Nanotechnology Regulation of Food Packaging

Over the last several years, the matter of how to define and regulate "nanomaterial" has emerged as an area of lively debate. This has been prompted in large part by a growing interest in the use of nanotechnology, which spans a multitude of commercial applications, including those in the food packaging arena. As a first step, some regulators have focused on developing appropriate terminology to describe nanotechnology and its associated terms.

To date, regulatory agencies and organizations have adopted various approaches to defining nanotechnology and its related vocabulary. In the United States, the Food and Drug Administration (FDA) has not yet defined "nanomaterial," "nanotechnology," or "nanoscale." The various draft guidance documents the Agency has issued to date on the topic reiterate FDA's view that nanotechnology represents an "evolving state of the science," and that a single definition of nanotechnology and its related terms is not appropriate for regulatory purposes until more can be learned about the interaction of nanomaterials with biological systems.[1]

In the European Union (EU), a more fixed approach has been adopted. The European Commission (EC) defines a nanomaterial as "a natural, incidental, or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm."[2] Likewise, Health Canada has adopted a working definition of nanotechnology. This Agency's working definition incorporates the 1 to 100 nanometer size range, but encompasses substances that are smaller or larger if they exhibit one or more nanoscale properties.

Regulation of Nanomaterials in the United States

FDA initiated the Nanotechnology Task Force in 2006 to address regulatory approaches for FDA-regulated products that contain nanomaterials. The Task Force published its recommendations the following year in the Nanotechnology Task Force Report 2007.[3] The report focused on engineered nanoscale materials (ENMs) rather than natural or incidental nanomaterials. Notably, the report discouraged the adoption of a precise definition of nanoscale materials in light of the evolving state of the science, and recommended a case-by-case assessment of ENMs.

FDA followed the recommendation and did not define ENMs in the draft guidance that the Agency published in June 2011, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology." The guidance indicates FDA's intention to make a distinction between products that have been deliberately manipulated to control particle size for purposes of achieving desired properties, and those products that contain incidental or background levels of nanomaterials or products that contain materials having a size that naturally falls within the nanoscale range.

Specifically, the draft guidance lists two points to be considered when evaluating new products:

• Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
• Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

In addition, the guidance states that new products will be assessed by looking at manufacturing changes made to currently cleared FDA products or their components, which might alter their dimensions, properties, or effects. FDA explained in a press release that, when the guidance is finalized, it intends to apply these points to products subject to Agency premarket review. For products not subject to FDA's premarket review, manufacturers are encouraged to consult with the Agency during the early stages of product development so that questions regarding the product's regulatory status, safety, and effectiveness may be appropriately addressed, where necessary.

On April 20, 2012, FDA released two additional draft guidance documents concerning nanotechnology. The first guidance concerns the manner in which significant manufacturing changes, including emerging technologies, may impact the regulation of food ingredients and food contact substances, including those food ingredients that are color additives. In this guidance, FDA emphasized that the Agency had not yet adopted fixed definitions for nanotechnology and its related terms.[4] FDA also echoed the two points that the Agency previously highlighted in the June 2011 draft guidance when considering whether an FDA-regulated product contains nanomaterials or nanotechnology.[5] Importantly, the Agency's draft guidance on manufacturing changes confirms that, though safety studies and methods potentially may need to be modified to fully evaluate nanomaterials, FDA's current regulatory scheme is sufficiently robust to assess whether the use of nanotechnology creates a significant enough change to alter the safety and regulatory status of food or food-contact products. In other words, FDA will assess the safety of nanotechnology as it does any other emerging technology or significant change in manufacturing process.

As with the draft guidance on food and food-contact materials, FDA's second draft guidance, "Guidance for Industry: Safety of Nanomaterials in Cosmetic Products (Draft Guidance)" confirms the overall sufficiency of the current regulatory scheme in place for assessing nanomaterials used in cosmetics.[6] Under the Federal Food, Drug, and Cosmetic Act, FDA approval or premarket clearance is not required for cosmetic products. Nonetheless, cosmetic manufacturers and distributors bear the responsibility of ensuring that ingredients do not otherwise cause the cosmetic to be adulterated or misbranded.[7] In this regard, the draft guidance recognizes that, as is the case with nanomaterials used in food and food-contact applications, unique toxicological considerations may need to be considered where nanomaterials are used in cosmetics. Nevertheless, the existing regulatory framework offers sufficient flexibility to conduct the necessary safety assessments for cosmetic products containing nanomaterials.

