Materials and Articles in Contact with Food and Articles in Contact with Food . ... • Declaration...
Transcript of Materials and Articles in Contact with Food and Articles in Contact with Food . ... • Declaration...
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Emma Bradley Fera Science Ltd
Materials and Articles in Contact with Food
Date: July 2017, Version 1
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What is migration? Factors affecting migration
Legislation How it all started
EU legislation
EFSA risk assessment
Overview
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Migration testing Specific and overall migration Screening and verification tests Why do we test? How do we test?
Other aspects NIAS, nanoparticles, functional barrier Declaration of compliance and supporting documentation Correction factors Harmonised non-plastic FCMs Non-harmonised FCMs
Overview
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Introduction
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FSA appointed Fera NRL for Chemical contaminants in 2008
Food contact materials
Dioxins and PCBs
Mycotoxins
PAHs
Trace elements
Also some Vet Drugs & Pesticides functions VMD and CRD
Chemical contaminants NRL
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What is migration?
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Packaging is beneficial Protects foodstuff from spoilage
However the transfer of chemicals from packaging to food may have a negative impact on the quality and safety of the food
No food contact material is completely inert
Need to ensure the safety of these materials
Migration from food contact materials
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The mass transfer from an external source into food by sub-microscopic processes
May impact food in two ways Food safety migration of harmful substances
Food quality migration of substances which impart taint or odour
What is migration?
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Migration occurs from: Food packaging
Materials and articles used in food manufacture, transport and storage
Materials and articles used in food preparation and consumption
What is migration?
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Migration is a diffusion and partitioning process that is dependent on:
The nature of the food contact material (FCM)
The nature and concentration of the migrating substance
The nature of the foodstuff
The nature, the extent and the type of contact between the food contact material/article and the foodstuff
Factors affecting migration
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Packaging
Impermeable materials:- glass & ceramics- metals & alloys
xyz
Food
Depiction of chemical migration from an impermeable material
The nature of the FCM
Packaging
Impermeable materials:
- glass & ceramics
- metals & alloys
x
y
z
Food
4
4
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Packaging
Permeable materials: - plastics- rubber & silicone- coatings
xy
z
Food
Depiction of chemical migration from a permeable material
The nature of the FCM
Packaging
Permeable materials:
- plastics
- rubber & silicone
- coatings x
y
z
Food
5
5
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Depiction of chemical migration from a porous material
The nature of the FCM
Packaging
Porous materials:
e.g. paper and board
x
z
Food
y
5
5
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Ingredients needed to make plastics Monomers and starting substances
Catalysts
Solvents and suspension media
Additives Antioxidants, antistatics, antifogging, slip additives, plasticisers,
heat stabilisers, nucleating agents, dyes and pigments
The nature of the substance
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Acrylonitrile
( >2000 substances )
Xylene
The nature of the substance
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0
0.2
0.4
0.6
0.8
1
1.2
1.4
0 50 100 150 200Time (days)
Mig
ratio
n in
to fo
od (m
g/kg
)
200 Da additive500 Da additive1000 Da additive
The nature of the substance
Chart5
000
0.9773370.2317770.040424
1.1804760.3274460.057156
1.236660.4006930.069811
1.2521990.462330.080628
1.2564970.5165330.090154
1.2576850.56540.098765
1.2580140.6101290.106682
1.2581050.6514540.114049
1.258130.6898510.120967
1.2581370.7256540.127509
1.2581390.7591080.13373
1.258140.7904080.139674
1.258140.8197160.145374
1.258140.847170.150857
1.258140.8728960.156148
1.258140.8970060.161264
1.258140.9196040.166222
1.258140.9407860.171035
1.258140.9606420.175716
1.258140.9792550.180275
1.258140.9967040.18472
1.258141.013060.18906
1.258141.0283930.193303
1.258141.0427670.197453
1.258141.0562410.201518
1.258141.0688730.205502
1.258141.0807140.209409
1.258141.0918140.213244
1.258141.102220.217011
1.258141.1119750.220714
1.258141.1211190.224354
1.258141.1296920.227936
1.258141.1377280.231462
1.258141.1452610.234935
1.258141.1523230.238357
1.258141.1589430.24173
1.258141.165150.245056
1.258141.1709670.248337
1.258141.1764210.251576
1.258141.1815340.254772
1.258141.1863260.257929
1.258141.1989790.267172
1.258141.2094030.276104
1.258141.217990.284753
1.258141.2250640.293144
1.258141.2308920.301299
1.258141.2356930.309237
1.258141.2396480.316974
1.258141.2429060.324524
1.258141.245590.331901
1.258141.2478010.339115
1.258141.2496230.346177
1.258141.2511230.353096
1.258141.252360.35988
1.258141.2533780.366537
1.258141.2544620.375226
1.258141.25530.383717
1.258141.2559470.39202
1.258141.2564460.400149
1.258141.2568320.408114
1.258141.257130.415924
1.258141.257360.423587
1.258141.2575370.431112
1.258141.2576750.438506
1.258141.2577810.445775
1.258141.2578960.456458
1.258141.2579740.466891
1.258141.2580280.477092
1.258141.2580640.487074
1.258141.2580880.496851
1.258141.2581050.506434
1.258141.2581060.507488
200 Da additive
500 Da additive
1000 Da additive
Time (days)
Migration into food (mg/kg)
PPreal MW200
0000100
1.1250.9773370.043980.02290684.790461
2.251.1804760.0531210.02766781.62916
3.3751.236660.055650.02898480.754816
4.51.2521990.0563490.02934880.51299
5.6251.2564970.0565420.02944980.446106
6.751.2576850.0565960.02947780.427608
7.8751.2580140.0566110.02948580.422491
91.2581050.0566150.02948780.421076
10.1251.258130.0566160.02948780.420685
11.251.2581370.0566160.02948880.420577
12.3751.2581390.0566160.02948880.420547
13.51.258140.0566160.02948880.420538
14.6251.258140.0566160.02948880.420536
15.751.258140.0566160.02948880.420535
16.8751.258140.0566160.02948880.420535
181.258140.0566160.02948880.420535
19.1251.258140.0566160.02948880.420535
20.251.258140.0566160.02948880.420535
21.3751.258140.0566160.02948880.420535
22.51.258140.0566160.02948880.420535
23.6251.258140.0566160.02948880.420535
24.751.258140.0566160.02948880.420535
25.8751.258140.0566160.02948880.420535
271.258140.0566160.02948880.420535
28.1251.258140.0566160.02948880.420535
29.251.258140.0566160.02948880.420535
30.3751.258140.0566160.02948880.420535
31.51.258140.0566160.02948880.420535
32.6251.258140.0566160.02948880.420535
33.751.258140.0566160.02948880.420535
34.8751.258140.0566160.02948880.420535
361.258140.0566160.02948880.420535
37.1251.258140.0566160.02948880.420535
38.251.258140.0566160.02948880.420535
39.3751.258140.0566160.02948880.420535
40.51.258140.0566160.02948880.420535
41.6251.258140.0566160.02948880.420535
42.751.258140.0566160.02948880.420535
43.8751.258140.0566160.02948880.420535
451.258140.0566160.02948880.420535
46.1251.258140.0566160.02948880.420535
49.51.258140.0566160.02948880.420535
52.8751.258140.0566160.02948880.420535
56.251.258140.0566160.02948880.420535
59.6251.258140.0566160.02948880.420535
631.258140.0566160.02948880.420535
66.3751.258140.0566160.02948880.420535
69.751.258140.0566160.02948880.420535
73.1251.258140.0566160.02948880.420535
76.51.258140.0566160.02948880.420535
79.8751.258140.0566160.02948880.420535
83.251.258140.0566160.02948880.420535
86.6251.258140.0566160.02948880.420535
901.258140.0566160.02948880.420535
