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Commentary
A Short Critique on the Stance of the
Netherlands Food and Consumer Product
Safety Authority on Melamine Polymer
Formaldehyde Exposures
Jaap C. Hanekamp
1,2
Abstract
In February 2021, the Netherlands Food and Consumer Product Safety Authority came out with their risk assessment on for-
maldehyde exposure from melamine crockery with bamboo fiber to especially young children. In this short commentary, I will
critique their assessment of this type of food-contact material (FCM). The main flaws are at least: (i) absence of a proper valuation
of the available principal scientific literature yielding a biased risk assessment; (ii) discounting the endogenous formaldehyde
formation that outweighs background exposure substantially; (iii) ad hoc positing of an unjustifiable and unfounded low back-
ground exposure levels to formaldehyde whereby risks of exposure to melamine formaldehyde is grossly exaggerated. This biased
assessment has created societal unrest that is wholly uncalled for. Additionally, it has wide-ranging European consequences for the
use of all melamine FCM.
Keywords
formaldehyde exposure, melamine FCM, Netherlands Food and Consumer Product Safety Authority, risk assessment
Introduction
The risks of formaldehyde-exposure to, particularly, toddlers
(age 1-3 years) from melamine crockery will be considered
in the below-presented critical evaluation of BuRO-report
TRCVWA/2021/768
1
“Advisory Report from the Director
of the Office for Risk Assessment and Research concerning
the Health Risks of Bamboo Cups” of the Netherlands Food
and Consumer Product Safety Authority (henceforth report).
This report has caused quite the political and regulatory stir,
both in the Netherlands and Europe. In this commentary, we
will take a closer look at the toxicological aspects of for-
maldehyde and the subsequent risk assessment as presented
in the report.
The Report’s Main Findings on Formaldehyde Risks of
Exposure From Melamine (Bamboo Fiber) Crockery
The report is on food-contact material (FCM) that is melamine
polymers containing bamboo fiber and the risks that type of
material could engender toward especially children. The main
report’s questions are (p.1):
1. “How severe is the health risk entailed by the observed
migration of formaldehyde from bamboo/melamine
consumer articles?
2. From what level of formaldehyde migration is there a
health risk for adults? ...
3. From what level of formaldehyde migration is there a
health risk for children (aged up to 3 years) if they eat
from children’s tableware made of bamboo/
melamine? ...”
Again, we will limit our analysis tot formaldehyde migra-
tion from FCM made of bamboo/melamine. The results of the
1
Science Department, University College Roosevelt, Middelburg, the
Netherlands
2
Department of Environmental Health Sciences, University of Massachusetts,
Amherst, MA, USA
Received 11 March 2021; accepted 11 March 2021
Corresponding Author:
Jaap C. Hanekamp, Science Department, University College Roosevelt, Lange
Noordstraat 1, NL-4331 CB Middelburg, the Netherlands.
Email: hjaap@xs4all.nl
Dose-Response:
An International Journal
April-June 2021:1-4
ªThe Author(s) 2021
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analysis presented by the authors of the report will have its
repercussions on pure melamine FCM, as stated on p. 14: “The
findings and conclusions for the migration of formaldehyde
and melamine from bamboo/melamine FCM also apply to mel-
amine FCM.” So whether or not melamine FCM contains bam-
boo fiber is irrelevant to thequestionoftherisksof
formaldehyde migration.
The Specific Migration Limit (SML) for formaldehyde is 15
mg/kg food. The report’s exposure assessment is based on the
consumption of hot beverages from bamboo/melamine cups. A
realistic assumption for this is 2 cups of hot beverages per day
(0.4 kg/day). The body weight is assumed to be 60 kg. For
children’s melamine bamboo crockery, a daily intake of 200
g of warm food and 100 g of warm drinks is assumed for a child
1-3 years old. The body weight is assumed to be 10.1 kg.
The report (p. 9) details on melamine crockery that “most of
the products (88%) met the migration limit of 15 mg/kg. How-
ever, some very high migration values - higher than 200 mg/kg
- have also been found. The highest migration value found for
formaldehyde is 247 mg/kg.”
