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 1 , a nanomaterial is:

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 2 . 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 3 .

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 4 . 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 5 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 6 and for a long time without having been intentionally designed as nanomaterials 7 .

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 8 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 9 , 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 10 . The OECD has produced a number of publications on the properties of selected nanomaterials 11 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 12 . 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 13 . 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 14 ).

1.4The EU regulatory framework for the risk assessment and risk management of nanomaterials 15

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 16 . 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 17 . 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”) 18 , 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 19 .

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 20 , 21 . So far guidance has already been published 22 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 23 . 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 24 , i.e. restrained to certain amendments of the REACH Annexes for nanomaterials, as the Commission in the General Report on the REACH Review 25 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 26 . 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 27 , arguing in essence that existing legislation is sufficient to address regulatory concerns on nanomaterials. Following this Communication, the European Parliament issued a Resolution 28 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 29 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" 30 . 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 31 and a Communication on the Second Regulatory Review of Nanomaterials in 2012 32 . 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 33 , 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 34 , 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 35 , 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 36 .

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') 37 .

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 38 , 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

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 40 and 108 CLP notifications 41 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 42 , 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 43 .

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 44 (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 45 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 46 ) and Chemical Safety Assessment (RIPoN 3 47 ). A third report of the RIPoN project relates to Substance Identity (RIPoN1 48 ). 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 49 .

·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 50 . 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) 51 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 52 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 53 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 54 . 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) 55 . 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 56 or in the risk management recommendations 57 .

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."  58  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 59 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 60 . 

The scientific debate has also raised questions whether new additional endpoints 61 , 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 62 .

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 63 . 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 64 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 65 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

66 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 67 .

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 68 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 69 . 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 70 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 71 , consideration of the most appropriate route of exposure or limitations of the applicability of test methods 72 , 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 73 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 74 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 75 .

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

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 76 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', 77 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 78 and Matrix 79 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 80 .

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 81 .

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 82 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 83 .

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):

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):

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)  84 . 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 measures of option 4 compared to option 2 is 77 K EUR (14% increase), with higher impact on lower tonnage bands (18% and 33% for 1-10t and 10-100t, respectively). The most costly measure within this option relates to the prioritisation of testing on soil and sediments (measure 17, which requires data generation at lower tonnages than for conventional substances, thus having a maximum impact in the 10-100 tonnes registration band) and additional justification further to water solubility for test waiving (measure 14). If compared to option 1, the cost increase is substantially higher (i.e. 14 fold).

Regulation clarity/certainty: While option 2 addresses the clarity in relation to legal requirements, this option includes additional requirements based on the scientific recommendation compiled by the JRC in the Nano support project. These should provide more certainty in the effectiveness in the regulatory requirements for this specific subgroup of chemicals.

5.2.1.7Option 5

Public Consultation: This is the best ranked option in terms of cost (for 40% of the respondents this option would have no impact on the costs of compliance).

Analysis 

Compliance cost (including administrative burden): The aim of this option being to reduce the cost of compliance, its implementation would indeed have a weighted average cost of 212 K EUR and entail savings of 62% for companies compared to option 2. Savings are in particular high for lower tonnages (92% and 90% for 1-10t and 10-100t, respectively). The estimated savings per nanoform, assuming they being registered together with a bulk form carrying the entire cost, has been estimated to range between -104 K EUR for the lower tonnage band to -699 K EUR for the upper one compared to option 2. In case of option 1 being the baseline, implementing option 5 would not cause any additional cost in lower tonnage bands but would cost 298 K EUR and 380 K EUR for 100-1000t and >1000t respectively.

There are two main reasons for such significantly lower cost:

·The specific requirements for a nanoform or set of nanoforms in terms of scope and characterisation under option 5 do not exist or are less demanding than the ones under option 2 (e.g. measure 18 versus measures 2 and 3 85 ).

·The option would exempt the registrants from providing any ecotoxicological and environmental fate information for the nanoform or set of nanoforms and in addition assumes provision of information by alternative means rather than by testing 86 .

This cost reduction does not affect the information supplied for the bulk or another (non-nano) form of a substance in the dossier. In general this option would not oblige data to be generated for the registered nanoform or set of nanoforms.

Regulation clarity/certainty: The option does provide further clarity to the registrants who will face easier tasks in fulfilling their requirements, imply savings and permit better planning. Essentially, the proposed option would reduce the standard information requirements for nanoforms of a substance and change the legal situation for substances with nanoforms produced in quantities below 100 tonnes per year per company to a situation comparable to what was applicable to existing chemicals before REACH was adopted.

5.2.1.8Option 6

Public Consultation: Option 6 was the worst ranked option in terms of impacts on costs (4 of the measures are particularly qualified as affecting or significantly affecting the costs of compliance 87 ). Indeed, almost 90% of the respondents indicated cost increases, and half expected a "significant increase".

Analysis. 

Compliance cost (including administrative burden): Option 6 would add further obligations to those established under options 4 and 2. It would add administrative requirements, e.g. presenting separate information for nanoforms of a substance that differ among themselves in terms of specific characteristics (coating, shape, form etc.). The option implies an average weighted cost increase by 121% compared to option 2. The total cost of this option is estimated to be 1,254 K EUR (466 K EUR for 1-10t and 2,256 K EUR for >1000t). Compared to option 1, the cost increase is 27 fold. There is also an estimated indirect additional cost of 10 K EUR per nanoform from measure 41 through registration of the bulk form of substances in 1-10t tonnage band, leading to (small in comparison to the impact of other measures) estimated total additional indirect costs of 5.8 million EUR (1.5% of the total cost in the 1-10t tonnage band, 0.2% in total). The highest costs come from the measures that effectively increase the number of nanoforms to be addressed (measures 41 and 49 88 addressing REACH Annexes III, IV and V) and those which reduce the availability of information via alternative means (measure 46). Further costs are incurred by requesting additional physico-chemical requirements from measure 44 and the toxicokinetic study from measure 51. However, it is to be noted that with better toxicokinetic information available, it can be reasonably assumed that at least some more tests can be waived (in particular in the higher tonnage bands) based on justifications referring to the toxicokinetic data or as the information is provided via alternative means; this means that despite more requirements being added, the general testing requirements (both new and existing testing) may be reduced so that the overall impact is lower than expected.

Regulation clarity/certainty: This option adds additional requirements. Because it is prescriptive and detailed, it supports the objective of providing clarity for the registration.

5.2.2Impact on SMEs

5.2.2.1Option 2

The costs for complying with option 2 are considerable, even more so in the lower tonnage bands (see above - the relative impact of the measures for the 1-10 t tonnage band is 1.6 times the one for > 1000t) where it is expected that more SMEs are active. However, the information gained through these measures is essential for demonstrating safe use of the nanoforms of the substance. In fact enhanced clarity is assumed to make it easier and more efficient also for small firms that are not lead-registrants to apprehend precisely and up-front what obligations REACH puts on them. However, the increase in the compliance cost may create a barrier for some SMEs and force them to exit the nanomaterial market.

5.2.2.2Option 3

SMEs are the businesses least able to access information and the most likely to misunderstand how REACH works. As such, they stand to gain the most from soft law measures aiming at providing more clarity on the registration obligations. Other considerations apply as for part of option 2.

5.2.2.3Option 4

The measures and their associated costs have proven to follow relatively closely the existing cost development between the different tonnages with the exemption for the tonnages 10 – 100 tonnes due to the expensive soil and sediment test that would be additionally required in that tonnage range. Assuming that SMEs have a higher relative representation in the lower production volumes, it is important to assess if the lower volumes are harder hit than the higher volumes. As shown in table 4-2, and comparing to option 2 this would be the case for the volumes 10-100 tonnes (mainly due to measure 17), but not that much for the volumes 1-10 tonnes, where it is expected more SMEs are active.

5.2.2.4Option 5

Like for other company sizes, the short term savings on compliance cost will benefit SMEs. However, the continuous lack of relevant information on safety might impede the commercial success of the SME in the medium to long term.

5.2.2.5Option 6

The impacts on the viability of SMEs explained under option 4 move in the same directions for this option, but their magnitude is much stronger. In particular for the lowest tonnage band (1-10 tonnes) the resulting cost increase, as compared to option 2, could be a challenge. SMEs involved in the manufacturing or importing of nanomaterials could see their viability severely affected.

5.2.2.6General discussion on impacts on SMEs

The requirements for registration and generation of information under REACH are strictly company-neutral and related solely 89 to the tonnage of the substance placed on the market by a company. However, in particular through the tiered tonnage thresholds, REACH is already providing some relief for SMEs, for all chemicals, as a higher proportion of SMEs is registering low(er) tonnage substances under the less onerous standard information requirements for the lower tonnage bands. Furthermore, SMEs benefit from significantly reduced registration fees and dedicated implementation support by ECHA 90 .

Any further adaptations (i.e. waivers for subgroups of chemicals) are based on scientific justification (generally available or demonstrated by registrants) and clear demonstration that such an adaptation does not impede the ability to safely manage the substance, but these cannot be dependent on the size of the registering company.

Measures addressing nanoforms, in all options apart from option 5, follow this same logic. SMEs seem to be proportionally affected more by the options, compared to the situation for conventional chemicals. That is principally because the nanoforms need to be characterised, a basic requirement to properly identify them, and thus defining the scope of the registration dossier, and subsequently enable better functioning of REACH 91 . At low tonnages, characterisation contributes, in relative terms, a higher proportion to the total costs (i.e. characterisation + testing), given that testing requirements are lower. The same 'disproportionate' effect is observed already in present REACH implementation e.g. for properly identifying a UVCB substance registered at low tonnage. The same argument applies to some of the related measures under options 2 and 4. Option 6 causes additional burdens for SMEs, but this has been clearly identified.

Option 5 includes several measures that attempt to mitigate impacts on SMEs also by further reduction of information requirements for lower tonnages via a generic waiver, applying to all nanoforms, of ensuring nanoform-relevant information and relying on data on whichever form of the substance that is available. A case by case assessment may in many cases eliminate need for further testing as relevant information for nanoforms may be available through alternative means (e.g. read across, worst-case approach), but a generic waiver applicable to all nanoforms of all low tonnage substances cannot be scientifically justified and thus represent a deviation from the REACH approach presented above.

