Calculation of the maximum acceptable specific migration of a substance from the SML under y

11 January 2012
Jens Hjslev Petersen, Eddo J. Hoekstra

Introduction
This spreadsheet is prepared in the framework of the Task Force on the Fourth Amendment of Directiv
Directive 2002/72/EC has been repealed by Regulation (EU) No 10/2011. According to the Regulation
specific migration in mg/kg, with the Specific Migration Limit (SML) for checking compliance. As usual,
experimental surface-to-volume ratio and the one for the real food application. Furthermore, for certain
simulant D reduction factor (DRF) before you compare your result with the SML.

If you are testing the release of a lipophilic substance that is listed in Annex IVa (which is the new poss
higher, you shall divide your experimentally result by a fat reduction factor (FRF). In cases where both
(TRF=DRF*FRF) cannot exceed 5. Since the application of the DRF and FRF is rather complex, a calc
calculate from the SML a maximum acceptable specific migration in your experimental set-up before y
your corrected experimentally obtained result with the SML and see if your material or article is in com
Detailed information about this calulator can be read in chapter 2 of the "Guidance document on the fa
aromatic amines":
http://ihcp.jrc.ec.europa.eu/our_labs/eurl_food_c_m/publications/publications#technical-guidelines

What do you need to do?

fill in the SML from Annex I or II of Regulation (EU) No 10/2011 or your limit of detection
fill in whether the SML is a detection limit or not
check whether your substance is listed "yes" in column (7) of Table 1 of Annex I of Regulation (EU) N
fill in the volume of the material/article if applicable
fill in the highest real food contact surface-to-volume ratio
fill in whether the food packaged in the material is intended for children
fill in the DRF, which you can find in the Annex of Directive 85/572/EEC (in force until 31/12/2012) or
1/1/2013), if food simulant D is used
fill in the fat content of the food to which the article comes into contact
fill in the surface-to-volume ratio in your migration experiment
select your food simulant
fill in your test result (facultative)

For questions and suggestions for improvement please contact:

[email protected]
Calculation of maximum acceptable specific migration of a substance from the SML in food or food simulant in your experimental conditions

11 January 2012
Jens Hjslev Petersen, Eddo J. Hoekstra

Colour codes: = obligatory information for the calculations

= facultative information
= calculated values

Note this calculator is not valid for: 1. substances behind the functional barrier

2. caps, gaskets, stoppers and similar sealing articles if the intended use of the article is not known

Data related to: IMPORTANT NOTES

Name
SML (mg/kg) Always 60 mg/kg; if SML=ND, please fill in your limit of detection

SML = ND? click and select

Migrating Substance
"yes" means that column (7) in Table 1 of Annex I of Regulation 10/2011 states "yes" for the
Fat reduction factor applicable? click and select substance and that 1) material/article will not come into contact with food intended for infants
and young children as defined by Directives 2006/141/EC and 2006/125/EC, 2) surface-to-volume
ratio is known or estimatable
Polymer type
Lot no.

Plastic FCM volume of material/article (ml)

when you leave the cell empty then it means that you deal with a non-fillable article
material surface-to-volume of food contact this is the surface-to-volume ratio of the material/article that will come into contact with food; If
ratio (dm2/kg) you do not know this value you should fill in the default value of 6 dm 2/kg
Name of sample
Type of food
Food intended for infant or young children (<3 click and select
years)?

Food in contact with FCM Simulant D Reduction Factor (DRF) click and select until 31/12/2012 DRF according to Council Directive 85/572/EEC; from 1/1/2013 DRF according to
Regulation 10/2011; you should fill DRF = 1 in the specific case where the SML=ND
Fat content (%) According to the food declaration obligatory value only when FRF is used
Fat reduction factor (FRF) 1 range 1-5

Allowed total reduction factor TRF (always 5) #VALUE! According to "4th amendment"
Surface-to-volume ratio (dm2/kg) By convention: 1 liter of food simulant = 1 kg

food or simulant click and select until 31/12/2012 food simulants according to Council Directive 85/572/EEC (D1=D and D2=50%
Migration Test Conditions
ethanol); from 1/1/2013 food simulants according to Regulation 10/2011
Time
Temperature
Specific migration (mg/kg)
Migration Test Results fill in only one result, i.e. specific migration in mg/kg or mg/dm 2.
Specific migration (mg/dm2)

mg/kg 0
Calculated maximum acceptable The calculator specifies both a maximum acceptable migration under the given test conditions
concentration in test
mg/dm2 #DIV/0!

