REGULATORY RISK ASSESSMENT OF NANOMATERIALS IN THE EU

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1 REGULATORY RISK ASSESSMENT OF NANOMATERIALS IN THE EU Karin Aschberger 1, Nanna Hartmann 1,2, Stefania Gottardo 1, Zuzana Klöslova 3, Julia Fabrega Climent 3, Valeria Amenta 1, Frans M. Christensen 1,4 (1) Nanobiosciences Unit, Institute for Health and Consumer Protection, European Commission-JRC, Ispra, Italy, (2) Current affiliation: DTU Environment, 2800 Kongens Lyngby, (3) European Chemicals Agency, FI Helsinki, Finland, (4) current affiliation: COWI Parallelvej 2, 2800 Kongens Lyngby, Denmark Abstract In the EU the safety of nanomaterials (NMs) is regulated by a legal framework, which implicitly or explicitly (recent revisions) addresses NMs. NMs are implicitly covered by the substance definition of REACH Regulation 1907/2006 and therefore have to be registered if produced or imported 1 tonne/year per manufacturer/importer and a Chemical Safety Report has to be prepared when the volume is 10 tonnes/year. Regardless of tonnage, NMs have to be classified for dangerous properties (CLP Regulation 1272/2008) and are also regulated by sector specific legislation. Recently revised legislations on biocides, cosmetic products, and food/food contact materials include specific provisions for NMs, including a definition, specific consideration of their risk and labelling and/or reporting requirements. Guidance for NM specific risk assessment is available for industrial substances, food/feed and cosmetic products. In addition, specific working groups have been established to develop best practices of NMs safety assessment and to facilitate harmonization of assessment practices and methodologies. Keywords: nanomaterial, regulation, risk assessment, safety 1. BACKGROUND There is currently no specific EU regulation on nanomaterials (NMs), however NMs are implicitly covered by the existing EU regulatory framework on chemicals and related products [1, 2]. In addition, some recently revised pieces of legislation explicitly address NMs as a form and similar provisions are under debate for some other pieces of legislation that are currently in preparation. Several expert bodies dealing with risk assessment of NMs agree that existing risk assessment methods are to a large extent applicable to NMs [3-6]. No generalizations on the risk of NMs are however possible and therefore a case-by-case approach for the risk assessment is currently recommended. 2. DEFINITION OF NANOMATERIAL The European Commission (EC) has adopted a recommendation (2011/696/EU) on the definition of the term "nanomaterial" for legislative and policy purposes in the EU [7]. It applies to natural, incidental or manufactured material in particulate form and uses size (size range nm for more than 50% of the article size distribution) as the most important defining property of the materials; alternatively also the specific surface area can be used. So far, the Biocidal Products Regulation (EU) 528/2012/EC [8] has implemented the EC definition. Other EU laws that were adopted before the EC definition, the Cosmetics Regulation (EC)

