Regulations,
Swiss Ordinance,
Guidance
and more….
Thomas Polster
hubergroup
Content:
1.
Regulation EU 1935/2004
2.
Regulation EU 2023/2006
3.
Swiss Ordinance 817.023.21
4.
Nestlé Guidance Note on Packaging Inks
5.
EuPia Guidline
6.
GMP
EU Regulation 1935/2004
Article 3
Food packaging 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:
• endanger human health
• bring about an unacceptable change in the composition of
the food
• or bring about a deterioration in the organoleptic
characteristics thereof.
EU Regulation 1935/2004
Article 16
Declaration of compliance
Materials and articles shall be accompanied by a written declaration
stating that they comply with the rules applicable to them
Appropriate documentation shall be available to demonstrate such
compliance.
EU Regulation 1935/2004
Article 17
Traceability
(1)
The traceability of materials and articles shall be ensured at all
stages
(2)
Business operators shall have in place systems and procedures
to allow identification of the businesses from which and to which
materials or articles and where appropriate, substances or
product covered by this regulation used in their manufacture are
supplied.
EU-Regulation 2023/2006
Commission Regulation (EC)
No 2023/2006 of 22 December 2006
on good manufacturing practice for materials and
articles intended to come into contact with food
• Effective quality system
• Starting materials in compliance with pre-established specifications
• Pre-established instructions and procedures
• Migration or Invisible Set off of components of printing inks shall not
exceed the limits
• No direct contact of printed surface with food
• Apply from 1 August 2008
Swiss Ordinance 817.023.21
The 2008 revision of the Swiss Ordinance on
Materials and Articles in Contact with Food (Swiss
Bedarfs-gegenständeverordnung) introduced new
provisions for food packaging inks and printed food
packaging (section 8b)
Printing Inks for food packaging must be formulated only from raw
materails covered by the inventory list of the Swiss Ordinance.
Annex 1: list I and II – Annex 6: list I - V )
Migration values of eveluated substances shall not exceed the limits
Migration values of non-eveluated substances (Part B of the lists) must
be below 10 ppb (0,01 mg/kg)
Ink and coating production regarding GMP
Swiss Ordinance 817.023.21
Responsibilities
The verification of compliance can only be done on the finished printed
and/or varnished food packaging
The manufacture of the final article has the legal responsibility to ensure
that it es fit for the intended purpose and for the compliance with the
Swiss Ordinance on materials and Articels in contact with food.
No direct food contact with the printed layer
Conventional inks and coatings could only be used if migration and
invisible set-off is impossible. Possible due to packaging design and/or
production process.
Nestlé Guidance on Packagin Inks
The document refers to the Nestlé Initiative on Packaging
Safety and Compliance and adresses the ink usage for decoration on
packaging materials. The document applies to printing inks and
coatings.
General requirements
Specific requirements
Part 1. UV & EB inks and coatings
Part 1. Conventional inks and coatings for offset printing
Part 3. Solvent-based & water based inks and coatings
Part 4. Ink-jet printing
Annex
Guidance on Packagin Inks
General requirements
Only ink and coatings that are carefully
formulated for food packaging applications ca be used.
The principle of low migration must be proved by the converter of
packaging materials. The ink and coating rawmaterials must be
comply with either existing restrictions, e.g. specific migration limits, or
– when no toxicolagical evaluation has been made – with migration
limit of 10 ppb.
The use of „Fanal“ type pigments must be avoided
Guidance on Packagin Inks
General requirements (continued)
The use of printed packaging materials at high
temperature must be thoroughly evaluated
The sensory impact of inks and coatings
must be thoroughly evaluated
It´s the final converter´s responsibility to ensure the best combination
of inks and coatings
Guidance on Packagin Inks
Efficient barrier
An efficient barrier consists of either glass,
plain aluminium (proven sufficient thickness),
silica, or the following virgin resins: PET, PVDC and EVOH
The following examples fall in this category:
Bag in a box where the bag is made of a barrier material (with plain
aluminium)
All types of labels/sleeves on cans, glass jars or rigid containers (e.g.
minimum thickness 90 um) wher the plastic is a demonstrated barrier
material and only if applied filling and closing.
Cans printed by litho and with UV-coating on the external face, without
inner coating
Guidance on Packagin Inks
UV & EB inks and coatings
(offset and flexo printing)
Both following requirements must be fulfilled:
Inks formulation must comply with the approved list of photo-initiators
and the restrictions of acrylates (see Tables 2 and 3 in Annex)
Migration must be tested by the converter before the first application
and results must be below: - regulatory limits or - any other existing
limits or - 10 μg/kg food for non-evaluated substances. (see protocol in
Annex for details)
Guidance on Packagin Inks
Conventional inks and coatings
for offset printing
•
Many conventional offset inks are available on the market place.
Thus, to avoid using inadequate inks (newspaper inks, non-food
grade inks), only inks and coatings that are designed for food
packaging and that are recommanded by the ink makers must be
used.
Guidance on Packagin Inks
Conventional inks and coatings
for offset printing
Inks complying with the following two sets requirements will be
preferred:
Composition:
• No mineral oils are used (traditional offset printing).
• Only selected vegetable oils and fatty acid esters minimizing
migrations and off-flavors are used.
• No Cobalt-based drying systems are used.
Migration must be tested by the converter before the first application
and results must be below: - regulatory limits or - any other existing
limits or - 10 μg/kg food for non-evaluated substances. (see protocol in
Annex for details)
Guidance on Packagin Inks
Solvent-based & water-based inks
and coatings (rotogravure and flexo printing)
The inks must be formulated taking into account the following elements:
TAA (Titanium Acetyl Acetonate) must not be used as an adhesion
promoter
Phthalate plasticisers must not be used
Solvents composition must be conform to Nestlé restriction (see Table 4
in Annex)
The use of Nitrocellulose inks is allowed in cases where the packaging
is heated with food prior to consumtion only it the temperature of the
printed layer does not exceed 100°C and for an exposure below 30 min.
Guidance on Packagin Inks
References
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Commission Regulation (EC) 1935/2004
Directive 2002/72/EC and subsequent amendments
Commission Regulation (EC) 2023/2006
Resolution of Council of Europe on packaging inks AP(2005)2
EUPIA Website: www.eupia.org
Ultra –Violet Curing, GPMU Safety Reps Handbook, October 2004
Swiss ordinance 817.023.21 as applied on April 1st, 2010
Guideline
Guideline
Printing Inks applied to the non-food contact surface of
food packaging materials and articles
• Raw materials according to the selection scheme
• Manufacturing in accordance with GMP
• No direct contact ink/food
• No visible set-off
• Global and specific migration shall not exceed the limits
Guideline
Selection scheme for raw materials
• Colorants in compliance with AP(89)1
• Raw materials shall not belong to:
• classification as cmr (cancerogenic mutagenic toxic for
reproduction)
• classified to ‘toxic‘ or ‘very toxic‘
• pigments based on toxic heavy metals
• substances listed in the EU Directive 76/769/EEC
Guideline
Selection scheme for raw materials
• Limits for migration (molecular weight < 1000 D)
• < 10 ppb*) for insufficient toxicological datas
• < 50 ppb for 3 neg. mutagenicity tests
• > 50ppb
for favourable toxicol. Datas (EFSA, FDA, etc.)
*) migration limit deadlines:
50 ppb until 2010, 10ppb until 2015
What is the Point of
Good Manufacturing Practice?
It is:
"a management tool designed to prevent migration,
organoleptic changes and contamination and to ensure
compliance with the most important requirements laid
down with regard to packaging."
GMP - Ink manufacturers
Good Manufacturing Practices
for the Production of packaging Inks
for the use on the non food contact surfaces
of food packaging and articles
intended to come into contact with food
EuPIA October 2005
EuPIA - GMP in the hubergroup
• Only approved raw materials
• Contamination free production
• Production plant in Ireland for
vehicles, concentrates and
CORONA MGA® - Process inks
• Separate mixing station in Munich
• GMP - requests in the whole dispersion varnish line
• Traceability to the raw materials
• Special cleaning systems
• Control of contamination
GMP - Converters (FPE/CITPA)
4. Method „Designing the packaging material for compliance“
This means that the combination of:
• the choice of substrates
• the choice of other raw materials
• the composition of laminates
• the application of inks, adhesives, varnishes and
other coatings
• and the choice of production techniques
will be such, that protection against migration, organoleptic changes
and contamination and compliance with the essential requirements is,
as it were, „built into“ the finished product.