Corrected test results (to be

compared with the legislative Specific migration (mg/kg) 0 Correction for DRF, FRF or TRF, and surface-to-volume ratio of real food contact
limit)

Sample in Compliance yes/no no

Be aware that influence of the expanded measurement uncertainty is not taken into account
Calculation of maximum acceptable specific migration of a substance from the SML in food or food simulant in your experimental conditions

11 January 2012
Jens Hjslev Petersen, Eddo J. Hoekstra

Colour codes: = obligatory information for the calculations

= facultative information
= calculated values

Note this calculator is not valid for: 1. substances behind the functional barrier

2. caps, gaskets, stoppers and similar sealing articles if the intended use of the article is not known

Data related to: IMPORTANT NOTES

Name Irganox
SML (mg/kg) 6 Always 60 mg/kg; if SML=ND, please fill in your limit of detection
SML = ND? no
Migrating Substance
"yes" means that column (7) in Table 1 of Annex I of Regulation 10/2011 states "yes" for the
Fat reduction factor applicable? yes substance and that 1) material/article will not come into contact with food intended for infants
and young children as defined by Directives 2006/141/EC and 2006/125/EC, 2) surface-to-volume
ratio is known or estimatable
Polymer type
Lot no.

Plastic FCM volume of material/article (ml) 600

when you leave the cell empty then it means that you deal with a non-fillable article
material surface-to-volume of food contact 6 this is the surface-to-volume ratio of the material/article that will come into contact with food; If
ratio (dm2/kg) you do not know this value you should fill in the default value of 6 dm 2/kg
Name of sample
Type of food
Food intended for infant or young children (<3 no
years)?

Food in contact with FCM Simulant D Reduction Factor (DRF) 1 until 31/12/2012 DRF according to Council Directive 85/572/EEC; from 1/1/2013 DRF according to
Regulation 10/2011; you should fill DRF = 1 in the specific case where the SML=ND
Fat content (%) 5 According to the food declaration obligatory value only when FRF is used
Fat reduction factor (FRF) 1 range 1-5

Allowed total reduction factor TRF (always 5) 1 According to "4th amendment"

Surface-to-volume ratio (dm2/kg) 18 By convention: 1 liter of food simulant = 1 kg

food or simulant D2 until 31/12/2012 food simulants according to Council Directive 85/572/EEC (D1=D and D2=50%
Migration Test Conditions
ethanol); from 1/1/2013 food simulants according to Regulation 10/2011
Time
Temperature
Specific migration (mg/kg) 14
Migration Test Results fill in only one result, i.e. specific migration in mg/kg or mg/dm 2.
Specific migration (mg/dm2)

mg/kg 18
Calculated maximum acceptable The calculator specifies both a maximum acceptable migration under the given test conditions
concentration in test
mg/dm 2
1

Corrected test results (to be

compared with the legislative Specific migration (mg/kg) 4.6666666667 Correction for DRF, FRF or TRF, and surface-to-volume ratio of real food contact
limit)

Sample in Compliance yes/no yes

Be aware that influence of the expanded measurement uncertainty is not taken into account
Calculation of maximum acceptable specific migration of a substance from the SML in food or food simulant in your experimental conditions

11 January 2012
Jens Hjslev Petersen, Eddo J. Hoekstra

Colour codes: = obligatory information for the calculations

= facultative information
= calculated values
= fixed values in this specific application

Note this calculator is not valid for: 1. substances behind the functional barrier

2. caps, gaskets, stoppers and similar sealing articles if the intended use of the article is not known

Data related to: IMPORTANT NOTES

Name PAA
SML (mg/kg) 0.01
SML = ND? yes
Migrating Substance

Fat reduction factor applicable? no

Polymer type
Lot no.

