Plan, the EU has defined a zero pollution vision for the year 2050, whereby air, water and soil pollution is reduced to levels no longer considered harmful to health and natural ecosystems and that respect the boundaries our planet can cope with, thus creating a toxic-free environment. Matters relevant to the management of POP-containing wastes should be analysed within the broader EU policy context set by the Green Deal objectives and the commitments made in the new CEAP. These include: ·the prioritisation of waste prevention and reuse; ·the recovery of economic value from waste that cannot be avoided, with minimal impact on climate change, the environment and human health; ·the strengthening of secondary raw material markets, in particular through the establishment of mandatory recycled content targets for secondary raw materials and green public procurement targets; ·the zero-pollution ambition and the objective of achieving “toxic-free” material cycles. Consequently a key challenge in defining policy actions relative to waste that contains POP substances is that of achieving an optimum balance between the overarching objective of eliminating POP substances from the environment and from new material cycles while at the same time increasing recycling and circularity and reducing greenhouse gas emissions associated to these actions. Main elements of the impact assessment Scope: ·This proposal aims to ensure the environmentally sound management of waste that contains POP substances, ensuring emissions to the environment are minimised, with a view to eliminating them as soon as possible. This IA relates to nine specific POP substances or families of substances. ·The limit values for POPs in waste determine the way in which POP waste can be treated, resulting in waste containing POP substances above certain limit values, following any necessary pre-treatment, generally having to be destroyed (and therefore making recycling impossible).

·As such the limits discussed do not determine whether secondary materials recovered from waste can be placed on the market. This is regulated by conditions and limits fixed for some POP substances in Annex I of the Regulation. These are out of the scope of the current proposal. Relation to relevant international conventions: ·The Stockholm Convention addresses the harmful effects of human health and the environment brought about by POP substances and seeks their phase-out. The Basel convention addresses trans-boundary shipment of hazardous waste and certain other wastes and seeks to ensure their environmentally sound management. The EU is a party to both conventions, as are the large majority of its Member States. ·Any changes in the list of POP substances in Annexes A, B and C of the Stockholm Convention have to be taken up under the EU POPs Regulation in its Annexes I, II or III as well as in its Annexes IV and V. Only changes to Annexes IV and V of the POPs Regulation, dealing with POP waste, are within the scope of this impact assessment. ·The need to review Annexes IV and V of the POPs Regulation, only two years after its recast, arises from the listing of new POP substances under the Stockholm Convention in 2019, as well as from specific review obligations for some flame retardant substances, imposed upon the Commission by the co-legislator. ·As further explained under section 3.1, the Commission has to propose the listing of POP substances identified under the Stockholm Convention into Annex IV (on waste) of the POPs Regulation. This is because such listing triggers the obligations defined in Article 7 of the Regulation which enables the Union to comply with its obligation, under the Stockholm and Basel Conventions, to manage POP waste in an environmentally sound way. ·Under the Basel Convention, limit values (or ranges of limit values), applicable to waste, for each POP substance listed in the Stockholm Convention, are agreed upon as a result of political negotiation and published in so-called POP Waste General Technical Guidelines, which are reviewed periodically and are not binding to the Parties of the Basel Convention. ·These values have been taken into consideration when defining the options considered in the impact assessment, but other considerations, resulting from a previous study by Ramboll (2019) are also relevant (e.g. information on analytical limits or existing limit values in the POPs Regulation). ·The maximum values defined under Annex V of the POPs Regulation do not have an equivalent under the Convention, but are part of the control system defined by the Regulation. Consequently the Commission also has to propose to list into this Annex V any substance identified as a POP under the Stockholm Convention. ·For POP substances listed in Annexes IV and V, the Commission has discretion, based on its assessment, on proposing specific limits values (for both new listings and for reviews of pre-existing values). Hierarchy of objectives: ·As described throughout the impact assessment report, the limit values defined for POPs in waste in Annex IV of the POPs Regulation determine the proportion of POPs containing waste that has to be destroyed versus the fraction that can be managed via non-destructive treatments (e.g. landfilled). To a greater or lesser extent, for all POP waste that is not destroyed, the risk remains that some of the POP substances they contain may be released to the environment (even if this risk, depending on the precise disposal option, may be very small). ·Subject to also complying with limit values in Annex I this waste can also potentially be recycled and the resulting material placed back on the market as a product. ·The overarching objective of the POPs Regulation is protection of human health and the environment against POP substances and, for waste, the objective is elimination or at least the minimisation of emissions. Consequently, this impact assessment attributes the greatest weight to this consideration, as compared to any others. ·As required by the POPs Regulation and described in the Communication from the Commission on the precautionary principle, this principle is taken into account in the methodology used to derive the values in Annex IV. It is applied to lower the proposed values as far as possible, down to the highest of the lower limitation criteria, even if lower than the values that could de determined to protect human / environmental health. This has been the case for PBDEs, HBCDD, PCDD/Fs, SCCPs and dicofol. ·The POPs Regulation also requires consideration of proportionality and, for example, economic impacts on the different operators (such as higher waste management costs, loss or revenue from recyclate sold, etc) could lead to higher Annex IV values being proposed.

·There are also environmental trade-offs in lowering POP limit values for waste. Doing so may reduce the release of POPs into the environment, but destructive treatment is associated with increased greenhouse gas emissions. ·As there are trade-offs between the different objectives, a certain level of discretion and judgement is required from the assessor (the Commission) in determining what represents, for instance, an acceptable trade-off between economic impacts for a group of stakeholders and health or environmental impacts. This is considered as part of an established methodology, which allows for a structured consideration. Methodology: ·The methodology used to determine the values proposed for Annex IV and Annex V values is well established. It was developed in the context of prior work commissioned by the European Commission to develop these limit values, following the adoption of the former POPs Regulation in the year 2004. ·It should be noted that this methodology is as such unrelated to the criteria and the process used to identify and list POP substances under the Stockholm Convention. ·The methodology determines for each substance a set of lower and upper limitation criteria based on technical, practical and economic criteria and which takes into account the application of the precautionary principle. ·The range is subsequently narrowed down to a single specific value. Consideration is given in particular to the precautionary principle, which by itself leads to as low a value as possible. However, other criteria can lead to higher values reflecting the trade-offs based on further assessment and (duly justified) policy choices. Further details are provided in section 5.2 and in Annex IV. ·The methodology also takes account of existing limit values, where the weighting of the different criteria have passed political scrutiny and often are the result of a negotiation (previously under comitology and currently under the ordinary legislative procedure). The values proposed by the Commission in this impact assessment will be examined under the ordinary legislative procedure, where the application of the criteria, the extent of application of the precautionary principle and the assessment of proportionality will be either validated or modified. ·This methodology has since its development been included as reference in the General Technical Guidance on POP Waste as non-binding guidance, under the Basel Convention. Assessment reports supporting limits on waste, done by the EU using this methodology, are largely appreciated internationally and provide a very significant contribution to such discussions under the Convention. This same methodology has also been used, in this same context, in a study by commissioned by Germany. ·The report by consultants used by the Commission in support of this impact assessment (which makes use of this methodology), as well as previous related studies of 2005, 2011 and 2019, are not subject to peer review, but are considered to be robust as they are based on hundreds of peer reviewed studies and publications and are subsequently assessed by the Commission. As indicated, these studies are widely considered and appreciated in the international context, under the Basel Convention, and have been the basis of former reviews of the POP waste annexes. Policy context The primary purpose of this initiative is to implement, for the substances concerned, the EU’s international obligations under the Stockholm and Basel Conventions and, more specifically, those derived from the POPs Regulation. Therefore protecting human health and the environment from the adverse effects caused by POP substances and eliminating or minimising emissions of POPs from waste are at the core of this impact assessment. This assessment builds upon and is linked to the European Green Deal, its objectives and the initiatives that stem from it. The table below presents an overview of the substances for which threshold values are proposed in this impact assessment, plus a short description of the use of the substances and the materials in which they are found. Most of the uses described are historic uses, now banned or severely restricted, but they are relevant in terms of waste arising from these products when they are disposed of. Substance Uses Where is it found? (in what types of waste, or articles upon becoming waste) Polybrominated diphenyl ethers (PBDEs): Tetrabromodiphenyl ether, Pentabromodipheny lether, Hexabromodiphenyl ether, Heptabromodiphenyl ether Decabromodiphenyl ether Flame retardants. Used often in conjunction with antomony trioxide to provide fire-resistance to plastics, textiles and other materials. In certain plastics and textiles contained in electrical and electronic equipment (EEE) and in vehicles. Also in some plastics used in construction and in textiles such as those in upholstered furniture, tarpaulins, etc. Hexabromocyclododecane (HBCDD) Flame retardant. Used to provide fire resistance in expanded and extruded polystyrene insulation panels. Limited use in other plastics (high-impact polystyrene) and textiles. Major use in thermal insulation panels used in construction. Also found in some EEE and in back-coated textiles. Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs) These substances have no use as such and are not produced or added to materials intentionally. They are unintentionally produced in combustion processes. Present as impurities in ashes from municipal waste incinerators and in other ashes. Also in other industrial waste. Dioxin-like PCBs Similar to dioxins, they are unintentionally produced in combustion processes. Also present in some PCB oils historically used as dielectric fluid or plasticiser. Present as an impurity in some ashes. Potentially present in oils from some remaining electrical transformers and capacitors. Short-chain chlorinated paraffins (SCCPs) Flame retardant. Used in some rubber and plastic materials. Used in industrial and mining rubber conveyor belts, hoses, cables, seals. Soft PVC plastic articles. In some construction sealants and paints. Perfluorooctanoic acid (PFOA) its salts and PFOA-related compounds Used to make fluorinated polymers such as PTFE. Provides water and oil repellency: water-proofing and anti-stain protection. Protective and lubricating functions, modifier of surface tension. Present in some fire-fighting foams, in water-proof textiles (eg outdoor jackets), upholstered furniture and carpets. Also found in electronics (semiconductors, coatings, seals, printed circuit boards). Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS related compounds Similar to PFOA, except not used in the manufacture of fluoropolymers. Similar to PFOA Pentachlorophenol (PCP), its salts and esters Pesticide and biocide. Used as a treatment to prevent wood and textiles from rotting, especially outdoors. Production and import in the EU ceased in 2002. Wood used in outdoor construction – poles, fences, awnings. Textiles – tents, tarpaulins. Dicofol Pesticide. Used in agriculture, mostly in Spain until 2010. No evidence of stockpiles. Probably no or very limited presence in the EU. Table 1: Substances in scope of the impact assessment, uses and relevant waste streams The EGD states that creating a toxic-free environment requires more action to prevent pollution as well as measures to clean and remedy it. The Commission has also committed to consider legal requirements to boost the market of secondary raw materials, including setting targets for mandatory recycled content, and to ensure that all EGD initiatives achieve their objectives in the most effective and least burdensome way possible, living up to a green oath to ‘do no harm’. In this context, the Commission adopted in May 2021 an EU Action Plan “Towards Zero Pollution for Air, Water and Soil”. The 2015 Communication on a Circular Economy Action Plan called for the promotion of non-toxic material cycles and better tracking of chemicals of concern in products as a way to facilitate recycling and improve the uptake of secondary raw materials.

