1. We Contribute to Safe Food Packaging – Regulatory

2. The packaging … The packaging is a complex high-tech product.
Mechanical protection
Product information
Functionality
Sustainability
Attractiveness and
… (in case of food packaging):no negative organoleptic impact on odour / taste during storage & transport!
Image source :
Purpose of this slide is to demonstrate where our products go to. Printing inks play an important role when manufacturing packaging

3. European food safety regulations
EU-Framework Regulation
(EC) No 1935/2004
GMP
(EC) No 2023/2006
Regenerated Cellulose Film
2007/42/EC
Ceramics
84/500/EEC
Plastic Materials
(EU) No 10/2011
Active and Intel-ligent Materials (EC) No 450/2009
No specific measures in EU
Glas
Wood
Cork
Rubbers
Metals
Silicones
Waxes
Textiles
Paper and Board
Adhesives
Printing Inks
Varnishes / Coatings
Ion-exchange resins
The European legislation on materials and articles in contact with food is devided in the framework regulation, a regulation for GMP (Good Manufacturing Practice) and different measures for specific groups of substances. Framework Regulation and GMP Regulation apply to all food contact materials and regulate the general requirements. Details on the individual materials or material groups are regulated in the specific measures. In the specific measures, the starting materials to be used, possible test methods and details to a declaration of conformity are regulated. Until now individual measures are existing only for a few materials (plastics, regenerated cellulose film, ceramic, Active and intelligent materials, rubber ??). For all other materials with the requirements of the framework Regulation and the GMP Regulation have to be observed

4. European food safety regulations
EU-Framework Regulation
(EC) No 1935/2004
Framework regulation for all materials in contact with food
Art. 3:
Materials shall be manufactured in compliance with GMP
No transfer of substances to the food which could
endanger human health
bring an unacceptable composition of the food
bring a deterioration in the organoleptic characteristics
GMP
(EU) No 2023/2006
Regenerated Cellulose Film
2007/42/EC
Ceramics
84/500/EEC
Plastic Materials
(EU) No 10/2011
Elastomers and Rubbers
Active and Intel-ligent Materials EC/450/2009
The Framework Regulation 1935/2004 regulates all materials that come in direct contact with food. Printing inks, for the outer packaging printing, are not covered by the regulation, since the colors are not in direct contact with food. Independent of the substrate (film, paper) all food packaging are regulated by the Regulation. According Article 3 Materials shall be manufactured in compliance with GMP so that they do not transfer their constituents to food in quantities that 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 (smell, taste, look, feel)
1st and 2nd are normally met when the existing limits (SML values) and the overall migration are observed.

5. European food safety regulations
GMP
(EC) No 2023/2006
Regulation on Good Manufacturing Practice for materials in contact with food
Effective quality management system
Material selection according to pre-established specifications
Operations according to pre-established procedures
The printed surface shall not come into direct contact with food
Migration and invisible set-off below limits
Documentation of compliance available for the authorities
Regenerated Cellulose Film
2007/42/EC
Ceramics
84/500/EEC
Plastic Materials
(EU) No 10/2011
Elastomers and Rubbers
Active and Intel-ligent Materials EC/450/2009
Article 3 of the Framework Regulation 1935/2004 prescribes that materials in contact with food shall be produced according to GMP. The basis is laid down in the Regulation 2023/2006. The key points here are:
The manufacturer must have an effective and documented quality assurance system
The selection of starting materials must comply with pre-established specifications; For the specifications customer and manufacturer are equally responsible.
The different operations shall be carried out in accordance with pre-established instructions and procedures
The printed surfaces shall not come into direct contact with food
Migration and invisible set-off shall not exceed the existing limits (SML)
The documentation shall be made available by the business operator to the competent authorities at their request

6. European food safety regulations
Regenerated Cellulose Film
2007/42/EC
Ceramics
84/500/EEC
Plastic Materials
(EU) No 10/2011
Active and Intel-ligent Materials (EC) No 450/2009
Regulation on plastic materials intended for contact with food
Only for materials made of plastic (printing inks are not in scope regarding their chemical composition)
Positive lists of evaluated substances
Rules for migration testing
Migration limits:
SML: Specific Migration Limit for single substances in mg/kg food
Overall Migration Limit: total migration limit for the ready material
Declaration of compliance mandatory
For materials and articles made of plastic a specific measure was approved by the EU (10/2011). This regulates materials
consisting exclusively of plastics, or
the plastic layer in plastic multi layers or
the plastic layer in multi-material-layer (for example, plastic paper composite)
Only for plastic materials - Printing inks are not in the scope
Only substances of the positive list may be intentionally used for the manufacture of plastics or the plastic layer. The positive list is part of the Regulation. Part of the Regulation are also rules for carrying out migration tests. For the substances of the positive list specific migration limits are specified (SML). The SML values ​​are the maximum amounts which are allowed to migrate per kg food. For all plastic materials and articles a declaration of conformity must be issued by the manufacturer of the materials. The details are regulated in the regulation. So far there is no specific regulation for printing inks in the EU. Therefore the evaluation of the plastic positive list will be used for evaluating substances for printing inks for food packaging. Since printing inks and plastics are chemically different, it is not possible to formulate inks exclusively with substances of the positive list. Therefore it is not possible to confirm compliance of printing inks with the plastic regulation