93.3751.258140.0566160.02948880.420535
97.8751.258140.0566160.02948880.420535
102.3751.258140.0566160.02948880.420535
106.8751.258140.0566160.02948880.420535
111.3751.258140.0566160.02948880.420535
115.8751.258140.0566160.02948880.420535
120.3751.258140.0566160.02948880.420535
124.8751.258140.0566160.02948880.420535
129.3751.258140.0566160.02948880.420535
133.8751.258140.0566160.02948880.420535
138.3751.258140.0566160.02948880.420535
145.1251.258140.0566160.02948880.420535
151.8751.258140.0566160.02948880.420535
158.6251.258140.0566160.02948880.420535
165.3751.258140.0566160.02948880.420535
172.1251.258140.0566160.02948880.420535
178.8751.258140.0566160.02948880.420535
179.6251.258140.0566160.02948880.420535
PPreal MW500
0000100
1.1250.2317770.010430.00543296.393026
2.250.3274460.0147350.00767594.90421
3.3750.4006930.0180310.00939193.76433
4.50.462330.0208050.01083692.805106
5.6250.5165330.0232440.01210691.961598
6.750.56540.0254430.01325291.201111
7.8750.6101290.0274560.014390.505024
90.6514540.0293150.01526889.861926
10.1250.6898510.0310430.01616889.264376
11.250.7256540.0326540.01700888.707205
12.3750.7591080.034160.01779288.186582
13.50.7904080.0355680.01852587.699483
14.6250.8197160.0368870.01921287.243395
15.750.847170.0381230.01985686.816145
16.8750.8728960.039280.02045886.415795
180.8970060.0403650.02102486.040589
19.1250.9196040.0413820.02155385.688911
20.250.9407860.0423350.0220585.359266
21.3750.9606420.0432290.02251585.050262
22.50.9792550.0440660.02295184.7606
23.6250.9967040.0448520.0233684.489065
24.751.013060.0455880.02374484.234522
25.8751.0283930.0462780.02410383.995905
271.0427670.0469250.0244483.772218
28.1251.0562410.0475310.02475683.562526
29.251.0688730.0480990.02505283.365953
30.3751.0807140.0486320.02532983.181679
31.51.0918140.0491320.02558983.008933
32.6251.102220.04960.02583382.846995
33.751.1119750.0500390.02606282.695188
34.8751.1211190.050450.02627682.552879
361.1296920.0508360.02647782.419473
37.1251.1377280.0511980.02666582.294414
38.251.1452610.0515370.02684282.177178
39.3751.1523230.0518550.02700882.067277
40.51.1589430.0521520.02716381.964252
41.6251.165150.0524320.02730881.867673
42.751.1709670.0526940.02744581.777135
43.8751.1764210.0529390.02757281.692262
451.1815340.0531690.02769281.612699
46.1251.1863260.0533850.02780581.538114
49.51.1989790.0539540.02810181.341206
52.8751.2094030.0544230.02834581.178992
56.251.217990.054810.02854781.045358
59.6251.2250640.0551280.02871280.93527
631.2308920.055390.02884980.844578
66.3751.2356930.0556060.02896280.769865
69.751.2396480.0557840.02905480.708316
73.1251.2429060.0559310.02913180.657612
76.51.245590.0560520.02919480.615841
79.8751.2478010.0561510.02924580.58143
83.251.2496230.0562330.02928880.553081
86.6251.2511230.0563010.02932380.529728
901.252360.0563560.02935280.510489
93.3751.2533780.0564020.02937680.49464
97.8751.2544620.0564510.02940180.477764
102.3751.25530.0564880.02942180.464731
106.8751.2559470.0565180.02943680.454666
111.3751.2564460.056540.02944880.446894
115.8751.2568320.0565570.02945780.440891
120.3751.257130.0565710.02946480.436255
124.8751.257360.0565810.02946980.432675
129.3751.2575370.0565890.02947480.429911
133.8751.2576750.0565950.02947780.427776
138.3751.2577810.05660.02947980.426127
145.1251.2578960.0566050.02948280.42433
151.8751.2579740.0566090.02948480.423111
158.6251.2580280.0566110.02948580.422283
165.3751.2580640.0566130.02948680.421721
172.1251.2580880.0566140.02948680.42134
178.8751.2581050.0566150.02948780.421082
179.6251.2581060.0566150.02948780.421059
PPreal MW1000
0000100
1.1250.0404240.0018190.00094799.370905
2.250.0571560.0025720.0013499.11052
3.3750.0698110.0031420.00163698.913577
4.50.0806280.0036280.0018998.745255
5.6250.0901540.0040570.00211398.596999
6.750.0987650.0044440.00231598.462997
7.8750.1066820.0048010.002598.339796
90.1140490.0051320.00267398.225147
10.1250.1209670.0054440.00283598.117486
11.250.1275090.0057380.00298898.015675
12.3750.133730.0060180.00313497.918856
13.50.1396740.0062850.00327497.826361
14.6250.1453740.0065420.00340797.73766
15.750.1508570.0067890.00353697.652323
16.8750.1561480.0070270.0036697.569994
180.1612640.0072570.0037897.490377
19.1250.1662220.007480.00389697.413222
20.250.1710350.0076970.00400997.338315
21.3750.1757160.0079070.00411897.26547
22.50.1802750.0081120.00422597.194526
23.6250.184720.0083120.00432997.125343
24.750.189060.0085080.00443197.057797
25.8750.1933030.0086990.00453196.991776
270.1974530.0088850.00462896.927183
28.1250.2015180.0090680.00472396.863929
29.250.2055020.0092480.00481696.801934
30.3750.2094090.0094230.00490896.741127
31.50.2132440.0095960.00499896.681442
32.6250.2170110.0097660.00508696.622819
33.750.2207140.0099320.00517396.565204
34.8750.2243540.0100960.00525896.508547
360.2279360.0102570.00534296.452803
37.1250.2314620.0104160.00542596.397927
38.250.2349350.0105720.00550696.343882
39.3750.2383570.0107260.00558696.290631
40.50.241730.0108780.00566696.23814
41.6250.2450560.0110280.00574496.186378
42.750.2483370.0111750.0058296.135315
43.8750.2515760.0113210.00589696.084923
450.2547720.0114650.00597196.035178
46.1250.2579290.0116070.00604595.986056
49.50.2671720.0120230.00626295.8422
52.8750.2761040.0124250.00647195.703204
56.250.2847530.0128140.00667495.568608
59.6250.2931440.0131910.00687195.438022
630.3012990.0135580.00706295.311111
66.3750.3092370.0139160.00724895.187581
69.750.3169740.0142640.00742995.067179
73.1250.3245240.0146040.00760694.94968
76.50.3319010.0149360.00777994.834885
79.8750.3391150.015260.00794894.722617
83.250.3461770.0155780.00811494.612718
86.6250.3530960.0158890.00827694.505044
900.359880.0161950.00843594.399467
93.3750.3665370.0164940.00859194.295871
97.8750.3752260.0168850.00879494.160639
102.3750.3837170.0172670.00899394.028512
106.8750.392020.0176410.00918893.899287
111.3750.4001490.0180070.00937993.772782
115.8750.4081140.0183650.00956593.648835
120.3750.4159240.0187170.00974893.527297
124.8750.4235870.0190610.00992893.408036
129.3750.4311120.01940.01010493.29093
133.8750.4385060.0197330.01027793.175866
138.3750.4457750.020060.01044893.062745
145.1250.4564580.0205410.01069892.896501
151.8750.4668910.021010.01094392.734132
158.6250.4770920.0214690.01118292.575386
165.3750.4870740.0219180.01141692.420038
172.1250.4968510.0223580.01164592.267887
178.8750.5064340.022790.0118792.118751
179.6250.5074880.0228370.01189492.102359
PPreal MWall
Time (hours)200 Da additive500 Da additive1000 Da additive
0000
1.1250.9773370.2317770.040424
2.251.1804760.3274460.057156
3.3751.236660.4006930.069811
4.51.2521990.462330.080628
5.6251.2564970.5165330.090154
6.751.2576850.56540.098765
7.8751.2580140.6101290.106682
91.2581050.6514540.114049
10.1251.258130.6898510.120967
11.251.2581370.7256540.127509
12.3751.2581390.7591080.13373
13.51.258140.7904080.139674
14.6251.258140.8197160.145374
15.751.258140.847170.150857
16.8751.258140.8728960.156148
181.258140.8970060.161264
19.1251.258140.9196040.166222
20.251.258140.9407860.171035
21.3751.258140.9606420.175716
22.51.258140.9792550.180275
23.6251.258140.9967040.18472
24.751.258141.013060.18906
25.8751.258141.0283930.193303
271.258141.0427670.197453
28.1251.258141.0562410.201518
29.251.258141.0688730.205502
30.3751.258141.0807140.209409
31.51.258141.0918140.213244
32.6251.258141.102220.217011
33.751.258141.1119750.220714
34.8751.258141.1211190.224354
361.258141.1296920.227936
37.1251.258141.1377280.231462
38.251.258141.1452610.234935
39.3751.258141.1523230.238357
40.51.258141.1589430.24173
41.6251.258141.165150.245056
42.751.258141.1709670.248337
43.8751.258141.1764210.251576
451.258141.1815340.254772
46.1251.258141.1863260.257929
49.51.258141.1989790.267172
52.8751.258141.2094030.276104
56.251.258141.217990.284753
59.6251.258141.2250640.293144
631.258141.2308920.301299
66.3751.258141.2356930.309237
69.751.258141.2396480.316974
73.1251.258141.2429060.324524
76.51.258141.245590.331901
79.8751.258141.2478010.339115
83.251.258141.2496230.346177
