NanoBabyFormulaReport - 13

NANO-
PARTICLES
IN BABY FORMULA:
Tiny new ingredients are a big concern
2 0 0 n m
Electron microscopy images of nanomaterials found in baby formula provided by Arizona State University, see appendix B for
additional information.
Acknowledgements
This report was written by Ian Illuminato, Health and Environment Campaigner, Friends of the Earth U.S.
We would like to thank the following individuals for reviewing this report: Lisa Archer, Food and Technology
Program Director, Friends of the Earth U.S.; Karen Cohn, MS, Children’s Environmental Health Promotion
Program Manager, San Francisco Department of Public Health; Jaydee Hanson, MA, Policy Director, Center
for Food Safety; Stephenie Hendricks; Jen Jackson, MA, Toxics Reduction & Healthy Ecosystems Programs
Manager, San Francisco Department of the Environment; Molly Jacobs, MPH, Project Manager, University
of Massachusetts Lowell; Kendra Klein, PhD, Staff Scientist, Friends of the Earth U.S.; Mark Miller, MD/MPH,
Assistant Clinical Professor, Departments of Pediatrics and Occupational and Environmental Medicine,
University of California San Francisco; Andrew Maynard, PhD, Director, Risk Innovation Lab, Arizona
State University; Robert Reed, PhD, Postdoctoral Researcher, Arizona State University; Jared Schoepf,
PhD candidate, Arizona State University; Tim Schwab, MA, Researcher, Food and Water Watch; Jeremy
Tager, Friends of the Earth Australia; Paul Westerhoff, PhD, PE, BCEE, Professor, Ira A. Fulton Schools of
Engineering, Arizona State University; and Tracey Woodruff, PhD, Professor, Department of Obstetrics,
Gynecology, and Reproductive Sciences, University of California San Francisco.
About Friends of the Earth:

Friends of the Earth U.S., founded by David Brower in 1969, is the U.S. voice of the world’s largest federation
of grassroots environmental groups, with a presence in 74 countries. Friends of the Earth works to defend
the environment and champion a more healthy and just world. Throughout our 47-year history, we have
provided crucial leadership in campaigns resulting in landmark environmental laws, precedent-setting legal
victories and groundbreaking reforms of domestic and international regulatory, corporate and financial
institution policies. www.foe.org
Any errors or omissions in this report are the responsibility of Friends of the Earth U.S.
©Copyright May 2016 by Friends of the Earth.
CONTENTS
Executive summary................................................................................................................................................................................4
1. Introduction........................................................................................................................................................................................ 8
a. Breastfeeding: Benefits and barriers................................................................................................................................. 8
b. Nanotechnology raises ethical and social justice concerns...................................................................................... 9
2. Findings & Analysis....................................................................................................................................................................... 10

a. Major baby formulas contain nanomaterials................................................................................................................ 10
b. Nano-hydroxyapatite...............................................................................................................................................................11
c. Nano titanium dioxide.............................................................................................................................................................11
d. Nano silicon dioxide................................................................................................................................................................12
3. Background: An introduction to nanotechnology........................................................................................................... 13

a. Defining nanomaterials for health and safety...............................................................................................................13
b. Manufactured vs. incidental nanoparticles.....................................................................................................................13
c. Nanomaterials are already used widely for their novel properties.......................................................................14
d. Why are food and agriculture companies interested in nanotechnology?........................................................14
4. Health Concerns: Novel risks of nanomaterials and nanofoods................................................................................ 15

a. Permeability and absorption...............................................................................................................................................15
b. Crohn’s disease and immune system dysfunction.......................................................................................................15
c. Additional health concerns...................................................................................................................................................16
d. Wastewater and environmental concerns......................................................................................................................16
e. Occupational health and safety concerns......................................................................................................................16
5. Regulation of Nanotechnology................................................................................................................................................ 18
a. Principles for the Oversight of Nanotechnologies and Nanomaterials...............................................................18
b. Nanomaterials policy recommendations........................................................................................................................18
c. Organic certifiers say no to nanotechnology................................................................................................................18
d. Responsible regulation in the European Union............................................................................................................18
e. U.S. regulatory inaction..........................................................................................................................................................18
f. Demanding regulatory action: FOE joins forces to sue the FDA...........................................................................19
6. Research Priorities........................................................................................................................................................................ 20
7. Policy Recommendations........................................................................................................................................................... 21
a. What government must do..................................................................................................................................................21
b. What industry must do.........................................................................................................................................................22
c. What concerned parents, individuals and organizations can do..........................................................................23
8. Appendices...................................................................................................................................................................................... 24
a. Appendix A: Methodology..................................................................................................................................................24
b. Appendix B: Results Summary..........................................................................................................................................25
9. References.........................................................................................................................................................................................28
Executive Summary throughout the United States. We commissioned
independent laboratory studies with a world-class
Unbeknownst to the general public, popular nanotechnology research facility at the Arizona
infant formulas sold throughout the United States State University (ASU) to learn more about the
contain infinitesimally small ingredients known as presence of engineered nanomaterials in popular
engineered nanoparticles or nanomaterials. While baby formulas. To our knowledge, these are the
some nanoscale ingredients may offer potential first laboratory studies focused on the detection of
benefits, their safety remains poorly understood, engineered nanomaterials in baby formulas that are
and a growing body of scientific research is raising marketed to the public.
concerns about their use in food and many other
consumer products. The groundbreaking analysis Friends of the Earth tested a selection of six baby
of nanomaterials in baby formula presented formula samples gathered from retailers in the San
here by Friends of the Earth is meant to inspire Francisco Bay Area.
greater public scrutiny, industry accountability We found nano-sized structures and particles of
and government regulation of nanotechnology, potential concern in all six of the baby formulas
particularly in the food sector. This analysis tested, including: Nano-hydroxyapatite (nano HA) in
builds on our 2014 nanotechnology report, Tiny needle-like and non needle-like form, nano titanium
Ingredients, Big Risks: Nanomaterials rapidly dioxide (TiO2), and nano silicon dioxide (SiO2) (the
entering food and farming. nano TiO2 and SiO2 results were inconclusive).
Nano ingredients pose threats to human health TiO2 was tentatively identified using a scanning
but are not regulated or assessed for safety before electron microscope (SEM) in the Similac® Advance®
they are put on the market. In the United States, OptiGRO™ (liquid) product, though after purchasing
the Food and Drug Administration (FDA) is charged a second sample several months later and using
with ensuring baby formulas are safe, however, a different separation process and transmission
the FDA does not approve the safety of infant electron microscopy (TEM) analysis, the presence of
formulas before they can be marketed. The FDA TiO2 could not be confirmed.
requires that baby formulas meet certain nutritional Nanoparticles found in popular baby
requirements and are screened for pathogens, and formulas tested by Friends of the Earth
companies must register with the FDA and provide
Baby Formula Brand Nanoparticles Found
a notice before marketing a formula. However, these
rules do not include screening or safety testing of Gerber® Good Start® Nano-hydroxyapatite
nanomaterials or other potentially toxic synthetic Gentle (nano HA)
ingredients. Baby formulas are intended for our Gerber® Good Start® Titanium dioxide and
most vulnerable population and should be regulated Soothe silicon dioxide (limited
with the utmost of care. A product fed to millions amount of particles
of infants should not be permitted to go to market detected)
if we are not certain that the ingredients it contains Enfamil™ Nano-hydroxyapatite
are safe for human consumption. All infant formulas (nano HA) in needle-like
should be thoroughly tested for safety. and non needle-like form
To put the nanoscale in context: a strand of DNA Similac® Advance® Titanium dioxide (nano
is 2.5 nm wide, a red blood cell is 7,000 nm wide, OptiGRO™ (liquid) TiO2 laboratory results
and a human hair is around 80,000 nm wide. One inconclusive)
nanometer is one billionth of a meter. One way Similac® Advance® Nano silicon dioxide
to understand how incredibly tiny these particles OptiGRO™ (powder) (laboratory results
are is to consider a tennis ball in comparison with inconclusive)
planet Earth. On scale, a tennis ball is the same Well Beginnings™ Nano-hydroxyapatite
size in relation to Earth as a nanoparticle is to a Advantage® (nano HA)
tennis ball.
Nanomaterials present novel risks to
Major baby formula brands contain human health
nanomaterials Recent studies have found that these nanomaterials
This analysis by Friends of the Earth reveals the use may pose risks to human health if ingested or
of engineered nanomaterials in baby formulas sold inhaled. Especially concerning: the nanomaterials
Nanoparticles in Baby Formula 4

found in the three powdered formulas we tested Nanomaterials are already used widely in
provide a probable inhalation hazard for babies, the commercial sector
parents and other care givers, as well as workers
Nanotechnology is a rapidly expanding, multi-billion
involved in the manufacturing of these products.
dollar industry involving manipulation of matter at
Nanomaterials have unique properties that the nanoscale. As of August 2008, the Project on
offer many new opportunities for food industry Emerging Nanotechnologies estimated that over
applications. They can be used as nutritional 800 manufacturer-identified nanotech products
additives, flavoring and coloring, anti-caking agents were publicly available, with new ones hitting the
or as antibacterial ingredients for food packaging. market at a pace of three to four each week.
However, the same properties exhibited at the
Many nanomaterials have already entered wide-
nanoscale that make these materials attractive for
scale commercial use and can be found in hundreds
use in the food industry may also result in greater
of products available on supermarket shelves,
toxicity for humans and the environment. (See full
including transparent sunscreens; light-diffracting
report for summary of the latest science).
cosmetics; penetration enhanced moisturisers; stain,
At the nanoscale, the physical, chemical, and optical moisture and odor repellent fabrics and clothing;
properties of familiar substances differ from those long-lasting paints and furniture varnishes; anti-
of the same substances in larger particle form. bacterial household appliances such as vacuum
Nanoparticles can be more chemically reactive and cleaners; refrigerators and air conditioners; and
more bioactive than larger particles. Because of sporting equipment.
their very small size, nanoparticles are more likely
Beyond baby formulas, other children’s products
than larger particles to enter cells, tissues and
that contain engineered nanoparticles include
organs.
skincare products and sunscreens, supplements,
food containers, pacifiers, teethers, blankets, toys
and stuffed animals, baby bottles, toothbrushes,
baby carriages, bibs, baby clothing and many other
products.
Nanotechnology is currently in the first generation
of innovation. In coming years and decades, the
next generation nanotechnology is forecast to
bring more complex nanodevices, nanosystems,
and nanomachines. Nanobiotechnology may be
used to manipulate the genetics of humans, animals
and agricultural plants at the atomic scale and
to incorporate synthetic materials into biological
organisms and biological materials into synthetic
structures.
EU responsible technology policies
European regulators have enacted a range of
precautionary policies for nanotechnologies.
The European Parliament is working towards
a moratorium on novel foods containing
nanomaterials. France, Belgium and Denmark
The European Union Scientific Committee on have implemented mandatory registries for
Consumer Safety (SCCS) finds that needle-like nanomaterials, and the EU has implemented a
nano-hydroxyapatite — one of the nanomaterials nanofood-labeling regime.
we found in Gerber®, Well Beginnings™, and
U.S. regulatory inaction
Enfamil™ formulas — is potentially toxic, could
be absorbed by and enter cells, and should not In stark contrast to the EU, the United States
be used in cosmetics such as toothpaste, teeth has not developed any mandatory regulations
whiteners and mouth washes. A material that or safety assessments for nanomaterials used in
should not be used in cosmetics raises greater food or consumer products. It is important for U.S.
concern when used in food. consumers to know that manufacturers are not

