TABLE OF CONTENTS 1 INTRODUCTION 1.1 Definition of Nanomaterials 1.2 Uses of nanomaterials and size of the market 1.3 Hazards and risks of nanomaterials 1.4 The EU regulatory framework for the risk assessment and risk management of nanomaterials 1.5 Two impact assessments on nanomaterials 1.5.1 Scope and purpose of the two impact assessments 1.5.2 The political discussion leading to the two impact assessments 1.5.3 Cross-relationship between the two impact assessments 2 PROBLEM DEFINITION 2.1 Policy context: the Registration process within REACH 2.2 The problem requiring action and its drivers 2.2.1 The problem and its consequences 2.2.2 Magnitude of the problem 2.2.3 Initiatives undertaken 2.3 What are the underlying causes of the problem? 2.4 How will the problem evolve? 2.4.1 Nanomaterials as nanoforms of phase-in substances

2.4.2 Quality of the dossiers 2.4.3 Industry, SMEs and innovation 2.5 Who is affected and how? 2.6 The EU's right to act and justification 3 OBJECTIVES – WHAT SHOULD BE ACHIEVED? 3.1 General objective 3.2 Specific objectives 3.3 Operational objectives 4 POLICY OPTIONS 4.1 Option 1: No change 4.2 Option 2: Clarifying the existing information requirements 4.3 Option 3: Soft law measures 4.4 Option 4: Scientific-technical recommendations tailoring information requirements 4.5 Option 5: Reduced information requirements 4.6 Option 6: Exhaustive information requirements 4.7 Interrelationship between options 4.8 The Baseline 4.9 Industry appeals to ECHA decisions on registration of substances with nanoforms 5 ANALYSIS OF IMPACTS 5.1 Public Consultation

5.2 Economic impacts 5.2.1 Conduct of business 5.2.2 Impact on SMEs 5.2.3 Innovation and research 5.2.4 Competitiveness, trade and investment flows 5.3 Health impacts 5.3.1 Introduction 5.3.2 Option 1 5.3.3 Option 2 5.3.4 Option 3 5.3.5 Option 4 5.3.6 Option 5 5.3.7 Option 6 5.4 Environmental impacts 5.4.1 Introduction 5.4.2 Option 1 5.4.3 Option 2 5.4.4 Option 3 5.4.5 Option 4 5.4.6 Option 5

5.4.7 Option 6 5.5 Animal testing 5.6 Classification and Labelling (CLP) 5.7 Summary of the impacts 5.7.1 Option 1 5.7.2 Option 2 5.7.3 Option 3 5.7.4 Option 4 5.7.5 Option 5 5.7.6 Option 6 5.7.7 Schematic summary 6 COMPARING THE OPTIONS 6.1 Qualitative comparison 6.2 The choice of the preferred option 6.3 The costs of the preferred option 6.4 Conclusion 7 MONITORING AND EVALUATION 8 GLOSSARY 9 APPENDIXES 9.1 APPENDIX I: Detail of the measures

9.1.1 Overview of the measures in option 2 9.1.2 Overview of the measures in option 3 9.1.3 Overview of the measures in option 4 9.1.4 Overview of the measures in option 5 9.1.5 Overview of the measures in option 6 9.2 APPENDIX II: Monitoring and evaluation 9.3 APPENDIX III: Ex-post assessment of 2010 registration dossiers 9.4 APPENDIX IV: Ex-post assessment of the REACH impacts to companies 9.5 APPENDIX V: Summary of the Public Consultation 9.5.1 Context 9.5.2 Typology of respondent 9.5.3 Main observations 9.5.4 Specific observations 9.5.5 Assessment of the measures 9.6 APPENDIX VI: Undertaken actions to ensure the quality of the registration dossiers 9.7 APPENDIX VII: 2013 BiPRO report: costs and benefits for industry of option 4 9.7.1 Costs of the measures 9.7.2 Benefits of the measures 9.8 APPENDIX VIII: Nanoforms, sets of nanoforms and the importance of characterisation 9.9 APPENDIX IX: Assessment of non-significant impacts

9.9.1 Functioning of internal market and competition 9.9.2 Impacts on consumers 9.9.3 Public authorities 9.9.4 Employment and labour markets 9.9.5 Standards and rights related to job quality 9.10 APPENDIX X: Summary of the Matrix Study 9.10.1 Methodology 9.10.2 Problem Definition 9.10.3 Options Development and Refinement 9.10.4 Cost Analysis 9.10.5 Impact Analysis 9.10.6 Impact on SMEs 9.10.7 Options Comparison 9.10.8 Conclusions 9.11 APPENDIX XI: Matrix report: impacts on competitiveness 9.11.1 Option 2 9.11.2 Option 4 9.11.3 Option 5 9.11.4 Option 6 9.12 APPENDIX XII: Measures included in the preferred option (initial Commission proposal)

9.12.1 The 3-step decision process towards the preferred option 9.12.2 Detail of the final measures within the preferred option 9.13 APPENDIX XIII: Analytical models used in preparing the impact assessment – Costing methodology 9.13.1 Main assumptions 9.13.2 General methodology and discussion in detail 9.13.3 Input tables 9.13.4 Characterisation costs 9.13.5 Adaptations, tiered approaches and administrative costs 9.13.6 Additional costs scenarios 9.13.7 Additional costs scenarios including the preferred option 9.13.8 Additional illustrative cases 9.14 APPENDIX XIV: REACH in brief 9.14.1 REACH 9.14.2 The Registration process 9.15 APPENDIX XV: Procedural information 9.15.1 Procedural issues and consultation of interested parties 9.15.2 Consultation of the Regulatory Scrutiny Board 9.15.3 Update of the information following the discussions and partial modification of the Commission proposal in the REACH Committee 9.16 APPENDIX XVI: Sensitivity analysis 9.16.1 Cost per nanoform

9.16.2 Grand total costs 9.16.3 Cost for the registrant 9.16.4 Alternative Methodology for cost calculation 9.16.5 Sensitivity analysis – summary 1INTRODUCTION 1.1Definition of Nanomaterials According to Commission Recommendation 2011/696/EU, a nanomaterial is: “A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm." Due to their small particle size, some nanomaterials show different mechanical, electrical, optical and other properties than the same material in bigger size. This effect can be used to increase the performance of materials in products or achieve entirely new functions. Nanomaterials need to be distinguished from the broader term ‘nanotechnology’, which in addition to nanomaterials refers to other nanostructured materials, including larger materials with surface or internal structures at the nanoscale. Most nanotechnology innovation is on such nanostructured materials, e.g. nanoelectronics. However, the health and safety discussion focuses on nanomaterials because the small size of nanoparticles means they can pass membranes and body cells where larger particles cannot. One implication of this is that tests of materials made up of particles in larger size in some cases will not identify hazards of the nanoforms of a substance. The 2011 Commission Recommendation on the definition of nanomaterial is currently undergoing a review. This may result in a revision of the Commission Recommendation in 2018 Based on the current analysis and feedback from stakeholders, this review will most likely only concern clarification of details and will not alter the current definition in a way that would lead to substantial differences for this Impact Assessment. 1.2Uses of nanomaterials and size of the market Most nanomaterials on the market in terms of volume are commodity materials, some of them having been in widespread use for decades. In 2012, the total annual quantity of nanomaterials on the market at the global level was estimated at around 11 million tonnes, with a market value of roughly 20 billion EUR. This estimate, however, excluded most pigments, cosmetics ingredients and plant protection products. In one way or the other, nanomaterials are contained in a very large number of manufactured products, certainly reflecting a market value of trillions of euros. Among the commodity materials, carbon black (e.g. in tyres) and synthetic amorphous silica (used in a wide variety of applications including food additives, paper, plastics, detergents, toothpaste, inks, paints, adhesives, insulation materials in construction etc.) represent by far the largest volume of nanomaterials currently on the market. There are many pigments, cosmetics ingredients and substances used in plant protection products which fulfil the nanomaterial definition. They have been produced and marketed in high volumes and for a long time without having been intentionally designed as nanomaterials. Some nanomaterials are the subject of intensive and worldwide research and development with a view to creating breakthrough innovations, e.g. in medicine, information technology, energy (e.g. batteries), environment (e.g. water treatment), transport, security, space etc. The benefits of innovation in nanomaterials range from saving lives, enabling new applications or reducing environmental impacts to improving the function of everyday commodity products. A number of different nanoforms may be developed from the same chemical substance by modifying shape, physical or particle-surface characteristics of the substance at nanoscale. Typical nanomaterials where such nanoforms have been developed include certain carbon allotropes (e.g. carbon nanotubes, fullerenes, graphene), nanotitanium dioxide, nanozinc oxide and nanosilver. Some of those materials have experienced strong growth in the past up to a certain market size. Nevertheless, none of those has so far created disruptive innovation, as this was predicted in the past. Still, there are nanomaterials such as graphene that are currently under development and are seen as having high innovation potential. There is a range of available information sources on nanomaterials markets and uses, including various market studies, national registries, research projects etc. Nevertheless, this information is incomplete, and not easily accessible to non-experienced users. Part of this information is confidential. 1.3Hazards and risks of nanomaterials Nanomaterials may not only have unique technical properties but also their toxicological profile and their interaction with the environment may differ significantly from the same material in bigger particle size. There is a wide range of available scientific studies on effects of nanoparticles. The OECD has produced a number of publications on the properties of selected nanomaterials and is in the process of adjusting existing Test Guidelines and developing new ones as well as specific Guidance Documents.