86.6251.258141.2511230.353096
901.258141.252360.35988
93.3751.258141.2533780.366537
97.8751.258141.2544620.375226
102.3751.258141.25530.383717
106.8751.258141.2559470.39202
111.3751.258141.2564460.400149
115.8751.258141.2568320.408114
120.3751.258141.257130.415924
124.8751.258141.257360.423587
129.3751.258141.2575370.431112
133.8751.258141.2576750.438506
138.3751.258141.2577810.445775
145.1251.258141.2578960.456458
151.8751.258141.2579740.466891
158.6251.258141.2580280.477092
165.3751.258141.2580640.487074
172.1251.258141.2580880.496851
178.8751.258141.2581050.506434
179.6251.258141.2581060.507488
PPreal MWall
200 Da additive
500 Da additive
1000 Da additive
Time (days)
Migration into food (mg/kg)
-
0.0
0.5
1.0
1.5
2.0
2.5
3.0
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5
Time (days)
Mig
ratio
n (m
g/dm
2 )
no fat10% fat20% fat30% fat50% fat
High fat = low caprolactam migration
Low fat = high caprolactam migration
The nature of the foodstuff
Chart22
0.46112050040.18292820690.13100806050.1210108310.0135818461
0.45124328250.25629567550.15605874520.14710198280.0047657233
0.5541017320.38249501920.28445156930.19091767590.0209877123
0.42274592570.32459063040.29234490410.23186947850.025423186
0.65126328320.59805564940.27792703310.2276572720.072766433
0.58922485240.40510256890.30586666620.18622241410.0487895159
0.93225991290.93611002590.48634121670.49058800340.1637789313
1.04026054520.91609153210.49622114480.47825029880.1975763745
1.24290899571.00949035180.7576964340.74755480050.3018636884
1.36385903951.25367243270.67414955820.74745702930.2049962253
1.78512253681.3942985561.10962684941.05837066920.7888602002
1.81880400031.53675454651.13222768141.27527964730.7728999204
2.39008262832.05208941261.951.63524027531.0489383856
2.11.97872456951.811.76509560511.0461020088
2.144444
no fat
10% fat
20% fat
30% fat
50% fat
Time (days)
Migration (mg/dm2)
cola 20C
TimeNot degassedDegassed
0.080.280.39
0.080.310.31
0.170.540.59
0.170.620.53
0.330.800.87
0.330.780.80
0.671.241.26
1.001.380
0.671.401
0.671.5171.360
1.001.7601.58
1.001.6521.491
2.002.0842.16
2.002.100
4.002.248
4.002.153
cola 20C
Not degassed
Degassed
Time (days)
Migration (mg/dm2)
cola 40C
Time
0.040.67
0.040.61
0.080.88
0.081.05
0.171.32
0.171.41
0.331.84
0.331.929
0.672.092
0.672.138
1.002.139
1.002.499
2.002.285
2.002.314
cola 40C
Time (days)
Migration (mg/dm2)
pork+ lard 5C
Timeno fat10% fat20% fat30% fat50% fat
0.080.460.180.130.120.01
0.080.450.260.160.150.00
0.170.550.380.280.190.02
0.170.420.320.290.230.03
0.330.650.600.280.230.07
0.330.590.410.310.190.05
0.670.930.940.490.490.16
0.671.040.920.500.480.20
1.001.241.010.760.750.30
1.001.361.250.670.750.20
2.001.791.391.111.060.79
2.001.821.541.131.280.77
4.002.392.051.951.641.05
4.002.101.981.811.771.05
4.002.14
pork+ lard 5C
no fat
10% fat
20% fat
30% fat
50% fat
Time (days)
Migration (mg/dm2)
pork + lard 20C
Timeno lard added10% lard added20% lard added30% lard added50% lard added
0.080.800.590.450.420.14
0.080.700.600.510.390.15
0.171.070.910.830.710.28
0.171.180.930.750.690.20
0.331.691.621.080.950.50
0.331.791.390.881.050.39
0.672.411.871.341.571.02
0.672.361.731.421.570.89
1.002.712.081.932.061.06
1.002.641.861.981.991.27
2.002.732.082.762.371.63
2.002.672.152.532.571.72
4.002.312.532.441.92
4.002.172.602.391.58
4.00
pork + lard 20C
no lard added
10% lard added
20% lard added
30% lard added
50% lard added
Time (days)
Migration (mg/dm2)
beer and wine
TimeBeerWine
0.080.650.70
0.080.640.76
0.171.051.31
0.170.851.14
0.331.331.77
0.671.8741.987
0.671.502.14
1.001.922.49
1.001.9882.467
0.331.151.49
0.331.102
1.001.846
1.001.754
2.002.1402.71
2.001.9802.62
4.002.2852.68
4.002.1252.39
22.53
beer and wine
Beer
Wine
Time (days)
Migration (mg/dm2)
all philadelphia
liquid foods
Time (hours)Philadelphia 5CPhiladelphia 20C
0.08333333330.41
0.08333333330.45
0.16666666670.70
0.16666666670.84
0.33333333331.14
0.33333333331.29
0.66666666671.79
0.66666666671.61
11.69
12.08
22.52
22.24
0.330.29
0.330.29
0.670.58
0.670.57
1.001.03
1.000.97
2.001.37
2.001.45
0.330.48
0.330.37
0.670.93
0.670.88
1.001.12
1.001.22
2.001.58
2.001.71
4.002.40
4.002.23
all philadelphia
Philadelphia 5C
Philadelphia 20C
Time (days)
Migration (mg/dm2)
orange juice
liquid foods
Time (hours)Orange juice 5COrange juice 20COrange juice 40C
0.08333333330.370.78
0.08333333330.310.76
0.16666666670.510.91
0.16666666670.541.06
0.33333333330.721.42
0.33333333330.771.42
0.66666666671.051.69
0.66666666671.181.73
11.251.91
11.311.80
21.661.86
21.621.84
0.330.60
0.330.44
0.670.59
0.670.51
1.000.67
1.000.86
2.000.94
2.000.80
4.001.51
4.001.17
10.001.52
10.001.53
0.080.19
0.080.31
0.170.15
0.170.17
0.330.25
0.330.29
0.670.87
0.670.69
1.000.82
1.000.74
2.001.08
2.001.19
4.001.46
4.001.39
orange juice
Orange juice 5C
Orange juice 20C
Orange juice 40C
Time (days)
Migration (mg/dm2)
apple sauce
liquid foods
Time (hours)Apple sauce 20C
0.080.12
0.080.12
0.170.26
0.170.34
0.330.44
0.330.42
0.670.64
0.670.73
1.000.81
2.001.09
2.001.08
4.001.23
0.080.14
0.080.19
0.170.28
0.170.27
0.330.45
0.330.41
0.670.70
1.000.87
1.000.915
2.000.99
4.001.16
apple sauce
Apple sauce 20C
Time (days)
Migration (mg/dm2)
mayonnaise
liquid foods
Time (hours)Mayonnaise 5CMayonnaise 20C
0.08333333330.02072492540.18
0.08333333330.038654130.25
0.16666666670.10045131150.39
0.16666666670.11146372020.41
0.33333333330.09677542920.69
0.33333333330.09217529330.58
0.66666666670.33842662530.89
0.66666666670.20745835130.87
10.28625388411.12
10.31938569190.99
20.38996344151.20
20.40462724211.36
0.08333333330.1495786072
0.08333333330.1815775711
0.16666666670.1968665882
0.16666666670.1612227527
0.33333333330.2246259142
0.33333333330.230703321
0.66666666670.2144518665
0.66666666670.3312040239
20.6436146066
20.6625288729
40.6162773008
40.8221616852
mayonnaise
Mayonnaise 5C
Mayonnaise 20C
Time (days)
Migration (mg/dm2)
ketchup
liquid foods
Time (hours)Ketchup 20CKetchup 70C
0.330.12
0.330.21
0.670.38
0.670.35
1.000.51
1.000.50
2.000.75
2.000.72
4.000.91
4.001.07
10.001.13
10.001.21
0.080.80
0.080.95
0.170.81
0.170.96
0.331.03
0.671.25
0.671.18
1.001.18
2.001.37
2.001.26
0.020.25
0.020.20
0.040.54
0.040.47
0.060.71
0.060.64
0.080.78
0.080.71
0.170.97
0.171.06
0.331.10
0.331.01
0.671.23
0.671.29
1.001.30
ketchup
Ketchup 20C
Ketchup 70C
Time (days)
Migration (mg/dm2)
yoghurt drink
Time (hours)Yoghurt drink 5C
0.080.15
0.080.15
0.080.12
0.170.16
0.170.21
0.170.22
0.330.34
0.330.30
0.330.27
0.670.53
0.670.42
1.000.57
1.000.61
1.000.61
2.000.84
yoghurt drink
Yoghurt drink 5C
Time (days)
Migration (mg/dm2)
margarine
liquid foods
Time (days)Margarine 5CMargarine 20C
1.000.160.83
1.000.190.83
2.000.291.34
2.000.231.36
5.000.562.15
5.000.502.28
9.000.752.31
9.000.672.39
10.000.822.48
10.000.86
20.001.172.87
20.001.272.87
margarine
Margarine 5C
Margarine 20C
Time (days)
Migration (mg/dm2)
cheese sauce
Time (minutes)Cheese sauce 90C
0.10.15
0.10.15
0.10.46
0.20.43
0.20.24
0.20.83
0.51.19
0.51.06
0.50.99
1.01.34
1.01.28
1.01.19
1.51.32
1.51.51
1.51.53
2.01.35
2.01.64
2.01.75
cheese sauce
Cheese sauce 90C
Time (minutes)
Migration (mg/dm2)
whipping cream
Time (days)Whipping cream 20C
0.080.36
0.080.35
0.670.97
0.671.14
1.001.38
1.001.33
2.001.36
2.001.30
0.080.42
0.080.36
0.080.43
0.170.50
0.170.60
0.330.71
0.330.62
0.330.71
0.671.14
0.671.26
0.671.20
1.001.27
1.001.28
1.001.07
whipping cream
Whipping cream 20C
Time (days)
Migration (mg/dm2)
UHT milk
Time (days)Milk 5CMilk 20CMilk 40C
0.670.40
0.670.38
0.330.35
0.330.25
1.000.52
2.000.97
4.001.20
4.001.31
10.001.33
10.001.45
0.330.43
0.330.45
0.330.62
0.670.53
0.670.69
0.670.63
1.000.76
1.000.77
2.001.01
4.001.49
4.001.43
4.001.37
0.080.76
0.080.67
0.171.11
0.170.81
0.331.27
0.331.34
0.671.51
1.001.69
2.001.69
0.170.53
0.170.49
0.331.04
0.330.95
0.671.14
0.671.18
1.001.30
1.001.06
2.001.29
2.001.34
4.001.67
UHT milk
Milk 5C
Milk 20C
Milk 40C
Time (days)
Migration (mg/dm2)
condensed milk
Time (hours)Condensed milk 20C
0.0833333333