Subsequently, the Communication of January 2018 on the interface between chemical, product and waste legislation laid down a general ambition to achieve materials that are safe, fit-for-purpose, designed for durability and recyclability and that have a low environmental impact. For those materials not yet fulfilling this overarching vision, it invited to a reflection on the appropriate balance between the benefits from circular use of a material and the health and environmental concerns relating to substances present in those materials. The new Circular Economy Action Plan includes numerous policy guidelines, relevant to waste streams and materials addressed by this initiative such as: ·putting in place measures to reduce waste and ensure that the EU has a well-functioning internal market for high quality secondary raw materials; ·a Sustainable Product Policy legislative initiative, setting out sustainability principles to regulate product durability, reusability, upgradability and reparability, addressing the presence of hazardous chemicals in products (including POPs), and increasing their energy and resource efficiency; ·increasing recycled content in products, while ensuring their performance and safety; ·enabling remanufacturing and high-quality recycling and reducing carbon and environmental footprints; ·increasing the uptake of recycled plastics and contributing to the more sustainable use of plastics, including proposing mandatory requirements for recycled content and waste reduction measures for key products such as packaging, construction materials and vehicles ·boosting the sorting, re-use and recycling of textiles; ·revising the Construction Product Regulation, including the possible introduction of recycled content requirements for certain construction products, taking into account their safety and functionality; The Chemicals Strategy for Sustainability, adopted in October 2020, states that in order to move towards toxic-free material cycles and clean recycling it is necessary to ensure that substances of concern in products and recycled materials are minimised. It also states that, as a principle, the same limit values for hazardous substances should apply to both virgin and recycled materials. However, it also recognises that there may be exceptional circumstances where a derogation to this principle may be necessary, subject to conditions such as that the use of the recycled material is limited to clearly defined applications where there is no negative impact on consumer health and the environment. The use of an exemption for a recycled material, as compared to virgin material, should be justified based on a case by case analysis. The European Parliament has in its resolutions on resource efficiency, on the Interface between chemical, products and waste legislation and on the Green Deal, shown consistent and strong support for increasing resource efficiency and the creation of markets for secondary raw materials. This includes setting of targets for recycling and mandatory recycled content. It has also been strongly supportive of the climate neutrality objectives put forward by the Commission and, in terms of waste management policy, calls for a strong reduction in incineration and landfilling. At the same time, throughout these communications it has firmly advocated for non-toxic material cycles, where the presence of legacy substances should not be perpetuated. Although the EP has stated that resource efficiency must also consider and be coherent with broader sustainability concerns, including environmental, ethical, economic and social dimensions, no particular directions are provided on how this balance should be struck. Recent resolutions , such as the objection to the Commission’s proposed measure under REACH to regulate legacy lead content in recovered PVC, and that on the Chemicals Strategy for Sustainability indicate a very clear position towards the prevalence of non-toxic cycles as a leading policy objective. The European Council has issued a number of relevant Conclusions such as those on “Delivering on the EU Action Plan for the Circular Economy”, which specifically look at the “Interface” Communication, on a “Sustainable Chemicals Policy Strategy” and on “More circularity - Transition to a sustainable society”. In all of them there is clear support for the objectives of resource efficiency, circularity, greenhouse gas emissions reduction, promotion of markets for high-quality and safe secondary materials, tracking of substances of concern and non-toxic material cycles. Legal context International context – the Stockholm Convention The Stockholm Convention on POPs was adopted in 2001 and entered into force in 2004. The overall objective of the Stockholm Convention is to protect human health and the environment from POPs. It promotes global action on these substances and requires Parties to take measures to eliminate or reduce the release of POPs into the environment. Specific reference is made to a precautionary approach as set forth in Principle 15 of the 1992 Rio Declaration on Environment and Development. Identification of POP substances POPs are identified based on characteristics and screening criteria listed in Annex D to the Convention. This requires providing evidence related to the persistence, bioaccumulation, long-range transport and adverse effects associated to any proposed substance. The POP Review Committee (POPRC), established under the Convention and composed by experts from all regions of the world, is responsible for assessing proposals for the listing of new substances. It examines proposals sent to the Secretariat of the Convention, develops risk profiles and risk management evaluations for substances under consideration and makes recommendations for listing the substance in Annexes A, B, and/or C of the Convention. The decisions on the listing, including on any specific exemptions or acceptable purposes that may be granted are adopted by the Conference of the Parties (CoP) which meets every two years. The text of the Convention envisages generic exemptions from the ban on production and use allowing laboratory-scale research, use as a reference standard and the presence as unintentional trace contaminants in products and articles. Articles containing POPs manufactured or already in use before the date of entry into force of the relevant prohibition or limitation are also subject to an exemption, provided that Parties submit information on the uses and a national plan for waste management for such articles to the Secretariat of the Stockholm Convention.