From the existing scientific information, it is clear that nanoparticles may to some extent pass body membranes, enter into blood circulation, reach body organs and cells, and cause impacts in these organs and cells. These impacts seem to be partly reversible, as the body is to a certain degree capable of eliminating nanoparticles but bioaccumulation may not be excluded. Under experimental conditions, the most commonly observed effects of exposure to nanoparticles, particularly following inhalation, are oxidative stress, inflammatory responses and in some cases genotoxic effects. The nature and dimension of these effects suggests significant risks, especially in the context of worker protection, unless appropriate risk management measures are taken. However, beyond this specific context, there are no indications that nanomaterials are on average more or less toxic than other chemicals. There is no evidence of widespread serious and acute human health incidents related to nanomaterials, despite the extensive use of many nanomaterials over decades. This said, for nanomaterials as for other chemicals, the link between them and their effects in human health and the environment is not easy to establish. Data on potential long-term impacts is limited to a few studies only (e.g. on carbon black). 1.4The EU regulatory framework for the risk assessment and risk management of nanomaterials The EU regulatory framework for managing the health and environmental risks of nanomaterials is made up of a mixture of requirements to identify and communicate chemical hazards and risks, as well as specific requirements for measures reducing chemical risks. REACH is the main legal instrument assessing the risks of chemical substances, including their nanoforms, and requiring risk management measures to ensure their safe use. Under REACH, chemical substances on their own, in mixtures or in articles manufactured or imported in the EU, meeting certain conditions (e.g. tonnage levels), must be registered with the European Chemicals Agency (ECHA). Before a substance is manufactured or placed on the EU market, its safe use must be demonstrated in the registration dossier. The registration dossiers of certain substances may be subject to evaluation. Depending on their properties and the level of risks, substances may be subject to authorisation or restriction. REACH applies equally to substances for which all, some or no forms are nanoforms, i.e. nanomaterials. Many substances exist in different forms (solids, suspensions, powders, nanomaterials, etc.). Under REACH, different forms can be considered within a single registration of a substance. The registrant must always demonstrate safe use and provide adequate information to address all different forms in the registration, including the chemical safety assessment and its conclusions (e.g. through different classifications where appropriate). The information requirements of REACH registration apply to the total tonnage of a substance, including all forms. Beside this general obligation, there is no specific provision to undertake specific tests for each different form, or to spell out the way in which the different forms have been addressed in the registrations, although the REACH dossier structure allows this and the technical advice in the guidance provided by ECHA encourages it. Although a wide range of commodity nanomaterials has been registered and tested, this has often been done without specific attention being paid to the effects at the nanoscale, as those materials were considered as normal chemical substances and assessed like any other substance. In practice, REACH registration dossiers often contain a variety of different studies, without clear explanation to which forms the information is related, and whether the information is relevant for other forms/nanoforms of the substance. According to Article 9 of the Regulation on classification, labelling and packaging of substances and mixtures (the “CLP Regulation”), hazard classification of substances and mixtures must take into account "the forms or physical states in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used". This in principle requires taking into account specific hazards of nanoforms. However, as testing is regulated under REACH and the CLP Regulation on its own does not require testing of substances, this may be done on the basis of available information, which in turn might not be detailed enough to identify hazards specific to particular nanoforms. Nanomaterials are also subject to a number of provisions in product-specific legislation. This includes pre-market notification of nanomaterials which are cosmetics ingredients to the EU Cosmetics Notification Portal. A catalogue of such nanomaterials was due for publication in 2014 but was delayed until 2017 (see catalogue at http://ec.europa.eu/DocsRoom/documents/23861) due to numerous unclear and obviously wrong notifications. The Scientific Committee for Consumer Safety may assess notified nanomaterials and identify relevant conditions to ensure their safe use in cosmetics. The Biocidal Products Regulation requires specific risk assessments for nanoforms of biocidal substances. The Food Additives Regulation stipulates that a significant change in particle size of a substance requires a new entry in the list of authorised substances or a change in specifications. Other legal instruments such as the legislation for plant protection products and medicinal products have general authorisation requirements for the products within their scope, including nanomaterials, however without specific provisions on nanomaterials. Ingredient lists are required for products for which the composition is most relevant for consumers. Labelling requirements in the form of ‘(nano)’ after the substance name in the ingredient list are currently applied for cosmetics, food and biocides. The information ‘(nano)’ is provided in a similar way as for other ingredients, thus not suggesting a specific difference from other ingredients. This form of labelling was in general supported by the Second Regulatory Review on Nanomaterials. Conversely, the Second Regulatory Review did not propose nano-specific labelling requirements for products without ingredient lists because such requirements were considered disproportionate and potentially misleading. This is because such labelling might suggest specific risks even when there is no indication for such risks. As this was conclusively covered in the Second Regulatory Review, the question of product labelling was not further assessed in the present impact assessments. Further relevant legislation includes worker protection legislation and, if found warranted, nanomaterials may be the object of specific workers protection provisions under the relevant EU legal instruments. So far guidance has already been published on how to apply existing legal provisions to nanomaterials. Without specifically mentioning nanomaterials, the General Product Safety Directive 2001/95/EC is intended to ensure a high level of product safety for consumer products that are not covered by specific sectorial legislation. 1.5Two impact assessments on nanomaterials 1.5.1Scope and purpose of the two impact assessments This impact assessment concerns the amendment of Annexes to REACH for the registration of nanomaterials. It is closely linked with a parallel impact assessment on transparency measures for nanomaterials on the market. The overarching objective of the two initiatives is to contribute to increasing trust in the safe use of nanomaterials (1) by providing transparent information on nanomaterials, their use and their safety, adapted to the needs of target audiences and (2) by improving risk assessment and risk management of nanomaterials through requiring more specific health and environmental information to demonstrate the safe use of nanoforms of substances. The purpose of this impact assessment is to assess relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety demonstrated in REACH registration dossiers. The scope is limited to measures that can be proposed via the Committee procedure, i.e. restrained to certain amendments of the REACH Annexes for nanomaterials, as the Commission in the General Report on the REACH Review concluded that "Some needs for adjustments have been identified, but balanced against the interest of ensuring legislative stability and predictability, the Commission concludes that changes to the enacting terms of REACH will not be proposed". The purpose of the impact assessment on transparency measures is to assess the most adequate way to provide information on markets and uses of nanomaterials and products containing nanomaterials to policy makers, consumers and workers and closely linked with the present impact assessment. The purpose of the impact assessment on transparency measures is to assess the most adequate way to provide information on markets and uses of nanomaterials and products containing nanomaterials to policy makers, consumers and workers. It is closely linked with a parallel impact assessment for a possible amendment of Annexes to REACH for registration of nanomaterials. 1.5.2The political discussion leading to the two impact assessments