5.2.3Innovation and research

Drivers for innovation and research are manifold and not always equally well understood. In this particular case, it should be borne in mind that the measures all are to be introduced in context of already existing REACH registration obligations so isolated effects of the different options are even more difficult to identify. Overall the discussions have identified two general positions, those who argue that extra health and safety requirements adds compliance cost to companies that otherwise would have been spent on developing new products (the findings of the REACH review indicate that there has been indeed a shift of resources from R&D to compliance); and those who argue the opposite way claiming that research and innovation is (also) fuelled by legislative requirements and that compliance information is not passive knowledge but also an asset that can help further development.

The ‘de-regulation’ argument as voiced by some companies being part of the consultation assumes that regulation simply increases costs and erodes competitiveness and existing or future innovation; several answers of decision makers in companies showed that “data generation as such does not necessarily lead to conception of new ideas and innovative activity”. Fulfilling the requirements of the REACH Regulation requires scarce company resources otherwise needed for other purposes, e.g. goal-oriented research and development activities and/or gaining better position in the global markets. This is confirmed in a study monitoring the impacts of REACH on innovation, competitiveness and SMEs 92 , where results show that about half of the companies have had to reallocate R&D staff to compliance activity.

The ‘pro-regulation’ argument builds e.g. on information gathered by the introduction of additional requirements in the options, addressing human health hazards and environmental fate and hazards may also help spark innovation as has been demonstrated by the effects of information generated thus far for the first registration dossiers. As soon as companies have performed the additional tests required, they gain additional information, on particular hazards and risks of these nanoforms, and also on relations between their characteristics and risks. Having this information early helps focus innovation to the more successful final solutions (i.e. ‘safety by design’) and helps secure investment. It may also induce further innovation, e.g. on alternatives with less hazards and risks. This does not apply only to the company's own development - harvesting the joined increased knowledge opens new innovation potential.

The impact assessment prepared in the run-up to REACH 93 forecasted no substantial changes related to REACH with regards to R&D investments by firms in the chemical sector. Similarly, the more recent CSES interim evaluation 94 mentions that there have been no significant effects in terms of innovation activities, which could however arise in the future. According to the preliminary findings in the same study cited above, in spite of forcing reallocation of resources to compliance for a significant share of companies, REACH has also increased activity in R&D for 26% of all companies. Indeed, an increase in knowledge of chemical substances and awareness of needs of upstream and downstream actors in value chains was reported by a significant share of respondents to a questionnaire, and about a fifth of respondents indicated that they had launched new products or services as a result of knowledge gained through the compliance process. Costs due to the registration process have resulted in withdrawal of substances for 30% of the respondents; however, among these, half have increased their R&D activity to identify alternative substances to use, and between 25 and 33% have changed their manufacturing processes in order to avoid the use of those substances. The REACH Review concluded that information generated for the registrations provide inspiration for the innovative use of existing substances and that REACH has had a positive impact on research into new substances. The survey of nanomaterial manufacturers and importers (ca. 15% with actual experience implementing REACH) highlighted REACH and CLP, alongside other reasons such as value chain readiness problems and lack of capital, to have negatively influenced time-to-market of nanomaterials, which might indicate shifts of resource allocations and loss of the momentum in gaining market shares for innovative applications 95 . The BiPRO study mentions that impacts on innovation from requirements related to substances with nanoforms could also arise in different directions, with increased knowledge as a possible driver of positive future impacts. Again, limitations in available data allow only a qualitative analysis.

Several measures aiming at improved clarity, especially in options 2 and 5, would allow better tailoring of the nanoform specific measures on the key aspects of hazard, exposure and risk assessment in REACH. Further measures reducing obligations for nanoforms, such as in option 5, might sometimes facilitate access to market for innovative SMEs; on the other hand, the reduced knowledge base or scientifically supported safety information could even impede innovation and market access.

Options implying an increase of requirements, such as options 4 and 6 (and depending on where the baseline is, also option 2), would entail both positive and negative impacts on innovation. On one hand, an increase in fixed costs could hamper innovation, as compliance costs would take away resources that could otherwise be devoted to R&D activities. This negative effect would be even stronger if costs would reduce the financial viability of a number of SMEs working with nanotechnologies. On the other hand, testing requirements would in the medium and long term increase the knowledge base in the sector with regard to the characteristics of nanomaterials, possibly facilitating their employment in new avenues for innovation in nanotechnologies. Please refer to Appendix XI for a table summarising an assessment performed by Matrix on the capacity to innovate under the different options.

To facilitate innovative SMEs developing nanomaterials would contribute to the long-term competitiveness and employment in Europe. However, given several indicators of drivers pulling in different directions and the general absence of data, a conclusive assessment of the effects of any of the options’ impact on innovation cannot be made.

5.2.4Competitiveness, trade and investment flows

The effects on the competitiveness of EU firms operating with nanomaterials could be twofold. On one hand, increments in costs would potentially harm the ability to compete in international markets. On the other, regulatory certainty, improvements in the knowledge and exchange of information could instead bolster competitiveness.

In the context of this assessment building on an established regulatory framework, EU based companies using nanoforms in the production of articles may be in disadvantage as compared to importers and non-EU companies, since these are not subject to the REACH registration obligation when the nanomaterial is integrated within an article (unless Article 7(2) of REACH 96 applies). EU based firms manufacturing nanomaterials will also be affected when competing with third country companies outside the EU territory. This is so because REACH is also applicable to the manufacture of products exported out of the EU territory. With the exception of Australia 97 , the EU’s main trading partners tackle nanomaterials through their existing chemicals legislation. Unlike in the EU, this most often means that new substances are subject to (limited) notification requirements prior to their placing on the market while existing substances are subject to measures only when the authorities have gathered enough evidence to introduce measures. For example, the US-EPA has interpreted that some nanomaterials represent ‘new uses’ triggering in some cases further testing requirements for companies 98 .

Given the general absence of data to underpin a quantitative conclusive assessment of the effects of either of the options’ impact on competitiveness, trade and investment flows, this analysis is based upon the qualitative assessment provided by Matrix 99 . Accordingly, options 2 and 3 are likely to impact negatively in the short term in the cost of production and possibly affect manufacturers or downstream users of substances with nanoforms; however, the options would at the same time decrease the cost of capital in the long term due to reduced uncertainties and would increase the market shares of companies due to a higher confidence in the products containing their nanomaterials. By reason of a probable increment of the costs of production with regard to options 2 and 3, the negative impacts on competitiveness of option 4, and even more that of option 6, are likely to outweigh the increase in the confidence of the products containing nanomaterials. Finally, option 5 would, disregarding the negative impact of reduced confidence in products themselves, help decrease the cost of production, allowing the entry into the market of new operators, which would result in stronger competition and hence would presumably result in a reduction of prices of the final products; this would eventually allow improving the international competitiveness of EU firms.

5.3Health impacts

5.3.1Introduction

It is a challenge to estimate the health impacts associated with chemicals in general: their intrinsic properties are not a priori known for such an analysis (that is the purpose of testing under REACH); nor are they easily translated into dose-response functions, not least because exposure depends on the way in which they are used. Given this it is even more difficult to monetise the benefits.

The most direct health and safety impact affect the workers handling nanomaterials. Control of risks and exposures is dependent on the level of information available.

Most of the health benefits are expected to take place with significant delays after implementation of appropriate measures. This is also because enhanced protection of workers’ safety will not automatically occur as a consequence of the measures taken with regard to the REACH registration requirements, but will only be achieved if appropriate risk reduction measures are implemented based on the information contained in the registration dossiers, which in turn can lead to additional costs.

There is a priori a lower risk for potential danger for the final consumer, in comparison with workers, because workers will experience higher levels of exposure during manufacturing processes involving nanomaterials. Health impacts are, therefore, likely to be smaller than in relation to occupational health.

More than 99% of the calculated health benefits of REACH refer to avoided cancer deaths 100 . However, for nanomaterials it may be relevant to refer to costs from other diseases, especially irritation, oxidative stress and genotoxicity. In any case, the majority of health benefits expected to be delivered by the measures discussed in the impact assessment will occur between 2022 and 2042, due to the latency of health risks and the consecutive extension of life years lost.

Two studies have recently been conducted and a third one is currently ongoing, which are not directly linked to nanomaterials or the assessed options, but rather to the assessment of benefits of better information on chemicals and the environmental legislation in general:

·A recent report by RPA and CSES on the potential extension of the registration requirements for substances manufactured or imported between 1 and 10 tonnes per year 101 assesses the costs and the benefits of different options for the modification of the information requirements for substances registered in the 1-10t band. The study assesses the benefits, expressed in terms of damage costs avoided, on the basis of the avoidance of one incidence of ‘disease’ per year per substance identified with a human health classification and improvement in 1 km of waterbody for every substance identified with a classification for aquatic toxicity. The study concludes that the baseline scenario provides €10.02 benefits for every €1.00 of cost and that by increasing the information requirements, there is a roughly proportionate increase in benefit in terms of damage costs avoided. Note that the assessment of the baseline cost was made for bulk substances and concerns only the information requirements relevant for 1 – 10 tonnes per year, with similar assumptions regarding cost per bulk substance as done in the analysis above for the nanoform or set of nanoforms.

·Another study compared the costs and benefits of environmental regulation in the UK 102 . According to this study, the cost benefit of environmental regulation in the UK has increased, with every £1 spent on compliance and enforcement returning £3 to society through economic, environmental and health benefits, according to government research. The environment ministry quantified the costs and benefits of 428 of its regulations affecting UK businesses, just over half of which were derived from EU or international legislation. The total estimated direct cost to business between 2012 and 2021 will be £6bn, of which 86% is related to compliance and 14% to administrative burden. The estimated direct benefit to business is £2bn a year, giving an estimated net cost of £4bn. But the wider benefit of regulation to parties other than business is about £10bn a year. Chemicals legislation, almost exclusively based on EU regulation, provided the best cost benefit ratio of almost 1 to 20.

