www.bfr.bund.de

DOI 10.17590/20181205-132313-0

EU maximum levels for cadmium in food for infants and young children sufficient Exposure to lead should fundamentally be reduced to the achievable minimum
BfR Opinion No. 026/2018 of 7 August 2018
Cadmium and lead occur naturally in the Earth’s crust from where they can be released
through natural and anthropogenic processes and find their way into the food chain. As thesesubstances can be harmful to human health, strict legal regulations already apply in the European Union to food for infants and young children. These have to be validated consistently,
however, and adapted as required. In doing so, the latest results of official food and veterinary monitoring are included in the process.
On the basis of the data on occurrence in food obtained from the Federal Control Plan (FCP)
2015, and Monitoring 2015, the German Federal Institute for Risk Assessment (BfR) has
made a health assessment of the occurrence of lead and cadmium in food for infants andyoung children. On behalf of Germany, the BfR comes to the conclusion that where theproducts tested in the categories “baby formula in powder form” and “ready to eat”, as well as“processed cereal-based foods in powder form” and “ready to eat” are concerned, no healthimpairment through cadmium is currently likely. This applies to children in the age group 0.5
to < 3 years, both at average and high consumption. From the data available, the BfR does
not derive any necessity to lower the maximum levels from a health point of view.
The “margin of exposure” (MoE) approach was applied in the frame of the examination of theoccurrence of lead in food for infants and young children. With substances such as lead, forwhich no statement on a “safe” uptake quantity is possible, this approach provides indications of the degree of urgency with which measures are required. The BMDL01 value for developmental neurotoxicity of 0.5 micrograms (µg) per kilogram (kg) body weight per day
served as the basis for the health assessment of the uptake of lead by infants and young
children. The uptake of lead was below this value in children with average consumption of
the tested products as well as high consumers. Fundamentally, however, the BfR holds withthe estimation that no safe intake quantity can be derived for lead where the developmental
neurotoxic effects in children are concerned. Exposure should therefore be reduced accordingly to the minimum achievable level.
Breast milk remains the ideal nutrition for infants. Because of the health advantages for bothmother and child, the BfR recommends that infants be breastfed exclusively up to the beginning of the fifth month and thereafter for as long as the mother and child care to do so once
complementary food has been introduced. If infants are not or not fully breastfed, however,they require industrially produced baby food. These products contain vital nutrients and continue to offer parents an alternative to breastfeeding. The general rule is that children should
be given complementary food from their fifth month of life at the earliest and from the seventhmonth at the latest to supplement breast milk or breast milk substitute products.

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1 Object of the assessment
The BfR has made a health assessment regarding the occurrence of lead and cadmium infood for infants and young children on the basis of the results of the Federal Control Plan
(FCP) 2015 and Monitoring 2015.

BfR Risk Profile:Cadmium levels in baby and infant food(Opinion No. 026/2018)
A Affected group(s)Probability of a healthimpairment through theregular high intake of
B formulae or processedcereal-based foods inpowder form or ready-toeat
Severity of the healthimpairment through theregular high intake of
C formulae or processedcereal-based foods inpowder form or ready-toeat

Infants and young children

Practically excluded

Possible

Unlikely

Probable

Certain

No information possible

D

Reliability of the available
data

High:
The most important data are on
hand and free of contradiction

E

Controllability by the
consumer [1]Control not necessary

Moderate:
Some important data are
missing or contradictory

Controllable throughprecautionary
measures

Low:
Numerous important data are
missing or contradictory

Controllable throughavoidance

Not controllable

Squares highlighted in dark blue indicate the properties of the risk assessed in this opinion (more detailed information on this is contained in BfR
Opinion No. 026/2018 of 07 August 2018).
Explanations
The risk profile is intended to visualise the risk outlined in the BfR Opinion. It is not intended for the purpose to comparing risks. The risk profile
should only be read in conjunction with the corresponding opinion.
Row C – Severity of the health impairment:
The severity of the potential risk cannot currently be quantified on the basis of the available data.
Row E – Controllability by the consumer[1] – The information contained in the row “Controllability by the consumer” should not be seen as a recommendation from the BfR; it has a purely
descriptive character.
GERMAN FEDERAL INSTITUT FOR RISK ASSESSEMENT (BfR)