In the late 1990’s and early 2000’s, nanotechnology and nanomaterials were increasingly seen as a major innovation opportunity. At the same time, concerns arose that nanomaterials may be linked to hazards and risks which were not covered by existing risk assessment practices and regulation. Responding to those concerns, the Commission issued in 2008 a Communication on Regulatory Aspects of Nanomaterials, arguing in essence that existing legislation is sufficient to address regulatory concerns on nanomaterials. Following this Communication, the European Parliament issued a Resolution calling on the European Commission, inter alia to establish a definition of nanomaterials, to review relevant legislation on its applicability to nanomaterials and to establish an inventory of nanomaterials, including aspects of their safety. At that stage, nanomaterials were largely perceived as a limited number of innovative substances which so far had been untested, and which may exhibit unpredictable hazard properties and risks to consumers and workers. This perception was fuelled by a diffuse debate on the nature and definition of nanomaterials, and unsuccessful attempts to obtain more information on nanomaterials on the market via voluntary notification schemes, such as those developed in the United Kingdom and Germany. Against this background, there were calls by some Member States and non-governmental organisations to set up mandatory registration schemes to provide information on products containing nanomaterials. In September 2010, following a high-level event on the regulatory framework for nanomaterials, the Belgian Presidency of the Council of the European Union recommended that action should be taken "to develop harmonised compulsory databases of nanomaterials and products containing nanomaterials" and that "such databases must be the base for traceability, market surveillance, gaining knowledge for better risk prevention and for the improvement of the legislative framework". Later on, France, Belgium and Denmark introduced national nanomaterial notification schemes. During the legislative process leading to the adoption of REACH, specific provisions on nanomaterials had not been included, as too little was known on nanomaterials to take this into account in the already very complex negotiations. However, soon after REACH was adopted, discussions started on its implementation for nanomaterials, and a subgroup of the REACH Competent Authorities expert group (“CASG Nano”) was set up. As a reaction to the Parliament Resolution, the Commission adopted the definition of nanomaterials in 2011 and a Communication on the Second Regulatory Review of Nanomaterials in 2012. The Communication concluded that nanomaterials were much more common, widespread and, at least for many of the substances analysed in an attached Staff Working Document, less toxic than the public debate suggested. The Communication reaffirmed the general applicability of REACH and other existing legislation to nanomaterials. In line with previous scientific opinions, it also confirmed that, while risk assessment methodologies were generally applicable to nanomaterials, a case-by-case approach was still warranted to provide the necessary information for different nanomaterials. It recognised that REACH was not clear enough to ensure sufficiently specific information on nanoforms in registration dossiers. As a follow-up and due to the expected significant impacts of the considered changes, the Communication on the Review of REACH in 2013 announced an impact assessment for a possible amendment of Annexes to REACH for registration of nanomaterials. Concerning the calls for mandatory registration schemes, the Commission did not take a stance but announced an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight. In addition, the Commission launched an online portal with available information on nanomaterials and their uses (the 'JRC Web Platform on Nanomaterials'). 1.5.3Cross-relationship between the two impact assessments The two Impact Assessments complement each other and provide responses on how to improve information on nanomaterials in their respective areas, as identified in the Second Regulatory Review. There are however important differences in the type of information concerned, the target audience, the degree and nature of the problem to be addressed, and the potential options that could be used (see table 1-1 below). The impact assessment on the REACH Annexes covers scientific information necessary to improve risk assessment and risk management of nanomaterials. This should, for the substances covered by the scope of REACH: ·provide clarity on which nanoforms of the substance are covered by the registration dossier; ·identify relevant hazard properties; ·show how the safe use of the nanoforms will be ensured; ·identify the main use categories in general terms. However, this information will only cover part of the perceived lack of information and it will remain at a technical level that is only understandable for specialists. Its scope is limited to actions which can be undertaken by adaptations to technical and scientific progress under REACH. The impact assessment on transparency measures is broader than REACH, and evaluates which information on nanomaterial markets and uses is needed for policy makers, enforcement authorities, consumers and workers. It excludes however scientific and technical information, which is assessed as part of the REACH Annex impact assessment, and thus the outcome of the REACH Annex impact assessment is part of the baseline of the impact assessment on transparency measures. Due to its broad scope, new regulatory provisions on this matter would require different legislation, which would need to be adopted in ordinary legislative procedure. Table 1-1: Differences between the impact assessments on REACH Annexes and transparency measures REACH Annexes Transparency measures Scope Substances subject to REACH Manufactured nanomaterials in general Nature of information concerned Substance properties for hazard and risk assessment and the safe use of nanomaterials Markets and uses of nanomaterials and products containing nanomaterials Main target audience Risk assessment specialists (public authorities, companies, etc.) Policy makers, enforcement authorities, consumers, workers Degree of problem High degree of consensus on the problem as such and the need to address it by a possible amendment of the REACH Annexes Possible add-on to REACH Annex revision; no consensus on the need for additional market information Type of procedure required Comitology (REACH) Co-decision for the legislative option (beyond the scope and purpose of REACH) 2PROBLEM DEFINITION 2.1Policy context: the Registration process within REACH The Registration, Evaluation, Authorisation and Restriction of Chemicals REACH Regulation replaced the previous legislation, with the aim to ensure the protection of human health and the environment from the risks of chemicals, including the promotion of alternative methods for assessment of hazards of substances (mainly in order to reduce animal testing), as well as the free circulation of the substances on the internal market while enhancing the competitiveness of the EU chemicals industry. The overall purpose of the registration under REACH is that the registrant must ensure the safety of the intended uses of a chemical (in all forms)and provide sufficient information to this effect. In order to meet the objectives of the legislation, REACH imposes registration obligations on companies and at the same time provides for a tiered tonnage based information requirements, risk based approach to exposure assessment and staggered registration timelines in order to allow necessary flexibilities to companies to comply with REACH obligations. In other words, the depth and level of detail of the information requirements depend on the volume of the substance placed on the market and the risks it poses.

2.2The problem requiring action and its drivers 2.2.1The problem and its consequences The Commission, in close collaboration with ECHA, assessed in 2011 how nanomaterials had been addressed in REACH registration dossiers submitted before December 2010. The assessment found that, in the absence of a definition of nanomaterial before October 2011 and of specific ECHA guidance (published only in April 2012), most registration dossiers for substances known to have nanoforms8 do not mention clearly which forms are covered or how the provided information relates to the nanoform. As of August 2015, 13 substance registrations and 108 CLP notifications had selected "nanomaterial" as a form of the substance for at least one form documented in the registration dossier/notification. Only little information was specifically addressing safe use of the specific nanoforms supposed to be covered by the registration dossiers. The registration dossiers therefore did not document if and how registrants ensured the safe use of the substance with nanoforms covered by the registration. In order to attain the aims of REACH, the Commission identified, based on the above mentioned assessment, a necessity for more specific requirements for the registration of substances with nanoforms ensuring further clarity on how they are to be addressed and safety demonstrated in registration dossiers. In case of inaction, the potential results can be: i) Insufficient demonstration of safe use in the REACH registration dossiers, resulting in increased risk for health and the environment, due to potentially poor risk management and safety measures, ultimately leading to harmful use and negative economic consequences. ii) Uncertainties for companies on what needs to be included in the REACH registration dossiers, resulting in ineffective implementation and consequently increased costs, affecting innovation, investment decisions and impaired competitiveness on global markets. The problem and its consequences are illustrated in the figure below: Figure 2-1: The problem and its consequences: 2.2.2Magnitude of the problem The magnitude of the problem can be determined by two factors: i) the extent of deficiencies in demonstration of safe use of nanoforms of a substance and the subsequent consequences, and ii) the size of the market of registered nanomaterials that is affected by the REACH provisions. Whereas the first factor, and in particular the deficiencies in the registration dossiers of substances containing nanoforms are qualitatively explained above, it is very difficult to quantify the magnitude of the problem due to the many variables and uncertainties involved. The figures related to the size of the market shown in section 1.2 Uses of nanomaterials and size of the market are very general. The exact size of the market at EU level is not known with precision, even less the proportion between the part of the market subject to registration (i.e. quantities of the registered substances in nanoforms are above 1 ton per year) and the substances in nanoform that would not be subject to registration requirements. Nevertheless, what is known is that 21 substances were registered as occurring (also) as nanoforms as of March 2018. The figures from the French notification system (FNS) suggest that most of the nanomaterials may have been registered as substances already (in 2014, 171 out of 287 substances i.e. 60% notified under the FNS, with an additional 5% anticipated to be registered by 2018). It is therefore sensible to assume that most of the nanoforms are not being registered as such but have either not yet explicitly been indicated as being nanoforms in the registration, or are being registered jointly with bulk forms of the substance without yet declaring so. The remaining 35% from FNS could be an indicator of the number of substances below the 1 tonne threshold, but does not indicate the proportion of the number of nanoforms of the non-registered substances with nanoforms to the total number of nanoforms on the market, or the proportion of the actual size of the market in volumes or in the value of products. In terms of volume, the information from the work on transparency measures (benefiting again principally from the FNS information) is that the vast majority can be attributed to nanoforms in some commodity products (e.g. pigments). 2.2.3Initiatives undertaken There have been important developments that have had an impact on the identified problem since the first registration round in 2010: ·Recommendation 2011/696/EU adopted by the Commission on October 2011 sets out a definition of the term nanomaterial. The definition clarifies terminology, but in itself does not provide clarity to the registrants on how to address nanomaterials in REACH registrations. The Commission is currently reviewing the nanomaterial definition. A three-part report addressing scientific-technical aspects of the definition has been published by the Joint Research Centre and the Commission will consider these as input in the review of the definition, scheduled to be finalised in 2018. The Commission might conclude to revise certain aspects of the abovementioned Recommendation. Such a potentially revised Recommendation will be fully integrated in the changes to the REACH Annexes to ensure coherence with other Regulations. The potential changes might influence some of the assumptions used in this impact assessment. Based on the review performed so far, it is reasonable to assume that clarification of the definition of the text rather than changes in content would be taking place. In any case, the revision of these assumptions would not affect the nature of the options in this impact assessment, but may impact the number of nanoforms to which the requirements of REACH (and the related changes to the Annexes) apply. If a material in a specific form is considered a nanoform before and after the revision of the nanomaterial definition, the REACH requirements introduced by the changes to the Annexes would apply in exactly the same way, whilst this would not be the case if a material was no longer a nanomaterial after the modification of the definition. ·The Commission conducted the comprehensive REACH Implementation Project on Nanomaterials (RIPoN) to provide advice on key aspects of the implementation of REACH with regard to nanomaterials concerning Information Requirements (RIPoN 2) and Chemical Safety Assessment (RIPoN 3). A third report of the RIPoN project relates to Substance Identity (RIPoN1). In April and May 2012, ECHA updated with three new appendices the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) and on registration, in order to take into account the recommendations from the RIPoN 2 and 3 projects. In February 2013, ECHA updated its advice on Nanomaterials in IUCLID from June 2010 . ·ECHA established in May 2012 a nanomaterials working group (ECHA-NMWG) to discuss scientific and technical questions relevant to REACH and CLP processes and to provide recommendations on strategic issues. It is an informal advisory group consisting of experts from Member States, the European Commission, ECHA and accredited stakeholders organisations, with the mandate to "Provide informal advice on any scientific and technical issues regarding implementation of REACH and CLP legislation in relation to nanomaterials." ·ECHA has finalised 13 decisions on the compliance of the registrations of 8 substances with nanoforms requesting further actions from addressed registrants in order to bring their registration dossiers into compliance with REACH information requirements. 5 out of these (concerning titanium dioxide, silic acid and aluminium sodium salt) have been appealed before the ECHA Board of Appeal. These cases will provide valuable information regarding the interpretation of the current REACH information requirements in relation to the registration of substances with nanoforms. The first four closely related decisions of the Board of Appeal (regarding the cases A-008-2015, A-009-2015, A-010-2015 and A-011-2015) were published on 12 October 2016. The Board annulled ECHA compliance check decisions and returned them to re-evaluation, as it found that the contested decisions are unclear regarding certain of the terminology used therein which gave ground to the appellant's claim that it is not clear how to comply with the decision. While the Board of Appeal decisions only refer to the specific drafting used by ECHA in these decisions, the Board of Appeal's observations also confirm the underlying problems as set out in section 2.3 that the measure accompanied by this impact assessment intends to address, i.e. that REACH information requirements are not clear enough for the registration of substances with nanoforms. The Board of Appeal's decision of 2 March 2017 on the appeal A-011-2014 regarding the compliance check on titanium dioxide annulled the ECHA compliance check decision, with the principal argument that under the current provisions in REACH, ECHA cannot request information on the characterisation of nanoforms as part of the substance identity information (Annex VI.2 of REACH), as the elements listed are exhaustive and adding new information requirements requires amending the REACH Annexes.

