H.B. Fuller on Food Safety May 6 2014

Ensuring Food SafetyHow to assess adhesives used in food contact packaging?

May 6, 2014

Alexandra RossElizabeth Staab

©2014 H.B. Fuller Company

Welcome

2

Alexandra RossProduct Regulatory Specialist

Elizabeth StaabMarketing Manager

Packaging Solutions


Agenda

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1. Megatrends influence Packaging

1. Megatrends influence Packaging

2. Monitoring the Risk from Packaging Adhesives

3. Adhesive Assessment for Final Food Contact Application

4. Questions & Answers


Megatrends

4

Demographic changes

Lifestyle Sustainability


Industry Megatrends

5

Demographic Changes


Industry Megatrends

6

Lifestyle


Industry Megatrends

7

Sustainability

Monitoring the Risk from Packaging Adhesives

8


Food Contact Regulation & Control

9

Migration

Monitoring&

Control

Kind and amount of

substances

Packaging Construction

Barrier of the

packaging

Surface / Volume Ratio

Contact time and

Temperature

Type of food


Food Contact Regulation & Control

10

Migration

Monitoring&

Control

Kind and amount of

substances

Packaging Construction

Barrier of the

packaging

Surface / Volume Ratio

Contact time and

Temperature

Type of food


What is the Risk of Adhesives?

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Possible migration into food should not endanger human health

(Article 3, Regulation (EC) No 1935/2004)

Hazard: Toxicity

Exposure: Effective amount

Risk = Hazard x Exposure


FEICA Food Contact Guidance

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Safe food in safe packaging by using safe adhesives

Guidance of a Food Contact Status

Declaration for Adhesives(issued February 2013)


Raw Material and Adhesive Related Evaluation

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Raw Material Data Gathering

Raw Material Evaluation

Adhesive Related Evaluation

Source: FEICA Food Contact Guidance


Raw Material Data Gathering

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Requested Information from RM Supplier

1.Date

2. Identification of Raw Material Supplier

3. Chemical Identification

4. Compliance Status

5. Compliance with Rejection List FEICA


Compliance Status

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Information in the Supply Chain

a. Regulation (EU) No 1935/2004Traceability & Article 3

b. Regulation (EC) No 2023/2006

GMP

c. Regulation (EU) No 10/2011 (Plastics Regulation):

Substances on Union List

Non-authorized substances

Dual use additives

d. Other: EU Member States Legislations or Recommendations

e. Non-EU Legislations:FDA Sections (e.g. 175.105, 175.300, 176.170, 176.180, etc..)


Rejection List FEICA

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Examples of Rejected Substances

Substances classified as CMRRegulation (EC) No 1272/2008

Substances containing heavy metals > 100 ppm Council Directive 94/62/EC

Phthalates According to Annex XVII of Regulation (EC) No 1907/2006

Epoxy DerivativesRegulation (EC) No 1895/2005

Substances that deplete the ozone layerRegulation (EC) No 1005/2009

DimethylfumarateRegulation (EU) No 412/2012

PBB & PBDE Directive 2011/65/EU (ROHS)



Raw Material Evaluation

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&


Toolbox for Raw Material Evaluation

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Food Contact Status Declaration

Adequate information

Comp. A

Comp. B

Comp. C

Comp. D

Comp. E

Comp. F

Plastics Regulation (EU) No 10/2011

BfR Recommendation (e.g. XIV, XXV)

FDA 175.105


Food Contact Status Declaration by Adhesive Supplier

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Adhesive Supplier Information

Product Information

Product Compliance

Adhesive Supplier Recommendations

Assessment of Suitability by DU


Adhesive Assessment for Final Food Contact Application

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Adhesive Evaluation by Downstream User

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Evaluation of Packaging

Evaluation of Migration

Potential

Migration Modeling / Test

Worst-Case Approach


Evaluation of Packaging

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Barrier Properties of Packaging Materials

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Functional Barrier (Definition according to Regulation (EU) No 10/2011):

A barrier consisting of one or more layers of any type of material which ensures that the

final material or article complies with Article 3 of Regulation (EC) No 1935/2004 and with

the provisions of this Regulation.

Barrier against permeation of: Oxygen

Water vapor

Carbon dioxyde

Nitrogen

Acting as a barrier against migration of substances (functional barrier)


Barrier and Migration Risks

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BA

RR

IER

+-

EVOH – Laminates

PET

PVDC / PVC

PA

PE

Corrugated Board

Carton

Paper

Barrier Properties of Packaging Materials

Could represent an absolute barrierGLASS, METAL, ALUFILM


Evaluation of Migration Potential - Test

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Typical Adhesive Applications

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Application Adhesive Barrier Migration Risk

CorrugatedHotmelt

Water-based - Low, secondary

packaging

Carton

Folding Box

Hotmelt

Water-based - Low

Flexible packaging

Laminated filmsIsocyanate-based +/- Medium

Bottle-LabelingWater-based

Hotmelt + Very low


32 cm

22 cm

Calculation Example 1 – Snack Food

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• Structure of laminate: OPP printed / met. OPP

• Food: 150 g (dry)

• Adhesive: Reactive, solventless; 0,28 g per bagPackage

• Identity: PM-Ref: 68320

• SML= 6 mg/kg

StabilizerA

• 1 kg food = 6,66 bags

• 0,28 g adhesive x 6,66 = 1,866 g / kg food

• Stabilizer A = 0,00186 g / kg food

Calculation

• 1,86 mg is far below SML of 6 mg / kg• Calculation means 100% migrates

• Assumed, no barrier in place

Results


Calculation Example 2 – Cereals

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• Packaging: Carton & Inliner

• Food: 375 g (dry)

• Adhesive: Hotmelt; 1 g / boxPackage

• Identity: PM-Ref: 93120

• SML(T) = 5 mg / kg

Stabilizer B

• 1 kg Cereals = 2,66 boxes

• Adhesive = 2,66 g / kg food

• Stabilizer B = 0,00266 g / kg food Calculation

• 2,6 mg is far below SML of 5 mg / kg• Calculation means 100% migrates

• Assumed, no barrier in placeResults


Key Learnings

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RM• Evaluation of Raw Materials Used

Barrier• Barrier Properties of Packaging Material

Adhesive• Evaluation of Adhesive by Manufacturer & Downstream User

Test• Migration Test if Required

This presentation is for informational purposes only and does not constitute an offer by H.B. Fuller to sell or a warranty of any kind.

Thank you

hbfuller.con/packaging-solutions

H.B. Fuller on Food Safety May 6 2014

Food

Transcript of H.B. Fuller on Food Safety May 6 2014