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2 Result
Cadmium
Health impairments through the uptake of cadmium via the consumption of foods for infants
and young children in the food categories “baby formula in powder form” and “ready to eat”,
as well as “processed cereal-based foods in powder form” and “ready to eat” are currently
unlikely for children in the age group 0.5 to < 3 years, both at average and high consumption(95th percentile of consumption). The BfR came to this conclusion after assessing the available data on occurrence from the Federal Control Plan (FCP) 2015 and Monitoring 2015.
The current maximum levels for cadmium for foods for infants and young children lie in therange of the 95th percentile of the levels determined in the FCP and Monitoring 2015.
Lead
The exposure of children in the age group 0.5 to < 3 years through the intake of lead via theconsumption of foods for infants and young children in the food categories “baby formula inpowder form” and “ready to eat”, as well as “processed cereal-based foods in powder form”
and “ready to eat” lie below the BMDL01 value for developmental neurotoxicity of 0.5 micrograms (µg) per kilogram (kg) body weight per day for children with average consumption
as well as high consumers on the basis of the levels indicated in the FCP and Monitoring2015. As no safe uptake quantity can be given for lead with regard to its effect on developmental neurotoxicity in children, however, exposure should generally be reduced to theachievable minimum.
3 Justification
3.1 Agent and hazard potential
Definitions of terminology
Directive 2006/141/EC on infant formulae and follow-on formulae uses the following definitions: Infants: children under the age of twelve months
 Young children: children aged between one and three years
 Infant formulae: foodstuffs intended for particular nutritional use by infants during the firstmonths of life and satisfying by themselves the nutritional requirements of such infants
until the introduction of appropriate complementary feeding Follow-on formulae: foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants.
Cadmium
Cadmium occurs naturally in the Earth’s crust and is released by both natural and anthropogenic processes. It is ubiquitous in the environment. Cadmium has a long biological half-lifein the human body (ten to 30 years) and accumulates in the liver and kidneys in particular.
The most sensitive toxicological endpoint of cadmium is renal toxicity. In their opinion of January 2009, the European Food Safety Authority (EFSA) derived a tolerable weekly intake
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Bundesinstitut für Risikobewertung
www.bfr.bund.de(TWI) of cadmium of 0.0025 milligrams (mg) (the equivalent of 2.5 μg) per kg body weight(EFSA 2009) on the basis of the effect of cadmium on the kidneys.
Lead
Lead occurs naturally in the Earth’s crust and is released by both natural and anthropogenic
processes. It is ubiquitous in the environment. Lead has a long biological half-life in bone (tento 30 years) and accumulates mainly in this organ. Toxic effects of lead affect haematosis,
the kidneys, the cardiovascular system and central nervous system. In their opinion published in 2010, EFSA comes to the conclusion that the internationally established provisional
tolerable weekly intake (PTWI1) for lead as a reference value for health risk assessment is nolonger appropriate to sufficiently protect consumers from the possible health effects of lead
exposure via food. More recent data substantiate that even very small quantities of lead can
produce damaging effects in the body. This means that no intake quantity without any healthimpairing effects can be given, which is the reason why EFSA is suggesting the use of the“margin-of-exposure (MoE2) approach”. The EFSA Panel on Contaminants in the Food Chain(CONTAM) has identified developmental neurotoxicity in children3 and cardiovascular effects
and nephrotoxicity in adults as critical effects for risk assessment. The corresponding BMDL
values4 in µg per litre (l) (equivalent to an alimentary uptake in µg per kg body weight perday) derived from blood lead levels were: developmental neurotoxicity: BMDL01, 12 µg per l(0.50 µg per kg body weight per day); effects on systolic blood pressure: BMDL01, 36 µg per l(1.50 µg per kg body weight per day); effects on the prevalence of chronic kidney disease:
BMDL10, 15 µg per l (0.63 µg per kg body weight per day). The BMDL01 value of 0.5 µg per
kg body weight per day is used in the following for the health assessment of the uptake oflead by infants and young children.
Maximum levels of cadmium and lead in food for infants and young children
Maximum levels for food for infants and young children are determined in Regulation (EU)2015/1005 for lead and Regulation (EU) No. 488/2014 for cadmium amending Regulation(EU) No. 1881/2006. Table 1 provides an overview of the regulated foods and corresponding
maximum levels.

1

Preliminary estimation of the quantity of a substance which can be ingested weekly over an entire lifetime without the occurrence of any health impairments.
2
MoE = as a dimensionless number, the Margin of Exposure stipulates the ratio between a defined point on the dose-response
curve at which a slight but measurable adverse effect exists in animal studies or epidemiological studies and the estimation of
exposure for certain population groups. The MoE does not imply any statement about the “safe” uptake quantity in the senseof a tolerable daily intake quantity. It is used when no dose without effect can be determined experimentally and it provides
risk management with indications about the degree of urgency with which measures are required.
3“Young children” EFSA (2010)
4
BMDL = Benchmark Dose Lower Confidence Limit; the BMDLx value equates to the statistical unilateral lower limit of the 95%
confidence interval of the dose or concentration which causes an increase in the frequency/extent of an effect by x %.

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Table 1: Maximum levels of cadmium and lead in food for infants and young children
Cadmium (Regulation (EU) No. 488/2014)
Lead (Regulation (EU) 2015/1005)
Food group
Max. level
Food group(mg per kg)
3.2.19. Infant formulae and follow-on
3.1.2.
Infant formulae and followformulae
on formulaeMax. level(mg per kg)a.

Powdered formulae manufactured from cow’s milk proteinsor protein hydrolysates

0.010

a.

Powder0.050

b.

Liquid formulae manufactured
from cow’s milk proteins orprotein hydrolysates

0.005

b.

Liquid0.010

c.

Powdered formulae manufactured from soya protein isolatesalone, or in a mixture with cow’s
milk proteins
Liquid formulae manufactured
from soya protein isolatesalone, or in a mixture with cow’s
milk proteins
Processed cereal-based foods
and other baby foods

0.020

3.1.3.

Processed cereal-based
foods and other baby
foods

0.050

d.

3.2.20.

0.010

0.040

It should be noted that with cadmium and lead, maximum levels for infant and follow-on formulae have been determined for the commercially available powder form on the one handand for liquid food on the other. For processed cereal-based food and other baby food, themaximum levels relate to the commercially available produce (Regulation (EU) No.
1881/2006) without differentiating the product condition.
3.2 Exposure
3.2.1 Occurrence
Foods for infants and young children were examined for cadmium and lead within the scopeof Monitoring 2015 and the FCP 2015. 444 data records from the FCP were evaluated forboth lead (Pb) and Cadmium (Cd), along with 77 (Pb) and 78 (Cd) from the monitoring offoods for infants and young children, which were grouped together in line with the maximum
levels set out in Regulations (EU) 2015/1005 and No. 488/2014. In Monitoring 2015, however, only data for cereal porridge was collected. No differentiated examination of powdered
and ready-to-eat foods could be made. The FCP data used here does not give any clear description of the form of the food as a powder or ready-to-eat product. On the basis of the description and evaluations in the FCP 2015 report, however, it is assumed that virtually all
samples analysed were in powder form (BVL 2015a, BVL 2015b).
Values below the limits of detection and quantification (LOD/LOQ) were taken into account inaccordance with the modified lower bound, medium bound and upper bound approaches.
With the modified lower bound, the values below the detection level were set to zero and thevalues below the quantification level to the detection level. If there was no information on thedetection level, the corresponding value was also set to zero. The medium bound takes into
consideration the values below the LOD/LOQ at half the value of each respective LOD/LOQ.
Finally, the values below the LOD/LOQ are set at the corresponding LOD/LOQ in the upperbound approach.