The lowest reported ingestion via food -0.025 mg/kgbw/
day- has been used as background exposure in the report. For
a child weighing 10.1 kg that would amount to 0.25 mg/day; for
an adult weighing in at 60 kg that would result in a daily
exposure of 1.5 mg. The report (p. 8) furthermore suggests that
there “certainly [is] an increased health risk if the TDI [0.15
mg/kgbw/day; see below] is exceeded at this background expo-
sure value.”
For adults (60 kg), the report (p.13) concludes that in “case
of a formaldehyde migration of 19 mg/kg or higher, the health-
based guidance value is exceeded and a health risk is
involved.” For toddlers between 1-3 (10.1 kg), the report con-
cludes that the “health-based guidance value is exceeded in
case of a formaldehyde migration higher than 4.2 mg/kg. The
SML of 15 mg/kg offers insufficient protection.”
Oral Toxicology
As a toxicological benchmark for formaldehyde, the report
takes the well-known TDI of 0.15 mg/kgbw/day for oral expo-
sure as published by Til et al.
2
Very briefly, formaldehyde was
administered in drinking-water to groups of 70 male and 70
female Wistar rats for up to 24 months. Survivors of subgroups
of 10 rats/sex/group each were killed after 12 or 18 months.
The mean formaldehyde doses administered were 0, 1.2, 15 or
82 mg/kgbw/day for males, and for females the doses were 0,
1.8, 21 or 109 mg/kgbw/day. The authors observations were
(italics added):
Oral administration of formaldehyde at doses of 82 and 109 mg/
kg/day to male and female rats, respectively, caused severe
damage to the gastric mucosa but did not result in gastric
tumours or tumours at other sites. The study did not provide
any evidence of carcinogenicity of formaldehyde after oral
administration. ...The general health and behav-iour of the
animals did not appear to be affected by any of the
formaldehyde treatments. ...There was no toxicologically sig-
nificant difference in mortality between controls and treated
animals ....
Til et al determined the formaldehyde No-Observed-
Adverse-Effect Level (NOAEL; keeping in mind the
sizeable jump between the NOAEL and the highest experi-
mental dose applied) to be 15 and 21 mg/kgbw/day for male
and female rats, respectively. The critical effect is stomach
irritation. The NOAEL of 15 mg/kgbw/day was chosen to
formulate the human oral Tolerable Daily Intake (TDI) of
0.15 mg/kgbw/day.
Gelbkea et al
3
used the NOAEL of Til et al to calculate the
actual drinkingwater concentrations of formaldehyde that were
fed to the rats in their experiment. Gelbkea et al state:
After 2 years of exposure the NOAEL for irritation in the sto-
mach was 15 mg/kg bw/d for males and 21 mg/ kg bw/d for
females, corresponding to 260 mg/l drinking water on average.
2
From this average of 260 mg/l drinkingwater that corre-
sponds to the NOAEL dose, Gelbkea et al, proposed a safe
exposure level of formaldehyde via foods, which they calcu-
lated to be at 32.5 mg/kg food per day.
Critical Reflections
A number of concerns stand out. Firstly, endogenously pro-
duced formaldehyde in humans, as a result of many different
physiological processes, only receives cursory reflection in the
report. A daily turnover of formaldehyde in humans of an
estimated 878-1310 mg/kgbw (kg bodyweight) per day, with
a half-life of only minutes, remains unmentioned (EFSA).
4
Considering this high metabolic turnover, formaldehyde does
not accumulate in the body. Human physiology is well-
equipped to deal with large (endogenous) loads of
formaldehyde.
5
Secondly, the background exposure of 0.025 mg/kgbw/day
proposed in the report is unrealistically low and is devoid of
any scientific rationale. Contrary to the report, European Food
Safety Authority (EFSA) estimates exposure to formaldehyde
from dietary sources maximally will be 100 mg formaldehyde
per day when no more than 1 kg of food per day is consumed.
EFSA, subsequently, considers daily intake to be approxi-
mately 1.4 – 1.7 mg/kgbw depending on chosen default adult
bodyweights (70 and 60 kg, respectively).
Indeed, a myriad of foodstuffs naturally contain formalde-
hyde, which via a normal diet would add to the daily back-
ground exposure way beyond the report’s chosen quantity.
Fruit and vegetables contain roughly between 3 and 60 mg/
kg product.
6
Cow’s milk can contain up to 3.3 mg/kg product.