Stockpiles and waste The Convention also envisages identification and safe management of stockpiles containing or consisting of POPs. Waste containing, consisting of or contaminated with POPs shall be disposed of in such a way that the POP content is destroyed or irreversibly transformed so that it does not exhibit POP characteristics. Where this does not represent the environmentally preferable option or where the POP content is low, waste shall be otherwise disposed of in an environmentally sound manner. Disposal operations that may lead to recovery or re-use of POP substances are explicitly forbidden. With regard to shipment of wastes, relevant international rules, standards and guidelines, such as the 1989 Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal have to be taken into account. Effectiveness Article 16 of the Convention requires that the effectiveness of the measures adopted by the Convention is evaluated at regular intervals. The objective of such effectiveness evaluation is assessing whether the Stockholm Convention is an effective tool to protect human health and the environment from persistent organic pollutants. The main conclusion from the latest evaluation, published in 2017, is that the Convention provides an effective and dynamic framework to regulate POPs throughout their lifecycle, addressing the production, use, import, export, releases, and disposal of these chemicals worldwide. However, inadequate implementation is the key issue identified in this evaluation. International context – The Basel Convention The Basel Convention entered into force on 5 May 1992 and has been ratified by all EU Member States. It aims to protect human health and the environment against the adverse effects resulting from the generation, management, transboundary movements and disposal of hazardous and other wastes. It does this via a set of provisions on the transboundary movement of wastes and their environmentally sound management (ESM). In particular, the Basel Convention stipulates that any transboundary movement (export, import or transit) of wastes is permissible only when the movement itself and the planned disposal of the hazardous or other wastes are environmentally sound. Table 2 in Section III of the Basel “General technical guidelines on the environmentally sound management of wastes consisting of, containing or contaminated with persistent organic pollutants” contains a list of “provisional definitions” for “low-POP content” which conceptually are equivalent to the limits in Annex IV of the POPs Regulation. For some substances such as PBDEs and dioxins the guidelines contain a range of values, rather than a single value (reflecting the lack of consensus on a single value). These values are discussed, introduced and sometimes modified, in the context of the review of the referred technical guideline. The guidelines themselves, and the values therein, are not legally binding but have international policy relevance and are intended to assist Parties to achieve environmentally sound management of these wastes. Under Article 15(2) of the POPs Regulation, the Commission must where appropriate, propose to adapt Annexes IV and V of the Regulation to technical progress, but there is no obligation to align to the values in the Basel guideline, or to do so in a defined timeframe. It is to be noted that, as further explained in the following section, the listing of newly identified POP substances under the Stockholm Convention in Annex IV of the POPs Regulation is, in practice, considered mandatory in order to meet the commitments of the EU under the Basel Convention. As regards Annex V values, neither the Basel nor the Stockholm convention have provisions on a “maximum POP content limit”, in the sense used in the POPs Regulation. However, given that the options to manage POP waste under the EU POPs Regulation are determined by establishing limit values both in Annex IV and V, establishing a limit value in both these annexes for newly listed substances, is also mandatory for the Commission. For substances newly listed in Annexes IV and V, the actual value that is introduced for the first time, or its review, for listed substances which already have a value, remains at the discretion of the Commission and is carried out “where appropriate”, as indicated in Article 15(2), based on the assessment made. Regulation (EU) 2019/1021 on Persistent Organic Pollutants As signatory to both the Stockholm Convention and the UNECE Protocol on POPs, the European Union created Regulation (EC) No 850/2004 on persistent organic pollutants (the “POPs Regulation”) to uphold the aims of the Convention and the Protocol at EU level. This Regulation entered into force on 20 May 2004 and was directly applicable in all Member States, including those which are not yet Parties to the Stockholm Convention or the UNECE POP Protocol. That Regulation has been repealed and replaced by Regulation (EU) 2019/1021 on persistent organic pollutants on 15 July 2019 . The POPs Regulation ensures a coherent approach in the transposition of obligations under these international Conventions in the EU (as opposed to this being done by each Party at the national level). The POPs Regulation contains provisions regarding manufacturing, placing on the market and use of chemicals, management of stockpiles and wastes and measures to reduce releases of unintentionally produced POPs. Exports of POPs are regulated under Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals. The exemptions to the prohibitions under the POPs Regulation are limited to a minimum. As indicated above, POPs are identified according to procedures defined under the Convention and are introduced in its relevant annexes by decisions adopted by the Conference of the Parties. The POPs Regulation has the following Annexes, which are mentioned frequently throughout the text of this impact assessment: ·Annex I: lists substances for which their manufacture, placing on the market and use (on their own, in mixtures or in articles) is prohibited. ·Annex II: lists substances for which their manufacture, placing on the market and use is restricted (this annex is currently empty).

·Annex III: lists unintentionally produced POP substances subject to release reduction provisions. ·Annex IV: lists substances that are subject to the waste management provisions defined in Article 7 of the Regulation. ·Annex V: provides a list of disposal and recovery operations permitted for waste which meet or exceed the Annex IV limit value (Part 1). It also defines a list of waste types which may be exempted from being treated according to Part 1, defines a maximum concentration of the POP in waste (Annex V limits) up to which the exception may apply, and defines the allowable alternative waste disposal options (Part 2). The POPs Regulation contains provisions requiring the setting up of emission inventories for unintentionally produced POPs, national and EU implementation plans and monitoring and information exchange mechanisms. Notably the POPs Regulation includes the development of thresholds for POPs in waste, which are detailed in Annexes IV and V of the Regulation . The main focus of this Impact Assessment is on the Annex IV thresholds: when these are exceeded, the waste cannot be recycled and should be treated in a way that the POP content is irreversibly transformed or destroyed. Annex V provides exceptions from Annex IV provisions for certain wastes, but is rarely used. Producers and holders of waste are obliged to undertake measures to avoid contamination of waste with POP substances. Waste with a POPs content higher than the lower (stricter) POP limits (under Annex IV) must generally be disposed of or recovered in such a way that the POP content is destroyed or irreversibly transformed. Certain specified wastes containing POPs above the limit in Annex IV, but below the limit in Annex V, may be otherwise dealt with without destructive treatment, subject to conditions (resulting in these waste being permanently disposed in hazardous waste landfills or in underground storage facilities). Neither of these values, applicable to waste, should be confused with the “unintentional trace contaminant limit” values set in Annex I, which apply to products placed on the market. The POPs Regulation has been amended several times to take into account changes in the annexes of the Convention and the Protocol as well as changes in other related EU legislation such as the REACH Regulation. The POPs Regulation underwent a recast in the year 2019 with the main purpose of aligning the POPs Regulation with the Lisbon Treaty and the general chemicals legislation. The scope and other substantive provisions were not changed as it was considered that the legislation operates in a satisfactory manner. Prior to this recast the Commission adopted amendments of the limit values in Annexes IV and V via implementing acts in accordance with the regulatory procedure with scrutiny referred to in Article 17(3) of Regulation (EC) No 850/2004. Such amendments were supported by studies carried out by external consultants, but without an impact assessment. Consequently, this impact assessment supports measures that target only the introduction or revision of limit values in Annexes IV and V of the Regulation and not any other aspect of the functioning of the Regulation. As detailed further in section 3.1. of this report the international obligations of the Union under the Stockholm Convention, implemented by the POPs Regulation, require that when new POP substances are identified and listed in Annexes A, B and C of the Convention, the Commission has to amend annexes I, II and /or III of the Regulation, accordingly. As regards Annex IV, on waste, listing of new POPs in this annex is the only way of ensuring the wastes containing these substances will be covered by the control and management regime defined in Article 7 of the Regulation. Therefore, listing in Annex IV, as well as in Annex V, becomes obligatory, in order to implement the control system defined in that article and thereby comply with the requirement under the Stockholm and Basel Conventions to ensure the environmentally sound management of POP waste. Other relevant EU legislation Information on other relevant EU legislation is contained in section 5.3. of Annex V of the present impact assessment. Enforcement: Enforcement of new of revised limit values for POP substances in waste requires that analytical methods are available, affordable and have sufficient sensitivity to check compliance. These conditions are met for all the substances in scope although the cost per analysis of some of the substances concerned (e.g. PCDD/Fs or PFOA) may exceed 400 €/ sample. The tightening or introduction of new limit values for some wastes, resulting in an increased amount of material requiring destructive treatment, may induce an increase in the amount of waste submitted to “informal” or outright illegal treatment or disposal (as further discussed for WEEE). Article 7(6) of the POPs Regulation imposes on Member States traceability and control obligations on all wastes containing POPs. The set-up of electronic registers for hazardous waste (and potentially other wastes), required under Article 35(4) of the Waste Framework Directive, is expected to play a relevant role in achieving this objective. The risk of increased illegal management of waste, which occurs whenever additional requirements are imposed in waste legislation, can be addressed by Member States in the context of, for example, cooperation under the existing IMPEL network and the control mechanisms in the Waste Shipment Regulation, currently under review. Economic context Most POP substances listed in Annex I of the POPs Regulation are banned and not manufactured or used in the EU, sometimes already for many decades. Some of them are subject to exceptions which allow a restricted number of uses, in most cases for a limited period of time. Article 7(3) of the POPs Regulation prohibits recovery operations that may lead to recycling, reclamation or re-use on their own of substances listed in Annex IV of the Regulation. According to Article 7(2) waste containing or contaminated with POP substances in concentrations equal or above the limits defined in Annex IV of the Regulation have to be treated in such a way as to ensure that the POP content is destroyed or irreversibly transformed.

