What India should do in terms of regulation of

printing inks
Reynold D’Souza
Sakata Inx India Private Limited
 WHY do anything?
• There are issues of Health and Environment
• There are serious financial risks
• It will enable exports
• It will enable technology
 Health and Environment Issues
• Migration of constituents into food.
– Food packaging migration incidents are 100 times
higher than pesticide, E. Coli, hormones, BSE and
food additive incidents such as benzoic acid (Grob
et al 2006 Zurich)
– High multiplier effect
– Serious financial risks
 Export Competitiveness
• Increased exports at the end of the day are not
just about the value of the currency, they are
mostly determined by factors like quality and
productivity. (Just the rupee depreciating is not
going to help exports- Financial Express July 7,
2018)
• The Government has constituted a standing
committee to formulate packaging standards
following rejection of Indian food products in
developed markets over concerns…
(MoneyControl October 24, 2017)
 Some serious Issues
• It is suspected that offset sheet fed inks has
been used in primary packaging of food items
such as cereals. It is suspected that this may
include PP non woven fabric. The cobalt driers
and mineral oils would not see this as a major
barrier. It is suspected that the mineral oils
had aromatic content. It is suspected the
mineral oils had polyaromatic content. These
bags can be seen in Indian supermarkets.
 Areas of regulatory requirement
• Concentrate on areas of potential export competiveness.
(Japan Economic Miracle Masahiro Takada, 1999)
• Concentrate on areas where there are specific known issues.
• Concentrate on sensitive areas like food and products used
by children.
• Harmonize with global legislation.
• Put a criteria sieving system without too much investment to
creating an inventory system.
• Popularize Eco Label communication elements for consumers
and disposal.
• Increase vigilance and testing to ensure implementation.
AREAS OF REGULATORY COVERAGE
 Simplified overview: Printing inks
All inks have their regulatory nuances
Printing
Inks

Solvent Specialty Water

Offset Inks
based Inks Based Ink

Gravure Digital Screen UV/EB Cold set

Flexography Inkjet Heatset

Toner
Sheet fed
(Laser)
 Overview: By application
Printing Inks

Consumer and
Industrial Tattoo Inks
Professional
COSIN
ingredients

Packaging Inks Publication Inks

Primary Cellulosic Books/

Medical Textiles
Food/Pharma Newspapers
packaging magazines
Packaging

Secondary Food
Packaging Children’s books
or toys
Other

Hybrid
Packaging
 Sensitivity by Ink: Newsink
• “The Working Group noted that the vast majority of
epidemiological studies covered workers who were in
the printing industry in North America or Europe
during the middle of the twentieth century. Very few of
the studies included workers whose employment was
after 1980. Given the rapid technological changes that
have go ne on in this industry n North America and
Europe in the past decade, it is questionable whether
the exposure circumstances that were prevalent in the
past are stilI prevalent. However, there may be areas of
the world in which the older processes are stilI
prevalent.” IARC Printing Inks
 Sensitivity by Ink: UV Inks
• UV inks only under special circumstances may be used on
primary food packaging. ‘The member carton makers are
recommended to stop the use of UV inks and varnishes – if
they have ever done so - for primary food packaging, or to
stop the use of the current UV inks and varnishes’ (ECMA)
• UV inks are sensitizing in nature, though after curing may
not be classified as sensitizing.
• Since uv inks are sensitizing special precautions need to be
deployed to reduce exposure (see UK COSHH Essentials)
• UV inks will contain the photoinitiator which could possibly
migrate across the functional barrier.
Sensitivity by Ink: Offset Sheet fed Low
Migration Low Odor Inks
• Absence of mineral oil both MOAH and
MOSH.
• Absence of cobalt driers.
• Absence of strong aldehydic odors from
certain vegetable oils.
• May use OPVs.
 Sensitive Applications-Children
• Children’s textbook may be given the status of
toys especially if used unsupervised and need
to conform to EN-71-3 or IS 9873 under Indian
Law. Thus heavy metals & PAH levels can be
controlled.
Sensitive application: Medical Textiles
• Medical textiles have been known to cause
what is called tampon deaths in India and
almost everywhere globally. The level of care
needs to be on par with food packaging. There
is a need to eliminate usage of solvents like
ethyl cellosolve which are endocrine
disruptors.
 Pharmaceuticals
• The level of care in pharmaceuticals which is of export
importance needs to parallel/exceed that of food
packaging. (packaging Type III DMF submission for USA)
• Some more emphasis to be given to slow formaldehyde
release from melamine formaldehyde resins as this affects
the dissolution of gelatin capsules a major export from
India. The law is in place- IS 14998.
• Tracking: Serialization will happen in the USA, India is
following suite. These concepts can be adopted for marking
and tracking of laminates during use and disposal.
FOOD PACKAGING INKS
 Types of inks in Food Packaging
Direct food contact Secondary Packaging
Special Inks or coatings Primary Packaging Most Offset Sheet-fed
Most uv ink and coatings

Absolute Barrier
Functional Barrier
Glass, Metal, tin and
Aluminum > 18µ
Impermeable

Cellulosic
Plastic
2007/42/ec
Low Migration Offset Ink: 10/2011/ec
No cobalt driers Food Packaging Ink
No mineral Oil Semi Permeable Packaging
Porous Packaging
 Food Packaging Inks
• Assumes a Functional Barrier
• Modes of migration
– Penetration Migration or Migration governed by Fick’s
Diffusion Law
– Set off Migration
– Permeation
• Consideration of material packed (Example: Oily
Food)
– IS 9845 refers to Food Type A to E
• Consideration of usage categories
– Microwave and Retort
 Migration Control
 Framework Law PFA Act 1954 or 1935/2004/ec
 Exclusion Criteria EUPIA for instance can be adopted
 Positive Lists (Swiss Ordinance/EUPIA Positive List)
 Negative List (Japan Printing Ink Makers Association)
 Good Manufacturing Practices example 2023/2006/ec. Applicable to the ink
maker is 2016-03-31 EUPIA 4th Edition
 Substance purity criteria: Due diligence on purity and NIAS EUPIA 2017-1129
 Solvent retention analysis by Head Space Analysis ASTM F 1884 or EN 13628
 Worst Case Calculations: EUPIA and EU Assumptions
 Migration simulation;
 Migration Testing Example: 10/2011/ec, EN 13130; Overall Migration Limit IS
9845
 Special substance lists from companies (example Nestle, Perfetti etc)
 Special criteria on uv and fanal pigments.
 Minimize solvents; Banned solvents
 Typical Statement: Framework Law
Only those printing inks may be used in an indirect food contact situation in the context of being a food
packaging ink if the printed package used to package food meets the requirements under PREVENTION
OF FOOD ADULTERATION ACT – 1954 and its updates.
(See 1935/2004/EC)

• This implies that the food packaging inks must be used for packaging food only if
– there exists a selected functional barrier
– the supply chain follows Good Manufacturing Practices
– Are used as per the technical guidelines and SDS set out.

• This implies that the printing inks should not transfer their constituents to foodstuffs in quantities
which could render them as an adulterant in the said food. This should be based on the reasonably
expected working life of the food or the food package, assuming a usage not in variation to
foreseeable and prescribed conditions of use. An adulterant would by definition
– endanger human health and/or
– bring about an unacceptable change in the composition of the food and/or
– bring about an unacceptable deterioration in the organoleptic characteristics thereof and/or
– bring about unacceptable visual appearance of the foodstuff.
Exclusion Criteria EUPIA 8th Revision
2012
CANNOT be used
in ink by deliberation
in any quantity
Toxic Substances
may be used under
mutual consent
Sensitization
substances absent in
the dried ink. (uv)
CMR substances
should not form
during ink
processing and
usage such as
(Ti(acac)x) and
Banned Aromatic
Amines
Substance Identity and Purity (ResAP (89)1)
Catalyst residues and preservative substances like MEHQ in uv monomers
may be part of the substance definition
 What Types of substance go into ink?
1. A GRAS ingredient (Generally Regarded As
Safe in Food)
2. An ingredient used in direct food contact
coatings.
3. An ingredient used in plastic
4. An ingredient permitted in ink (Swiss/ EU
Council or EUPIA positive List)
5. Other: Not allowed.
THE SOLVENTS ARGUMENT
SHOULD WE BAN TOLUENE? AND MIBK
AND MEK?
 THE TOLUENE
PROBLEM
• Conventional Vinyl inks may not meet a SML 1.2 mg toluene/kg food (EFSA/WHO
derived/Swiss Ordinance)
• Conventional Vinyl inks cannot meet a limit of 2mg toluene/m2 (Korea)
• Toluene-induced chronic impairment of auditory function has been demonstrated in a
number of animal studies. (RAR Report EU)
• Dimethyl sulfide, toluene and Xylene are cadaver odor’s so dogs do not eat toluene
tainted food. (‘Scientist search for death’s aroma’ C&EN April 4, 2016).
• All toluene facilities must have carbon absorbers. Minimum recovery 92%. Encapsulated
rotogravure printing exempted. (EU Ecolabel)
• Toluene is a HAP and VOC (VOC tax Switzerland/China)

