The Law of the European Union on Nanotechnologies: Comments on a Paradox

The Law of the European Union onNanotechnologies: Comments on a Paradox

Estelle Brosset

European Union (EU) law and policy on nanotech-nologies reveals what might seem like a paradox. Evenif the EU acts as a leading investor in this area, there isno regulation specifically targeting nanotechnologies.While a great number of European regulations couldbe applicable to nanomaterials, these still requirefurther examination. However, the adaptation ofcurrent provisions has not been successful so far due toterminological inconsistencies, which have not beencompletely resolved by the adoption of the recommen-dation of the European Commission on a definition fornanomaterials.

INTRODUCTION

‘There’s plenty of room at the bottom.’1 This was howRichard Feynman, an American physicist, advocatedfor scientific research on infinitely small structures at aconference in 1959. Scientific progress has since thenled to the birth of nanotechnologies. This new type oftechnology refers to a set of scientific and technologicalactivities, conducted at an atomic and molecular level,to develop2 materials and processes endowed with newfunctions and features. ‘Nanotechnologies’ not onlyrefer to the study of infinitely small structures, but alsoextend to practical applications of the knowledge gen-erated to build3 new products,4 such as nanomaterials

that constitute the basic components of manufacturedproducts.5 The qualities of different nanomaterials(e.g., optical, catalytic, mechanical, magnetic, thermal)can undergo changes, with some properties appearingand others disappearing.

Not surprisingly, these scientific and technologicaldevelopments have given rise to a remarkable level ofindustrial development. This development has beenaccompanied by a growing concern about the potentialrisks associated with nanotechnologies, given that sometechnologies are already marketed6 and physical andchemical features of these products are likely to gener-ate significant ethical risks as well as new health andenvironmental concerns. For instance, nanomaterialscould penetrate into the lungs or into the vascularsystem and thereby affect the whole body. They couldthus hypothetically lead to long-term genetic damage.Nanomaterials may also be released into the air, wateror soil, and affect our physical environment. Althoughcurrent techniques enable the measurement of theexposure to nanoparticles for specific workers in a con-fined area, knowledge about exposure to air particlesremains limited. Moreover, measuring exposurethrough food products is still difficult, and requiresa case-by-case approach.7 One thing becomes clear

1 R. Feynman, ‘There’s Plenty of Room at the Bottom’, Lecture deliv-ered at the Annual Meeting of the American Physical Society, Cali-fornia Institute of Technology (29 December 1959), found at: <http://www.zyvex.com/nanotech/feynman.html>.2 Nanotechnological activities can broadly be divided into twoapproaches. The ‘top-down’ approach has been pioneered by themicroelectronic industry. It consists of diminishing the size of anobject to nanometric proportions. This technique is currently the mostoften used one to produce microprocessors or nanomaterials. The‘bottom-up’ approach is applied in research laboratories and in thenanosciences, and involves assembling molecules in a controlledway into new objects, structures and engines.3 Nanomaterials also exist in nature, for instance, in volcanic ashes,clouds and clay, smoke of forest fires and marine salt resulting fromevaporation of sprayed marine water.4 Three main areas can be distinguished: nanoelectronics, nanobio-technology and nanomaterials. The latter refers to the precise controlof nanometric dimensions, morphology of substances or particles tobuild nanostructured materials. See: <http://www.economie.gouv.fr/cedef/dossier-documentaire-nanotechnologies>.

5 J.-P. Dupuy and F. Roure, Les Nanotechnologies: Éthique et Pro-spective Industrielle (Conseil Général des Mines, 2004), at 12.6 These include nanoproducts used for medical purposes (bandages,heart valves, etc.), as well as domestic purposes (electronics com-ponents, sports clothing and socks, toys, cooking utensils, packagingmaterials, fridges, etc.).7 The Scientific Committee on Emerging and Newly Identified HealthRisks (SCENIHR) states: ‘Health and environmental hazards havebeen demonstrated for a variety of manufactured nanomaterials. Theidentified hazards indicate potential toxic effects of nanomaterials forman and the environment. However, not all nanomaterials have toxiceffects. Some manufactured nanomaterials have already been in usefor a long time (e.g. carbon black, TiO2), showing low toxicity. There-fore, the hypothesis that smaller means more reactive, and thus moretoxic, cannot be substantiated by the published data. In this respect,nanomaterials are similar to normal chemicals/substances in thatsome may be toxic and some may not. As there is no a generallyapplicable paradigm for nanomaterial hazard identification yet, acase-by-case approach for the risk assessment of nanomaterials isstill recommended.’ SCENIHR, Risk Assessment of Products ofNanotechnologies (European Commission, 2009), found at: <http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf>, at 56.

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from this brief survey of developments and risks: thereare still many issues to resolve.

