COMPARISON OF PRINTING-RELATED LABELS AND …...To obtain an OK Compost certification by TUV Austria...

EPEA GmbH -‐ Part of Drees & Sommer ● www.epea.com Sitz der Gesellschaft: Obere Waldplätze 11 ● 70569 Stuttgart, Germany

Vertreten durch den Standort Hamburg: Trostbrücke 4 ● 20457 Hamburg, Germany Geschäftsführer: Dr.-‐Ing. Peter Mösle ● Amtsgericht Stuttgart HRB 767065

COMPARISON OF PRINTING-RELATED LABELS AND ORDINANCES Health Printing Initiative January 2019

Authors: Frieke Heens, Christina Krebs, Jenny Pfau

Editors: Katja Hansen, Douglas Mulhall

This is a summary of a more detailed investigation into this topic. The more detailed investigation is available on request. The comparison is supported by Stichting DOEN

© 2019 EPEA GmbH – Part of Drees & Sommer 2

COMPARISON OF RELATED LABELS AND ORDINANCES

C2C Cradle to Cradle C2CPII Cradle to Cradle Product Innovation Institute CEPI Confederation of European Paper Industries EuPIA European Printing Ink Association INGEDE International Association of the Deinking Industry REACH Registration, Evaluation, Authorisation and Restriction of Chemicals

This comparison covers environmental labels used to evaluate printing components like inks as well as printed matter. These include Cradle to Cradle Certified TM, Blue Angel, Nordic Ecolabel /Nordic Swan, EU Ecolabel, Swiss and draft German Ordinances on food contact and composting standards (OK Compost, DIN CERTCO). Other standards like REACH and guidelines provided by industry organizations like CEPI, EuPIA and INGEDE were taken into consideration but not evaluated per se, as these are not considered to be certification labels or printing-specific regulations. The development and upscaling of printing inks safe for users and environment is a central focus for Healthy Printing, and is connected to biocompatibility1. Among the various certifications, labels and standards, Cradle to Cradle is the only certification that allows for continuous improvement through graduated levels of certification. Gold and Platinum level certifications are the only ones that clearly evaluate if a printing product is designed to be biocompatible for the biological cycle according to transparently published criteria. However, other labels contain requirements connected to this. Blue Angel is in several aspects stricter than Cradle to Cradle Silver level, because it addresses some items more specifically than C2C certifications including aromatics in mineral oil, sourcing, and especially occupational exposure to process chemicals. The restricted chemicals according to Blue Angel requirements are also restricted for C2C Silver level, however C2C Gold has additional criteria with respect to the ink ingredients and their toxicity for human and environmental health. In this way Blue Angel could be considered as ‘on the way’ to biocompatibility. It also addresses de-inkability that no C2C certification addresses. Deinkability affects recyclability of paper, but is not a measure of materials health, as many inks containing toxic ingredients are de-inkable. As well Blue Angel addresses occupational health that only C2C Platinum addresses. Other labels like Nordic Swan are stricter than lower levels of C2C certification. The approach taken by the Swiss and German ordinances differ from

1 The term ‘biocompatible’ is a central aspect for healthy printing and has a specific meaning as being not harmful to living systems, including in its degradation byproducts as it decomposes in the environment.