required to list nanomaterial ingredients on product Friends of the Earth, are calling for precautionary
packaging in the United States. In our investigation, action. More than 70 groups from six continents
Friends of the Earth did not find any baby formulas have endorsed a guiding document published
that listed nanoparticles as ingredients, including in 2007 called Principles for the Oversight of
the samples we found — via laboratory testing — to Nanotechnologies and Nanomaterials.
contain nanoparticles. In 2011, the Center for Food Safety, along with
Nanotechnology raises ethical and social Friends of the Earth and other organizations,
justice concerns filed a lawsuit calling out the FDA for failure to
Serious ethical and social justice concerns must be take action on a 2006 citizen petition to regulate
addressed in the regulation of nanotechnology. In nanotechnology. In response to the lawsuit, the FDA
the case of baby formula, infants may be at greater released voluntary, non-binding recommendations
risk of suffering health harms because of their more for industry that were finalized in 2014.
vulnerable physiology. Children’s immune, central Given the potentially serious health and
nervous, reproductive, and digestive systems are environmental risks and social implications
still developing, and at certain early stages of associated with nanofoods, Friends of the Earth
development, exposure to toxicants can lead to calls for a moratorium on the further commercial
irreversible damage which can increase risk of release of food products, food packaging, food
disease later in life. coatings, food contact materials and agrochemicals
Food sector workers represent another vulnerable that contain engineered nanomaterials until
population as they may come into contact with nanotechnology-specific safety and labeling
nanomaterials during production, packaging, laws are established and the public is involved in
transport and waste disposal of food, food decision-making.
packaging and agrochemicals. As one example, the Friends of the Earth recommends the FDA
U.S. Occupational Health and Safety Administration conduct a thorough review of the nanoparticle
states that nanoscale titanium dioxide, which ingredients found in baby formulas. The agency
we found in baby formula samples, is a potential must, in the meantime, use its authority to enforce
occupational carcinogen. manufacturer recall of baby formulas containing
Friends of the Earth and allied engineered nanoparticles, as these ingredients
organizations demand regulatory action may put people at risk.
In response to mounting scientific evidence on We also demand greater accountability and

the potential harms of nanotechnology, non- transparency from food producers and retailers to
governmental organizations worldwide, including allow consumers to make informed choices about

this novel set of technologies. If nanotechnology
is to be developed safely, responsibly and
transparently, there is an urgent need for further
research and dissemination of information to policy
makers, regulators, consumers and the scientific
community. Nano ingredients pose threats
Summary of recommendations: to human health but are not
For a detailed description of the following regulated or assessed for safety
recommendations, see the full report. before they are put on the market.
What government must do: A product fed to millions of infants
• Enact a moratorium on new commercial should not be permitted to go to
nanotech products market if we are not certain that
• Assess safety of and recall baby formulas with the ingredients it contains are
nanoparticle ingredients safe for human consumption.
• Regulate nanomaterials as novel substances
• Extend the size-based definition of
nanomaterials up to 500 nm in size
• Protect workers
• Ensure transparent, mandatory safety
assessment and product labeling
What industry must do:

• Recall formula containing nanomaterials
• Remove nanomaterials from product formulas
• Create nanomaterial policies
• Ensure transparency in the supply chain
What concerned parents, individuals and

organizations can do:
Until government and companies manage
nanotechnology in a responsible and transparent
manner, there are steps we can take to protect our
health.
• Breastfeed when and if possible
• Hold government and industry accountable: Join
Friends of the Earth to demand a moratorium
on the use of nanotechnology in the food sector
and urge policy makers to regulate and label
food, food packaging and agricultural products
containing manufactured nanomaterials
• Contact baby formula manufacturers and
ask them to remove nanomaterials from their
products
Visit our website to learn more about
nanotechnology, take action and support our efforts
to create a safe, just, resilient and sustainable food
system. http://www.foe.org/nanotechnology

1. Introduction according to the agency’s own assertion, “The FDA
does not approve infant formulas before they can
Unbeknownst to the general public, popular be marketed” (U.S. Food and Drug Administration,
infant formulas sold throughout the United States 2014a). The FDA requires that baby formulas meet
contain infinitesimally small ingredients known as certain nutritional requirements and be screened
engineered nanoparticles or nanomaterials.1 The for pathogens, and companies must register with
safety of these nanoscale ingredients remains the FDA and provide a notice before marketing a
poorly understood and a growing body of scientific formula (FDA, 2014a). However, these rules do not
research is raising concerns about their use in include screening or safety testing of nanomaterial
food and many other consumer products. The ingredients. All infant formulas should be thoroughly
groundbreaking analysis of nanomaterials in baby tested for safety before entering the market.
formula presented here by Friends of the Earth is
meant to inspire greater public scrutiny, industry The use of minimally tested, unlabeled nanoscale
accountability and government regulation of materials in children’s products, a broad array of
nanotechnology, particularly in the food sector. This consumer products, food and agriculture is growing
analysis builds on our 2014 report, Tiny Ingredients, despite evidence that these materials can be
Big Risks. toxic to human health and the environment. While
regulators in the EU have taken action to regulate
Nanotechnology is a rapidly expanding, multi-billion nanomaterials in food and consumer products, the
dollar industry involving manipulation of matter at lack of safety assessment, oversight and labeling of
the molecular scale. As of August 2008, the Project nanomaterial ingredients in the United States further
on Emerging Nanotechnologies estimated that over exacerbate concerns.
800 manufacturer-identified nanotech products
were publicly available with new ones hitting the
market at a pace of three to four each week (Project
on Emerging Nanotechnologies (PEN), 2015a).
Nanomaterials have unique properties that
offer many new opportunities for food industry
applications. They can be used as nutritional
additives, flavoring and coloring, anti-caking agents
or as antibacterial ingredients in food packaging.
However, the same properties exhibited at the
nanoscale that make these materials attractive for
use in the food industry may also result in greater To put the nanoscale in context: a strand of
toxicity for humans and the environment. DNA is 2.5 nm wide, a red blood cell is 7,000 nm
At the nanoscale, the physical, chemical and optical wide, and a human hair is 80,000 nm wide. One
properties of familiar substances differ from those nanometer is one billionth of a meter. One way
of the same substances in larger particle form. to understand how incredibly tiny these particles
Nanoparticles can be more chemically reactive and are is to consider a tennis ball in comparison with
more bioactive than larger particles. Because of planet Earth. On scale, a tennis ball is the same
their very small size, nanoparticles are more likely size in relation to Earth as a nanoparticle is to a
than larger particles to enter cells, tissues and tennis ball.
organs.
a. Breastfeeding: Benefits and barriers
Nano ingredients pose novel threats to human
health but are not regulated or assessed for It is estimated that worldwide, baby food and
safety before they are put on the market. There formula sales will amount to 30 billion USD in 2015
is no nanotechnology-specific regulation or (Nielsen, 2015). Yet, data proves that breast milk
safety assessment required before manufactured is indisputably the healthiest food for a growing
nanomaterials can be used in food, food packaging infant and helps to reduce health risks for both
or agricultural products in the United States. The mother and child (U.S. Department of Health and
U.S. Food and Drug Administration is charged Human Services, 2011). However, mothers face
with ensuring baby formulas are safe, however, myriad obstacles to breastfeeding. The U.S. Office
1 Nanotechnology is the engineering of functional systems at the molecular scale. For the purposes of this report, we use the term “nano” to
include particles up to 500nm in size, due to the evidence of nano-specific problems associated with particles up to this size range. We use
the terms nanomaterial and nanoparticle interchangeably.

of the Surgeon General has identified many of these transport and waste disposal of food, food
barriers, which range from the influence of social packaging and agrochemicals. As one example,
norms and the marketing of breast milk substitutes OSHA states that nanoscale titanium dioxide, which
to health problems, employment and childcare, we found in some of the baby formula samples we
lack of support or fear of stigma (U.S. HHS, 2011). tested, is a potential occupational carcinogen.
These barriers make it essential for families to have
a safe and healthy alternative for feeding (U.S.
HHS, 2011). It is also important to note that in many
cases mothers may not be able to or choose not to
breastfeed.
b. Nanotechnology raises ethical and social justice
concerns
Serious ethical and social justice concerns must be
addressed in the regulation of nanotechnology. In
the case of baby formula, infants may be at greater
risk of suffering health harms from exposure to
toxics like nanomaterials because of their more
vulnerable physiology (Moya, Bearer, & Etzel, 2004).
Children’s immune, central nervous, reproductive
and digestive systems are still developing, and at
certain early stages of development, exposure to
toxicants can lead to irreversible damage which can
increase risk of disease later in life.
An additional concern is that low-income families
are given baby formulas at no cost via the U.S.
Special Supplemental Nutrition Program for Women, Nanotechnology and the Environment
Infants and Children (WIC) (Kent, 2006), thereby
The data presented here focus on human health
increasing their children’s potential exposure to
concerns. For an overview of environmental risks
nanomaterials in baby formula.
associated with nanotechnology, see our 2014
Food sector workers represent another vulnerable report, Tiny Ingredients, Big Risks: Nanomaterials
population as they may come into contact with rapidly entering food and farming
nanomaterials during production, packaging,

electron microscope (SEM) in the Similac® Advance®
OptiGRO™ (liquid) product, though after purchasing
a second sample several months later and using
a different separation process and transmission
electron microscopy (TEM) analysis, the presence of
TiO2 could not be confirmed.
To our knowledge, these are the first laboratory
studies focused on the detection of engineered
nanomaterials in baby formulas that are marketed
to the public.
• The Gerber® Good Start® Gentle, Well Beginnings
Arizona State University laboratory. ™ Advantage® and Enfamil ™ formula samples
were found to contain nano-hydroxyapatite
2. Findings & Analysis (note: two separate samples of Gerber® Good
Start® Gentle were tested three times and
Friends of the Earth commissioned independent
found to contain nano HA; duplicate tests were
laboratory testing of baby formulas with a world-
conducted on all samples).
class nanotechnology research facility at the
Arizona State University (ASU). Table 1 below • The Gerber® Good Start® Soothe baby formula
provides a summary of our test results. This section likely contains nano titanium dioxide (TiO2)
also provides a brief summary of toxicological and nano silicon dioxide (SiO2) (note: limited
concerns for the nanoparticles found. Descriptions amount of particles detected).
of the likely function of these nano ingredients • The Similac® Advance ® OptiGRO™ (liquid)
were drawn from publically accessible information baby formula likely contains titanium dioxide
from manufacturers, scholarly articles, government nanoparticles (nano TiO2) (note: laboratory
documents and other media and research materials. results were inconclusive).
See Appendix A for details on study methodology
• The Similac® Advance® OptiGRO™ (powder)
and Appendix B for additional details about
baby formula likely contains nano silicon dioxide
laboratory results.
(note: laboratory results were inconclusive).
a. Major baby formula brands contain
Table 1: Nanoparticles found in popular baby
nanomaterials
formulas tested by Friends of the Earth
Friends of the Earth tested a selection of six baby
formula samples gathered from retailers in the Baby Formula Brand Nanoparticles Found
San Francisco Bay Area. We found nano-sized Gerber® Good Start® Nano-hydroxyapatite
structures and particles of potential concern in all Gentle (nano HA)
six of the baby formulas tested, including: Nano-
hydroxyapatite (nano HA) in needle-like and non Titanium dioxide and
needle-like form, nano titanium dioxide (TiO2), and Gerber® Good Start® silicon dioxide (limited
nano silicon dioxide (SiO2) (the nano TiO2 and SiO2 Soothe amount of particles
results were inconclusive). detected)
TiO2 was tentatively identified using a scanning Nano-hydroxyapatite

Enfamil™ (nano HA) in needle-like
and non needle-like form
Baby formulas are intended for our
Titanium dioxide (nano
most vulnerable population and Similac® Advance®
TiO2 laboratory results
OptiGRO™ (liquid)
should be regulated with the utmost inconclusive)
of care. A product fed to millions of Silicon dioxide
Similac® Advance®
infants should not be permitted to (laboratory results
OptiGRO™ (powder)
go to market if we are not certain inconclusive)
that the ingredients it contains are Well Beginnings™ Nano-hydroxyapatite
safe for human consumption. Advantage® (nano HA)