·Member States have started Substance Evaluation of some substances with nanoforms in the Community Rolling Action Plan (CORAP) due to concerns related to nanoforms. The Decision regarding silica has been agreed by consensus in the Member States Committee in December 2014 requiring information on physicochemical properties (including surface-treated nanoforms), additional toxicity studies for four specific forms (representing different ranges of characterisers of the registered forms), all toxicological information on surface-treated forms and the uses of the individual forms. The decision has been challenged by two groups of registrants in front of the Board of Appeal.50 ·Further adjustment of the OECD Test Guidelines is currently being discussed by the OECD Working Party on Manufactured Nanomaterials (WPMN). Eight test guidelines have been identified as requiring adaptation. It is reasonable to assume that the above mentioned initiatives, and in particular the RIPoNs and the subsequent nano-specific ECHA guidance as well as ECHA Decisions have addressed some aspects of the identified problem. Of the thousands of dossiers which were submitted by the second registration deadline on 1 May 2013, only four indicated to cover nanomaterials ECHA has not yet reviewed the many thousands new registrations in depths; by July 2017, 21 substances with nanoforms have however additionally identified nanoforms in the registration dossiers. The on-going review of the Nanomaterial definition has identified technical difficulties that may have partly influenced registrants’ approaches in the registration dossiers. Thus, the exact magnitude of the problem at present has multiple facets; assessing it in-depth would require significant additional resources and time. Nevertheless, it can be deducted that there is a need to further address the problem. Furthermore, the results of the public consultation conducted for the purpose of this impact assessment indicated that the majority of the stakeholders considered the current provisions on information requirements for the registration of nanomaterials as not clear. Member States, NGOs as well as part of industry were of that opinion. 2.3What are the underlying causes of the problem? Preparation and handling of registration dossiers for substances with nanoforms requires expert knowledge as many obligations or specific information requirements are derived from more general obligations for substances in general. A registration dossier with one or several nanoforms requires a detailed knowledge of REACH, the comprehensive ECHA guidance and in some cases even familiarity with policy documents published by the Commission setting out the principles for the registration of nanomaterials. While it is undisputed that REACH covers nanomaterials by virtue of its focus on 'substances', nanomaterials are not specifically mentioned and there are many factors that have led to a lack of understanding of how REACH should function for nanomaterials in the actual registration process. In a simplified form, the most important causes to the problems can be illustrated by the following graph: Figure 2-2: The causes to the problem: The following key underlying causes have been identified explaining why the current system has not delivered as expected by the Commission: I.No nanomaterial definition at the time of the registration Until October 2011, there was no definition that could be used to distinguish nanomaterials as forms different from other forms of the same substance . This made it open to each company to decide if their production also covered nanomaterials warranting specific attention when registered as a nanoform(s) together with other forms of the same substance. The cause for confusion or uncertainty is now partly resolved with the Commission Recommendation but it is a challenge in some cases to determine whether a material is or is not nanomaterial due to lagging progress in determination methods. However, the definition is still not an integral part of REACH and it does not provide an answer to how to distinguish between different nanoforms. Furthermore, for the registration dossiers submitted by the 2010 deadline, which were assessed by the Commission, the definition of nanomaterials was not available. Many substances were considered by registrants as bulk substances before the introduction of the nanomaterial definition. These companies did not explicitly identify registered substances (in their respective forms) as nanomaterials, and no major update of the dossiers has been observed folowing the introduction of the nanomaterial definition. II.The physico-chemical properties are not extensively listed The physico-chemical properties of the substance must be described in the REACH registration dossier as they directly influence its toxicological and ecotoxicological properties, distribution and fate. For nanoforms, the relevance of some properties is limited, while other properties are not specifically listed, potentially leading to issues with the characterisation, as forms with importantly different risk profiles may have not even been differentiated at the onset of risk assessment. The same applies to the requirements to provide sufficient information on test materials, as it is the only way to assess the applicability of the test results. Concrete examples of material characterisers, relevant in the nanoscale, are the size of particles, their shape and their surface coating/functionalisation. As the size gets smaller, the effects of particle surface and whatever might be attached to it become more prominent in comparison to the volume (mass). In addition, the scale of nanoparticles is in the same order of magnitude as the molecular tools driving the biological processes in organisms and more characteriser-selective binding of proteins to the surface (also known as corona) may influence biological recognition and signalling in cells. These differences may lead to differences in risk assessment conclusions or in the risk management recommendations. III.There is uncertainty about the applicability of test methods to nanomaterials The OECD notes that "the approaches for the testing and assessment of traditional chemicals are in general appropriate for assessing the safety of nanomaterials, but may have to be adapted to the specificities of nanomaterials." Indeed, for many years it has been discussed and analysed whether nanomaterials (i.e. substances in nanoform) can be tested by using the test methods used for other substances. Both the EU's scientific committees and the OECD have recommended that existing methods should be applied also for nanomaterials, while care should be given to how the nanomaterials are prepared and dosed in the test systems. The scientific debate has also raised questions whether new additional endpoints, in particular in view of possible different modes of action may be needed for (certain) nanomaterials. In addition to on-going scientific and technical work in OECD-WPMN and internationally, several large scale research projects are on-going on the health and safety assessments. They will contribute to further adjustment of the current methods as well as for the further development of new approaches aiming at predictive, safe by design approaches for emerging nanotechnology products.

IV.There is insufficient guidance over the substance identification for substances with nanoforms and the scope of the registration dossier From a generic perspective, REACH is simple: each substance must be registered in a dedicated registration dossier in accordance with the principle of 'one substance – one registration'. However, there are many variables that influence naming and determination of sameness of substances. The co-regulators therefore decided to leave the decision on how to distinguish between substances to the manufacturers and importers supported by ECHA in the enquiry process. Detailed guidance to help this decision making has been prepared and is available on ECHA's website. However, by the time the guidance was made, not enough was known to advise on substances with nanoforms and on the potential additional physico-chemical properties (see above) that could be used for the purpose. Later attempts to bring more specific guidance was made with RIPoN1. Whilst it did not succeed in gathering consensus on all its recommendations, it clarified that nanoforms within a dossier can be addressed individually based on their differences. The differentiation would be triggered by the difference in so-called 'characterisers' in contrast to 'identifiers' that otherwise identify an individual substance and trigger a separate registration dossier. The final report of RIPoN1 was provided to ECHA, but given the impossibility to gather consensus, it has not been translated into guidance available to firms. Accordingly, nanoforms can be seen as forms of a substance or as distinct substances. In the latter case, the question arises whether they are treated as “new” substances and whether they would be subject to immediate registration. When more experience from the evaluation of registrations is available, ECHA will provide guidance on treating nanomaterials as forms of a substance or as distinct substances with the aim of enabling effective data sharing. The results of RIPoN1 suggest, however, that some flexibility will be needed. Whether nanoforms have been addressed in one or several registrations, for the Commission the key issue remains whether the registration provides clear information on the safe use for all forms of the substance. Regardless of how registrants organise their dossiers, it is expected that the scope of the registration is clear; it should be clear which nanoforms on the market are covered by the dossier. Any third party should also be in a position to verify whether a nanomaterial has in fact been registered, and relate it with corresponding demonstration of safety. Experience indicates that this has proven difficult so far. V.There is uncertainty on how to deal with the multiplicity of forms in the chemical safety assessment (CSA) As stated in the Second Regulatory Review on Nanomaterials (COM (2012) 572), the REACH approach to hazard assessment and risk characterisation, with its built-in flexibility, makes it overall suitable also for substances with nanoforms. Within the registration information requirements of the REACH Annexes VII-X and in the Chemical Safety Assessment that is to be conducted for the registration of substances at quantities of 10 tonnes or more per year, data for one form of a substance can be used to demonstrate the safety of another form (application of rules for grouping and read-across). This requires a case-by-case scientific approach, implying: (i) clarity whether and which nanoforms of a substance are covered by a registration and that these nanoforms should be adequately characterised, with the user able to identify which operational conditions and risk management measures apply to them; (ii) information should be provided on which forms of a substance have been tested, with the test conditions adequately documented, and (iii) conclusions of a chemical safety assessment should cover all forms in a registration. Where data from one form of a substance are used in demonstration of the safe use of other forms, a scientific justification should be given on how, applying the rules for grouping and read-across, the data from a specific test or other information can be used for the other forms of the substance. Similar considerations should apply to exposure scenarios and the risk management measures. The assessment indicates that the curent general REACH provisions (although complemented by ECHA guidance) have often not lead to an implementation that would follow such an approach in a situation where multiple forms of a substance are included in the registration. Unclear scope of the registration but also unjustified assumptions in application of relevance of data on one form to another were frequent. As can be observed also from some concrete examples provided55,56,57, these may lead to situations where risk is not adequately assessed and consequently managed. 2.4How will the problem evolve? The Nano Support project undertaken by the Commission suggested that almost all the reviewed registration dossiers contained insufficient information to be able to determine if safe use of the materials placed on the market as nanoforms of a registered substance has been demonstrated. ECHA has since then confirmed these observations as part of the formal evaluation procedures pursuant to REACH and has faced appeals to some of the decisions that attempt to address issues identified above. It is thus assumed that the initiatives undertaken as referred to in section 2.2.3 Initiatives undertaken : the examination of testing proposals and compliance checks by ECHA, the RIPoN project, the definition and the revised definition of nanomaterials, ECHA's nanomaterials working group, the CoRAP and the adjustment recommendations by the OECD WPMN – will at least not efficiently solve the way REACH addresses nanomaterials and will therefore not suffice to solve the problem in the short term. Based on existing evidence, the situation may develop as follows: 2.4.1Nanomaterials as nanoforms of phase-in substances Most nanomaterials have been registered so far as nanoforms of phase-in substances, meaning that they fall under the phase-in provisions (2010, 2013 and 2018 deadlines for registration). Since there is not enough clarity on the specific REACH information requirements for nanomaterials throughout the registration procedure, this means that the specificities in terms of how to handle them safely have most likely not been extensively described. Based on current information, it is probable that this will continue to be the case, so that the registrations of substances with nanoforms in 2018 will also contain multiple nanoforms of substances without sufficient information for all forms covered. 2.4.2Quality of the dossiers In addition to the legal means foreseen by REACH to ensure the compliance of the submitted dossiers with the registration requirements – examination of testing proposals and compliance check, ECHA has undertaken a series of support actions with the aim to gradually bring the addressed dossiers into compliance according to ECHA's interpretation of the registration requirements. Without further action, it is therefore reasonable to expect that, for the few current registration dossiers with often well-known nanomaterials included, the situation will improve over the next couple of years based on the on-going work of ECHA Committees and several decisions of the Board of Appeal on nanomaterials in 2016 and 2017 in the compliance checks and substance evaluations. The latter, annuling a number of decisions, had however showed limitations of what can be achieved. However, some caveats are to be taken into account:

