Materials and Articles in Contact with Food and Articles in Contact with Food . ... • Declaration of compliance and supporting ... article should be confirmed by a verification method.”

Emma Bradley Fera Science Ltd

Materials and Articles in Contact with Food

Date: July 2017, Version 1

What is migration? Factors affecting migration

Legislation How it all started

EU legislation

EFSA risk assessment

Overview

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

Introduction

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

What is migration?

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

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?

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?

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

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

Packaging

Permeable materials: - plastics- rubber & silicone- coatings

xy

z

Food

Depiction of chemical migration from a permeable material


Packaging

Permeable materials:

- plastics

- rubber & silicone

- coatings x

y

z

Food

5

5

Depiction of chemical migration from a porous material


Packaging

Porous materials:

e.g. paper and board

x

z

Food

y

5

5

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

Acrylonitrile

( >2000 substances )

Xylene


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


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



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



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


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




Plastics



as amended


NOGE



(EC) No 450/2009 Active and intelligent

materials

(EU) No 321/2011 restriction of use of

Bisphenol A in plastic infant feeding bottles


plastic kitchenware




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


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)


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


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


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


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


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

Other aspects

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?

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

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

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

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

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?

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

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

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

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

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

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

Tool available from the EURL-FCM website

https://ec.europa.eu/jrc/en/eurl/food-contact-materials#calculator-for-the-correction

Correction factors

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

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

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

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

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

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

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

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

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




Plastics



as amended


NOGE



(EC) No 450/2009 Active and intelligent

materials

(EU) No 321/2011 restriction of use of Bisphenol A in plastic infant feeding bottles


plastic kitchenware




EU legislation non-plastics

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

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

Which elements?

Which simulant(s)?

Which test conditions?

Ceramics

0

10

20

30

40

50

60

70

80

90

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

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

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

Roadmap published July 2012

Context: problem definition

Objectives

Options

Initial assessment of impacts

Evidence base, planning, consultation

Non-harmonised FCMs

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?

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?

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

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

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

Documents

Materials and Articles in Contact with Food and Articles in Contact with Food . ... • Declaration of compliance and supporting ... article should be confirmed by a verification method.”