International standards compliance for hazardous chemicals, materials, or substances is important to promote workplace and customer safety and to foster the global marketability of your products while trying to minimize any litigation exposure to your company. While the hazardous nature of most nanomaterials remains the subject of ongoing scientific investigation, a new international standard concerning preparation of Safety Data Sheets (SDSs) that applies specifically to engineered and manufactured nanomaterials has been developed and will soon be published. Gaining familiarity with the standard's provisions and, if necessary, making prompt efforts to bring your company into compliance with the standard is consistent with good commercial manufacturing practices and diligent risk management.
This article will be the first of two discussing two emerging international standards for SDSs and consumer labeling for engineered or manufactured nanomaterials, or products containing engineered or manufactured nanomaterials. This article focuses on the first of two fairly recent International Organization for Standardization (ISO) standards being developed concerning nanomaterials. ISO/PDTR 13329 concerns the proper preparation of SDSs for products containing manufactured nanomaterials.1 The second developing standard is ISO/DTS 13830, concerning the labeling of manufactured nano-objects or products containing manufactured nano-objects.
ISO Preliminary Draft Technical Report
ISO Preliminary Draft Technical Report 13329 ("ISO 13329") has been voted on by the ISO membership and approved. However, it is presently undergoing a final reconciliation with some minor suggested revisions that various member bodies proposed be included in the final published technical report (the "standard"). Further, this standard is not a stand-alone document but is expressly stated to be used in conjunction with ISO 11014: (2009), which deals with the proper preparation for SDSs for chemical products.2 Both ISO 11014: (2009) and ISO 13329 take into account the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) document on hazard communication.
The objective of ISO 13329 is to provide content and consistency in the communication of information on safety, health, and environmental matters in SDSs for chemical products containing manufactured nanomaterials. It is intended to supplement ISO 11014: (2009) on the preparation of SDS generally, and in addressing the preparation of SDS for both manufactured nanomaterials and mixtures containing manufactured nanomaterials.
Any discussion of nanomaterials or chemical mixtures containing nanomaterials requires a basic understanding of certain nano-nomenclature. In 2010, ISO approved and published Technical Standard 80004—Parts 1 & 2 (2010), "Nanotechnologies—Terminology and Definitions for Nano-Objects—Core Terms and Nanoparticle, Nanofibre and Nanoplate."3 As a preliminary suggestion, anybody seeking to interpret ISO 13329 should obtain ISO 80004 Parts 1 and 2 and any amendments to those provisions to understand the defined terms that run throughout these nanomaterial-related standards.
When we refer as something being "nanoscale," we are generally referring to a material with at least one but maybe two or three external dimensions in the nanoscale range of between 1 and 100 nanometers. For purposes of ISO 13329, there are several key definitions set forth within the standard. A "nanomaterial" is any material with any external dimensions in the nanoscale or having an internal structure or surface structure in the nanoscale. An "engineered nanomaterial" is a nanomaterial that is designed for a specific purpose or function. This is in contrast to a naturally occurring nanomaterial, such as nanoscale particles found in volcanic ash, nanoscale particles in sand on the beach, or nanoscale ultrafine particle byproducts from an internal combustion engine.
An "engineered nanomaterial" is something that man has designed for a specific purpose or function. For purposes of ISO 13329, a "manufactured nanomaterial" is a nanomaterial intentionally produced for commercial purposes to have specific properties or composition. The principal distinction between "manufactured nanomaterial" and "engineered nanomaterial" is that an engineered nanomaterial could be created for use in the laboratory, but a manufactured nanomaterial is one that is produced for a specific commercial purpose in order to employ its unique physicochemical properties or other nanoscale phenomena in a commercial application.
A "chemical product" is a substance or mixture. A "substance" is defined as any chemical elements and their compounds in the natural state or obtained by any production process. A "mixture" is a mixture or solution composed of two or more substances in which they do not react. An SDS is a hazard information sheet. A "hazard class," "hazard category," and "hazard statement" are defined, respectively, as those terms are used in GHS. Finally, a "particle" is defined as a discrete element of the material, regardless of its size.4
The Standard's Provisions
Section 3 of ISO 13329 sets forth the general considerations regarding SDS preparation for all manufactured nanomaterials. First, the standard recommends that, in most cases, a manufacturer should prepare an SDS for all manufactured nanomaterials, regardless of whether or not the bulk version of the material is classified as hazardous.
There are three exceptions to the general recommendation. The first exception is if the manufacturer possesses testing or assessment results that meet requirements of competent authorities, are based on national or international standards or generally accepted scientific practices, and have indicated that the nanomaterials are nonhazardous.
The second exception is where it is not envisaged by the manufacturer that the manufactured nanomaterials can be released as discrete particles under reasonably anticipated conditions for use. This would include intended uses and reasonably foreseeable misuses—for example, if the nanomaterials have been used to form a substrate and are strongly bound in the matrix, and the matrix does not exhibit a hazard itself.
