Expert Commentary

Nanolabeling Standards Should Spur Regulatory Action

Product labeling is an important risk management tool to alert consumers to a latent hazard inherent with the use or disposal of a product that cannot be eliminated by design or manufacturing improvements and also to reduce legal exposure. Labeling may also educate a consumer about the composition of a product to meet consumer expectations for proper disclosure and to promote informed decisions about whether to purchase a product. Labeling may be required by industry consensus, national or international standards, or governmental regulation.


Nanotechnology
January 2013

Global concerns about the safety of manufactured nanomaterials have led to the development of international consumer product labeling guidance, which will likely be published in 2013. Gaining familiarity with such guidance for proper consumer product labeling of manufactured nanomaterials, or products containing them, is consistent with good commercial manufacturing practices and diligent risk management.

This article is the second of two discussing two emerging international standards for Safety Data Sheets and consumer labeling for engineered or manufactured nanomaterials, or products containing engineered or manufactured nanomaterials. (See the first article, published in October 2012: International Standards for Safety Data Sheets Are Coming for Manufactured Nanomaterials.) This article focuses on the second of two fairly recent International Organization for Standardization (ISO) documents being developed concerning nanomaterials.

Evolution of ISO/DTS 13830

The ISO draft technical specification No. 13830 (ISO/DTS 13830) concerns the labeling of manufactured nano-objects (MNOs) or products containing manufactured nano-objects (PCMNOs).1 ISO/DTS 13830 has not yet been approved (in fact, the draft technical specification was initially put up for a ballot in January of 2011 and was voted down) and is still in the process of final debate and further revision by ISO member bodies in Technical Committee 229 Nanotechnologies.2 This article is intended to summarize pertinent provisions of this draft technical specification and will be updated once the final specification document is voted on by the ISO membership and approved.

Prior to January 2011, ISO/DTS 13830 had been a joint document created by the European Committee for Standardisation ("CEN") Technical Committee 352 Nanotechnologies and ISO TC–229 Nanotechnologies. Since the down vote in January 2011, ISO TC–229 Nanotechnologies has assumed full responsibility for developing this technical specification under the leadership of France.

The United States, as an ISO member body in TC–229, solicited comments from members of its Working Group 3 of the US TAG in July and August of 2012 on ISO/DTS 13380. On August 31, 2012, the US Technical Advisory Group (TAG) submitted its comments for suggested revisions to the existing draft technical specification document. All other interested member bodies were doing the same, and those comments were tabulated and circulated for reconsideration by all member bodies last fall. More feedback was provided by the US TAG on the proposed comments from all member bodies at that time.

Although ISO/DTS 13830 has further debate and revision to undergo before it will be in a draft form amenable to a new ISO member ballot, this will likely occur in 2013. It is important that stakeholders be aware of the draft provisions of the technical specification now because these requirements may be incorporated in substance into foreign regulatory schemes even before ISO/DTS 13830 is approved. This is largely because a substantial number of the ISO member bodies already voted in support of the earlier document as it existed in January 2011. It stands to reason that, in certain countries, the political pressure to adopt the labeling requirements in this draft technical specification could become law or could at least become part of any applicable local industry standard adopted for use in those countries, even before ISO/DTS 13830 is finally approved by ISO.

ISO/DTS 13830's Provisions and Significance

ISO/DTS 13830 has slightly differing terminology from ISO/TR 13329: 2012 that was discussed in our last article in October 2012.3 While ISO/TR 13329 talked in terms of engineered nanomaterials and manufactured nanomaterials, ISO/DTS 13830 speaks in terms of MNOs and PCMNOs.4 Again, a "nano-object" is defined as a material with one to three external dimensions in the nanoscale range of 1 to 100 nanometers.5

The purpose of ISO/DTS 13830 is to encourage a standardized approach to voluntary labeling of MNOs and consumer PCMNOs and to provide guidance on the use of specific terms in this type of labeling.6

ISO/DTS 13830 expressly does not supersede or substitute for any applicable legal requirements and specifies that local law in a specific country or region would otherwise control the labeling of these products.7 Finally, ISO/DTS 13830 expressly states that it does not apply to naturally occurring nano-objects, and also that consumer products containing nano-objects that are incidental are also outside the scope of the standard.8