Recent studies have suggested that these toothpaste, teeth whiteners and mouth washes (EU
nanomaterials may pose risks to human health if SCCS, 2014; EU SCCS, 2015). The SCCS opinion
ingested or inhaled (see below health concerns for states: “The available information indicates that
each nanomaterial found). Especially concerning: nano-hydroxyapatite in needle form is of concern
the nanomaterials found in the three powdered in relation to potential toxicity. Therefore, needle-
formulas we tested provide a probable inhalation shaped nano-hydroxyapatite should not be used in
hazard for babies, parents and other care givers, cosmetic products.”
as well as workers involved in the manufacturing Some chemical company material safety data
of these products (Note: inhalation concerns would sheets (MSDS) list hydroxyapatite as an inhalation
not pertain to the liquid version of the Similac® hazard and cite the lack of data available to
Advance® formula). provide a complete safety profile (Sigma-Aldrich,
Baby formulas are intended for our most vulnerable 2008; Merz NA, Inc., 2015). Other similarly shaped
population and should be regulated with the utmost needle-like nanoparticles have been shown to
of care. A product fed to millions of infants should have the potential to cause diseases in the lungs
not be permitted to go to market if we are not similar to those caused by inhalation exposure to
certain that the ingredients it contains are safe for asbestos, including mesothelioma and lung cancer
human consumption. (Poland et al., 2008; Jacobs, 2014; HHS et al., 2013).
Additionally, a 2014 study found that both nano HA
b. INGREDIENT: Nano- and nano titanium dioxide (TiO2) increased reactive
hydroxyapatite (nano HA) oxygen species (ROS) and inflammation in cells (Tay
et al., 2014).
FORMULAS: Gerber®, Well Further research could ascertain if the needle-like
Beginnings ™ and Enfamil™ shape of nano HA could become an inhalation
hazard for parents and children as the formula is
Potential Uses sold in powder form. Another important research
Nano-hydroxyapatite is most likely a calcium source question would be to understand if the nano version
for these baby formulas. It can also be used to of this calcium supplement could produce an
stabilize the ingredients in the formula mixture. undesirable increase in calcium intake. Increased
Conventional hydroxyapatite is used as a calcium calcium absorption can cause hypercalcemia and
source for supplements and is derived from the interfere with brain and heart function (Mayo Clinic,
bones of cows. Hydroxyapatite forms 70 percent of 2015).
our bones (International Osteoporosis Foundation,
2015). Through nanotechnology, hydroxyapatite can c. INGREDIENT: Nano titanium
now be manufactured into needle-like nanoparticles dioxide (TiO2) (note: laboratory
to take advantage of properties at the nanoscale. results inconclusive)
Nano HA is described in scientific literature as a FORMULA: Similac® Advance
novel ingredient used experimentally for rebuilding ® liquid version; Gerber® Good
bones in surgery and to repair tooth enamel (Huber Start® Soothe
et al., 2006; McArthur et al., 2013; Tschoppe et
Potential Uses
al., 2011). Toothpaste containing nano HA can be
purchased in the United States, many brands and Nano TiO2 is a brightener or whitener for food and
dozens of products are available for purchase online beverage products and is also used as an anti-
(Amazon, 2015). Friends of the Earth did not find caking agent.
any description of nano HA use in baby formula, Health Concerns
however, some manufacturers list a food use for this
In contrast to bulk particles of titanium dioxide,
ingredient among other advertised applications (Del
nanoscale titanium dioxide is biologically very
Nanbio Technology GMBH, 2015).
active. Studies show that titanium dioxide can
Health Concerns damage DNA (Trouiller et al., 2009), disrupt the
In October of 2015, the European Union Scientific function of cells, interfere with the defence activities
Committee on Consumer Safety (SCCS) provided of immune cells and, by adsorbing fragments of
evidence that needle-like nano-hydroxyapatite bacteria and ‘smuggling’ them across the gastro-
is potentially toxic, could be absorbed and enter intestinal tract, can provoke inflammation (Ashwood
cells and should not be used in cosmetics such as et al., 2007; Donaldson et al., 1996; Dunford et al.,

1997; Long et al., 2006; Lucarelli et al., 2004; Wang
et al., 2007b). A single high oral dose of titanium
dioxide nanoparticles was found to cause significant
lesions in the kidneys and livers of female mice
(Wang et al., 2007b).
Nano titanium dioxide is highly mobile in the body
and has been detected in both humans and animals
in the blood, liver and spleen (Landesanstalt für
Umwelt, Messungen und Naturschutz Baden-
Württemberg (LUBW), 2010). A 2015 study found
that food grade TiO2 can be absorbed in the
bloodstream (Laetitia et al., 2015). A study using
pregnant mice found that nanoparticles of titanium
dioxide were transferred from mother to offspring
and was associated with brain damage, nerve
system damage and reduced sperm production in
male offspring (Takeda et al., 2009).
d. INGREDIENT: Nano silicon

dioxide (SiO2) (note: laboratory
results inconclusive)
FORMULA: Similac® Advance®

OptiGRO™ powder version;
Gerber® Good Start® Soothe
Potential Uses
Arizona State University (image 1) Arizona State University
Used as a ‘trickle and flow’ aid in powdered food laboratory where baby formulas were tested.
products, as a clearing agent in beer and wine, as a
food additive (amorphous silicon found to be nano)
and as a food coating.
Health Concerns
Nanosilicon has been found in the livers of rats and
mice after oral administration. In vitro studies show
a significant percentage of the nanosilicon remains
undissolved and that “the presence of undissolved
nanosilicon particles in the gut in vivo is considered
likely” (Dekker et al., 2013; SRU, 2011). Animal
studies have shown placental transfer and foetal
uptake of silicon. Scientists have warned that the
enhanced sensitivity of the foetus may mean that
even low doses of nanomaterials may cause adverse
effects (Correia et al., 2015).

3. Background: An introduction & Kallinteri, 2006). When considering the health
and environmental implications of nanoparticles,
to nanotechnology their size range must be more broadly defined. It
The term “nanotechnology” does not describe is essential to also consider the hazards associated
a singular technology but rather encompasses a with sub-micron (100-1,000 nm) particles and
range of technologies that operate at the scale of microparticles (greater than 1,000 nm).
the building blocks of biological and manufactured The problematic nature of the arbitrary 100 nm
materials — it constitutes manipulation of matter on ceiling is underscored by studies showing that small
an atomic, molecular and supramolecular scale. particles outside this size range can pose greater
The term nanotechnology is generally understood to health hazards than particles within it. Wang et al
encompass both nanoscience and the broad range conducted an in vivo study in which 20 nm and 120
of technologies that operate at the nanoscale: nm particles of zinc oxide powder were fed to mice
(Wang et al., 2007). Both nanoparticles resulted in
• Nanoscience: The study of phenomena
organ damage and thickening of the test animals’
and materials at the atomic, molecular and
blood, but it appeared that the larger nanoparticles
macromolecular scales, where properties differ
actually resulted in greater liver damage. In another
from those at the larger scale.
in vivo experiment, mice were fed high doses of 58
• Nanotechnology: Design, characterization, nm and 1,058 nm zinc powder. The microparticle
production and application of structures, devices zinc caused more severe liver damage, while the
and systems by controlling shape and size at the nanoparticle zinc caused anaemia and more severe
nanoscale. kidney damage (Wang B, 2006).
• Nanomaterials: articles, nanotubes, nanowires, In a 2010 report, the UK’s House of Lords Science
quantum dots, fullerenes (Buckyballs) etc. and Technology Committee recommended that
any definition of a nanomaterial must be based on
a. Defining nanomaterials for health and safety
evidence for behavior that is different from that
There is still no internationally accepted set seen in the bulk, rather than some arbitrary size
of definitions and measurement systems for such as 100 nm (Nature Nanotechnology, 2010).
nanotechnology, although work towards these has The authors of a review of the nanotoxicological
begun. For the purpose of this report we use the implications of nanomedicines suggest that: “In
term “nano” to include particles up to 500 nm in practice, the useful range of nanomedicines more
size due to the evidence of nano-specific problems normally falls within the range of 5-250 nm as these
associated with particles up to this size range. tend to have a similar range of properties based
We urge regulators to adopt this definition — the on physiological and anatomical consequences”
health and environmental hazards of nanoparticles (Garnett & Kallinteri, 2006). Researchers
should be based on physiological and anatomical investigating the biological effects of nanoparticles
behaviors of small particles rather than arbitrary have also defined their relevant size range to be
size distinctions. up to a few hundred nanometres (Hansen et al.,
The definition of nanomaterials is in flux. The U.S. 2006). Still other researchers publishing in the
Food and Drug Administration uses a definition drug delivery (Des Rieux et al., 2006) and food
of 1-1,000 nm for drugs and requests information (Sanguansri & Augustin, 2006) (Mozafari et al.,
for ingredients less than 1,000 nm in size for other 2006) literature have argued that a useful size
products it regulates. The European Medicines definition for nanomaterials used in these fields is
Agency also defines nanotechnology in a size range 1-1,000 nm.
of less than 1,000 nm across. b. Manufactured vs. incidental nanoparticles
Despite these definitions, there is an emerging Manufactured nanoparticles are those that are
trend to define nanotechnology as only applying deliberately produced, in contrast to nanoparticles
to materials, structures and systems that measure that “exist in nature,” or are by-products of other
no more than 100 nm in size. This distinction is human activities. Manufactured nanomaterials
artificial, especially from the viewpoint of biological include nanoparticles (e.g. metal oxides) and also
interactions. Many particles, which measure more nanostructures such as nanotubes, nanowires,
than 100 nm, present a suite of physiological quantum dots, dendrimers and carbon fullerenes
and anatomical behaviors, for example greater (Buckyballs), among others.
reactivity, bioactivity and bioavailability (Garnett
“Incidental” nanoparticles (also called ultrafine

particles in the study of air pollution and its properties of familiar substances differ from those of
epidemiology) are a by-product of forest the substances in larger particle form. For example,
fires, volcanoes, vehicle combustion and high- in larger particle form zinc oxide (ZnO) is white and
temperature industrial processes including opaque, as a nanoparticle zinc oxide is transparent,
combustion, welding and grinding (Institute of enabling it to be used to provide UV protection in
Occupational Medicine, 2004). products such as transparent cling wrap packaging.
c. Nanomaterials are already used widely for their In nanoparticle form, the antimicrobial properties
novel properties of silver are far greater, a property which has
encouraged manufacturers to use it in chopping
Many nanomaterials have already entered wide- boards, refrigerators, food storage containers and
scale commercial use and can be found in food packaging.
hundreds of products available on supermarket
shelves, including transparent sunscreens; light- Altered properties of nanoparticles are a result
diffracting cosmetics; penetration enhanced of both the influence of quantum mechanics1
moisturisers; stain-, moisture- and odor-repellent and the much greater relative surface area that
fabrics; long-lasting paints and furniture varnishes; nanomaterials have compared with larger particles.
anti-bacterial household appliances such as The large surface area of nanomaterials results in
vacuum cleaners, refrigerators and air conditioners; their increased chemical reactivity and biological
and sporting equipment (Project on Emerging activity (Nel et al., 2006), making them attractive
Nanotechnologies (PEN), 2015a). for use in food fortification (adding micronutrients
to foods) or as antimicrobials in food packaging.
However, the altered properties of nanomaterials,
especially their high chemical reactivity and greater
capacity to penetrate biological membranes, also
present serious new toxicity risks (Royal Society &
Royal Academy of Engineering, 2004).
Nanotechnology has existing and potential
applications in all aspects of agriculture, food
processing, food packaging and even farm and food
monitoring. These include:
• Methods to enable foods such as soft drinks, ice
cream, chocolate, or chips to be marketed as
Beyond baby formulas, children’s products that “health” foods by reducing fat, carbohydrate or
contain engineered nanoparticles include skincare calorie content or by increasing protein, fiber or
products and sunscreens, supplements, food vitamin content;
containers, pacifiers, teethers, blankets, toys and • Production of stronger flavoring, coloring,
stuffed animals, baby bottles, toothbrushes, baby nutritional additives and processing aids to
carriages, bibs, baby clothing and many other increase the pace of manufacturing and to lower
products (PEN, 2015b). costs of ingredients and processing;
Nanotechnology is currently in the first generation • Development of foods with novel colors, flavors
of innovation. In coming years and decades, next or nutritional properties to suit consumers’
generation nanotechnology is forecast to bring dietary needs, allergies or taste preferences;
more complex nanodevices, nanosystems and
nanomachines (Roco, 2001). Nanobiotechnology • Packaging or edible coatings to increase
may be used to manipulate the genetics of humans, food shelf life by detecting spoilage, bacteria
animals and agricultural plants at the atomic or the loss of food nutrients, and to release
scale, and to incorporate synthetic materials into antimicrobials, flavors, colors or nutritional
biological organisms and biological materials into supplements;
synthetic structures (Roco & Bainbridge, 2003). • Re-formulation of on-farm inputs to produce
d. Why are food and agriculture companies more potent fertilizers, plant growth treatments
interested in nanotechnology? and pesticides that respond to specific
conditions or targets.
At the nanoscale, the physical, chemical and optical
1 A fundamental branch of physics concerned with describing the interactions and motions of tiny molecules, atoms, and even smaller matter.

