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Dr. Jörg-Peter Langhammer – 4th FCM Forum, Suzhou

Recent developments regarding Food Packaging Inks in Europe: Legal

and activities update

Friday, 2 December 2016

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Agenda

1. Legal Update: German Ink Ordinance, Swiss Ordinance

2. EuPIA GMP (Good Manufacturing Practice)

3. Siegwerk – Risk Assessment Strategy on NIAS

4th FCM Safety Forum – Suzhou, 02.12.2016 – Dr. Jörg-Peter Langhammer

1. German Ink Ordinance


3. Risk Assessment on NIAS from ink manufacturers perspective

(Siegwerk)

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Agenda

1. Food packaging safety – a must have

2. Ensuring compliance – a complex challenge

3. Siegwerk – how we support our customers

1. Legal Update: German Ink Ordinance


3. Risk Assessment on NIAS from ink manufacturers perspective (Siegwerk)

4th FCM Safety Forum – Suzhou, 02.12.2016 – Dr. Jörg-Peter Langhammerwww.fo

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4th FCM Safety Forum – Suzhou, 02.12.2016 – Dr. Jörg-Peter Langhammer4

Draft German Ink Ordinance – Intention of regulation

„21st Amendment to the German regulation on food contact materials (German Ink

Ordinance)“

(Basis: EU Framework Regulation 1935/2004, Article 6 on National specific measures:

In the absence of specific measures referred to in Article 5, this Regulation shall

not prevent Member States from maintaining or adopting national provisions

provided they comply with the rules of the Treaty.)

► Intention of regulation: Prevention of unauthorised substance transfer from printed layers on food contact materials

First introduction December 2010/Status as of July 2016

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Draft German Ink Ordinance - Scope

§2 Definitions, No. 7:

„Printing Inks: Printing Inks or varnishes, which are applied on food contact materials via a printing or

varnishing process.“

…to be specifically regulated:

- printing inks for front and lamination print

- printing inks for intentional direct Food Contact („DFC“)

- printing inks for foreseeable direct Food Contact (e.g. bread bags, napkins)

• Ink layers on absolute barriers are not regulated by the Ink Ordinance

• Decorating colours for food contact materials made from ceramics are not printing inks

• Preparations for mass colouring of food contact materials are excluded

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Draft German Ink Ordinance – Regulation contents

positive list principle for direct food contact Authorised to use exclusively materials from Annex 14, Table 1

(includes Annex 1 of Regulation No. 10/2011)

further materials authorised for indirect (foreseeable) food contact Annex 14, Table 1 and 2 (Table 2 will be applicable only for 4 years)

Nanomaterials authorised, as long as no detectable migration (no limit!)

Non listed materials as long as not CMR and < 10ppb

Migration limits for metals (Ba, Fe, Co, Cu, Li, Mn, Zn) in analogy to Regulation EU No. 10/2011

Migration limits for primary aromatic amines 10 µg/kg as a sum

2 µg/kg for 22 specifically mentioned PAAs (CMR Category 1A and 1B)

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Draft German Ink Ordinance – Positive list Annex 14

Categories: Monomers, Colorants, Solvents, Additives, Photoinitiators

“SMGs“ (Spezifische Migrationsgrenzwerte) = SMLs

Group limits

Other specifications

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Comparison positive list entries for ink raw materials in different legislation

Legislation/Country Number of raw material entries

GB 9685-2016/China Appendix A.4: 189

Swiss Ordinance Annex 6: A-1090/B-4005

Draft German Ink Ordinance Annex 14: 593 + 600 (10/2011)

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German ink ordinance: Stakeholder criticism and arguments

Favour European harmonized Regulation on printing inks

Oppose firmly any measure on a national level

Risk of patchwork legislation in Europe

German Ordinance could lead to disruption of internal EU market

Where is the health concern?