·Improvement via evaluation processes (compliance check, substance evaluation) is cumbersome, expensive (to both authorities and industry), will take years and conflicts with the obligation that the burden of proof is with industry if the pertinent information is only made available upon request from the authorities. ·It is likely that dossiers that are not directly implicated within the scope of these actions may not change, with the associated risks it may have on safety. ·There continues to be ground for concerns that the root cause to the current problems, if unaddressed, will exacerbate due to the expected increasing number of dossiers and the growing number of companies involved. 2.4.3Industry, SMEs and innovation Information generated for the registrations provide inspiration for the innovative use of existing substances. As concluded by the REACH Review, REACH has had so far a positive impact on research into new substances. Nanomaterials may be considered complex chemicals due to the potential increased complexity of dossiers (e.g. with multiple forms under one dossier) and to the importance of the relation between the individual nanoform and the specific use. Such relationship often requires a tailored risk management response as well as good communication along the value chain for the adequate risk assessment and risk management. Consequently, when specifically referred to substances with nanoforms, it can be assumed that what needs to be included and how safety is demonstrated in the REACH registration dossiers for substances with nanoforms, may add to the compliance cost and affect industry investments and market decisions. The REACH review studies highlighted that REACH compliance costs were considerably higher than estimated. Due to the burdensome processes and costs of information requirements, both nanotechnology and other companies, have shifted and may need to shift resources from R&D to REACH compliance. Accordingly, along with other constrains reported by nanotechnology companies, such as delays for the innovative products to market, high prices due to lack of investments in large scale processes, the way REACH registration deals with nanomaterials could form a challenge for the companies in the sector. SMEs are of particular concern. Indeed, smaller firms represent a significant portion of manufacturers, importers or downstream users in the nanomaterials sector. Hence, concerns remain that the way REACH addresses nanomaterials may discourage SMEs from the nanotechnology sector to innovate. Based on current knowledge, the situation will aggravate over time as it is anticipated that more small firms will be subject to registration obligations when substances in volumes at one or more tonnes will have to be registered in June 2018. 2.5Who is affected and how? Immediately affected is industry dealing with nanomaterials with an obligation to register substances with nanoforms (both EU manufacturers and importers) that are manufactured or imported over one tonne per year per manufacturer/importer. The effects will go from a possible change (positive or negative) of the administrative burden and a clearer legislative environment for fulfilling the obligations. External studies performed for the European Commission in the context of the REACH Review estimate the total number of European nanomaterial manufacturers in the range of 200 to 400. The numbers of importers or downstream users were not assessed in the study. All stakeholders involved in the implementation of REACH and working with nanomaterials will be affected. Among them, ECHA, competent authorities and enforcement authorities, will be affected when performing their dedicated tasks in accordance with REACH. By the provision of adequate information on safe use of registered substances with nanoforms there will also be positive effects on workers' health protection, on the environment and to a lesser extent on the health of the public at large. Lastly, clarifying REACH information requirements will eliminate regulatory uncertainty and confirm the effectiveness of the regulatory system but might as well increase compliance costs; all this will influence investors’ views on Europe as a site for innovation and manufacturing. 2.6The EU's right to act and justification The current initiative concerns clarification of the existing provisions established in REACH Annexes. The legislation is based on Article 114 TFEU. According to the principle of subsidiarity established in Article 5 TFEU, the EU's right to act is justified based on the fact that the chemicals market is an important part of the internal market and that initiatives in Member States would be in breach of the freedom for firms to manufacture or use nanomaterials in the EU market. Any modifications to REACH including its annexes can legally only be made at the EU level. If the EU does not take action there will be continued uncertainty for companies producing (and using) nanomaterials about their legal obligations for registration and continued lack of information about those materials which are the basis for risk assessment and safe handling. Actions at national level to deal with the described problems would have to be taken outside the REACH framework. They would by their nature entail the risk of distorting and fragmenting the internal market. In addition, there are no indications that special national or regional conditions warrant different ways and levels of protection. Based on these considerations, there is a clear added value of action to be taken at the EU level. 3OBJECTIVES – WHAT SHOULD BE ACHIEVED? 3.1General objective The aim of REACH, as provided for in its Article 1, is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances (mainly to reduce animal testing), as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. As identified in section 2.2.1, the registration dossiers of substances with nanoforms currently do not document how the registrants ensure safe use of those forms. In line with the aim of the legislation, the general objective of this initiative is therefore to ensure that REACH is fit for the purpose of dealing with substances with nanoforms.

Figure 3-1: The general objective and the problem: 3.2Specific objectives In order to achieve the general objective and to address the two main consequences of the problem as identified above i.e. the uncertainty on how to comply and the insufficient demonstration of safe use, the following specific objectives have been established: ·Clarify the REACH information requirements for registrants on how substances with nanoforms must be registered pursuant to REACH; ·Ensure adequate demonstration of safe use of nanoforms in registration dossiers. Figure 3-2: The specific objectives and the consequences of the problem: 3.3Operational objectives Furthermore, the following operational objectives are to be accomplished: ·Ensure that the registration dossiers clearly specify that they cover one or several nanoforms of a substance; ·Make sure that the registration dossiers contain justifications for using data/test results from non nanoforms or between nanoforms; ·Guarantee that the registration dossiers identify the uses of and the related exposure from nanoforms; ·Increase trust of downstream users/consumers in nanomaterials in order to facilitate market uptake and innovation; ·Speed up the process of achieving registration dossiers covering nanoforms that are of adequate quality. 4POLICY OPTIONS At the start of the impact assessment process, the Commission identified five different options grouping a large number of specific measures for analysis and stakeholder consultation. These are in addition to the 'no change scenario' as described in chapter 2.4 above on how the problem will evolve. In identifying some of the individual measures considered, the Commission was supported by the Nano Support project and REACH Review studies, as well as contributions from EU Scientific Committees, OECD and ISO cooperation, expert networks and scientific literature on nanotechnologies and nanomaterials. Numerous measures were proposed based on a scientific assessment on the needed information to make a qualified assessment of the safe use of nanomaterials in addition to the information that the JRC – ECHA review team identified in the concrete registration dossiers submitted up until December 2010. These were grouped under options 2 and 4. In addtion to those, the Commission has identified other possible measures that have been grouped in options 3, 5 and 6. In most cases, the measures could be individually assessed in terms of effectiveness and efficiency addressing the general objective. It is to be noted that the legal procedure this initiative is framed into does not allow to make changes to the enacting terms of REACH, but just to its Annexes; there is thus no possibility to modify the tonnage registration thresholds, explaining why the possibility to lower the threshold for substances with nanoforms below 1 tonne has not even been considered. Furthermore, there has been no evidence to indicate a need to change the tonnage thresholds structure as imposed by REACH specifically for substances with nanoforms, if it is on one hand understood that in most situations, nanomaterials will represent forms of the substance with identical chemical composition rather than be considered as substances by themselves, and on the other that REACH obligations pertain to the aggregated tonnage of all forms of the substance placed on the market by the economic operator.

