Category Archives: regulation

Canada’s consultation on nanoscale forms of substances on the Domestic Substances List (DSL)

Yes, there’s a redundancy in the head but there doesn’t seem to be a way around it. Ah well, it seems about seven weeks after Peter Julian (Member of Parliament) introduced his bill in the Canadian House of Commons to regulate nanotechnology (Aug. 29, 2016 posting), Environment and Climate Change Canada (ECCC) and Health Canada (HC) have announced a consultation on nanoscale materials. From an Aug. 4, 2016 posting by Lynn L. Bergeson on Nanotechnology Now (Note: Links have been removed),

On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL). See http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=FA3C8DBF-1 Canada will use the proposed approach to: (1) establish a list of existing nanomaterials in Canada for prioritization; (2) identify how the information available will be used to inform prioritization of nanomaterials for risk assessment; and (3) outline the proposed outcomes of the prioritization process. In 2015, Canada conducted a mandatory survey under Section 71 of the Canadian Environmental Protection Act, 1999 (CEPA). The survey applied to persons who manufactured or imported any of 206 nanomaterials at a quantity greater than 100 kilograms (kg) during the 2014 calendar year. See http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=28ABBAC9-1%20-%20s1 Based on the results of the survey, ECCC and HC will prepare a final list of confirmed existing nanomaterials in Canada and will use the list for subsequent prioritization. ECCC and HC propose that, where possible, the substances identified via the survey be “rolled up into” their broader parent nanomaterial groups for the purposes of prioritization. According to ECCC and HC, this will allow, when possible, a more robust look at the hazard, volume, and use data as appropriate, rather than considering an individual substance-by-substance approach. ECCC and HC state that further consideration for sub-grouping (such as by use, unique property, or functionalization) may need to be considered for prioritization and/or risk assessment. …

You can find the Government of Canada’s 2015 Consultation Document: Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List page here, which set the stage for this prioritization exercise.

You can also find the Proposed prioritization approach for nanoscale forms of substances on the Domestic substances list page here where you’ll find information such as this,

Possible nanomaterial groupings, based on parent substance

Aluminum oxide
Iron (II)/(II/III) oxide
Modified silica
Bismuth oxide
Magnesium oxide
Silicon oxide
Calcium carbonate
Manganese (II & III) oxide
Silver
Cerium oxide
Nanocellulose
Titanium dioxide
Cobalt (II) oxide
Nanoclays
Yttrium oxide
Copper (II) oxide
Nickel (II) oxide
Zinc oxide
Gold
Quantum dots
Zirconium oxide

You can also find information on how to submit comments,

Stakeholders are invited to submit comments on the content of this consultation document and provide other information that would help inform decision making. Please submit comments to one of the addresses provided below by September 25, 2016 [emphasis mine]. ECCC and HC will respond to comments and adapt the proposed approach based on the feedback received on this document, as described in Section 1.2.

Comments on this consultation document can be submitted to one of the following addresses:

By Mail:
Environment and Climate Change Canada
Substances Management Information Line
Chemicals Management Plan
351 St. Joseph Boulevard
Gatineau, Québec
K1A 0H3

By Email:
eccc.substances.eccc@canada.ca
Please type “Consultation on Prioritization Approach for Nanomaterials” in the subject line of your message.

By Fax:
819-938-5212

Suddenly, there’s lots (relative to the last few years) of action on nanotechnology regulation in Canada.

Everything old is new again: Canadian Parliament holds first reading of another bill to regulate nanotechnlogy

Back in March 2010, Canadian New Democratic Party (NDP) Member of Parliament (MP) Peter Julian introduced a bill to regulate nanotechnology (Bill C-494) in Canada. The Conservative government was in power at the time. I can’t remember how many readings it received but it never did get passed into legislation. Now, Mr. Julian is trying again and, coincidentally or not, the Liberals are in power this time. A July 26, 2016 post by Lynn L. Bergeson and Carla N. Hutton for the National Law Review (Note: Links have been removed),

On June 8, 2016, the Canadian House of Commons held its first reading of an Act to amend the Canadian Environmental Protection Act, 1999 (CEPA) (nanotechnology) (C-287).  The bill would add Part 6.1 to CEPA primarily to implement procedures for the investigation and assessment of nanomaterials. …