It is uncertain whether these issues are resolvedby existing law. With the exception of Frenchlaw, under which ‘nano’ is considered a legal term,8

nanotechnology-specific legal provisions are largelyabsent at various levels of regulation.9 This is also thecase for EU law. Even though the EU is a leading inves-tor in nanotechnology,10 it has not adopted nanospecificregulation. Given the inherent shortcomings of a nano-specific regime11 and given the potential scope ofexisting obligations, the European Commission recom-mended that ‘[m]aximum use should be made ofexisting regulation’.12 The absence of specific legal pro-visions on nanotechnology, therefore, does not meanthere is a legal vacuum.13 Rather, a great number ofregulations could be applicable to nanomaterials,14 andthe Commission found that ‘[o]verall, it can be con-cluded that current legislation covers to a large extentrisks in relation to nanomaterials’.15 Indeed, far from a

legal vacuum, one can speak of a ‘nanophony’ of regu-lation.16

Even though many regulations are potentially appli-cable to nanotechnology, some sort of vacuum remains.Although the Commission has suggested adaptingcurrent regulations,17 this has been difficult for severalreasons. Notably, there have been terminological diffi-culties that persist even though the Commissionadopted a recommendation on the definition of ‘nano-material’. This article explores this paradox: there is aninstitutional urgency to regulate nanomaterials andnanoproducts, and a wide variety of laws and regula-tions can potentially be applied;18 however, at the sametime, many substantive issues still need to be resolved.The apparent inflation thus masks remaining vacuums.

APPARENT LEGISLATIVEINFLATION

Inflation appears, first, in the form of a sense of insti-tutional urgency to regulate nanotechnologies, but alsoin the form of normative wealth since nanotechnologiesare covered by a great number of EU regulations.

INSTITUTIONAL URGENCYSince the European Commission published its Com-munication ‘Towards a European Strategy forNanotechnology’ in 2004,19 it has become clear thatthere is a sense of urgency among the Europeaninstitutions to act on nanotechnologies. Institutionaldocuments, including agendas, an action plan,20

recommendations21 and European Parliament

8 S. Lacour, ‘La Version Juridique du Nanomonde’, 12:7 CompteRendu de l’Académie des Sciences, Physiques (2011), 693. See alsothe French Environment Code, Article L 523.1, and the ImplementingDecree n° 2012-232 of 17 February 2012 on the Annual Declarationof Nanomaterials, 43 Official Journal (19 February 2012), at 2863.9 There is no international convention on the subject, although thereare supporters. See, e.g., K. Abbott, G.E. Marchant and D.J.Sylvester, ‘A Framework Convention for Nanotechnology?’, 38:8Environmental Law Reporter (2008), 10507; S. Dawson, ‘Proposal foran International Framework Convention to Assess the EnvironmentalRisk of Commercially Available Nanomaterials’, 15:2 University ofBaltimore Journal of Environmental Law (2008), 129. More generally,see G.E. Marchant and D.J. Sylvester, ‘Transnational Models forRegulation of Nanotechnology’, 34:4 Journal of Law, Medicine andEthics (2006), 714.10 Under its Sixth Framework Programme (2002–2006), the EuropeanCommission invested approximately €1.4 billion in more than 550projects in the field. Support for research related to nanotechnologiesincreased from €1.4 billion between 2003 and 2006 to more than €1.1billion for the 2007–2008 period. This increase will continue until theend of the Seventh Framework Programme in 2013. In addition tothese EU-wide investments, Member States have also invested innanotechnologies individually (more than €2.5 billion in 2007–2008).See Decision 1982/2006/EC of 18 December 2006 Concerning theSeventh Framework Programme of the European Community forResearch, Technological Development and Demonstration Activities(2007–2013), [2006] OJ L421.11 These shortcomings include: undifferentiated treatment of a widerange of different practices; a risk of economic paralysis inhibitingtechnological innovations; controversies related to risk management,compatibility with other legal systems; and so on.12 Commission of the European Communities Communication of12 May 2004 ‘Towards a European Strategy for Nanotechnology’,COM(2004) 338.13 S. Desmoulin, ‘Évolution du Droit et Développement des Nanotech-nologies’, 64 Revue Actualité et Dossier en Santé Publique (2008),71.14 A.-M. Ponce Del Castillo ‘La Réglementation Européenne enMatière de Nanotechnologies’, 2065:20 Courrier Hebdomadaire duCRISP (2010), 5.15 Commission of the European Communities Communicationof 17 June 2008 on Regulatory Aspects of Nanomaterials,COM(2008) 366 at 3.

16 C. Fichet, ‘Nanotechnologies dans le Domaine Médical: UnRemède Face à la Crise en Mal de Réglementation’, 180 Les PetitesAffiches (2009), 3.17 COM(2004) 338, n. 12 above, at 18.18 P. Thieffry, ‘La Prise en Compte du Risque des Nanoparticules etNanomatériaux. Information et Réglementation en amont. Mise enPerspective Juridique’, in: S. Lacour (ed.), La Régulation des Nano-technologies, Clair-obscur Normatif (Larcier, 2010), 181, at 194. Seealso S. Desmoulin, n. 13 above, at 72; and European ParliamentResolution of 24 April 2009 on Regulatory Aspects of Nanomaterials(2008/2208(INI)), found at: <http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2009-328>, atpoint Q.19 COM(2004) 338, n. 12 above.20 Commission of the European Communities Communication of 7June 2005 on Nanosciences and Nanotechnologies: An Action Planfor Europe 2005–2009, COM(2005) 243.21 Commission of the European Communities Recommendation of 7February 2008 on a Code of Conduct for Responsible Nanosciencesand Nanotechnologies Research, COM(2008) 424, at 46–52. See A.Bochon, ‘Evaluation of the European Commission Recommendationfor a Code of Conduct for Responsible Nanosciences and Nanotech-nology Research’, 8:2 Nanotechnology Law and Business (2011),117.

