22 DE Metals&Al...e n t r a t i o n i n µ g / L Zeit in Minuten Thallium Zitronensäure MW (n=3)...

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Research project:

„Aluminium release from foodpackaging“

Stefan Merkel

Stefan Merkel, 3rd meeting on 24-26 May 2016, FIP FCM Network Page 2

Food

• Unprocessed food - fruits, vegetables, tea leaves, spices

• Processed food - aluminium containing food additives

• Drinking water - natural content, treatment

Food contact materials made of uncoated aluminium

• Kitchen utensils, baking sheets and moulds,foils (cans, tubes)In particular if used in contact with acidic (e.g. fruit juices), alkaline (e.g.lye dough products) or salty, liquid foodstuffs

Drugs for oral application

• Antazida (aluminium hydroxide, aluminium glycinate)

Sources of aluminium exposure - oral

Picture notpublished


Health-based guidance value

Use of Lowest-Observed Adverse Effect Levels (LOAELs) and No-Observed AdverseEffect Levels (NOAELs) of several studies in mice, rats and dogs after dietaryadministration of aluminium compounds

Endpoints: neurotoxicity, effects on testes, embryotoxicity and neurodevelopmentaltoxicity

In view of the cumulative nature of aluminium in the organism after dietary exposure, itwas considered more appropriate to establish a tolerable weekly intake (TWI).

Lowest LOAEL/NOAEL[mg/kg bw/day ]

uncertainty factorTWI

[mg/kg bw/week]

50 300 1,2

10 100 0,7

EFSA Opinion 2008

TWI: 1 mg aluminium/kg bw/week


Exposure assessment

Major route of exposure to aluminium for the general population is through food, mainlyfrom cereals and cereal products, vegetables, beverages and certain infant formulae.

Drinking water and food contact materials are a minor source.

Adults: Large variation from 0.2 to 1.5 mg aluminium/kg bw/week

Children: 0.7 to 2.3 mg aluminium/kg bw/week

EFSA Opinion 2008

Conclusion:The TWI of 1 mg aluminium/kg bw/week is likely to be exceeded in a significantpart of the European population.

EFSA Opinion 2008


Provisions for the use of aluminium as food contact material

Materials and articles, including active and intelligent materials and articles, shall bemanufactured in compliance with good manufacturing practice so that, under normal orforeseeable conditions of use, they do not transfer their constituents to food inquantities which could:

(a) endanger human health;

or

(b) bring about an unacceptable change in the composition of the food;

or

(c) bring about a deterioration in the organoleptic characteristics thereof.

ANNEX I, List of groups of materials and articles which may be covered by specific

Measures

… Metals and alloys still missing!

“Framework Regulation“ (EG) 1935/2004, Art. 3


Council of Europe Resolution CM/Res(2013)9 on metals andalloys used in food contact materials and articles

specific release limits, SRL, for 21 elements:

Metals and alloy components Metal contaminants and impurities

Element SRL [mg/kg LM]

Tl

Sb

Pb

Li

Hg

Cd

Be

Ba

As

0,0001

0,04

0,01

0,048

0,003

0,005

0,01

1,2

0,002

Element SRL [mg/kg LM]

Zn

V

Sn

Ni

Mo

Mn

Fe

Cu

Cr

Co

AlAg

5

0,01

100

0,14

0,12

1,8

40

4

0,25

0,02

50,08




Data provided by industryand member states

Tolerable intake of aluminium is already utilised by dietary intake of aluminium

Additional exposure should be minimised as far as possible

SRL of 5 mg Al/kg food is achievable, if…

Derivation of the SRL for aluminium (ALARA-prinziple):



SRL of 5 mg Al/kg food is achievable, if…

Storage of acidic (e.g. fruit juices), alkaline (e.g. lye dough products) or salty, liquidfoodstuffs in uncoated aluminium utensils is limited in order to minimise release.

The producer should provide specific labelling of uncoated aluminium for users. Withregard to retail packs, the suppliers must ensure that these are labelled withappropriate information for the end consumer. E.g. “User information: do not use thisutensil for storage and processing of acidic, alkaline or salty food”

Guidance should be available from producers of uncoated aluminium utensilsregarding the use of their product with strongly acidic, alkaline or salty foodstuffs.


© Ivan Simunik / www.pixelio.de © Jonathan Keller / www.pixelio.de



BfR recommends not to use uncoated aluminium trays for dippingand baking of lye rolls and pretzels for more than 25 years.

Rate of complaints, Bavaria

Source: Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Jahresbericht 2013

• Average concentration in theobjected samples: 26,7 mg Al/kg

• 1 pretzel/d

• 25 % consumption of the EFSAPTWI

Exposure scenario

60 kg 80 g

Food control authorities frequently discover more than 10 mg Al/kg in lye pretzels androlls.

Problems in the use of aluminium as food contact material


Release of metals from food contact materials

Uncoated aluminium utensils

BfR Research Project

Espresso makers Foil dishes

Picture not published


Al release from espresso makers

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AlFre

isetz

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[mg/k

gLM

]

Kanne 1

Kanne 2

Kanne 3

SRL: 5 mg/kg

test water coffee test water test water

dishwasher


Dishwashers should not be used for cleaning


Al and Tl release from foil dishes

Test Conditions: 2 h/70°C


Aluminium Thallium

Compared to benchmark food:

- higher release by simulants citric acid and lactic acid

- lower release by synthetic tap water



Test Conditions: 2 h/70°C and 2 h/100°C


Aluminium Thallium

Al: citric acid overestimates the release compared to tomato purée

Tl: higher release in benchmark foods


Al release from foil dishes

Test Conditions: 100 °C


Linear release of aluminium after a certain lag time


Linear release of thallium (without lag time) followed by a saturation state

Tl release from foil dishes

Test Conditions: 100 °C

0.0

0.1

0.2

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1.0

Ko

nze

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inµ

g/L

Zeit in Minuten

ThalliumZitronensäure MW (n=3)

SLW MW (n=3)

Tomate Sauerkrautsaft*

Apfelmus Grenzwert


* elevated background level (0,45 µg/kg)

applesauce+water(1+1)

sauerkraut juice*

sythetic tap water

citric acid

tomato purée

SRL

time in min

concentr

ation

inµ

g/L


Kinetic release tests:


Test Conditions: 100 °C, citric acid 0.5%


Release of Al is doubled with every increase of 10°C

Aluminium Thallium


Further Al-food contact materials

Dishes for cook and chill technique

Camping tablewear, pans, pots…


Pictures not published

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Stefan Merkel

Federal Institute for Risk Assessment

Max-Dohrn-Str. 8-10 10589 Berlin, GERMANY

Tel. +49 30 - 184 12 - 4932

[email protected] www.bfr.bund.de

Research project:��„Aluminium release from food packaging“Slide Number 2Slide Number 3EFSA Opinion 2008Provisions for the use of aluminium as food contact materialProvisions for the use of aluminium as food contact materialProvisions for the use of aluminium as food contact materialProvisions for the use of aluminium as food contact materialProblems in the use of aluminium as food contact materialSlide Number 10Al release from espresso makersAl and Tl release from foil dishes�Test Conditions: 2 h/70°C�Al and Tl release from foil dishes�Test Conditions: 2 h/70°C and 2 h/100°C�Al release from foil dishes�Test Conditions: 100 °CSlide Number 15Slide Number 16Slide Number 17Thank you for your attention

22 DE Metals&Al...e n t r a t i o n i n µ g / L Zeit in Minuten Thallium Zitronensäure MW (n=3)...

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