4.1Option 1: No change Option 1 is a continuation of the current situation under REACH assuming that there are no new policy actions and that the implementation is based on what currently is known i.e. including the guidance update from April and May 2012, the use of the Commission Recommendation on the definition of Nanomaterial and the updates of OECD Test Guidelines. The assessment of this option makes certain assumptions of how the current situation may develop over time when dossiers are brought into compliance. Since the legal text allows for different interpretations of the REACH registration requirements vis-à-vis substances with nanoforms, the no-change scenario is set where Industry's current stance to the level of compliance is effectively maintained. The figure below illustrates how the no-change scenario is expected to evolve along time in terms of demonstration of safe use as ECHA applies tools to improve compliance and Member States conduct substance evaluations. Figure 4-1: Evolution of the no-change scenario 4.2Option 2: Clarifying the existing information requirements This option's aim is to clarify what companies are expected to do when registering nanoforms, by introducing changes to the description of certain information requirements in the REACH Annexes. The information requirements are in accordance with the registration obligations of REACH and the specific ECHA guidance, which takes into account CA/59/2008 Rev1 and the scientific-technical recommendations from RIPoN 2 and 3 reports from 2011. While ECHA's guidance still needs to be provided in some cases (the appropriateness of some available tests to substances in nanoform is still under discussion), these measures would outline necessities for an accurate information base to allow for a reasonable hazard assessment. This option would therefore, according to ECHA, not change any existing obligations as they are understood to exist and these measures are/will be pursued as such in formal ECHA evaluation, but it would provide companies with a clearer understanding on what information they must provide in the registration dossier. As a matter of fact, when asked in the framework of the Nano Support project, ECHA indicated that it considered that the measures listed in option 2 are derived from the general REACH requirements and are thus part of the baseline. The figure below illustrates where the current requirements of REACH for substances with nanoforms are in terms of demonstration of safe use, according to ECHA, compared to option 1.Figure 4-2: Requirements according to ECHA compared to the baseline: 4.3Option 3: Soft law measures Option 3 pursues the same goals as option 2 i.e. providing more clarity on the registration obligations for substances with nanoforms, but instead of amending the legal provisions in the REACH Annexes, this option would introduce measures of a non-legally binding nature. Within the operation of REACH, already a wealth of different soft law measures are applied; of these, the following would also be applied to improve the clarity of obligations for registrants of substances with nanoforms: ·Development of further specific ECHA Guidance; presently there is only rather generic guidance on nanomaterials available to registrants and it is integrated in the general guidance on registration; ·Enhanced use of the Directors Contact Group to further identify possible solutions for problems related to registration of substances with nanoforms; ·Initiatives to enhance information and dissemination at EU and Member State level; the overall understanding of how REACH applies to substances with nanoforms has been shared between Member States and stakeholders that take part in the discussions in CARACAL; however, based on the empirical evidence on how companies have complied, much more communication is necessary in view of raising awareness. The core difference between option 2 and option 3 is that option 3 is limited to the clarification of the current REACH requirements for substances with nanoforms through guidance, whereas option 2 imposes these clarified requirements by amending the REACH Annexes. As such the potential of option 3 is limited by the outcome of the cases before the Board of Appeal (and possibly subsequently the Court) on the interpretation of the current REACH requirements for substances with nanoforms. If the Board of Appeal confirms ECHA's interpretation, then option 3 and option 2 would impose virtually the same requirements, whereas if the Board of Appeal rules (partly) against ECHA's interpretation then some or most of the requirements under option 2 could not be demanded under option 3. Based on the Board of Appeal's decision of 2 March 2017, it is clear that some of the requirements under option 2 cannot be requested under option 3.

4.4Option 4: Scientific-technical recommendations tailoring information requirements At the time when information requirements in the Annexes to REACH were drafted, no consideration was given to nanomaterials and their specific properties. Thus this option's aim is, beyond the mere clarification of requirements pursued by options 2 and 3, to achieve demonstration of safe use in cases where the existing information requirements in REACH are not tailored for substances with nanoforms or where specific considerations are required. The measures this option proposes, such as limitation of the application of waivers, consideration of the most appropriate route of exposure or limitations of the applicability of test methods, are directly taken from the Nano Support project. The option is assuming full implementation of option 2. 4.5Option 5: Reduced information requirements This option has a twofold aim: on one hand, to clarify a number of issues regarding how substances with nanoforms should be addressed when being registered; on the other, to alleviate the burden on companies, by reducing certain information requirements for nanoforms and by promoting the use of non-testing methods and exposure categorisation. This double aim would be addressed by two sets of measures: ·First, measures providing clarity on how nanoforms are addressed and safety demonstrated under REACH by clarifying relevant provisions and specifying information requirements for nanoforms with the aim to provide for specific solutions that increase predictability for registrants in the current regulatory framework. ·Second, measures reducing certain information requirements on nanoforms for the purpose of the registration at 1 – 10 tonnes and 10 – 100 tonnes. 4.6Option 6: Exhaustive information requirements Option 6 goes beyond options 2, 3 and 4 by putting additional emphasis on the generation and documentation of further information. The objective of the option is to reduce uncertainty, considering that knowledge is still under development regarding the influence of particle and nanomaterial-specific properties on risk. The option would contain three types of measures: ·More prescriptive rules as regards the organisation of the chemical safety assessment and its documentation for individual nanoforms and the influence of particle and nanomaterial-specific properties; ·Request specific information (e.g. toxicokinetics, repeated dose toxicity testing) in a targeted fashion and at lower tonnages; ·Address some remaining open questions regarding the scope of current REACH provisions, drafted without specific consideration to nanomaterials (e.g. coverage of new substances with nanoforms by phase-in provisions in Annex III of REACH, substance identification in Annex IV,V). The option is assuming full implementation of options 2 and 4. 4.7Interrelationship between options It is useful to keep in mind that options 2, 4 and 6 are sequentially staggered, with option 4 adding further requirements to those contained in option 2 and option 6 adding again more to option 4. Options 2 and 3 aim to achieve the same result (subject to confirmation that the interpretation that the measues in option 2 are already in line with the current REACH requirements), though option 2 does so through legislative adaptation and option 3 through guidance and other soft law measures. Option 1 captures how most of the registrants have implemented the current legislative requirements – subject to possible updates as required by ECHA compliance decisions, and option 5 reduces certain information requirements for nanoforms. The table and the figure below illustrate how the options are built and how they compare to one another and the REACH requirements according to ECHA:

