Impact of Legislation on Printed Electronics for Packaging

Impact of Legislation on Printed Electronics for Packaging The Current & Future Impact of Legislation on Printed Electronics for Packaging Dr Sean Smyth & John Nelson 06 October 2015

Impact of Legislation on Printed Electronics for Packaging Agenda • Objectives • Key Findings – Current Legislative Landscape – Issues related to production, substance restriction & supply chain – Legislative position of key end-use applications – Impact of end-of-life / recycling issues • Conclusions and Recommendations –– Forecast of evolution in relevant regulations to 2020

Impact of Legislation on Printed Electronics for Packaging Objectives • Current legislative landscape for printed electronics for packaging • Production, substance restriction and the supply chains • Key end-use applications for printed electronics packaging (food, beverage, FMCG, pharma, toys & related products) • Impacts of end-of-life/recycling – EU WEEE legislation. • The evolution in regulations to 2020

Impact of Legislation on Printed Electronics for Packaging • Brand (and retailer) requirements changing • Packaging has to do more – Appeal and promotion – Engagement – Smart capabilities

Impact of Legislation on Printed Electronics for Packaging Relevant Legislation in Europe • Directive 94/62/EC (Packaging and packaging waste). Packaging must be: – Constructed to deliver requisite hygiene, safety, acceptance to adequately protect the product – Designed to minimise its impact on the environment – Not contain any of heavy metals above set thresholds, 100 ppm for: Cd, Cr 6+ (VI), Pb, Hg – Release minimum levels of noxious and other hazardous substances when burnt or sent to landfill • Responsibility lies with the entity that places a package on the market • Applicable to individual packs and components “that can be separated by hand or by using simple physical means”

Impact of Legislation on Printed Electronics for Packaging Food Packaging Regulations • Regulation 1935/2004 on Food Contact Materials (FCMs) – The Framework regulation for a stricter regime • An FCM must not: – Endanger human health – Bring about an unacceptable change in the composition of the food – Have a negative effect on the organoleptic qualities [taste, smell, texture] of the food • Delegated acts – The Plastics Regulation 10/2011, requires: – Specific migration levels for seven metals – including copper, lithium, manganese and zinc – A ‘positive list’ of over 900 plastics monomers and additives – Adherence by testing, submitting a Declaration of Conformity (Do. C) through the supply chain.

Impact of Legislation on Printed Electronics for Packaging Printing inks and coatings • No EU law, several de facto standards for food packaging: – Swiss Ordinance on Packaging Inks of 2005 – 2012 Recommendation from the European Printing Inks Association (EUPIA) – Council of Europe recommendation – Nestlé Guidance Note on Printing Inks • Common requirements are disseminated down supply chains: – Migration limits set at 10 ppb for low MW components – Lists of approved and banned substances • Danger of set-off migration – covered by GMP Regulation 2023/2006 • German Ordinance in preparation, unlikely EU law by 2018, (even if preferable)

Impact of Legislation on Printed Electronics for Packaging Nanomaterials • No EU definition of nanomaterials • Popular concern is pushing legislators towards restrictions – nanoparticle inks are commonly used in printed electronics – this is a concern • They already require explicit qualification under EU laws: – Plastics in contact with food, Regulation 10/2011, – Active and intelligent packaging, Regulation 450/2009. • Action could come through Ro. HS Directive (unlikely), REACH Regulation (more likely). Currently considering synthetic amorphous silica, but legality of this assessment is under challenge

Impact of Legislation on Printed Electronics for Packaging Active and Intelligent packaging • Regulation 450/2009 – Active and Intelligent Materials/Articles intended to contact food • Printed electronics potentially may be intelligent articles as a system that “monitors the condition of packaged food or the environment surrounding the food” • Materials in an active or intelligent material or article must not migrate into food • A presumption of conformity is given if a functional barrier separates the intelligent article from the food • The functional barrier defence is not valid if the intelligent article contains – Substances classified as carcinogenic, mutagenic or toxic to human reproductivity (CMR) – Nanoparticles Qualification must instead be done by the European Food Safety Authority (EFSA)

