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Food contact materials
1. Emma Bradley – Fera Science Ltd
Materials and Articles in
Contact with Food
2. • What is migration?
• Factors affecting migration
• Legislation
• How it all started
• EU legislation
• EFSA risk assessment
Overview
3. • 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
5. • 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
7. • 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
8. • 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?
9. • 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?
10. • 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
11. Packaging
Impermeable materials:
- glass & ceramics
- metals & alloys
x
y
z
Food
Depiction of chemical migration from an
impermeable material
The nature of the FCM
14. • 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
16. 0
0.2
0.4
0.6
0.8
1
1.2
1.4
0 50 100 150 200
Time (days)
Migrationintofood(mg/kg)
200 Da additive
500 Da additive
1000 Da additive
The nature of the substance
17. 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)
Migration(mg/dm
2
)
no fat
10% fat
20% fat
30% fat
50% fat
High fat = low caprolactam migration
Low fat = high caprolactam migration
The nature of the foodstuff
18. The nature of the contact
• Interaction between food and packaging
• Direct versus indirect contact
• Point or continuous contact
19. 0
2
4
6
8
10
12
0 1 2 3 4 5 6 7 8 9 10
Time (days)
MIgration(mg/kg)
15°C
30°C
40°C
The nature of the contact –
time and temperature
21. 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
23. • First step to harmonising legislation
• Defines what is meant by ‘food contact materials and
articles’
• Two general principles
• Inertness
• Safety
Framework Regulation
24. 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
25. • 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
26. • 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
27. • 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
28. • 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
29. 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
30. 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
31. • 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
32. • 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?
33. • 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?
34. • 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?
35. • The functional barrier concept
• Authorisation of nano-materials before use
• Declaration of compliance and supporting documents
What rules does the Regulation set?
36. • 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
37. • 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
38. • 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
40. • 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
41. • 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
42. • 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
43. • The EU SML’s 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
44. • 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
46. • Rules defined to test for compliance of migration from
food contact materials and articles
• Technical guidelines drafted
Migration testing
47. • 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
48. • 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
49. • 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
50. • 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
51. • Replacing specific migration by overall migration
• Residual content
• Migration modelling
• Food simulant substitutes
Screening approaches
52. • 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
53. • 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
54. • 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
55. • 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
56. • 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
57. • 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-1980’s along with the rules for
using simulants
• Migration into and analysis of foods
Verification methods
58. • Select simulant based on food type
• Select exposure type
• Select exposure conditions - time and temperature
Migration into food simulants
59. 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
60. • 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
61. • 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
62. (*) 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
63. • Total immersion
• Pouch
• Reverse pouch
• Article fill
• Migration cell
Which exposure types
64. Conditions of contact in worst
foreseeable use
Test conditions
Contact temperature Test temperature
T ≤ 5°C 5°C
5 °C < T ≤ 20°C 20°C
20 °C < T ≤ 40°C 40°C
40 °C < T ≤ 70°C 70°C
70 °C < T ≤ 100°C 100°C or reflux temperature
100 °C < T ≤ 121°C 121°C(*)
121 °C < T ≤ 130°C 130°C (*)
130 °C < T ≤ 150°C 150°C (*)
150 °C < T < 175°C 175°C (*)
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 100°C or at reflux temperature for duration of four times the
time selected according to the conditions in Table1.
Test conditions for specific migration
65. 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
66. • 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
67. • 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
68. • 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
69. • 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
70. 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
71. 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 175°C
and
Food simulant D2 for
2 hours at 100oC
High temperature applications only
OM9 Food simulant E for
2 hours at 175°C
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
72. • 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
73. • 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
74. • 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
75. 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
77. • 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?
79. • 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
80. • 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
81. 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
82. • 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?
83. • 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
84. • 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
85. • 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
86. • 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
87. • 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
88. • 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
89. • Tool available from the EURL-FCM website
https://ec.europa.eu/jrc/en/eurl/food-contact-
materials#calculator-for-the-correction
Correction factors
90. • 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
91. • 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
92. • 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
93. • 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
94. • 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
95. • 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
96. • 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
97. • 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
98. • 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
99. 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
100. • 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
101. • 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 µg/kg
• Cadmium 5 µg/kg
Ceramics
104. • Migration was found to be sample and element
dependent – don’t always observe the same trend
• Effect of pigment ‘position’ under-, in- or on-glaze?
• Effect of repeated use in the home?
Ceramics – migration testing
105. • 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
106. • Roadmap published July 2012
• Context: problem definition
• Objectives
• Options
• Initial assessment of impacts
• Evidence base, planning, consultation
Non-harmonised FCMs
107. • 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?
108. • 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?
