Printing Inks - Issues, Guidance and Regulations
Printing Inks - Issues, Guidance and Regulations
Printing Inks - Issues, Guidance and Regulations
February 2010
Topics
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Chris Whitehead – February 2010
► A leading supplier to the
Printing and Packaging
Industries.
► #1 or #2 supplier in every
major market segment we
serve.
Most complete portfolio of product offerings
► Nov. 2004 CVC acquired ANI Inks and BASF Printing Systems.
► Sep. 2005 XSYS acquired Flint Ink, a privately owned company with
operations in USA, Europe, Latin America, Asia and India/Pacific.
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Chris Whitehead – February 2010
Powerful Roots – Sources of Expertise
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Chris Whitehead – February 2010
nternational Corporation
Morrison
Inks
Inks
Chemical
s News/Publicatio
n
B&T
CQIB
NT
INENT
BASF
O
NA Graphics
I N KS
Temple Inks
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Chris Whitehead – February 2010
Top 7 Printing Inks Manufacturers
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Chris Whitehead – February 2010
The Executive Management Team
Charles Knott
CEO
Dermot
DermotHealy Bill
BillMiller Dr.
Dr.Dirk
DirkAulbert Dr.
Dr.Thomas
ThomasTelser Craig
CraigFoster Jan
Healy Miller Aulbert Telser Foster JanPaul
Paul
President President President President President van
President President President President President vander
derVelde
Velde
Packaging
Packagingand Flexographic Sr.
and Flexographic Sr.Vice
VicePresident
President
Print
PrintMedia
MediaEurope
Europe Americas
Americas Narrow
NarrowWebWeb Products
Products Pigments
Pigments Procurement
Procurement
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Chris Whitehead – February 2010
Company Profile
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Chris Whitehead – February 2010
Flint Group – Strategic Direction
At Flint Group
our Mission is Customers Employees Integrity Continuous
Improvement
Leadership
Teamwork
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Chris Whitehead – February 2010
Packaging & Narrow Web
Combined - a global approach
Organisation Packaging and Narrow Web
Dirk Aulbert
President
Packaging &
Narrow Web
Michael
MichaelFien
Fien
Finance
FinanceDirector
Director
Packaging
Packaging&&
Narrow
NarrowWeb
Web
Dirk
DirkAulbert
Aulbert Doug
DougAldred
Aldred
Eva
EvaFreudenthaler
Freudenthaler Dave
DaveHiserodt
Hiserodt Susan
SusanKuchta
Kuchta Matias
MatiasKatila
Katila George
GeorgeLyle
Lyle
Operations
Operations Vice
VicePresident
President
Vice
VicePresident
President Vice
VicePresident
President Vice
VicePresident
President General
GeneralManager
Manager General
GeneralManager
Manager
Packaging
Packaging&& Sales,
Sales,Packaging
Packaging
Marketing
Marketing&& BM
BMNarrow
NarrowWeb
Web BM
BMPackaging
PackagingInks
Inks Narrow
NarrowWeb
Web Narrow
NarrowWeb
Web
Narrow
NarrowWeb
Web &&Narrow
NarrowWeb
Web
Technology
Technology North
NorthAmerica
America North
NorthAmerica
America Latin
LatinAmerica
America Asia
Asia
Europe
Europe Europe
Europe
BM = Business Management
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Chris Whitehead – February 2010
Packaging & Narrow Web – Our offer
We offer a complete range for all applications,
including:
► Flexography
High quality solvent and water based Flexo Inks for everything you need
in Packaging Applications
Dedicated press stable water based Flexo Inks for Narrow Web
Low viscous excellent printable UV Flexo Inks for Narrow Web
applications
► Gravure
Wide product range in solvent based and water based for Gravure
packaging printing
► Letterpress, Screen and Offset
Tailor made UV Inks for a wide range of Label Applications in Letterpress,
Screen and Offset
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Chris Whitehead – February 2010
Segments we serve:
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Chris Whitehead – February 2010
Packaging & Narrow Web Sites Worldwide