0.0833333333
0.0833333333
0.1666666667
0.1666666667
0.1666666667
0.3333333333
0.3333333333
0.3333333333
0.6666666667
0.6666666667
0.6666666667
1
1
1
2
2
2
4
4
4
condensed milk
Condensed milk 20C
Time (days)
Migration (mg/dm2)
honey
Time (hours)Honey 20C
0.0833333333
0.0833333333
0.0833333333
0.1666666667
0.1666666667
0.1666666667
0.3333333333
0.3333333333
0.3333333333
0.6666666667
0.6666666667
0.6666666667
1
1
1
2
2
2
4
4
4
honey
Honey 20C
Time (days)
Migration (mg/dm2)
water
Time (days)Water 5CWater 20CWater 40C
0.080.160.570.91
0.080.200.620.89
0.170.290.821.39
0.170.310.831.39
0.330.381.161.60
0.330.371.081.67
0.670.621.552.03
0.670.601.531.88
1.000.802.15
1.000.751.771.97
2.001.152.062.19
2.001.131.962.18
4.001.532.042.17
4.001.542.092.13
0.080.16
0.080.20
0.170.29
0.170.31
0.330.38
0.330.37
0.670.62
0.670.60
1.000.80
1.000.75
2.001.15
2.001.13
4.001.53
4.001.54
81.95
82.02
82.24
122.21
122.25
122.29
162.36
162.36
162.31
202.27
202.36
202.36
water
Water 5C
Water 20C
Water 40C
Time (days)
Migration (mg/dm2)
ethanol
Time (days)Ethanol 5CEthanol 20CEthanol 40C
0.0833333333
0.0833333333
0.0833333333
0.1666666667
0.1666666667
0.1666666667
0.3333333333
0.3333333333
0.3333333333
0.6666666667
0.6666666667
0.6666666667
1
1
1
2
2
2
4
4
4
10
10
10
ethanol
Ethanol 5C
Ethanol 20C
Ethanol 40C
Time (minutes)
Migration (mg/dm2)
acetic acid
Time (days)3% acetic acid 5C3% acetic acid 20C3% acetic acid 40C
0.0833333333
0.0833333333
0.0833333333
0.1666666667
0.1666666667
0.1666666667
0.3333333333
0.3333333333
0.3333333333
0.6666666667
0.6666666667
0.6666666667
1
1
1
2
2
2
4
4
4
10
10
10
acetic acid
3% acetic acid 5C
3% acetic acid 20C
3% acetic acid 40C
Time (minutes)
Migration (mg/dm2)
Sheet2
Sheet3
-
The nature of the contact
Interaction between food and packaging
Direct versus indirect contact
Point or continuous contact
-
0
2
4
6
8
10
12
0 1 2 3 4 5 6 7 8 9 10
Time (days)
MIg
ratio
n (m
g/kg
)
15C30C40C
The nature of the contact time and temperature
Chart3
000
0.8335762.3387614.397714
1.1784993.3031976.183221
1.4430274.0432437.437322
1.665944.6658048.339666
1.8622575.2114668.990101
2.0396845.6994779.459018
2.2027966.1403149.797077
2.3545766.54049710.040796
2.4970936.90464210.216502
2.6318577.23637710.343174
2.7584917.53875710.434497
2.8809087.81445310.500335
2.9982988.06585210.5478
3.111238.29511110.582019
3.2201748.50418510.606689
3.3255248.69485410.624474
3.4276118.86873910.637297
3.526729.02731910.646541
3.6230939.17194210.653205
3.7169469.30383410.658009
3.8084629.42411810.661473
3.8978079.53381510.66397
3.9851259.63385610.66577
4.0705459.72509210.667068
4.1541839.80829810.668004
4.236149.8841810.668679
4.3165119.95338310.669165
4.39537810.01649510.669516
4.47281810.07405210.669768
4.54889910.12654310.669951
4.62368310.17441410.670082
4.69722710.21807110.670177
4.76958210.25788610.670245
4.84079710.29419610.670294
4.91091310.32731110.67033
4.97997210.35751110.670355
5.0480110.38505210.670374
5.1150610.4101710.670387
5.18115410.43307710.670397
5.2463210.45396710.670403
5.31058610.47301910.670408
5.49821610.5206910.670417
5.67853610.55684910.67042
5.85202710.58427610.670421
6.01909110.6050810.670421
6.18007210.62085910.670421
6.3352710.63282810.670421
6.48494710.64190710.670421
6.62934310.64879310.670421
6.76867410.65401610.670421
6.9031410.65797810.670421
7.03292710.66098310.670421
7.15821110.66326210.670421
7.27915510.66499110.670421
7.39591710.66630210.670421
7.54535210.66757210.670421
7.68795210.6684510.670421
7.82403510.66905810.670421
7.95390210.66947810.670421
8.0778410.66976910.670421
8.19612110.6699710.670421
8.30900310.67010910.670421
8.41673510.67020510.670421
8.51955110.67027210.670421
8.61767510.67031810.670421
8.75653210.67036210.670421
8.88599610.67038710.670421
9.00670210.67040210.670421
9.11924310.6704110.670421
9.22417110.67041510.670421
9.32200110.67041810.670421
9.33245410.67041810.670421
15C
30C
40C
Time (days)
MIgration (mg/kg)
15
General 'Exact' Solution
TimeConcentrationMassMass per AreaPercent
hoursmg/kgmgmg/dm2%
0000100
1.50.8335760.8335760.13892992.281705
31.1784991.1784990.19641789.087971
4.51.4430271.4430270.24050586.638637
61.665941.665940.27765784.574634
7.51.8622571.8622570.31037682.756876
92.0396842.0396840.33994781.114035
10.52.2027962.2027960.36713379.603737
122.3545762.3545760.39242978.198373
13.52.4970932.4970930.41618276.878767
152.6318572.6318570.43864375.630955
16.52.7584912.7584910.45974874.458419
182.8809082.8809080.48015173.324926
19.52.9982982.9982980.49971672.237985
213.111233.111230.51853871.192317
22.53.2201743.2201740.53669670.18357
243.3255243.3255240.55425469.208109
25.53.4276113.4276110.57126968.262858
273.526723.526720.58778767.345189
28.53.6230933.6230930.60384966.452839
303.7169463.7169460.61949165.583837
31.53.8084623.8084620.63474464.73646
333.8978073.8978070.64963563.909193
34.53.9851253.9851250.66418863.100693
364.0705454.0705450.67842462.309766
37.54.1541834.1541830.69236461.535346
394.236144.236140.70602360.776479
40.54.3165114.3165110.71941860.032306
424.3953784.3953780.73256359.302052
43.54.4728184.4728180.7454758.585017
454.5488994.5488990.7581557.880566
46.54.6236834.6236830.77061457.188122
484.6972274.6972270.78287156.507161
49.54.7695824.7695820.7949355.837202
514.8407974.8407970.80679955.177809
52.54.9109134.9109130.81848654.528579
544.9799724.9799720.82999553.889144
55.55.048015.048010.84133553.259165
575.115065.115060.8525152.63833
58.55.1811545.1811540.86352652.02635
605.246325.246320.87438751.42296
61.55.3105865.3105860.88509850.827911
665.4982165.4982160.91636949.090595
70.55.6785365.6785360.94642347.420963
755.8520275.8520270.97533845.814565
79.56.0190916.0190911.00318244.267674
846.1800726.1800721.03001242.777107
88.56.335276.335271.05587841.340097
936.4849476.4849471.08082539.954194
97.56.6293436.6293431.1048938.617196
1026.7686746.7686741.12811237.327095
106.56.903146.903141.15052336.082039
1117.0329277.0329271.17215534.880304
115.57.1582117.1582111.19303533.720273
1207.2791557.2791551.21319332.600417
124.57.3959177.3959171.23265331.519285
130.57.5453527.5453521.25755930.135633
136.57.6879527.6879521.28132528.815263
142.57.8240357.8240351.30400627.555234
148.57.9539027.9539021.3256526.352757
154.58.077848.077841.34630725.205183
160.58.1961218.1961211.3660224.109991
166.58.3090038.3090031.38483423.064783
172.58.4167358.4167351.40278922.06727
178.58.5195518.5195511.41992521.115272
184.58.6176758.6176751.43627920.206711
193.58.7565328.7565321.45942218.920998
202.58.8859968.8859961.48099917.72226
211.59.0067029.0067021.50111716.604613
220.59.1192439.1192431.51987415.562568
229.59.2241719.2241711.53736214.591012
238.59.3220019.3220011.55366713.685177
239.59.3324549.3324541.55540913.588389
30
General 'Exact' Solution
TimeConcentrationMassMass per AreaPercent
hoursmg/kgmgmg/dm2%
0000100
1.52.3387612.3387610.38979478.344803
33.3031973.3031970.55053369.41484
4.54.0432434.0432430.67387462.562564
64.6658044.6658040.77763456.798111
7.55.2114665.2114660.86857851.745689
95.6994775.6994770.94991347.227069
10.56.1403146.1403141.02338643.145239
126.5404976.5404971.09008339.439845
13.56.9046426.9046421.15077436.068134
157.2363777.2363771.20606332.996507
16.57.5387577.5387571.2564630.196694
187.8144537.8144531.30240927.643955
19.58.0658528.0658521.34430925.316183
218.2951118.2951111.38251823.193419
22.58.5041858.5041851.41736421.257551
248.6948548.6948541.44914219.492097
25.58.8687398.8687391.47812317.882044
279.0273199.0273191.50455316.413709
28.59.1719429.1719421.52865715.074616
309.3038349.3038341.55063913.853387
31.59.4241189.4241181.57068612.739648
339.5338159.5338151.58896911.723938
34.59.6338569.6338561.60564310.797629
369.7250929.7250921.6208499.952851
37.59.8082989.8082981.6347169.182428
399.884189.884181.6473638.479816
40.59.9533839.9533831.6588977.839047
4210.01649510.0164951.6694167.254676
43.510.07405210.0740521.6790096.721741
4510.12654310.1265431.6877576.235713
46.510.17441410.1744141.6957365.792464