There is an existing safety standard that governs the graphic display and layout of consumer product safety labels in the United States, which is called American National Standards Institute (ANSI) Z535.4. ANSI Z535.4 is a consensus industry standard document. It is used routinely as a basis for establishing the standard of care in consumer product safety litigation in the United States. In contrast, ISO/DTS 13830 merely provides "guidance" on when a manufacturer ought to provide a label for MNOs or PCMNOs. Although ISO/DTS 13830 is not a legal document per se, once approved, it may also give rise to legal standards of care in U.S. domestic litigation, and it may have the de facto effect of law in places like the European Union, where even the 2010 draft was strongly supported "as is."

The guidance on the format and content for labels applies to products sold to consumers that are MNOs or are PCMNOs that are unbound and could be released as free nano-objects under reasonably foreseeable conditions for both use and disposal, or are either MNOs or PCMNOs that contain a significant level of incidental nano-objects that could similarly be released during use or disposal.9 Section 5 of ISO/DTS 13830 recommends that the prefix "nano" only be used in product labeling and circumstances where (1) the product contains MNOs, including their agglomerates, and (2) the product displays nanoscale phenomena that are not commonly shown for that type of product.10 This means that the phenomena must be attributable to the use of the nano-objects, as opposed to and distinguishable from the normal properties of the individual atoms, molecules, or other bulk material substances that the nano-objects may be derived from.11

Label Statement

One of the most important sections of ISO/DTS 13830 is Section 11, which governs label statements. Under Section 11 of ISO/DTS 13830, if a nano-object is used, the specification provides that the minimum statement in the label should consist of the term "nanoscale" or use of the phrase "nano," either before or after the name of the particular substance (i.e., for "X" as the chemical substance, the statement of either "X (nano)" or "contains a manufactured form of nanoscale X" would suffice). So, for example, if the nano-substance is "carbon black," then two appropriate labeling statements could be used in the alternative. The first would simply say "carbon black" followed in parenthesis by the word "nano," and the second would be a statement that says "this product contains a manufactured nanoscale form of carbon black."12

Consideration should also be given, where appropriate, to the inclusion of other specific information about the actual MNOs used, such as whether they are free or bound in a matrix, whether they represent a mixture of two types or more of MNOs, whether there are any special disposal requirements, what the specific source of the MNOs is (such as derived from clay), what the functions of the MNOs are in the product (for example, the use of the nano-object form ensures more complete dissolution of the product), or whether the product is unstable under specific conditions such as exposure to ultraviolet light, heat from friction, and so forth.13 All of this language must be easy to understand, conspicuously stated, legible, and indelible.14

Conclusion

We will monitor the progress of ISO/DTS 13830 and will alert you to any substantial revisions in the final Technical Specification approved by ISO ballot in 2013. In the meantime, manufacturers of MNOs and PCMNOs should already strive for compliance with any existing consensus industry labeling standards applicable to their products globally, including these proposed guidance specifications, because all such standards shape the legal standard of care that may be used against your company in a court of law. At the same time, consensus industry standards, and these proposed guidance standards, may also inform and be the basis for both domestic and foreign regulation of consumer products.


1ISO/DTS 13830: ISO/TS 13830: 2010 (E) Guidance on the Voluntary Labeling of Consumer Products Containing Manufactured Nano-Objects (Planned First Edition 2013).

2ISO/TC–229 U.S. Technical Advisory Group ("US TAG") Working Group 3/PG 14 is responsible for this draft technical specification in the United States.

3ISO/TR 13329:2012 has been fully adopted and published since our October article and is now available from ISO.

4ISO/DTS 13830: ISO/TS 13830: 2010 (E) at Section 3, 3.3–3.4.

5Id.

6Id. at Section .02.

7Id.

8Id. at Section 1.

9Id. at Section 4.

10Id. at Section 5.

11Id. at Section 3, 3.9.

12Id. at Section 11.

13Id. at 11.2.

14Id. at Section 10, 10.1.


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