However, prior to such destruction of the POPs in waste, such waste can be subjected to pre-treatment operations (described in Part 1 of Annex V to the Regulation) to separate them from the waste or to separate the parts of the waste that contain POPs from those that do not (or do so below the Annex IV concentration). One of the issues at stake when defining the Annex IV concentration limits is how this affects the amounts of waste that can be recycled, rather than being disposed of using a treatment that will destroy it, together with the POPs it contains. The possible trade-offs in terms of emissions reduction and human and environmental health protection also need to be considered. Depending on the limit value chosen for a POP substance listed in Annex IV, and the specific waste streams concerned, the amount of waste that can be recycled will vary and a stricter limit could result in the cessation of recycling altogether. Such a situation may have important economic consequences for operators engaging in recycling and waste disposal operations, for users of secondary materials recovered from waste that contains POPs and for other actors in the waste treatment and secondary material supply chain. Lowering Annex IV values, thereby impeding that greater amounts of material containing legacy POPs are recycled and are re-introduced into the market also has potential favourable economic effects that can materialise in a reduction in healthcare costs, environmental remediation costs and other indirect costs associated to these impacts, for instance, on services provided by ecosystems (e.g. pollination, nutrient cycling, etc.). These impacts are substance and waste stream specific and are analysed in detail in other sections of this report. Annex V limit values are of very limited practical and economic relevance given they only determine the maximum POP concentration, applicable to a restricted list of waste types, up to which derogations from being subjected to destructive treatment applies. Notwithstanding, exceeding the Annex V limit value generally will only imply that, subject to authorisation by the competent authorities, the waste may be disposed of in a permanent underground storage facility for hazardous waste (rather than in a hazardous waste landfill). Public context According to a Eurobarometer survey of the year 2016, approximately two-thirds of EU citizens are concerned about being exposed to hazardous chemicals in their daily life, and this includes a quarter who are ‘very much’ concerned. At least half the citizens in every Member State are concerned. An extensive open public consultation on the core societal concern relative to the presence of legacy chemicals in recycled materials, relevant to this assessment, was carried-out in the context of the Commission Communication on the interface between chemical, product and waste legislation adopted in January 2018. This consultation ran from 23 July to 29 October 2018 and received 461 valid responses from a wide variety of stakeholders including individual citizens . The outcome of this consultation has fed into this report. 2.Problem definition International concern regarding the global pressures caused by the manufacture, use and release of POP substances into the environment, with severe, long-lasting trans-boundary effects on human health and on that of ecosystems led to the creation of the Stockholm Convention. The Convention, with a strong focus on the precautionary principle, was brought into EU law by the first regulation on persistent organic pollutants, recast in 2019. The purpose of this assessment is not to analyse the global problems associated with POPs or the overall effectiveness of existing policies. Rather it looks at these problems in the context of addressing specific substances and setting possible limit values for waste, all under the light of the current EU policy context. What are the problems? The problems caused by POP substances, including those subject to this assessment, are related to their intrinsic physical and chemical properties, to how and where they have been used and to the effects that their progressive release has on the health of human beings and of the ecosystems and the services these provide. In one way or another all POP substances are recognised to have adverse, generally long-term, effects upon living organisms. They persist for a very long time in the environment and in our bodies and can be transported unchanged to almost any remote point of the globe, far away from where they were produced or used. The figure below shows the “problem tree” which links problem drivers, problems and consequences associated to POPs subject to the measure under consideration. Figure 1: Problem tree

Pollution by POPs Persistent organic pollutants, including those in scope of this measure are found in water, sediments and soil, in waste and accumulating in the bodies of living organisms, including human beings. These cause different and often substance-specific adverse effects on human health and on ecosystems including on reproduction, sexual development, growth or on learning and neurological development, to name just a few. Pollution by POPs thereby results in human disease and mortality and in the degradation of ecosystems and the services they provide. In Europe, several past and on-going large-scale bio-monitoring programs have investigated the presence of POPs used as pesticides or flame retardants and of other hazardous chemicals in human body fluids such as blood or urine. Two of the most relevant EU projects are DEMOCOPHES and the on-going HBM4EU with the participation of 30 countries, the European Environment Agency and the European Commission. In 2004, a study by the WWF attracted high media attention when it revealed the presence of numerous hazardous chemicals, including POPs, in the blood of EU citizens. More recently, a study done in 2014 on the Flemish population has revealed that 77% of 50-65 year olds had PFOS and PFOA levels in their blood that exceeded reference values for absence of risk. Evidence from these and other sources points to significant environmental exposure to some POPs. Pollution by these substances spreads throughout the globe, does not disappear naturally (or does so only very slowly) and can exert its effects for decades to come. It is extremely difficult to clean-up or to otherwise address pollution by these substances which makes substitution and elimination of POPs, together with tight control on their emissions, the only appropriate approach to their management. POPs can be present in recycled materials Having established that POPs are present in certain wastes it is easy to conceive that some of these POP substances will be recycled together with the materials in which they are contained (e.g. plastic, wood, paper) and be introduced back into the economy as products containing recycled materials. This is particularly relevant when contaminated materials are used to produce products for consumers, including for children and other vulnerable populations, with the resulting risk of exposure. According to EEB and as further mentioned on the “interface” Communication, POPs have appeared in consumer products containing recycled materials such as toys, food containers and kitchen utensils. The staff working document to the referred Communication provided an overarching vision regarding the presence of substances of concern (including POPs) in recycled materials: Materials should be safe, fit-for-purpose and designed for durability, recyclability and low environmental impact. These materials and the articles made from them should, to the extent possible, be designed, manufactured, traded and recycled free from substances of concern. The reason being that they may be reused and eventually disposed of in a way that maximises the materials’ economic benefits and utility to society while maintaining a high level of human health and environmental protection. For materials not fulfilling this overarching vision, the policy options in this document aim to launch a reflection on the appropriate balance between the overall long term benefits from circular use of a material and the overall long term health and environmental concerns relating to substances present in that material. This vision has been further developed under the Chemicals Strategy for Sustainability and clearly reflects the challenges faced to deal with, and ideally remove, all POP substances from recycled materials, ensuring they are safe, while at the same time striving to preserve the value of materials in the economy for as long as possible. The presence of POPs in recycled materials represents a potential risk to the users of these materials, reduces the confidence of supply chain operators (e.g. plastic converters) and of consumers in recycled materials. Consequently, a successful circular economy with well-functioning markets for secondary materials can ideally only be based on safe, toxic-free materials. All POP substances have been phased out or are heavily restricted. For other substances of concern whose use continues and are essential for society, appropriate risk management measures have to be in place. Keeping this very clearly in mind, the challenge addressed in this report lies is determining maximum levels of POP contamination that can be tolerated in waste that will not be subjected to destructive treatment, including, potentially, being recycled (Annex IV limits). Waste that exceeds such limits, set under the POPs Regulation, will be subjected to destructive treatment, generally incineration, or to another environmentally sound disposal option, such as landfilling in a hazardous waste landfill or underground storage facility. This will inevitably lead to the elimination, not only of the POP substance, but also to the loss of all the material associated to it and, very often, to an increase in CO2 emissions. This happens because once a material becomes contaminated with a POP substance it is usually very difficult to remove it or to separate clean from contaminated material. This loss of potentially recyclable material could in some cases have an effect on the supply of relevant materials, for instance secondary technical plastics obtained from waste electrical and electronic equipment (which would be relevant, for instance, if mandatory recycled content targets were to be introduced). We are immersed in a climate emergency The world is in the midst of a climate crisis as repeatedly confirmed by reports by the UN Intergovernmental Panel on Climate Change (IPCC) and fully backed and recognised as a key political priority by the EU. Putting in place a more circular economy is a fundamental step towards achieving climate targets. As stated in the referred report by the Ellen McArthur Foundation, the greenhouse gas emissions causing climate change are a product of our ‘take-make-waste’ extractive economy, which relies on fossil fuels and does not manage resources for the long-term. The circular economy can contribute to emissions reduction by transforming the way we make and use products. The referred publication states that applying circular economy strategies in just five key areas (cement, aluminium, steel, plastics, and food) can eliminate almost half of the emissions from the production of goods – 9.3 billion tonnes of CO2eq in 2050 – equivalent to cutting current emissions from all transport to zero. In industry, this transformation can be partly brought about by recycling the materials used to make goods and assets. This reduces the demand for virgin materials such as steel, aluminium, cement, and plastics, and the emissions associated with their production. To a greater or lesser extent, recycling of the materials containing POPs addressed in this report can contribute to this effort by reducing the emissions resulting from the production of their substitute primary materials and, potentially, by avoiding net emissions from their incineration (even if these can be at least partially off-set by emissions avoided by not burning fossil-fuel).

