Effective December 31, 2007, BSI British Standards (BSI) issued "Publicly Available Specification" (PAS 130:2007), "Guidance on the labeling of manufactured nanoparticles and products containing manufactured nanoparticles." Although BSI’s guidance document was funded by the UK Department of Innovation, Universities and Skills, it is only a guidance document and should not be treated as an "official" British standard.
BSI issued its guidance document because it believes "product specifications enable businesses to reliably select or avoid ingredients and other essential conditions of business such as insurance contracts. . . [and] . . . Appropriate consumer labeling is necessary to identify ingredients in nanoparticle form and to inform consumers of their presence in final products." BSI stresses at the outset that nano-labeling must take into consideration the level of consumer knowledge and understanding, and suggests applying a precautionary principle:
Lack of scientific evidence of risk should not prevent appropriate precautionary actions being take. These should be proportionate, non-discriminatory, and consistent with previous action, considering both costs and benefits and be subject to review. European Commission, Communication on the Precautionary Principle, 2 February 2000 – Com (2000) 1 Final [3]
BSI is clear that its guidance document does not apply to natural and/or incidental nanoparticles. Nor does it apply to nanoparticulates in liquid state [nanoemulsions], "unless encapsulated in a solid or gel shell." Rather, the document focuses solely on "manufactured nanoparticles," which it defines as a "solid entity with size from approximately 1 nm to 100 nm in at least two dimensions that has been produced by a manufacturing process." The guidance also covers products in which nanoparticles "are intentionally added, mixed, attached, embedded or suspended."
Reminiscent of the "Magic Nano" labeling fiasco in Germany in 2006, BSI prudently recommends that "nano" should only be used on product labels if products do in fact contain "nanoscale entities."
BSI further recommends the labeling of all manufactured nanoparticles and products using/incorporating same "except where the nanoparticulate component of the product is intimately bound and could not be released under reasonable and foreseeable conditions of use or disposal."
Getting to the core of the issue, BSI suggests that nanoproduct labels contain the following information: (i) instructions for use due to any new nanoenabled efficacy/features; (ii) instructions for any different handling, maintenance, cleaning, storage, or disposal resulting from nanoparticle content; (iii) information sufficient to allow tracing of the complete manufacturer and distribution chain for the product .
Examples of suggested labeling formats include: (i) "contains manufactured nanoparticles," (ii) "this product contains manufactured nanoparticles," (iii) "contains manufactured nanoparticles of X [chemical substance]," (iv) "this product contains manufactured nanoparticles of X," (v) "contains 0.1 g nanoparticles of X," (vi) "contains a dispersion of manufactured nanoparticles of X in Y," and/or (vii) "titanium oxide, size range Xnm – Ynm, specific surface area Zm2g-1."
Finally, BSI advises manufacturers to consider listing the following additional information in nanolabels where appropriate: (i) whether the nanoparticles are free or bound in a solid matrix; (ii) whether the product contains a mixture of various nanoparticles; (iii) whether the product has any special disposal requirements; (iv) the specific source of the nanoparticles; (v) a description of the specific function of the nanoparticles in the product; and (vi) any information necessary for safe opening of the product.