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resolutions22 on nanotechnologies have piled up at highspeed, most of them calling for ‘safe and responsible[nanotechnologies] development’23 as well as a regula-tory framework based on the precautionary principle.24

These documents have been accompanied by a plethoraof consultative activities,25 targeted not only at scientificcommittees and agencies,26 but also at a wider group ofstakeholders, including the public at large. In the Com-mission’s view, ‘[d]ialogue with the public is essential tofocus attention on issues of real concern rather than“science fiction” scenarios’.27 As a result, a significantamount of reports, reviews28 and public surveys29 hasemerged. European scientific committees and networkshave played a particularly active role in producing thisoutput.

Granted, a sense of urgency and a proliferation of policydocuments are general phenomena in law, but in thefield of nanotechnologies the very rapid industrialdevelopments raise fundamental questions about theability of the current regulations to deal with these

emerging technologies in ‘real time’.30 This means thatregulation has to move fast. Moreover, the EU has toremain competitive at the international level, consider-ing that other countries, such as the United States,31 arealso getting involved with nanotechnologies.

The discussion on a definition of ‘nanomaterials’ pro-vides a good example of the sense of urgency existingamong the European institutions. The European Parlia-ment was the first to declare a ‘state of emergency’ as itconsidered the discussion on nanomaterials to be bur-dened with ‘a significant lack of knowledge and infor-mation, leading to disagreement starting at the level ofdefinitions’.32 The Parliament consequently asked for adefinition before any further legislative action would beundertaken.33 In response, the Commission startedworking on a definition immediately. Hence, the Euro-pean Commission initiated an accelerated procedure toconsult the Scientific Committee on Emerging andNewly Identified Health Risks (SCENIHR) to providescientific advice on the framing of a definition of ‘nano-material’. The procedure highlighted that the Commis-sion saw an urgent need to agree on a definition: whenSCENIHR missed its deadline by a few weeks, the Com-mission decided to publish a draft recommendationbased on the provisional opinion of the Committee,without awaiting its final report.

This sense of urgency should be maintained. The Euro-pean institutions acknowledge the need for adjustingthe political goals: most of the related institutionaldocuments are provisionally formulated, as is commonin areas which are constantly evolving. Hence, regula-tory reviews, 34 as well as progress reports on imple-menting the various strategies,35 are required.

NORMATIVE WEALTHIn addition to the institutional mobilization that hastaken place, the impression of inflation is given by the

22 European Parliament Resolution of 28 September 2006 on Nano-sciences and Nanotechnologies: An Action Plan for Europe 2005–2009 (2006/2004(INI). See also European Parliament Resolution of24 April 2009, n. 18 above.23 COM(2004) 338, n. 12 above, at 6.24 For instance, in its Code of Conduct, the Commission states: ‘Giventhe deficit of knowledge of the environmental and health impacts ofnano-objects, Member States should apply the precautionary prin-ciple in order to protect not only researchers, who will be the first to bein contact with nano-objects, but also professionals, consumers, citi-zens and the environment in the course of [nanosciences and nano-technologies] research activities.’ COM(2008) 424, n. 21 above, atparagraph 4.2.25 M. Kaiser, M. Kurath, S. Maasen and C. Rehmann-Sutter, Govern-ing Future Technologies: Nanotechnology and the Rise of an Assess-ment Regime (Springer, 2009).26 Due to the cross-cutting nature of nanotechnology and the potentialscope of its application, many committees and agencies are involved.These include two scientific committees under the European Com-mission – the Scientific Committee on Emerging and Newly IdentifiedHealth Risks (SCENIHR) and the Scientific Committee on ConsumerProducts; the European Group on Ethics in Science and New Tech-nologies; the European Medicines Agency (EMA); the EuropeanChemicals Agency; and the European Food Safety Authority (EFSA).27 COM(2004) 338, n. 12 above.28 See, e.g., SCENIHR, Opinion on Risk Assessment of Products ofNanotechnologies (19 January 2009), found at: <http://ec.europa.eu/health/archive/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf>; SCENIHR, Opinion on: The Scientific Aspects ofthe Existing and Proposed Definitions Relating to Products of Nano-science and Nanotechnologies (29 November 2007), found at:<http://ec.europa.eu/health/archive/ph_risk/committees/04_scenihr/docs/scenihr_o_012.pdf>; EFSA Scientific Opinion, Guidance on theRisk Assessment of the Application of Nanoscience and Nanotech-nologies in the Food and Feed Chain (EFSA, 2011), found at: <http://www.efsa.europa.eu/fr/search/doc/2140.pdf>; The European Groupon Ethics in Science and New Technologies to the European Com-mission, Opinion on the Ethical Aspects of Nanomedicine (17January 2007), found at: <http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion_21_nano_en.pdf>.29 See, e.g., the consultation on the proposal for a definition of theword ‘nanomaterial’ (carried out in October–November 2010) at:<http://ec.europa.eu/environment/consultations/nanomaterials.htm>.