4810.21807110.2180711.7030125.388229
49.510.25788610.2578861.7096485.019573
5110.29419610.2941961.7156994.683366
52.510.32731110.3273111.7212184.376751
5410.35751110.3575111.7262524.097124
55.510.38505210.3850521.7308423.842108
5710.4101710.410171.7350283.609539
58.510.43307710.4330771.7388463.39744
6010.45396710.4539671.7423283.204009
61.510.47301910.4730191.7455033.027603
6610.5206910.520691.7534482.586201
70.510.55684910.5568491.7594752.251395
7510.58427610.5842761.7640461.997442
79.510.6050810.605081.7675131.804818
8410.62085910.6208591.7701431.65871
88.510.63282810.6328281.7721381.547887
9310.64190710.6419071.7736511.463827
97.510.64879310.6487931.7747991.400067
10210.65401610.6540161.7756691.351704
106.510.65797810.6579781.776331.315021
11110.66098310.6609831.776831.287196
115.510.66326210.6632621.777211.266091
12010.66499110.6649911.7774991.250083
124.510.66630210.6663021.7777171.237941
130.510.66757210.6675721.7779291.226184
136.510.6684510.668451.7780751.218052
142.510.66905810.6690581.7781761.212426
148.510.66947810.6694781.7782461.208535
154.510.66976910.6697691.7782951.205843
160.510.6699710.669971.7783281.203981
166.510.67010910.6701091.7783521.202693
172.510.67020510.6702051.7783681.201802
178.510.67027210.6702721.7783791.201186
184.510.67031810.6703181.7783861.200759
193.510.67036210.6703621.7783941.200353
202.510.67038710.6703871.7783981.200119
211.510.67040210.6704021.77841.199985
220.510.6704110.670411.7784021.199907
229.510.67041510.6704151.7784021.199863
238.510.67041810.6704181.7784031.199837
239.510.67041810.6704181.7784031.199835
40
General 'Exact' Solution
TimeConcentrationMassMass per AreaPercent
hoursmg/kgmgmg/dm2%
0000100
1.54.3977144.3977140.73295259.280429
36.1832216.1832211.03053742.747955
4.57.4373227.4373221.23955431.135905
68.3396668.3396661.38994422.780875
7.58.9901018.9901011.4983516.758324
99.4590189.4590181.57650312.416498
10.59.7970779.7970771.6328469.286322
1210.04079610.0407961.6734667.029665
13.510.21650210.2165021.702755.40276
1510.34317410.3431741.7238624.229866
16.510.43449710.4344971.7390833.384284
1810.50033510.5003351.7500562.774674
19.510.547810.54781.7579672.335184
2110.58201910.5820191.763672.01834
22.510.60668910.6066891.7677821.789916
2410.62447410.6244741.7707461.625236
25.510.63729710.6372971.7728831.506513
2710.64654110.6465411.7744231.420921
28.510.65320510.6532051.7755341.359215
3010.65800910.6580091.7763351.314729
31.510.66147310.6614731.7769121.282657
3310.6639710.663971.7773281.259535
34.510.6657710.665771.7776281.242866
3610.66706810.6670681.7778451.230848
37.510.66800410.6680041.7780011.222185
3910.66867910.6686791.7781131.215938
40.510.66916510.6691651.7781941.211435
4210.66951610.6695161.7782531.208189
43.510.66976810.6697681.7782951.205849
4510.66995110.6699511.7783251.204161
46.510.67008210.6700821.7783471.202945
4810.67017710.6701771.7783631.202068
49.510.67024510.6702451.7783741.201436
5110.67029410.6702941.7783821.20098
52.510.6703310.670331.7783881.200651
5410.67035510.6703551.7783931.200414
55.510.67037410.6703741.7783961.200244
5710.67038710.6703871.7783981.20012
58.510.67039710.6703971.7783991.200032
6010.67040310.6704031.7784011.199968
61.510.67040810.6704081.7784011.199922
6610.67041710.6704171.7784031.199847
70.510.6704210.670421.7784031.199819
7510.67042110.6704211.7784031.199809
79.510.67042110.6704211.7784041.199805
8410.67042110.6704211.7784041.199803
88.510.67042110.6704211.7784041.199803
9310.67042110.6704211.7784041.199802
97.510.67042110.6704211.7784041.199802
10210.67042110.6704211.7784041.199802
106.510.67042110.6704211.7784041.199802
11110.67042110.6704211.7784041.199802
115.510.67042110.6704211.7784041.199802
12010.67042110.6704211.7784041.199802
124.510.67042110.6704211.7784041.199802
130.510.67042110.6704211.7784041.199802
136.510.67042110.6704211.7784041.199802
142.510.67042110.6704211.7784041.199802
148.510.67042110.6704211.7784041.199802
154.510.67042110.6704211.7784041.199802
160.510.67042110.6704211.7784041.199802
166.510.67042110.6704211.7784041.199802
172.510.67042110.6704211.7784041.199802
178.510.67042110.6704211.7784041.199802
184.510.67042110.6704211.7784041.199802
193.510.67042110.6704211.7784041.199802
202.510.67042110.6704211.7784041.199802
211.510.67042110.6704211.7784041.199802
220.510.67042110.6704211.7784041.199802
229.510.67042110.6704211.7784041.199802
238.510.67042110.6704211.7784041.199802
239.510.67042110.6704211.7784041.199802
comparison
General 'Exact' Solution
TimeConcentrationConcentrationConcentration
hours15C30C40C
0000
0.06250.8335762.3387614.397714
0.1251.1784993.3031976.183221
0.18751.4430274.0432437.437322
0.251.665944.6658048.339666
0.31251.8622575.2114668.990101
0.3752.0396845.6994779.459018
0.43752.2027966.1403149.797077
0.52.3545766.54049710.040796
0.56252.4970936.90464210.216502
0.6252.6318577.23637710.343174
0.68752.7584917.53875710.434497
0.752.8809087.81445310.500335
0.81252.9982988.06585210.5478
0.8753.111238.29511110.582019
0.93753.2201748.50418510.606689
13.3255248.69485410.624474
1.06253.4276118.86873910.637297
1.1253.526729.02731910.646541
1.18753.6230939.17194210.653205
1.253.7169469.30383410.658009
1.31253.8084629.42411810.661473
1.3753.8978079.53381510.66397
1.43753.9851259.63385610.66577
1.54.0705459.72509210.667068
1.56254.1541839.80829810.668004
1.6254.236149.8841810.668679
1.68754.3165119.95338310.669165
1.754.39537810.01649510.669516
1.81254.47281810.07405210.669768
1.8754.54889910.12654310.669951
1.93754.62368310.17441410.670082
24.69722710.21807110.670177
2.06254.76958210.25788610.670245
2.1254.84079710.29419610.670294
2.18754.91091310.32731110.67033
2.254.97997210.35751110.670355
2.31255.0480110.38505210.670374
2.3755.1150610.4101710.670387
2.43755.18115410.43307710.670397
2.55.2463210.45396710.670403
2.56255.31058610.47301910.670408
2.755.49821610.5206910.670417
2.93755.67853610.55684910.67042
3.1255.85202710.58427610.670421
3.31256.01909110.6050810.670421
3.56.18007210.62085910.670421
3.68756.3352710.63282810.670421
3.8756.48494710.64190710.670421
4.06256.62934310.64879310.670421
4.256.76867410.65401610.670421
4.43756.9031410.65797810.670421
4.6257.03292710.66098310.670421
4.81257.15821110.66326210.670421
57.27915510.66499110.670421
5.18757.39591710.66630210.670421
5.43757.54535210.66757210.670421
5.68757.68795210.6684510.670421
5.93757.82403510.66905810.670421
6.18757.95390210.66947810.670421
6.43758.0778410.66976910.670421
6.68758.19612110.6699710.670421
6.93758.30900310.67010910.670421
7.18758.41673510.67020510.670421
7.43758.51955110.67027210.670421
7.68758.61767510.67031810.670421
8.06258.75653210.67036210.670421
8.43758.88599610.67038710.670421
8.81259.00670210.67040210.670421
9.18759.11924310.6704110.670421
9.56259.22417110.67041510.670421
9.93759.32200110.67041810.670421
9.97916666679.33245410.67041810.670421
comparison
15C
30C
40C
Time (days)
MIgration (mg/kg)
-
Legislation
-
Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)
2007/42/EC Regenerated cellulose film
Framework Regulation (EC) No 1935/2004
Plastics
(EC) No 2023/2006 Good Manufacturing Practice
84/500/EEC Ceramics,
as amended
1895/2005/EC BADGE/BFDGE/
NOGE
93/11/EEC Nitrosamines and
nitrosatable substances
(EC) No 450/2009 Active and intelligent materials
(EU) No 321/2011 restriction of use of
Bisphenol A in plastic infant feeding bottles
(EU) No 284/2011 polyamide and melamine
plastic kitchenware
(EU) No 10/2011 Plastics Implementation
Measure, as amended/corrected
(EC) No 282/2008 Recycled plastics
EU legislation
-
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/index_en.htm
-
First step to harmonising legislation
Defines what is meant by food contact materials and articles
Two general principles Inertness
Safety
Framework Regulation
-
Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:
(a) endanger human health;
(b) bring about an unacceptable change in the composition of the food;
(c) bring about a deterioration in the organoleptic characteristics thereof.