4. Health Concerns: Novel The absorption rate of substances via the
gastrointestinal tract appears to depend on
risks from nanomaterials and properties such as size and surface structure. In one
nanofoods study looking at rats, the smaller the nanoparticles,
the higher the uptake via the digestive tract. (LUBW,
The lack of standards and internationally recognized 2010) In another study, mice were fed 4 nm gold
measurement methods coupled with the lack of particles; these were later detected in the liver,
transparency of the nanotechnology industry create kidney, spleen, lung and brain. Larger particles
significant challenges to understanding where (58 nm) remained in the gastrointestinal tract
engineered nanoparticles are being used and what (Sachverständigenrat für Umweltfragen (SRU),
the potential routes of exposure are. 2011). Nanoparticles also show greater adhesion
Nanomaterials have unique properties that to biological surfaces within our bodies versus
offer many new opportunities for food industry larger particles (for example, the walls of our
applications. However, the same properties gastrointestinal tract), which can increase rates of
exhibited at the nanoscale which make these uptake (Chen et al., 2006a).
materials attractive for use in the food industry Powell et al have observed that the daily exposure
may also result in greater toxicity for humans and of people in the Western world to sub-micrometer-
the environment. sized mineral particles has resulted in “pigmented
Nanoparticles pose new risks because: cells” in parts of the intestinal tract, meaning cells
• They can be more chemically reactive and more loaded with these particles (e.g. aluminosilicates
bioactive than larger particles of the same titanium dioxide). The particles have been observed
chemicals. to be composed of aluminosilicates, titanium dioxide
and a small percentage of non-aluminum-containing
• Due to their very small size, nanoparticles have silicates such as silicon (SiO2) and magnesium
been demonstrated to be more likely than larger trisilicate (talc) (Powell et al., 2010; Powell et al.,
particles to enter cells, tissues and organs. 1996).
• Greater bioavailability and greater bioactivity In the July 19, 2012, report, “Effects of Silver
may introduce new toxicity risks. Nanoparticles on the Liver and Hepatocytes in
vitro,” published in Toxicological Sciences, author
Birgit Gaiser, Ph.D., states,
At the moment, there is not much information
available on the topic of ingested nanoparticles
and human health. There is evidence that a
small percentage of these particles or particle
components [of nano titanium dioxide or nano
silver]…can move on from the intestinal tract
into the blood, and reach other organs. This is
why we believe it is important to assess the risk
of even small amounts of particles in the human
body (Belli, 2012).
Studies have shown that nanomaterials may affect
the human intestine. When human colon cells
were treated with nano-sized polystyrene, which is
commonly used in food packaging, the cells became
more permeable to iron (Spiegel, 2012).
a. Permeability and absorption b. Crohn’s disease and immune system dysfunction
Numerous in vivo experiments using rats and mice It is well known that people with asthma are
have demonstrated gastrointestinal uptake of especially susceptible to air pollution. In effect,
nanoparticles (Chen et al., 2006; Desai et al., 1996; asthma sufferers act as the proverbial “canary
Hillyer & Albreicht, 2001; Wang et al., 2007; Wang et in the coal mine,” alerting those around them
al., 2007b) and small microparticles (Hazzard et al., that air pollution levels are getting dangerously
1996; McMinn et al., 1996; Wang et al., 2006). high. Scientists have more recently suggested

that the growing prevalence of Crohn’s disease Preliminary environmental studies also suggest
— a damaging and chronic inflammation of the that these substances may be toxic to ecologically-
gastrointestinal tract that can lead to cancer — important species such as water fleas (Bang et al.,
may be a similar warning signal in relation to 2011). For more on environmental concerns, see the
microparticles in our food (Ashwood et al., 2007). Friends of the Earth report Tiny Ingredients, Big
Some data suggests that existing levels of Risks.
nanoparticles up to a few hundred nanometers
in size in processed food may be associated with
rising levels of immune system dysfunction and
inflammation of the gastrointestinal tract, including
Crohn’s disease (Ashwood et al., 2007; Gatti et al.,
2004; Lomer et al., 2001; Lucarelli, et al., 2004).
Individuals with Crohn’s disease or colon cancer
have been found with nanomaterials in their
intestinal tissue (SRU, 2011).
This data points to the need for more research. The
relationship between the development of Crohn’s
disease and factors such as genetic susceptibility,
immune system health, psychological health and
environmental factors, including exposure and
physiological response to nano or microparticles, e. Occupational health and safety concerns
remains poorly understood. Other theories point In the food sector, workers may come into
to abnormal or exaggerated response to the contact with nanomaterials during production,
individual’s intestinal bacteria as a mechanism of packaging, transport and waste disposal of food,
action for Crohn’s. food packaging and agrochemicals (European
c. Additional health concerns Food Safety Authority (EFSA), 2009). However, in
the absence of a mandatory registration, worker
Nanoparticles of silver, titanium dioxide, zinc and notification or product labeling, many workers may
zinc oxide — materials now used in nutritional be unaware that they are handling nanomaterials or
supplements, food packaging and food contact that they may need to use protective equipment.
materials — have been found to be toxic to cells in Additionally, it is not currently clear in the literature
test tube and animal studies. if existing Personal Protective Equipment (PPE) can
In 2009, a team led by Roel Schins at the protect individuals from nanoscale particles.
Environmental Health Research Institute in To date, there is very little data relating to the
Düsseldorf, Germany, published research suggesting exposure of workers to nanomaterials. A number
that some nanoparticles, including silicon and of nanomaterials used in the food industry, such as
titanium dioxide, can induce DNA damage in human zinc oxide and titanium dioxide, have been shown
intestinal cells (Gerloff et al., 2009). to be harmful when inhaled, raising occupational
d. Wastewater and environmental concerns health and safety concerns for workers handling
these materials. The U.S. Occupational Safety and
The final disposition of nanomaterials and their
Health Administration (OSHA) has cautioned, “…
entry into the environment is also of concern.
certain inhaled nanoparticles may be deposited in
Nanomaterials from products or food, such as
the respiratory tract and may cause inflammation
leftover formula, can end up going down drains and
and damage to lung cells and tissues” (OSHA, 2013).
arrive in wastewater treatment plants. Wastewater
OSHA has furthermore stated that, nanoscale TiO2
treatment plants (WWTPs) are concerned about
particles have higher mass-based potency than
nanomaterials because they do not behave the
larger particles and that occupational exposure (by
way relevant bulk materials behave. WWTPs are
inhalation) to nanoscale TiO2 particles is considered
especially concerned about nano-metals because
a potential occupational carcinogen (OSHA, 2013).
some metals — such as silver and copper — are
more toxic to aquatic animals. These issues Studies have also shown that nanomaterials
have been highlighted by various U.S. agencies/ can enter the bloodstream via the lungs, raising
associations (Tri-TAC, 2011; National Association of major occupational health and safety concerns
Clean Water Agencies (NACWA), 2015). (Oberdörster et al., 2005).

POTENTIAL HEALTH EFFECTS OF
NANOPARTICLES FOUND IN BABY FORMULA
Summary of scientific data*
Associated with brain damage, nerve

system damage and reduced sperm
production in male mouse offspring
Inhalation hazard
Can be absorbed by and enter cells
Highly mobile throughout body; detected in

human blood, liver and spleen
Increased reactive oxygen species and

inflammation in cells
DNA damage
Gastrointestinal inflammation
Lesions in kidney and liver of mice exposed

to high oral dose
Interferes with defense activities of immune

cells
Transferred from mother to offspring in

mouse studies
Nano hydroxyapatite
• Can be absorbed by and enter cells
• Increased reactive oxygen species and inflammation in cells
• Inhalation hazard
Nano silica
• Found in livers of rats and mice after oral administration
• Placental transfer and fetal uptake
Nano titanium dioxide
• DNA damage
• Interferes with defense activities of immune cells
• Gastrointestinal inflammation
• Lesions in kidney and liver of mice exposed to high oral dose
• Increased reactive oxygen species and inflammation in cells
• Detected in human blood, liver and spleen
• Transferred from mother to offspring in mouse study; associated
with brain damage, nerve system damage and reduced sperm
production in male offspring
* Drawn from studies of nano hydroxyapatite, nano silicon and nano titanium oxide;
not all impacts pertain to each nanoparticle. For complete details see report.

5. Regulation of accompanied by a fact sheet (As You Sow, 2015)
to inform companies and consumers about the
Nanotechnology potential risks of nanomaterials. The goal of the
Research and regulation are not keeping up with the policy is to provide a single set of recommendations
pace of commercialization of nanotechnologies. Yet, for food manufacturers endorsed by groups working
governments, scientists and scientific bodies such as on nanomaterials policy issues to avoid confusion
the U.S. National Research Council have presented and multiple sets of recommendations. However,
more than sufficient evidence to justify a proactive we recognize that voluntary measures do not fill
regulatory regime and a properly funded research the gaping hole left by a lack of regulation to guide
program that will effectively target areas of greatest industry and protect workers, public health and the
environmental and health concern. environment.
a. Principles for the Oversight of Nanotechnologies c. Organic certifiers say no to nanotech

and Nanomaterials The largest organic certifiers in several countries
In response to mounting evidence of harm and the have banned the use of engineered nanoparticles
lack of government oversight, in 2007 a coalition in food as part of their standards of organic
of domestic and international advocacy groups, production and processing, including the UK’s
including Friends of the Earth, called for strong, Soil Association (Smithers, 2008), the Biological
comprehensive, oversight of the technology and Farmers of Australia (Biological Farmers of Australia
its products and urged action based on eight (BFA), 2012) and the Canada General Standards
principles: 1) a precautionary foundation, 2) Board (Organic & Non-GMO Report, 2010).
mandatory nano-specific regulations, 3) health and d. Responsible regulation in the European Union
safety of the public and workers, 4) environmental
Regulators in the European Union (EU) have
protection, 5) transparency, 6) public participation,
taken various steps to protect public health vis
7) inclusion of broader impacts and 8) manufacturer
a vis nanotechnology. The European Parliament
liability. These demands were published as the
is negotiating a possible moratorium on novel
Principles for the Oversight of Nanotechnologies
foods containing nanomaterials (European
and Nanomaterials, which was endorsed by more
Parliament, 2014). France, Belgium and Denmark
than 70 groups from six continents.
have implemented mandatory registries for
b. Nanomaterials Policy Recommendations nanomaterials, and the EU has implemented a
nanofood-labeling regime.
Responding to rising concern about manufacturers
using unregulated nanomaterials in food, a coalition In relation to one of the nano-ingredients found
of advocacy groups in the U.S. and abroad, led in our study (nano-hydroxyapatite or nano HA)
by As You Sow, released Nanomaterials Policy the European Commission, which is the main
Recommendations (As You Sow et al., 2015) for executive body of the European Union, states,
companies in food-related industries to assist them “The Commission has concerns on the use of
in avoiding or reducing the risks from nanomaterials Hydroxyapatite in nano form because of the
in food products and packaging. potential for nanoparticles of Hydroxyapatite to be
absorbed and enter into the cells” (EU Scientific
The recommendations urge companies to: Committee on Consumer Safety (SCCS), 2014). In
October of 2015, the EU Commission’s Scientific
• Adopt a detailed public policy explaining their
Committee on Consumer Safety (SCCS) published
use of nanomaterials, if any;
an opinion on nano HA stating, “The available
• Publish a safety analysis for any nanomaterials information indicates that nano-hydroxyapatite
being used; in needle form is of concern in relation to
• Issue supplier standards; potential toxicity. Therefore, needle-shaped nano-
hydroxyapatite should not be used in cosmetic
• Label all products that contain nanoparticles
products” (SCCS, 2015).
smaller than 500nm; and
e. U.S. regulatory inaction
• Adopt a hierarchy of hazard controls approach
to prevent exposure of employees to In stark contrast to the precautionary action being
nanomaterials. taken in the EU, the U.S. response has largely been
one of regulatory inaction. The U.S. Food and Drug
The nanomaterials policy recommendation is
Administration (FDA) is charged with ensuring the