30 See also European Parliament Resolution of 24 April 2009, n. 18above, at point N.31 The first European common positions were adopted right after theUnited States enacted its first national programme on nanotechnolo-gies in 2003, providing long-term funding on nanotechnologyresearch. Since 2000, nanotechnologies have also become a policypriority for countries in the Far East, Australia and New Zealand.32 See European Parliament Resolution of 24 April 2009, n. 18 above,at point F.33 Ibid., at point 7.34 See, e.g., Commission of the European Communities Communica-tion of 3 October 2012 on the Second Regulatory Review on Nano-materials, COM(2012) 572.35 Commission of the European Communities Communication of 9June 2007 on Nanosciences and Nanotechnologies: An Action Planfor Europe 2005–2009. First Implementation Report 2005–2007,COM(2007) 505; Commission of the European Communities Com-munication of 29 October 2009 on Nanosciences and Nanotechnolo-gies: An Action Plan for Europe 2005–2009. Second ImplementationReport 2007–2009, COM(2009) 607.

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amount of current EU provisions related to nanomate-rials.36 The most well-known example is the REACHRegulation.37 Under the Regulation, a chemical sub-stance refers to ‘a chemical element and its compoundsin the natural state or obtained by any manufacturingprocess’.38 The Regulation also covers substances usedfor preparations that are ‘a mixture or solution com-posed of two or more substances’ as well as substancesfound in end products.39 It is clear that nanomaterialsare covered by this definition,40 and that every sub-stance, introduced in a given volume, under the shapeof a nanomaterial, has to be registered.41 Nanomaterialsalso have to comply with Regulation 1272/2008 onClassification, Labeling and Packaging of Substancesand Mixtures,42 provided that the criteria for classifica-tion as hazardous substance are fulfilled. That may bethe case as some nanomaterials may lead to respiratorysensitization and can be considered carcinogenic.43 TheEuropean Commission has adopted guidelines to helpeconomic operators implement these two regulationswith respect to nanomaterials.44

A review by the Commission confirmed45 the existenceof a large number of regulations covering a variety ofproducts containing nanomaterials.46 Simply put, theregulations vary with respect to the final products (e.g.,tablets, food supplies, phytosanitary products) or thespecific part of the environment they affect (e.g., water,air, soil).47 For instance, Regulation 258/97 on Novel

Foods and Novel Food Ingredients48 covers not only‘foods and food ingredients with a new or intentionallymodified primary molecular structure’,49 but also ‘foodsand food ingredients to which has been applied a pro-duction process not currently used, where that processgives rise to significant changes in the composition orstructure of the foods or food ingredients which affecttheir nutritional value, metabolism or level of undesir-able substances’.50 Consequently, foods produced withthe help of nanotechnologies are considered ‘new foods’and can be submitted to the Regulation’s assessmentprocedure.51 In addition, existing regulations on waste52

are also applicable to nanowaste. ‘Waste’ refers to ‘anysubstance or object which the holder discards orintends or is required to discard’.53 This definition isrelated to the behaviour of the waste holder, and isneutral with respect to the physical characteristics ofwaste, including its nanoparticular characteristics.Therefore, waste regulations are also applicable tonanowaste.54

However, there are still many unresolved issues whenapplying these various laws and regulations to nano-technologies.55 For instance, how can it be demon-strated that food produced using nanotechnologicalprocesses or with nanomaterials as ingredients are dif-ferent from regular foods?56 How can the Waste Direc-tive apply its well-known dangerous/non-dangerousproducts distinction when, on the one hand, nanoma-terials do not produce waste per se,57 and, on the otherhand, the listed dangerous properties do not rely onproduct size?58 These questions point to the difficulty of36 N. Hervé-Fournereau, ‘La Régulation des Nanotechnologies: Des

Normes Techniques aux Normes tout Court ou la Nébuleuse Norma-tive’, in: S. Lacour, n. 18 above, 43, at 67.37 Regulation 1907/2006/EC of 18 December 2006 Concerning theRegistration, Evaluation, Authorisation and Restriction of Chemicals(REACH), [2006], OJ L96/267. For a discussion of the Regulation,see: E. Brosset, ‘Le Nouveau Règlement Communautaire surles Substances Chimiques (REACH)’, 1 Revue Juridique del’Environnement (2008), 5.38 Regulation 1907/2006/EC, n. 37 above, Article 3.39 Ibid., Article 7.40 COM(2008) 366, n. 15 above, at 2.1.41 E. Juet, S. Lacour and N. Leca, ‘Les Nanotubes de Carbone dansREACH: Les NTC Sont-ils des Substances Chimiques comme lesAutres ?’, in: S. Lacour, S. Desmoulin-Canselier and N. Hervé-Fournereau, De l’Innovation à l’Utilisation des Nanomatériaux, leCadre Normatif des Nanotubes de Carbone (Larcier, 2012), 228.42 Regulation 1272/2008 of 16 December 2008 on Classification,Labelling and Packaging of Substances and Mixtures, [2008] OJL353/1.43 Regulation 1907/2006/EC, n. 37 above, Article 36.44 See: <http://ec.europa.eu/enterprise/sectors/chemicals/reach/nanomaterials/index_en.htm>.45 COM(2008) 366, n. 15 above.46 N. Hervé-Fournereau, ‘La Sécurité Sanitaire et Écologique vis-à-visdes Nanomatériaux’, Cahiers Droit, Sciences et Technologies (2008),59, at 60.47 See, e.g., G. Van Calster, ‘Regulating Nanotechnology in the Euro-pean Union’, 15:8–9 European Environmental Law Review, (2006),238. See also J. D’Silva, ‘Comparative Analysis of the Regulation ofNanomedicine in the European Union and United States’, in:S. Lacour (ed.), Des Nanotechnologies aux Technologies Émer-gentes (Larcier, 2013), 163.