Framework Regulation Article 3
-
If an article is intended for food contact it shall be labelled for food contact or bear the symbol with a glass and fork
Not obligatory where the intention for food contact is obvious by the nature of the article e.g. knife, fork, wine glass
Framework Regulation - labelling
-
Labelling, advertising and presentation of food contact materials shall not mislead the consumer
Instructions for safe use shall be provided
Labelling can also act as a means of identification for product traceability
Framework Regulation - labelling
-
The traceability should be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility
Framework Regulation - traceability
-
Empowers the Commission to set requirements for specific materials or substances (1) Active and intelligent materials and articles (2) Adhesives (3) Ceramics (4) Cork (5) Rubbers (6) Glass (7) Ion-exchange resins (8) Metals and alloys (9) Paper and board (10) Plastics (11) Printing inks (12) Regenerated cellulose (13) Silicones (14) Textiles (15) Varnishes and coatings (16) Waxes (17) Wood
Framework Regulation specific measures
-
Framework Regulation Declaration of compliance
Declaration of compliance (DoC)
Framework Regulation 1935/2004 states: Materials and articles shall be accompanied by a written
declaration stating that they comply with the rules applicable to them
Appropriate documentation shall be made available to the enforcement authorities to demonstrate such compliance
-
Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)
2007/42/EC Regenerated cellulose film
Framework Regulation (EC) No 1935/2004
Plastics
(EC) No 2023/2006 Good Manufacturing Practice
84/500/EEC Ceramics,
as amended
1895/2005/EC BADGE/BFDGE/
NOGE
93/11/EEC Nitrosamines and
nitrosatable substances
(EC) No 450/2009 Active and intelligent
materials
(EU) No 321/2011 restriction of use of
Bisphenol A in plastic infant feeding bottles
(EU) No 284/2011 polyamide and melamine
plastic kitchenware
(EU) No 10/2011 Plastics Implementation
Measure, as amended/corrected
(EC) No 282/2008 Recycled plastics
EU legislation
-
First material type to be covered by specific measures
Regulation (EU) No 10/2011 Consolidated legislation for plastic materials and articles
Directive 2002/72/EC, as amended
Directive 82/711/EEC, as amended
Directive 85/572/EEC, as amended
Directive 78/142/EEC
Plastics
-
Materials and articles and parts thereof consisting exclusively of plastics
Multi-layer plastic materials and articles held together by adhesive or other means
Materials and articles referred to above that are printed and/or covered by a coating
What does the Regulation cover?
-
Plastic layers or coatings forming gaskets in caps and closures that make a set of 2 or more layers of different types of materials
Plastic layers in multi-material, multi-layer materials and articles
What does the Regulation cover?
-
Union List of authorised monomers and additives for use in the manufacture of plastics
Restrictions and specification for authorised substances including specific migration limits
Overall migration limit
Rules on non-intentionally added substances (NIAS)
Rules on compliance testing
What rules does the Regulation set?
-
The functional barrier concept
Authorisation of nano-materials before use
Declaration of compliance and supporting documents
What rules does the Regulation set?
-
Authorised monomers and additives
Annex 1 to Regulation
Means that only substances authorised at EU level may be used in the production of food contact plastics
Union list
-
Potential health risk may occur from non- or incompletely reacted monomers or other starting substances or from low molecular weight additives which are transferred into food via migration from the plastic food contact material
Therefore monomers, other starting substances and additives should be risk assessed and authorised before their use in the manufacture of plastic materials and articles
Restrictions on substances
-
The European Food Safety Authority (EFSA)
Risk assessment should consider: The substance itself
Any relevant impurities
Any foreseeable reaction and degradation products
The potential migration under worst foreseeable conditions of use
The toxicity
Risk assessment
-
http://www.efsa.europa.eu/en/panels/fip.htm
-
Based on the risk assessment the authorisation should if necessary set out specifications for the substance and restrictions of use, quantitative restrictions or migration limits to ensure the safety of the final material or article
Risk management
-
Inertness limit
Does not cover volatile substances
Expressed per food contact surface area = 10 mg/dm2
For infant foods expressed per kg/food = 60 mg/kg
Overall migration limit
-
Safety limit
SML set out in Annex I
If no SML specified in Annex I then 60 mg/kg
SML related to food
Specific migration limits
-
The EU SMLs are based on toxicology and exposure
However, pending a best estimation of exposure, the EU system is based on migration assuming that:
1 person of 60 kg
ingest daily 1 kg of food
in contact with 6 dm2 of surface
containing the substance at the maximum concentration permitted (SML)
Specific migration limits
-
Dual use additives/flavourings No technical effect in food
Lowest restriction applies for authorised food additives
For non-authorised food additives/flavourings SML are applicable
Specific migration limits
-
Migration testing
-
Rules defined to test for compliance of migration from food contact materials and articles
Technical guidelines drafted
Migration testing
-
Regulation (EU) No 10/2011 states:
Official control should establish testing strategies which allow the enforcement authorities to perform controls efficiently making best use of available resources. Therefore it should be admissible to use screening methods for checking compliance under certain conditions. Non-compliance of a material or article should be confirmed by a verification method.
Testing strategies
-
Food removed from packaging before the expiry date or any date by which the manufacturer has indicated the product should be used for reasons of quality or safety
If instructions are given then they should be followed
Non-edible parts removed
Analysis
Specific migration materials and articles already in contact with food
-
Special cases Some substances are ubiquitous and their presence does not
necessarily mean migration from the material or article
Some migrants react with food components
Specific migration materials and articles already in contact with food
-
Screening tests More severe
Can be used to demonstrate compliance
Simpler and cheaper
Verification tests Can be used to demonstrate compliance or non-compliance
Required for enforcement
Foods worst foreseeable contact conditions
Food simulants rules defined for conventional migration tests
Specific migration materials and articles not yet in contact with food
-
Replacing specific migration by overall migration
Residual content
Migration modelling
Food simulant substitutes
Screening approaches
-
For stable and non-volatile substances
Overall migration test conditions must be at least as severe as those prescribed for specific migration
Only applicable for substances with an SML greater than the analytical tolerance
For Simulant D2 = 3 mg/dm2, i.e. 18 mg/kg applying the conventional food contact ratio
For aqueous simulants = 2 mg/dm2, i.e. 12 mg/kg applying the conventional food contact ratio
Replacing specific migration with overall migration
-
Known from formulation information
Demonstrate complete extraction Polymer dissolution and subsequent precipitation
Successive solvent extraction
Selection of extraction solvent dependent on both the polymer and the substance
cp,0
Residual content
-
Based on diffusion theory and a consideration of partitioning effects
Diffusion coefficient of the migrant in the plastic (DP)
Partition coefficient of the migrant between the plastic and the food or food simulant (KP,F)
Migration modelling
-
A number of commercial and freeware software packages are available to predict the extent of migration from the cp,0 value
These models have been tuned to provide an overestimation of migration in the majority of cases so that they can be used with confidence in compliance testing
Migration modelling
-
To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants overestimate migration compared to the regulated food simulants
Food simulant substitutes
-
Migration into and analysis of food simulants
The packaging can be tested for its suitability before use by employing food simulants that are intended to mimic the migration properties of different categories of foods
Introduced in the early-1980s along with the rules for using simulants
Migration into and analysis of foods
Verification methods
-
Select simulant based on food type
Select exposure type
Select exposure conditions - time and temperature
Migration into food simulants
-
Simulant Abbreviation
Ethanol 10% (v/v) Simulant A
Acetic acid 3% (w/v) Simulant B
Ethanol 20% (v/v) Simulant C
Ethanol 50% (v/v) Simulant D1
Vegetable Oil Simulant D2
Modified polyphenylene oxides, particle size 60-80 mesh, pore size 200 nm
Simulant E for dry foods
Food simulants
-
Simulants A, B and C For foods with hydrophilic character
Simulant B For foods with pH < 4.5
Simulant C Alcoholic foods with an alcohol content of up to 20%
Foods with a relevant amount of organic ingredients that render the food more lipophilic
Annex III general assignment
-
Simulants D1 and D2 For food with a lipophilic character
Simulant D1 Alcoholic foods with an alcohol content of > 20%
Foods containing oil in water emulsions
Simulant D1 Foods with free fat at the surface
Simulant E For dry foods
Annex III general assignment
-
(*) simulant B can be omitted if the food has a pH of more than 4.5 (**) the testing in simulant D2 can be omitted if it can be demonstrated by means of an appropriate test that there is no `fatty contact with the plastic food contact material 3 = Simulant D-Reduction factor
Column 1 Column 2 Column 3
Reference number
Description of food Simulants
A B C D1 D2 E
08.05 Mustard (except powdered mustard under heading 08.17)
X X(*) X/3(**)
Annex III food category assignments
-
Total immersion
Pouch
Reverse pouch
Article fill
Migration cell
Which exposure types
-
Conditions of contact in worst foreseeable use
Test conditions
Contact temperature Test temperature T 5C 5C
5 C < T 20C 20C 20 C < T 40C 40C 40 C < T 70C 70C 70 C < T 100C 100C or reflux temperature 100 C < T 121C 121C(*) 121 C < T 130C 130C (*) 130 C < T 150C 150C (*) 150 C < T < 175C 175C (*)
T > 175 C Adjust the temperature to the real temperature at the interface with the food
(*) (*) This temperature shall be used only for food simulants D2 and E. For applications
heated under pressure migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100C or at reflux temperature for duration of four times the time selected according to the conditions in Table1.