·The DG GROW study referred to in section 5.2.3 Innovation and research shows that around 53% of companies have improved their risk management procedures because of REACH, with personal protection equipment and new safety instruction indicated with more frequency. When distinguishing by the role of the company within the supply chain, 51% of manufacturers and 70% of formulators changed their risk management measures; these shares decrease going down the supply chain but still remain relatively high (from 48% for distributors to 27% for suppliers of articles). This is an important finding and certainly constitutes a positive economic effect: various studies have concluded that expenditure on occupational safety and health is an investment that “pays off” and calculated the Return on Prevention (ROP) to be 2.2 103 or the Benefit-Cost Ratio to be between 1.04 and 2.70 104 . 

In summary, while there are many indications that health benefits are to be expected as a result of better information availability for registered substances with nanoforms, it has not been possible to quantify all the potential benefits that are expected to occur as a result of introducing the various options examined in this impact assessment. The analysis that follows is thus based mainly on a qualitative assessment of each of the options.

5.3.2Option 1

Public Consultation: It can be deduced from the overwhelming majority of respondents indicating a need for change and the majority (51%) supporting the measures under option 2 (which are also part of options 4 and 6) leading to increased information on potential health hazard of nanoforms, that 'no change' does not score high in relation to safety.

Analysis: Even if it is expected that, depending on the outcome of the pending appeal cases concerning the ECHA compliance check decisions (see 2.2.3 Initiatives undertaken), over time the availability of information for substances with nanoforms will improve via the control mechanisms foreseen in REACH (i.e. moving towards a similar situation as under option 2 in the medium/long term), option 1 may entail risks for the health of workers and consumers in the short/medium term, leading to potential long term impacts (see discussion on cancer above).

5.3.3Option 2

Public Consultation: In the public consultation, the majority of respondents (51%) considered the implementation of measures under option 2 (which are also contained in options 4 and 6) in their preferred option. Its measures also rank first in relation to the contribution to safety.

Analysis: Enhanced clarity can improve the effectiveness of current information requirements to generate relevant information leading to adequate risk management, delivering health benefits. This is the case, for instance, from the additional information about the nature of the nanoform being tested, established under measure 2, or the requirement that the nanoform is specifically addressed (measure 3), but especially from the requirement of identification of uses and exposure assessment for the nanoform (measure 9).

Overall, this option would entail positive impacts on occupational health safety.

5.3.4Option 3

Public Consultation: In public consultation, this option ranked 4th in the safety category.

Analysis: Depending on the legal interpretation of present information requirements, the “soft law” approach would have similar health effects than those for option 2, although slightly lower, and with longer delays, similar to what has been described for option 1. This is expected to be so because, compared to option 2, guidance and the other accompanying soft law measures contained in option 3 are not as binding as formal requirements in the legal text, and therefore companies may not be as inclined to adapt their registration practices to nanomaterials specificities. Moreover, the ECHA evaluation process is assumed not to be sufficient on its own to ensure an immediate implementation by companies.

5.3.5Option 4

Public Consultation: More than 40% of the respondents considered implementation of measures under option 4 (i.e. measures listed under options 2 and 4 combined) in their preferred option. Its measures rank second in relation to the contribution to safety.

Analysis: This option entails an important increase in requirements beyond option 2. Measures requiring data on dustiness (measure 10), route of exposure (measure 11) and non-bacterial in vitro gene mutation study (measure 13) could potentially entail significant improvements in occupational safety, especially in terms of prevention of lung cancer, as they would increase information on exposure to hazardous substances. Those health impacts would affect workers in the chemical sector but also those in downstream sectors using nanomaterials. Benefits would also indirectly affect employers, as they are legally responsible for workplace safety and have to conduct risk assessments for their workers, as specified by the European Framework Directive 89/391/EC.

5.3.6Option 5

Public Consultation: this option ranked last in the safety category.

Analysis: This option could potentially entail a higher risk of disease for workers due to the fact that less information for risk assessment will be available. The considerations developed for option 4 in terms of reduction of risk, in particular in relation to lung cancer, are reversed here. While there is no clarity with regard to actual risks in relation to nanoformcompared to bulk chemical, this option could allow potential dangers to materialise. For instance, the omission of mutagenicity and acute toxicity tests in lower tonnages could result in missing the identification of adverse health impacts (e.g. cancer) and possibility of accidental death from acute exposure.

5.3.7Option 6

Public Consultation: this option ranked third in relation to the contribution to safety, after options 2 and 4.

Analysis: As a consequence of its increased information requirements, option 6 further reinforces the prevention of occupational diseases. Additional requirements related to toxicokinetics (measure 51), physico-chemical characterisation (measure 44) and separate documentation for each nanoform (measure 45) can enhance the informational benefits of testing. Establishing inhalation as the appropriate route of exposure in repeated dose toxicity study unless such exposure can be excluded (measure 50) can help protect from cancer and respiratory diseases.

5.4Environmental impacts

5.4.1Introduction

The UK study mentioned above in section 5.3 Health impacts, also points to environmental benefits arising from the cost spent on environment legislation. A study conducted by a consultant 105 identified several ways in which REACH can reduce the discharge of chemicals into the environment, which is confirmed by the provisional results from the study on impacts of REACH on innovation, competitiveness and SMEs (see section 5.2.3 Innovation and research), according to which around 39% of companies have improved their management of environmental emissions and waste due to REACH.

The impacts on the environment are however hard to quantify. This is mainly due to the lack of meaningful reference systems, i.e. ecosystems that are small enough to be useful while not being too simplistic to transfer the results to more commonplace, larger ecosystems. One way to assess the benefits of measures (and regulation in general) is to evaluate the ability to identify (and where necessary to manage) chemicals that are hazardous to the environment: aquatic toxicity and persistence, bioaccumulation and toxicity (PBT) are the most common indicators that have been picked also in the ESTAT REACH Baseline study 106 and recent RPA and CSES study 107 .

Nanoforms should be considered as any other forms of chemical. Possible impacts range from: probably insignificant dissolution or immediate agglomeration and precipitation, to persistence in ecosystems and organisms with genetic and morphologic consequences as well as potentially different susceptibilities depending on species. There is already evidence of specific nanomaterials in the environment and their impact 108 and SCENIHR recently delivered an opinion which included an assessment of the environmental impact of one specific substance with nanoforms (nanosilver) 109 . More comprehensive work has recently been concluded 110 , however it is considered that extrapolation from the scarce information on the few specific nanomaterials available at present is more appropriate than drawing conclusions from the environmental impacts of chemicals in general. The analysis is, however, limited to a qualitative discussion.

As regards the public consultation, the ranking on safety did not differentiate between health and environmental impacts and the conclusions summarised in the chapter on health above are not repeated. It should be noted that apart from the two more general measures related to environment (option 4, measure 14 on water solubility, option 6, measure 44 on consideration of modification of hazard along the life cycle), environmental measures scored marginally lower in importance to safety than those related to health.

5.4.2Option 1

In analogy to consideration on health impacts and depending on the outcome of the appeal 11/2014 (see 3.2 Specific objectives), over time the availability of information for substances with nanoforms is expected to improve via the control mechanisms foreseen in REACH (i.e. moving towards a similar situation as under option 2 in the medium/long term), option 1 may entail risks for the environment in the short/medium term with potential long term impacts in case of persistent nanoforms.

5.4.3Option 2

Specification under this option improves the information derived from tests or alternative methods such as read-across, which will enable positive impacts in terms on environmental protection. This is the case, for instance, for measure 3 (and related measure 7) requiring that environmental endpoints are addressed specifically for nanoforms. More precise information related to nanoforms will generate more accurate information that can lead to a better functioning of the Regulation on Classification, Labelling and Packaging of Chemicals, which is the key legislation used to trigger action in downstream environment legislation on e.g. waste and water.

5.4.4Option 3

The “soft law” approach would have similar effects than those for option 2, although slightly lower and with delay, similar to what has been described for option 1, and depending on the legal interpretation of the current REACH requirements. It is reasonable to assume that compared to option 2, some adverse impacts on the environment may occur as they will not be addressed immediately. Some companies will not follow guidance or voluntarily follow best practices identified by others and not all registration dossiers will be subject to ECHA evaluation.

5.4.5Option 4

Similarly as for health impacts, requirements under option 4 provide further concrete measures in addition to also implemented option 2 clarification measures to adequately assess hazard to the environment and thus limit any potential risk. Measure 15 (specification that long term testing should not be waived based on lack of short term toxicity) contributes to preserve wildlife, measure 17 (requiring that testing on soil and sediment organisms is conducted already for low tonnages) and measure 16 (preventing the waiving of algae testing based on insolubility) help preventing harm for cases where nanoforms might end up in the aquatic environment, while measure 13 (requiring non-bacterial in vitro gene mutation study), provides information regarding toxicity to mammalian wildlife and agricultural animals.

5.4.6Option 5

The reduced information required pertinent to nanoforms of a substance might generally increase the risk to the environment, in particular due to measure 32, which excludes an obligation to provide any ecotoxicological or environmental fate information specifc to the nanoform or set of nanoforms.

5.4.7Option 6

This option provides limited additional protection to the environment, in comparison with option 4. Measures 42 and 44 increase test relevance as they augment knowledge on nanoform fate and transformation through the life-cycle, while measures 39, 40 and 45 help protecting environmental harm through imposing separate documentation for each nanoform.

5.5Animal testing

The table 5-1 below includes a rough estimation of the cumulative number of animals used for the testing of one nanofom or set of nanoforms, using assumptions on the average animal use per test from a report made by the JRC 111 and the same assumptions as in section 6.2 on the generation of information via alternative means. One can observe that the main impact stems from measures under option 2. The impact of additional measures under option 4 is marginal while under option 6 they are more significant. As expected, animal use is lower in option 5 as the obligation to have information relevant to the nanoforms or set of nanoforms is waived by several measures.