Impact of Legislation on Printed Electronics for Packaging Medical Devices, Pharma and Biopharma • High-value products, a good initial market for smart packaging systems • EU laws prescribe certain data that must be supplied with these – a printed electronic system may supplement, but not supplant these • The EU Falsified Medicines Directive will create new requirements for compulsory: – Tamper-evidence markings – Full supply chain track-and-trace systems Achieved with existing technology, scope for printed electronic solution • As with food and beverage packages, migration of substances is an issue

Impact of Legislation on Printed Electronics for Packaging CE (Conformité Européene) Mark Directives • Electrical and Electronic Equipment (EEE) are regulated by CE Mark Directives • Affixing a CE Mark signals compliance with all relevant EU directives. • The mark indicates that the item meets the essential requirements of these directives – This is recorded on a Declaration of Compliance (Do. C), – The most common mechanism for doing this is testing to harmonised standard(s). • CE marking is done by the legal entity that ‘places an item on the market’

Impact of Legislation on Printed Electronics for Packaging CE Mark Directives (cont. ) For the SCOPE project the CE mark directives to consider are: • The Low Voltage Directive 2006/95/EC. Does not apply, printed electronic systems fall below the minimum voltage limit of 50 V • The EMC Directive 2004/108/EC – covering electromagnetic compatibility of EEE. For smart packaging the currents involved and benign EM environment involved will not present a problem • R&TTE Directive 1999/5/EC – This covers devices using radio frequencies, including RFID tags. – There is no minimum voltage limit – Devices must respect the EU harmonised spectrum, smart packaging classified as a short-range devices (SRD) – The provisions of R&TTE apply to shipments of RFID tags and similar but once this is integrated into packaging it will be packaging and CE Marking is not necessary. • The Toys Directive 2009/48/EC – applicable to toys (under 14 s). If packaging has a “Play value of its own” it is in scope. Separate migration levels exist

Impact of Legislation on Printed Electronics for Packaging International Standards for Printed Electronics • Standards from the International Electrotechnical Commission (IEC) qualify EEE for legal compliance and internal qualification in supply chains • In Europe, these are adopted by the CEN and CENELEC and included in harmonised lists for specific directives issued by the European Commission • The IEC has a dedicated group TEC 118 for printed electronics • Focus on supply chain standards to speed qualification of printed electronics materials and equipment, rather than qualifying final products • The first of these is due for publication in Q 1 2016 • Interim qualification can be achieved through adopting product-specific standards to printed electronics - e. g. for smart (bank) cards

Impact of Legislation on Printed Electronics for Packaging Substance Restriction Legislation - Ro. HS • Ro. HS Directive 2011/65/EU restricts in EEE: – Cadmium - 0. 01%/wt; Hexavalent chromium - 0. 1%/wt; Lead - 0. 1%/wt; Mercury - 0. 1%/wt – Polybrominated biphenyls (PBB) - 0. 1%/wt – Polybrominated diphenyl ethers (PBDE) - 0. 1%/wt And, from 2019, six phthalates • RFID tags and similar components are subject to the Ro. HS Directive, until they are integrated into another article e. g. a smart package • As Ro. HS is now a CE Mark directive, marking of shipments is necessary and widely accepted by industry

Impact of Legislation on Printed Electronics for Packaging Substance Restriction Legislation – REACH • Registration, Evaluation, Authorisation and Restriction of Chemicals • REACH Regulation 1907/2006 assesses all chemicals in the EU, restrict hazardous materials • Chemicals used at 1 -100 tonnes p/a must be registered by June 2018, full technical risk profile • REACH has two mechanisms for controlling risk – Where risk may be controlled substances of very high concern (SVHCs) are added to a candidate list. These cannot be used after a prescribed date, unless an Authorisation is obtained from the ECHA (gaining Authorisation is complex and prohibitively expensive and only covers specific uses requested by the applicant) – For uncontrolled risks are managed by Restriction under REACH’s Annex XVII. 64 entries limit the use of certain chemicals to certain conditions • Companies should be aware of the presence of any restriction list or SVHC in products and – due to time and cost considerations – look to substitute these