Europe / Middle East / Africa
Curitiba, Brazil
Dandenong South, Australia
Sao Paulo, Brazil
Bangalore, India
Santiago de Chile, Chile
Bogota, Colombia
San Jose, Costa Rica
Santa Domingo, Rep.Dom
Guayaquil, Ecuador
Lima, Peru
Mother plant
Puerto Principe, Trinidad
Buenos Aires, Argentina Satellite facility
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Mexico City, Mexico
Chris Whitehead – February 2010
Narrow Web Market Shares - Global
Flint Group
Others
Siegwerk
SUN
EIC
18 2008 data
Chris Whitehead – February 2010
Narrow Web Market Shares – North America
SUN
Siegwerk EIC
Water Ink
Technology
19 2008 data
Chris Whitehead – February 2010
Narrow Web Market Shares – Europe
Others
Flint Group
SUN
Zeller Gmelin
Siegwerk
20 2008 data
Chris Whitehead – February 2010
Narrow Web Labels
► Including
UV Flexo
Water based Flexo
UV Rotary Screen
UV Letterpress
UV Offset
► Typical end products
Pressure-sensitive labels, cut &
stack labels, in mould labels,
resistant labels, thermal labels,
pharmaceutical labels,
cosmetic labels
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Chris Whitehead – February 2010
Food Contact
European Situation
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Chris Whitehead – February 2010
A First Definition
► Regulation
“Immediately” in law in all Member States
► Directive
Has to be legislated in each Member State separately
• They can get stricter if they want
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Chris Whitehead – February 2010
Food Packaging Issues
Ink
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Chris Whitehead – February 2010
Food Packaging Issues
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Chris Whitehead – February 2010
Rules & Regulations
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Chris Whitehead – February 2010
Community Legislation
(EC) No 1935/2004 Reference:
Figure 1: Overview of Community Legislation Framework References of European and National
Legislations –
(Last update 25/06.2008 (EC) No 2023/2006
European Commission Working Document
Good Manufacturing Practice
(Applicable to all food contact materials)
Plastic Materials
2007/42/EC 84/500/EEC Elastomers
Regenerated Ceramics & Rubbers
Cellulose Films 93/11/EEC
Nitrosamines
2004/1/EC
1st Amendment
93/8/EEC
80/766/EEC (EC) No 597/2008 1st Amendment
VC in PVC 1st Amendment
2004/19/EC Analysis
2ndAmendment
97/47/EEC
2ndAmendment
2005/79/EC 81/432/EEC
3rd Amendment VC in
food analysis
2007/19/EC
4th Amendment
2008/39/EC
5th Amendment
975/2009
6th Amendment
Active &
Paper & Metals & Ion Exchange Varnishes
Glass Intelligent Wood Cork Textiles Adhesives Printing Inks Silicones Waxes
Board Alloys Resins and Coatings
Materials
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Chris Whitehead – February 2010
European and National Law
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Chris Whitehead – February 2010
What does this mean to us?
► 1935/2004 Article 3
General requirements
• 1. 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;
– or
• (b) bring about an unacceptable change in the composition of the food;
– or
• (c) bring about a deterioration in the organoleptic characteristics
thereof
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Chris Whitehead – February 2010
Traceability
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Chris Whitehead – February 2010
What does this mean to us?
► 2023/2006
In force August 1 2008
Demands that all members of Food Packaging Chain have a
• Good Manufacturing Practice
– Follow it
» Demonstrate compliance
– Including imported articles
Every member has responsibility
• No member can assume responsibility of another actor in chain
Annex
• Relating to inks
– Their application not to infringe Article 3 of 1935/2004
» Must be formulated in such a way as to allow this to occur
: when correctly applied
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Chris Whitehead – February 2010
What does this mean to us?
► 2002/72
Introduces substances with limits (SML etc.)