The final exception applies where a hazard class of manufactured nanomaterials is known, and it is believed that the manufactured nanomaterials are present in concentrations less than the cutoff levels identified in Table 1 of Section 4 of the standard.5
Section 3 of 13329 further provides that all information in the SDS should be written in a clear and concise manner and be prepared by a competent person who should take into account the specific needs of the user audience as far as it is known. The SDS should provide comprehensive information and/or conclusions about the data that are evaluated, making it easy for any reader to identify all of the hazards, including any associated with the material's nanostructure. Finally, in addition to the minimum information requirements of the standard, the SDS should also contain any available information relevant to the safe use of the material.
The format of a manufactured nanomaterial SDS under ISO 13329 should conform to the 16 sections specified in ISO 11014: (2009).6 If any relevant information is not found for any one of the required 16 sections of the SDS, this fact should be explicitly indicated on the SDS under the appropriate section using phrases such as "not available" or "not applicable." The SDS should not have any blanks under any of the headings. Lastly, a separate SDS should be provided for different forms of the same chemical if they pose different hazards.
Section 3.2 of ISO 13329 deals with the contents and general layout of an SDS for manufactured nanomaterials. The provisions from Section 3.2.1 regarding chemical product and company identification through Section 3.2.16 mirror the 16 required sections for an SDS as specified in ISO 11014: (2009).7 Unfortunately, a complete treatment of each of the 16 sections of the Standard is beyond the scope of this overview, but a discussion of four important subsections should help illustrate the importance of obtaining the final standard and preparing for compliance with it.
Key Components of the Standard
Subsection 3.2.2, relative to hazard identification, states that the SDS should describe "all of the hazards associated with the chemical substance or mixture for which the SDS is being prepared." The standard recommends that GHS hazard statements be used to describe hazards. The standard discourages the use of vague or potentially misleading descriptions such as "may be dangerous," "no health effects," "safe under most conditions of use," or "harmless." Finally, if the manufactured nanomaterial or mixture is classified according to the GHS, the specific hazard and category should be identified.8
Subsection 3.2.3 for the composition/information on ingredients provides that if a nanomaterial has the same Chemical Abstracts Service (CAS) number as the bulk material, then you should use that CAS number but also state that the material is a manufactured nanomaterial. Further, the standard suggests that you identify the composition of the manufactured nanomaterial(s), including stabilizing additives, and where applicable, identify any impurities to the extent that this is necessary for classification and identification of occupational health and safety measures. If the manufactured nanomaterial is surface coated, the hazard properties of the surface coating should also be evaluated. The information on the chemical composition of nanomaterial should include all ingredients, but especially those with hazardous properties, where the ingredients are present in amounts above the cutoff values given in Table 1 under Section 4 of the standard.9
Subsection 3.2.9 regarding physical and chemical properties provides that, in addition to the physical and chemical properties that are listed in Annex A to ISO 11014: (2009) at Section A.10, which includes features such as appearance of the chemical product, odor, pH, melting point/freezing point, boiling point, etc., an SDS specifying the physical and chemical properties of a manufactured nanomaterial should also include the following:
Subsection 3.2.11 regarding toxicological information states that any available toxicological information on the manufactured nanomaterial should be evaluated, and any scientifically valid conclusions from such information should be summarized in the SDS. If toxicological hazards have been identified for the bulk material, this information should also be included. If no effects are known, it should be clearly stated whether this is due to a lack of testing data or if the studies reviewed showed no effect for a particular end point. If there are any data gaps due to missing toxicological test work, then reference should be made to appropriate scientific studies and ongoing research projects.11
Section 4.1 of ISO 13329 sets forth a table that provides the general cutoff values and concentration limits for each hazard class.12 If the mixture contains manufactured nanomaterials classified as hazardous in concentrations above the cutoff values in Table 1 for the relevant hazard classes, the SDS for the mixture should be prepared as described in the standard. Attached to ISO 13329 is an "Annex" that sets forth examples of measurement methods used to assess certain physicochemical properties for manufactured nanomaterials. The standard clearly states that, due to the diversity of nano-objects, most of the listed methods in the Annex will be applicable only for a minority of the nano-objects, and only for part of the possible concentrations in which the nano-objects are presented in the toxicological tests. The standard points out that there is an urgent need for the development and validation of additional measuring methods for these parameters.13
All chemical manufacturers, distributors, importers, exporters, and transporters of manufactured nanomaterials should already be in compliance with ISO 11014: (2009) for chemical products and chemical mixtures as of the date of this publication. Insurers for these entities, company risk managers, and hazard communication professionals should be poised to obtain ISO 13329 once it is published and take immediate steps to ensure compliance with the standard for any chemical products or mixtures containing manufactured nanomaterials.
Compliance with these international standards will reduce exposure to litigation risk for alleged hazardous chemical exposure for manufactured nanomaterials and will preserve and enhance market access for your company's products around the globe.
See more information on this topic: Nanolabeling Standards May Spur Regulatory Action.
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ISO/PDTR 13329: (2011–10–21) Nanotechnologies—Safety Data Sheet (SDS) preparation for manufactured nanomaterials. This document has not yet been published for purchase from ISO.
ISO 11014: (2009) Safety data sheet for chemical products—content and order of sections.
ISO 80004 (2010), Parts 1 and 2, as amended, Nanotechnologies—Terminology and Definitions for Nano-Objects—Core Terms and Nanoparticle, Nanofibre, and Nanoplate.