48 Regulation 258/97/EC of 27 January 1997 Concerning NovelFoods and Novel Food Ingredients, [1997] OJ L43/1.49 Ibid., Article 1.2(c).50 Ibid., Article 1.2(f).51 Under the assessment procedure, the competent body of theMember State which receives an application must make an initialassessment and determine whether or not an additional assessmentis required. If neither the Commission nor the Member States raise anobjection, and if no additional assessment is required, the MemberState informs the applicant that a product may be placed on themarket. In other cases, an authorization decision is required. Thisdecision is adopted in accordance with the measures proposed by theCommission within the Committee on Food Safety and AnimalHealth. Ibid., Article 6.52 Directive 2008/98/EC of 19 November 2008 on Waste and Repeal-ing Certain Directives, [2008] OJ L312/3.53 Ibid., Article 3.54 A. Langlais-Hesse, ‘L’Analyse du Cycle de Vie des Nanomatéri-aux’, in: S. Lacour, n. 18 above, 225, at 241.55 See G. Van Calster, n. 47 above.56 S. Naomi, ‘What’s Cooking? From GM Food to Nanofood: Regu-lating Risk and Trade in Europe’, 11:2 Environmental Law Review(2009), 97.57 For instance, domestic waste that could contain nanomaterialswould not be able to be sent to the toxic waste sector and are at riskof being incinerated with regular waste. See C. Verdure, ‘Nanotech-nologies et Déchets: De la Dissonance à l’Unisson?, in: S. Lacour,n. 18 above, 249.58 Ibid. See also A. Langlais-Hesse, n. 54 above, at 229ff.



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adapting secondary legislation to nanotechnologies,and show that there may, after all, still be legalvacuums.

THE PERSISTENCE OFLEGAL VACUUMS

Despite the sense of institutional urgency and wealth ofnorms applicable to nanotechnologies, many vacuumsremain in EU law. First of all, the adjustment of currentprovisions to nanotechnologies has often not been suc-cessful. Moreover, there are various inconsistenciesrelating to the definition of ‘nanomaterials’, which havenot yet been resolved by the Commission’s Recommen-dation on a definition.59

A SCARCITY OF NANOSPECIFICPROVISIONSAs noted before, the Commission has advocated for anapproach to nanotechnology regulation that consists ofapplying existing rules rather than introducing new,nanospecific provisions. The upshot has been thatinconsistencies between these existing provisions withrespect to nanotechnologies have come to the fore. Inresponse to pressure from the European Parliament,60

the Commission conceded the need for adjustment ofregulations in a review of existing provisions on nano-technologies.61

Some of these adjustments have already been carriedout. Notably, the first specific mention of nanomateri-als appeared in the 2009 Cosmetics Regulation.62 Thischange was far from symbolic; the reference to nano-materials introduces particular obligations and hasprovoked a significant debate among policy makers. Itis, first of all, an obligation of notification. In additionto general notification obligations for all cosmetic prod-ucts,63 products using nanomaterials are subjected toadditional notification obligations, and the responsibleperson64 has to include in this notification all the infor-

mation listed in the Regulation.65 If necessary for safetyreasons, this information can be used by the Commis-sion to modify Annex II of the Regulation on prohibitedsubstances in cosmetic products and Annex III onrestricted substances.66 The Regulation also includeslabelling provisions for any nanomaterial ingredients.67

Several nanospecific provisions have also been adoptedin the area of food regulation.68 These include, forexample, obligations of authorization in the area ofplastic materials and articles intended to come intocontact with food.69 This means that substances innanoform can only be used if they are explicitly autho-rized and included in an EU list of authorized sub-stances. Other specific provisions can be found inDirective 2011/65 on the Restriction of the Use ofCertain Hazardous Substances in Electrical and Elec-tronic Equipment,70 which states in a recital that:

As soon as scientific evidence is available . . . the restrictionof other hazardous substances, including any substances ofvery small size or with a very small internal or surface struc-ture (nanomaterials) which may be hazardous due to prop-erties relating to their size or structure, and theirsubstitution by more environmentally friendly alternativeswhich ensure at least the same level of protection of con-sumers should be examined. To this end, the review andamendment of the list of restricted substances in Annex IIshould be coherent.71