The bill would define nanomaterial as any manufactured substance or product or any component material, ingredient, device or structure that:  (a) is within the nanoscale (one nanometer (nm) up to and including 100 nm), in at least one external dimension; or (b) if it is not within the nanoscale, exhibits one or more properties that are attributable to the size of a substance and size effects.  The bill mandates a risk assessment process to identify the potential benefits and possible risks of nanotechnologies before nanoproducts enter the market.  It would also create a national inventory regarding nanotechnology, including nanomaterials and nanoparticles, using information collected under CEPA Sections 46 and 71 and “any other information to which the Ministers have access.” On July 25, 2015, Canada published a notice announcing a mandatory survey under CEPA Section 71(1)(b) with respect to certain nanomaterials in Canadian commerce.  …

I do have a few observations about the proposed bill. First, it’s more specific than what we have in place now. As I understand current CEPA regulations, they do not cover materials at the nanoscale which are already imported and/or produced at the macroscale and are considered safe, e.g. titanium dioxide. It is assumed that if they’re safe at the macroscale, they will be safe at the nanoscale. I gather this bill is designed to change that status.

Second, there is no mention in Julian’s press release (text to follow) of the joint Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative which was designed to harmonize US and Canadian regulatory approaches to nanotechnology. Would bill C-287 introduce less harmony or was it designed to harmonize our approaches?

Third, I don’t see a big problem with the idea of an inventory, the issue is always implementation.

Finally, it appears that this bill means more bureaucrats or computerized systems and I’m not sure it addresses the problem that I believe it is trying to address: how to deal with uncertainty about the risks and hazards of an emerging technology while meeting demands for economic progress.

Very finally, here’s Peter Julian’s June 8, 2016 press release,

Julian’s bill to include Nanotechnology under Environmental Protection Act

You can watch the video here: https://peterjulian.ca/Introduction_of_Private_Member_Bill_C287_An_Act_t…

OTTAWA – Today [June 8, 2016], Peter Julian, MP (New Westminster-Burnaby) re-introduced Bill C-287 in the House of Commons, which aims to include a framework that would regulate nanotechnology in the Canadian Environmental Protection Act.

“I first introduced this Bill in 2010. I am pleased to see that some of the aspects of this Bill are being considered by Health Canada and Environment Canada, such as the development of a registry for nanomaterials in commerce and use in Canada. However, there is much more that needs to be done to ensure the responsible use of nanotechnologies in Canada”, said Julian.

Nanotechnology is the application of science and technology to manipulate matter at the atomic or molecular level. Nanomaterials are any ingredient, device, or structure that is between 1 and 100 nm. These materials are present in more than 1000 consumer products, including food and cosmetics. The increasing proliferation of nanoproducts has not been met with an adequate regulatory framework.

Julian’s Bill C-287 would establish a balanced approach ensuring the responsible development of nanotechnology and the safe use off nanomaterials in Canada. The Bill mandates a risk assessment process to identify the potential benefits and possible risks of nanotechnologies before nanoproducts enter the market. It would also require a comprehensive, publicly accessible database that lists existing nanomaterials identified by the Government of Canada.

“While nanotechnology can be very beneficial to people, there are certain risks to it as well. We must identify and mitigate possible risks to better protect the environment and human health before they become an issue. Canada must ensure our regulatory processes ensure nanomaterial safety before the introduction of these substances in Canada”, said Julian.

I’m including links to my 2010 email interview with Peter Julian (published in three parts),

March 24, 2010 (Part one)

March 25, 2010 (Part two)

March 26, 2010 (Part three)

I also covered a hearing on nanomaterials and safety held by the Canadian House of Commons Standing Committee on Health on June 10, 2010 in a June 23, 2010 posting.

Two European surveys on disposal practices for manufactured nano-objects

Lynn L. Bergeson’s Aug. 10, 2016 post on Nanotechnology Now announces two surveys (one for producers of nanoscale objects and one for waste disposal companies) being conducted by the European Commission,

Under European Commission (EC) funding, the European Committee for Standardization Technical Committee (CEN/TC) 352 — Nanotechnologies is developing guidelines relating to the safe waste management and disposal of deliberately manufactured nano-objects.