What are the problem drivers? Some waste contains POPs POP substances in scope of this initiative have been used in industry for many decades to manufacture products. In many cases the functionalities sought are associated to the chemical nature of these substances and is what actually makes them “POP substances”. Examples of these are perfluorinated substances used to provide water repellence to clothes, to make anti-stick polymers for cookware or to provide better extinguishing properties to fire-fighting foams. A similar situation exists with members of a family of large bromine-containing organic molecules, known as PBDEs, used to make materials such as plastics and textiles fire-resistant. Therefore, waste sometimes contains POP substances. This is the consequence of our industrial history and, even though these substances may today be banned or restricted, some still appear in waste, and will do so for many years to come. This is particularly true for waste from products that have long life-cycles, such as materials used in construction, in vehicles and certain types of electrical and electronic equipment. The POPs Regulation contains no limit values or these are inadequate For substances that have been recently listed under the Stockholm Convention, such as the pesticide dicofol or the perfluorinated substance known as perfluorooctanoic acid (PFOA), its salts and related compounds, there are currently no limit values in Annexes IV and V of the POPs Regulation. For other substances limit values exist but may have become outdated due to scientific and technical progress or some actors find them not protective enough and consider they should be modified (reduced). The purpose of the initiative supported by this impact assessment is to amend Annexes IV and V of the POPs Regulation to list substances that have been recently listed by the Convention and to, as appropriate, introduce new or revise existing limit values for POP substances, applicable to waste. Section 6.2 of Annex VI of this impact assessment contains further information about the substances in scope. In practical terms, concerns about the value of the limits in Annex IV of the POPs Regulation translates into concerns about the environmentally sound management of POP waste. In general, wastes containing listed POP substances at concentrations equal to or above the limit have to be subjected to destructive treatment, preceded by any necessary pre-treatment to separate waste that contains POPs from that which does not (or does so below the limit value). Waste below that limit can be recovered or disposed of by other means, including recycling (subject to limits in Annex I) or landfilling in a non-hazardous waste landfill. For a limited number of waste streams, possible recovery operations, as defined in Annex II of the Waste Framework Directive, permitted below the Annex IV value, include operations R5 “recycling/reclamation of other inorganic materials” and R10 “Land treatment resulting in benefit to agriculture or ecological improvement”. These operations are relevant only to a few waste streams containing relevant concentrations of POP substances in scope of this study. As further explained under the relevant substance sections in section VI, and in the description of the methodology in Annex IV of this report, such specific waste treatments are generally better addressed separately via dedicated legislation (e.g. via EU and/ or national sewage sludge legislation, EU and national legislation dealing with fertilisers). There are insufficient means for sorting and decontaminating POP waste Once problematic substances such as POPs are introduced into materials, for instance flame retardants in plastics or the biocide pentachlorophenol in wood, it is very difficult to remove them without destroying those materials. This often jeopardises any future recycling of the material based on technical or economic feasibility. To a lesser extent, the same happens with attempts to separate waste parts or fragments containing POP substances (or POP substances above a certain concentration) from those that do not. This situation presents itself when dealing with waste from the collection and sorting of materials, complex articles and other products where the presence and amount of the relevant POP substance is variable and results in some being contaminated, and some not. Examples of this are shredded plastics from the treatment of end-of-life vehicles, from the treatment of electrical and electronic equipment, or insulation material or wood from the demolition of buildings. Therefore, one crucial element in the assessment of how to deal with POPs in waste is having a sound understanding of the state-of-the-art in sorting and decontamination technologies, that could be applicable and economically feasible to treat any given waste. The availability of technologies and treatments to extract POP substances from materials or to separate contaminated from clean material, enables the production of clean (or cleaner) materials from POP waste and contributes to increase recycling rates. This also potentially enables the setting of lower annex I and IV limit values, reducing the likelihood of having an impact on recycling rates. The relevance of this is recognised in the new Circular Economy Action Plan that states that to increase the confidence in secondary raw materials the Commission will, among other actions: “support the development of solutions for high-quality sorting and removing contaminants from waste, including those resulting from incidental contamination”. Furthermore, the Chemicals Strategy for Sustainability indicates that: “Regulatory actions need to go hand-in-hand with increased investments in innovative technologies to address the presence of legacy substances in waste streams, which could in turn allow to recycle more waste.” Unfortunately, proven and effective industrial scale decontamination technologies are extremely limited and applicable detection and sorting technologies, relevant to the POP substances and waste types under discussion are still also quite scarce.

In light of the above, it seems clear that sorting and decontamination technologies have a key role to play in achieving more abundant and cleaner flows of recycled materials. A number of relevant projects are currently underway, financed by Horizon 2020 . New funding opportunities are available in calls for proposals under the current programme and will soon also be available under Horizon Europe . Deficiencies in the interaction between the legislation on chemicals, products and waste The Commission Communication on the interface between the legislation on chemicals, products and waste identified four main issues that are a barrier to the implementation of a more circular economy in Europe: 1.lack of information about the presence of substances of concern (including POPs) in articles; 2.lack of agreed methodologies to support decisions on how to deal with such substances in recycled materials; 3.uncertainties about when a material is waste or not; and 4.Inconsistencies and implementation problems in the way we classify waste as hazardous waste (as compared to how we classify substances and mixtures). All these issues can be relevant in dealing with waste streams containing POPs and can lead to highly granular impacts which are associated to specific substances and waste streams. An example of this are the diverging national / regional ways of implementing waste classification rules that make certain plastic waste containing flame retardants (PBDEs) at or above the Annex IV limits be considered hazardous waste in some regions but not in others (as reported by some stakeholders). This in turn has an influence on the cost and administrative burden associated to moving this waste across Europe (for recycling) and on the operational costs and permit requirements for the treatment installations. Such aspects, which are not a direct consequence of the limit values to be determined are discussed in the relevant sections, in particular for WEEE plastics containing PBDEs, but there is not enough information to quantify their (possible) additional impact nor to propose specific measures to address it. Further actions to address these problems are taking place in the context of the new Circular Economy Action Plan and the Chemicals Strategy for Sustainability as well as under the on-going amendment of the Waste Shipment Regulation where the issue of the cross-border movement of wastes, the nature of the notification requirements for waste and the associated procedures are regulated. How will the problem evolve? In very general terms the baseline is expected to result in maintaining the current emission levels of POPs to the environment, leading to increased pressures on the environment and on human health which is already largely impacted by the presence of hazardous chemicals in the environment . The evolution of the problems outlined above, in a business-as-usual scenario, is nonetheless rather case specific and depends on the waste streams concerned, the current practice, specific legal requirements and the status of the relevant treatment technologies. On the one hand, for substances that have not been in use in the EU for years, sometimes decades, such as the pesticide dicofol, the amount of waste that remains to be generated is very small and, consequently so is the impact and their contribution to the overall problem. On the other hand, other waste streams are expected to become more important in terms of both the volumes generated and the time over which this will happen (Ramboll, 2019). This includes waste from electrical and electronic equipment (that may contain certain brominated flame retardants) - one of the fastest growing waste streams in the EU - or from long life-cycle materials, such as expanded polystyrene insulation panels used in buildings (that may contain another POP-listed flame retardant, HBCDD). As detailed in section 2.2, action will be taken on problem drivers to improve the interaction between chemicals, product and waste legislation, including on the better tracking of substances to support the development of sorting and decontamination technologies. This will allow for better identification and management of waste that contains POPs, ensuring its sound environmental management in a manner that maximises elimination of the POP substances and the recovery of materials. For some of these waste streams the development of novel sorting or decontamination technologies could have a profound impact on the treatment and potential recovery of material from POP-contaminated waste. A promising example of this is the PolyStyreneloop project for the treatment of polystyrene insulation foams, partially funded through the LIFE program and currently being implemented in a demonstration industrial plant under construction in the Netherlands. Further analysis of each of these cases is provided in the relevant substance chapters of supporting study by RPA (2021) [Study to support the assessment of impacts associated with the review of limit values in waste for POPs listed in Annexes IV and V of Regulation (EU) 2019/1021. European Union 2021. ISBN 978-92-76-41943-3]. Who is affected and how?