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Bundesinstitut für Risikobewertung
www.bfr.bund.deOccurrence of cadmium, Monitoring and FCP 2015
With foods made from cow’s milk proteins or protein hydrolysates (powder), hereinafter referred to as “baby formula in powder form”, and complete meals, high percentages (77% and
50% respectively) lie below the detection and quantification limits (LOD/LOQ) for cadmium.
With a mean cadmium level of 0.003 mg per kg and/or a 95th percentile of 0.007 mg per kg(medium bound), the maximum level that applies to foods made from cow’s milk proteins(powder) of 0.01 mg per kg is not reached. Overall, the maximum level for cadmium was exceeded by one sample of baby formula in powder form. The highest levels of cadmium in theexamined food products for infants and young children are to be found in processed cerealbased food (powder) with 0.019 mg per kg (mean, medium bound) and/or 0.037 mg per kg in
the 95th percentile (medium bound). A maximum level of 0.040 mg per kg was set for processed cereal-based food, a level which was not quite reached through the 95th percentile ofthe measured levels. There were a total of six samples in FCP and two in Monitoring which
exceeded the maximum level for cadmium in processed cereal-based food.
Table 2: Occurrence of cadmium in foods for infants and young children (FCP 2015, Monitoring 2015)
Cadmium in foods for infants and young children in mg per kg
Modified lower%
Food groups
Medium bound2 Upper bound3
bound1
N
<LOD/
LOQ
mean
P95
mean
P95
mean
P95
Food made from cow’s milk proteins
257
77
0.001
0.006
0.003
0.007
0.005
0.007
or protein hydrolysates (powder)*Food made from soya protein iso20
0
0.013
0.017
0.013
0.017
0.013
0.017
lates alone, or in a mixture (powder)
Processed cereal-based food (pow199
11
0.019
0.037
0.019
0.037
0.019
0.037
der)*
Rusk or biscuits for infants and
30
3
0.013
0.021
0.013
0.021
0.013
0.021
young children
Complete meals for infants and
16
50
0.005
0.017
0.005
0.017
0.006
0.017
young children*Each containing one sample of ready-to-eat food for infants and young children
Modified lower bound: Values <LOD =0, Values <LOQ=LOD
Medium bound: Values < LOD/LOQ=1/2 LOD/LOQ
Upper bound: Values <LOD/LOQ=LOD/LOQ

The data on occurrence in the food group “Complete meals for infants and young children”
were not taken into consideration when estimating exposure due to the small number ofsamples and composition of the group from a wide range of different complementary foods
containing meat, fish or fruit. The data on occurrence in rusk and biscuits were not includedin the exposure estimation either.
EFSA opinion on the occurrence of cadmium (2009), comparison
With values ranging from 0.0037 to 0.0073 mg per kg, higher levels of cadmium went into theintake estimation conducted by EFSA (2009) for food for infants and young children compared to the current intake estimation. With 0.0177 mg per kg, the mean cadmium level determined by EFSA (2009) for processed cereal-based food in powder form lay in a range
similar to the level of 0.019 mg per kg determined in the FCP and Monitoring 2015.
Occurrence of leadWith 44 to 85%, the FCP and Monitoring 2015 data for lead in food for infants and young
children show a high percentage of values below the limits of detection and quantification
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Bundesinstitut für Risikobewertung
www.bfr.bund.de(Table 3). Differences in the occurrence in baby formula and processed cereal-based food in
powder form in the 95th percentile of the medium and upper bound can be explained by theconsiderable differences in the limits of detection and quantification between the individuallaboratories.
Table 3: Occurrence of lead in food for infants and young children (FCP 2015, Monitoring 2015)
Food group

Food made from cow’s milk proteinsor protein hydrolysates (powder)*Food made from soya protein isolates alone, or in a mixture (powder)
Processed cereal-based food (powder)*Rusk or biscuits for infants andyoung children
Complete meals for infants andyoung children

Lead in food for infants and young children (mg per kg)
Modified lower
Medium%Upper bound³
bound1bound²
N
<LOD/
LOQ
mean
P95
mean P95
mean
P95
257

72

0.005

0.026

0.010

0.026

0.016

0.039

20

85

0.005

0.043

0.009

0.043

0.014

0.043

198

72

0.004

0.016

0.008

0.016

0.013

0.030

30

77

0.005

0.015

0.007

0.015

0.009

0.015

16

44

0.009

0.041

0.010

0.041

0.010

0.041

*Each containing one sample of ready-to-eat food for infants and young children
1
Modified lower bound: Values <LOD =0, Values <LOQ=LOD²Medium bound: Values < LOD/LOQ=1/2 LOD/LOQ³Upper bound: Values <LOD/LOQ=LOD/LOQ

On average and in the 95th percentile, the levels of lead in baby formula in powder form arebelow the maximum level of 0.05 mg per kg for foods made from cow’s milk proteins or protein hydrolysates (powder). This applies to all individual values for lead in this food category
measured within the scope of FCP. The average levels and 95th percentile for processedcereal-based foods (powder) examined in the FCP as well as in Monitoring are also below
the maximum level of 0.05 mg per kg. One individual value measured in the FCP was above
the maximum level for lead in processed cereal-based food.
The data on occurrence in the food group “Complete meals for infants and young children”
were not taken into consideration in the exposure estimation due to the small number ofsamples and the composition of the group from a wide range of different complementary
foods containing meat, fish or fruit. The data on occurrence in rusk and biscuits were notincluded in the exposure estimation either.
Occurrence of lead, EFSA opinion (2012), comparison
EFSA made an estimate of the intake of lead by young children (aged 0.5 to 6 years) in 2012
in which it listed a mean level of 0.003 – 0.004 mg per kg for baby formula in powder form, alevel which lies below the lead level of 0.01 mg per kg measured in the FCP and Monitoring2015. With 0.013 mg per kg, the value for cereal-based foods lay slightly above the level of
0.008 mg per kg determined in the FCP and Monitoring 2015. It should be taken into consideration here that the data included in the EFSA opinion also came from other European
countries, which means they are only comparable to a limited degree.