59 Recommendation 2011/696/EU of 18 October 2011 on the Defini-tion of Nanomaterial, [2011] OJ L275/38.60 See European Parliament Resolution of 24 April 2009, n. 18 above,at point 3.61 COM(2004) 338, n. 12 above, at 18.62 Regulation 1223/2009 of 30 November 2009 on Cosmetic Products(Recast), [2009] OJ L342/59. Nanomaterials are frequently used forcosmetic products. Titanium dioxide and zinc oxide are used in UVfilters; nanosilver is used in some toothpastes for its antibacterialproperties; and fullerenes are often used as anti-ageing products.63 Ibid., Article 13(f).64 The Regulation specifies the ‘responsible person’ in Article 4: ‘Fora cosmetic product manufactured within the Community, and notsubsequently exported and imported back into the Community, themanufacturer established within the Community shall be the respon-sible person . . . . For an imported cosmetic product, each importer

shall be the responsible person for the specific cosmetic product heplaces on the market.’ Ibid., Articles 4.3 and 4.5.65 Ibid., Article 16.3.66 Ibid., Article 16.5 and Annexes II and III.67 Ibid., Article 19.1(g)(ii). See also Article 16.10, which indicates that:‘By 11 January 2014, the Commission shall make available a cata-logue of all nanomaterials used in cosmetic products placed on themarket, including those used as colorants, UV-filters and preserva-tives in a separate section, indicating the categories of cosmeticproducts and the reasonably foreseeable exposure conditions. Thiscatalogue shall be regularly updated thereafter and be made publiclyavailable.’68 See, e.g., Regulation 1333/2008/EC of 16 October 2008 on FoodAdditives, [2008] OJ L354/31. According to Article 12 of this Regula-tion: ‘When a food additive is already included in a Community list andthere is a significant change in its production methods or in thestarting materials used, or there is a change in particle size, forexample through nanotechnology, the food additive prepared bythose new methods or materials shall be considered as a differentadditive and a new entry in the Community lists or a change in thespecifications shall be required before it can be placed on the market.’69 See Regulation 10/2011/EU of 14 January 2011 on Plastic Mate-rials and Articles Intended to Come into Contact with Food, [2011] OJL12/1, Article 9.2. To date, authorization is only required for titaniumdioxide nanoparticles that can be used as additives (or polymerproduction aids), for example, in plastic bottles for enhancing theirtransparency. See also Regulation 1169/2011/EU of 25 October 2011on the Provision of Food Information to Consumers, [2011], OJ L304/18, Article 18, which states that: ‘All ingredients present in the form ofengineered nano-materials shall be clearly indicated in the list ofingredients. The names of such ingredients shall be followed by theword “nano” in brackets.’70 Directive 2011/65/EU of 8 June 2011 on the Restriction of the Useof Certain Hazardous Substances in Electrical and Electronic Equip-ment, [2011] OJ L174/88.71 Ibid., at recital 16.



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However, adjustments of existing provisions are still farfrom covering the whole array of nanotechnologicalactivities. For instance, Directive 2011/65 simply refersto ‘nanomaterials’, but does not introduce a bindingobligation. Moreover, notwithstanding the EuropeanParliament’s efforts,72 the sole provision in the Directiveis the inclusion of a review clause that could limit theuse of nanomaterials in the future. The fact that theterm ‘nanomaterials’ is only in brackets in the text isactually significant!

Moreover, several proposed amendments failed to beadopted. For instance, during the negotiations on theREACH Regulation, the European Parliament73 advo-cated for the inclusion of specific provisions on nano-particles. Those amendments were, however, rejectedin the final draft. Apart from some technical and mid-term adjustments,74 no substantial revisions have beenmade – not even on the issue of most concern withrespect to nanomaterials: the thresholds established bythe Regulation.75 Those thresholds76 are irrelevant tonanotechnologies as long as the average total produc-tion of nanomaterials per producer seems to reachapproximately 750 kilograms a year.77 Even if nanoma-

terials would fall under the ambit of the Regulation,they would still be exempted from its core provisions inpractice. Although the Regulation provides for generalprocedures – an authorization procedure and a restric-tion procedure78 – not related to the aforementionedthresholds (meaning that they also apply to nanomate-rials), the scope of those procedures does not cover thewhole range of nanomaterials. It would thus be morepractical to consider a lower threshold or to think aboutadding relevant criteria79 to make the Regulation moreclearly applicable to nanomaterials. This would alsobetter reflect the position of key stakeholders.80

However, this has not yet happened. One of the diffi-culties is that adjustments for nanomaterials imply theexistence of measurement methods and risk assess-ments that would facilitate compliance with the REACHprovisions on evaluation and registration procedures –but this is far from being the case.81 Furthermore,adjustments inevitably involve determining the scopeof new provisions, which involves defining what isconsidered a ‘nanomaterial’.

THE PERSISTENCE OFTERMINOLOGICALINCONSISTENCIESThe heading of this section may appear outdated: aftera long and intensive process, the Commission adopted

