printing inks current legal requirements
TRANSCRIPT
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
Dr. Andreas Grabitz
VIGC seminar
Brussels
November 18th 2015
Printing inksCurrent legal requirements
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
Agenda
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Printing ink legislation• Overview of European legislation• Draft of German printing ink ordinance
• Current status• Scope• Restrictions• Impact for EB prints• Time line
Introduction• Eurofins
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
Eurofins worldwide: An International Network of State-of-the-Art Laboratories
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Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
About Us
Key facts• Founded 1987 in Nantes (FR)• IPO 1997 in Paris (FR)• Network of +200 labs in 40 countries• +20‘000 employees
Food Environmental Pharmaceutical Product Testing
Analyses & Consultancy
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
European Legislation - Overview
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GMP-Regulation(EC) No. 2023/2006
Framework-Regulation(EC) No. 1935/2004
PaperMetalsAdhesives LacquersSilicones Printing Inks
Plastics
(EU) No. 10/2011
Ceramics
84/500/EEC2005/31/EG
(Limit forrelease of lead
(Pb) andcadmium (Cd) from ceramics)
Elastomeres
93/11/EEC
(Limit fornitrosamines)
Coatings
(EC) No. 1895/2005
(Limit forcrosslinker
BADGE and itsdegradation
products;Ban on
NOGE und BFDGE)
Cellulose
2007/42/EC
Cap-Sealing
(EC) No. 372/2007 597/2008
(BothRegulatinons
were valid onlyfor
1 year andexpired 2009Today in the
scope of Reg. No. 10/2011)
Aktv. & Intlg.Materials
(EC) No. 450/2009
Recycled Plastics
(EC) No. 282/2008
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Framework Regulation (EC) No. 1935/2004
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Article3
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
b) bring about an unacceptable change in the composition of the food
c) bring about a deterioration in the organoleptic characteristics thereof.
Article 1
Purpose and subject matter
(2) This Regulation shall apply to materials and articles, including active and intelligent food contact materials and articles, (hereinafter referred to as materials and articles) which in their finished state:
a) are intended to be brought into contact with food
b) are already in contact with food and were intended for that purpose;
c) can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use.
L 338/4 EN Official Journal of the European Union 13.11.2004
REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 27. October 2004
on materials and articles intended to come into contact with food and repealing Directives 80/590/EECand 89/109/EEC
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
German Printing Ink Ordinance (PIO)
Status• 1st Draft in 2010• 5th Draft published in July 2014• 6th Draft and notification TRIS notification announced for 2015
• National measure according to Article 6 of the Framework Regulation (EC) No. 1935/2004
• Impact on European printing ink industry can be expected to be very high (see Swiss ordinance from 2010).
• As main parts of the German PIO will identical to the Swiss PIO industry and authorities arealready well prepared.
Article 6
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.
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
German Printing Ink Ordinance
Scope
Misuse which can be reasonably be expected under normal and foreseeable use
A misuse which can‘tbe reasonably expected
• Inks and lacquers for direct and reverse print („indirect food contact“)
• Printing inks and lacquers for direct food contact
• Printing inks and lacquers which are not intended but under normal foreseeable usage come into contact with food (gliding reference toArticle 1 (2) of Regulation (EC) No. 1935/2004) Direct food contact print
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
Structure
• Nanoparticles are generally forbidden if they are not listed specifically as nanoparticles in Annex 14. This is currently the case for the listed pigments if they do not migrate.
• For primary aromatic amines listed in Annex 1 Nr. 7 maximum migration shall < 0.002 µg/kg food List is not in line with carcinogenicity
criteria category 1A and 1B in REACH
• These substances are listed in 5 categories (monomers, dyes and pigments, solvents, additives and photoinitiators
• Limits and substance evaluation are mainly in line with Swiss ordinance
CAS number Substance name95-80-7 2,4-Diaminotoluene
99-55-8 2-Amino-4-nitrotoluene
101-14-4 4,4'-Methylene-bis-(2-chloraniline)
106-47-8 4-Chloraniline
137-17-7 2,4,5-Trimethylaniline
139-65-1 4,4'-Thioaniline
615-05-4 2,4-Diaminoanisole
Carcinogenic PAAs Cat. 2 listed in Annex 1 No. 7
• Declaration of compliance mandatory for Printed articles Printing inks Raw materials for printing inks
• Only substances listed in Annex 14 might be used to manufacture printing inks (positive list!)
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
Restrictions
Substancespermitted for
Annex 14 table 1 Annex I of Reg. 10/2011
Non-evaluatednon CMR substances
Annex 14 table 2. Transitional list ofpigments
Indirect foodcontact
Yes Yes, by glidingreference
Yes, if nomigration isdetectable
„intended“ directfood contact
Yes Yes, by glidingreference
No No
Non-intended but foreseeable directfood contact
Yes Yes, by glidingreference
No 4 years after entryinto force
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
Acrylate monomers
CAS number Name Abbreviation Status in current draft
of German PIOStatus in Swiss PIO
57472-68-1 Dipropylene Glycol Diacrylate DPGDA not listed List 3 B
94108-97-1 Ditrimethylolpropanetetraacrylate DiTMPTetraA not listed List 3 B
28961-43-5 Trimethylolpropane ethoxylatetriacrylate eoTMPTA 0,05 List 3 B
109-17-1 Tetraethylene glycol dimethacrylate TEGDMA not listed List 3 B
1680-21-3 Triethylene glycol diacrylate TEGDA not listed List 3 B
42978-66-5 Tripropylene Glycol Diacrylate TPGDA not listed List 3 B
15625-89-5 Trimethylolpropane Triacrylate TMPTriA not listed 0,05
13048-33-4 Hexamethylene diacrylate HDDA not listed List 3 B
4986-89-4 Pentaerythritol Tetraacrylate PETetraA not listed List 3 B
3524-68-3 Pentaerythritol triacrylate PETIA not listed List 3 B
55818-57-0 Bisphenol A diglycidyl diacrylate BPA-EA 0,05 List 3 B
57472-68-1 Dipropylene Glycol Diacrylate DPGDA not listed List 3 B
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
Time line
End of 2015 (?) Final draft and TRIS notificationQ4 2016 3 to 6 month stand still period for comments from MS
Notification to WHO with 60 days holding periodEnd 2016 pass German BundesratBeginning of 2017 Come into forceBeginning of 2019 2 years transition2021 End of transition period for foreseeable food contact
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz
Contact Person / Packaging Materials
Please feel free to contact us and we‘ll gladly help…
Eurofins Product TestingSmedeskovvej 388464 GaltenDenmarkPhone: +45 70 22 42 76Mobil: +32 473 310 004E: [email protected]
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Sales Representative Eurofins Product TestingThe Netherlands / Belgium
Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz 14
Thanks for your attention!