safety and security of our nation’s food supply, yet
the agency has not developed binding guidance for
industry on the use of nanomaterials in food and
consumer products.
U.S. consumers remain in the dark about the
presence of nanomaterials in products they
purchase. No product registry or labeling
requirements are in place. The lack of established
regulations allows foods with nano ingredients to
remain on the market while the public unknowingly In stark contrast to the
takes on potential health risks. It is important for precautionary action being taken in
U.S. consumers to know that manufacturers are not
required to list nanomaterial ingredients on product
the EU, the U.S. response has largely
packaging in the United States. been one of regulatory inaction. The
Friends of the Earth was unable to find any baby U.S. Food and Drug Administration
formula products in which include nanoparticles (FDA) is charged with ensuring the
were listed ingredients, including the samples safety and security of our nation’s
we found to contain nanoparticles via laboratory food supply, yet the agency has not
testing.
developed binding guidance for
Governments, scientists and scientific bodies
industry on the use of nanomaterials
such as the U.S. National Research Council have
presented more than sufficient evidence to justify a in food and consumer products.
proactive regulatory regime and a properly funded
research program that will effectively target areas of four other non-profit organizations, filed a lawsuit
greatest environmental and health concern. regarding the agency’s failure to respond to their
f. Demanding regulatory action: FOE joins forces to 2006 petition.
sue the FDA In its formal response to the lawsuit, FDA took
In 2006, a group of eight non-profit organizations, steps in the right direction by acknowledging that
including Friends of the Earth, submitted a citizens there are differences between nanomaterials and
petition to the U.S. Food and Drug Administration their bulk counterparts and that nanomaterials have
demanding that the government formally recognize potential new risks and may require new testing.
the inherent differences of nanomaterials and In 2014, the agency finalized a voluntary, non-
address their associated new risks to human binding guidance for industry. In the guidance,
health and the environment by regulating their FDA proposed classifying nanomaterials as food
use in consumer products. In response, the FDA additives, which would require premarket testing
took a number of preliminary actions including and approval. The FDA states in its guidance that
forming a task force, which issued a report and they “are not aware of any food ingredient...on
recommendations, holding multiple public meetings the nanometer scale for which there are generally
and workshops and publishing a number of FDA available data sufficient” to determine that the
scoping documents and guidance. ingredient is Generally Recognized As Safe (U.S.
However, by 2011, the FDA had still not issued FDA, 2014b).
binding regulations. In December 2011, the Center In other words, FDA likely will not accept industry
for Food Safety, along with Friends of the Earth and claims that nano-scale food substances can be
assumed to be safe simply because their macro-
scale counterparts are deemed to be safe. However,
None of the baby formulas found
the agency continues to decline to enact mandatory
to contain nanoparticles listed regulations.
nano ingredients on the label. U.S. In alignment with FDA’s 2014 guidance, Friends
consumers remain in the dark about of the Earth believes that the nanoparticles we
the presence of nanomaterials in found in commercially available baby formulas
products they purchase. must undergo premarket safety assessment and
approval.

6. Research Priorities in their risk assessment. Nanoparticles may
interact with other substances present in the
Although sufficient data exists to inform food matrix, and such effects and interactions
precautionary action on nanotechnology, there is of engineered nanomaterials need to be
a pressing need for more research to understand, characterized. Understanding their fate in the
identify, assess, control and remediate potential environment is also important, as it may result in
impacts of nanomaterials. indirect human exposure (Food and Agriculture
In 2012, the U.S. National Research Council (NRC) Organization of the United Nations and World
set out an environment, health and safety research Health Organization, 2013).
strategy for beginning to deal with the gigantic In relation to food and other products containing
gaps in knowledge surrounding the environmental nanomaterials, there are significant gaps in our
and human health impacts of nanomaterials. That knowledge, including information on:
research strategy became part of the National
Nanotechnology Initiative in the U.S., in what • The extent to which nanomaterials from
was supposed to be an integrated, collaborative packaging, surfaces and coatings migrate into
effort by many departments to ensure that the foods.
development of nanotechnology industries • Where and how nanomaterials distribute in the
was done well. A year later, the NRC report, human body following ingestion.
Research Progress on EHS Aspects of Engineered • The long-term chronic effects of ingesting
Nanomaterials (NRC, 2013) analyzed progress nanomaterials, including impacts on sensitive
to date. Of the 20 indicators NRC used to assess and vulnerable populations.
progress, there has been little or no progress in 19.
The report noted, “…despite increasing budgets • How nanomaterials interact with the human
for nanotechnology-EHS research and a growing body and in the environment (European
number of publications, regulators, decision makers Environment Agency, 2013).
and consumers still lack the information needed • How, where and in what quantities nanomaterials
to make informed public health and environmental enter the environment (Royal Commission on
policy and regulatory decisions” (NRC, 2013). Environmental Pollution, 2008).
The U.S. President’s Council of Advisors on Science • Once nanomaterials are released, how durable
and Technology, in its 2013 assessment of the they are and the extent to which they are
National Nanotechnology Initiative, expressed transformed in the environment (NRC, 2013;
concerns about “…a lack of integration between SRU, 2011)
nanotechnology-related [environmental health and • The fate, behaviour and ecotoxicity of
safety] research funded through the NNI and the nanomaterials throughout their life cycle; How to
kind of information policymakers need to effectively characterize, track and detect nanomaterials in
manage potential risks from nanoparticles” complex environments (NRC, 2013).
(Sargent, 2014). Additionally, the European Food
Safety Authority has admitted that risk assessments
for nano-products in food and feed will inevitably
have significant uncertainties because testing
methods and data on risk and exposure are missing
(EFSA, 2008).
A 2013 report by the Food and Agriculture
Organization of the United Nations and the World
Health Organization further expresses the need
to better understand the novel properties of
nanoparticles, particularly pertaining to safety:
Additional safety concerns may arise owing to
the characteristic properties of nanomaterials
that make them different from their microscale/
macroscale counterparts. For example, the very
high surface area of engineered nanomaterials
has consequences that need to be considered

7. Policy Recommendations
Friends of the Earth urges our govenment
Given the potentially serious
regulators to further investigate the safety of health and environmental risks and
nanomaterials and establish manditory pre- social implications associated with
market safety assessment and oversight of nanofoods, especially products
nanotechnology. We also demand greater
accountability and transparency from food
created for infants, Friends of the
and consumer producers and retailers to allow Earth is calling for a moratorium on
consumers to make informed choices about this the further commercial release of
novel set of technologies. food products, food packaging
If nanotechnology is to be developed safely, and coatings, food contact materials
responsibly and transparently, there is an urgent and agrochemicals that contain
need for further research and dissemination of
information about its current uses and associated
engineered nanomaterials until
human and environmental health concerns to nanotechnology-specific safety
inform the scientific community, companies, policy and labeling laws are established
makers, regulators and consumers. Friends of the and the public is involved in
Earth’s vanguard study has helped to shed light
on the use of engineered nanomaterials in baby
decision-making.
formulas. Nevertheless, focused efforts by our
government, industry and academia will be required
in order to inform about the totality of engineered Given the potentially serious health and
nanomaterial products already on the market. environmental risks and social implications
associated with nanofoods, especially products
Nanotechnology-enabled agricultural inputs and
created for infants, Friends of the Earth is calling for
food ingredients continue to be developed and
a moratorium on the further commercial release of
discussed in the scientific literature, yet the public
food products, food packaging and coatings, food
is left in the dark about their use, while regulators
contact materials and agrochemicals that contain
stand idle in addressing the potential knowledge
engineered nanomaterials until nanotechnology-
gaps and human and environmental health
specific safety and labeling laws are established and
concerns. As we enter a new era of greater
the public is involved in decision-making.
food awareness, public demand for healthy
and sustainable food, and for transparency, is For additional recommendations, please refer to
growing. People are demanding more information Principles for the Oversight of Nanotechnologies
about the food they eat — what it contains, how it and Nanomaterials (CFS, 2007).
is produced, and how it may impact human health a. What government must do:
and the environment — so they can make informed
Enact a moratorium on new commercial nanotech
choices about what they feed their families.
products
While independent and university scientists are
Government regulators should deny products
hard at work creating methodologies and systems
produced with nanomaterials access to the market
to detect engineered nanoparticles, government
until they determine how to properly assess and
regulators should deny these products access to the
manage them to protect human health and the
market while we learn more about their safety, and
environment.
how to properly manage them to protect human
health and the environment. Assess safety of and recall baby formulas with
nanoparticle ingredients
Friends of the Earth believes future non-
governmental organization, academic and especially Friends of the Earth recommends that the FDA
government initiatives to further investigate the conduct a thorough review of the nanoparticle
use and safety of engineered nanoparticles in ingredients found in baby formulas. The agency
baby formulas and other commercially available must, in the meantime, use its authority to enforce
foods and products is of utmost importance to a manufacturer recall of baby formulas containing
ensure the safe and sustainable development of engineered nanoparticles as these ingredients may
nanotechnologies. put human health at risk.

Regulate nanomaterials as new substances • The presence of nanomaterials must be
All deliberately manufactured nanomaterials must disclosed to workers and other downstream
be subject to rigorous nano-specific health and users along the supply chain.
environmental impact assessment and must be • Public involvement in decision-making is
demonstrated to be safe prior to approval for required.
commercial use in foods, food packaging, food b. What industry must do:
contact materials, agricultural applications or other
consumer products. Recall formula containing nanomaterials
Extend the size-based definition of nanomaterials Manufacturers should remove all baby formulas
to 500 nm containing nanoparticles from store shelves until the
safety of these ingredients can be substantiated and
All particles up to 500 nm in size must be appropriately regulated by the FDA.
considered to be “nanomaterials” for the purposes
of health and environment assessment given the Remove nanomaterials from product formulas
early evidence that they may pose health risks All baby formula and food manufacturers should
similar to particles less than 100 nm in size which review the ingredients contained in their products
have to date been defined as “nano.” to ensure they are free from manufactured
Protect workers nanomaterials; this may involve inquiries with third
party ingredient suppliers.
• The Occupational Health and Safety
Administration should adopt nano-specific Create nanomaterial policies
regulations to protect workers from and inform • Companies should create clear policies to
them of potential exposure. avoid the use of engineered nanomaterials in
• Research on occupational exposure and their products until nanotechnology-specific
personal protective devices in the workplace regulation is put in place to protect the public,
should be a priority. workers and the environment from potential new
hazards associated with nano-toxicity.
Ensure transparency in safety assessment and
product labeling • Manufacturers should refer to the Nanomaterials
Policy Recommendations published by a
• All relevant data related to safety assessments coalition of domestic and international advocacy
and the methodologies used to obtain them groups, including Friends of the Earth, to help
must be placed in the public domain. inform companies and consumers about the
• All manufactured nano-ingredients must be potential risks of nanomaterials (As You Sow et
clearly indicated on product labels to allow al., 2015).
members of the public to make an informed
choice about product use.
Ensure transparency in the supply chain • Eat fresh food when and if possible. Processed
• If companies continue to use nano-ingredients, and packaged foods are more likely than
they must be clearly indicated on product fresh foods to be a source manufactured
labels, allowing members of the public to make nanoparticles.
informed choices about product use. Hold government and industry accountable
• Companies producing baby formulas containing • Write to your local representatives and members
nanomaterials must create a registry of potential of regional, state and federal government
side effects as reported by consumers (parents requesting their support for a moratorium on
of babies consuming these products). This the use of all nanotechnology in the food sector.
should be modeled after the registries that Demand that governments regulate and label
pharmaceutical companies are required to create food, food packaging and agricultural products
which both receive reports of side effects of new that contain manufactured nanomaterials before
products and incorporate this information into allowing any further commercial sales.
required consumer education inserts at point of • Ensure that food and agricultural manufacturers
sale. take seriously public concerns about nanofoods.
c. What concerned parents, individuals and Contact the manufacturers of the baby formulas
organizations can do: or foods you consume often and ask them
Until government and companies manage about what steps they are taking to keep unsafe,
nanotechnology in a responsible and transparent untested nanomaterials out of the food they sell.
manner, there are steps we can take to protect our Visit our website to learn more about
health. nanotechnology, take action and to support our
Avoid foods that potentially contain nanomaterials efforts to create a safe, just, resilient and sustainable
food system. Friends of the Earth-United States
• Breastfeed when and if possible. http://www.foe.org/nanotechnology

