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Interpretation of EU 2023/2006: GMP in carton packaging



ECMA GMP



Legislation



Plastic materials EC 10/2011

5th amendment 2015/174

Paper & Board Printing inks

EC 1935-2004 Framework regulation EC 2023-2006 GMP

Legislation

Adhesives



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



Legislation



Customer information - end use



Customer information – end use

Intended use

Forseeable use (other then intended)

To be specified by end-user



Type of food (dry / fatty)




Consistency

Texture




Conditions of filling

Conditions of retail




Direct food contact situation?

Innerbag PE / PP / PET

Innerbag metalised / multilayer




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




Risk assessment



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



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



Generally does not apply to cardboard packaging

1 kg food packed in 6 dm²

10 cm 1

0 c

m

Risk assessment



Cereal carton 500g

Size 19 x 5 x 23 cm

Surface = 12,9 dm2

Ratio: 25.88

Risk assessment



Raw materials - board & inks



Raw materials

Virgin fibre

recycled



Raw materials



Raw materials

According Eupia:



Raw materials



Raw materials



In-Process controls



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



Hazards can be physical:

Proces controls



Hazards can be Chemical:

Proces controls



Hazards can be (micro) biological:

Proces controls



Finished product Migration



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



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)





Date: 16 Maart 2010









Ecma GMP



ECMA GMP



Management commitment

Open communication Risk assessment

Hygiene/QA (

ECMA GMP



ECMA GMP

www.ecma.org



ECMA GMP



Interpretation of EU 2023/2006: GMP in carton packaging

Documents

Interpretation of EU 2023/2006: GMP in carton packaging€¦ · GMP in carton packaging . This information is confidential and proprietary to Graphic Packaging International ... •Feica