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3.2.2 Consumption data
Consumption data from the VELS5 study (Heseker et al. 2003; Banasiak et al. 2005) wereused as the data basis for the consumption of food for infants and young children. This study
was conducted throughout Germany between 2001 and 2002 on 816 infants and young children aged from six months to less than five years. On two occasions, the parents kept threeday consumption records of all foods consumed by each child. The consumption data of thechildren in relation to individual body weight was used as the basis for calculating intake.
The present evaluations on consumption relate to data from the VELS study for children
aged from six months to under three years. In line with the maximum level regulation of leadand cadmium (Table 1), consumption data were evaluated separately as baby formula orprocessed cereal-based food and a distinction was also made between the consumption of
powder and the ready-to-eat product in each instance (Table 4). No intake estimation could
be made for food made from or with soya protein isolates, for which a maximum level was
set in Regulation (EU) No. 488/2014, as the proportion of consumers in the VELS study was
too low at 1%. Average consumption (mean value) and high consumption (95th percentile,“high consumers”) are examined for every age group exclusively in the respective groups ofconsumers of food for infants and young children.
Table 4: Consumption of food for infants and young children in children aged 6 months to under three
years (Basis: VELS study, consumers only, long-term consumption)
Quantity consumed in g per kg body weight per
day (Basis: consumers only, long-term consumption)
1 to < 3
0.5 to < 3 years
0.5 to < 1 year
years
(n=435)(n=95)(n=340)Baby formula in powder form
Percentage of
10 %
31 %
5%
consumers
Mean value
3.2
3.9
2.0
95th percentile
8.2
8.6
7.4
Baby formula – ready to eat

Percentage ofconsumers
Mean value
95th percentile

Processed cereal-based food in
powder form

Percentage ofconsumers
Mean value
95th percentile

Processed cereal-based food –ready to eat

Percentage ofconsumers
Mean value
95th percentile

25 %

66 %

14 %

27.3

32.4

20.2

54.5

61.8

39.1

31 %

62 %

22 %

2.0

2.9

1.2

6.8

7.8

4.1

35 %

73 %

24 %

9.4

14.9

4.9

31.9

38.4

12.1

3.2.3 Intake estimation
The chronic exposure of infants and young children to cadmium and lead through the consumption of baby formula and cereal porridge on the basis of the data on occurrence contained in the FCP and Monitoring 2015 is presented in Table 5 and Table 8. The intake esti5

VELS-Study = “Consumption study to determine the food intake of infants and young children for the estimation of an acutetoxicity risk through residues of plant protection products“:
http://download.ble.de/02HS007.pdf

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Bundesinstitut für Risikobewertung
www.bfr.bund.demate is based on mean levels in the food groups (medium bound) and mean consumption
quantities (“average consumers”) or consumption quantities in the 95th percentile (“high consumers”). As there can be a significant difference between the consumption behaviour of
infants in their first year of life and young children aged 1 to 3 years, a differentiated examination was made for the children aged 0.5 to < 1 year and from 1 to < 3 years in addition to
intake for all infants and small children (0.5 to < 3 years).
For risk characterisation (see Chapter 3.3), intake of cadmium as well as of lead was compared with the respective toxicological reference values. To this end, the tolerable weekly
intake (TWI) for cadmium of 2.5 µg per kg body weight and week was used. The MoE approach was used for lead in order to determine the margin between the BMDL01 value of 0.5µg per kg body weight per day for developmental neurotoxic effects and the exposure of children to lead from the consumption of food for infants and young children. The corresponding
results have been included in the following tables for the sake of clarity.
Finally, total intake of lead as well as of cadmium was evaluated throughout all food groups
for infants and young children considered in the assessment. This intake estimate was calculated by way of example in the sense of a worst case scenario for the group of consumers
who had the highest exposure to cadmium or lead through the consumption of one of thefoods considered from the group of foods for infants and young children (Table 6 for cadmium; Table 10 for lead).
3.2.3.1 Intake of cadmium
Only one data set each was available for the occurrence of cadmium and lead in ready-to-eat
food for infants and young children (baby formula and processed cereal-based food). For thisreason, the data on levels in powder and a reconstitution factor of seven were used to estimate the intake through ready-to-eat food for infants and young children. This equates to alevel of cadmium for ready-to-eat baby formula of < 0.001 mg per kg (mean, medium bound)and 0.001 mg per kg (95th percentile, medium bound). A level of 0.003 mg per kg (mean,
medium bound) and 0.005 mg per kg (95th percentile, medium bound) was calculated forready-to-eat processed cereal-based food.
Table 5: Intake of cadmium via food for infants and young children (Basis: VELS, consumers only; FCP
and Monitoring 2015, mean levels, medium bound)
Intake of cadmium in µg per kg body weight and day (Basis: consumers only, medium bound)
0.5 to < 3 years
Average consumers1
Baby formula in powder form
Percentage of consumers

0.5 to < 1 year
High consumers²

10 %Cd intake
0.010
2.7 %
TWI exhaustion
Baby formula – ready to eat
Percentage of consumers
25 %Cd intake
0.012
TWI exhaustion
3.3 %Processed cereal-based food in powder form
Percentage of consumers
31 %Average consumers1

1 to < 3 years
High consumers²

Average consumers1

High consumers²

10 %

31 %

31 %

5%

5%

0.024
6.9 %

0.012
3.3 %

0.026
7.2 %

0.006
1.6 %

0.022
6.2 %

25 %
0.023
6.5 %

66 %
0.014
3.9 %

66 %
0.026
7.4 %

14 %
0.009
2.4 %

14 %
0.017
4.7 %

31%

62 %

62%

22 %

22 %

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2

Cd intake
0.038
TWI exhaustion
10.5 %
Processed cereal-based food – ready to eat
Percentage of consumers
35 %

0.128
36.0%

0.055
15.4 %

0.148
41.5%

0.024
6.6 %

0.077
21.6 %

35 %

73 %

73 %

24 %

24 %

Cd intake
TWI exhaustion

0.086
24.1 %

0.040
11.3 %

0.104
29.1 %

0.013
3.7 %

0.033
9.2 %

0.026
7.2 %

Average consumers: mean consumption x mean content (medium bound)thHigh consumers: 95 percentile of consumption x mean content (medium bound)