2 1223/2009 [9] and Regulation (EU) 1169/2011 [10] on provision of food information to the consumer, apply different definitions. These legislations refer to the same size range as the EC definition, however include only intentionally manufactured (or produced) and/or insoluble or biopersistent materials and currently do not consider particle size distributions. These definitions are currently being discussed in relation to aligning with the EC definition. 3. REACH AND CLP REGULATIONS Regulation 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) does not explicitly refer to NMs, but they are implicitly covered by its substance definition, which addresses chemicals in whatever size, shape or physical state. The registration deadlines and information requirements for chemicals thus apply to NMs. Chemicals have to be registered if produced or imported 1 tonne/year per manufacturer/importer and a Chemical Safety Report has to be prepared when the volume is 10 tonnes/year. The registration deadlines are staggered and depend on the tonnages and hazardous properties: 1000 tonnes/year: 30/11/2010; 100 tonnes/year: 31/5/2013; 1 tonne/year: 31/5/2018. The 2010 deadline applied also for registration of most hazardous substances (CMR 1 ) and substances very toxic to the aquatic environment (R50/R53 2 ). NMs can be registered as a nanoform in the dossier of the corresponding bulkform of a substance or in a separate registration dossier. In addition, chemicals, and thus NMs, have to be classified for dangerous properties according to Regulation 1272/2008 on Classification, Labelling and Packaging (CLP) [11] independent of their tonnage. Different forms (particle size) of the same substance (chemical identity) have to be classified differently if their hazard profile is different Nanomaterials specific ECHA guidance Proposals for guidance on NM was developed under the REACH Implementation Projects on Nanomaterials (RIPoNs) on 1) Substance Identification, 2) Information requirements (incl. testing strategies) and 3) Chemicals Safety Assessment [12, 13]. The proposals/recommendations of the RIPoN2 and 3 projects have been incorporated in appendices, updating the 'Guidance on Information Requirements and Chemical Safety Assessment' (IR & CSA) by the European Chemicals Agency (ECHA) [14]. The guidance refers to physicochemical characterization, toxicological information, dose-response curve, occupational exposure and ecotoxicological information NANO SUPPORT project An assessment and analysis of REACH registration dossiers submitted by the 2010 deadline (NANO SUPPORT project) revealed that only 3 dossiers had selected 'nanoform' as form of the substance from the available pick-list in IUCLID 3. An additional 22 dossiers, likely to cover nanomaterials, were identified by specific searches (known NMs and free text searches). These dossiers generally provided little information to enable the identification of a NM or 'nanoform' of a substance. Registrants made some attempts to specifically address NMs in the dossiers. However, for endpoints with test data, such as human health and environment endpoints, the test materials were usually not well characterized and different (nano)forms were not clearly distinguished [15]. It should be noted that these dossiers were prepared before the EC Recommendation on the definition of a nanomaterial (2011/696/EU) [7] and ECHA guidance documents including specific recommendations for characterization, exposure and toxicological information on nanomaterials [14] were available. Meanwhile, new and updated dossiers more specifically addressing NM have become available; however still a low 1 carcinogenic, mutagenic, reprotoxic 2 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment 3 International Uniform Chemical Information Database, a software application to capture, store, maintain and exchange data on intrinsic and hazard properties of chemical substances

3 number (additional 7 since the 2010 registration deadline) of registrations have selected nanomaterials as form of the substance from the available pick-list in IUCLID. 4. COSMETIC PRODUCTS The Cosmetic Products Regulation EC No 1223/2009 [9] was the first legislation containing specific provisions for NMs including a definition (different from the EC Definition) and specific provisions for NMs. Cosmetic products containing NMs have to be notified to the EC before being placed on the market, including information on the identification of the NM, specifications related to size of particles, physical and chemical properties, the toxicological profile, the safety data specified for the category of cosmetic products, and the reasonable foreseeable exposure conditions. A specific challenge in the safety assessment of cosmetic products/ingredients which obviously concerns also NMs, is the ban of animal testing of finished cosmetic products and (combinations of) ingredients. The Scientific Committee for Consumer Safety (SCCS) has prepared in cooperation with relevant bodies a 'Guidance on the safety assessment of nanomaterials in cosmetics' [16]. This document provides guidance on the requirements for safety assessment, physicochemical characterization, exposure assessment, hazard identification and test methodologies with consideration of specific characteristics of NMs. An overview on the status of 'Alternative in vitro assays in nanomaterial toxicology' is given by Hartung and Sabbioni 2011 [17]. Specific rules apply to colorants, UV-filters or preservatives used in cosmetic products, as substance with these functions have to be approved before use in cosmetics. To this end, the SCCS has published an opinion on the use of nano-zno [18] and nano-tio2 [19] in cosmetics. The Cosmetic Products Regulation includes also an obligation to clearly indicate (label) all ingredients present in the form of nanomaterials in the list of ingredients ['titanium dioxide (nano)']. Most of the Regulation's provisions entered into force on 11 July BIOCIDES The Biocidal Products Regulation (BPR) (EU) No 528/2012 [8] includes specific provisions for NMs. Biocidal products containing NMs are not eligible for a simplified authorization procedure and the approval of an active substance for biocidal use does not cover nanoforms, except where explicitly mentioned. To approve nanomaterials as active substances and for subsequent product authorization, the test methods applied to the NMs shall be accompanied by an explanation addressing their scientific appropriateness taking into consideration the specific characteristics of each NMs. Labelling requirements apply to biocidal products and treated articles, which are defined as any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products (e.g. nanosilver in odorless socks or a paint where the biocidal activity is not a primary function). The name of all NMs contained in biocidal products and subject to condition for treated articles is required to be followed by the word 'nano' in brackets on the list of ingredients. 6. FOOD AND FOOD CONTACT MATERIALS Although not explicitly mentioned, the use of nanotechnology in food production is currently covered by Regulation No 258/97 concerning 'novel foods' and 'novel food ingredients' [20, 21]. 'Novel food' is food not consumed to any significant degree in the EU prior to May 1997 (when the first Novel Foods legislation entered into force). It comprises newly developed, innovative food, or food produced using new technologies and production processes or food which has been traditionally consumed outside of the EU. Novel food and food ingredients have to undergo a safety assessment by the European Food Safety Authority (EFSA) and an authorization procedure before being placed on the market. Previously authorized food additives are considered as new additives if there is a significant change in production methods or in the starting materials

4 used, or if there is a change in particle size, for example through nanotechnology, and therefore they need to be evaluated and authorized. The Novel Food Regulation is currently under revision. The revised EU 'Plastic Food Contact Materials' Regulation 10/2011 [10] states that substances in nanoform shall only be used if explicitly authorized and mentioned in the specifications of its Annex I (positive list). It currently lists one NM (Titanium nitride). In addition, Carbon black (primary particles of nm, aggregated to a size of nm) and amorphous silicon dioxide (primary particles of nm, aggregated to a size of 0,1 1 μm which may form agglomerates within the size distribution of 0,3 μm to the mm size) have been listed without specifically mentioning them as NM or nanoparticle. The 'Active and Intelligent Materials and Articles' Regulation 450/2009 specifies that the risk of nanoparticles in intelligent packaging systems should be assessed on a case-by case basis as regards their risk until more information is known [22]. Nanoparticles in food contact materials are not be covered by the functional barrier concept, which allows the use of certain non-authorized substances behind a functional barrier, provided they fulfill certain criteria and their migration remains below a given detection limit [22, 23]. The Food Information Regulation 1169/2011 (European Commission 2011) also explicitly addresses NM and requires labelling of ingredients present in the nano-form from December For the risk assessment of NM in food and feed, food additives, enzymes, flavourings, food contact materials, novel foods, feed additives and pesticides, the European Food Safety Authority (EFSA) has published a "Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain" [24]. It provides guidance on the physico-chemical characterization requirements and on testing approaches to identify and characterize hazards, including information from in vitro genotoxicity, ADME and repeated dose 90-day oral toxicity studies in rodents. The guidance allows for reduced information to be provided when no exposure to NM is verified by data indicating no migration from food contact materials or when complete degradation/dissolution is demonstrated with no absorption of NM as such. A systematic, tiered approach for the safety assessment of NM in food was also prepared by an expert group organized by the International Life Science Institute (ILSI) [25]. The basic process of the safety evaluation of NM used in food (as for novel-food) is a comparative approach, which makes full use of existing data on a relevant non-nano comparator [25]. 7. CONCLUSIONS AND OUTLOOK Nanomaterials safety assessment is currently explicitly addressed by legislation on food, food contact materials, cosmetic products and biocides. The revision of REACH Annexes to explicitly address nanomaterials is currently under examination taking into consideration also the results of the NANO SUPPORT project. Labelling and reporting (product register) requirements to improve transparency to consumers and traceability of NM's use have been introduced in the EU for some consumer products; some EU countries have introduced national inventories for all consumer products. An EU-wide inventory for all consumer products is under evaluation. Guidance for NM specific risk assessment is available for chemicals, food and cosmetic products. In addition, specific working groups for assessing and managing the safety of nanomaterials have been established at ECHA, EFSA. and SCCS specifically evaluates certain NMs in cosmetics. The main tasks of the ECHA's GAARN (Group Assessing already Registered Nanomaterials) and NMWG (Nanomaterials Working Group) and EFSA's Network on Risk Assessment of Nanotechnologies in Food and Feed are to develop best practices of nanomaterials safety assessment and to facilitate harmonization of assessment practices and methodologies. In addition, they should contribute to increase confidence and mutual understanding among stakeholders. ACKNOWLEDGEMENTS We acknowledge the contribution of all JRC and ECHA colleagues to the NANO SUPPORT project.

5 REFERENCES 1. European Commission, Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on Regulatory aspects of nanomaterials, 2008: Brussels, p European Commission, Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee: Second Regulatory Review on Nanomaterials, in OJ, E. Commission, Editor 2012, European Commission: Brussels. 3. SCENIHR, Opinion in the appropriateness of the risk assessment methodology in accordance with the technical guidance documents for new and existing substances for assessing the risks of nanomaterials, 2007, Scientific Committee on Emerging and Newly Identified Health Risks: Brussels. 4. SCENIHR, Risk Assessment of Products of Nanotechnologies, 2009, Scientific Committee on Emerging and Newly Identified Health Risks: Brussels. 5. EFSA Scientific Committee, The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety- Scientific Opinion of the Scientific Committee. The EFSA Journal, : p OECD, Important issues on risk assessment of manufactured nanomaterials, in Series on the Safety of Manufactured Nanomaterials 2012: Paris. 7. European Commission, Commission Recommendation of 18 October 2011 on the definition of nanomaterial, in Official Journal of the European Union, E. Commission, Editor 2011, European Union: Luxemburg. p European Parliament and Council, Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, in L , Publications Office of the European Union: Luxembourg. p European Parliament and Council, Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, in Official Journal of the European Union, E. Union, Editor 2009, Publications Office of the European Union: Luxembourg. p European Parliament and Council, Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004, in Official Journal of the European Union, E.P.a. Council, Editor p European Parliament and Council, Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, in Official Journal of the European Union2008. p Aitken, R.A., et al., Specific Advice on Exposure Assessment and Hazard/Risk Characterisation for Nanomaterials under REACH (RIP-oN 3) - Final Project, in RNC/RIP-oN3/FPR/1/FINAL2011, REACH Nano Consultation. 13. European Commission, REACH Implementation Project: Substance Identification of Nanomaterials (RIP-oN 1), I. JRC, Editor ECHA. Updated Guidance on Information Requirements and Chemical Safety Assessment for Nanomaterials /10/2012; Available from: European Commission, NANO SUPPORT Project (I) - Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of available information - Report on analysis and assessment and options for adapting REACH, E. Commission, Editor 2012, JRC, ECHA: Brussels. p SCCS, Guidance on the safety assessment of nanomaterials in cosmetics 2012, Scientific Committee on Consumer Safety: Brussels.

6 17. Hartung, T. and E. Sabbioni, Alternative in vitro assays in nanomaterial toxicology. Wiley Interdiscip Rev Nanomed Nanobiotechnol, SCCS, Opinion SCCS/1489/12 on Zinc oxide (nano form); Addendum to the Opinion SCCS/1489/12 on Zinc oxide (nano form); COLIPA S76, 2012, Scientific Committee on Consumer Safety: Brussels. p SCCS, Opinion SCCS/1489/12 on Titanium Dioxide (nano form); COLIPA S75, 2013, Scientific Committee on Consumer Safety: Brussels. p European Commission, Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX [common procedure], European Parliament and Council, Regulation (EC) No. 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, in Official Journal of the European Communities, E. Union, Editor p European Commission, Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food. Official Journal of the European Union, L135: p European Commission, Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food, in Official Journal of the European Union, E. Union, Editor 2011, Publications Office of the European Union p EFSA Scientific Committee, Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. EFSA Journal 2011, (5): p Cockburn, A., et al., Approaches to the safety assessment of engineered nanomaterials (ENM) in food. Food and Chemical Toxicology, (0): p

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