8. APPENDICES formula. The lack of standards and internationally
recognized measurement methods coupled with
Appendix A: Methodology a lack of transparency from the nanotechnology
Friends of the Earth commissioned independent industry, reinforced by the lack of U.S. regulation of
laboratory testing of baby formulas with a world- nanotechnology, creates significant challenges to
class nanotechnology research facility at the understanding where engineered nanoparticles are
Arizona State University (ASU). This study was being used.
lead by Paul Westerhoff PhD, PE, BCEE, Professor, Advanced analytical methods were employed to
Ira A. Fulton Schools of Engineering at Arizona detect nanoparticles in the baby formulas tested.
State University, Dr. Robert Reed (Postdoctoral The samples were tested by transmission electron
Researcher at ASU) and Jared Schoepf (PhD microscopy (TEM) and energy dispersive X-ray
candidate at ASU). Additional details about the detection (EDX), including centrifugal ultrafiltration
study are included in the Analysis Report prepared of the Gerber® sample prior to TEM to ensure that
by the laboratory. the crystal structures were not “artifacts” of sample
Friends of the Earth tested a selection of six baby drying.
formula samples gathered from the following three EDX elemental peak readings for the Gerber®
retailers in the San Francisco Bay Area: Walgreens ‘Gentle’ formula suggested the nanostructures
in Berkeley and Safeway in Berkeley and Oakland. observed contained both Calcium and Phosphorous.
We encourage the replication of our study and The EDX reading combined with a comparison of
additional analysis geared towards learning more similar electron microscopy images suggest the
about the presence of engineered nanoparticles in formula likely contains nano hydroxyapatite (nano
baby formula and other consumer products. HA). Similar readings and conclusions were also
Sample preparation details made for the Enfamil™ and Well Beginnings ™ baby
formula samples. To confirm the presence of nano
The foods (~0.125 g each) were suspended in 40
HA in the formulas, two food grade hydroxyapatite
mL ultrapure water and sonicated for 30 minutes to
products were analyzed by TEM and EDX to find
suspend particles. These samples were centrifuged
out if the hydroxyapatite (HA) formed in the sample
at 15,000 G for 15 minutes to settle any particles
preparation process for TEM or if it is an additive
present. The organics-rich supernatant was poured
to the baby formula. The sample preparation was
off, leaving a pellet of particulate matter in the
maintained the same as with all six of the baby
centrifuge tube. This was re-suspended in 20 mL
formulas. One food-grade reference sample was
ultrapure water and sonicated for five minutes,
composed solely of needle-like HA (Product 1)
then 100 uL volumes were pipetted onto a copper/
while the other sample had majority spherical-
lacey carbon transmission electron microscopy grid
shaped HA (Product 2). It was concluded that the
and allowed to dry. Microscopy was performed on
sample preparation process does not solely form HA
a Philips CM200 transmission electron microscope
needle-like structures. The analysis provides positive
with energy dispersive spectroscopy. Mean particle
confirmation that detected HA in baby formulas was
diameter was measured manually with ImageJ
likely added, rather than an artifact of any sample
software. Particle number size distributions were
handing.
developed and the percentage of particles less than
100 nm in width determined. TiO2 was tentatively identified using a scanning
electron microscope (SEM) in the Similac® Advance®
The detection of nanoparticles is a complex
OptiGRO™ (liquid) product, though after purchasing
matter requiring state-of-the-art, experimental and
a second sample several months later and using
costly devices and techniques, especially when
a different separation process and transmission
attempting to quantify or characterize engineered
electron microscopy (TEM) analysis, the presence of
nanoparticles in a complex matrix such as baby
TiO2 could not be confirmed.

Summary of reference food grade hydroxyapatite
Hydroxyapatite Food-Grade Product 1
• 99% pure food-grade product purchased from USA manufacturer (American

Elemental)
• Needle-like hydroxyapatite structures dominated the product
Hydroxyapatite Food-Grade Product 2
• Dietary supplement purchased from USA manufacturer (NOW® Foods) Calcium

Hydroxyapatite
• Spherical-shaped hydroxyapatite dominated the product
Appendix B: Results summary

Baby formula Laboratory analysis Nanoparticles Ingredient uses Health concerns
brand and image of nanoparticles found and
purchase (TEM/EDS) particle size
location
Gerber® Good Start® Nano- Nano HA is most The European Union has
Gentle hydroxyapatite likely a calcium provided evidence in their SCCS
(nano HA) source for the opinion that needle-like nano-
Purchased at
formula. It can hydroxyapatite is potentially toxic,
Safeway® (Berkeley,
Average individual also be used as a could be absorbed and enter
CA)
particle size of 28 ± stabilizer cells and should not be used in
7 nm (width) 237 ± cosmetics (SCCS, 2014; SCCS,
119 nm (length) 2015).
Some chemical company material
safety data sheet (MSDS) list
hydroxyapatite as an inhalation
hazard and further cite the lack
of toxicology studies available
(Sigma-Aldrich, 2008; Merz NA,
Inc., 2015).

location
Gerber® Good Start® Nano titanium TiO2 is a brightener Studies show that titanium dioxide
Soothe dioxide (TiO2) or whitener for can damage DNA (Trouiller et al.,
and silicon dioxide food and beverage 2009), disrupt the function of
Purchased at
(SiO2) (limited products, anti- cells, interfere with the defense
Walgreens
amount of particles caking agent activities of immune cells and, by
(Berkeley, CA)
detected) adsorbing fragments of bacteria
SiO2 is used as a
and ‘smuggling’ them across
Particles under 100 ‘trickle and flow’
the gastro-intestinal tract, can
nm aid in powdered
provoke inflammation (Ashwood
food products, as
et al., 2007; Donaldson et al., 1996;
a clearing agent
Dunford et al., 1997; Long et al.,
in beer and wine,
2006; Lucarelli et al., 2004; Wang
as a food additive
(SiO2) et al., 2007b).
(amorphous silicon
found to be nano) A study using pregnant mice
and as a food found that transfer nanoparticles
coating of titanium dioxide to their
offspring. This resulted in brain
damage, nerve system damage
and reduced sperm production
in male offspring (Takeda et al.,
2009).
See Similac® Advance® OptiGRO™
summary results for more
information about SiO2 health
(TiO2) concerns.
Enfamil™ Mixture of needle- Nano HA is most The European Union has

like and non likely a calcium provided evidence in their SCCS
Purchased at
needle-like nano- source for the opinion that needle-like nano-
Safeway® (Oakland,
hydroxyapatite formula. It can hydroxyapatite is potentially toxic,
CA)
(nano HA) also be used as a could be absorbed and enter
stabilizer cells and should not be used in
Average particle
cosmetics (SCCS, 2014; SCCS,
size of 11 nm (width)
2015).
and 75 nm (length)
200 nm
safety data sheet (MSDS) list nano
Inc., 2015).
Similac® Advance® Titanium dioxide TiO2 is a brightener Studies show that titanium dioxide
OptiGRO™ (liquid) nanoparticles or whitener for can damage DNA (Trouiller et al.,
(laboratory results food and beverage 2009), disrupt the function of
Purchased at
inconclusive) products, anti- cells, interfere with the defense
Walgreens
caking agent activities of immune cells and, by
(Berkeley, CA) Particle sizes
adsorbing fragments of bacteria
between 16 and 530
and ‘smuggling’ them across
nm, average particle
the gastro-intestinal tract, can
size is unknown
provoke inflammation (Ashwood
et al., 2007; Donaldson et al., 1996;
Dunford et al., 1997; Long et al.,
2006; Lucarelli et al., 2004; Wang
et al., 2007b).
A study using pregnant mice
found that transfer nanoparticles
of titanium dioxide to their
offspring. This resulted in brain
damage, nerve system damage
and reduced sperm production
in male offspring (Takeda et al.,
2009).

location
Well Beginnings™ Needle-like nano- Nano HA is most The European Union has
Advantage® hydroxyapatite likely a calcium provided evidence in their SCCS
(nano HA) source for the opinion that needle-like nano-
Purchased at
formula. It can hydroxyapatite is potentially toxic,
Walgreens Average size 28 ± 5
also be used as a could be absorbed and enter
(Berkeley, CA) nm (width) 160 ± 30
stabilizer cells and should not be used in
nm (length)
cosmetics (SCCS, 2014; SCCS,
2015).
safety data sheet (MSDS) list nano
Inc., 2015).
Similac® Advance® Nano silicon dioxide Used as a ‘trickle Nano silica has been found
OptiGRO™ (laboratory results and flow’ aid in in the livers of rats and mice
(powder) inconclusive) powdered food after oral administration. In
products, as a vitro studies show a significant
Purchased at Average diameter
clearing agent in percentage of the nano silica
Walgreens of 7 ± 1 nm
beer and wine, as remains undissolved and that “the
(Berkeley, CA)
a food additive presence of undissolved nano
(amorphous silicon silica particles in the gut in vivo is
found to be nano) considered likely” (Dekker et al.,
and as a food 2013; SRU, 2011). Animal studies
coating have shown placental transfer and
foetal uptake of silica. Scientists
have warned that the enhanced
sensitivity of the foetus may
mean that even low doses of
nanomaterials may cause adverse
effects (Correia et al., 2015).