Tatiana Correia has written a July 15, 2016 description of the committee’s surveys for Innovate UK Network,

Under  the European Commission funding, CEN TC 352 European standardisation committee  are  developing guidelines relating to the safe waste management and  disposal of deliberately manufactured nano-objects. These are discrete pieces  of  material with one or more dimensions in the nanoscale(1). These may  also  be  referred  to  as  nanoparticles,  quantum  dots, nanofibres, nanotubes  and  nanoplates.  The  guidelines  will provide guidance for all waste  management  activities  from  the  manufacturing  and  processing of manufactured  nano-objects  (MNOs). In order to ensure that the context for this  document  is  correct,  it  is useful to gain an insight into current practice in the disposal of MNOs.

Here’s a link to the Questionnaire relating to current disposal practice for Manufactured Nano-objects in Waste – Companies manufacturing or processing manufactured nano-objects and to the Questionnaire relating to current disposal practice for Manufactured Nano-objects in Waste – Waste disposal companies.

The deadline for both surveys is Sept. 5, 2016.

European Commission okays use of nanoscale titanium dioxide in cosmetics and beauty products (sunscreens)

Lynn L. Bergeson has a July 21, 2016 post on Nanotechnology Now with information about a July 14, 2016 European Commission (EC) regulation allowing nanoscale titanium dioxide to be used as a UV (ultraviolet) filter, i.e., sunscreen in various cosmetic and beauty products. You can find more details about the regulation and where it can be found in Bergeson’s posting. I was most interested in the specifics about the nano titanium dioxide particles,

… Titanium dioxide (nano) is not to be used in applications that may lead to exposure of the end user’s lungs by inhalation. Only nanomaterials having the following characteristics are allowed:
– Purity ¡Ý [sic] 99 percent;
– Rutile form, or rutile with up to 5 percent anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes;
– Median particle size based on number size distribution ¡Ý [sic] 30 nanometers (nm);
– Aspect ratio from 1 to 4.5, and volume specific surface area ¡Ü [sic] 460 square meters per cubic meter (m2/cm3);
– Coated with silica, hydrated silica, alumina, aluminum hydroxide, aluminum stearate, stearic acid, trimethoxycaprylylsilane, glycerin, dimethicone, hydrogen dimethicone, or simethicone;
– Photocatalytic activity ¡Ü [sic] 10 percent compared to corresponding non-coated or non-doped reference, and
– Nanoparticles are photostable in the final formulation.

I’m guessing that purity should be greater than 99%, that median particle size should be greater than 30 nm, that aspect ratio should be less than 460 square meters per cubic meter, and that photocatalytic activity should be less than 10%.

If anyone should know better or have access to the data, please do let me know in the comments section.

European Commission (EC) responds to a 2014 petition calling for a European Union (EU)-wide ban on microplastics and nanoparticles

Lynn Bergeson’s July 12, 2016 posting on Nanotechnology Now features information about the European Commission’s response to a petition to ban the use of microplastics and nanoparticles throughout the European Union,

On June 29, 2016, the European Commission (EC) provided a notice to the European Parliament regarding its response to a 2014 petition calling for a European Union (EU)-wide ban on microplastics and nanoparticles. … In its response, the EC states that nanoparticles “are ubiquitous in the environment,” and while some manufactured nanomaterials may potentially be carcinogenic, others are not. The EC states that the general regulatory framework on chemicals, along with the sectoral legislation, “are appropriate to assess and manage the risks from nanomaterials, provided that a case-by-case assessment is performed.” The EC notes that the need to modify the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to include more specific requirements for nanomaterials was identified. According to the EC, a final impact assessment of the proposed changes is being prepared, and the modification of technical REACH Annexes to include specific considerations for nanomaterials is planned for early 2017. The EC states that it created a web portal intended to improve communication regarding nanomaterials, and that this web portal will soon be superseded by the EU Nano Observatory, which will be managed by the European Chemicals Agency (ECHA).

I was imagining the petition was made by a consortium of civil society groups but it seems it was initiated by an individual, Ludwig Bühlmeier. You can find the notice of the petition here and the petition itself (PDF) here. I believe the still current EC portal “… intended to improve communication regarding nanomaterials …” is the JRC (Joint Research Centre) Web Platform on Nanomaterials.