It can be seen from Table 5 that, with a daily intake of 0.148 µg per kg body weight, consumption of products from the food group “processed cereal-based foods in powder form”
leads to the highest intake of cadmium in high consumers in the age group 0.5 to < 1 year. A
lower intake of 0.055 µg per kg body weight results for average consumers in the same agegroup.
If this intake quantity is compared with the toxicological reference value for cadmium (TWI:
2.5 µg per kg body weight per week), a proportionate exhaustion of 41.5% results for highconsumers of the food group “processed cereal-based food in powder form” in the age group
0.5 to < 1 year and 15.4% for average consumers in the same age group (see Chapter 3.1.3
Risk characterisation).
Table 6 shows total cadmium intake via the examined ”foods for infants and young children”
for the group of consumers of “processed cereal-based foods in powder form”. This groupwas selected for the estimation of total intake in a worst case scenario because exposure
was highest here compared to the other observed consumers of food for infants and young
children (Table 5). Total intake relates to intake via processed cereal-based food in powder
form and the additional intake of this group of consumers via the food groups “baby formulain powder form” and “ready to eat”, as well as “processed cereal-based food – ready to eat”.
Table 6: Total intake of cadmium via food for infants and young children for consumers of processedcereal-based food in powder form (Basis: VELS, consumers only; FCP und Monitoring 2015, medium
bound)
Intake of cadmium in µg per kg body weight and day (Basis: only consumers of processed cereal-based food in powder form, medium bound)
0.5 to < 3 years
Average consumers1

1

High consumers²

0.5 to < 1 year
Average consumers1

High consumers²

1 to < 3 years
Average consumers1

High consumers²

Total intake by consumers of processed cereal-based food in powder form
31 %
31 %
62 %
Valid N
0.058
0.159
0.091
Cd intake

62 %
0.216

22 %
0.032

22 %
0.100

16.3 %

60.5 %

8.9 %

27.9 %TWI exhaustion

44.6 %

25.5 %

Average consumers: mean consumption x mean content (medium bound)th² High consumers: 95 percentile of consumption x mean content (medium bound)

The result of the estimation of total intake shows that in the group of consumers of “processed cereal-based food in powder form”, with average consumption quantities, cadmium
intake exhausts less than 30% of the TWI value through the consumption of all observed“foods for infants and young children” in all age groups. High consumers in the age group 0.5
to < 1 Jahr achieve the highest intake quantities of cadmium of 0.216 µg per kg body weightper day, which equates to a TWI exhaustion of 60.5%.
In addition to this, exposure was calculated in a hypothetical scenario assuming that the levels in food for infants and young children were equivalent to the maximum levels (Table 7).
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This calculation was not made for “processed cereal-based food – ready to eat” as no measured data on occurrence in this food group were included in the intake estimate. The exposure estimation for “processed cereal-based food – ready to eat” is based on the data onlevels contained in “processed cereal-based foods in powder form”, which was included in
the calculation using a reconstitution factor of seven (7).
Table 7: Intake of cadmium via food for infants and young children under the assumption of levels
equivalent to the maximum levels (Basis: VELS, consumers only)
Intake of cadmium in µg per kg body weight and day (Basis: consumers only, maximum
level)
0.5 to < 3 years
0.5 to < 1 year
1 to < 3 years
Average consumers1

High consumers2

Baby formula in powder form
Percentage of consumers
10 %Cd intake
0.032
TWI exhaustion
9.1 %Baby formula - ready to eat
Percentage of consumers
25 %Cd intake
0.016
TWI exhaustion
4.5 %Processed cereal-based food in powder form
Percentage of consumers
31 %Cd intake
0.079
TWI exhaustion
22.2 %
1
2

Averageconsumers1

High consumers2

Averageconsumers1

High consumers2

10 %
0.082
23.0 %

31 %0.039
11.0 %

31 %0.086
24.0 %

5%
0.020
5.5 %

5%
0.074
20.8 %

25 %
0.041
11.5 %

66%
0.162
45.4%

66 %
0.309
86.6 %

14 %
0.101
28.3 %

14 %0.195
54.7 %

31 %0.271
76.0 %

62 %
0.116
32.6 %

62 %
0.313
87.6 %

22 %
0.050
14.0 %

22 %
0.163
45.5 %

Average consumers: mean consumption x contents equivalent to maximum levelthHigh consumers: 95 percentile of consumption x contents equivalent to maximum level

The result of this hypothetical exposure estimation shows that average consumers reach thehighest cadmium intake of 0.162 µg per kg body weight per day via the food group “babyformula - ready to eat” in the 0.5 to < 1 year age group, which equates to a TWI exhaustionof 45% (Table 7). For high consumers, the maximum cadmium intake is also in this age
group in the scenario for “processed cereal-based food in powder form”, with a cadmium
intake of 0.313 µg per kg body weight and day, which equates to a TWI exhaustion of 87.6%.
An estimation of the intake of cadmium through the consumption of soya-based baby formula
could not be made due to the low number of consumers in the VELS study and resultant uncertainties. Furthermore, the BfR does not have any data on consumption by the youngest
infants aged under six months, so no exposure estimate could be made for this age groupeither. It has to be assumed that the consumption of baby formula in relation to body weightis higher in this age group than in the older age groups considered here, whereas that ofprocessed cereal-based food is lower.
3.2.3.2 Intake of lead
Only one data set each was available for the occurrence of cadmium and lead in ready-to-eat
food for infants and young children (baby formula and processed cereal-based food). For thisreason, the data on levels in powder and a reconstitution factor of seven were used to estimate intake through ready-to-eat food for infants and young children. This results in a level ofPage 11 of 18

Bundesinstitut für Risikobewertung
www.bfr.bund.delead in ready-to-eat baby formula of 0.001 mg per kg (mean, medium bound) and 0.004 mg
per kg (95th percentile, medium bound). A level of 0.001 mg per kg (mean, medium bound)and 0.002 mg per kg (95th percentile, medium bound) was calculated for ready-to-eat processed cereal-based food.
Table 8: Intake of lead via food for infants and young children (Basis: VELS, consumers only; FCP and
Monitoring 2015, mean levels, medium bound)
Intake of lead in µg per kg body weight and day (Basis: consumers only, medium bound)
0.5 to < 3 years
Average consumers1