Regulation of Nanomaterials in the European Union

In the EU, the focus has been on developing a comprehensive science-based definition of the term "nanomaterial." This is due, in part, to a resolution issued by the European Parliament in April 2009 that called for the inclusion of a definition of nanomaterials as part of nano-specific amendments to relevant legislation.[8]

In response to this resolution, the EC asked its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) to provide scientific guidance on factors to consider when defining "nanomaterials." The guidance was published by SCENIHR on December 8, 2010.[9] SCENIHR concluded that, while physical and chemical properties of materials may change with size, "there is no scientific justification for a single upper and lower size limit associated with these changes that can be applied to adequately define all nanomaterials." Instead, the committee suggested that a tiered approach may be required, depending on size of the material. Whether a material is manufactured or natural, or a nanocomposite or persistent, also should be encompassed in the definition.

On October 18, 2011, the EC adopted Commission Recommendation 2011/696/EU, inviting EU agencies and Member States to use the following definition of "nanomaterial" in the promulgation and implementation of legislation concerning nanoscale products and technologies:

• A natural, incidental, or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm to 100 nm.
• In certain cases where warranted by environmental or health or safety concerns, the 50% threshold for the number size distribution may be reduced to between 1 and 50%.
• Fullerenes, graphene flakes, and single-wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

This definition captures not only engineered nanoscale materials but also those substances that naturally or incidentally contain one or more external dimensions that are less than 100 nm in size.

Prior to the EC's publication of the nanomaterial definition, the EU already had adopted several pieces of legislation, as well as technical guidance, that contain references to nanomaterials. For example, the EU Plastics Regulation, Commission Regulation (EU) No 10/2011, specifically excludes "nanoform" materials from the scope of the clearance, for their non-nanoform counterparts. In other words, separate clearances must be sought for substances that are in nano-form, even if their non-nanoform counterparts are already the subject of an existing listing on the Plastics Regulation. The Plastics Regulation also states that, "new technologies that engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, such as nanoparticles" are not subject to the functional barrier concept under the legislation."[10]

Regulation of Nanomaterials in Canada

Currently, Canada does not have in place any legislation that explicitly references nanomaterials in food packaging or food products; rather, the potential risks and benefits of nanomaterials in food packaging are evaluated within existing legislative and regulatory frameworks.[11] Nonetheless, Health Canada published a Policy Statement on the Working Definition of Nanomaterial on October 6, 2011. The Policy Statement defines a nanomaterial as any manufactured substance or product and any component material, ingredient, device, or structure that is:

1. At or within the nanoscale (1 to 100 nanometers) in at least one external dimension, or has internal or surface structure at the nanoscale, or;
2. Smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties that are attributable to size and their effects, and are distinguishable from the chemical or physical properties of individual atoms and molecules, and bulk material.[12]

According to Health Canada, this definition will assist the Agency in establishing a framework for internal inventories, and provide a means to integrate new knowledge on the materials into the regulatory decision making processes.[13] In this regard, the Agency has recommended that manufacturers of health and food products containing nanomaterials schedule a pre-submission meeting with the regulatory authorities to discuss the information that may be required for an assessment of the product's safety.[14]

Conclusion

It appears that nanotechnology is here to stay, and with it, a complex number of questions have arisen as to whether and how nanomaterials should be regulated. This complexity is well-evident in attempts by regulatory bodies to establish working definitions for nanomaterials, a task that has proven difficult because of the array of materials potentially encompassed by these definitions. Even more challenging will be adhering to the regulatory requirements applicable to nanomaterials globally without clear guidance at the outset on determining whether a material qualifies as a "nanomaterial" for regulatory purposes.

[1] See "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives" (Draft Guidance), April 2012.

[2] See European Commission Recommendation on the definition of nanomaterials (2011/696/EU), dated Oct. 18, 2011.

[3] Available at:http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/default.htm

[4] See supra, note 1.

[5] Id. at page 5.

[6] See "Guidance for Industry: Safety of Nanomaterials in Cosmetic Products" (Draft Guidance), April 20, 2012.

[7] Section 602 of the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. 361 and 362.

[8] See European Parliament resolution of April 24, 2009 on regulatory aspects of nanomaterials (2008/2208(INI)), no. 7.

[9] See SCENIHR opinion, "Scientific Basis for the Definition of the Term ‘nanomaterial,'" dated Dec. 8, 2010.

[10] Paragraph (27) of Recitals of Commission Regulation (EU) No 10/2011.

[11] http://www.hc-sc.gc.ca/dhp-mps/nano-eng.php

[12] Id.

[13] See the Policy Statement on Health Canada's Working Definition for Nanomaterial, available here.

[14] The required information may include details on the intended use of the nanomaterial, its manufacturing methods and physico-chemical properties, toxicological and environmental fate data, as well as risk assessment and risk management strategies, if relevant.