Table 5-3: Animal use per option per nanoform (or set of nanoforms), use of alternative methods considered possible, with default assumptions (see Appendix XIII):

a The column represents animal use for bulk form registration, which can be directly compared with the other estimates under REACH

b For the 1-10 tonnage band animal testing is required only for phase-in substances that fulfil the Annex III conditions; therefore, for most substances no information requirements beyond physico-chemical properties are requested, apart from option 6 (due to measure 41)

c    Indirect impact of measure 41: 8 additional animals. See Appendix XIII for details

d    Estimated baseline consequent to Board of Appeal Decision 2 March 2017(see discussion in section 4.9).

Table 5-4: Total estimated animal use per option (in thousands):

a    Only one number is used to represent option 1, assuming 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 the registration of that substance includes

b    Weighted average

c    Estimated indirect impact of Measure 41: 4387 animals (4.3% of use in 1-10t tonnage band, 0.1% of total estimated use). See Appendix XIII for details

d    Estimated baseline consequent to Board of Appeal Decision 2 March 2017(see discussion in section 4.9).

5.6Classification and Labelling (CLP)

Depending on the changes to be made in the Annexes of the REACH Regulation (in particular Annex VI), the changes would affect not only the registration requirements as analysed above, but also the requirements under the CLP Regulation and Annex II of REACH in relation to the communication in the supply chain via Safety Data Sheets for the registered substances or certain nanoforms thereof. As expected by the main objectives of REACH, the changes would have a ‘domino effect’ with impacts on the implementation of the CLP Regulation (and subsequent regulation relying on CLP), communication in the supply chain via Safety Data Sheets in general and even in view of companies operating with substances with nanoforms in volumes of less than 1 tonne per year, as well as to the chemical safety assessment by downstream users. This is because the provisions of the CLP Regulation require the notifiers of hazardous substances to the C&L Inventory to notify to ECHA the information on the identity of the substance as required under sections 2.1 to 2.3.4. of Annex VI to REACH, based on the available information and taking into account different classification for different forms. There are no requirements to generate information, but it is expected that any available information (that will become available as a consequence of the implementation of the options examined in this impact assessment) is acted upon also under CLP.

For the purpose of this impact assessment, none of these impacts are explicitly entered under cost, as they are considered 'business as usual', i.e. standard implementation of the CLP Regulation which relates to any increase in available information and is not nanomaterial or REACH Annexes modification specific.

5.7Summary of the impacts

5.7.1Option 1

With more companies and more specialised substances with nanoforms being subject to REACH registration in the coming years, maintaining the status quo is expected to give rise to further problems similar to those already identified in the submitted registration dossiers. Mitigating factors are ECHA’s and the Member States’ evaluation processes (note that legal interpretation of some important aspects of present information requirements or the ability to request certain information under REACH are presently under appeal) and the general learning process in the private sector on what REACH entails.

Overall it is expected that the no-action scenario will maintain uncertainties among companies which could reduce the appetite in innovating in the nanomaterial sector. Coupled with question marks about whether REACH provides an adequate answer to the safety assessment needed for nanoforms this option may not only lead to a suboptimal protection level but may also be bad for business, both at the micro economic level and viewed from a broader perspective on the ability to embrace new technologies and products. The public consultation also established very neatly that the current system is not clear, hence almost all actors agree on the need to do something.

5.7.2Option 2

Under this option firms must register nanoforms and are expected to incur significant costs. The biggest cost in this option is associated with the 'characterisation' of the nanoforms and the characterisation of test samples used to fulfil information requirements for nanoforms. However, as explained in earlier parts of this impact assessment, without this information it is not possible to determine what is covered by the registration dossier, nor determine the relevance of the test results that have been used to claim the safe use of the registered substance with nanoforms. It is important to stress that the measures under option 2 are already considered as present compliance requirements by ECHA as an indispensable requirement in order to deliver the 'case-by-case' assessment broadly recommended by science. Based on the outcome of the appeal case on ECHA’s compliance check decisions (see 2.2.3 Initiatives undertaken and 4.9 Industry appeals to ECHA decisions on registration of substances with nanoforms), some of the costs may thus be incurred also under option 1 through a lengthy and resource-intensive process of ECHA requesting additional information from registrants. A key benefit of option 2 is to shorten this process, make it more effective and providing upfront clarity to registrants on what needs to be included in the dossiers when assessing nanoforms of a substance. Although SMEs may be disproportionately affected as compared to larger companies, this option requires essential information for demonstrating safe use.

The clearest benefits compared to option 1 would come from the enhanced clarity in terms of which information is required for the registration of nanoforms and the correspondingly better, targeted and quicker information to protect human health and the environment. It could also help reduce the uncertainty amongst downstream users where information suggests some reluctance to accept nanomaterials where they can be avoided. Most importantly, the overarching aim of REACH registration of demonstrating safe use will be helped by the introduction of these measures.

Generating relevant information on nanoforms or sets of nanoforms may at present, as for substances in general, still require significant use of animals, even when assumptions on use of alternative information (QSAR, read-across, grouping) are made.

Overall, it can therefore be concluded that the introduction of the measures in option 2 represent a good trade-off between the costs and the potential benefits. It has been marked with the highest efficiency and safety score in the public consultation with a majority of respondents (51%) supporting the measures in their preferred option. Furthermore, the option is coherent with the tiered information requirements foreseen in REACH (i.e. the higher the volume for which a substance is registered, the more information has to be provided).

5.7.3Option 3

REACH is already today supported by thousands of pages of guidance ranging from general ECHA guidance that has gone through a rigorous approval process involving all the stakeholders of relevance to the particular guidance to FAQs that can address very particular technical needs where doubt may arise.

Since April 2012, the ECHA guidance has already been complemented with appendices containing specific guidance of relevance to registration of nanoforms of substances, with the last update in May 2017. The foundation for this guidance was the comprehensive RIPoN that was initiated by the Commission in collaboration with ECHA in 2009, as well as further research work and implementation experience.

This impact assessment, largely backed by the views expressed by most stakeholders in the public consultation, supports the conclusion that, while better guidance always should remain a goal as such, only relying on these non-legislative initiatives may not deliver the objectives this project aims to achieve or, would only deliver with a certain delay. This being said, there will be a need for reviewing the existing guidance where it is relevant in function of the changes that may be introduced following this initiative. As has been the case before, this will be done in an inclusive manner to ensure broad consensus. This secondary introduction of revised guidance once REACH has been modified will obviously have beneficial effects on all the objectives. In terms of animal use and depending on the legal interpretation for current requirements (see discussion for option 1 and 2 above) this option would be in the range of option 2. The option is coherent with the tiered information requirements foreseen in REACH.

5.7.4Option 4

The measures in this option would introduce additional obligations over and above option 2 and what today is possible to request pursuant to REACH in a normal registration dossier except for cases where a substance has been selected for substance evaluation where additional data can be requested.

The measures are based on scientific recommendations on what is relevant to pay special attention to as regards nanomaterials, in addition to the information that is already asked for in REACH. Most measures were already identified by the RIPoN as scientific/technical recommendations and later brought forward as proposals for measures under the Nano support project.

In REACH providing data for several endpoints can be waived based on 'water solubility'. As water solubility has been identified as an inappropriate basis for waiving for many nanoforms, the consequence in this option is that all current waivers building on that information may also not be appropriate and cannot automatically be used for nanoforms. This option will thus require that registrants generate more information than today either by developing additional justification why the already existing data is relevant and adequate, or performing the test.

Furthermore there are measures that will require additional tests in lower volume bands for nanoforms compared with option 2. This has cost implications that have a relative higher weight for lower volume registration dossiers, and as such impacts SMEs more strongly. At the same time these measures are addressing some of the key loopholes of the present hazard assessment when it comes to particulate nanoforms and thus also where some of the most important health / environment benefits can be achieved. In the public consultation, this option was ranked second in terms of safety as well as efficiency. Separately, the option received high appreciation by the majority of the respondents to a separate question with regard to its efficiency as a whole. Some increase in animal use is expected, however with the purpose of ensuring that all tests (including animal tests) contribute with genuinely relevant information for the safety assessment of nanoforms of a substance.

It is arguable whether the option is coherent with the tiered information requirements foreseen in REACH as some of the measures require tests currently only foreseen at higher tonnages already for lower tonnages, e.g. where a given tests foreseen at lower tonnages cannot be used for nanoforms.

5.7.5Option 5

This option has been designed predominantly with a view to make it less costly to register substances with nanoforms, spur innovation and be of help to SMEs. This option contains two sets of measures; measures aiming to provide clarity for registrants and measures reducing information requirements and thus compliance burden.

On the cost side asking for substantially less information for nanoforms reduces the registration cost for companies and will reduce the number of animals needed for testing. However, this may have an adverse impact on the demand side due to concerns of accepting a higher risk for nanomaterials, where already today there is information pointing to the avoidance of nanomaterials by European downstream users.

The option might increase the risks to human health and environment, as in particular the second set of measures exempts nanoforms of substances from requirements applicable to other chemicals, even beyond what can be supported scientifically, so any hazards specific to nanoforms will remain undetected. This will most likely lead to more public debate about the safety of nanomaterials and further pressures at national level in some Member States to take action. In the public consultation, while option 5 scored first in terms of cost, it ranked last in terms of safety and third in terms of efficiency.

It is arguable whether the option is coherent with the tiered information requirements foreseen in REACH, as some of the measures lower the requirements for nanoforms of substances registered in a given tonnage band compared to bulk substances without sound justification.

5.7.6Option 6

In addition to the content of options 2 and 4 (for most measures), this option pushes further the separation between nanoforms and other forms of the substance in the registration dossier, which has impacts on the operation of the registration process under REACH.

On the cost side, the option will lead to significant compliance costs. The additional cost stems from significantly increased administrative cost in establishing the dossier in a way that effectively means that one dossier is a collection of two or more parallel dossiers. Additional costs are due to the need to generate more data by conducting also some specific tests on nanoforms which are not required for substances in general.

On the benefit side, the option will provide significantly more information for the protection of human health and the environment (note that much of the benefit is due to the implementation of all measures under options 2 and 4, which are also included in option 6) and thereby further reduce any doubt as to the completeness with which the conclusion of safe use has been made.