Building a regulatory framework for nanotechnology in India

For the second time in less than six weeks (the first time is described in my June 13, 2016 posting on India’s draft guidelines for the safe handling of nanomaterials) I’ve stumbled across an article about the need for more nanotechnology safety measures in India. From a June 23, 2016 article by Prateek Sibal for The Wire (Note: Links have been removed),

India ranks third in the number of research publications in nanotechnology, only after China and the US. This significant share in global nanotech research is a result of sharp focus by the Department of Science and Technology (DST) to research in the field in the country. The unprecedented funding of Rs 1,000 crore for the Nano Mission was clearly dictated by the fact that India had missed the bus on the micro-electronic revolution of the 1970s and its attendant economic benefits that countries like China, Taiwan and South Korea continue to enjoy to this day.

At the same time, the success of the Nano Mission is not limited to research but also involves training the required human resource for further advancement in the field. An ASSOCHAM and TechSci Research study reported in 2014: “From 2015 onwards, global nanotechnology industry would require about two million professionals and India is expected to contribute about 25% professionals in the coming years.”

A missing element in India’s march towards becoming a nanotechnology powerhouse is the lack of focus on risk analysis and regulation. A survey of Indian practitioners working in the area of nano-science and nanotechnology research showed that 95% of the practitioners recognised ethical issues in nanotech research. Some of these concerns relate to the possibly adverse effects of nanotechnology on the environment and humans, their use as undetectable weapon in warfare, and the incorporation of nano-devices as performance enhancers in human beings.

One reason for lack of debate around ethical, and public-health and -safety, concerns around new technologies could be the exalted status that science and its practitioners enjoy in the country. A very successful space program and a largely indigenous nuclear program has ensured that policymakers spend much of their time feting achievements of Indian science than discussing the risks associated with new technologies or improving regulation.

After describing some of the studies raising health concerns, Sibal describes the issue for policymakers (Note: Links have been removed),

The challenge that remains in front of policymakers is that of regulating a field where vast areas of knowledge are still being investigated and are unknown. In this situation, over-regulation may end up stifling further development while under-regulation could expose the public to adverse health effects. Further, India’s lack of investment in risk studies only sustains the lull in the policy establishment when it comes to nanotech regulations.

The Energy and Resources Institute has extensively studied regulatory challenges posed by nanotechnology and advocates that an “incremental approach holds out some promise and offers a reconciliation between the two schools- one advocating no regulation at present given the uncertainty and the other propounding a stand-alone regulation for nanotechnology.”

Kesineni Srinivas, the Member of Parliament from Vijayawada, has taken cognisance of the need for incremental regulation in nanotechnology from the view point of public health and safety. (Disclosure: The author worked with the Vijayawada MP on drafting the legislation on nanotechnology regulation, introduced in the winter session of Parliament, 2015.)

In December 2015, Srinivas introduced the Insecticides (Amendment) Bill in the Lok Sabha to grant only a provisional registration to insecticides containing nanoparticles with a condition that “it shall be mandatory for the manufacturer or importer to report any adverse impact of the insecticide on humans and environment in a manner specified by the Registration Committee.” This is an improvement over the earlier process of granting permanent registration to insecticides. However, the fate of the bill remains uncertain as only 14 private member bills have been passed in Parliament since the first Lok Sabha in 1952.

Prateek Sibal will be joining Sciences Po (the Paris Institute of Political Sciences), Paris, as a Charpak Scholar in 2016.

I always appreciate these pieces as they help me to adjust my Canada-, US-, Commonwealth- and European-centric views.

Introducing the LIFE project NanoMONITOR

I believe LIFE in the project title refers to life cycle. Here’s more from a June 9, 2016 news item from Nanowerk (Note: A link has been removed),

The newly started European Commission LIFE project NanoMONITOR addresses the challenges of supporting the risk assessment of nanomaterials under REACH by development of a real-time information and monitoring system. At the project’s kickoff meeting held on the 19th January 2016 in Valencia (Spain) participants discussed how this goal could be achieved.