9. References
Amazon. (2015). nano hydroxyapatite toothpaste. Retrieved August 22, 2015 from Amazon.com: http://www.amazon.com/s/
ref=sr_pg_1?rh=i%3Aaps%2Ck%3Anano+hydroxyapatite+toothpaste&keywords=nano+hydroxyapatite+toothpaste&ie=UT-
F8&qid=1440961076and spIA=B00FPW7EMA,B00QJA4GB4
As You Sow (2015). Nanomaterials Fact Sheet. Retrieved August 27, 2015 from As You Sow: http://www.asyousow.org/wp-con-
tent/uploads/2015/03/nanomaterials-in-food-and-food-packaging-fact-sheet.pdf
As You Sow, Center for Food Safety, Center for International Environmental Law, Environmental Working Group, Food and
Water Watch, Friends of the Earth, Green America, Institute for Agriculture and Trade Policy, Iinternational Center for Technol-
ogy Assessment, International Union of Food, and Pesticide Action Network (2015). Policy for Nanomaterials in Food and Food
Packaging. Retrieved August 27, 2015 from As You Sow : http://www.asyousow.org/our-work/environmental-health/nanomateri-
als/policy-for-nanomaterials-in-food-and-food-packaging/
Ashwood, P., Thompson, R.P., and Powell, J.J. (2007). Fine particles that adsorb lipopolysaccharide via bridging calcium cations
may mimic bacterial pathogenicity towards cells. Experimental Biology and Medicine, 232(1): 107-117.
Ballestri, M., Baraldi, A., Gatti, A.M., Furci, L., Bagni, A., Loria, P., Rapaná, R.M., Carulli, N., and Albertazzi, A. (2001). Liver and
kidney foreign bodies granulomatosis in a patient with malocclusion, bruxism, and worn dental prostheses. Gastroenterology,
121(5): 1234-8.
Bang, S.H., Le, T.H., Lee, S.K., Kim, P., Kim, J.S., and Min, J. (2011). Toxicity Assessment of Titanium (IV) Oxide Nanoparticles Using
Daphnia magna (Water Flea). Environ Health Toxicol. 2011; 26: e2011002.
Belli, B. (2012, November 1). Processed Foods and Food Packaging Already Contain Nanoparticles—Some of Which Could Be
Harmful to Our Health. Retrieved August 22, 2015 from The Environmental Magazine : http://www.emagazine.com/includes/
print-article/magazine/9623/
Biological Farmers of Australia (BFA). (2012, 03 26). Nanotechnology prohibited from Australian Certified Organic beauty
products. Retrieved August 6, 2015 from Fat Cow: http://www.fatcow.com.au/c/biological-farmers-of-australia-bfa/nanotechnol-
ogy-prohibited-from-australian-certified-organic-beauty-products-n914841
Bonner, J. C. (2010). Nanoparticles as a Potential Cause of Pleural and Interstitial Lung Disease. Annals of the American Thoracic
Society, 7(2): 138–141.
Center for Food Safety (CFS) (2007). Principles for the Oversight of Nanotechnologies and Nanomaterials. Center for Food
Safety.
Chen, L., Remondetto, G.E., and Subirade, M. (2006a). Food protein-based materials as nutraceutical delivery systems. Trends in
Food Science & Technology, 17(5): 272–283.
Chen, Z., Meng, H., Xing, G., Chen, C., Zhao, Y., Jia, G., Wang, T., Yuan, H., Ye, C., Zhao, F., Chai, Z., Zhu, C., Fang, X., Ma, B., and
Wan, L. (2006b). Acute toxicological effects of copper nanoparticles in vivo. Toxicology Letters, 163(2):109-20.
Correia Carreira, S., Walker, L., Paul, K., Saunders, M. (2015). The toxicity, transport and uptake of nanoparticles in
the in vitro BeWo b30 placental cell barrier model used within NanoTEST. Nanotoxicology, 9 Suppl 1:66-78. doi:
10.3109/17435390.2013.833317. Epub 2013 Sep 3.
Dekker, S., Bouwmeester, H., Bos, P.M., Peters, R.J., Rietveld, A.G., Oomen, A.G. (2013). Knowledge gaps in risk assessment of
nano silica in food: evaluation of the dissolution and toxicity of different forms of silica. Nanotoxicology, 7(4):367–377, 368.
Del Nanobio Technology GMBH (2015). Nano Hydroxyapatite. Retrieved August 18, 2015 from Alibaba.com: http://www.alibaba.
com/product-detail/Nano-Hydroxyapatite_112524578.html?spm=a2700.7724857.35.1.OU2PTd
Desai, M.P., Labhasetwar, V., Amidon, G.L., and Levy, R.J. (1996). Gastroinestinal uptake of microparticles: Effect of particle size.
Pharmaceutical Research, 13(12): 1838-45.
Des Rieux, A., Fievez, V., Garinot, M., Schneider, Y.J., and Prèat, V. (2006). Nanoparticles as potential oral delivery systems of
proteins and vaccines: a mechanistic approach. Journal of Controlled Release, 116(1): 1-27.
Donaldson, K., Beswick, P.H., and Gilmour, P.S. (1996). Free radical activity associated with the surface of particles: a unifying
factor in determining biological activity?. Toxicology Letters, 88: 293-298.
Dunford, R., Salinaro, A., Cai, L., Serpone, N., Horikoshi, S., Hidaka, H., and Knowland, J. (1997). Chemical oxidation and DNA
damage catalysed by inorganic sunscreen ingredients. FEBBS Lett, 418: 87-90.
EU Scientific Committee on Consumer Safety (SCCS) (2012, December 18). OPINION ON Zinc oxide (nano form) COLIPA S 76.
Retrieved August 15, 2015 from European Commission: http://ec.europa.eu/health/scientific_committees/consumer_safety/
docs/sccs_o_103.pdf
EU Scientific Committee on Consumer Safety (SCCS) (2013, July 22). OPINION ON Titanium Dioxide (nano form) COLIPA n°
S75. Retrieved August 15, 2015 from European Commission: http://ec.europa.eu/health/scientific_committees/consumer_safety/
docs/sccs_o_136.pdf
EU Scientific Committee on Consumer Safety (SCCS) (2014, NA). Request for a scientific opinion: Hydroxyapatite (nano) CAS
No 1306-06-5. Retrieved July 24, 2015 from European Commission : http://ec.europa.eu/health/scientific_committees/consum-
er_safety/docs/sccs_q_103.pdf

EU Scientific Committee on Consumer Safety (SCCS) (2015, October 16). European Commission. Retrieved October 18, 2015
from Opinion On Hydroxyapatite (nano): http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_191.
pdf
European Environment Agency (2013, January 23). Late lessons from early warnings: science, precaution, innovation. Luxem-
bourg.
European Food Safety Authority (EFSA) (2008). Scientific Statement of the Panel on Food Additives and Nutrient Sources
added to Food on a request from the Commission on Silver hydrosol as a source of silver added for nutritional purposes to food
supplements. The EFSA Journal, 884, 1-3 .
European Food Safety Authority (EFSA) (2009). The Potential Risks Arising from Nanoscience and Nanotechnologies on Food
and Feed Safety. The EFSA Journal, 958, 1-39.
European Parliament. (2014, November 25). Novel foods: MEPs call for moratorium on nano-foods and labelling of
cloned meat. Retrieved August 02, 2015 from European Parliament News: http://www.europarl.europa.eu/news/en/news-
room/20141125IPR80424/Novel-foods-MEPs-call-for-moratorium-on-nano-foods-and-labelling-of-cloned-meat
Food and Agriculture Organization of the United Nations and World Health Organization. (2013). State of the art on the initia-
tives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors.
Retrieved August 04, 2015 from Food and Agriculture Organization of the United Nations: http://www.fao.org/docrep/018/
i3281e/i3281e.pdf
Garnett, M.C., Kallinteri, P. (2006). Nanomedicines and nanotoxicology: some physiological principles. Occupational Medicines,
56(5): 307-11.
Gatti, A.M., Rivasi, F. (2002). Biocompatibility of micro- and nanoparticles. Part I: in liver and kidney. Biomaterials, 23(11): 2381-7.
Gatti, A.M. (2004). Biocompatibility of micro- and nano-particles in the colon. Part II. Biomaterials, 25: 385-392.
Gatti, A.M., Tossini, D., Gambarelli, A., Montanari, S., and Capitani, F. (2004). Investigation of the presence of inorganic micro-
and nanosized contaminants in bread and biscuits by environmental scanning electron microscopy. Critical Reviews in Food
Science and Nutrition, 49(3): 275-82. doi: 10.1080/10408390802064347.
Gerloff, K., Albrecht, C., Boots, A.W., Förster, I., and Schins, R.P.F. (2009). Cytotoxicity and oxidative DNA damage by nanoparti-
cles in human intestinal Caco-2 cells. Nanotoxicology, 355-364.
Hansen, T., Clermont, G., Alves, A., Eloy, R., Brochhausen, C., Boutrand, J.P., Gatti, A.M., and Kirkpatrick, C.J. (2006). Biological
tolerance of different materials in bulk and nanoparticulate form in a rat model: sarcoma development by nanoparticles. Journal
of the Royal Society Interface, 3(11): 767-75.
Hazzard R.A., Hodges, G.M., Scott, J.D., McGuinness, C.B., and Carr, K.E. (1996). Early intestinal microparticle uptake in the rat.
Journal of Anatomy, 189 (Pt 2):265-71.
Hillyer, J.F., Albreicht, R.M. (2001). Gastrointestinal persorption and tissue distribution of differently sized colloidal gold nanopar-
ticles. Journal of Pharmaceutical Sciences, 90(12): 1927-36.
Huber, F.X., Belyaev, O., Hillmeier J., Kock, H.J., Huber, C., Meeder, P.J., and Berger I. (2006). First histological observations on the
incorporation of a novel nanocrystalline hydroxyapatite paste OSTIM® in human cancellous bone. BMC Musculoskelet Disord, 7:
50.
Institute of Occupational Medicine . (2004). Nanoparticles: An occupational hygiene review. Retrieved August 24, 2015 from
Health and Safety Executive : http://www.hse.gov.uk/research/rrpdf/rr274.pdf
International Osteoporosis Foundation. (2015). Introduction to Bone Biology: All About Our Bones. Retrieved August 22, 2015
from International Osteoporosis Foundation: http://www.iofbonehealth.org/introduction-bone-biology-all-about-our-bones
Jacobs, M., Ellenbecker, M., Ticker, J., and Hoppin, P. (2014). IARC’s Review of Carbon Nanotubes: Substantiating Early Warn-
ings of Harm. Retrieved November 16, 2015 from Physicians for Social Responsibility (PSR): http://www.psr.org/environ-
ment-and-health/environmental-health-policy-institute/responses/iarcs-review-carbon-nanotubes.html
Keenan, C.R., Goth-Goldstein, R., Lucas, D., and Sedlack, D.L. (2009). Oxidative Stress Induced by Zero-Valent Iron Nanoparticles
and Fe(II) in Human Bronchial Epithelial Cells. Environmental Science and Technology, 43(12) 4555–4560.
Kent, G. (2006). WIC’s promotion of infant formula in the United States. Int Breastfeed J., 1: 8.
Laetitia, C.P., Thoree, V., Bruggraber, S.F.A., Koller, D., Thompson, R.P.H., Lomer, M.C., and Powell, J.J. (2015). Pharmaceutical/
food grade titanium dioxide particles are absorbed into the bloodstream of human volunteers. Particle and Fibre Toxicology,
12:26 DOI: 10.1186/s12989-015-0101-9.
Lomer, M.C., Harvey, R.S., Evans, S.M., Thompson, R.P., and Powell, J.J. (2001). Efficacy and tolerability of a low microparticle diet
in a double blind, randomized, pilot study in Crohn’s disease. European Journal of Gastroenterology & Hepatology, 13(2): 101-6.
Long, T.C., Saleh, N., Tilton, R.D., Lowry, G.V., and Veronesi, B. (2006). Titanium dioxide (P25) produces reactive oxygen spe-
cies in immortalized brain microglia (BV2): Implications for nanoparticle neurotoxicity. Environmental Science and Technology,
40(14): 4346-4352.
LUBW Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg. (2010, August ). Nanomaterialien: Tox-
ikologie/Ökotoxikologie. Retrieved July 25, 2015 from Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Würt-
temberg: http://www.lubw.baden-wuerttemberg.de/servlet/is/62024/U10-S05-N10.pdf?command=downloadContent&file-
name=U10-S05-N10.pdf