LIST OF ABBREVIATIONS

EXECUTIVE SUMMARY


a C2C Material Health assessment, because they address what is potentially migrating, but still allow threshold levels of toxic ingredients, and do not address impacts on next use. Toxic substances are regulated if they exceed the respective migration limit, however they can still be used as long as the respective thresholds are met. Cradle to Cradle certified TM is the only certification that addresses after-use scenarios for printed matter such as the return of paper sludge to the biosphere via incineration or composting. It goes beyond composting certifications (e.g. OK Compost and DIN CERTCO), which are much more focussed on the compostability of substrates, and therefore only a very few criteria are developed for the inks on certified compostable materials. Companies who want to claim biocompatibility of their printing products could use specific sections of labels and regulatory ordinances to start on the way to healthy printing, but the C2C Gold and Platinum levels are still the ‘gold standard’. In the European Union, there is no specific regulation on printing inks. The European Food contact regulation has set general requirements to protect consumers from migration of toxic substances into food. In the absence of specific EU legislation, the European Printing Ink Association (EuPIA) has developed several guidelines for the selection of raw materials for (food) packaging inks. There are different rules amongst the several EU member states. Countries like Germany and Switzerland are frontrunners since they developed specific legislation for inks used for food contact. For printed publications or other non-food contact materials there is no legislation foreseen. However, more than five thousand different chemicals are used in the production of printing inks. While some labels contain measures to evaluate toxicity, Cradle to Cradle is the only label that evaluates the toxicity of each individual ingredient in printing inks instead of working with exclusion lists or migration limits. One of the goals of CEPI is to enhance the quality of paper recycling. Cradle to Cradle aims to optimize material health of all printed products (food and non-food applications), which results in higher quality of recycled paper streams. This is in line with CEPI aims. The C2C certification program is also valid worldwide, whereas some labels are confined to geographic regions like the EU.


The healthy printing initiative aims to establish an endpoint that defines printing products as safe and healthy, and to support mechanisms for scaling up products that aim to achieve that endpoint. The Cradle to Cradle (C2C) gold level certification is closest to meeting this requirement because products certified at the Gold level are completely optimized, meaning each component has been analysed and assessed according to published transparent criteria as being healthy and environmentally safe, and in the case of paper is biocompatible. Lower C2C certification levels are on the way toward that baseline acknowledging the continuous improvement approach of C2C certification. Goal of the comparison is to establish whether other certifications and ordinances or parts thereof can also be seen to define healthy print products (i.e. are at the same level of C2C gold certification), and/or if other print product specific labels and ordinances have additional requirements not currently covered by C2C certification. This summary first gives a brief overview of various European product labels or ordinances for the application toward printing products or printing inks, and then compares them against the goals defined above. It covers public labels like Blue Angel (Blauer Engel), Nordic Swan, EU Ecolabel as well as regulatory guidelines like the Swiss and German Ordinance, which is integrated in the ‘Bedarfsgegenstände-Verordnung’ (Commodities Ordinance). The EU has not established harmonized legislation specifically governing printing inks on their own. The legal requirements in the EU with relevance for food contact materials are found in different regulations and directives. This includes regulation no. 1935/2004, which sets out general requirements for all food contact materials. Broad requirements for printing inks are included in the Regenerated Cellulose Directive, 2007/42/EC. More specifically, Article 5 prohibits contact between the printed surfaces of regenerated cellulose film and food. The absence of a harmonized approach to printing underscores the importance of these other labels and ordinances.

Some offset printing inks are marketed as bio-inks or vegetable inks which primarily refers to the renewable content of the solvent. Offset inks are oil based, and contain either mineral oil or vegetable oil (e.g. soy oil), or both. Bio-inks of vegetable-based inks contain some content of vegetable oils. The term “bio-ink” applies to the solvent only, and therefore it is not very meaningful to determine whether an ink is safe for use, recycling and composting. Other important ingredients in offset inks are resins, pigments, driers and waxes. The resins of printing inks can be derived from renewable sources as well such as alkyd resins from vegetable oils (e.g. soybean oil, linseed oil) and resins derived from pine tree. Some remarks about vegetable-based printing inks in the context of the different ecolabels:

INTRODUCTION & SCOPE

RENEWABILITY & COMPOSTABILITY OF PRINTING INKS


• If soy oil is used as solvent, there may be sourcing issues associated with it. Blue

Angel requires that such raw materials are not sourced from rainforest deforestation or genetically modified plants. Sourcing is addressed at Cradle to Cradle Gold level, sustainable sourcing is encouraged but currently not mandatory.

• The production process of resins from renewable sources does also include the introduction of process chemicals. The Cradle to Cradle CertifiedTM program is the only standard in which those chemicals are addressed and assessed.

