Dr.Jörg-Peter Langhammer Vice-President Global HSE+Sustainability. Siegwerk Druckfarben AG & Co KGaA

Transcription

1 Dr.Jörg-Peter Langhammer Vice-President Global HSE+Sustainability Siegwerk Druckfarben AG & Co KGaA

2 LegislationandHealthandSafetyIssues

3 Introduction to Siegwerk Experience 180-year history in tailored ink technology and service Revenues Net sales of one billion Euro Solutions Focus on ink solutions for packaging Production Global output of more than 255 kt printing inks per year Organization 5,200 'Siegwerkers' in more than 35 countries Customers Serving customers in more than 100 countries worldwide

4 Table of contents 1. Chemical Legislation - REACH - GHS / CLP - Consequences for the workplace 2. Food Contact Materials Legislation - Legal requirements EU - Brand Owner requirements - Migration - Compliance management and support

5 Table of contents 1. Chemical Legislation - REACH - GHS / CLP - Consequences for the workplace 2. Food Contact Materials Legislation - Legal requirements EU - Brand Owner requirements - Migration - Compliance management and support

6 REACH Registration,Evaluation, Authorisation and Restriction of CHemicals Regulation (EC) No. 1907/2006 REACH is said to be the most complex legislation ever adopted by the EU 141 articles and 17 annexes on > 800 pages Legally binding in the EU, Norway, Liechtenstein and Iceland

7 REACH Key Elements of REACH Registration All Substances manufactured and imported into EEA > 1t/y Information for safe use is communicated in the supply chain Evaluation Examination of registrant testing proposals (animal tests?) Check of registration dossiers Evaluation of substances (CoRAP) Regulatory Risk Management Authorisation (SVHC!) Restriction (Annex XVII) Harmonised classification (CLP Annex VI)

8 REACH Registration of every chemical substance >1 t/y Registration by every individual manufacturer, importer or Only Representative Regardless if the substance is new or well-known European Chemical Agency ECHA One substance, one registration" registered No data, no market

9 REACH Tips for Downstream Users Review your chemical inventory Identify substances that are not yet registered by your suppliers (e.g. SDS section 3) Check supply continuity with your supplier Consult the REACH registration database and check if another supplier has registered the substance already echa.europa.eu/reach-2018

10 REACH Upcoming critical deadline for all substances > 1 t/y ( ) Downstream users don t need to register Costs very much depend on type of substance, # of co-registrants, tonnnage band More data often leads to worse classifications (especially in UV sector!) Polymers are exempted from registration, monomers only Registration statistics as of 28/08/ registrations for unique substances 26% Germany, 12% UK, 9% Netherlands, 8% France Bestseller: EtOH (488x), Ca(OH) 2 (467x), Ethylene oxide (426x)

11 GHS / CLP-key elements Classify Manufacturers, importers and downstream users classify substances and mixtures Label and package Suppliers label and package them in accordance with CLP Communicate Manufacturers, importers and downstream users notify substance to ECHA s classification and labelling inventory Safety Data Sheets (REACH Annex II) Harmonise CLP implements UN GHS in Europe The classification of certain substances is harmonised

12 GHS: Globally Harmonized System Classification of hazards in: - 3 Groups: physical hazards, health hazards and environmental hazards - 29 Hazard classes: type of danger - Hazard category: severity of hazard New Pictograms (GHS01 - GHS09) Signal words ( Warning and Danger ) Hazard statements Precautionary statements

13 GHS: Globally Harmonized System Check consistency with SDS Check language Evaluate H+P statements Store the product correctly

14 GHS: Globally Harmonized System Harmonization in progress Still lots of differences (building block approach!)

15 Safety Data Sheets (SDS) Global Standard: UN GHS; EU: Annex II of REACH Regulation 16 sections Since : CLP / GHS classification required in SDS Local language is a must! To be provided on paper or electronically Check your SDS for compliance (use e.g. ECHA/CEFIC checklists)! When to expect a safety data sheet (SDS) Substance or mixture is classified as hazardous Substance is PBT/vPvB Substance is on Candidate List (SVHC) Non-classified mixture contains certain substances above specified limits (to be provided on request)

16 Safety Data Sheets (SDS) Special attention to: Section 2: Product classification and labelling consistent with labels? sensitizing (H317 / 334)? Section 3: Hazardous ingredients in line with section 2? check substance classification Section 8: Exposure controls and PPE carefully check glove section

17 Table of contents 1. Chemical Legislation - REACH - GHS / CLP - Consequences for the workplace 2. Food Contact Materials Legislation - Legal requirements EU - Brand Owner requirements - Migration - Compliance management and support