25
 TOLUENE C&L and Limits

IN A WORST CASE CALCULATION ASSUME ALL THE TOLUENE IN THE FILM ENTERS THE
FOOD.
Conclusion: Toluene is in meat, poultry, milk and coffee (350 µg/kg), controlled not
banned. Need to CONTROL. 26
 MEK CAS No 78-93-3
• SML 5 mg/kg Food.
• The majority of in vitro and in vivo genotoxicity tests have
demonstrated no activity. MEK is not an allergen. Although
the toxicological database is limited, based on the available
data, there are no toxicological concerns regarding the use of
MEK as a previous cargo. No impurities of concern are
expected.
• Flam. Liq. 2 H225 / Eye Irrit. 2 H319 / STOT SE 3 H336
• RTECS # EL6475000

27
 MIBK CAS Rn 108-10-1
• GHS Hazard Statements: Flam. Liq. 2 H225/ Acute Tox. 4 H332/ Eye Irrit. 2 H319/
SML 5 MG/KG Food.
• RTECS #: SA9275000
• Non genotoxic carcinogen
• Listed on California Proposition 65.
• Recent studies on inhalation carcinogenicity in rats and mice provided some
evidence of the carcinogenic activity of MIBK in kidney and liver, respectively, at the
highest dose tested. However, MIBK was not genotoxic in a variety of in vitro and in
vivo assays suggesting that it is not carcinogenic in animals by a genotoxic
mechanism.
THE ENVIRONMENT
 The Environment
• Restriction of heavy metals like Pb, Hg, Cd and
Cr(VI) as under 94/62/EC and CONEG
• Where appropriate Composting Standard IS
16556 or EN 13432 : 1) material 2) disintegration
3) biodegradable. 4) compost standard is to
include ink considerations and contribution.
• Circular Economy and printing inks: Delamination
studies and ink removal studies are ongoing.
Important that inks used in India be similar to
those globally.
Current mainstay ink in India: Vinyl ink
• Uses toluene but rarely meets SML.
• Uses vinyl chloride-vinyl acetate-vinyl alcohol resin. This
resin is imported.
• May have an incineration problem as it has a chlorine
content.
• May have a problem with some recycling processes as it is
not used globally.
• Restricts India’s export to Africa, Middle East & other
locations.
• Alternative inks: India makes appropriate resins and is THE
leader in ink adhesion promotors for PU and PA inks used
globally. Flexography is growing perhaps faster than gravure
today in India, but is being slowed down by use of toluene
based inks.
A POSSIBLE PLAN
 A POSSIBLE STANDARD
• Framework Law
• Good Manufacturing Practices
• Purity criteria on ingredients
• Exclusion Criteria
• Criteria on degradative products including formation
of banned amines.
• Specific list of materials with migration limits
• Worst Case Calculations and communication
• Migration Testing
 Supportive regulation
• GC Head space analysis of solvent ASTM F
1884 or EN 13628
• Migration Testing IS 9845 to be expanded.
 WHO?
• India has yet to adopt UN GHS.
• The First International Convention on Sustainable
Trade and Standards, was convened by the
Quality Council of India (QCI) in collaboration
with the United Nations Forum on Sustainability
Standards (UNFSS) and the Ministry of Commerce
and Industry, Government of India at New Delhi,
India from 17 to 18 September 2018.
• Hence AIPIMA can adopt an industry standard to
meet domestic and export demand, in
anticipation of a country standard.
THANKS