Positive list is incomplete

Massive cost burden

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2015 2016 2017 2018 2019

6th draft

intra-ministry consultations8 MS sub-

mitting

detailed

opinion!

06/07/16

Notification (TRIS)

Notification

(WTO )

End of impact assessment (compliance

costs)

06/07/17 end of

official

postponement

Breaking News - On 29.11.2016 European Commission officially anounced:- to have requested Germany to postpone their unilateral legal initiative

- to be willing to launch EU legislation on printed FCM/printing inks by 2018

- Currently it is unknown what Germany will do after July 2017

Draft German Ink Ordinance: Timeline so far

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Agenda






3. Risk Assessment on NIAS from ink manufacturers perspective (Siegwerk)


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A sector of CEPE aisbl

12

European Printing Ink Association

Founded in 2003

Operates under the umbrella of CEPE, the European Council of the Paint, Printing Ink and Artists’

Colours Industry

Represents > 80 manufacturers of printing inks and varnishes in > 160 manufacturing sites

Represents > 90% of ink sales in Europe

Employs ~ 12,000 people

Membership: Every member of a National Association representing the printing ink industry is

automatically a member of EuPIA (dual membership principle)

EuPIA in a Nutshell

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GMP requirements globally

In many parts of the world, we see legal requirements that companies producing

food contact materials must comply with GMPs

- In Europe this is regulated by the European regulation (EC) No 2023/2006

- In the USA this is regulated by FDA regulation 21 CFR Part 110

- In China this is regulated by the National Standard of the People’s Republic of

China GB 31603-2015

Many trade associations along the food packaging chain have created Good

Manufacturing guides, so EuPIA as well

- EuPIA has recently updated its GMP policy. It became public on

31st March 2016 (new GMP comprises of 47 [13] pages)

- This GMP policy aims to assist in controlling food safety hazards in the design and manufacture of inks,

varnishes and coatings designed to be printed onto Food Contact Materials, and formulated for use on either

the non-food contact or the food contact surfaces of food contact materials

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GMP on EuPIA‘s website

Published

31st March 2016

EuPIA homepage: www.eupia.org

The new GMP is publically available on the EuPIA website,

currently in English & German.

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EuPIA GMP: differences old/new version

Differences GMP March 2009 GMP March 2016

ScopeNon-DFC surfaces of

food packaging onlyBoth DFC and non-DFC surfaces of FCM’s

Level of detail Overview Greater level of detail, includes flow-charts & worked examples

Risk Assessment Not explicitly mentioned FMEA process, including guidelines for scoring

Demonstrating

complianceNot explicitly mentioned

Evidence based, example analytical result validating cleaning

process

Auditing Internal audit using checklist External audit by customers, in addition to internal audits

Updating Last updated 2009 Will be regularly updated to reflect changes

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EuPIA GMP adresses direct food contact scenario

The EuPIA GMP recognises that there is a higher potential risk for contamination &

hygiene issues associated with Direct Food Contact (DFC) inks & coatings, due to the

much shorter diffusion path. To mitigate this risk the following controls are

implemented:

A more rigorous process of selection of raw materials, and formulation design, to minimise the presence of non-

intentionally added substances (NIAS). This limits the number of raw materials that can be used

A more controlled process for manufacture in which contamination control

(from previous batches & cleaning materials), and hygiene control are implemented

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EuPIA GMP in comparison

The EuPIA GMP is a stand-alone GMP Standard and is specific to ink requirements.

Members of EuPIA need to adopt this GMP (in Europe).

Siegwerk is about to roll-out this EuPIA GMP globally.

Being EuPIA GMP compliant automatically means being both EU GMP regulation

2023/2006 and Chinese GB 31603-2015 compliant

There is high similarity between EuPIA GMP and IFS 6 (Interna-tional Food Standard)

accredited standards such as BRC IOP or ISO 22002-4.