• Effectively direct food contact
– Substances in inks
» Need to supply information to allow “adding up” of “common”
substances
– Colorants & Solvents Excluded
Being replaced by Plastics Implementation Measure
• Due to come into force July 2010
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Chris Whitehead – February 2010
Other regulations
► F&DA
Does not apply in Europe
Primarily for intentional direct food contact
Effectively no colourants
One of the criteria of EuPIA selection of Raw Materials
► Inks Resolution – AP (2005) 2
Adopted by Council of Europe
Not ratified in any Member State
Not supported by EuPIA
If it were adopted
• 80 % of Food packaging cannot be printed
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Chris Whitehead – February 2010
Self Regulation
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Chris Whitehead – February 2010
Current Disclosure
► Statement of Composition
Sets out materials used in Plastics Directive – with a limit
• % in dry ink film is declared
– To allow “totting-up” with other sources of same material
Dual Use substances
Other as separate disclosure
Model Document
► Further information
Potential migrants
• <1000 Daltons
• With relevant information
– CAS, PM, SML etc
– Worst Case Calculation where possible
Template
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Chris Whitehead – February 2010
Statement of Composition
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Chris Whitehead – February 2010
Disclosure Template
Potential Migratable Components Disclosure
Strictly Confidential
Notes:
(A) Percentage of component in ink/coating - expressed as percentage of solids of dry ink
(1) For example:
Plastics Directive (PD)
Synoptic Document (SD) with SCF List number
(2) Worst case calculation used to show the applied dry weight of ink or coating which would mean that the specified component would exceed the restriction level.
This is based on product weight in previous column, 100 % coverage (in case of inks etc), 6
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Chris Whitehead – February 2010
Disclosure Example
Potential Migratable Components Disclosure
Strictly Confidential
Notes:
(A) Percentage of component in ink/coating - expressed as percentage of solids of dry ink
(1) For example:
Plastics Directive (PD)
Synoptic Document (SD) with SCF List number
(2) Worst case calculation used to show the applied dry weight of ink or coating which would mean that the specified component would exceed the restriction level.
This is based on product weight in previous column, 100 % coverage (in case of inks etc), 6
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Chris Whitehead – February 2010
Some Current Issues
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Chris Whitehead – February 2010
EuPIA Public Inventory List
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Swiss Ordinance – 817.023.21
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Chris Whitehead – February 2010
Swiss List
► A European List
► Some End Users thinking of making it Global
Not feasible
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Chris Whitehead – February 2010
Sheetfed Litho inks
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Chris Whitehead – February 2010
EuPIA Information Note on Sheetfed inks
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Chris Whitehead – February 2010
Low Migration Systems
► Solvent Based
Direct film packaging
• No real issues
• Flint Group major supplier
► Waterbased
Again no major issue
• Can be a lot of minor components which may be potential migrants
• Amines present in ink above SML
– Should evaporate/react with paper
– Needs confirming by testing
» Has been done several times and never a problem so far
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Chris Whitehead – February 2010
Low Migration Systems
► Litho
Nestlé approved
• Novasens Premium
• Ultraking 7000 XLM
► Narrow Web
Flexocure Gemini
• Should meet specifications
– When tested in final application
• Other systems will also comply
– Some application dependency
Low migration system in Development
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Chris Whitehead – February 2010
Primary Food Packaging
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Chris Whitehead – February 2010
European Parliament and Council Directive 94/62/EC of
20 December 1994 on packaging and packaging waste
► Article 3
Definitions
'packaging` shall mean all products made of any materials of any
nature to be used for the containment,protection, handling,
delivery and presentation of goods,
• a) sales packaging or primary packaging,
– i. e. packaging conceived so as to constitute a sales unit to the
final user or consumer at the point of purchase;
• b) grouped packaging or secondary packaging,
– i. e. packaging conceived so as to constitute at the point of
purchase a grouping of a certain number of sales units whether
the latter is sold as such to the final user or consumer
• c) transport packaging or tertiary packaging
► On this basis
Primary packaging not just direct food contact
• Some conflict with 1935/2004
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Chris Whitehead – February 2010
Self Adhesive Labels on Food Packaging
► Effectively in Scope
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Chris Whitehead – February 2010
Migration
► Use a barrier
Absolute Barrier
• Metal Can
• Glass Bottle
Functional Barrier
• Defined also as 9µ Al Foil
► Therefore
Not possible in most packaging to be sure that barrier is present
• Multi-layer structures may act as “Effective Functional Barrier”
• Must test in the final form
– This is true for all packaging
» Even if “Low Migration” ink being used
Certainly no coatings are barrier
• Even if there were some would need to be double applied
– To ensure no pinholes
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Chris Whitehead – February 2010
Low Migration Ink - definition
► Proposed by EuPIA
► A "low migration ink" designed for use on food packaging is
formulated using selected components which should ensure that
migration from the resultant printing ink film will be within
accepted migration
provided that the packaging structure is suitable, and the packaging ink is
applied under Good Manufacturing Practices in accordance with
guidance given by the ink supplier for the intended application
► This should be supported by indicative analytical testing and/or
relevant worst case calculations.
► As a result – assuming correct application and appropriate
packaging type – any migration from the printed packaging
should be within currently accepted limits.
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Chris Whitehead – February 2010
Migration assessment
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Chris Whitehead – February 2010
What to use where?
Is the inner wrap a Wrap to Is the outer Possible vapour Ink Examples
Case barrier to ink be printed wrap a barrier to phase transfer or Recommendat
ingredients? ink ingredients? set-off ion
No Inner Not relevant Not relevant Low migration single wrap packaging, e.g.
1 - printed paper bag or cardboard box, also PE
coated ones, or
- printed flexible pouch or rigid container made of
non-barrier material (e.g. PP or PE), or
- plastic bottle with printed label
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Chris Whitehead – February 2010
What to use where?
Is the inner wrap a Wrap to Is the outer Possible vapour Ink Examples
Case barrier to ink be printed wrap a barrier to phase transfer or Recommendat
ingredients? ink ingredients? set-off ion
No Inner Not relevant Not relevant Low migration single wrap packaging, e.g.
1 - printed paper bag or cardboard box, also PE
coated ones, or
- printed flexible pouch or rigid container made of
non-barrier material (e.g. PP or PE), or
- plastic bottle with printed label
No Outer No Not relevant Low migration - cereals in PP pouch in a printed cardboard box
2
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Chris Whitehead – February 2010
What to use where?
Is the inner wrap a Wrap to Is the outer Possible vapour Ink Examples
Case barrier to ink be printed wrap a barrier to phase transfer or Recommendat
ingredients? ink ingredients? set-off ion
No Inner Not relevant Not relevant Low migration single wrap packaging, e.g.
1 - printed paper bag or cardboard box, also PE
coated ones, or
- printed flexible pouch or rigid container made of
non-barrier material (e.g. PP or PE), or
- plastic bottle with printed label
No Outer No Not relevant Low migration - cereals in PP pouch in a printed cardboard box
2
No Outer Yes Yes Low migration - printed box made of aluminium laminated board,
3 containing sweets wrapped in paper or PP
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Chris Whitehead – February 2010
What to use where?
Is the inner wrap a Wrap to Is the outer Possible vapour Ink Examples
Case barrier to ink be printed wrap a barrier to phase transfer or Recommendat
ingredients? ink ingredients? set-off ion
No Inner Not relevant Not relevant Low migration single wrap packaging, e.g.
1 - printed paper bag or cardboard box, also PE
coated ones, or
- printed flexible pouch or rigid container made of
non-barrier material (e.g. PP or PE), or
- plastic bottle with printed label
No Outer No Not relevant Low migration - cereals in PP pouch in a printed cardboard box
2
No Outer Yes Yes Low migration - printed box made of aluminium laminated board,
3 containing sweets wrapped in paper or PP
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Chris Whitehead – February 2010
What to use where?