Table 4-1: Underlying logic of the policy options, additional to the no-change scenario 2 3 4 5 6 Clarifying the existing information requirements Soft law measures Scientific-technical recommendations tailoring information requirements Reduced information requirements Exhaustive information requirements Underlying logic of the options Clarification of the existing information requirements (according to ECHA's interpretation), by changing the Annexes to REACH Clarification of the existing information requirements, by implementing soft law measures (but no changes to the REACH Annexes) On top of option 2, additional measures aiming to ensure the demonstration of safe use by changing the Annexes to REACH, in cases where the existing requirements are not specific for substances with nanoforms or where specific considerations are required Clarification of existing information requirements and at the same time alleviating the burden on companies (and SMES in particular), by changing the Annexes to REACH On top of options 2 and 4, requesting additional information specific to nanomateirals (not required for substances in general) in order to further reduce the uncertainty Criteria for the measures therein Measures proposed by Nano Support project, and considered by ECHA as currently (implicitly) required by REACH (derived from general REACH Requirements) Further develop the ECHA Guidance, increase the involvement of Member States, ECHA and the Commission, raise awareness Measures proposed by the Nano Support project, and considered by ECHA as not currently required by REACH Increase clarity on information requirements for registrants while reducing information requirements for lower tonnages Generation of additional information and its detailed documentation Figure 4-3: The options compared to current practice and ECHA's interpretation of the current requirements 4.8The Baseline Establishing the baseline for this impact assessment as required by the guidelines is not straight forward. The current situation is set out as option 1 (current practice) in Figure 4-3. With time, assuming ECHA will fully implement compliance checks according to their own interpretation of current REACH requirements, the information generated under option 1 will eventually increase to that obtained by option 2. However, given the current pace of compliance checks by ECHA and the associated workload it is doubtful that ECHA will be able to conduct compliance checks for all substances possibly occuring in nanoforms. Furthermore, there are several compliance check decisions which through a Board of Appeal decisions further determine whether ECHA's interpretation of the current legal requirements is correct or not (see more in 4.9. Industry appeals to ECHA decisions on registration of substances with nanoforms below). Similar considerations apply to option 3. The soft law option will explain what the information requirements are in ECHA's interpretation, but as registrants apply guidance in a more flexible manner than clear legal obligations, it is expected that the information generated under option 3 will eventually, but more slowly and with more efforts by ECHA to ensure correct application of guidance, increase to that of option 2 (again subject to confirmation by the Board of Appeal that the measures in option 2 are already in line with the current REACH requirements). Therefore, for the purpose of this impact assessment, and without prejudice to the opinion of the Board of Appeal on the compliance check decisions, it has been assumed that ECHA's interpretation of the legal requirements is correct and that consequently, the information requirements as set out in option 2 can be considered as the baseline for what should be provided for the registration of nanoforms in REACH. However, should the Board of Appeal decide against ECHA in the pending cases, the baseline would be closer to option 1, i.e. what industry has provided so far and without additonal data generation. In the light of the dynamic character of the developments under options 1 and 3, for a precise calculation of costs and benefits it would be necessary to introduce a time dependence and appropriate discounts in the impact assessment. However, given the uncertainties of this timeline and of the speed by which ECHA could be expected to require data generation using the compliance check procedure, this impact assessment does not attempt to include this additional time variable. Instead, for simplicity reasons, the impact assessment will present the costs for option 1 without the data to be additionally generated, hence only looking at current practice, and for options 2 and 3 considering the full additional data. This has the following consequences: -costing of option 1 does not include the cost (for registrants and for ECHA) of bringing the information content of registration dossiers to the level defined by option 2; -options 2 and 3 will have the same cost because any use of ECHA administrative resources under option 3, and therefore also the likely higher effort and corresponding cost on ECHA of bringing the information content of registrations to the level defined by option 2, is not included in the costing model. For the purpose of this impact assessment, conceptually, a similar logic as for costs explained above, can be applied to capture the benefits of each option for the same snapshots of time as for costs. The benefits would be expected only to the extent the underlying data is available (i.e. generated when required) and therefore an assumption can be made that safe use is demonstrated and applied. Option 1 can thus not be associated with the benefits that would evolve from the efforts by ECHA and competent authorities in a long run to bring the information content of registration dossiers to the desired level as defined by option 2. Thus, option 1 (under the current practice and without considering the developments in time) would not generate benefits. On the other hand, the benefits of option 3 can be considered comparable to that of option 2, based on the assumption that comparable underlying data is generated by the two options. 4.9Industry appeals to ECHA decisions on registration of substances with nanoforms As indicated above, ECHA's Board of Appeal is presently considering several industry appeals against ECHA compliance check decisions requesting nanoform specific information in line with what would be required by option 2. While each case is specific, industry's arguments as well as ECHA's rationale are of more general nature, so the Board's decisions are expected to provide the Board's general views on information currently required in the registration dossier, thus outlining whether ECHA's or industry's interpretation of current REACH requirements for the registration of nanoforms is correct, or whether the requirements are somewhere in between. This is graphically presented in the figure below, marking the space in which the no-change scenario might evolve, should ECHA's position not be favoured: Figure 4-4: The no-change scenario and the decision by the Board of Appeal: *Taking into account the Board of Appeal's decision on the appeal A-011-2014 regarding the compliance check on titanium dioxide, it should be emphasised that the requirements under the 'no change' scenario will never fully evolve to the requirements under the 'ECHA scenario'. The Board of Appeal's decisions will not affect the assessment of the options in absolute terms as presented in this report, but rather the relative change that each option represents compared to the baseline (which is therefore for transparency provided in relation to both options 1 and 2). The Board of Appeal's decision of 2 March 2017 on the appeal A-011-201450 annulled the ECHA compliance check decision on titanium dioxide, with the principal argument that, under the current provisions of REACH the elements that are listed in Annex VI.2 are exhaustive so that the additional information on the characterisation of nanoforms requested by ECHA as part of the substance identity information is considered as new information requirements that fall under the exclusive competence of the EU legislator to establish by amending the REACH Annexes. In addition, the Board of Appeal confirmed that the registrant has the liberty to define the registered substance broadly. If he does so, then the hazards of all the possible forms of the substance covered by that substance definition must be addressed by the toxicological and ecotoxicological information provided in the registration dossier. Consequently, as for the measures and scenarios of this impact assessment, the Board of Appeal's decision implies that the option 2 'ECHA scenario' (e.g. in particular characterisation under Annex VI.2. covered by measure 2 as explicitly addressed by Board of Appeal's decision) cannot be in its entirety considered as part of the baseline. Thus, it can be concluded that the baseline (i.e. the 'no change' scenario) cannot fully bring the requirements to the level of requirements as set by option 2.

The robustness of the approach in finding an adequate overall conclusion was assessed. While any difference in the interpretation of the baseline leads to different evolution of the no-change scenario and would therefore also affect the relative impact of the implementation of the options compared to the no-change scenario, an approach using the total impact (e.g. total implementation cost) and the assessment of the impact of individual measures allows the comparison between the options and avoids excessive sensitivity to the evolution of the no-change scenario. This argument does not apply to option 3, that would for example remain bound by any potential legal constraint identified and that would in turn modify the assessment accordingly, including the estimation of costs and uses of animals. As the Board of Appeal Decision confirmed the lack of competences of ECHA to request under the current provisions of REACH nanoform-specific information to be submitted as part of the Annex VI.2, option 3 in itself cannot resolve all of the issues discussed under section 2.2 The problem requiring action and its drivers. Thus, there is need for further action beyond soft law measures. 5ANALYSIS OF IMPACTS This section introduces first a summary of the main findings of the Public Consultation and then develops a qualitative (and quantitative, where possible) analysis of the economic, social and environmental impacts of each of the options. Quantified costs for each option will be presented based on data models utilising certain assumptions. It is important to note that quantitative estimates on costs from different studies vary due to different methodologies, assumptions and interpretations of the options, but are adequate to support qualitative grading and indicative of the magnitude of the impacts. In particular, the estimates are often built on the basis of assumptions and interpretations of the different measures. As is often the case for health and environmental issues, as well as for innovation and competitiveness, it is impossible to establish a meaningful direct causal link between a single measure and the associated, often long term, benefit it may bring to society. This is not unique to the present impact assessment. In absence of better alternatives and for simplicity, it is generally assumed that correct risk management of nanomaterials will lead to health benefits similar to managing risks for bulk substances. For the same reason the benefits assessment as well as the assessment on innovation and competitiveness will be mainly qualitative. 5.1Public Consultation The results of the Public Consultation are presented in detail throughout the analysis of the impacts and in Appendix V. Overall, when asked about their preferences for the options as a whole, a majority of the 142 respondents preferred option 5, closely followed by option 6; and then options 2 and 4, while option 3 had the lowest preference. Respondents can be grouped into three main categories, according to their preferences: industrial and trade associations and private companies, which preferred clearly option 5; government authorities, academic/research institutions, NGOs, consumer associations and individual citizens, which preferred option 6 followed by option 4; and 'others', for which the preference is more or less equally shared between options 6, 4 and 2. When asked about the cost, the efficiency and the safety of each measure contained in the options, option 2 received the highest ranking for both efficiency and safety, option 5 the highest ranking for cost and the lowest for safety, and option 6 the lowest ranking for cost but only the third highest for safety. Option 4 ranked second, both for safety and efficiency and fourth for cost. Given the staggered interrelationship between options 2, 4 and 6, the outcome in terms of ranking of the three options for costs is coherent, while the ranking for safety is somewhat surprising. In response to a separate question regarding the efficiency of the options as a whole, option 4 received high appreciation by the majority of the respondents. 5.2Economic impacts 5.2.1Conduct of business 5.2.1.1General considerations Companies placing on the market substances with nanoforms (manufacturers and importers) would be directly affected by the measures under this proposal (downstream users of such substances will be indirectly impacted). A large part of how the conduct of business is affected by each of the options relies on the analysis of the testing costs and the administrative burden on registrants (understood as the costs linked to the information obligations placed on businesses, including the need to undertake tests). This section is mainly focused on the compliance costs for registrants (i.e. companies placing substances with nanoforms on the market). Two supporting studies by BiPRO and Matrix have been conducted to support this impact assessment. Based on the information available from the two studies and the understanding of the possible applications of the different measures, the Commission services have made their own calculations. Other impacts on the conduct of business, including that for SMEs and how the clarity/certainty of the regulatory requirements are going to be affected by each of the measures, are also explained, mostly in a qualitative manner. It should be noted that the costs for business have been assessed from the perspective of cost incurred from registration requirements, while some of the information may be available from normal business operation (e.g. characterisation/reproducible product and functionality, safety information for investment) or from compliance with other legislation (e.g. sector specific legislation such as for Cosmetic Products). 5.2.1.2Costs calculations The cost calculations and related underlying assumptions are presented in detail in Appendix XIII. In the tables below, the cost of registering a nanoform (or in grand total, all nanoforms estimated to be registered) is presented, as a function of the tonnage band to which the nanoform is associated, and the impact of the measures considerd to be applied under each option. In accordance with the baseline narrative developed under section 4.8 The Baseline, presentation of costs under option 1 do not include compliance costs according to ECHA's interpretation of the current REACH requirements.

The total costs and not the incremental cost as compared to the baseline are presented in all the following tables. Some relative figures are however provided in the accompanying text assessing individual options under section 5.2.1 Conduct of business. Most assumptions and estimations come within a certain range (e.g. minimum/maximum costs). Therefore, in most calculations a 'typical' value is used while individual ranges are used as specific examples to discuss the sensitivity of the results. The resulting tables are presented below: Costs of registration per nanoform For the calculations in table 4-1, it has been assumed that it is possible to apply alternative methods to fulfil an information requirement (e.g. read-across between substances, grouping, QSAR, etc.) also for different forms of the same substance and to justify relevance of data on one form for the other or identify the worst form. Although currently the documented use of such methods for nanoforms is limited, it is expected to increase with the development of the knowledge base. In the absence of better information, it is assumed that this leads to the same percentage of reduction for testing needs, as has been observed for conventional substances. Within option 1, the costs are presented in two ways: one (1a) indicating the cost for one information dataset for substance regardless of the number of forms, and the other (1b) indicating the cost per nanoform/set of nanoforms calculated by dividing the first cost figure by an estimated average number of nanoforms or sets of nanoforms for a substance at a given tonnage band.