Test conditions for specific migration
-
Contact time in worst foreseeable use
Test time
t 5 min 5 min
5 min < t 0.5 hour 0.5 hour
0.5 hours < t 1 hour 1 hour
1 hour < t 2 hours 2 hours
2 hours < t 6 hours 6 hours
6 hours < t 24 hours 24 hours
1 day < t 3 days 3 days
3 days < t 30 days 10 days
Above 30 days See specific conditions
Specific conditions
Alternative 1 Exp -9627 * (1/T1-1/T2)
T1 frozen/cold 278 K (5oC)
T1 room temperature 298 K (25oC)
Alternative 2 Frozen: 10 days 20oC
Refrigerated: 10 days 40oC
RT/6 months: 10 days 50oC
RT all: 10 days 60oC
Alternative 3 Equilibrium at 10 days 40oC
Test conditions for specific migration
-
Combinations of contact times and temperatures Subject the test specimen successively to all of the worst case
conditions appropriate to the sample
Using the same portion of food simulant
Special considerations
-
Repeat use articles Three successive migration tests
Compliance with the result obtained form the third exposure
One exposure/test is sufficient if scientific proof that the migration does not increase and the migration limit is not exceeded
For substances in Annex I that have an SML of not detectable then the first exposure/test result should be used
Special considerations
-
Regulation (EU) No 10/2011 Plastic materials and articles shall not transfer their
constituents to food simulants in quantities exceeding 10 mg/dm2 of food contact surface
Plastic materials and articles intended to be brought into contact with food intended for infants and young children, shall not transfer their constituents to food simulants in quantities exceeding 60 mg/kg of food simulant
Overall migration limit
-
Residual content of migratable substances
Food simulant substitutes Scientific evidence that the food simulant substitutes
overestimate migration compared to regulated food simulants
Screening approaches overall migration
-
Standardised test conditions for overall migration
Test Number
Contact time at contact
temperature Intended food contact conditions
OM1 10 d at 20oC Frozen, refrigerated
OM2 10 d at 40oC long term storage including short term heating
OM3 2 h at 70oC Short term heating
OM4 1 h at 100oC High temperature application
OM5 2 h at 100oC or at
reflux or 1 h at 121oC
High temperature applications up to 121oC.
OM6 4 h at 100oC or at
reflux Any food contact conditions with food simulants A, B or C, at temperature exceeding 40oC.
OM7 2 h at 175oC High temperature applications with fatty foods
-
Substitute test for OM7 with food simulant D2
Test Number
Contact time at contact
temperature Intended food contact conditions
OM8 Food simulant E for 2 hours at 175C
and Food simulant D2 for
2 hours at 100oC
High temperature applications only
OM9 Food simulant E for 2 hours at 175C
and Food simulant D2 for
10 days at 40oC
High temperature applications including long term storage at room temperature
In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM8 or OM9
-
All foods Distilled water or water of equivalent quality or food simulant A
Food simulant B
Food simulant D2 shall be performed
All foods except for acidic foods Distilled water or water of equivalent quality or food simulant A
Food simulant D2
Food simulants for overall migration
-
All aqueous and alcoholic foods and milk products Food simulant D1
All aqueous, acidic and alcoholic foods and milk products
Food simulant D1
Food simulant B
Food simulants for overall migration
-
All aqueous foods and alcoholic foods up to an alcohol content of 20%
Food simulant C
All aqueous and acidic foods and alcoholic foods up to an alcohol content of 20%
Food simulant C
Food simulant B
Food simulants for overall migration
-
Standard reference Title Plastics Materials and articles in contact with foodstuffs - Plastics - EN 1186-1:2002 Part 1: Guide to the selection of conditions and test methods for overall migration EN 1186-2:2002 Part 2: Test methods for overall migration into olive oil by total immersion EN 1186-3:2002 Part 3: Test methods for overall migration into aqueous food simulants by total immersion EN 1186-4:2002 Part 4: Test methods for overall migration into olive oil by cell EN 1186-5:2002 Part 5: Test methods for overall migration into aqueous food simulants by cell EN 1186-6:2002 Part 6: Test methods for overall migration into olive oil using a pouch EN 1186-7:2002 Part 7: Test methods for overall migration into aqueous food simulants using a pouch EN 1186-8:2002 Part 8: Test methods for overall migration into olive oil by article filling EN 1186-9:2002 Part 9: Test methods for overall migration into aqueous food simulants by article filling EN 1186-10:2002 Part 10: Test methods for overall migration into olive oil (modified method for use in cases where incomplete extraction of olive oil occurs) EN 1186-11:2002 Part 11: Test methods for overall migration into mixtures of C-labelled synthetic triglycerides EN 1186-12:2002 Part 12: Test methods for overall migration at low temperatures EN 1186-13:2002 Part 13: Test methods for overall migration at high temperatures EN 1186-14:2002 Part 14: Test methods for 'substitute tests' for overall migration from plastics intended to come into contact with fatty foodstuffs using test media iso-octane and 95 % ethanol EN 1186-15:2002 Part 15: Alternative test methods to migration into fatty food simulants by rapid extraction into iso-octane and/or 95 % ethanol
CEN overall migration methods
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Other aspects
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Known ingredients such as monomers, catalysts, solvents, suspension media, additives etc.
Known or unknown isomers, impurities, reaction products and breakdown products of these ingredients
Possible contaminants from manufacturing process Recycled materials
Irradiated products
Contamination from indirect sources such as printing inks, coatings, adhesives, secondary packaging
IAS
NIAS
What can migrate?
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Specific extraction Clean-up
Specific analysis
Generic extraction
Minimal clean-up Generic analysis
IAS - Know exactly what to measure
Predictable NIAS oligomers,
impurities, literature references
NIAS - Complete unknowns
Targeted Non-targeted
Targeted vs non-targeted analysis
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GC-MS technologies EI Library comparisons
Access to molecular species using CI source
GC-QTOF-MS allows high resolution accurate mass data to be collected too
LC-HR-MS technologies TOFs, QTOF, Orbitrap instruments
Accurate mass, fragmentation, database comparisons
Profiling
Determination of NIAS
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Differentiating between samples by detecting (and identifying) marker substances and requires: Experiments to be set-up to allow the collection of good quality
data
Accurate, precise, reproducible and robust methods
Software to process the data e.g. MPP
Filter and align peaks across the samples
Filter the entities
Principal component
analysis
Hierarchical cluster
analysis
Create prediction models
Profiling
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Evaluation of the total migrate (4h 60oC, 95% EtOH)
Professor Thomas Simat, ILSI, 2008
Mass balance for a plastic laminate
Comment: This is an unusually good case and the migration is dominated by plasticisers and additives and only a relatively small proportion (27%) remains unknown. In some FCMs, more than 80% may be unknown or at least not-studied.
Mass balance: specific versus overall migration
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Prediction will never be complete: ppm or ppb concentrations means having to understand reaction
pathways with e.g. only 0.0001% yield
Reactions may be energetically unfavourable, mechanistically complex, difficult or impossible to predict, and yet can be significant
Can all NIAS be predicted?
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Nanoparticles Different toxicological properties
Substances should be assessed on a case-by-case basis
Risk assessment of the conventional particle size of a substance do not cover engineered nanoparticles
Substances in nanoform shall only be used if explicitly authorised and mentioned in the specifications of Annex 1
Nanoparticles
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A plastic layer which is separated from the food by a functional barrier may contain non-authorised substances provided:
They are not mutagenic, carcinogenic, toxic to reproduction
They are not in nanoform
That any migration into food or food simulant is not detectable (using a method with a detection limit of < 10 ppb)
Set-off must also be considered
Functional barrier
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A written declaration should be available for plastic materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles
Annex IV provides a list of the information that it is necessary to include in the declaration of compliance
Declaration of compliance
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Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply
Migration test results, calculations, modelling or other analysis
Evidence on the safety or reasoning that the material or article is compliant
Supporting documentation
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Fat reduction factor Exposure to substances migrating from FCMs uses the
conventional assumption that a person consumes daily 1 kg food
However, a person ingests at most 200 g of fat on a daily basis
Applies to lipophilic substances that only migrate into fat
Migration test result is divided by the FRF before comparing with the migration limit
The FRF is not applicable to
Foods intended for infants and young children
Materials for which the surface area to mass of food not known
Correction factors - FRF
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For fat containing foods the result obtained with food simulant may in certain cases significantly overestimate migration into food
Simulant D reduction factor (DRF) DRF is given in the Annex 1
Migration test result is divided by the DRF before comparing with the migration limit
Correction factors simulant D
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Tool available from the EURL-FCM website
https://ec.europa.eu/jrc/en/eurl/food-contact-materials#calculator-for-the-correction
Correction factors
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Drafted by industry bodies, NRLs and individual experts Sampling
Materials and articles already in contact with food or using food as a simulant testing for specific migration
Verification of compliance with migration limits using food simulants
Screening
Analytical determination of migrants
Reporting of the final migration test result
Technical guidelines
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Regulation (EU) No 321/2011, bans the use of bisphenol A (BPA) for the manufacture of polycarbonate infant feeding bottles
Amending Regulation (EU) 10/2011
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Amend Regulation (EU) 10/2011 Recently the European Food Safety Authority (the Authority) issued favourable scientific evaluations for additional substances which should now be added to the current list.