EuPIA GMP can be easily audited by converters and brand owners: ink manufacturers will

be able to present continuous improvement by audits/corrective measures, FMEA (Failure

Mode and Effects Analysis) based risk assessments

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Agenda






3. Risk Assessment on NIAS from ink manufacturers perspective

(Siegwerk)


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Definition of NIAS – dealing with NIAS

NIAS are all chemical substances which are not IAS

and do not have an intended and specific function

within the ink formulation.

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IAS/NIAS examples: different perspectives

„IAS“ in the ink raw material – example:

Styrene-acrylic dispersion

Styrene

Acrylic acid

Emulsifier

Initiator

„NIAS“ in the ink – example: water-based ink

Styrene

Acrylic acid

Emulsifier

Initiator

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Regulatory framework for risk assessment of NIAS

Regulation (EU) No 10/2011:

“In principle, non-intentionally added substances will have to comply with the general safety requirements of Article 3 of the

Framework Regulation and are subject to risk assessment in line with Article 19 of the Plastics Regulation.”

Status of NIAS How to handle?

Listed in positive lists with SML

(evaluated)

Apply that SML

Not listed in positive lists

(not evaluated) Risk assessment

Evaluated as by-product in official

toxicological dossier

Considered „safe“ up to evaluated amount;

for higher amounts perform

risk assessment

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Categories of NIAS

Known NIAS (usually added by the raw material producer) – known chemical structure

- Starting monomers

- Catalysts

- Process aids

Unpredicted NIAS (may result from side reactions, degradation reactions, former production steps, cross-

contamination in the production) – often unknown chemical

structure

At Siegwerk for consumer safety reasons all migratory species are

subject to risk assessments. No differences are made whether talking

about IAS or NIAS !

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Risk Assessment process

Hazard

Assessment

Exposure

Assessment

Risk

Assessment = x

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Hazard Assessment procedure in detail

What is the safe tolerable daily dose of NIAS ?

Hazard

Assessment

Start: Definition of basic data requirements

acc. to field of application (NP, H)

Raw Material Introduction Process (RMIP)

SMLs

No SMLs

- Published and recognised

toxicological data

- QSAR predictions

- Read across

- TTC concept (ToxTree)

- (Bioassays for exclusion of

genotoxicity and endocrine

activity)

Self-derived SML

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Exposure Assessment procedure

Migration (tiered approach)

Worst Case Calculation (100% migration)

Migration Modelling (AKTS)

Migration Testing

Advanced approach*

e.g. FACET analysis

(European stakeholder software a.o.

incorporating food consumption data)

Exposure

Assessment

* taking into account real food consumption data and usage of packaging material

Exposureconcentration in food

(migration level)food consumption packaging material usage= x x

What is the estimated daily exposure to NIAS ?

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Risk Management Measures

Risk

Assessment

Hazard

Assessment

Exposure

Assessment= x

RMM

Protection of consumer

by reduction of exposure/hazard

Substitution(change hazard)

Barrier(change exposure)

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NIAS - flow of information

Raw Material based

Risk Assessment strategy

Product based(SoC)

from supplier

internal

to customerSupply chain

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Guidance documents on NIAS

Draft EuPIA Guidance for Risk Assessment of Non Intentionally Added

Substances (NIAS) and Non Listed Substances (NLS) in printing inks for food

contact materials (to be published soon)

ILSI Guidance on best practices on the Risk Assessment of NIAS in Food Contact Materials (FCM) and

Articles (2015)

PlasticsEurope Risk Assessment of Non-Listed Sustances (NLS) and NIAS under Article 19 (EC/10/2011)

(2014)

CEFIC/FCA Guideline on Risk Assessment of Non-Listed Sustances (NLS) and NIAS under the requirements

of Article 3 of the Framework Regulation (EC) 1935/2004 (2016)

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Thank you!

Contact person:

Dr. Jörg-Peter Langhammer

Vice President Global HSE + Sustainability

[email protected]

Phone: +49 2241 304 245www.food

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