Printing inks and Compliance assessment - Waters Corporation · 2019-10-04 · Printing Inks....

Titel: Legal Requirements on Printinig Inks | Version: 26/09/2019 | Author: Dr. Andreas Grabitz

Printing inks and Compliance assessment


Agenda

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Legal requirements on printing inks in FCM• Overview on European FCM legislation• The German printing ink ordinance• The (new) Swiss printing ink ordinance• Overview EuPIA activities• Possibilities for own compliance assessment of printing inks.

Introduction• Eurofins


Eurofins Group

Key facts• Founded in 1987 in Nantes (FR)• Stock market launch 1997 in Paris

(FR)• Network of more than 800

laboratories in 47 countries• +45.000 employees


Eurofins global network

4


Eurofins Divisions

Food Environment Pharma Consumer products

Analytics & consultancy

5


Material specific requirements

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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/EC

(Limit for therelease of lead

(Pb) andcadmium (Cd)

Elastomeres

93/11/EEC

(Limit forrelease of

Nitrosamines)

Coatings

(EC) No. 1895/2005

(Limit forrelease of cross

linking agentrBADGE andbreak down products;

Ban of NOGE and BFDGE)

Cellulose

2007/42/EC

Sealings

(EC) No. 372/2007 597/2008

(Bothregulations

were in forceonly for one

year. Phasedout in 2009.

Today in scopeof (EU)

10/2011)

Aktv. & Intlg.Materials

(EC) No. 450/2009

Recycled plastics

(EC) No. 282/2008

Titel: Legal Requirements on Printinig Inks | Version: 26/09/2019 | Author: Dr. Andreas Grabitz 7

Framework Regulation (EC) No. 1935/2004

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Article3General 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 1Purpose 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 thatpurpose;

c) can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normalor 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


The German printing ink ordinance


The (new) Swiss printing ink ordinance

https://www.blv.admin.ch/blv/de/home.html


The (new) Swiss printing ink ordinance

Usage as:I Monomers (M)II Colorants and Pigments (C)III Solvents including energy curing monomersIV AdditivesV Photoinitiators


EuPIA GMP

http://www.eupia.org/index.php?id=29

http://www.eupia.org/index.php?id=29


EuPIA GMP

Foreword 1 Scope 2 Normative References 3 Terms and Definitions 4 General requirements

4.1 Quality Management 4.2 Outsourcing 4.3 Establishment 4.4 Equipment 4.5 Risk Assessment and Management

4.5.1 Chemical contamination 4.5.2 Microbiological contamination 4.5.3 Physical contamination 4.5.4 Risk assessment method

4.6 Hygiene Management 4.7 Identification and Traceability 4.8 Recall of defective FCM Printing Inks 4.9 Change Management 4.10 Packaging 4.11 Storage

5 Management Responsibility 5.1 Commitment 5.2 Responsibility and authority


EuPIA GMP

6 Resource Management 6.1 Human resources

7 Product Realisation7.1 Planning 7.2 Customer related processes 7.3 Design and development 7.4 Purchasing (technical) 7.5 Production provisions 7.6 Quality Control 7.7 Retained samples 7.8 Control of monitoring and measurement equipment

8 Measurement, analysis, and improvement

Appendix A. Glossary B. FMEA (Failure Modes and Effects Analysis)C. Worked example of cleaning agent worst case calculation D. Migration and Worst Case Calculation E. Change Management F. Product Selector G. Worked Examples for Raw Materials Selection


EuPIA GMP


EuPIA Exclusion list


Compliance work for FCM printing inks


Compliance work for printing inks

Statements of Composition



Statements of Composition

CAS-Nr. FCM Nr.PM-Ref.

Nr. Substance Restriction% in dry weight

Limit (calculated)

Riskassessment comment

64-17-5 113 16780 Ethanol OML=60 0,000 Under Converter Control

141-78-6 327 30140 Ethylacetat OML=60 0,000 Under Converter Control

5567-15-7 C.I. Pigment Yellow 83 11,106 0

Potential PAA:6358-64-1: 2,5-Dimethoxy-4-cloroanilin95-79-4 5-Chloro-2-methylanilin

77-90-7 138 93760 Acetyltributyl-citrat OML=60 4,787 20,891 WCC

109037-78-7 Titanium-chelat 4,667 0,04 Will break down into

approved food additives



COO- SO3- OH

N

N

Na+

Na+

SO3-

N H2

Na+

COO- OH

NH2

Na+

N

Cl

Cl

N

O

O

N

N

Pigment Red 57:1 (CAS 5281-04-9)

Pigment Violett 23 (CAS 6358-30-1)

Primary aromatic amines from pigments



Primary aromatic amines from pigments

Requirement from the plastic regulation (EU) Nr. 10/2011

Requirement in BfR recommendation IX (for pigments in masterbatches!):

When applied as specified primary aromatic amines may not be released from finsihed food contactmaterial in detectable amount. The detection limit is 0.01 mg/kg and applies to the sum of released primaryaromatic amines. Additionally primary aromatic amines classified as carcinogens classified ascarcinogensin classes IA and IB of CLP Regulation (EC) No. 1272/2008 may not be released reffered tothe single substance with a detection limit of 0.002 mg/kg food or food simulant. Azodyes that may break down into primary aromatic amines classified as carcinogens in classes IA and IB of the CLP regulation(EC) No 1272/2008 must not be used.

Requirement in the Swiss printing ink ordinance

Plastic materials and articles shall not release primary aromatic amines, excluding those appearing in Table 1 of Annex I, in a detectable quantity into food or food simulant. The detection limit is 0,01 mg of substance per kg of food or food simulant. The detection limit applies to the sum of primary aromatic amines released.

Printed food contact materials and articles must not release primary aromatic amines to food or food simulants in any detectable amounts. […] The detection limit of the method is 0.01 mg/kg food or food simulant. This detection limit applies to the sum of all migrating primary aromatic amines.


Set-off


Set-Off


Summary

Legal framework• German printing ink ordinance provisionally suspended• Swiss ordinance completely revised (but no relevant changes for inks)• Extensive work from EuPIA

Possibilities for own compliance work• Food contact relevant information from ink supplier

• EuPIA GMP must be considered• EuPIA Exclusion List must be considered• Idealy supplier provides statement of composition with comments• Important to consider PAA / azo dyes

• worst case calculations are possible also for users of inks• Consider set-off problem


Contact / Packaging Materials

Renate Eschen Ludmila Schneider Maciej Dalmann Dr. Anil Berger (Assistant, -6840) (Customer Service, -6844) (Sales, -6848) (BU-Manager, -6841)

Katja Grell Janina Welz Dr. Andreas Grabitz (Customer Service, -6842) (Customer Service, -6843) (Consultant, -6849)

Eurofins Consumer Product Testing GmbH Am Neuländer Gewerberpark 421079 HamburgGermanyT: +49 40 49294-6940 | F: +49 40 49294-6800E: [email protected] oder [email protected]

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Anna ScheferCustomer Service, 6844

Anke FuchsCustomer Service, 6843


Thanks for your attention!

Printing inks and Compliance assessment - Waters Corporation · 2019-10-04 · Printing Inks....

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Transcript of Printing inks and Compliance assessment - Waters Corporation · 2019-10-04 · Printing Inks....