Is the inner wrap a Wrap to Is the outer Possible vapour Ink Examples
Case barrier to ink be printed wrap a barrier to phase transfer or Recommendat
ingredients? ink ingredients? set-off ion
No Inner Not relevant Not relevant Low migration single wrap packaging, e.g.
1 - printed paper bag or cardboard box, also PE
coated ones, or
- printed flexible pouch or rigid container made of
non-barrier material (e.g. PP or PE), or
- plastic bottle with printed label
No Outer No Not relevant Low migration - cereals in PP pouch in a printed cardboard box
2
No Outer Yes Yes Low migration - printed box made of aluminium laminated board,
3 containing sweets wrapped in paper or PP
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Chris Whitehead – February 2010
What to use where?
Is the inner wrap a Wrap to Is the outer Possible vapour Ink Examples
Case barrier to ink be printed wrap a barrier to phase transfer or Recommendat
ingredients? ink ingredients? set-off ion
No Inner Not relevant Not relevant Low migration single wrap packaging, e.g.
1 - printed paper bag or cardboard box, also PE
coated ones, or
- printed flexible pouch or rigid container made of
non-barrier material (e.g. PP or PE), or
- plastic bottle with printed label
No Outer No Not relevant Low migration - cereals in PP pouch in a printed cardboard box
2
No Outer Yes Yes Low migration - printed box made of aluminium laminated board,
3 containing sweets wrapped in paper or PP
Yes Inner Not relevant No Standard - glass bottle or can with printed label, or
6 - coated/printed cans where set-off can be
excluded, e.g. without internal lacquer
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Chris Whitehead – February 2010
What to use where?
Is the inner wrap a Wrap to Is the outer Possible vapour Ink Examples
Case barrier to ink be printed wrap a barrier to phase transfer or Recommendat
ingredients? ink ingredients? set-off ion
No Inner Not relevant Not relevant Low migration single wrap packaging, e.g.
1 - printed paper bag or cardboard box, also PE
coated ones, or
- printed flexible pouch or rigid container made of
non-barrier material (e.g. PP or PE), or
- plastic bottle with printed label
No Outer No Not relevant Low migration - cereals in PP pouch in a printed cardboard box
2
No Outer Yes Yes Low migration - printed box made of aluminium laminated board,
3 containing sweets wrapped in paper or PP
Yes Inner Not relevant No Standard - glass bottle or can with printed label, or
6 - coated/printed cans where set-off can be
excluded, e.g. without internal lacquer
Yes Outer Not relevant Not relevant Standard - glass bottle in printed outer container
7
EuPIA
59 proposed document – to be ratified by Packaging Chain
Chris Whitehead – February 2010
Summary
► Through use of
GMP
Statement of Composition
Other disclosures
► Ink-maker can supply full support to Packaging Chain
to allow evaluation and confirmation of conformance
to:
GMP – 2023/2006
Framework Regulation – 1935/2004
► Ensuring maximum consumer safety
► This is not the end of the line
► Continued Improvement – pro-active – is a basic
concept of the industry.
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Chris Whitehead – February 2010
REACH
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Chris Whitehead – February 2010
Importers – EU Customs territory
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Chris Whitehead – February 2010
Definitions
An article is the term for any object that has been given a specific shape, surface or design
which determines its function to a greater degree than does its chemical composition (e.g.
manufactured goods such as textiles, electronic chips, furniture, books, toys, kitchen
equipment).
ECHA – Guidance for Identification and naming of substances under REACH
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Chris Whitehead – February 2010
Who is a Downstream User?
Manufacturer / Importer
Downstream users
Industrial user
1) Use as a processing aid Professional user
2) incorporation into articles
Distributor Consumer
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Chris Whitehead – February 2010
Who is a Downstream User?