Despite the growing number of engineered nanomaterials (ENMs) already available on the market and in contract to their benefits the use, production, and disposal of ENMs raises concerns about their environmental impact.

A REACH Centre June 8, 2016 press release, which originated the news item, expands on the theme,

Within this context, the overall aim of LIFE NanoMONITOR is to improve the use of environmental monitoring data to support the implementation of REACH regulation and promote the protection of human health and the environment when dealing with ENMs. Within the EU REACH Regulation, a chemical safety assessment report, including risk characterisation ratio (RCR), must be provided for any registered ENMs. In order to address these objectives, the project partners have developed a rigorous methodology encompassing the following aims:

  • Develop a novel software application to support the acquisition, management and processing of data on the concentration of ENMs.
  • Develop an on-line environmental monitoring database (EMD) to support the sharing of information.
  • Design and develop a proven monitoring station prototype for continuous monitoring of particles below 100 nm in air (PM0.1).
  • Design and develop standardized sampling and data analysis procedures to ensure the quality, comparability and reliability of the monitoring data used for risk assessment.
  • Support the calculation of the predicted environmental concentration (PEC) of ENMs in the context of REACH.

Throughout the project’s kick off meeting, participants discussed the status of the research area, project goals, and expectations of the different stakeholders with respect to the project outcome.

The project has made this graphic available,

LIFE_NanoMONITOR

You can find the LIFE project NanoMONITOR website here.

India’s draft guidelines for the safe handling of nanomaterials

I believe this is the first time I’ve seen any guidelines for the safe handling of nanomaterials that are neither from Europe nor from the US. I imagine that’s due to translation issues or lack of publicity rather than a failure to create guidelines.

In any event, Indrani Barpujari, Advisor (Governance) at the Atal Bihari Vajpayee Institute of Good Governance and Policy Analysis, Bhopal, India, has written a commentary on draft regulations for India (from her Draft Guidelines for Safe Handling of Nanomaterials commentary in Economic and Political Weekly, Vol. 51, Issue No. 23, 04 Jun, 2016 ISSN [Online] – 2349-8846 [appears to be open access]),

It is indeed laudable that as a first step towards regulation of nanotechnology in India, the Nano Mission under the Department of Science and Technology has come out with the draft “Guidelines and Best Practices for Safe Handling of Nanomaterials in Research Laboratories and Industries.” Taking cognisance of the imperative for safe handling of nanomaterials, the Nano Mission has constituted a task force consisting of eminent experts who have prepared this document. Involving the control of matter at the nanoscale, nanomaterials are characterised by small dimensions, large surface area, and high reactivity which while making them amenable to a large variety of applications in various sectors also render them potentially dangerous for human health and environmental safety, with considerable scientific uncertainty regarding the risks. Nanotechnology presents before policymakers a classic case of “Collingridge dilemma” or a “dilemma of control” with policy decisions required to be taken on the basis of uncertain scientific facts and under conditions of some urgency. It is the unique combination of “high expectations and huge uncertainties” (Van Lente 2010) associated with nanotechnology which has provided the required thrust for the current guidelines.

The draft guidelines, basically intended as standard operating procedure (SOP) for handling nanomaterials in research laboratories and industries, prescribe a combination of engineering controls, work practices and personal protective equipment as part of a robust exposure control strategy. These lay down the process for identifying hazards, taking note of the specific effect of surface chemistry, shape, size and morphology on toxicity caused to various organs. These address the potential exposure pathways and concomitant safety measures to mitigate the same. While prescribing certain best practices for handling nanomaterials generally, the guidelines also lay down another set of best practices specifically pertaining to the making and handling of nanopowders and use of products relating to food and healthcare. A precautionary approach is advocated with detailed life cycle assessment and strong binding procedures with respect to stakeholder involvement for various players while formulating best practices in the food sector particularly.

While the draft guidelines as a first step cover reasonable ground, it may be relevant to look at these in the context of the discourse on nanotechnology regulation abroad as well as in India. The focus of modern “risk societies” being more on “manufactured risks” or risks which are the product of human activity (Giddens 1999), governments, particularly in the developed world, are increasingly realising the need for risk-based regulation, to address potential risks from emerging technologies like nanotechnology, while promoting their development. Preliminary steps have been taken to regulate nanotechnology despite the admitted difficulty in doing so owing to the scientific uncertainty regarding its risks and limited amenability to traditional risk management approaches (Schummer and Pariotti 2008).