0.5 to < 1 year
High consumers2

Baby formula in powder form
Percentage ofconsumers
10 %Pb intake
0.034
MoE
14.7
Baby formula - ready to eat
Percentage ofconsumers
25 %Pb intake
0.040
12.5
MoE

Average consumers1

1
2

0.011
45.5

High consumers2

Average consumers1

High consumers2

10 %
0.085
5.9

31 %
0.041
12.2

31 %
0.089
5.6

5%
0.020
25.0

5%
0.077
6.5

25 %
0.081
6.2

66 %
0.048
10.4

66 %
0.092
5.4

14 %
0.030
16.7

14 %
0.058
8.6

62 %
0.024
20.8

62 %
0.064
7.8

22 %
0.010
50.0

22 %
0.033
15.2

73 %

73 %

24 %

24 %

0.017
29.4

0.045
11.1

0.006
83.3

0.014
35.7

Processed cereal-based food in powder form
Percentage ofconsumers
31 %31 %Pb intake
0.016
0.055
31.3
9.1
MoE
Processed cereal-based food - ready to eat
Percentage ofconsumers
35 %35 %Pb intakeMoE

1 to < 3 years

0.037
13.5

Average consumers: mean consumption x mean content (medium bound)thHigh consumers: 95 percentile of consumption x mean content (medium bound)

It can be seen from Table 8 that the food group “baby formula - ready to eat” makes the biggest contribution towards the intake of lead via the consumption of food for infants and young
children among high consumers in the age group 0.5 to < 1 year with a daily intake of 0.092µg per kg body weight. With 0.048 µg per kg body weight, intake among average consumersof this food group in the same age group is considerably lower.
Table 9: Total intake of lead via food for infants and young children by consumers of baby formula –ready to eat (Basis: VELS, consumers only; FCP and Monitoring 2015, medium bound)
Intake of lead in µg per kg body weight and day (Basis: only consumers of baby formula ready to eat, medium bound)
0.5 to < 3 years
AverageHigh conconsumers1
sumers²1

Baby formula - ready to eat
Percentage
25 %of consumers
0.062
Pb intake
8.1
MoE

0.5 to < 1 year
AverageHigh conconsumers1
sumers²

1 to < 3 years
Averageconsumers1

High consumers²

25 %

66 %

66 %

14 %

14 %

0.123
4.1

0.079
6.3

0.125
4.0

0.039
12.8

0.104
4.8

Average consumers: mean consumption x mean content
th² High consumers: 95 percentile of consumption x mean content

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Table 9 shows total lead intake via the examined ”foods for infants and young children” forthe group of consumers of “baby formula - ready to eat”. This group was selected for the estimation of total intake in a worst case scenario because exposure was highest here compared to the other observed consumers of food for infants and young children (Table 8). Total intake relates to uptake via “baby formula - ready to eat” and the additional intake of thisgroup of consumers via the food groups “baby formula in powder form” and “processed cereal-based food in powder form” and “ready to eat”. With 0.125 and 0.123 µg per kg bodyweight per day respectively, the highest intake quantities for lead resulted for high consumers in the age groups 0.5 to < 1 year and 0.5 to < 3 years.
In addition to this, exposure was calculated in a hypothetical scenario under the assumptionthat the levels in food for infants and young children were equivalent to the maximum levels(Table 10). For most of the foods examined, however, the 95th percentile of the levels of leadlies well below the current maximum levels, which means that this is a less realistic worst
case assumption compared to cadmium. For lead too, the food group “cereal porridge –ready to eat” was not taken into consideration in this scenario either, as no data on measured levels in this food group were included in the intake estimation. The exposure estimation for “processed cereal-based food - ready to eat“ is based on data on the occurrence in“processed cereal-based food in powder form“, which were included in the calculation using
a reconstitution factor of seven.
With 0.618 µg per kg body weight and day, the highest intake of lead was to be found in theyoungest age group of 0.5 to under 1 year for high consumers of “baby formula - ready toeat”.
Table 10: Intake of lead via food for infants and young children under the assumption of levels equivalent
to the maximum levels (Basis: VELS, consumers only)
Intake of lead in µg per kg body weight and day (Basis: consumers only, maximum
level)
0.5 to < 3 years

0.5 to < 1 year

Averageconsumers1

Averageconsumers1

Baby formula in powder form
Percentage of consumers

1
2

High consumers2

10 %1 to < 3 years
High consumers2

Averageconsumers1

High consumers2

10 %

31 %

31 %

5%

5%

Pb intake
0.162
3.1
MoE
Baby formula - ready to eat
Percentage of consumers
25 %Pb intake
0.273
1.8
MoE
Processed cereal-based food in powder form
Percentage of consumers
31 %

0.410
1.2

0.197
2.5

0.429
1.2

0.098
5.1

0.371
1.3

25 %
0.545
0.9

66 %
0.324
1.5

66 %
0.618
0.8

14 %
0.202
2.5

14 %
0.391
1.3

31 %

62 %

62 %

22 %

22 %

Pb intake
MoE

0.339
1.5

0.145
3.4

0.391
1.3

0.062
8.1

0.203
2.5

0.099
5.1

Average consumers: mean consumption x contents equivalent to the maximum levelthHigh consumers: 95 percentile of consumption x contents equivalent to the maximum level

It was not possible to make an intake estimate on the consumption of soya-based baby formula due to the small number of consumers in the VELS study and resultant uncertainties.
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Furthermore, the BfR does not have any data on consumption by the youngest infants aged
under six months, which is why no exposure estimation could be undertaken for this age
group. It has to be assumed that in relation to body weight, the consumption of baby formulain this age group is higher than in the older age groups observed here, and that the consumption of processed cereal-based food is lower. Due to the higher levels of lead in baby
formula compared to processed cereal-based food, this would result in a higher overall exposure to lead.
Intake of lead – EFSA opinion 2012, comparison
The EFSA made an intake estimate of lead by young children (aged 0.5 to six years) in 2012.
Data from the DONALD6 study conducted in the years 2006-2008 was used here for Germany, but this data was not collected in a representative manner compared to the VELS study.
Average total intake of lead via all foods is given here as roughly 1.0 µg per kg body weightper day (medium bound). Accordingly, the figure for high consumers is approx. 1.4 µg per kg
body weight per day (medium bound).
Due to the differences in the age groups observed and in the data basis for the consumption
quantities, a comparison with this estimate of the intake of lead through the consumption offood for infants and young children would not appear expedient.
3.3 Risk characterisation and opinion on maximum levels
3.3.1