Society as a whole: (people): Human health and environmental burdens associated to emissions resulting from insufficient management of POP waste, including from recycling POP-contaminated materials into new products, have environmental, social and economic consequences that are often not well accounted for. The positive impacts associated to enhanced recycling, including the avoidance of greenhouse gas emissions and the reduction in the use of primary raw materials, also have to be factored in. EU consumers: EU consumers currently do not have sufficient, reliable and comparable information on the possible presence of POP substances in recycled materials or how this can relate to the articles they buy. Their safety and confidence in recycled materials can consequently be affected. The provision of different types of product-related information is within the scope of actions under the Sustainable Products Initiative, currently being developed by the Commission. Non-EU consumers: Imposing new or more demanding limits on the POP content of certain wastes, and setting limitations to their recycling in Europe, may lead to increased shipments of waste (particularly of illegal shipments) for recycling or disposal in other parts of the world with lower treatment and consumer protection standards than in Europe. Whether these shipments take place also largely depends on the classification of wastes as hazardous or not and on the specific applicable provisions for the shipment of waste to the receiving countries. Recyclers: Recycling companies, such as those processing waste electrical and electronic equipment can be impacted by changes in limit values that reduce the amount of waste that can be ultimately recycled. Reductions in Annex IV limit values can decrease, at least in the short term, the amount of recyclable material and, potentially, also their revenue. Additionally, higher waste management costs associated to treatment of non-recyclable fractions can be expected. Additional impacts in terms of the logistics of collection, transport and operation of recycling installations is also likely if changes in Annex IV values would result in the classification of the waste as hazardous waste. Other waste operators: Waste operators other than recyclers will potentially benefit from the diversion of previously recyclable material to other treatments, such as incineration, landfilling or physical-chemical treatments. These flows may originate from recyclers, having to dispose of greater fractions of their incoming waste or directly from waste producers. Therefore, some of the costs identified in this impact assessment are distributional costs. Waste producers: Producers of waste may lose revenue and even incur in additional waste management costs due to having to dispose of waste subjected to stricter requirements that require disposal rather than recycling, or having to bear additional sorting and pre-treatment costs. Users of secondary raw materials: Reduced availability of recycled materials and the consequent need to source primary materials may have a negative impact on the supply secondary materials and a negative economic impact upon their users, therefore also undermining the trust in secondary raw materials markets. The reduction in availability of material for recycling can have impacts on the ability to ensure compliance with mandatory recycling targets for the affected materials / product categories where such requirements are set or may be set in the future. On the other hand, reduced POP concentrations in secondary materials result in greater customer confidence on their quality and safety which, next to supply issues, is a key factor to establish trust and consequently uptake of secondary raw materials. Public authorities: Public authorities are responsible for implementing the relevant EU acquis and, as regards waste, for ensuring that waste is managed in an environmentally sound manner, without overall adverse effects on human health and the environment. The introduction of new or stricter limits affecting waste streams has as an immediate effect on control and enforcement activities, which can require increased inspection, analytical or enforcement work as well as vigilance of potential increase in illegal waste management and shipment. In the particular case of domestic incineration ashes contaminated with dioxins and furans, analysed in this impact assessment, additional costs could apply derived from the need to establish separate collection systems for new streams of hazardous household waste (further information provided in section 6.3). 3.Why should the EU act? Legal basis Pursuant to Article 192(1) of the Treaty on the Functioning of the European Union, the European Parliament and the Council of the European Union adopted the Regulation (EU) 2019/1021, of 20 June 2019, on Persistent Organic Pollutants (recast). The initiative is in an area of shared competence, but its necessity and its EU-added value have been clearly recognised throughout the years. The risk that POP substances may be introduced into products via recycled materials is addressed in the basic act and for specific chemicals listed in the Stockholm Convention. Therefore, it is necessary to establish concentration limits as a management measure to ensure that the amount of POPs in waste that is to be recycled into such materials is low. Article 3(6) of the POPs Regulation determines that waste consisting of, containing or contaminated “by any substance listed in Annex IV”, is regulated by Article 7. That article determines how POP waste should be controlled and managed in the Union. Together with Annexes IV and V, Article 7 provides the framework to implement the obligation of ensuring environmentally sound management of waste, established under the Stockholm and Basel Conventions. Article 15(2) on amendment of Annexes of the Regulation specifies that: “The Commission shall keep Annexes IV and V under constant review and shall, where appropriate, make legislative proposals to amend these Annexes in order to adapt them to the changes to the list of substances set out in the Annexes to the Convention or the Protocol or to modify existing entries or provisions in the Annexes to this Regulation in order to adapt them to scientific and technical progress”. All aspects regarding the general motivation to act, the instrument chosen and similar considerations were addressed and validated by the co-legislator during the recast of the POPs Regulation in the year 2019. In revising Annexes IV and V the Commission has limited room of manoeuvre. In practice the Commission has to propose the listing of new substances identified as POPs under the Stockholm Convention in Annex IV and V (to meet its international commitments under the Convention). For substances listed in Annex IV (and V) the Commission has discretion on the choice of the numerical values that will be proposed (in establishing a value for the first time or in deciding to review it), given that the “low POP content” values provisionally listed in Table 2 of the General POPs Technical Guidelines developed under the Basel Convention are not legally binding. These define the different options considered in the current impact assessment. Further information on legal aspects relative to POP substances is provided in Annex V to this impact assessment report. Subsidiarity: Necessity of EU action

Pollution by POPs cannot be solved by the Member States acting alone. The chemical substances considered are transported across internal EU boundaries far from their sources. Avoiding releases from waste is a priority in this respect. The protection of the environment and of human health through a system that guarantees the sound management of POP waste can only be efficient if common rules are defined and established at the EU level. This matter is further explained in section 2.1. on “problem definition”, in section 2.2.4 as regards the interface between chemical, product and waste legislation and is further illustrated by the reported implementation issues described in footnote 50 and in section 6.1.3, relative to PBDEs, of this impact assessment. Consequently the measure supported by this impact assessment addresses at an EU level wastes containing newly listed POP substances under the Stockholm Convention, adapting to technical progress, as appropriate, the limit values of some substances already listed. Such obligations arise as a consequence of the implementation of the POPs Regulation, adopted in the year 2004 and recently recast in the year 2019. No further considerations, regarding subsidiarity of this initiative, to specifically amend the waste annexes of the POPs Regulation, are considered necessary as these obligations stem from the existing legal framework. Further information on the processes of the Stockholm Convention, its Parties and on the operation of the POPs Regulation are provided in the introduction, in section 1.3 and in Annex V of this impact assessment report. Subsidiarity: Added value of EU action If national regulations were in place, cross-border effects could appear such as imbalances in the level of treatment of POP waste and there would be a risk of fragmentation of the Internal Market for the associated waste and recovered materials leading to unfair competition and uneven protection of human health and the environment, that should be avoided (see sections 2.1 and 2.2). Following a similar reasoning, providing common limits and treatment standards for POP waste, including those that enable the recycling of certain materials from POP waste, provide legal certainty and thereby contribute to enhancing the recycling of materials from waste, for instance from WEEE, and the uptake of secondary raw materials in the EU. 4.Objectives: What is to be achieved? The aim of this regulatory intervention is to update the threshold values set in Annexes IV and V of the POPs regulation, which determine how waste is treated, particularly whether waste can be recycled or it should be destroyed or irreversibly transformed. The POPs Regulation's overarching objective is the protection of human health and the environment against POP substances. General objectives Taking into account the overarching objective of the POPs Regulation, the general objectives of this initiative are to ensure – to the extent possible – an optimal balance with the European Green Deal's ambitions related to toxic-free material cycles, increasing recycling and circularity and reducing GHG emissions. Figure 2: Objectives tree of the measure. Transition to high-quality, toxic-free material cycles As indicated the main objective of the POPs Regulation is the protection of human health and the environment against the adverse effects caused by POP substances. This overarching objective is embodied in this first general objective whereby management of POP waste, including is recycling where this is possible, should be carried out in an environmentally sound manner, with a minimal impact on human health and the environment. The resulting secondary materials should always be safe and fit-for-purpose and, to the greatest extent feasible, free of toxic substances. It will also reduce the extent of leaching of toxic substances to the environment, and thus contribute to the Zero-Pollution Ambition by reducing environmental and health impacts . In order to achieve this, suitable, state-of-the art sorting and decontamination technologies must be available. Increase circularity and recycling It is essential to boost the production and uptake of secondary raw materials and to support the creation of a well-functioning internal market for them. This is one important part of the way towards a more circular economy, where the value of products, materials and resources is maintained in the economy for as long as possible, and the generation of waste minimised. This is also an essential contribution to the EU's efforts to develop a sustainable, low carbon, resource efficient and competitive economy. A transition towards secondary materials of comparable quality and composition to primary materials must be ensured to strengthen their supply chain and the confidence of consumers in recycled materials and in products made from them.