Thus, it may be surmised that the developed world’s engagement with nanotechnology to harness its benefits has been characterised by an almost unprecedented focus on regulating its risks and developing an anticipatory governance framework, taking on board different stakeholders including the public and incorporating societal concerns. On the other hand, with an almost single-minded focus on promotion in the initial years, the official pursuit of nanotechnology in India has not accorded much priority to its potential risks with the result than a large number of nano-based products are already out in the markets, without any regulation (Barpujari 2011a). In India, the government is the primary promoter of nanotechnology, pursued under the mission on nanoscience and technology (Nano Mission) with a huge budget outlay targeted at the development of nano-applications and creating adequate infrastructural and human capabilities for this purpose.

The Indian scientific establishment has high expectations from nanotechnology, with the technology expected to help meet the development needs of the country, while also positioning India as a forerunner in the global arena. Srivastava and Chowdhury (2008) observe that Indian scientists at the helm of affairs perceive that Indian science should not lose out on this opportunity to establish itself as a global leader and that it should not “miss the bus” as it did during the previous semiconductor revolution. Sahoo and Deshpande Sarma’s (2010) survey on risk perceptions among thirty scientists working in public-funded scientific institutions/laboratories indicate that Indian scientists are not very much perturbed by the risks of nanotechnology, and few take special precautions while working with nanomaterials, while very few are interested in taking up risk research.

The fact that the policy establishment is yet to take into serious consideration the potential risks of the technology is also evident from the low priority accorded to risk research, which should precede regulation. A very small number of projects are being publicly funded to look into toxicity issues, and there is almost no engagement with the social sciences and humanities, as evidenced by the lack of government funding for such studies.

At the same time, it must be acknowledged that different stakeholders in India particularly policy researchers, civil society actors and research institutions pursuing risk research have been persistently making the case for nanotechnology regulation in the country and taken the lead in charting the way ahead. It is acknowledged that problems in developing risk-based regulation are particularly compounded for a developing country like India, owing to a lack of resources, expertise and regulatory mandate. The absence of regulation, it is anticipated, would be even worse as in the event of some of the risks materialising, developing countries would be ill-equipped to handle and mitigate these (Barpujari 2011b).

Particularly noteworthy is a regulatory matrix for India developed by TERI [The Energy and Resources Institute] (2009) comprising several central legislation, rules and notifications which could have relevance for regulation of environmental risks, occupational health and safety risks arising from nanotechnology development and applications in India. Another report (TERI 2012) has provided leads for adopting a precautionary approach and developing an anticipatory regulatory framework for nanotechnology in the South Asian region, taking the particular case of India, Pakistan and Sri Lanka.

Vajpayee offers more insight with her suggestions for “The Way Ahead” and I strongly suggest reading her commentary if you’re interested in a perspective from South Asia. There’s also a list of references at the end of the commentary, should you wish to explore further.

Nanoparticles in baby formula

Needle-like particles of hydroxyapatite found in infant formula by ASU researchers. Westerhoff and Schoepf/ASU, CC BY-ND

Needle-like particles of hydroxyapatite found in infant formula by ASU [Arizona State University] researchers. Westerhoff and Schoepf/ASU, CC BY-ND

Nanowerk is featuring an essay about hydroxyapatite nanoparticles in baby formula written by Dr. Andrew Maynard in a May 17, 2016 news item (Note: A link has been removed),

There’s a lot of stuff you’d expect to find in baby formula: proteins, carbs, vitamins, essential minerals. But parents probably wouldn’t anticipate finding extremely small, needle-like particles. Yet this is exactly what a team of scientists here at Arizona State University [ASU] recently discovered.

The research, commissioned and published by Friends of the Earth (FoE) – an environmental advocacy group – analyzed six commonly available off-the-shelf baby formulas (liquid and powder) and found nanometer-scale needle-like particles in three of them. The particles were made of hydroxyapatite – a poorly soluble calcium-rich mineral. Manufacturers use it to regulate acidity in some foods, and it’s also available as a dietary supplement.

