On July 9, 2010, the U.S. Technical Advisory Group (TAG) to the International Organization for Standardization’s (ISO) Technical Committee 229 on Nanotechnologies presented a webinar requesting general public input regarding ISO’s draft technical specification (TS) entitled “Labeling of Manufactured Nano-Objects and Products Containing Manufactured Nano-Objects.” The U.S. TAG is accredited by the American National Standards Institute, the leading standards organization in the U.S. ISO has 163 members countries and its standards often become the de facto standard of care for certain industries.
The document discussed during the webinar is a draft technical specification developed jointly by ISO and the European Committee for Standardization. In general, a TS can be thought of as a guidance document which is one step down in authority from an actual standard. However, it may ultimately become a full-fledged standard in a few years if ISO and its members are so inclined. This particular draft TS will be voted on by ISO in late 2010, and any comments will be resolved in early-to-mid 2010. If passed, the draft TS will most likely take effect in late 2011.
The draft TS has four basic purposes: (i) encourage a standardized approach to nano-product labeling; (ii) ensure that companies in the nano supply chain can adequately identify manufactured nano-objects in products in order to make informed decisions regarding purchasing, distribution, handling, use, and disposal; (iii) standardize labeling use of the “nano” prefix and suffix where appropriate; and (iv) “provide guidance on the use of other specific terms in” nano-labeling.
The draft TS is limited to manufactured nano-objects and products containing such objects. Incidental and natural nano-objects are excluded from coverage, as are products containing manufactured nano-objects bound in a matrix which are not subject to release under reasonably foreseeable use or disposal scenarios.
Getting to the heart of the draft TS, the document recommends the use of the prefix or suffix “nano” when products either contain manufactured nano-objects or display nanoscale phenomena. Additionally, the draft TS suggests that products not containing nano-objects but displaying unique characteristics commonly associated with nanoscale materials should bear a negative label: “This product does not contain manufactured nano-objects.”
The draft TS also provides five suggested forms of nano-disclosure for use in the existing ingredient section of product labels:
- “a manufactured nanoscale form of X;”
- “0.1 g of nanoscale X;”
- “X, approximately size range P nm - Q nm, specific surface area R m2 g-1;”
- “a dispersion of manufactured nanoscale X in Y;” and/or
- “[nanoscale shape of] X, with an aspect ratio of 1:20.”
In addition to these suggested ingredient statements, the draft TS also asks manufacturers to consider including the following information in their nanoproduct labels: (i) whether the nano-objects are in free or unbound form; (ii) any special disposal needs; (iii) the source from which the nano-objects were derived; (iv) the intended function or purpose of the nano-objects in the product; (v) instructions for the safe opening of the nanoproduct package; and (vi) any necessary warnings regarding potential product instability.
Finally, the draft TS recommends that business-to-business nanoproduct labels contain sufficient information for the purposes of (i) unambiguous product identification; (ii) “employee training, batch control, and [explaining] contract conditions of purchase;” and (iii) assigning purchasers “responsibility for identification, safety, [and] production control systems.”
Unfortunately, the entire draft TS is not currently publicly available in written form. However, there is a 2007 document published by the British Standards Institute upon which the draft appears to be based. Although it is difficult to fully analyze the draft TS without having a copy in hand, anyone with comments regarding its general approach should e-mail the U.S. ISO Liaison Representative at: firstname.lastname@example.org.