Impact of Legislation on Printed Electronics for Packaging The Packaging Directive 94/62/EC • Packaging minimising effect on the environment, through EN 13427: 2004 • The two principal means for doing this are: – Source reduction – minimising the use of materials at the design phase – Recyclablity at end-of-life – separate smart label / printed electronic to avoid contaminating materials that will be recovered and reused • Responsibility for following EN 13427 lies with the entity placing it on the market – packagers expect cooperation from their suppliers in doing this • Other considerations (cutting food waste) can be balanced against calls for reduced material use or recyclability

Impact of Legislation on Printed Electronics for Packaging The WEEE Directive • Waste Electrical and Electronic Equipment • In EU collection and processing of EEE at end-of-life is governed by WEEE Directive 2012/19/EU, this has a closed scope (10 categories), but will move to open scope in Jan 2019 • This mandates marking EEE with a ‘crossed wheelie bin’ symbol, collection targets for at end-of-life and an obligation on its manufacturers/importers to finance disposal • Is smart packaging in scope of WEEE? 2015 – Packaging with electrical function is considered out of scope and treated as packaging waste. RFID tags with security features forming part of product packaging are specifically excluded 2019 – Smart packaging will legally be in scope. WEEE enforcement authorities are examining the position, so may change. Engagement with authorities is strongly recommended

Impact of Legislation on Printed Electronics for Packaging Batteries and Accumulators Directive • Equipment / systems with a battery may be subject to the Batteries and Accumulators Directive 2006/66/EC • Directive 2006/66/EC requires items in scope – Not use mercury or cadmium in its cells – The collection and processing of such equipment at end-of-life – Funding on the ‘Producer Pays Principle’ – Marking with a symbol (Crossed Wheelie Bin) • A current reading from the European Commission is that if the battery powers a secondary rather than primary function an article is not in scope of this directive • After 2019 under an open scope of WEEE it is possible that powered smart packaging will be subject to the obligation to make batteries easily removable in waste streams

Impact of Legislation on Printed Electronics for Packaging Conclusions • General packaging Directive 94/62/EC and EN 13427 provide a proven and easy-to-follow mechanism to achieve a compliance, unlikely to change before 2020 • In food packaging the major concern is migration. Functional barriers provide compliance unless CMRs and nanomaterials are used New implementing measures for Directive 1935/2004 are not expected by 2020, may be a regulation on printing inks, either German or EU • Good manufacturing practices in food packaging will be useful in cosmetics, pharmaceuticals (developing PS 9000) and medical devices

Impact of Legislation on Printed Electronics for Packaging Evolution in regulations to 2020 • Most CE mark directives will be updated, these changes will not change the applicability of those relevant to smart packaging – R&TTE and Ro. HS • REACH will be more dynamic, but long lead times give scope to manage threat through monitoring • Opening of the scope of the WEEE Directive in January 2019 will impose new requirements on smart packaging that make their use prohibitively expensive Regulators are responsive to input in this area engage with them

Impact of Legislation on Printed Electronics for Packaging Recommendations • Consumer engagement RFID is quick route to market – pull from brands. Existing IEC RFID standards provide a mechanism for qualification • Smart label format will provide a multi-function platform for trailing any RFID or other printed electronic system • Adoption of printed electronics in supply chains can be speeded when qualified to future IEC standards • Avoid regulated materials (unless essential) in printed electronics as this will ease adoption, follow migration limits in inks, food and toy regulations • Information on this status should be communicated down the supply chain • Engagement with authorities to gain an exemption from an open WEEE scope in 2019 should be a top priority

Impact of Legislation on Printed Electronics for Packaging Thank you for your attention! Dr Sean Smyth – Print Consultant John Nelson – Commissioning Editor Phone: +44 (0)1372 802113 Phone: +44 (0)1372 802055 Email: ssmyth@smithers. com Email: jnelson@smithers. com www. smitherspira. com @seaninprint