Lucarelli, M., Gatti, A.M., Savarino, G., Quattroni, P., Martinelli, L., Monari, E., and Boraschi, D. (2004). Innate defence functions of
macrophages can be biased by nano-sized ceramic and metallic particles. 15(4): 339-346.
Mozafari, M.R., Flanagan, J., Matia-Merino, L., Awati, A., Omri, A., and Suntres, Z. (2006). Recent trends in the lipid-based nano-
encapsulation of antioxidants and their role in foods. Journal of the Science of Food and Agriculture, DOI: 10.1002/jsfa.2576.
Mayo Clinic (2015). Hypercalcemia . Retrieved August 25, 2015 from Mayo Clinic : http://www.mayoclinic.org/diseases-condi-
tions/hypercalcemia/basics/definition/con-20031513
McMinn, L.H., Hodges, G.M., and Carr, K.E., (1996). Gastrointestinal uptake and translocation of microparticles in the streptozoto-
cin-diabetic rat. Journal of Anatomy, 189 (Pt 3): 553-9.
Moya, J., Bearer, C.F., and Etzel, R.A. (2004). Children’s Behavior and Physiology and How It Affects Exposure to Environmental
Contaminants. Pediatrics, 113 (4): 996-1006.
McArthur, Fomuki, W.T., Tanner, M.C., and Huber, F.X. (2013). The nanocrystalline hydroxyapatite paste Ostim® may present a new
possibility in the treatment of persistent nonunion. OA Case Reports, 2(12): 118.
Merz North America, Inc. (2015). Calcium hydroxyapatite Safety Data Sheet (SDS). Retrieved August 15, 2015 Merz North Ameri-
ca: http://www.merzusa.com/wp-content/uploads/SF7806-02.pdf
National Association of Clean Water Agencies (NACWA) (2015). Retrieved December 10, 2015 from The National Association of
Clean Water Agencies : http://www.nacwa.org/images/stories/public/2015-08-06nanomaterials-comments.pdf
National Research Council (2013). Research Progress on Environmental, Health, and Safety Aspects of Engineered Nanomateri-
als . Washington, DC: The National Academies Press.
Nature Nanotechnology (2010). Nanofood for thought. Nature Nanotechnology, 5: 89.
Nel, A., Xia, T., Mädler L., and Li, N. (2006). Toxic potential of materials at the nanolevel. Science, 311(5761): 622-7.
Nestlé (2013). Nestlé in Society: Creating Shared Value and meeting our commitments 2013. Retrieved December 03, 2015 from
Nestlé: http://storage.nestle.com/Interactive_CSV_Full_2013/files/assets/basic-html/index.html#73
Nielsen (2015, August 25). Oh Baby! Baby Food and Formula Sales Will Reach Nearly $30 Billion Around the World. Retrieved
August 27, 2015 from Nielsen : www.nielsen.com
Oberdörster, G., Maynard, A., Donaldson, K., Castranova, V., Fitzpatrick, J., Ausman, K., Carter, J., Karn, B., Kreyling, W., Lai, D.,
Olin, S., Monteiro-Riviere, N., Warheit, D., Yang, H., and ILSI Research Foundation/Risk Science Institute Nanomaterial Toxicity
Screening Working Group (2005). Principles for characterising the potential human health effects from exposure to nanomateri-
als: elements of a screening strategy. Particle Fibre Toxicology, 2:8.
Occupational Safety and Health Administration (2013, 04). OSHA FactSheet: Working Safely with Nanomaterials. Retrieved Au-
gust 17, 2015 from United States Department of Labor: https://www.osha.gov/Publications/OSHA_FS-3634.pdf
Organic & Non-GMO Report (2010). Retrieved August 6, 2015 from Organic & Non-GMO Report: http://www.non-gmoreport.
com/downloadables/org&nongmo_april10.pdf
Poland, C.A., Duffin, R., Kinloch, I., Maynard, A., Wallace, W.A.H., Seaton, A., Stone, V., Brown, S., MacNee, W., and Donaldson,
K. (2008). Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study.
Nature Nanotechnology, 3: 423 - 428.
Powell, J.J., Ainley, C.C., Harvey, R.S., Mason, I.M., Kendall, M.D., Sankey, E.A., Dhillon, A.P., and Thompson, R.P. (1996). Characteri-
sation of inorganic microparticles in pigment cells of human gut associated lymphoid tissue. Gut, 38(3): 390-5.
Powell, J.J., Faria, N., Thomas-McKay, E., and Pele, L.C. (2010). Origin and fate of dietary nanoparticles and microparticles in the
gastrointestinal tract. Journal of Autoimmunity, 34(3): J226-33.
Project on Emerging Nanotechnologies (2015a). Consumer Products Inventory. Retrieved August 04, 2015 from The Project on
Emerging Nanotechnologies: http://www.nanotechproject.org/inventories/consumer/analysis_draft/
Project on Emerging Nanotechnologies (2015b). Goods for Children. Retrieved August 04, 2015 from The Project on Emerging
Nanotechnologies : http://www.nanotechproject.org/cpi/browse/categories/goods-for-children/
Roco, M.C. (2001). From Vision to the Implementation of the U.S. National Nanotechnology Initiative. Journal of Nanoparticle
Research, 3(1) :5-11.
Roco, M.C., Bainbridge, W.S. (2003). Converging Technologies for Improving Human Performance Nanotechnology, Biotechnolo-
gy, Information Technology and Cognitive Science. Dordrecht: Springer.
Royal Commission on Environmental Pollution (2008, November). Novel Materials in the Environment: The case of nanotechnol-
ogy. Norwich.
Royal Society and Royal Academy of Engineering (2004). Nanoscience and nanotechnologies: opportunities and uncertainties.
London: The Royal Society .
Sachverständigenrat für Umweltfragen (SRU) (2011, September 01). Vorsorgestrategien für Nanomaterialien . Retrieved August
18, 2015 from Sachverständigenrat für Umweltfragen: http://www.umweltrat.de/SharedDocs/Downloads/DE/07_Veranstaltun-
gen/2011_09_Uebergabe_Sondergutachten_Nanomaterialien_BMU.html;jsessionid=8C6D2E203567829446A99DF2B9719E45.1_
cid335
Sanguansri, P., Augustin, M.A. (2006). Nanoscale materials development – a food industry perspective. Trends in Food Science &
Technology, 17: 547-556.

Sargent, J.F. Jr. (2014, December 16). The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations
Issues . Retrieved August 02, 2015 from Federation of American Scientists : http://www.fas.org/sgp/crs/misc/RL34401.pdf
Schneider, J.C. (2007). Can microparticles contribute to inflammatory bowel disease: Innocuous or inflammatory? Exp Biol Med,
232: 1-2.
Sigma-Aldrich (2008). Material Safety Data Sheet: Hydroxyapatite nanopowder.
Retrieved August 15, 2015 from University of Wisconsin Whitewater: https://www.uww.edu/apps/riskmanagement/msds/hy-
droxyapatite-_nanopowder-_200nm-bet--_97p-_synthetic_sigma-aldrich_8.28.07.pdf
Sisco Research Laboratories Pvt. Ltd. (NA, NA NA). MATERIAL SAFETY DATA SHEET M-HYDROXYAPATITE NANOPOWDER.
Retrieved August 03, 2015 from Sisco Research Laboratories Pvt. Ltd.: http://www.srlchem.com/
Smithers, R. (2008, January 15). Soil Association bans nanomaterials from organic products. Retrieved August 6, 2015 from The
Guardian: http://www.theguardian.com/environment/2008/jan/15/organics.nanotechnology
Spiegel (2012, February 12). Diskussion um Gefahren: Nanopartikel verändern Eisenaufnahme im Darm. Retrieved August 18,
2015 from Spiegel : http://www.spiegel.de/wissenschaft/medizin/diskussion-um-gefahren-nanopartikel-veraendern-eisenauf-
nahme-im-darm-a-814794.html
Takeda, K., Suzuki, K., Ishihara, A., Kubo-Ierie, M., Fujimoto, R., and Tabata, M. (2009). Nanoparticles Transferred from Pregnant
Mice to Their Offspring Can Damage the Genital and Cranial Nerve Systems. Journal of Health Science, 55(1): 95-102.
Tay, C.Y., Fang, W., Setyawati, M.I., Chia, S.L., Tan, K.S., Hong, C.H.L., and Leong, D.T. (2014). Nano-hydroxyapatite and Nano-tita-
nium Dioxide Exhibit Different Subcellular Distribution and Apoptotic Profile in Human Oral Epithelium. ACS Applied Materials &
Interfaces, 6 (9): 6248–6256.
Tri-TAC (2011, August 17). Policies Concerning Products Containing Nanoscale Materials (Docket ID number EPA–HQ–OPP–
2010–0197) . Retrieved December 10, 2015 from Tri-TAC Technical Advisory Committee: http://www.tritac.org/documents/let-
ters/2011_0816_Tri-TAC%20Comments_Nanomaterials%20Policy.pdf
Trouiller, B., Reliene, R., Westbrook, A., Solaimani, P., and Schiestl, R.H. (2009). Titanium dioxide nanoparticles induce DNA
damage and genetic instability in vivo in mice. Cancer Research, 69(22), 10.1158/0008–5472.CAN–09–2496. http://doi.
org/10.1158/0008-5472.CAN-09-2496
Tschoppe P., Zandim D.L., Martus, P., and Kielbassa, A.M. (2011). Enamel and dentine remineralization by nano-hydroxyapatite
toothpastes. Journal of Dentistry .
U.S. Department of Health and Human Services (2011). The Surgeon General’s Call to Action to Support Breastfeeding. Washing-
ton: U.S. Department of Health and Human Services.
U.S. Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Institute for
Occupational Safety and Health (NIOSH) (2013, April). Occupational Exposure to Carbon Nanotubes and Nanofibers. Retrieved
December 5, 2015 from Centers for Disease Control and Prevention: http://www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf
U.S. Food and Drug Administration (2014a). FDA Takes Final Steps on Infant Formula Protections. Retrieved August 15, 2015
from Food and Drug Administration: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048694.htm
U.S. Food and Drug Administration (2014b). 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 Sub-
stances, Including Food Ingredients that Are Color Additives. Retrieved August 8, 2015 from U.S. Department of Health and
Human Services: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm300661.htm
University California San Diego (2007). Widely Used Iron Nanoparticles Exhibit Toxic Effects on Cells. Retrieved January 18, 2015
from University California San Diego: http://jacobsschool.ucsd.edu/news/news_releases/release.sfe?id=647
Wang, B., Feng, Y.W., Wang, T.C., Jia, G., Wang, M., Shi, J.W., Zang, F., Zhao, Y.L., and Chai, Z.F. (2006). Acute toxicity of nano-
and micro-scale zinc powder in healthy adult mice. Toxicology Letters, 161(2): 115-23.
Wang, B., Feng, W., Wang, M., Wang, T., Gu, Y., Zhu, M., Ouyang, H., Shi, J., Zhang, F., Zhao, Y., Chai, Z., Wang, H., and Wang, J.
(2007). Acute toxicological impact of nano- and submicro-scaled zinc oxide powder on healthy adult mice. Journal of Nanopar-
ticle Research, (10)2: 263-276.
Wang, J., Zhou, G., Chen, C., Yu, H., Wang, T., Ma, Y., Jia, G., Gao, Y., Li, B., Sun, J., Li, Y., Jiao, F., Zhao, Y., and Chai, Z. (2007b).
Acute toxicity and biodistribution of different sized titanium dioxide particles in mice after oral administration. Toxicology Let-
ters, 168(2): 176-185.
Yamawaki H, I. N. (2006). Mechanisms Underlying Nano-Sized Air-Pollution- Mediated Progression of Atherosclerosis Carbon
Black Causes Cytotoxic Injury/Inflammation and Inhibits Cell Growth in Vascular Endothelial Cells. Circulation Journal, 70(1): 129-
40.

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NANO-

About Friends of the Earth:

2. Findings & Analysis....................................................................................................................................................................... 10

3. Background: An introduction to nanotechnology........................................................................................................... 13

4. Health Concerns: Novel risks of nanomaterials and nanofoods................................................................................ 15

Nanoparticles in Baby Formula 4

Nanoparticles in Baby Formula 5

In response to mounting scientific evidence on We also demand greater accountability and

Nanoparticles in Baby Formula 6

What industry must do:

What concerned parents, individuals and

Nanoparticles in Baby Formula 7

Nanoparticles in Baby Formula 8

Nanoparticles in Baby Formula 9

TiO2 was tentatively identified using a scanning Nano-hydroxyapatite

Nanoparticles in Baby Formula 10

Nanoparticles in Baby Formula 11

d. INGREDIENT: Nano silicon

FORMULA: Similac® Advance®

Nanoparticles in Baby Formula 12

Nanoparticles in Baby Formula 13

Nanoparticles in Baby Formula 14

Nanoparticles in Baby Formula 15

Nanoparticles in Baby Formula 16

Associated with brain damage, nerve

Can be absorbed by and enter cells

Highly mobile throughout body; detected in

Increased reactive oxygen species and

Lesions in kidney and liver of mice exposed

Interferes with defense activities of immune

Transferred from mother to offspring in

Nanoparticles in Baby Formula 17

a. Principles for the Oversight of Nanotechnologies c. Organic certifiers say no to nanotech

Nanoparticles in Baby Formula 18

Nanoparticles in Baby Formula 19

Nanoparticles in Baby Formula 20

Nanoparticles in Baby Formula 21

Nanoparticles in Baby Formula 23

Nanoparticles in Baby Formula 24

Hydroxyapatite Food-Grade Product 1

• 99% pure food-grade product purchased from USA manufacturer (American

Hydroxyapatite Food-Grade Product 2

• Dietary supplement purchased from USA manufacturer (NOW® Foods) Calcium

Appendix B: Results summary

Nanoparticles in Baby Formula 25

Enfamil™ Mixture of needle- Nano HA is most The European Union has

Nanoparticles in Baby Formula 26

Nanoparticles in Baby Formula 27

Nanoparticles in Baby Formula 28

Nanoparticles in Baby Formula 29

Nanoparticles in Baby Formula 30

Nanoparticles in Baby Formula 31

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