CadmiumComparison of the highest intake quantity of cadmium (high consumers of the food group“processed cereal-based food in powder form” in the 0.5 to < 1 year age group) with the toxicological reference value for cadmium (TWI: 2.5 µg per kg body weight per week) results in a
proportional exhaustion of 41.5%, and 15.4% for average consumers in the same age group.
Health risks for the age groups 0.5 to 3 year-old children through the intake of cadmium via“processed cereal-based food in powder form” are therefore unlikely.
Only one data set is available for the food group “processed cereal-based food - ready toeat”. The intake estimate for this food group was made on the basis of the data on occurrence in “processed cereal-based food in powder form”. With 29.1%, the highest TWI exhaustion with this food group resulted for children aged 0.5 to < 1 year (high consumers).
Health risks for the age groups 0.5 to 3 year-old children through the intake of cadmium via“processed cereal-based food – ready to eat” are therefore unlikely.
Compared to processed cereal-based food, the consumption of “baby formula” by infants andyoung children results in a lower exhaustion of the TWI value for cadmium for all age groups.
With 7.2%, the TWI exhaustion through consumption of the food group “baby formula inpowder form” was highest in the age group of 0.5 to < 1 year-old children (high consumers).
Only one data set is available for the food group “baby formula - ready to eat”. The intake
estimate for this food group was made on the basis of the data on occurrence in “baby formula in powder form“. With 7.4%, the highest TWI exhaustion with this food group resulted
for children aged 0.5 to < 1 year (high consumers). Health risks for the age groups 0.5 to 3

6

DONALD-Study = DOrtmund Nutritional and Anthropometric Longitudinally Designed Study

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year-old children through the intake of cadmium via “baby formula in powder form” and“ready to eat” are therefore unlikely.
If a closer look is taken at the estimation of total cadmium intake through all observed “foods
for infants and young children” in the group of consumers of “processed cereal-based food in
powder form”, the result of risk characterisation is also that the occurrence of health risks isunlikely. With average consumption quantities, less than 30% of the TWI value is exhausted.
High consumers in the age group 0.5 to < 1 year have the highest total intake of cadmium
through foods for infants and young children of 0.216 µg per kg body weight per day, which
equates to a TWI exhaustion of 60.5%.
The foods observed should be seen as the main source of nutrition for these age groups.
The intake of cadmium through the consumption of foods made from or containing soya protein isolates, which can have high levels of cadmium, and food for infants and young children
based on other protein sources were not taken into consideration in this exposure estimation.
No health assessment for children aged under six months was undertaken either. Althoughchildren of this age have a higher intake of food in relation to their body weight, higher intake
of processed cereal-based food in relation to body weight, which made the biggest contribution towards exposure to cadmium in this exposure estimation due to the higher levels of
cadmium they contain in comparison to baby formula, is not to be assumed.
When average consumption quantities are used as the basis, the hypothetical exposure estimation - made on the assumption that the levels in food for infants and young children areequivalent to the current maximum levels – produce the highest TWI exhaustion of 45%
through consumption of the food group “baby formula - ready to eat” in the 0.5 to < 1 year
age group. The maximum TWI exhaustion for high consumers was 87.6% in the same agegroup in the scenario for “processed cereal-based food in powder form”.
The currently valid maximum levels of cadmium permitted in food for infants and young children lie in the range of the 95th percentile of the levels determined within the scope of the
FCP and Monitoring 2015.
3.3.2 Lead
Comparison of the highest uptake quantity of lead (high consumers of the food group “babyformula - ready to eat” in the 0.5 to < 1 year age group) with the BMDL01 for developmental
neurotoxicity produces an MoE of 5.4. For average consumers of this food group in the sameage group, the MoE is 10.4.
For the food group “baby formula in powder form”, the lowest MoE resulted for children aged
0.5 to < 1 year (high consumers) with 5.6.
Compared to baby formula, the consumption of “processed cereal-based food” leads to lower
uptake quantities of lead by infants and young children, and thereby to higher MoE values.
With 7.8, the lowest MoE for children aged 0.5 to < 1 year (high consumers) resulted for the
food group “processed cereal-based food in powder form”.
Only one data set is available for the food group “processed cereal-based food - ready toeat”. The uptake estimate for this food group was made on the basis of the data on occurrence in “processed cereal-based food in powder form“. With 11.1, the lowest MoE for thisfood group resulted for children aged 0.5 to <1 year (high consumers).

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The exposure of infants and young children through the uptake of lead via the consumptionof foods in the group of “food for infants and young children” observed here is below the
BMDL01 value for developmental neurotoxicity of 0.5 µg per kg body weight per day for children with average consumption, as well as for high consumers based on the levels reported
in the FCP and Monitoring 2015. As no safe uptake quantity can be given for lead with regard to developmental neurotoxic effects in children, however, exposure should generally be
reduced to the achievable minimum.
When comparing the estimation of total intakes of lead through all observed “foods for infants
and young children” in the group of consumers of “baby formula - ready to eat” with the
BMDL01 value for developmental neurotoxicity, MoE values of 4.0 (group of high consumers
aged 0.5 to < 1 year) to 12.8 (group of average consumers aged 1 to < 3 years) result.
The foods observed should be seen as the main source of nutrition for these age groups.
The intake of lead through the consumption of foods made from or containing soya protein
isolates, which have levels of lead similar to those for food produced on the basis of cow’s
milk protein, and food for infants and young children based on other protein sources, were
not taken into consideration in this exposure estimation. No health assessment was undertaken either for children aged under six months for whom a higher lead uptake is to be expected compared to older children, as they have a higher intake of baby formula in relation totheir body weight.
When average consumption quantities are used as the basis, the hypothetical exposure estimation made on the assumption that the levels in food for infants and young children areequivalent to the current maximum levels for lead produce the lowest MoE value of 1.8
through consumption of the food group “baby formula - ready to eat” in the 0.5 to < 3 year
age group. For high consumers, the lowest MoE value of 0.8 results for the age group 0.5 to< 1 year in the scenario for “baby formula - ready to eat”.
This, however, is based on the worst case assumption that foods with very high levels of leadare eaten constantly in large quantities over a longer period of time. The likelihood that thisassumption will apply is very slight. For most of the foods examined, however, the 95th percentile of the levels of lead lies well below the current maximum levels. The low MoE values
are therefore unlikely.
Fundamentally, the ALARA principle should be applied when establishing maximum levels
for lead. ALARA stands for “As Low As Reasonably Achievable”, which means that exposure
to a substance should be reduced to the greatest reasonably possible extent. According to
the data of the FCP and Monitoring 2015, with 0.026 – 0.039 mg per kg (medium boundupper bound for baby formula in powder form) and 0.016 – 0.030 mg per kg (medium boundupper bound for processed cereal-based food in powder form), the levels of lead in the 95th
percentile in “baby formula in powder form” lie slightly below the maximum level of 0.05 mg
per kg established for this food category in Regulation (EU) 2015/1005 for infant formulaeand follow-on formulae in powder form and for processed cereal-based food.