Manufacturer / Importer
Downstream users
Formulator 2
Formulator 1 Formulator 3
Ink-maker
Printer/Converter
Professional user
Distributor Consumer
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Chris Whitehead – February 2010
Timeline of REACH implementation
Pre-registration
>1000tonnes
CMR 1, 2 > 1 t
R50/53 > 100t
100-1000 tonnes 1-100 tonnes
31 May 2018
1 Dec 2008 30 Nov 2010 31 May 2013
1June 2007
1 June 2008
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Chris Whitehead – February 2010
Current situation
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Chris Whitehead – February 2010
Use Descriptors
Indicator of how substance is handled (human PROC 2 – used in closed systems with
Process PROC exposure) occasional controlled exposure
PROC 10 Roller coating (printing)
Category
Indicator of the type of the product in which PC 9 Coatings
Product PC the substance is used PC18 Inks
Category
Indicator of the type of article in which the AC 7-2 Metal Products; Toys
Article AC substance is used Not needed in application report
-with no intended release
Category -- with intended release
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What is an Article?
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Chris Whitehead – February 2010
Articles
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Chris Whitehead – February 2010
Be Grateful
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Chris Whitehead – February 2010
Carbon Footprint & Sustainability
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Chris Whitehead – February 2010
Carbon Footprint as part of Sustainability
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Chris Whitehead – February 2010
The Buzzwords
► Green
What is “green?”
• Water vs.solvent vs.UV
► Sustainable
► Global Warming
► Carbon Footprint
► Environmentally Friendly
Water-based inks are better for this ?
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Chris Whitehead – February 2010
Is there one Answer?
► No
► It is a case by case basis
Water can be “greener” than solvent
Water can be “less green” than solvent
► Define “Green”
► It is the total concept we need to look at
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Chris Whitehead – February 2010
They all start in the same place
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Chris Whitehead – February 2010
Application
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Chris Whitehead – February 2010
Recyclability of paper – de-inking
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Chris Whitehead – February 2010
Sustainability
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Chris Whitehead – February 2010
Renewable Raw Materials
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Chris Whitehead – February 2010
Greenhouse Gas Emissions
Global
49
Billion
tonnes
Europe
4.2 bn Tonnes
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Chris Whitehead – February 2010
GHG EMISSIONS EXAMPLE: EUROPE
GHG Emissions Europe per sector:
Solvent Use
0.19%
Industry
7.60% Ink use = 0.004 %
Agriculture
9.20%
21%
Energy
60%
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Chris Whitehead – February 2010
Carbon Footprint
► Carbon Footprint
EuPIA (DE) figure of 0.495 kWh/kg
• Production of inks
– Average
Therefore the Carbon Footprint for the same
• Varies from country to country
• Dependent on source of electricity
– Sweden 1 kWh = 44 gms CO2
– Greece 1 kWh = 814 gms CO2
– Other countries in between
» France = 84 gms CO2
» Germany = 500 gms CO2 (wide variation)
» UK = 430 gms CO2
Transport
• Truck
– 4.1 gms CO2 per 100 kms
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Chris Whitehead – February 2010
Carbon Footprint (cont.)
► Raw Materials
Pigments and Resins
• Manufacture per kilo similar to the ink manufacture
– Make up 25-40% of ink
► Raw Material Transport
All bulk shipped, therefore transport impact per kilo minimal
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Chris Whitehead – February 2010
FACTS: CARBON FOOTPRINT – Potato Chips
Raw Materials
Manufacturing
► 75 g CO2
per package
Packaging
Ink contribution:
Transportation
0.01%*
(*estimate)
Package Disposal
Distribution
(trucking)
8%
Brewery
Operations
4%
Malt
6%
Paper (Carton
and Label &
Ink)
2%
Barley
Glass
13%
22%
Added carbon
dioxide
2%
89
Source: Wall Street Journal; New Belgium Brewing Co.
Chris Whitehead – February 2010
Carbon Footprint - Magazine
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Chris Whitehead – February 2010
Summary
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Chris Whitehead – February 2010