Printing inks Current legal requirements

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


Agenda

2

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


Eurofins worldwide: An International Network of State-of-the-Art Laboratories

3


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


European Legislation - Overview

5

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

Title: Legal requirements on printing inks | Version: 13/10/2015 | Author: Dr. Andreas Grabitz 6

Framework Regulation (EC) No. 1935/2004

6

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


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.


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


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!)


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


No No

Non-intended but foreseeable directfood contact


No 4 years after entryinto force


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


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


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]

13

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!

Documents

Printing inks Current legal requirements