Andrew’s May 17, 2016 essay first appeared on The Conversation website,

Looking at these particles at super-high magnification, it’s hard not to feel a little anxious about feeding them to a baby. They appear sharp and dangerous – not the sort of thing that has any place around infants. …

… questions like “should infants be ingesting them?” make a lot of sense. However, as is so often the case, the answers are not quite so straightforward.

Andrew begins by explaining about calcium and hydroxyapatite (from The Conversation),

Calcium is an essential part of a growing infant’s diet, and is a legally required component in formula. But not necessarily in the form of hydroxyapatite nanoparticles.

Hydroxyapatite is a tough, durable mineral. It’s naturally made in our bodies as an essential part of bones and teeth – it’s what makes them so strong. So it’s tempting to assume the substance is safe to eat. But just because our bones and teeth are made of the mineral doesn’t automatically make it safe to ingest outright.

The issue here is what the hydroxyapatite in formula might do before it’s digested, dissolved and reconstituted inside babies’ bodies. The size and shape of the particles ingested has a lot to do with how they behave within a living system.

He then discusses size and shape, which are important at the nanoscale,

Size and shape can make a difference between safe and unsafe when it comes to particles in our food. Small particles aren’t necessarily bad. But they can potentially get to parts of our body that larger ones can’t reach. Think through the gut wall, into the bloodstream, and into organs and cells. Ingested nanoscale particles may be able to interfere with cells – even beneficial gut microbes – in ways that larger particles don’t.

These possibilities don’t necessarily make nanoparticles harmful. Our bodies are pretty well adapted to handling naturally occurring nanoscale particles – you probably ate some last time you had burnt toast (carbon nanoparticles), or poorly washed vegetables (clay nanoparticles from the soil). And of course, how much of a material we’re exposed to is at least as important as how potentially hazardous it is.

Yet there’s a lot we still don’t know about the safety of intentionally engineered nanoparticles in food. Toxicologists have started paying close attention to such particles, just in case their tiny size makes them more harmful than otherwise expected.

Currently, hydroxyapatite is considered safe at the macroscale by the US Food and Drug Administration (FDA). However, the agency has indicated that nanoscale versions of safe materials such as hydroxyapatite may not be safe food additives. From Andrew’s May 17, 2016 essay,

Hydroxyapatite is a tough, durable mineral. It’s naturally made in our bodies as an essential part of bones and teeth – it’s what makes them so strong. So it’s tempting to assume the substance is safe to eat. But just because our bones and teeth are made of the mineral doesn’t automatically make it safe to ingest outright.

The issue here is what the hydroxyapatite in formula might do before it’s digested, dissolved and reconstituted inside babies’ bodies. The size and shape of the particles ingested has a lot to do with how they behave within a living system. Size and shape can make a difference between safe and unsafe when it comes to particles in our food. Small particles aren’t necessarily bad. But they can potentially get to parts of our body that larger ones can’t reach. Think through the gut wall, into the bloodstream, and into organs and cells. Ingested nanoscale particles may be able to interfere with cells – even beneficial gut microbes – in ways that larger particles don’t.These possibilities don’t necessarily make nanoparticles harmful. Our bodies are pretty well adapted to handling naturally occurring nanoscale particles – you probably ate some last time you had burnt toast (carbon nanoparticles), or poorly washed vegetables (clay nanoparticles from the soil). And of course, how much of a material we’re exposed to is at least as important as how potentially hazardous it is.Yet there’s a lot we still don’t know about the safety of intentionally engineered nanoparticles in food. Toxicologists have started paying close attention to such particles, just in case their tiny size makes them more harmful than otherwise expected.