18 FCM Regulations: European food safety regulations overview EU-Framework Regulation (EC) No 1935/2004 Basic principles (Article 3): 1. No risky migration 2. No change in food composition 3. No deterioration of food GMP (EC) No 2023/2006 Regenerated Cellulose Film 2007/42/EC Ceramics 84/500/EEC Plastic Regulation (EU) No 10/2011 Elastomers and Rubbers Active and Intelligent Materials EC/450/2009 Positive lists Migration limits: a) SML-Value (Specific Migration Limit) in ppm (mg/kg) = based on 1 kg Foodstuff/simulant b) Overall Migration limit of 10 mg/dm² resp. 60 mg/kg foodstuff/simulant (60 ppm) c) Calculation basis: 1 kg/6 dm² resp. as is Food:Surface ratio Union Guidelines on Reg. (EU) No 10/2011 on plastic materials and articles intended to come into contact with food Union Guidance on Reg. (EU) No 10/2011 as regards information in the supply chain

19 FCM Regulations on global scale... Packaging-related regulation examples Principles of GRAS and ToR FDA CFR 175.xxx family (USA) Framework regulation 1935/2004 Plastics Regulation No 10/2011 (European Union) Ordinance on Packaging Inks (CH) Food Safety and Standards (India) The Pure Food Ordinance (Bangladesh) GB GB (China) Food Sanitation Law (Japan) Food Act of 1996 (Taiwan) MERCOSUR GMC 3/92 MERCOSUR GMC 56/92 (South America) No. 111 (B.E.2531) (Thailand) Food Sanitation Law (Indonesia)

20 Don t forget: Brand owner requirements - going beyond regulations Printing for large brands Own guideline for packaging inks or packaging materials Often publically available and used as reference by other brand owners adds further complexity Own exclusion lists for certain substances (incl. SVHC), pigments and solvents Application of EuPIA Exclusion Policy Definition of regional regulation to follow globally: Swiss Ordinance Own positive list for photo initiators All large brand owners (e.g. Perfetti, Nestlé, P&G, Unilever) set their own standards

21 Migration case examples Case A 2006 starting in Italy, spreading over Europe Photo initiator ITX found in baby milk Presumably set-off from inks caused contamination of juice, baby milk, etc. in packaging process Millions of liters of juice and baby milk recalled by Nestle today ITX banned by many authorities & brand owners Case B 2009 in Europe Benzophenone from sleeves found in cream Chemical migrated from printed sleeve via thin plastic bottle (HDPE) into food stuff Product was recalled due to many consumer complaints on odor and taste

22 Migration: high risk of substance transfer Set-off scheme Diffusion scheme Set-off principle Transfer from ink to reverse side of substrate (reels, stacks, piles, etc.) Reverse side later in direct food contact Diffusion principle Diffusion across packaging materials into food (or via gas transfer) Even rigid materials (e.g. PE bottle) are not always a sufficient barrier

23 The LM matrix (MxPy) Significant discrepancy between composition of LM systems available on the market. The MxPy Matrix : tool developed by Siegwerk technology team to characterise semi-quantitatively the formulation profile of UV inks or varnishes dedicated for food packaging applications. Molecular Weight Cost Migration Standard Low Odour Low migration Monomer M 1 M2 M3 / Photo-initiator P1 P2 P3 P4 : Polymeric PI

24 Migration Testing Exposure Simulation with a liquid simulant Immersion 1-side exposure in stainless steel cells Various packaging directly filled with simulant Direct injection of simulant LC/MS State-of-the-art quantification (specific identification, sensitivity) Official or in-house methods Sleeves on PEHD bottle PES cups In Mould Labels

25 EuPIA Guidance on migration issued July 2017 Framework Regulation (EU) 1935/2004 requires testing under real conditions Only reference for migration testing methodology of FCM isplastic regulation (EU) 10/2011 For printed FCM orfor non-plastic FCM however this may lead to erroneous results Examples: certain polyolefines at 60 C, false positive results of due to e.g. PI degradation by simulants Consequences: unnecessary time-to-market delays caused by misconception amongst stakeholders Alternatives need to be considered! seeeupia Guidance on migration (based on expertise combining analytical Know-How with ink formulation Know-How)

26 Product safety guidance: Statement of Composition (optional) SW information on Migrants Customer advantage Statement of Composition (SoC) Enables converter to make safe use of Siegwerk inks in own products pursue a worst case calculation to evaluate potential migration risks issue own declaration of conformity for printed package to brand owner Transparency allows individual risk evaluation per application or job

27 Thank you! Contact person: Dr. Jörg-Peter Langhammer Vice President Global HSE + Sustainability Joerg-peter.langhammer@siegwerk.com Phone: