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, 21020 Ispra, Italy, (2) Current affiliation: DTU Environment, 2800 Kongens Lyngby, (3) European Chemicals Agency, FI-00121 Helsinki, Finland, (4) current affiliation: COWI Parallelvej 2, 2800 Kongens Lyngby,
Denmark
Karin.aschberger@ec.europa.eu
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 1-100 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)
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.
3.1. 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 physico- chemical characterization, toxicological information, dose-response curve, occupational exposure and ecotoxicological information.
3.2. 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