Reduce Greenhouse Gas Emissions All policy actions should to the extent possible contribute to the overarching objective of making the EU a carbon-neutral economy by 2050, as well as to meeting intermediate greenhouse gas emission reduction targets. Consequently the net greenhouse gas emissions resulting from the policy options chosen, taking into account the full life-cycle of associated materials and products, should not run counter to this objective. Specific objectives In very specific terms the objective of the measure is to list in the POPs Regulation new substances listed under the Stockholm Convention and to introduce or revise the limit values in its Annexes IV and V, for a defined set of substances, ensuring that the best possible balance is achieved in fulfilling the three general objectives listed above, taking into account the hierarchy of objectives described below. Hierarchy of objectives The objective of protection of transition to high quality, clean (toxic-free) material cycles captures the importance attached to human health and the environment and the precautionary principle. Therefore this objective is given a greater weight in the methodology used to propose limit values for POPs in waste, which is described in further detail in section 5.2 below and in Annex IV of this report. In addition to including a human / environmental health benchmark values for each substance, associated to risks that may occur during waste disposal / recovery, the method applies a so called “target function” as an approach to apply the precautionary principle. This approach is further explained and illustrated in Annex IV, but in practice it results in proposing values which are as low as possible, limited only by analytical, practical or proportionality limitations. The proposed value is thereby usually the highest of the lower limitation criteria values determined. The POPs Regulation also requires consideration of proportionality. The principle of proportionality is laid down in Article 5 of the Treaty on European Union. It seeks to set actions taken by EU institutions within specified bounds. Under this rule, the action of the EU must be limited to what is necessary to achieve the objectives of the Treaties. In other words, the content and form of the action must be in keeping with the aim pursued (in this case protection of human health and the environment). Article 5 of Protocol number 2 to the Treaty, on the application of the principles of subsidiarity and proportionality, further indicates that “draft legislative acts shall take account of the need for any burden, whether financial or administrative, falling upon the Union, national governments, regional or local authorities, economic operators and citizens, to be minimised and commensurate with the objective to be achieved”. Article 7(1) of the POPs Regulation requires that producers and holders of waste undertake reasonable efforts to avoid contamination of waste with POP substances and recital 34 of the Regulation also recalls the principle of proportionality. Consequently, although the overarching objective of the limit values proposed in the impact assessment is human health and environmental protection, the Commission is still required to assess aspects associated to the other Green Deal objectives and aspects included in the methodology, such as economic feasibility or disposal capacity, in order to get to a balanced and proportionate proposal for the preferred policy option. 5.What are the available policy options? What is the baseline from which options are assessed? The baseline describes a situation where no changes would be introduced in Annexes IV and V to the POPs Regulation. This means that newly listed substances under the Convention would not be included in the relevant Annexes. In the case of substances for which limits have already been set under the POPs Regulation, and for which scientific and technical progress advises that the values be reviewed, this change would also not happen. In all of these cases, and beyond the fact that such inaction would mean, in the first case, failing to implement its obligation to ensure environmentally sound management of waste under both the Stockholm and Basel Conventions, the result would be that the existing situation is maintained. Given that all options considered comprise the introduction of new limit values for newly listed substances or the tightening of existing ones, a general consequence can be deduced: under the baseline scenario waste containing the different POP substances would continue being managed as usual and less POP-containing waste would be destroyed than under the other options. Any situation that does not lead to destruction or irreversible transformation of the POP substances is a potential source of future emissions. This can happen by reintroduction into the economy in products (which may result in exposure and emissions during their service life and upon becoming waste) or as leakage into the environment as a result of non-destructive waste management options (e.g. landfill, disposal on land for agricultural purposes, etc.). To a greater or lesser extent this unavoidably contributes to increased pollution by POPs, resulting in additional pressures on the environment and in the associated adverse impacts on human health, ecosystems and biodiversity. The precise baseline is different for each substance and its related waste streams. A summary of the baseline and of the impacts associated to the options is provided in sections 6 and 7 of this report and further supporting information can be found in Annex VI to this report and, particularly, in the individual substance chapters in the support study by RPA(2021). Methodology to set the limit values The approach used to set the limit values is based on an established methodology. This methodology was originally developed in a study by BiPRO (2005) and subsequently used in further studies in support of the review of limit values for waste under the POPs Regulation done by ESWI (2011) and Ramboll (2019). Consequently this methodology was developed and promoted by the European Commission and has been subsequently introduced in guidance issued at the international level under the Basel Convention. This methodology has been used in support of all previous amendments of annexes IV and V of the POPs Regulation (since 2004) and is, to our knowledge, broadly accepted by stakeholders. The Commission considers the technical studies underpinning this assessment to constitute the best available evidence base. It takes account of hundreds of peer-reviewed and non-peer reviewed reports. The Commission services have reviewed the support studies and these are subject to quality control by the consultants that developed them. The Commission’s analysis is highly valued by members of the international community and are one of the few detailed inputs into the discussions on low-POP content limit values under Basel. The Commission is not aware of similar reports by other Parties that aggregate and analyse published information about POP substances in waste for proposing limit values in waste (other than a report published by Germany in 2015 in the context of the POPs Regulation).

This section summarises the key elements of this methodology. Further details can be found in Annex IV of this impact assessment. Setting the limit values The basic principle of the method to determine the Annex IV values is based on establishing the concentration range for a possible limit value for each of the relevant substances by means of a set of different lower and upper limitation criteria To determine the range of possible limit values for every substance, four lower and two upper limitation criteria are applied. The actual range is determined by the highest of the lower limitation criteria and the lowest of the upper limitation criteria. The lower limitation criteria are the following: ·Analytical potential (A): It must be possible to control limit values analytically. Values presented in Annex VI correspond to quantification limits achievable in most laboratories, for unfavourable waste matrices and therefore are not the most sensitive quantification limit possible. This explains why for some substances these reported values are higher than reported background values. ·Background contamination (B): Limit values should be above existing environmental background contamination. ·Disposal and recovery capacities (C): Limit values should be established in a way that the (new) required capacities for waste recovery and disposal are realistically available. ·Economic feasibility (D): costs to economic operators should not be disproportionate. In addition, where a relevant unintentional trace contaminant (UTC) value has been defined in Annex I of the POPs Regulation, this value is also used as a lower limitation criteria. It is not considered proportionate to impose a stricter limit for the purpose of waste management that for the placing on the market of products. The upper limitation criteria are the following: ·Risks (Y) (possible adverse effects on human health and the environment): Limit values should be established in a way that adverse effects on human health and the environment are avoided and human health and the environment are protected from persistent organic pollutants as far as possible. ·Existing limit values (Z) agreed at Union level: Limit values should not conflict with existing limit values (e.g. by exceeding them). Figure 3: Methodology: lower and upper limitation criteria (ESWI 2011). To reduce the range that results from these limitation criteria to a specific POP concentration limit the methodology applies two “target functions”: ·Target function I: "Reduce results for different waste matrices to the most unfavourable waste matrix". This function refers to the analytical potential criterion and ensures that a value is selected that is feasible and implementable for all relevant waste streams.