Plastic FCM volume of material/article (ml)

when you leave the cell empty then it means that you deal with a non-fillable article
material surface-to-volume of food contact this is the surface-to-volume ratio of the material/article that will come into contact with food; If
ratio (dm2/kg) you do not know this value you should fill in the default value of 6 dm2/kg
Name of sample
Type of food According to Annex III
Food intended for infant or young children (<3 click and select
years)?

Food in contact with FCM Simulant D Reduction Factor (DRF) 1

Fat content (%) According to the food declaration obligatory value only when FRF is used
Fat reduction factor (FRF) 1 range 1-5

Allowed total reduction factor TRF (always 5) 1 According to "4th amendment"

Surface-to-volume ratio (dm2/kg) By convention: 1 liter of food simulant = 1 kg

food or simulant B
Migration Test Conditions
Time
Temperature
Specific migration (mg/kg)
Migration Test Results fill in only one result, i.e. specific migration in mg/kg or mg/dm2.
Specific migration (mg/dm2)

mg/kg 0
Calculated maximum acceptable
concentration in test The calculator specifies both a maximum acceptable migration under the given test conditions
mg/dm2 #DIV/0!

Corrected test results (to be

compared with the legislative Specific migration (mg/kg) 0 Correction for DRF, FRF or TRF, and surface-to-volume ratio of real food contact
limit)

Sample in Compliance yes/no no

Be aware that influence of the expanded measurement uncertainty is not taken into account
Calculation of maximum acceptable specific migration of a substance from the SML in food or food simulant in your experimental conditions

11 January 2012
Jens Hjslev Petersen, Eddo J. Hoekstra

Colour codes: = obligatory information for the calculations

= facultative information
= calculated values
= fixed values in this specific application

Note this calculator is not valid for: 1. substances behind the functional barrier

2. caps, gaskets, stoppers and similar sealing articles if the intended use of the article is not known

Data related to: IMPORTANT NOTES

Name formaldehyde
SML (mg/kg) 15 sum of formaldehyde and hexamethylenetetramine
SML = ND? no
Migrating Substance

Fat reduction factor applicable? no

Polymer type
Lot no.

Plastic FCM volume of material/article (ml)

when you leave the cell empty then it means that you deal with a non-fillable article
material surface-to-volume of food contact this is the surface-to-volume ratio of the material/article that will come into contact with food; If
ratio (dm2/kg) you do not know this value you should fill in the default value of 6 dm2/kg
Name of sample
Type of food According to Annex III
Food intended for infant or young children (<3 click and select
years)?

Food in contact with FCM Simulant D Reduction Factor (DRF) 1

Fat content (%) According to the food declaration obligatory value only when FRF is used
Fat reduction factor (FRF) 1 range 1-5

Allowed total reduction factor TRF (always 5) 1 According to "4th amendment"

Surface-to-volume ratio (dm2/kg) By convention: 1 liter of food simulant = 1 kg

food or simulant B
Migration Test Conditions
Time
Temperature
Specific migration (mg/kg)
Migration Test Results fill in only one result, i.e. specific migration in mg/kg or mg/dm2.
Specific migration (mg/dm2)

mg/kg 0
Calculated maximum acceptable
concentration in test The calculator specifies both a maximum acceptable migration under the given test conditions
mg/dm2 #DIV/0!

Corrected test results (to be

compared with the legislative Specific migration (mg/kg) 0 Correction for DRF, FRF or TRF, and surface-to-volume ratio of real food contact
limit)

Sample in Compliance yes/no no

Be aware that influence of the expanded measurement uncertainty is not taken into account
European Commission
Joint Research Centre
Institute for Health and Consumer Protection
Address: Via E. Fermi 2749, 21027 Ispra (VA), Italy
E-mail: [email protected]
Tel.: +39-0332-785319
Fax: +39-0332-785707
http://ihcp.jrc.ec.europa.eu/our_labs/eurl_food_c_m
http://www.jrc.ec.europa.eu/

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