Due to the measure’s comprehensive and prescriptive nature ruling out room for adaptation and thus adding substantial additional cost on firms, the efficiency of the option, with the exception of the three measures 41 (reducing the exemption possibilities for phase-in substances provided by Annex III), combined measures 42/44 112 (requiring consideration of modifications of the nanoforms during use) and 51 (requiring a toxicokinetic screening), is considered low which was identified also by the respondents in the public consultation.

The additional measures under this option increase animal use significantly, in particular due to the identification of additional nanoforms requiring assessment and the reduced ability to rely on alternative information.

It is arguable whether the option is coherent with the tiered information requirements foreseen in REACH, as some of the measures require tests currently only foreseen at higher tonnages already for lower tonnages.

5.7.7Schematic summary

The following figure illustrates in a schematic way the main impacts of the options:

Figure 5-1: The main impacts of the options:

6COMPARING THE OPTIONS

6.1Qualitative comparison

The graph below illustrates how demonstration of safe use for nanoforms of substances would be achieved timewise by each of the options.

Figure 6-1: Demonstration of safe use by the different options:

*Taking into account the Board of Appeal's decision on the appeal A-011-2014 regarding the compliance check on titanium dioxide.

As discussed in section 4.9, on the basis of the Board of Appeal's decision in case A-011-2014, option 2 cannot be considered as covered in its entirety by existing REACH information requirements. However, the Board of Appeal concludes in its decision in case the registrant defines the registered substance broadly, the hazards of all possible forms of the substance covered by the substance definition must be addressed by that relevant toxicological and ecotoxicological information. As already indicated before it is noteworthy that:

·Option 1 would eventually reach a similar level of demonstration of safe use (but still somewhat lower) as option 2, and this would take considerable time;

·Option 2 would achieve the level set rather quickly after its implementation;

·Option 3 would achieve the same level as option 1, with a somewhat shorter delay;

·Options 4 and 6 would go beyond that level rather quickly after their implementation;

·Option 5 would result rather quickly after its implementation in a higher level of demonstration of safe use than option 1, but lower than the rest of the options.

Table 6-1 below summarises schematically the results of the analyses in qualitative terms. The scores indicate whether the impacts are positive or negative compared to option 1.

Table 6-1: Qualitative summary of the main impacts of the options, per category:

Key to the scores applied as compared to the no-change (current practice) scenario:

In conclusion, all options except option 5 would provide, in different degrees, higher protection of health and the environment than option 1 - in decreasing order: 6, 4, 2 and 3 -, but with an inverse effect on the conduct of business. Option 5 is the only option that, although having negative effects on human health and the environment, would have positive impacts on compliance costs and on SMEs; indeed, although the impacts on SMEs differ for each of the options, none of them includes specific mitigation measures, except for option 5 which provides for a reduction of the requirements for the lowest tonnage registrations where more SMEs are active. Advantages for smaller size companies are already embedded in the general tiered information requirements of REACH, which establishes different level of obligations depending on the tonnage level the substance is registered in, as well as in the fee structure that provides for lower registration fees for SMEs.

6.2The choice of the preferred option

This impact assessment has led to a better understanding of the specific measures contained in the different options and of the practical implications that implementing them would have, based on repeated discussions with stakeholders, ECHA experts and Member States. Instead of a simple choice between the options as such, it has therefore been considered more appropriate to choose a combination from the underlying specific measures of different options.

The choice has thus been made taking into account how each of the measures addresses the causes of the problem (their effectiveness) and how much they cost (their efficiency). Some measures have been left out as they would not address (sufficiently) the causes of the problem, they would be too costly or they are already covered (partially or totally) by other measures. Furthermore, in order to increase their effectiveness and their efficiency, some of the measures have been slightly modified in the preferred option compared to what was proposed initially. These modifications have been considered in the assessment of the preferred option as set out in Appendix XII. Schematically, the approach to choose the measures within the preferred option can be illustrated as follows:

Figure 6-2: The 3-step decision process to choose the measures within the preferred option:

Combining the observations from the qualitative comparison in 6.1 above and the conclusion of the Matrix study 113 that, based on a multi criteria analysis, option 2 scored significantly higher than any other option, and that there were a number of measures contained within each of the other options that deserve attention, it follows that the preferred option needs to be built on option 2 by adding specific measures from the other options.

Considering the scientific and economic evidence at hand, the commitments already made by the Commission and the increased pressures from Member States to take action to address the concerns associated with the safety of nanomaterials balanced against the interest of ensuring a competitive chemicals sector with scope for innovation and growth, the preferred option is consequently a combination of different measures. In the initial Commission proposal, to which most of the information in the report refers to as ‘the preferred option’, these are: all measures of option 2, plus six measures of option 4 (measures 10,12,13,14,16,17) and three measures from option 6 (measures 41, 42 and 51). The reasoning behind the choice of each of the measures is explained in detail in Appendix XII; the summary of the justification for the inclusion of the measures within the preferred option is as follows:

·The preferred option is based on all measures from option 2, with some modifications as explained above.

·The six measures from option 4 have been retained in the preferred option due to their appropriateness in addressing the specific nature of nanoforms of a substance and considering their efficiency; measures 16 and 17 have been modified in order to optimise the way they address nanoforms, but without placing an excessive burden on companies, in particular those registering at lower tonnages, where also SMEs are more strongly represented.

·The three measures from option 6 have been chosen for the clearly identified cost effectiveness in addressing the objectives; measure 41 would close the potential loophole for nanoforms of phase-in substances while maintaining the prioritisation aspect of Annex III; measure 42 would ensure transparency and increased confidence in the safety assessment along more complex value chains of substances with nanoforms; measure 51 would provide data on toxicokinetics of nanoforms for the chemicals safety assessment (only registrations above 10 tonnes per year), while modification ensures that any need for additional testing would be scrutinised via testing proposal examination.

Based on the discussion in the REACH committee and some further concerns expressed by the Member States on the detail of the selection of measures, the Commission modified the initial proposal, following the same overarching objectives and the 3-step process described above. For detail, see table of changes in Section 9.15.3 in Appendix XV. Beside several changes to the drafting for increased clarity but non-measureable changes in impacts on cost or animal use, the final Commission proposal as voted in the REACH committee includes also the following measures:

·Dissolution rate and dispersion stability are considered as principal physico-chemical parameters of nanoforms and are as such explicity expected for all registered nanoforms (extended measure 2).

·For low volume registrations, testing of acute toxicity of nanoforms via inhalation route rather than the default oral route (measure 11) has been promoted from the recommendation to mandatory requirement.

Impacts on SMEs have been considered in selecting the measures in the preferred option. Some of the possible additional measures were fully excluded, some others modified, to minimise adverse impacts. Some measures or elements of them (in particular in option 5) were explored to further minimise impact on SMEs.

The figure below shows how the preferred option compares to the other options in terms of demonstration of safe use for nanomaterials.

Figure 6-3: The preferred option compared to the other options:

6.3The costs of the preferred option

The assessed costs of the measures within the preferred option (both the initial and final Commission proposal) are reflected in the tables below 114 , compared to the costs for options 1 to 6:

Table 6-3: Costs of options per nanoform, with the preferred option (per tonnage band, use of alternative information methods possible) (in thousand Euro):

a The column represents the cost for a substance with one (bulk) form, which can be directly compared with the majority of REACH registration cost assessments for substances, as the usual assumption in those calculations is that one test is performed per substance per information requirement

b The costs of 1a are divided by an estimated average number of nanoforms or sets of nanoforms for a substance

c Weighted average

d Indirect impact of measure 41 on registration of bulk form may bring an estimated additional cost of 10 K EUR per nanoform of substance otherwise benefiting from Annex III exemption. Relative additional contribution 2.2% (option 6) and 8% (preferred option). 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.

Table 6-4: Grand total costs, with the preferred option (per tonnage band, use of alternative information methods possible) (in million Euro):

a Note that 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 the registration of that substance includes

b Indirect impact of measure 41 on registration of bulk form may bring an estimated additional cost of 5.8M Euro for substances otherwise benefiting from Annex III exemption. Relative additional contribution 2.2% (option 6) and 8% (preferred option). More details in Appendix XIII

c    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.

Table 6-5: Registration costs for a substance with one nanoform/set per company and per tonnage band (use of alternative information considered possible, typical cost) (in thousand Euro):

a The column represents the cost for a bulk form, which can be directly compared with the majority of REACH cost assessments for substances, as the usual assumption in those calculations is that at most one test is performed per substance

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 above

c Following assumption on registration of nanoform only, no additional indirect cost of measure 41 through registration of bulk form

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 in Appendix XIII, for costs per nanoform under different assumptions (depending on whether alternatives to testing exist or not and on different assumptions on the cost of testing) and for the Grand Total costs under different assumptions on the existence of alternatives and on the number of nanoforms).

The more comprehensive description of impact of the changes between the initial and final Commission proposal, also on animal use, is provided in the Section 9.15.3 of Appendix XV.

6.4Conclusion

Based on the above evidence and analysis, a comparison of the options in terms of effectiveness, efficiency and coherence can be summarised in the following table 6-6:

Table 6-6: Qualitative comparison of options in terms of effectiveness, efficiency and coherence:

Magnitude of impact as compared with the baseline scenario (the baseline is indicated as 0): ++ strongly positive; + positive; – – strongly negative; – negative; ≈ marginal/neutral

Option 1 scores neutrally under the assumption that industry continues applying its current interpretation of the REACH registration requirements and no particular actions by ECHA or Member States are taken to require additional data. 

Option 2 scores positively against all of the objectives. It is indeed a package of measures that shows a good ratio between what it demands and what it delivers in return.

Option 3 may deliver within the limits of the current legal obligations, but would not be as efficient as option 2, as it entails similar costs while the degree of clarity/certainty provided by the changes in the guidance would not be the same than that provided by changes in the legal text and it would take longer to implement.