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3.4 Conclusion
Cadmium
Based on the data on occurrence from the FCP and Monitoring 2015, health impairments forchildren in the age group 0.5 to < 3 years through the intake of cadmium via the consumptionof food for infants and young children in the food categories “baby formula in powder form”
and “ready to eat”, as well as “processed cereal-based food in powder form” and “ready toeat”, are unlikely with average as well as high consumption (95th percentile of consumption).
The current maximum levels for cadmium in food for infants and young children lie within therange of the 95th percentile of the levels determined in the FCP and Monitoring 2015.
Lead
Based on the data on occurrence determined in the FCP and Monitoring 2015, the exposureof children in the age group 0.5 to < 3 years to lead through the intake of food for infants andyoung children in the food categories “baby formula in powder form” and “ready to eat”, aswell as “processed cereal-based food in powder form” and “ready to eat” lies below the
BMDL01 value for developmental neurotoxicity of 0.5 µg per kg body weight per day for children with average consumption as well as high consumers. As no safe uptake quantity canbe given for lead, however, with regard to its developmental neurotoxic effect in children,
exposure should be reduced to the achievable minimum as a basic principle.

More information on the topic of infants and young children at the BfR website
BfR Brochure “Breastfeeding recommendations for pregnant women”
https://www.bfr.bund.de/cm/364/stillempfehlungen-fuer-schwangere-englisch.pdf
BfR Opinion “Lead and cadmium do not belong in toys”
https://www.bfr.bund.de/cm/349/lead_and_cadmium_do_not_belong_in_toys.pdf
BfR Brochure “Checklist for the time after birth” (German only)
https://www.bfr.bund.de/cm/350/checkliste-fuer-die-zeit-nach-der-geburt.pdf

BfR “Opinions App”

4 References
Banasiak U, Heseker H, Sieke C, Sommerfeld C, Vohmann C (2005): Abschätzung der Aufnahme von Pflanzenschutzmittel-Rückstanden in der Nahrung mit neuen Verzehrsmengen
für Kinder. Bundesgesundheitsbl – Gesundheitsforsch – Gesundheitsschutz 1, 48:84-98.
Blume K., Lindtner O., Schneider K., Schwarz M., Heinemeyer G. (2010): Aufnahme vonUmweltkontaminanten über Lebensmittel: Cadmium, Blei, Quecksilber, Dioxine und PCB;
Informationsbroschüre des Bundesinstitut für Risikobewertung (BfR) [in print]

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BVL (2015a): Bundesweiter Überwachungsplan 2015, BVL-Report 11.1, Berichte zur Lebensmittelsicherheit.
http://www.bvl.bund.de/SharedDocs/Downloads/01_Lebensmittel/02_BUEp_dokumente/BUE
p_Bericht_2015.pdf?__blob=publicationFile&v=3
BVL (2015b): Monitoring 2015, BVL-Report 11.3, Berichte zur Lebensmittelsicherheit.
http://www.bvl.bund.de/SharedDocs/Downloads/01_Lebensmittel/01_lm_mon_dokumente/01_Monitoring_Berichte/archiv/lmm_bericht_2015.pdf?__blob=publicationFile&v=5
EFSA (2009): Cadmium in food, Scientific Opinion of the Panel on Contaminants in the Food
Chain, EFSA Journal 2009; 980:1-139.
EFSA (2010): Lead in food, Scientific Opinion of the Panel on Contaminants in the Food
Chain, EFSA Journal 2010; 8(4):1570. [151 pp.]. doi:10.2903/j.efsa.2010.1570. Available
online: www.efsa.europa.eu
EFSA (2012): Lead dietary exposure in the European population. Scientific Report of EFSA,EFSA Journal 2012; 10(7): 2831.
Heseker H, Oeppining A, Vohmann C (2003): Verzehrsstudie zur Ermittlung der Lebensmittelaufnahme von Säuglingen und Kleinkindern für die Abschätzung eines akuten Toxizitätsrisikos durch Rückstände von Pflanzenschutzmitteln (VELS). Forschungsbericht im Auftragdes Bundesministeriums für Verbraucherschutz, Ernährung und Landwirtschaft, Universität
Paderborn.
Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on
formulae and amending Directive 1999/21/EC.
Commission Regulation (EC) No. 1881/2006 of 19 December 2006 setting maximum levels
for certain contaminants in foodstuffs.
Commission Regulation (EU) No. 488/2014 of 12 May 2014 amending Regulation (EC) No.
1881/2006 as regards maximum levels of cadmium in foodstuffs.
Commission Regulation (EU) 2015/1005 of 25 June 2015 amending Regulation (EC) No.
1881/2006 as regards maximum levels of lead in certain foodstuffs.

About the BfR
The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany.
It advises the Federal Government and Federal Laender on questions of food, chemical andproduct safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.

This text version is a translation of the original German text which is the only legally binding
version.

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