Putting particle size to one side for a moment, hydroxyapatite is classified by the US Food and Drug Administration (FDA) as “Generally Regarded As Safe.” That means it considers the material safe for use in food products – at least in a non-nano form. However, the agency has raised concerns that nanoscale versions of food ingredients may not be as safe as their larger counterparts.Some manufacturers may be interested in the potential benefits of “nanosizing” – such as increasing the uptake of vitamins and minerals, or altering the physical, textural and sensory properties of foods. But because decreasing particle size may also affect product safety, the FDA indicates that intentionally nanosizing already regulated food ingredients could require regulatory reevaluation.In other words, even though non-nanoscale hydroxyapatite is “Generally Regarded As Safe,” according to the FDA, the safety of any nanoscale form of the substance would need to be reevaluated before being added to food products.Despite this size-safety relationship, the FDA confirmed to me that the agency is unaware of any food substance intentionally engineered at the nanoscale that has enough generally available safety data to determine it should be “Generally Regarded As Safe.”Casting further uncertainty on the use of nanoscale hydroxyapatite in food, a 2015 report from the European Scientific Committee on Consumer Safety (SCCS) suggests there may be some cause for concern when it comes to this particular nanomaterial.Prompted by the use of nanoscale hydroxyapatite in dental products to strengthen teeth (which they consider “cosmetic products”), the SCCS reviewed published research on the material’s potential to cause harm. Their conclusion?

The available information indicates that nano-hydroxyapatite in needle-shaped form is of concern in relation to potential toxicity. Therefore, needle-shaped nano-hydroxyapatite should not be used in cosmetic products.

This recommendation was based on a handful of studies, none of which involved exposing people to the substance. Researchers injected hydroxyapatite needles directly into the bloodstream of rats. Others exposed cells outside the body to the material and observed the effects. In each case, there were tantalizing hints that the small particles interfered in some way with normal biological functions. But the results were insufficient to indicate whether the effects were meaningful in people.

As Andrew also notes in his essay, none of the studies examined by the SCCS OEuropean Scientific Committee on Consumer Safety) looked at what happens to nano-hydroxyapatite once it enters your gut and that is what the researchers at Arizona State University were considering (from the May 17, 2016 essay),

The good news is that, according to preliminary studies from ASU researchers, hydroxyapatite needles don’t last long in the digestive system.

This research is still being reviewed for publication. But early indications are that as soon as the needle-like nanoparticles hit the highly acidic fluid in the stomach, they begin to dissolve. So fast in fact, that by the time they leave the stomach – an exceedingly hostile environment – they are no longer the nanoparticles they started out as.

These findings make sense since we know hydroxyapatite dissolves in acids, and small particles typically dissolve faster than larger ones. So maybe nanoscale hydroxyapatite needles in food are safer than they sound.

This doesn’t mean that the nano-needles are completely off the hook, as some of them may get past the stomach intact and reach more vulnerable parts of the gut. But the findings do suggest these ultra-small needle-like particles could be an effective source of dietary calcium – possibly more so than larger or less needle-like particles that may not dissolve as quickly.

Intriguingly, recent research has indicated that calcium phosphate nanoparticles form naturally in our stomachs and go on to be an important part of our immune system. It’s possible that rapidly dissolving hydroxyapatite nano-needles are actually a boon, providing raw material for these natural and essential nanoparticles.

While it’s comforting to know that preliminary research suggests that the hydroxyapatite nanoparticles are likely safe for use in food products, Andrew points out that more needs to be done to insure safety (from the May 17, 2016 essay),

And yet, even if these needle-like hydroxyapatite nanoparticles in infant formula are ultimately a good thing, the FoE report raises a number of unresolved questions. Did the manufacturers knowingly add the nanoparticles to their products? How are they and the FDA ensuring the products’ safety? Do consumers have a right to know when they’re feeding their babies nanoparticles?

Whether the manufacturers knowingly added these particles to their formula is not clear. At this point, it’s not even clear why they might have been added, as hydroxyapatite does not appear to be a substantial source of calcium in most formula. …

And regardless of the benefits and risks of nanoparticles in infant formula, parents have a right to know what’s in the products they’re feeding their children. In Europe, food ingredients must be legally labeled if they are nanoscale. In the U.S., there is no such requirement, leaving American parents to feel somewhat left in the dark by producers, the FDA and policy makers.

As far as I’m aware, the Canadian situation is much the same as the US. If the material is considered safe at the macroscale, there is no requirement to indicate that a nanoscale version of the material is in the product.

I encourage you to read Andrew’s essay in its entirety. As for the FoE report (Nanoparticles in baby formula: Tiny new ingredients are a big concern), that is here.