7. Swiss legislation
Section 8b “packaging inks” of Swiss Ordinance
Printing inks shall only be formulated with substances listed in annex 1 or annex 6.
The existing limits shall not be exceeded.
Migration of substances listed in annex 6b shall not exceed 0.01mg/kg.
Inks must be manufactured and applied according to GMP.
On , amendments to the Swiss Ordinance with regulations on printing inks came into force. The regulations apply to the printing on the non food contact side (outer side) of food packaging. Materials for that a transfer of substances to the food can be excluded (for example, labels for glass bottles) are not subject to regulation. The Swiss ordinance contains with Annex 1 a list of substances for plastics (analogous EU Regulation 10/2011) and Annex 6 an ink specific substance list. Printing inks for food packaging may only be made from the materials listed in Annex 1 or Annex 6 Annex 6 consists of 2 parts: 6a: evaluated substances – the existing limits shall not be exceeded 6b: non-evaluated substances - this can be used when migration can not be detected. The detection limit is defined as 0.01 mg / kg food. Inks shall be produced and processed according to GMP

8. Draft of German legislation
New chapter for printing inks in the German Consumer Goods Ordinance.
Printing ink manufacturers are cooperating actively.
Printing ink manufacturers prefer and support a European regulation.
 Still under discussion – not finalised!
For some years, a draft for a national German regulation is discussed. To the existing Bedarfsgegenständeverordnung a new chapter regarding printing inks should be added Printing ink manufacturer are cooperating actively.
We are prefering and supporting an European regulation Regulation is still in draft form and has not yet been adopted. A specific timetable is not known. Accordingly, compliance with the Regulation cannot be confirmed.
Not for the regular presentation:
The draft provides rules for both the outside printing as well as for direct contact with food (intended or forseable food contact). The regulation shall include a positive list of evaluated substances including the relevant limits. The positive list is currently still ongoing. For printing on the non food contact side of food packaging, raw materials that are not listed in the positive list can be used in printing inks if they do not migrate. The regulation also requires that a written statement of compliance with the regulation needs to be created at each stage of production. This relates from the raw material manufacturer, the printing ink manufacturer, the manufacturer of the food contact material to the packager of the foodstuff.

9. In addition to statutory provisions…
National recommendations, resolutions and other texts may be relevant.
Many customers have their own (individual) requirements.
Some brand owners go far beyond the law with their own guidelines and questionnaires.
I addition to the Food Contact Materials law, there are a number of other requirements that may need to be fulfilled, depending on the individual requirements of the printer, brand owner or retailer…

10. Ways of mass transfer/migration
Migration by Set-Off:
Mass transfer within the packaging (migration) and into the packaging (diffusion):
stack or reel
Image source:
hubergroup Deutschland GmbH
Set off migration is possible, if the printed surface gets into contact with the unprinted surface (backside) during the storage in a stack or a reel
A contamonation of the packed foodstuff is possible by:
a. diffusion of a contaminant from the environment (outside) through the packaging into the foodstuff
b. Migration from a layer of the packaging into the foodstuff

11. Set off during production, storage and filling
Packaging
coating/ink
migrant
substrate
- Visualisation of set off migration into foodstuff caused by the contact of a printed to a unprinted surface of a packaging material

12. Set off during production, storage and filling
Packaging

13. Set off during production, storage and filling
Packaging

14. Set off during production, storage and filling
Packaging
Foodstuff

15. Migration – mass transfer inside the packaging
Foodstuff
Packaging
Visualisation of a migration of components from the packaging material into foodstuff
Worst-Case-Szenario: all migratable substances change over into the foodstuff

16. Migration – mass transfer inside the packaging
Foodstuff

17. Diffusion – mass transfer into the packaging
Foodstuff
Packaging
Environment
Visualisation of a mass transfere from the environment into the foodstuff caused by a two step process
Diffusion of a contaminat from the environment into the packaging
migration of components from the packaging material into foodstuff
Worst-Case-Szenario: all migratable substances change over into the foodstuff

18. Diffusion – mass transfer into the packaging
Foodstuff
Packaging
Environment

19. Diffusion – mass transfer into the packaging
Foodstuff
Environment

20. Avoidance of mass transfer - absolute barrier
Packaging
Foodstuff
Barrier (absolute)
Migration can be avoided by using a absolute barrier (e.g. aluminium foil > 12 µm) as a component (layer) of the packaging
the used absolute barrier is impenetrable for all kinds of migrants

21. Avoidance of mass transfer - absolute barrier
Packaging
Foodstuff
Barrier (absolute)

22. Avoidance of mass transfer - absolute barrier
Barrier (absolute)
Packaging
Foodstuff

23. Reduction of mass transfer - functional barrier
Packaging
Foodstuff
Barrier (functional)
Migration can specifically be reduced if a functional barrier is in place
the used barrier is semipermeable or semiunpermeable only for a part of the potential migrants. So only the migrants that are able to pass the barrier will reach into the packed food

24. Reduction of mass transfer - functional barrier
Packaging
Foodstuff
Barrier (functional)

25. Reduction of mass transfer - functional barrier
Packaging
Foodstuff
Barrier (functional)

26. EuPIA and food packaging safety
EuPIA has published many papers to support their members and the industry:
Guidance documents / Customer information notes
Statement of Composition
Suitability list for photo-initiators
Exclusion policy
GMP – Good manufacturing practise

27. EuPIA Exclusion Policy
Since 1996 the printing ink industry in Europe has been committed to comply with a voluntary common list for the exclusion of certain raw materials.
This list is progressively updated.
The EuPIA Exclusion Policy is supplementary to relevant legislation.
Excluded substances to be found in Group A and Group B.

28. EuPIA GMP – Good Manufacturing Practise
demanded in (EC) No 2023 / 2006
assists in controlling food safety hazards in the design / manufacture of inks, varnishes and coatings
includes requirements on product composition, quality and hygiene management
supporting manufacturers of FCM’s in supplying compliant products (EC) No 1935/2004 and (EC) No 2023/2006.
EuPIA members are expected to adopt this GMP
Any organisation designing / manufacturing FCM Printing Inks shall have a documented quality management system in place

29. Communication along the Supply Chain
Details of Intended Application
Substrate
Adhesive
Printing
Ink
Manufacturer
Printer,
Converter
Packer
Food
Manufacturer
Raw
Materials
Processing Instructions, Constituents, Restrictions
Effective Communication along Food Packaging Chain
Fundamental basis for safe food packaging and
Recommendation of suitable printing inks
From top to bottom
Details about the intended application
From bottom to top
All information to enable food packer to confirm conformity

30. Communication along the Supply Chain
TI, SDS,
Statement of Composition
with List of
Potential Migrants
TI, SDS,
Regulatory
Information Sheet
Declaration of
Conformity
Evaluation of
Potential Migration
Printing
Ink
Manufacturer
Printer,
Converter
Packer
Food
Manufacturer
Raw
Materials
Processing Instructions, Constituents, Restrictions
Supply chain: from left to right
Raw Material Supplier
The only legal obligation for raw material suppliers is to provide information regarding REACH and CLP regulation. This covers only details about substances classified as hazardous, which are present above 0,1%. For raw materials of food packaging inks, this is not sufficient.
Regulatory Information Sheet, including information on listing in food contact regulations
Ink Manufacturer:
General information about processing (Technical Information Sheet)
Safety data sheet
Statement of Composition: potential migrants, WCC
Formulations conform with Swiss Ordinance
Formulations to enable producing of printed packaging materials conform with 1935/2004
Printer / Converter:
Declaration of Conformity for printed packaging materials: All information provided by sub-suppliers is needed
Evaluation of conformity: WCC and/or migration testing using simulants or migration testing with food

31. What we do for our customers
EuPIA template on Statement of Composition (SoC)
Name and number of printing ink
Confirmation that Framework Regulation can be fulfilled
EuPIA GMP
fulfilled
EuPIA requirements fulfilled
Members of the European Printing Ink Association (EuPIA) have decided to provide relevant information on migrants in a standard format: the „Statement of Composition“. This SoC is not to be confused with a Declaration of Compliance (DoC) which is required by the Plastics Regulation for the final FCM article.
It provides information on the applicable regulatory background and on the EuPIA committments…

32. What we do for our customers
Statement of Composition
Dual Use Information
Substance information
Amount in dry ink
Restrictions
… as well as detailed information on migratable substances in the ink.
In a table we provide information on all relevant substances with the potential to migrate from the ink into the packed food.
You will find the CAS number, the PM Ref number and the name of the substance in the left columns, and applicable migration limits in the middle columns.
With the information on the amount of a specific substance in the dried ink film, a converter is enabled to fulfill his own compliance assessment for his specific application. This can be done, for example, with a worst case calculation or with migration tests.

33. Products … and processes
Use of FCM inks and coatings alone does not mean low migration printing.
Products and Processes are equally important.
People tend to replace products only rather than focussing on the entire process.
Image source: Sun Chemical
At 1,2,3,7,8,9 we find the products, at 4,5,6,10,11,12 the processes. It is much easier to change products than processes.
Also films and foils

34. Please take this with you …
It is technically possible and economically attractive to design/manufacture/sell printed sensitive packaging with certainty.
The suppliers of the packaging industry developed fit-for-purpose components and offer these in industrial volumes.
It is only a matter to combine the existing elements, which are products and processes.
Manufacturing safe food packaging is no rocket science. It is realised every day.