72 There have been numerous amendments. For instance, the Par-liament suggested that ‘there is increasing scientific evidence thatsome carbon nanotubes may behave like asbestos fibres and thushave severe impact on human health. The same applies to nanosilverparticles which may end up in the environment and may have severeimpacts on soil, aquatic and terrestrial organisms.’(Amendment 6).Therefore, it has advocated for their inclusion in Annex IV on hazard-ous substances (Amendment 88). See Report on the Proposal for aDirective of the European Parliament and of the Council on theRestriction of the Use of Certain Hazardous Substances in Electricaland Electronic Equipment (15 June 2010, 2008/0240(COD)), foundat: <http://www.europarl.europa.eu/sides/getDoc.do?language=EN&reference=A7-0196/2010>.73 Recommendation for Second Reading on the Council CommonPosition for Adopting a Regulation of the European Parliament and ofthe Council concerning the Registration, Evaluation, Authorisationand Restriction of Chemicals (REACH), A6-0352/2006 (13 October2006), found at: <http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+REPORT+A6-2006-0352+0+DOC+XML+V0//EN>, Amendment 24.74 Regulation 1907/2006/EC, n. 37 above, Annexes IV and V, containlists of exemptions to the Regulation for substances related to theirintrinsic properties. However, amendments of Annex IV have sparkeda debate at the nanolevel: three substances have been removed fromthe Annex and cannot be exempted anymore because they can beconsidered hazardous at the nanolevel (e.g., carbon and graphite).Regulation 987/2008 of 8 October 2008 Amending Regulation 1907/2006 on the Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH) as regards Annexes IV and V, [2008] OJ L268/9.75 There is a one-tonne threshold for the application of the registrationprocedure (Regulation 1907/2006/EC, n. 37 above, Article 6.3) and aten-tonne threshold for the obligation to carry out a chemical safetyreport (ibid., Article 14.1).76 See also E. Vergès, ‘Régime Juridique d’Identification et de Suivides Nanoparticules et des Nanomatériaux: Enjeux et Obstacles Liésà la Maîtrise Sociale de l’Infiniment Petit’, in S. Lacour, n. 18 above,209, at 217.77 D. Gazagne, ‘Le Cadre Juridique Européen et Français desNanomatériaux: Un Défi Réglementaire’, 37 Journal Gazette duPalais (2010), 25.

78 These include the Regulation’s authorization requirement adoptedfor specific substances listed in Annex XIV, which includes carcino-genic, mutagenic or toxic substances of a first (confirmed toxicity) andsecond category (strong presumption of toxicity) and substances, thatare persistent, bioaccumulative and toxic or very persistent and verybioaccumulative (known as PBT and vPvB), but also other sub-stances ‘giving rise to an equivalent level of concern’ which could be,case by case, included in the Annex. See also Regulation 1907/2006/EC, n. 37 above, Article 68, which does not solely target the mosthazardous substances, but covers any substance irrespective of theirtonnage: ‘When there is an unacceptable risk to human health or theenvironment, arising from the manufacture, use or placing on themarket of substances, which needs to be addressed on aCommunity-wide basis, Annex XVII shall be amended . . . by adopt-ing new restrictions, or amending current restrictions in Annex XVII,for the manufacture, use or placing on the market of substances ontheir own, in preparations or in articles. . . . Any such decision shalltake into account the socio-economic impact of the restriction, includ-ing the availability of alternatives.’79 Other physical (specific surface, raised or smooth area, structure,etc.) or chemical (molecular structure, composition, surface chemis-try, etc.) properties also constitute essential characteristics of nano-materials.80 The European Trade Union Confederation (ETUC), for instance,advocated different thresholds and/or different units being used forthe recording of nanomaterials within the REACH Regulation. SeeResolution on Nanotechnologies and Nanomaterials, ResolutionAdopted by the ETUC Executive Committee during its Meeting inBrussels, on 24 and 25 June 2008, found at: <http://www.etuc.org/a/5163>.81 SCENIHR, Modified Opinion (after Public Consultation) on theAppropriateness of Existing Methodologies to Assess the PotentialRisks Associated with Engineered and Adventitious Products ofNanotechnologies (10 March 2006), found at: <http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf>.



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Recommendation 2011/696 on the Definition of Nano-material.82 The definition, covering ‘natural, incidentalor manufactured materials including particles inagglomerates or aggregates’,83 has a very broad scope. Itdefines a nanomaterial as ‘a material containing . . .where, for 50% or more of the particles in the numbersize distribution, one or more external dimensions is inthe size range 1 nm-100 nm’.84 In doing so, the defini-tion puts an end to the debate on high density amongpolicy makers.85 The definition is the result of a politicalcompromise in which several criteria were combined.The main criterion is ‘the size of the constituent par-ticles of a material, without regard to hazard or risk’.86

Acknowledging scientific reports stating that therewould not be a single property that is able to describethe new effects or functions appearing at thenanolevel,87 the Commission opted for a seeminglymore stable criterion: a size criterion using upper andlower thresholds.88 In addition, the definition adds acumulative criterion to this central criterion, meaningthat a majority (at least 50%) of particles of the materialis nano-sized.

However, finally Commission’s Recommendationoffers more than a single solution: it provides a wholerange of them. To foster compromise, but also to inte-grate the varying physical realities of nanomaterials(which can comprise powder suspension, solution, gel,agglomerates, aggregates, etc.), the definition includesseveral alternative criteria. The first alternative links tothe criterion of size distribution, which cannot beapplied to all materials – in particular, solid materials,agglomerates and aggregates. In those cases, the Rec-ommendation suggests an alternative criterion –namely the surface area by volume: ‘Where technicallyfeasible . . . compliance with the definition in point 2may be determined on the basis of the specific surfacearea by volume . . . greater than 60 m2/cm3.’89 The

second alternative provided by the Recommendationsuggests that ‘[i]n specific cases and where warrantedby concerns for the environment, health, safety or com-petitiveness the number size distribution threshold of50% may be replaced by a threshold between 1 and50%’.90 However, the reasons for which numeric distri-bution could be lowered (environment, health, safety,competitiveness) are rather ambiguous and general.91