Meats contain between 0.1 – 20 mg formaldehyde/kg, beef
sitting at the lower end of the scale and pork at the higher end.
7
Fish of different varieties, its consumption generally regarded
as adding to a healthy diet, contain between roughly 1–293 mg/
kg. Cod, haddock, whiting and other fish belonging to the
2Dose-Response: An International Journal
Gadidae family show the highest concentrations, even after
roasting or boiling.
8
Estimating a children’s ballpark formaldehyde exposure
through a normal diet, total food-intake is appraised by the
EFSA
9
at 114.4 g/kgbw per day. For dietary exposure assess-
ments, a body weight of 12 kg should be used as default for
European toddlers (1-3 years). A toddler consuming ‘one piece
of fruit’ or a mixture thereof per day -e.g. made form apples,
grapes, bananas or pears, weighing in at some 200 gr., would
amount to a formaldehyde intake between +2 – 11 mg. Vege-
tables, say some 150 gr., per day, would add to this intake
between +1–5mgofformaldehyde. Some 100 gr. of meat
will add up to +2 mg of formaldehyde to the toddler’s intake.
Consumption of 100 gr of fish, instead of meat, could add to the
overall intake between +0.1 mg – 29 mg/day. The higher
values are certainly not impossible considering the popularity
of e.g. cod and haddock. Fresh dairy products will add little to
the formaldehyde intake, and will not be considered here. Also,
bread and related products such as crackers are not considered.
Even this cursory glance at a toddler’s diet shows that natural
formaldehyde intake via foods is, on average, at least +10 mg
per day. This is much higher than the report’s formaldehyde
background of 0.25 mg/day.
Thirdly, the report’s statement (p. 8) that there is an
increased health risk if the TDI is exceeded at the background
exposure is false and without merit. That is firstly related to the
NOAEL-derived TDI with a factor 100. That makes for a very
conservative TDI that will not indicate hazard if exceeded.
Secondly, average food-intake of maximally 100 mg/day is
only 0.1-0.2%of the daily endogenous formaldehyde produc-
tion and turnover, which, again, remains deceptively undis-
cussed in the report.
Fourthly, the inference made in the report that the existing
SML of 15 mg formaldehyde/kg is insufficiently protective is
false for the following reasons:
1. Migration tests are expressly maximized for leaching
formaldehyde from melamine crockery. Warm solid
foods will have a lower migration-potential than a 2 h
experiment with a 70C acetic acid 3%watery solution.
2. Formaldehyde migration is limited by the total load
present in the melamine crockery. Over time, leaching
will decline to nil so that formaldehyde leaching is not a
permanent fixture of melamine crockery use.
3. Migrated formaldehyde into warm solid consumables
will bind, to some extent, to food-content chemicals,
making them less biologically available.
4. The TDI derived from Til et al
2
translates into 32.5 mg/
kg food per day as done by Gelbkea et al,
3
which is
substantially higher than even the current SML of 15
mg formaldehyde/kg that would need to leach into
warm consumables in contact with melamine crockery
on a daily basis.
5. The scientifically unmotivated and arbitrarily low for-
maldehyde background exposure unrealistically
emphasizes formaldehyde migration levels from mela-
mine crockery.
6. The disregarded high natural endogenous production
turnover of formaldehyde unrealistically emphasizes
formaldehyde migration levels and its purported risks
from melamine crockery.
In Conclusion
Summarizing, the report’s assessment of the risks of formalde-
hyde exposure from melamine crockery is biased, lacks thor-
oughgoing analysis -e.g. no exposure assessment from foods is
presented- and neglects important and recent literature. This
bias is exacerbated by choosing unrealistically low formalde-
hyde background exposures from foods and discounts the sub-
stantial endogenous formaldehyde production. As a result,
unrealistic and unfounded worst-case scenarios are pandered
to regulators and the media.
Finally, the report exudes archetypal precautionary reflec-
tions superficially donned in toxicological vernacular, inexcu-
sably publicizing fear toward the general public. The latter has
no basis in the known physiology and toxicology of formalde-
hyde, establishing the report to be incompatible with the known
science of formaldehyde.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to
the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, author-
ship, and/or publication of this article.
ORCID iD
Jaap C. Hanekamp https://orcid.org/0000-0002-6575-3658
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