Option 4 fares better in terms of effectiveness, but this comes at a cost that is not negligible. However, some individual measures display a good ratio between what they cost and what they deliver. For example, the substitution of mutagenicity test on bacteria by a test that works better for nanomaterials (measure 13) will deliver more reliable information on mutagenicity for nanoforms, while the costs are proportionate.

Option 5 induces savings but fails on demonstrating safe use and results in reduced human health and environmental protection. However, it contains measures that score high in terms of effectiveness on providing clarity on the information requirements for nanoforms of a substance and with lower costs especially for SMEs.

Option 6 would bring incremental improvements to the level of protection compared to options 2 and 4, but these improvements are, in general and in particular at lower tonnages, outweighed by the considerable extra costs imposed on firms, not least SMEs. However, it contains some individual measures that also display a good ratio between what they cost and what they deliver (for example measures 41, 42 and 51).

The preferred option (initial Commission proposal)

As evident from the above analysis, the preferred option is much more effective than options 1, 3 and 5, and it is more effective than option 2, as on top of clarifying the registration requirements, it adds specific considerations for substances with nanoforms. Its effectiveness is slightly higher than that of option 4, due to the generation of additional information specific to nanomaterials, and comparable to that of option 6. In terms of efficiency, considering that quantification and monetisation of benefits was not possible and bearing in mind the general objective of the initiative to ensure adequate demonstration of safe use for nanomaterials, in order to identify the most efficient policy option, the trade-offs between benefits and costs were assessed based on the cost-effectiveness of the most effective options. The effectiveness of options 1, 3 and 5 was considered insufficient to attain the objectives of the initiative, thus their cost-effectiveness is not further assessed. The cost of the preferred option is slightly higher than the cost of option 2 (15%), however as mentioned above, option 2 is less effective in terms of ensuring adequate demonstration of safe use. The cost of the preferred option is effectively the same as option 4 whereas its effectiveness is higher than that of option 4. Thus, the preferred option is more cost-effective than option 4. The cost of the preferred option is half that of option 6, whereas their effectiveness is comparable. Thus, the preferred option is more cost-effective than option 6. Based on this analysis, it can be concluded that the preferred option is the most cost-effective option that would attain the objective of the initiative to ensure adequate demonstration of safe use for nanomaterials.

It is to be noted that, compared to option 1, the cost increase of the preferred option would be significant (almost 14-fold). However, based on the decision of the Board of Appeal in case A-011-2014 (see discussion in section 4.9), it is not appropriate to compare the cost to option 1, even if that could be construed from many of the REACH dossiers as the level of information presently provided, but rather to what can be considered as the baseline. The average costs increase of registering a substance with one nanoform per company and per tonnage band compared to this estimated baseline is 26%. However, the cost increase in the low tonnage band is significant (79%).

The total additional cost of the preferred option as compared to the baseline is approximately 274 million EUR.

Three measures in the preferred option stand out as being mainly responsible for the cost increase compared to option 2: measure 41 addressing the exemption system introduced by REACH Annex III (essentially exempting any health and safety assessment below 10 tonnes unless a substance has already been identified as a CMR substance), measure 13 (i.e. requiring higher tonnage genotoxicity testing at lower tonnage due to the scientific unsuitability of the test method foreseen), and measure 51 with the requirement to perform a toxicokinetic screening. The first two, in particular, affect costs for the lower tonnages where most SMEs are expected to be active.

Measure 41 aims at generating an equal amount of information for non-classified substances with nanoforms in volumes below 10 tonnes. The existing exemption in REACH Annex III for non-classified substances was introduced to ease the burden for firms producing substances with a longstanding well-recorded knowledge base in relatively modest volumes. Accepting that nanoforms (even newly generated and potentially without any recorded knowledge base) may be registered together with 'phase-in' bulk form of a substance rather than being registered as new substances makes it not compatible with such an understanding. Eliminating the waiver in Annex III for substances with nanoforms completely (measure 41 as foreseen originally under option 6) would subject ‘existing’ nanoforms of substances (including those which may have been with unchanged nanoforms on the market for a long time already) to the same requirements as new nanoforms as they would have to provide the full data package. A modified measure 41 as included in the preferred option is thus nuanced and would apply only to priority substances with nanoforms (see Appendix XII for details).

Measure 13 is justified, as the genotoxicity test currently foreseen at low tonnages is scientifically unsuitable for many nanoforms. In order to acquire for nanoforms the same knowledge as for general substances, another test must thus be used – the best option for nanoforms being a test currently foreseen for the next higher tonnage band.

Measure 51 on toxicokinetic screening could be justified for nanoforms of a substance because due to their small size they may translocate to other parts of the human body than bigger particles. By knowing where the specific types of particles translocate in organisms the measure offers in return enhanced access to reliable use of alternative and non-test methods for a range of other end-point tests (however, this would be limited mostly to those foreseen in the higher tonnage bands). It should be noted that additional toxicokinetic tests may often not be needed – relevant information may be generated when some tests e.g. 28-day repeated dose toxicity testing are perfomed. Applying the measure would however ensure that this information is always available for nanoforms of a substance. It is estimated that the additional stand-alone cost for a toxicokinetics study, when one is still required, is more than offset in the higher tonnage registration band by the increased ability to reduce the cost of other testing and the increased application of alternatives such as read-across, that often times presupposes in particular toxicokinetic information.

The total cost (Grand total) of the preferred option would be about 1.3 billion EUR, i.e. 174 million EUR in addition to the costs for option 2 (which itself creates costs of 1.17 billion EUR) and 1.2 billion EUR in addition to option 1 (which itself creates costs of 97 million EUR). Based on the decision of the Board of Appeal of ECHA in case A-011-2014 (see discussion in section 4.9), which sets the baseline between Option 1 and 2, the additional cost of the preferred option as compared to the baseline is approximately 274 million EUR (increase of 26%).

As already mentioned, it is not possible to make a comparably accurate calculation on the benefits side. Two benchmarks can be established for the purpose of comparison of the overall costs and benefits of the options:

·The 2003 Extended Impact Assessment of REACH estimated health benefit for all chemicals over 30 years from its entry into force to be 50 billion EUR. The proposed changes of the REACH Annexes for registration of substances with nanoforms would allow to fully achieve the benefit potential for these substances, which can, however, not be quantified.

·The estimated costs should be considered in the context of the size of the nanomaterial market. As noted in 1.2 Uses of nanomaterials and size of the market, the global nanomaterial market value is estimated to be of roughly 20 billion EUR, which, for the EU would mean ca. 4 billion EUR if one assumes that the share of sales of nanomaterials is comparable to the share of sales of chemicals in the EU compared to global sales (i.e. ca 20%). Considering the value of the products into which the nanomaterials are incorporated, the estimation goes up to 2 trillion EUR globally by 2015, i.e. 400 billion in the EU.

The preferred option would also be the most coherent one with REACH, since it applies within the margins of the mandate and the scope of the legislation and ensures that the legislation is fit for nanomaterials as for any other chemical.

As regards the use of animals (see full Table in the Section 9.15.3 of Appendix XV), the preferred option is almost neutral (it is estimated that it uses 620 (612 + 8 due to indirect impact on registration of bulk by measure 41) instead of 614 animals per nanoform or set of nanoforms), in total 11,500(12,000-4,528 due to indirect impact on registration of bulk by measure 41) animals less than option 2. This is mainly due to the estimated positive impact of the measure regarding toxicokinetics. The use in lowest tonnages is marginally higher (16 instead of 9 animals).

Overall, the preferred option is the best ranked one among all assessed options.

The preferred option (final Commission proposal)

The qualitative analysis of the preferred option presented in the previous chapter remains. For detailed assessment and impact on cost and animal use of the changes made in the final Commission proposal please refer to Appendix XV.

Each of these changes aims at increasing the relevance of available information on nanoforms and is expected to bring benefit in the quality as well as effectiveness of safety assessment. It is however not possible to quantify this benefit.

The average cost per nanoform is estimated to be increased by EUR 31K, with a total additional cost estimate EUR 63M, a 4.5% increase as compared to the original Commission proposal. The highest relative increase (~20%) as compared to the original proposal is estimated for low tonnage registrants. The total cost for the registration of all nanoforms assumed to be on the market is estimated at 1.4 billion EUR, i.e. 337 million EUR in addition to the estimated baseline. Regarding the scenario of registration of bulk with 4 nanoforms, the cost of registration compared to baseline would increase by 27%.

In terms of animal use, on average an additional 8 animals per nanoform – 597 in total - are expected to be used under the final Commission proposal, leading to the estimated total additional use of 16 thousand animals (1.232 million, or +1.3% compared to original Commission proposal). This estimate is still within estimates for animal use under the baseline scenario, as additional animal testing is offset in the calculation by the increased ability to read-across, based on better and available non-animal supporting data.

7MONITORING AND EVALUATION

For monitoring and evaluation, the existing provisions pursuant to REACH, apply, namely: Title VI on Evaluation, Article 117 on Reporting and Title XIV on Enforcement. Based on these already existing review mechanisms ECHA in the first place and then the Commission will be able to regularly follow the effectiveness and effects of the changes. These will be reported every five years, and every three years as regards the status of implementation and use of non-animal methods and testing strategies.

A standing ECHA expert group on nanomaterials will continuously monitor technical implementation and the impact the adaptations will have. On a policy level, CARACAL and as necessary its dedicated subgroup CASG Nano will follow the uptake of revised provisions by the industry and the perception of the wider stakeholder base, in particular the Member States and NGOs. This group would also help to maximize the impact of these REACH adaptations in pursuing objectives on transparency on nanomaterials, by facilitating dissemination of public nanomaterial-related registration information.

A simple indicator of whether the changes are performing adequately will be the number of registrations of substances with nanoforms, number of nanoforms documented in the dossiers and associated consequences (e.g. nanoform specific documentation of safe use, classification), where appropriate. Another indicator will be the the quality of the information provided. The reporting by Member States on the operation of the Regulation on their respective territories and on the enforcement, according to Article 117 will also be important.

Under Article 138, REACH registration requirements are also subject to a review by 1 June 2019, including registration requirements for nanomaterials.

8GLOSSARY

Agglomerate: a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components.

Aggregate: a particle comprising of strongly bound or fused particles.

Characterisation: substance characterisation is an analytical process through which the chemical identity and composition of a substance may be demonstrated. Every manufacturer or importer intending to undertake a registration dossier must characterise their substances fully. The nature of a given substance will determine which analytical tests are appropriate and clearly, technical expertise is essential at this stage.

Chemical Safety Assessment CSA: the chemical safety assessment is carried out to demonstrate that the risks from the exposure to a substance, during its manufacture and use, are controlled when specific operational conditions and risk management measures are applied.

Chemical Safety Report CSR: the chemical safety report documents the chemical safety assessment undertaken as part of the REACH registration process, and is the key source from which the registrant provides information to all users of chemicals through the exposure scenarios.

Classification, labelling and packaging CLP: CLP of substances and mixtures is the Regulation on classification, labelling and packaging of substances and mixtures. Its main objectives are to facilitate international trade in chemicals and to maintain the existing level of protection of human health and environment. 

CMR: A substance classified in the hazard classes cancenogenicity, germ cell mutageneticity or reproductive toxicity.

ECHA: the European Chemicals Agency (ECHA), located in Helsinki, is the driving force among regulatory authorities in implementing the EU's ground-breaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern.

EMA: European Medicines Agency (EMA)

Endpoint: a biological endpoint is a direct marker of disease progression - e.g. disease symptoms or death - used to describe a health effect (or a probability of that health effect) resulting from exposure to a chemical.

Exposure to a particular chemical may lead to a series of endpoints. The most sensitive endpoint (critical endpoint) is the one that occurs at the lowest exposure level.

The derivation of a tolerable daily intake (TDI) or an acceptable daily intake (ADI) is based on the NOAEL (no observed adverse effect level) of the most sensitive endpoint and will also ensure protection against all other adverse effects.

EFSA: European Food Safety Authority (EFSA)

Form: generally the term 'form' can be understood to identify the state of a substance e.g. granular, lamellar, sheets, but is usually (and in this document) applied more widely to allow differentiation when one or more intrinsic physico-chemical properties (i.e. characterisers) differ. Form would therefore include bulk(solid) in different crystalline forms, different powders etc. A form fulfiling the nano-definition is called nanoform (see below).

Identification: Unambiguous substance identification is a pre-requisite to most of the REACH processes. Actors in the supply chain must have sufficient information on the identity of their substance. The following information on the manufactured or imported substance shall be included in the dossier in order to unambiguously identify the substance:

·Substance name and related identifiers, molecular and structural formulae, if applicable;

·Information on the composition and purity of the substance;

·Spectral data and analytical information to verify the identity and composition of the substance;

·Clear and concise description of the analytical methods.

Measure: each of the proposed actions that compose the options included within this impact assessment.

Nanomaterial: 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. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %. By way of derogation, some specific materials are always nanomaterials (graphene flakes, single wall carbon nanotubes, fullerenes), based on Commission Recommendation No 2011/696.

Nanoform: a form of a substance that falls within the scope of the definition of a nanomaterial (see above). There is a defined minimum list of characterisers that enable characterisation of (and differentiation between) nanoforms. Substance may be in many forms, include multiple nanoforms. As different nanoforms may exhibit very similar behaviour – a proposition that needs to be adequately justified – such sets of similar nanoforms can be approached jointly using same documentation requirements. Within this assessment, the term nanoform is often used to describe individual entities for which documentation requirements are considered in the different options. Such entities may be nanoforms, but may also be sets of similar nanoforms, providing that the range of characterisers for each set is well described, that the same information requirements datasets apply, and it can be assumed that if data generation is required at most one test would be required for the set.

Non-phase-in substances: all substances that do not fulfil any of the criteria for phase-in substances are considered as non-phase-in substances. Normally, non-phase-in substances have not been manufactured, placed on the market or used in the EU before 1 June 2008, unless they were notified under Directive 67/548/EEC.

Potential manufacturers and importers of non-phase-in substances have to submit an inquiry to ECHA and subsequently register the substance in accordance with REACH before they can manufacture or import the substance.

Options: in the framework of this exercise, it refers to possible amendments of REACH Annexes that will enable to ensure further clarity on how substances with nanoforms are addressed and safety of nanoforms demonstrated in registration dossiers.

Particle: minute piece of matter with defined physical boundaries.

Phase-in substances: substances which were already manufactured or placed on the market before REACH's entry into force. In accordance with REACH (Article 3(20)), phase-in substances must fulfil at least one of the following criteria:

·Substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);

·Substances that have been manufactured in the EU (including the countries that joined on 1 January 2007) but have not been placed on the EU market after 1 June 1992;

·Substances that qualify as "no-longer polymer".

Three distinct registration deadlines have been defined for these substances.

QSAR models: Quantitative structure–activity relationship models (QSAR models) are regression or classification models used in the chemical and biological sciences and engineering.

Read-across approach: “Read-across” is a technique of filling data gaps. To “read-across” is to apply data from a tested chemical for a particular property or effect (cancer, reproductive toxicity, etc.) to a similar untested chemical. The read-across technique is often applied within groups of similar chemicals assembled for assessment using either analogue approach (grouping based on a very limited number of chemicals) or category approach (grouping based on a larger number of chemicals). In an analogue/category approach, not every chemical needs to be tested for every endpoint. REACH Annex XI, Section 1.5. sets out the requirements for the application of this strategy.

Set of similar nanoforms: See nanoform above

SCCS: Scientific Committee on Consumer Safety (SCCS)

SCENIHR: The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is one of three independent non-food scientific committees which give scientific advice on consumer safety, public health and the environment. It was set up by the European Commission to consider in particular emerging issues arising from new technologies. The Committee provides opinions on emerging or newly identified health and environmental risks and on broad, complex or multidisciplinary issues requiring a comprehensive assessment of risks to consumer safety or public health and related issues not covered by other Community risk assessment bodies.

For further information on the SCENIHR see: http://ec.europa.eu/health/scientific_committees/emerging/index_en.htm

9APPENDIXES

9.1APPENDIX I: Detail of the measures

9.1.1Overview of the measures in option 2

9.1.2Overview of the measures in option 3

9.1.3Overview of the measures in option 4

9.1.4Overview of the measures in option 5

9.1.5Overview of the measures in option 6

9.2APPENDIX II: Monitoring and evaluation 

9.3APPENDIX III: Ex-post assessment of 2010 registration dossiers

We quote below the main conclusions of the JRC Nano Support report. To consult the full report, please refer to: Nano support project, JRC, 12 March 2012 http://ec.europa.eu/environment/chemicals/nanotech/pdf/jrc_report.pdf

The current REACH regulation, including information requirements, does not contain any specific provisions related to substances with nanoforms. Additionally, the current REACH guidance is not tuned to address the properties of nanomaterials. In this respect, it should be noted that a REACH Competent Authority document (CA/59/2008 rev1) has clarified that the REACH provisions apply to nanomaterials and that registrants should attempt to apply the existing guidance in their registrations. An additional complicating factor for registrants was the fact that there was no adopted EC Recommendation on the definition of nanomaterial at the time of the first registration deadline (December 2010). Moreover the REACH Implementation Projects (RIP-oNs), addressing how the REACH guidance could be updated, were not finalised by the time.

a) Identification of dossiers addressing substances with nanoforms:

According to the dossiers analysed in the report, registrants generally did not provide the constituent/primary particle size distribution needed to explicitly verify whether nanoform(s) is/are addressed by a given dossier. This is not unexpected as constituent/primary particle size distribution is not a REACH standard information requirement. On the other hand, given other information found in various places of the (…) [analysed] dossiers and expert judgment, it is believed that the 25 dossiers address (or with very high probability address) nanomaterials and/or nanoforms.

b) Analysing and assessing the information reported on ‘nano’ in those dossiers:

The information on identification/characterisation of the substances addressed by a given dossier was of varying level of detail. Some (…) explicitly mentioned that a nanoform was covered by the registration. In those dossiers a nanoform was described in a generic way.

Regarding information on other parameters relevant for identifying or characterising nanoforms/nanomaterials, it was found that about half of the dossiers reported information (in various places of the dossiers) indicating that the registered substance could be surface treated, but specific information (including analytical data) on the type and extent of such treatments was only indicated in one dossier.

Information on particle size (distribution) was given under the ‘granulometry’ endpoint and in some cases in the Substance Identity section (IUCLID section 1). The quality of the information on this endpoint varied among the different dossiers, but a number of issues with significant impacts on the assessment of nanomaterials were identified. First, the methods used were in several cases not appropriate for the measurement of particle size distributions of nanomaterials (e.g. the method does not detect particles in the 1- 100 nm range). Second, the results from several methods do not distinguish between primary particles, aggregates, and agglomerates, and registrants did not clearly and consistently make a distinction between these. Thirdly, members of a joint submission did not provide their own granulometry data. For joint submissions, normally one set of particle size data were given in the lead dossier. As particle size (distribution) depends on the manufacturing process, and is logically not amenable to read-across, the project suggests that members of a joint submission should submit their own individual granulometry data. It should be noted that under the current REACH regulation, submission of granulometry data individually by members of a joint submission would require an ‘opt out’ for this endpoint, which has some consequences in relation to fees and the possibility for prioritisation of the dossier for compliance check.

About half of the dossiers provided some additional information on other possible characterisers such as density and surface area. However, typically the description of the method used to obtain the reported data was not included.

The ambiguity in relation to the scope and identification/characterisation of nanoforms addressed by the registrations generally cascaded through the dossiers. A few dossiers did distinguish between ‘bulk’ and ‘nano’. Though the purpose was to explicitly address different forms, this was done in varying level of detail between dossiers, as well for information (CSRs and endpoints) within those dossiers and did not go to a level beyond considering ‘nano’ as one form, i.e. differences in characteristics between nanoforms of the same substance were not addressed.