Consequently, they can lead to many different interpre-tations. The size criterion is no clearer than the previ-ous one (on distribution), given that the lowerthreshold could be crossed for some materials, such asfullerenes, graphene flakes and single wall carbonnanotubes,92 and given that the upper limit is not com-pletely scientifically accurate.93

Hence, even though the Commission argued that otherdefinitions were insufficiently precise, the Europeandefinition does not radically depart from them.94 It isthus not surprising that the definition did not make amajor impact on ongoing legislative activities. Forinstance, Regulation 1169/2011 on the Provision of FoodInformation to Consumers 95 does not use the Commis-sion’s definition but states that:

‘[E]ngineered nanomaterial’ means any intentionally pro-duced material that has one or more dimensions of the orderof 100 nm or less . . . including structures, agglomerates oraggregates, which may have a size above the order of 100 nmbut retain properties that are characteristic of thenanoscale.96

Although the definition uses a size criterion, it is lessdeterminate than the Commission’s definition: it setsno minimum threshold and the upper threshold of100 nm can, in some cases, be crossed. Moreover, thereis no reference to a numerical distribution (e.g., morethan 50%). Ultimately, the definition refers to proper-ties at the nanolevel ‘that are different from those of thenon-nanoform of the same material’.97 However, no

82 Recommendation 2011/696/EU, n. 59 above.83 Ibid., at recital 4. See also ibid., at point 4 for the definitions of‘particle’, ‘aggregate’ and ‘agglomerate’.84 Ibid., at point 2.85 For an overview of different proposals, see European ParliamentResolution of 24 April 2009, n. 18 above, at point F. See also <http://chemicalwatch.com/7163/eu-commission-directorates-argue-over-nano-definition>.86 Recommendation 2011/696/EU, n. 59 above, at recital 4.87 G. Lövestam et al., Considerations on a Definition of Nanomaterialfor Regulatory Purposes (Joint Research Centre of the EuropeanCommission, 2010), at 29.88 The upper limit is relevant given the proven ability of smallersized particles to cross biological boundaries and affect the naturalprotection of tissues and organs. The lower threshold of 1 nm ismotivated by the necessity to distinguish nanomaterials from atomsand molecules.89 Recommendation 2011/696/EU, n. 59 above, at point 5. However,‘[a] material should be considered as falling under the definition inpoint 2 where the specific surface area by volume of the material isgreater than 60 m2/cm3’. Ibid. This means that if the results of thesize-distribution analysis indicate that the material is a nanomaterial,this finding will prevail over the volume analysis.

90 Ibid., at point 2.91 In particular, the inclusion based on competitiveness in point 2 isstrange: what is the economic advantage of defining a material as‘nano’ when this qualification will necessarily lead to additionalregulations?92 Recommendation 2011/696/EU, n. 59 above, at point 3.93 Ibid., at recital 8, in which the Commission acknowledges that‘there is no scientific evidence to support the appropriateness of thisvalue (100 nm)’ and that ‘[t]he use of a single upper limit value mightbe too limiting for the classification of nanomaterials and a differen-tiated approach might be more appropriate’.94 See, e.g., the definition by the International Organisation forStandardisation (ISO), which the Commission departs from: ‘TheInternational Organisation for Standardisation defines the term “nano-material” as “material with any external dimensions in the nanoscaleor having internal structure or surface structure in the nanoscale”. Theterm “nanoscale” is defined as size range from approximately 1 nm to100 nm.’ Ibid., recital 9.95 Regulation 1169/2011 of 25 October 2011 on the Provision of FoodInformation to Consumers, [2011] OJ L304/18.96 Ibid., Article 2(t).97 Ibid., Article 2(t)(ii).



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such reference to typical properties can be found in theCommission’s Recommendation on the definition of‘nanomaterial’. The non-application of the Commis-sion’s definition is not a good sign for its credibility.

CONCLUSION

After ten years of institutional urgency and legislativeefforts, which can perhaps be characterized by an over-regulation of nanotechnologies, EU law in this field isstill at an embryonic stage. Only a few provisions targetnanotechnologies specifically. Moreover, the definitionof ‘nanomaterial’ suggested by the European Commis-sion, which could be considered as a turning point is,from my point of view, still ambiguous. However, thisobservation is not restricted to the EU – legal frame-works in other jurisdictions are also still characterizedby a piecemeal approach. Admittedly, nanotechnolo-gies’ political status remains to be clarified.98 Hence, theadoption of a legal framework still constitutes a chal-lenge both within and outside of the EU.

Estelle Brosset is senior lecturer in Public Law and Euro-pean Law at the University of Aix-Marseille (France),Member of the Center of Research and Studies on Inter-national and European Law, and holder of the JeanMonnet Chair. This article is based on research carriedout for the project ‘Nano-Norma-De l’innovation àl’utilisation: quel cadre normatif pour les nano-objets’.More information on the project can be found at:<http://www.nanonorma.org>.

98 See S. Lacour, n. 8 above.



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Documents

The Law of the European Union on Nanotechnologies: Comments on a Paradox