Table 5-1: Costs of options per nanoform and per tonnage band (use of alternative information considered possible, typical cost) (in thousand Euro): 1a 1 b Estimated baselinee 2 3 4 (including 2) 5 6 (including 2 and 4) >1000 tonnes 772 77 1049 1157 1049 1256 458 2256 100-1000 tonnes 538 77 770 814 770 939 375 1736 10-100 tonnes 183 37 334 359 334 471 40 869 1-10 tonnesc 49 12 91 116 91 137 12 466d Weighted Average 358 47 516 565 516 642 212 1254 a Costs per substance regardless of the number of forms – one test performed per substance per information requirement b To calculate and present the cost per nanoform or set of nanoforms, the costs for conducting all tests according to the measures constituting option 1 are divided by an estimated average number of nanoforms or sets of nanoforms for a substance at a given tonnage band c Weighted average: depending on applicable conditions of Annex III to REACH, the implications differ between registrants in the 1-10 tonnage band; more details in Appendix XIII d Indirect impact of measure 41 on registration of bulk forms may bring an estimated additional cost of 10 K EUR per nanoform of substance otherwise benefiting from Annex III exemption. Relative additional contribution 2%. More details in Appendix XIII e Estimated baseline consequent to Board of Appeal Decision 2 March 2017(see discussion in section 4.9). Option 2 cannot be considered baseline in its entirety. Grand Total costs Multiplying the figures in table 4-1 by the estimated total number of nanoforms or sets of nanoforms and the number of substances with nanoforms per tonnage band provides an estimation of the total costs. Table 5-2: Registration costs – Grand total per tonnage band (use of alternative information considered possible, typical cost) (in million Euro): 1a Estimated baselined 2 3 4 (including 2) 5 6 (including 2 and 4) >1000 tonnes 36 482 532 482 578 211 1038 100-1000 tonnes 43 426 450 426 519 207 960 10-100 tonnes 9 84 90 84 118 10 217 1-10 tonnesb 10 73 93 73 110 10 373c Total 97 1065 1165 1065 1325 437 2588c a Note that in this grand total cost table only one number is used to represent option 1; it assumes that, whether sufficient for risk assessment or not, at most one test is performed per substance per information requirement, regardless of the number of nanoforms that the registration of that substance includes

b Weighted average: depending on applicable conditions of Annex III to REACH, the implications differ between registrants in the 1-10 tonnage band; more details in Appendix XIII c Indirect impact of measure 41 on registration of bulk forms may bring an estimated additional cost of 6 M EUR. Relative additional contribution 1.6%. More details in Appendix XIII d Estimated baseline consequent to Board of Appeal Decision 2 March 2017(see discussion in section 4.9). Option 2 cannot be considered baseline in its entirety. Additional scenarios are provided under Appendix XIII for costs of nanoform registration without alternative information available, costs per registration dossier and costs per company. Interpretation, uncertainties and sensitivity analysis Assessment of individual options is provided in the following chapters, but some broad features of tables 5-1 and 5-2 should be highlighted: ·Higher costs for nanoforms to be registered under higher tonnages reflect more extensive information requirements as set out in REACH ; ·Total costs rather than cost incremental to the baseline are presented; ·As explained in section 4.8, option 1 estimates present cost reflecting information found in many REACH dossiers of substances with nanoforms at present; ·As explained in section 4.8, option 3 will in time lead to costs as in the baseline – (see discussion in section 4.9 on the Board of Appeal decision in the case A-011-2014). It should be emphasised that the costs presented above, in particular the Grand Total costs, are highly sensitive to several key assumptions, namely the number of substances with nanoforms subject to registration, the number of nanoforms within a substance, the extent to which use of alternative methods for providing information (read-across, ability to apply worst case approach etc.) can be applied between the substances and the nanoforms, testings costs, etc. As evident from Appendix XVI, where different scenarios are examined, the uncertainties of the average cost is likely to be in the order of at least +/- 50%. Individual materials may present specific challenges when tested and the cost difference between them can correspondingly be significantly larger, within one order of magnitude of the average cost. The actual number of registrants sharing the costs of the information requirements for an individual nanoform will also influence proportionally the actual cost per registrant. In the Grand Total, costs are directly related to the assumed number of nanoforms, i.e. the higher the number of forms, the higher the grand total cost. As the information related to the number of nanoforms covering nanomaterials on the market is highly uncertain, the assumptions are associated with significant uncertainty. 5.2.1.3Option 1 As explained in section 2.4 How will the problem evolve?, it is reasonable to expect that the situation will improve over the next years and the issues stemming from the differences in understanding how REACH addresses substances with nanoforms at present will diminish due to the mechanisms foreseen in REACH, such as compliance checks by ECHA, continuous development of guidance, and the learning process within industry. However, the process would be cumbersome, take time and uncertainties for companies (on how to comply with the REACH registration requirements) would remain in the short to medium term. Many more companies will get involved by 2018 (1-100 tonnes) and as new nanomaterials make it to the market, many of the same issues will persist. When preparing this initiative, it has also been shown that there exist clear discrepancies between the involved parties on what REACH entails when it comes to nanomaterials. As recalled above, there is indeed a certain grey area with regard to the interpretation of the current information requirements as applicable to substances with nanoforms, and thus different interpretation of the evolving baseline scenario. This leads to legal uncertainties that will not be resolved (or at least not quickly and not for all operators) with this option. The assessment of this option makes the assumption that there will not be significant improvements in the short term of the information provided, and this is reflected in the cost estimation of the option in table 5-2. 5.2.1.4Option 2 Public Consultation: 94% of respondents from industry report that costs of compliance would "significantly increase" under this option, whereas other stakeholders do not expect an impact.

Analysis According to ECHA's interpretation, this option does not change any existing obligations, but explicitly explains what information companies must provide. Under this interpretation, option 2 would constitute the baseline. Compliance cost (including administrative burden): The weighted average cost of providing information for a nanoform or set of nanoforms in accordance with option 2 is estimated to be 565 K EUR (depending on the tonnage band ranging from 116 to 1,157 K EUR - the higher the tonnage band, the bigger the cost). The most costly measures within this option are related to the characterisation of the nanoform (measure 2) and providing information on characterisation of test samples as a consequence of the insertion of clarifications in the REACH Annexes I and VI to X according to the OECD requirements (measure 4). These measures weigh more strongly in the low 1-10 t tonnage band (a 2.4 fold relative increase) and less at higher tonnages (1.5 fold increase for >1000t). The Board of Appeal's decision on 2 March 2017 in the case A-011-2014 (see discussion in section 4.9) indicates option 2 in its entirety cannot be considered as baseline. It is estimated that the difference (per nanoform) is in the order of 25K to 108 K EUR (the higher the tonnage band, the bigger the cost). In the grand total, the cost of this measure amounts to approximately 100 M EUR (or 9.4% of the estimated baseline). When comparing to option 1, the major cost increase comes from testing that might be required for individual nanoforms or sets of nanoforms and is therefore proportional to the number of nanofoms registered under one substance. Regardless of whether the registrants had not assessed different forms covered in the registration, or had perhaps just not included documentation of such assessment in the dossier, option 2 would cause additional costs that might be substantial compared to what they have incurred until now. In the medium/long term as ECHA progresses with evaluation, registrants are forced to upgrade the dossiers, the difference would eventually diminish, however, option 2 would still incur at least a total additional cost of 100 M EUR (as compared to the estimated baseline), with high relative increase in the lowest tonnage band. Regulation clarity/certainty: The option is expected to increase clarity and hence reduce regulatory uncertainties, which would permit firms to better plan business activities entailing the use of nanomaterials. Also, the increased knowledge base regarding the properties of nanomaterials is likely to reduce costs in the long run, also via increased trust for investors that there are no hidden liabilities and general demand side trust in the safety of nanomaterials. 5.2.1.5Option 3 Public Consultation: For a large number of the respondents, option 3 would either increase the costs of compliance (44%), or have no impact on it (39%). Analysis Compliance cost (including administrative burden): Non-binding measures could have an impact on costs, e.g. specific guidance leading to different interpretations of the legislation can increase or decrease compliance costs. However, any cost changes will by definition not stem from a change of the obligations, but could stem from e.g. administrative cost of organising data differently or different testing costs. The compliance cost as well as the ability to address the problem in its entirety depends on the interpretation of the current information obligations. Pursuing the same objective as option 2, soft measures are effectively limited to those that might be pursued as current compliance. Assuming ECHA's interpretation is correct, it is thus expected that the costs for this option would be similar to those of option 2. It is worth noting however that the costs might potentially occur at different points in time, since compliance costs triggered by option 2 would occur immediately after implementation and that those triggered by soft law recommendations would likely take some time to occur. If interpretation of compliance is different (see discussion in section 4.9 on the Board of Appeal decision) and since the Board of Appeal ruled (partly) against ECHA's interpretation in terms that some of the requirements under option 2 cannot be considered as current REACH requirements) then the total cost of this option would differ, i.e. being lower that the total cost of option 2. Regulation clarity/certainty: Since the measures contained in this option aim at providing explanations about what the obligations for companies are or where more information can be found, this option would increase clarity and reduce uncertainty for companies. The degree of clarity/certainty provided by changes solely in the guidance would, however, be weaker than that provided by changes in the legal text itself. 5.2.1.6Option 4 Public Consultation: Option 4 is ranked fourth in terms of cost burden. Analysis Compliance cost (including administrative burden): A condition for option 4 to work properly is that the registrants provide correct data in accordance with option 2. With option 4, a few new tests are introduced or would be made compulsory for registrants at lower production levels than hitherto. The weighted average total cost of option 4 is estimated to be 642 K EUR (137 K EUR for 1-10t – 1,256K EUR for >1000t). The weighted average cost of the additional me