Further, it was found that test data provided for physico-chemical, human health and environmental endpoints generally did not describe the test material in great detail. Further, description of sample preparation, which is an important aspect known to influence the outcome of a given study, was varying and sometimes lacking. On a positive note it seems that this situation is improving for recent (eco-)toxicological studies of nanomaterials, probably supported by the fact that scientific journals continuously raise their requirements in this respect.

It is the outcome of this assessment that, in order to address the above mentioned ambiguities, it is essential to outline in a transparent manner what is registered in terms of nanoforms and how these are addressed in terms of information requirements and assessment.

The information that needs to be generated should be focussed on demonstrating safety of the different forms that are manufactured, imported and used on the EU market. To facilitate generation of specific information there is a strong need for developing nontesting methods and for creating stakeholder consensus on the use of non-testing data. An important prerequisite for this is a clear understanding of the characteristics of the nanoforms within the relevant registration dossiers. In any case, it is important that a transparent scientific discussion is made by the registrant when using such methods for nanoforms/nanomaterials.

9.4APPENDIX IV: Ex-post assessment of the REACH impacts to companies

Large variations exist in the registrations costs of substances with nanoforms. The compliance costs are largely taken out of R&D resources in smaller companies, even if it should be noted that these costs are not fixed costs, hence after the registration has successfully been done only marginal costs will be incurred e.g. to keep the data up to date.

In cases where companies are unable to transfer the compliance cost to the product price - typically seen as a problem for SMEs - it may affect their competitiveness. This was one of the reasons why REACH changed the requirements for non-phase-in substances only to apply from 1 tonnes instead of the previous 10 kg. In addition, REACH offers a possibility for companies to apply for up to a five year registration exemption for Process and Product Oriented Research and Development. In 2012 there were only 4 SME companies out of overall 105 applications suggesting that this segment of companies may need extra help in this regard.

The nanotechnology companies were asked about potential changes to legislation. Although only 15% of those that responded had any experience with REACH, they considered, mainly due to administrative burden and time-to-market, the possible modifications of “Considering all nanomaterials as new substances”, “Chemical Safety Report with exposure assessment for all registered nanomaterials” and “Notification requirement for all nanomaterials placed on the market on their own, preparations or in articles” mainly negative for the enhancement of competitiveness and innovation, while “Simplified registration also for nanomaterials manufactured or imported in quantities of less than one tonne” a third of manufacturers considered the effect negative and a fourth indicated no effect.

REACH contribution to the development of emerging technologies

The regulatory uncertainties (e.g. leading to additional testing costs and authorisation) and lack of capital were considered the main challenges in bringing nanomaterials to market in Europe. The main REACH and CLP impacts on products of emerging technologies were considered to be administrative burden and information requirements, as well as negative effect to time-to-market and marginal cost structure.

A set of six recommendations on key policy options put forward by the consultant were:

·I Reduce uncertainties related to regulatory aspects (e.g. testing costs, authorisation);

·II Streamline information/testing requirements between sectoral legislations;

·III Substances produced by emerging technologies should not be treated more stringently than any other substances (or forms of substance);

·IV Strengthen the integration of REACH provisions into the Research & Development & Innovation processes;

·V Enhance market uptake of safer chemicals;

·VI Ensure affordable means for financing REACH compliance in Research & Development & Innovation process.

9.5APPENDIX V: Summary of the Public Consultation

9.5.1Context

The Public Consultation exercise was a targeted process that sought to gather stakeholder views relating to the Problem Definition, the Baseline scenario and the five additional substantive options under consideration. The consultation ended on 13 September 2013. The results are not binding for the Commission's decision, but can affect the decision-making process, as they give an idea of what the perception of the European society is.

Given the current limited number of registrations of substances with nanoforms under REACH, it was unlikely that respondents would be able to do more than make an estimation of cost, efficiency and impact, as it relates to the measures and options under consideration. That having been said, it appears to be the case that respondents were able to give nuanced and considered responses and that as a result, the survey presents a detailed assessment of each option and the specific measures within them. Note: term nanomaterial (and not nanoform) is used below, in consistency with the terminology applied at the time.

9.5.2Typology of respondent

A total of 142 questionnaires were submitted:

·A majority of respondents were representing an organisation (82%), the rest being individuals;

·Belgium 116 , Germany and UK were the Member States where most responding organisations are located;

·86% of the respondents considered that the current requirements for the registration of nanomaterials as unclear or very unclear.

Graph 9.5-1: Profile of the respondents

Organisations belonged to half of all Member States. In terms of geographic spread, a little over a quarter of the respondents were based in Belgium (most probably due to the location of organizations (NGOs, trade associations) representing interests of stakeholders in more than one or all MSs), with Germany being the second highest, the United Kingdom the third highest, Italy fourth and France fifth.

Graph 9.5-2: Nationality of the respondents

The organizational profile suggests that industrial/trade associations were the largest group, followed by private companies. NGOs made up one in ten respondents, with ten respondents stating themselves to be an environmental NGO. Government authorities made up 15% of respondents, with the remainder made up of consumer associations, academic bodies and other.

9.5.3Main observations

9.5.3.1Rankings

Respondents were asked a series of questions regarding the potential impact of the measures contained in each of the options on overall cost (increase or reduce the cost of compliance), efficiency (higher or lower overall efficiency of the regulatory process for nanomaterials within REACH in terms of striking the balance between appropriate demonstration of safe use and the cost to achieve it) and safety (increase or reduce the demonstration of safe use of nanomaterials). The table 9.1 below compares the overall summary results for each of the options when the assessment was done for each of the measures within the options.

Table 9.5-1: Ranking of Policy Options by Individual Measure

It needs to be stressed that respondents were not explicitly asked to rank options, but the summary table 9-1 provides interesting comparative insight. Notable points include option 2 receiving the highest ranking for both efficiency and safety, option 5 receiving both the highest ranking for cost and the lowest for safety, and option 6 receiving the lowest ranking for cost but only 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 the three options for costs is coherent, while the ranking for safety is somewhat surprising.

Table 9.5-2: Overall ranking of Policy Options

Based on a separate question regarding the efficiency of the options as a whole, option 4 received high appreciation by the majority of the respondents.

9.5.3.2Preferences

When asked about their preferences, results are slightly different: respondents as a whole opt clearly for option 5, and then 6; options 2 and 4 are the next favoured ones, being option 3 the last preference.

Considering that options 6 and 4 include measures of options 4 and 2 respectively, respondents as a whole have as a majority promoted measures under option 2 (51%), followed by measures included under option 4 (41%).

Graph 9.5-3: Options preferences

When narrowing down by type of respondent (eight different types), the results diverge as follows:

Graph 9.5-4: Options preferences by typology of respondent

By analysing the results, some common tendencies are noticed:

Graph 9.5-5: Options preferences by category

Overall, respondents can be grouped into three main categories, according to their preferences:

·Industrial and trade associations and Private companies, which opt clearly for option 5;

·Individual citizens, Government authorities, Academic/research institutions, NGOs, Consumer associations opt for option 6 followed by option 4;

·Others 117 for which the preference is more or less equally shared between options 6, 4 and 2.

9.5.4Specific observations

We report here some specific observations that derive from the breakdown of the results per category (except for Option 3).

9.5.4.1Option 2

Three measures outstand particularly among the 9 proposed ones that integrate this option with regards the negative impact they can have on costs; they refer to bioaccumulation, uses and exposure and endpoints specificities of nanomaterials.  118

Graph 9.5-6: Option 2 - Costs

Key to the scores applied as compared to the baseline scenario:

When analysed by stakeholder category industrial associations as well as private companies believe that this option would increase the cost of compliance (94% in both cases), whereas for the rest of stakeholders the option would not have any impact on the costs.

9.5.4.2Option 4

A vast majority of respondents to the public consultation (almost 80%) agree that costs of compliance with REACH regulation would increase under option 4. Industrial associations and companies see this option as particularly harmful for costs (9 out of 10 respondents consider that this option will increase costs, more than half of them believe that it will do so significantly). As for option 2, 3 of the 9 proposed measures are especially negatively perceived. 119

Graph 9.5-7: Option 4 - Costs

In contrast, this option is considered as contributing to the safe use of nanomaterials (in 63% of respondents). There is here a clear difference of perception between industry and the rest of stakeholders: two thirds of the respondents from industry consider this option as not having any impact on safety, whereas among academic institutions, consumer associations, government authorities, NGOs and individual citizens, almost all the answers recognize that it increases or significantly increases safety. The remark for safety extends to the perception of how this option impacts on efficiency.

Graph 9.5-8: Option 4 - Safety

Special mention is to be made to the measure requiring the inclusion of information on dustiness 120 , which is considered as having the most impact on safety (for 91% of the respondents) and as providing the highest increase in efficiency (74%).

9.5.4.3Option 5

For a large number of the respondents (40%), option 5 would have no impact on the costs of compliance.

The perception that this option will not have any impact on costs is especially true among industrial associations (58%). Moreover, an important percentage of these believe that the option will even help to reduce the costs of compliance (36% for Industrial associations and 53% for Companies).

Graph 9.5-9: Option 5 - Costs

Three measures out of the 21 that are contained in this option stand out for stakeholders as impacting most positively on the cost of compliance, and these refer to the reduction of methods for nanomaterial combination, the consideration of aggregates as constituent particles and the omission of mutagenicity and acute toxicity tests for lower tonnages. 121

However, the option is ranked as the lowest in terms of safety.

9.5.4.4Option 6

Graph 9.5-10: Option 6 – Costs

This option comes on a second place in the overall assessment of options by the public.

The observations are similar to those already stated for option 4: high reluctancy from industrial associations and private companies, good acceptance from the rest of stakeholders regarding its impacts on safety and efficiency.

9.5.5Assessment of the measures

9.5.5.1Option 2: relation of answers per measure

9.5.5.2Option 3: perception of the impact on safety according to companies

9.5.5.3 Option 4: relation of answers per measure

9.5.5.3Option 5: relation of answers per measure

9.5.5.4Option 6: relation of answers per measure

9.5.5.5Perception of the options in terms of: Cost, Safety and Efficiency, per category of respondent (number of received responses)