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Interpretation of EU 2023/2006: GMP in carton packaging€¦ · GMP in carton packaging . This...
Transcript of Interpretation of EU 2023/2006: GMP in carton packaging€¦ · GMP in carton packaging . This...
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Interpretation of EU 2023/2006: GMP in carton packaging
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ECMA GMP
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Legislation
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Plastic materials EC 10/2011
5th amendment 2015/174
Paper & Board Printing inks
EC 1935-2004 Framework regulation EC 2023-2006 GMP
Legislation
Adhesives
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Paper & board • Cepi guideline 2010
• CoE resap 2002/1
• BfR recommendation XXXVI
Ink & coating • Eupia guideline
• Swiss ordinance
• German ink regulation expected ?
Adhesive
• ECMA recommendation
• Feica guidance
Lower level technical reference (soft law)
Legislation
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Legislation
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Customer information - end use
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Customer information – end use
Intended use
Forseeable use (other then intended)
To be specified by end-user
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Type of food (dry / fatty)
Customer information – end use
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Consistency
Texture
Customer information – end use
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Conditions of filling
Conditions of retail
Customer information – end use
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Direct food contact situation?
Innerbag PE / PP / PET
Innerbag metalised / multilayer
Customer information – end use
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Ecma questionnaire
Useful tool document in support of GMP
4. Cardboard/Ink /lacquer/adhesive
4.1
Quality:
UV conventional sensory optimised migration optimised
UV conventional sensory optimised migration optimised
Hotmelt sensory optimised migration optimised
Other ink/lacquer/adhesive systems:
4.2
No
4.3
No
If No, what materials are not suitable for the purpose?
(please give justification)
Page: 4 von 4
Model checklist for cardboard food requisite articles(to be used with an initial order or material change)
If umportant points cannot be answered with Yes or No, a risk analysis is to be performed in the case
of doubt so the risk potential can be assessed.
Does the customer have requirements/specifications about which
materials must be used in the packaging?
Others:
Dispersion
Does the packaging have interior print?
Yes
Exact statement on printing ink and lacquer is required:
Tip to sales: if Yes, have MIGRATION clarified.
Do 'food harmlessness declarations' exist for these materials which
include the use of the materials for the planned purpose?
Cardboard:
Inks:
Lacquers:
Adhesive:
Yes
Customer information – end use
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Risk assessment
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Risk assessment
low Frozen food
Dry biscuit
Dried soup in metal pouch
high Microwave cooking
Chocolates
Loose breadcrumb
Cartons, sustainability in packaging
temperature
Fat content
Protective barrier
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The EU cube concept
A cube with 10cm sides will contain 1 litre eq to 1 kg of food.
Global migration tolerance 60 mg/kg or 10 mg/dm2
1 kg food packed in 6 dm²
10 cm 1
0 c
m
Confusion ?
Risk assessment
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Generally does not apply to cardboard packaging
1 kg food packed in 6 dm²
10 cm 1
0 c
m
Risk assessment
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Cereal carton 500g
Size 19 x 5 x 23 cm
Surface = 12,9 dm2
Ratio: 25.88
Risk assessment
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Raw materials - board & inks
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Raw materials
Virgin fibre
recycled
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Raw materials
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Raw materials
According Eupia:
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Raw materials
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Raw materials
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In-Process controls
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Date: 16 Maart 2010
Proces controls
Possible
sources of
contamination
detergent
additives
lubricants
Min. oils
UV
photo
initiator
resin
storage
coating
fibre
climate
storage
transport
printpress
ink
board
environment
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Hazards can be physical:
Proces controls
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Hazards can be Chemical:
Proces controls
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Hazards can be (micro) biological:
Proces controls
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Finished product Migration
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Presented by: Pieter Geers | Date: Tuesday, November 17, 2009
Tests with standardised migration cell
Food simulant TENAX®
Example:
EN 1186-13
Standard testing method for global migration of paper and board
Migration test
Finished product migration
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Presented by: Pieter Geers | Date: Tuesday, November 17, 2009
5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0 32.5 35.0 37.5 min
0.00
0.25
0.50
0.75
1.00
1.25
1.50
1.75
uV(x100,000)
Chromatogram
BH
T
Ten
ax
C24
C30
GC1 275 g
GZ 260g + 45 PET
GZ 280g + 20 PE
Blanc sample (only Tenax)
Finished product migration
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Finished product migration
Date: 16 Maart 2010
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Finished product migration
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Finished product migration
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Ecma GMP
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ECMA GMP
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Management commitment
Open communication Risk assessment
Hygiene/QA (
ECMA GMP
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ECMA GMP
www.ecma.org
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ECMA GMP
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Interpretation of EU 2023/2006: GMP in carton packaging