For certain other substances, the restrictions and/or specifications already established at the EU level should be amended on the basis of a new favourable scientific evaluation by the Authority.
Adds new substances and amends restrictions and specifications of already authorised substances on the
Union list
Regulation (EU) No 1282/2011, 1183/2012, 202/2014, 2015/174
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This draft will be presented for vote at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) Toxicological section on 13 April 2016
As well as adding substances to the Union list, the amendment also includes changes to testing, e.g.:
Repeat use testing for primary aromatic amine migration
Defining conditions for which hot-fill testing is appropriate
etc
6th Amendment to Regulation (EU) 10/2011
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BPA roadmap http://ec.europa.eu/smart-regulation/roadmaps/docs/ 2015_sante_534_bpa_measure_en.pdf
Options No policy change
Modify legislative restrictions for BPA in plastic food contact materials at EU level
Modify legislative restrictions for BPA in plastic food contact materials at EU level and introduce measures for BPA in coatings and varnishes at EU level
Modify legislative restrictions for BPA in plastic food contact materials at EU level and introduce measures for BPA in food contact coatings and varnishes as well as other food contact materials in which BPA may be present
Ban on BPA in food contact materials at EU level
BPA roadmap
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Applicable to polyamide and melamine plastic kitchenware that falls under CN code ex 3924 10 00
Products originating in or consigned from China and Hong Kong are controlled
Prior Notification The importer is required to notify Port Health of the estimated
date and time of physical arrival of the consignment 2 working days in advance
Regulation (EU) No 284/2011
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Checks on Imports Documentary checks on 100% of consignments
Identity and physical checks (including laboratory analysis) on 10% of consignments (selected at random)
Primary aromatic amine release from nylon kitchenware
Formaldehyde release from melamine-ware
Regulation (EU) No 284/2011
http://images.google.co.uk/imgres?imgurl=http://img.diytrade.com/cdimg/344507/6634831/0/1218631739/Nylon_Kitchen_Tool.jpg&imgrefurl=http://www.diytrade.com/china/4/products/4581937/Nylon_Kitchen_Tool.html&usg=__Xm6s_bUsWN3mNfgwXWXbHaW8nCI=&h=586&w=1012&sz=55&hl=en&start=11&um=1&itbs=1&tbnid=Mgpy0snhEU-ZdM:&tbnh=87&tbnw=150&prev=/images?q%3Dnylon%2Bkitchen%2Butensils%2Bimage%26um%3D1%26hl%3Den%26sa%3DX%26rlz%3D1W1ADRA_en%26tbs%3Disch:1
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Aim
Ensure compliance with Article 3 of Regulation 1935/2004
Critical control point is the recycling process
Scope
All mechanically recycled plastic for FCM placed on EU market originating from recyclers in EU and third countries
Not chemical recycling or recycled plastics behind a functional barrier
Recycled Plastic FCMs Regulation (EU) No 282/2008
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Individual authorisation of recycling processes - EFSA
Quality of input
Efficiency of the process to sort input and reduce contaminants
Restrictions on the application of recyclate
Requirements on quality assurance system in GMP
DoC required and voluntary labelling
Recycled plastic FCMs
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Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)
2007/42/EC Regenerated cellulose film
Framework Regulation (EC) No 1935/2004
Plastics
(EC) No 2023/2006 Good Manufacturing Practice
84/500/EEC Ceramics,
as amended
1895/2005/EC BADGE/BFDGE/
NOGE
93/11/EEC Nitrosamines and
nitrosatable substances
(EC) No 450/2009 Active and intelligent
materials
(EU) No 321/2011 restriction of use of Bisphenol A in plastic infant feeding bottles
(EU) No 284/2011 polyamide and melamine
plastic kitchenware
(EU) No 10/2011 Plastics Implementation
Measure, as amended/corrected
(EC) No 282/2008 Recycled plastics
EU legislation non-plastics
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COUNCIL DIRECTIVE (84/500/EEC) migration of lead (Pb) and cadmium (Cd) into food contact ceramic articles
Current limits for fillable articles
Lead 4.0 mg/L
Cadmium 0.3 mg/L
Where does the Pb and Cd come from?
Cadmium Bright colours
Lead Glaze
Ceramics
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2009 2010 EFSA Opinions on Pb and Cd
Exposure should be reduced
2011 Problem definition and initial discussion with EU Member States
2012 Discussion on values that derive from the risk assessment
Lead 10 g/kg
Cadmium 5 g/kg
Ceramics
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Which elements?
Which simulant(s)?
Which test conditions?
Ceramics
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0
10
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40
50
60
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80
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0 0.5 1 1.5 2 2.5 3 3.5 4
Conc
entr
atio
n (
g/dm
2 )
Cadmium
Tomato sauce
Acetic acid
Citric acid
Pre-conditioning
Exposure number
Comparing migration
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Migration was found to be sample and element dependent dont always observe the same trend
Effect of pigment position under-, in- or on-glaze?
Effect of repeated use in the home?
Ceramics migration testing
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Technical problems with exposures at elevated temperature (handling hot acid, loss of simulant through evaporation) Testing regime must be pragmatic whilst at the same time
protecting the user
Time - pre-conditioning resulted (in general) in a higher migration in the third exposure
Ceramics migration testing
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Roadmap published July 2012
Context: problem definition
Objectives
Options
Initial assessment of impacts
Evidence base, planning, consultation
Non-harmonised FCMs
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No action at EU level leaving Member States to set up specific requirements at national level
Establishment of lists of substances, materials or processes used together with migration limits
Negative lists of substances not to be used in FCM
What are the options?
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Setting out obligations and criteria for risk assessment of substances and/or materials
Setting out obligations and criteria for information exchange throughout the manufacturing chain via declaration of compliance and supporting documentation
Setting out detailed material specific rules on good manufacturing practice
What are the options?
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http://ec.europa.eu/food/safety/chemical_safety/food_contact_materials/non_harmonised/index_en.htm
http://www.efsa.europa.eu/en/topics/topic/non_plastic_fcm
Non-harmonised FCMs
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DG SANCO
http://ec.europa.eu/food/food/chemicalsafety/foodcontact/index_en.htm
EFSA
http://www.efsa.europa.eu/en/panels/cef
EURL
https://ec.europa.eu/jrc/en/eurl/food-contact-materials
Useful links
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Email: [email protected] Tel: +44 (0) 1904 462604
Materials and Articles in Contact with FoodSlide Number 2Slide Number 3IntroductionSlide Number 5What is migration?Slide Number 7Slide Number 8Slide Number 9Slide Number 10Slide Number 11Slide Number 12Slide Number 13Slide Number 14Slide Number 15Slide Number 16Slide Number 17Slide Number 18Slide Number 19LegislationSlide Number 21Slide Number 22Slide Number 23Slide Number 24Slide Number 25Slide Number 26Slide Number 27Slide Number 28Framework Regulation Declaration of complianceSlide Number 30Slide Number 31Slide Number 32Slide Number 33Slide Number 34Slide Number 35Slide Number 36Slide Number 37Slide Number 38Slide Number 39Slide Number 40Slide Number 41Slide Number 42Slide Number 43Slide Number 44Migration testingSlide Number 46Slide Number 47Slide Number 48Slide Number 49Slide Number 50Slide Number 51Slide Number 52Slide Number 53Slide Number 54Slide Number 55Slide Number 56Slide Number 57Slide Number 58Slide Number 59Slide Number 60Slide Number 61Slide Number 62Slide Number 63Slide Number 64Slide Number 65Slide Number 66Slide Number 67Slide Number 68Slide Number 69Slide Number 70Slide Number 71Slide Number 72Slide Number 73Slide Number 74Slide Number 75Other aspectsSlide Number 77Slide Number 78Slide Number 79Slide Number 80Slide Number 81Slide Number 82Slide Number 83Slide Number 84Slide Number 85Slide Number 86Slide Number 87Slide Number 88Slide Number 89Slide Number 90Slide Number 91Slide Number 92Slide Number 93Slide Number 94Slide Number 95Slide Number 96Slide Number 97Slide Number 98Slide Number 99Slide Number 100Slide Number 101Slide Number 102Slide Number 103Slide Number 104Slide Number 105Slide Number 106Slide Number 107Slide Number 108Slide Number 109Slide Number 110Email:[email protected]: +44 (0) 1904 462604