·Target function II: “Reduce the limit value to the lowest limit value within the feasible range of options” in the final decision on an Annex IV limit proposal in the range between upper and lower limitation criteria. This function contributes to ensuring the highest level of protection to human health and the environment via the application of the precautionary principle (referred to as “criterion X” in ESWI (2011). See for instance the limitation criteria diagrams for HBCDD and SCCP in Annex VI where, in application of this criteria, and to take due account of difficulties in determining reliable health based limit values for some substances (see footnote 11 and Annex IV, section 4.3), the values proposed are lowered from the health based / existing limit value (upper limitation criteria to the highest of the lower limitation criteria. The precautionary principle and the principle of proportionality The precautionary principle is detailed in Article 191 of the Treaty on the Functioning of the European Union (TFEU). It aims at ensuring a higher level of protection through preventative decision-taking in the case of risk. It is also included in the Stockholm Convention (Articles 5-7). This is done in this impact assessment through "Target function II" of the methodology (cfr above), which puts the limit values at the lowest possible values. As already indicated in section 1 (see footnote 11) for many POP substances, due to the non-threshold nature of some of their effects and because of their extreme persistency, it is not possible to scientifically define safe, no-effect limit values, at least for some of their adverse effects. This report compiles and uses such limits, where it has been possible to determine them, but the referred target function II, which implements the precautionary approach, takes this element of uncertainty into account by reducing the limit values proposed, to the extent feasible. It flows from the Union principle of proportionality and from the specific reference to ‘reasonable efforts’ by producers and holders of waste in Article 7(1) of the POPs Regulation that, in implementing the POPs Regulation, the precautionary principle is to be applied in a proportionate manner. The principle of proportionality, set out in Article 5 of the Treaty on European Union, and recalled in recital 34 of the POPs Regulation, has been upheld in this impact assessment in three ways. First, in the methodology to set the limit values, "Target Function I" ensures that limit values are feasible and implementable for all relevant waste streams (cfr above).. Furthermore, when assessing the proportionality of the proposed limit values, an assessment of economic feasibility for the main operators affected is carried-out. For transparency, diagrams provided in Annex VI for each substance provide, where relevant, several benchmarks for economic feasibility, associated to the different options under consideration (e.g for PBDEs and PCDD/Fs). Each assessment is case-specific and made, to the best judgement of the assessors in the responsible Commission service, on the basis of available information. Aspects such as the number, size and nature of stakeholders affected and their estimated capacity to absorb additional costs and investments, are taken into account, normally based on a qualitative analysis. Second, as explained in Sections 4 and 6, the assessment of the impacts of the different options not only takes into account health and environment considerations, but also the Green Deal's objectives of toxic-free material cycles, increasing recycling and reducing GHG emissions Third, a policy choice has been made as regards waste treatments that result in application on land, which avoids double regulation. This is done by leaving the regulation of limit values for POP substances associated very specific and sensitive waste treatment operations to existing specific legislation, where relevant. This includes Directive 86/278/CEE (the Sewage Sludge Directive), currently under review and where limits are being considered for relevant organic pollutants; and Regulation (EU) 2019/1009 on EU fertilising products where limits for relevant organic substances are set for waste derived materials incorporated into fertilisers (which are applied on land). Policy options Description of the policy options Given the existing provisions under the Stockholm Convention and the POPs Regulation, the Commission has no discretion regarding the choice of instrument or the substances to address. Consequently, the policy options considered in this impact assessment to support the initiative are exclusively linked to the precise limit values to be proposed for each substance concerned and, potentially to the time for entry into application and the transitional periods. As discussed in the problem definition section nine substances or substance groups are addressed in this impact assessment. They are all in the scope of the proposed amendment to adapt entries in Annexes IV and V of the POPs Regulation to changes in the substances listed in the Annexes to the Convention. The initiative also seeks to modify existing entries in these Annexes to adapt them to scientific and technical progress. The obligations of the Commission regarding each of the substances in scope are summarised in the table below: Substance Obligation to act PBDEs Proposal to review of limits “as appropriate” according to Article 15(2) of the POPs Regulation. There is an indication from the co-legislator in the POPs Regulation should propose to review the Annex IV value to 500 mg/kg, “where appropriate”, by 16 July 2021. HBCDD At the discretion of the Commission. Proposal to review of limits “as appropriate” according to Article 15(2) of the POPs Regulation. There is an indication from co-legislator in the POPs Regulation to review the Annex IV value by 20 April 2019. PCDD/Fs (dioxins and furans) At the discretion of the Commission. Proposal to review of existing limits “as appropriate” according to Article 15(2) of the POPs Regulation. Dioxin-like PCBs At the discretion of the Commission. Adaptation to technical progress and proposal for a modification of the existing entry for PCDD/Fs, and to include or not, based on its assessment, dioxin-like PCBs into this limit value, “as appropriate” according to Article 15(2) of the POPs Regulation. Short-chain chlorinated paraffins SCCPs) At the discretion of the Commission. Proposal to review of existing limits “as appropriate” according to Article 15(2) of the POPs Regulation. PFOA, its salts and related compounds Required. Proposing to list the substance in Annex IV and V of the POPs Regulation is necessary to comply with the obligation under the Basel and Stockholm Conventions to ensure the environmentally sound management of waste containing these substances. A limit value in Annexes IV and V is to be proposed “as appropriate” according to Article 15(2) of the POPs Regulation PFHxS, its salts and related compounds Required. Same as above. Pentachlorophenol (PCP) its salts and esters Required. Same as above. Furthermore, these substances were already listed under Regulation (EC) 850/2004 (previous POPs Regulation). Dicofol Required. Listing the substance in Annexes IV and V of the POPs Regulation is necessary to comply with the obligation under the Basel and Stockholm Conventions to ensure the environmentally sound management of waste containing these substances. A limit value in Annexes IV and V is to be proposed “as appropriate” according to Article 15(2) of the POPs Regulation. Table 2: Summary of reason to act, per substance in scope. Policy Option 1: Baseline Assuming no change under the baseline, the following would be the situation for the different substances or substance groups:

New Substances (for which there is no value in Annexes IV or V) ·Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds and dicofol – these are newly listed substances under the Stockholm Convention, and have to be included in the POPs Regulation with new limit values set for them for the first time. Under the baseline, this would not happen and the EU would be in breach of its international obligations. ·Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds - these are envisaged to be listed by the Stockholm Convention in 2022. At this point, and based on the current assessment, the Commission together with the European Parliament and the Council will need to include them in the proposal to amend Annexes IV and V of the POPs Regulation. ·Pentachlorophenol (PCP), its salts and esters – these substances were listed in annexes A and C of the Stockholm Convention in May 2015 and were introduced in Regulation (EC) No. 850/2004 in the year 2019. Due to administrative and procedural reasons these values could not be included in the POPs recast and consequently are currently not listed in Annexes IV or V of the POPs Regulation. A proposal has to be made to introduce this substance in Annexes IV and V of Regulation (EU) 2019/1021 (after it repealed the previous Regulation). POPs listed in the POPs Regulation for which limit values are already set ·PBDEs, HBCDD, SCCP, Dioxins & Furans (PCDD/Fs) – these are already listed substances so under the baseline they would remain at their current limit values because their review is not considered appropriate (e.g. because of disproportionate impacts or no benefits expected). ·Dioxin-like PCBs – These are currently addressed by the existing “group” entry for polychlorinated biphenyls (PCBs) in Annex IV which covers all 209 congeners (variants) of this substance. This report assesses the option of addressing a subgroup of 12 PCBs, known as dioxin-like PCBs, that closely resemble the toxic properties of dioxins and furans. Two approaches are possible, dealing with them on their own, as a separate group of substances, or together with dioxins and furans. Under the baseline, dioxin-like PCBs would not be addressed specifically (but only in a limited way under the current group value covering all PCBs). Policy Option 2 – Medium value In Policy Option 2, new limit values under Annex IV are established for the new substances and limit values are tightened for certain listed POPs where this could be justified. The former is the case for the newly listed substance PFOA, its salts and PFOA-related compounds as well as for PFHxS, its salts and PFHxS-related compounds, which are expected to be listed in the face-to-face segment, planned for June 2022, of the 10th meeting of the Conference of the Parties of the Stockholm Convention. Exceptions where no medium level values are considered are: ·the new substance dicofol, because introducing a lower (stricter) limit value aligned with that of other listed organochlorine pesticides would be effective and have no measurable economic impact. Therefore only a single (lower) policy option is considered, captured under “option 3”. ·the pesticide PCP, which had been listed under the previous POPs Regulation and for which such value had already obtained political agreement in 2019. Therefore only a single (lower) policy option is considered, captured under “option 3”. For the remaining existing substances in scope – PBDEs, HBCDD, SCCPs and dioxins & furans (including dl-PCBs) a middle limit value is considered in the impact assessment. Policy Option 3 – Low value Under Policy Option 3, stricter limit values under Annex IV are established for eight substances. In the case of PBDEs Option 3 is analysed as two sub-options whereby Option 3a results in implementing the lower limit value immediately (estimated in 2021 for the purpose of calculations) and Option 3b