• There are no requirements for a minimum % of renewable content in the respective ecolabels and Cradle to Cradle CertifiedTM program.

• A high % of renewable content is possible for offset printing ink since solvents, resins, waxes and additives can be renewably sourced, however the exact % of renewable content is usually not communicated. Under European regulations, packaging can only be claimed as compostable and biodegradable when certified in accordance with the criteria of the European standard EN 134323. This standard covers packaging as a whole. Consequently, printing inks are treated as constituents that cannot be claimed per se as compostable. Printing inks (without substrate) would be not be able to meet the required biodegradation rates according to EN 134323 since pigments are inert and therefore non-degradable. However, it is possible to certify ink additives to be used in the manufacture of products made of compostable materials by demonstrating compliance with the requirements of DIN EN 13432 by proving that they are harmless to the composting process2. Even if it is possible to use biodegradable (non-pigment) ink components, this is not considered in the composting standards (e.g. OK Compost, DIN CERTCO) for ink constituents because it is assumed that the quantity of each certified ink contained in the product does not exceed 1 mass % of the end product (dry weight) individually and less than 5 mass% in total (dry weight). Therefore the compostability certification for printing inks, is more an evaluation of ecotoxicity and cannot be used as a biodegradability claim. To obtain an OK Compost certification by TUV Austria (previously Vinçotte), the inks must not exceed the prescribed limits for heavy metals, which in the case of packaging printing inks primarily entails a restriction of the copper-containing pigments, and compromises in the colour shade have to be accepted for gold, blue and green shades. The certification scheme by DIN CERTCO for ink constituents (based on DIN EN 13432) also prescribes limit values for metals, but additionally requires testing the inks for plant toxicity3.

Some remarks about compostability in the context of the different ecolabels:

2 Examples of certification programs based on EN13432 are OK Compost (by TUV Austria, previously Vincotte) and DIN- Geprüft compostable by DIN CERTCO (TUV Reinland) 3 http://www.dincertco.de/media/dincertco/dokumente_1/certification_schemes/Zusatzstoffe_additives_certification_scheme.pdf


• It is not required to demonstrate compliance with the requirements of DIN EN 13432 for Blue Angel, European Ecolabel and Nordic Swan.

• In the Cradle to Cradle CertifiedTM program, a material reutilization score is determined, which is based on the recyclability/compostability and the renewable/recycled content of the materials.

• At Cradle to Cradle Gold level, the ink must either meet the compostability requirements according to DIN 13432, or contain a minimum % of renewable and biodegradable components.

a) Cradle to Cradle

The Cradle to Cradle CertifiedTM Program is a multi-attribute and multi-level certification that acknowledges continuous improvement of products and processes towards the goal of being beneficial for people and the planet. It is the only certification covered here that allows for continuous improvement through graduated levels of certification. It covers a broad range of products and is not limited to print products. The certification program looks at a product through five quality categories: material health, material reutilization, energy management, water stewardship and social fairness. A product receives an achievement level in each category - with the lowest achievement level representing the product’s overall level. For printing inks and printed products, the material health category often determines the overall certification level. The certification program assesses products in a defined biological or technical cycle. For paper print products, the use scenario is within the biosphere, i.e. paper print products should be optimized toward contact with and release into the biosphere at the end of a cascade use of the fiber4. The term cascade when used in the paper industry means that the fibers in the paper are recovered and reused several times in different products until they are too short to be reused and are returned to the environment by burning or composting. Products certified at the Gold level are completely optimized, meaning each component has been analysed and assessed as a healthy and environmentally safe ingredient, and in the case of paper are biocompatible. In C2C Silver certified products, no severe issues for human health have been identified but the products still have some optimization potential. This could be due to content of pigments based on organochlorine chemistry, additives with a concern for environmental toxicity (i.e. toxic to aquatic systems and slow degradation) or due to lack of data from the supply chain.

4 The term ‘paper’ must be used carefully and investigated during certification. Paper used in printing or packaging is often coated with plastics and in this case presents a special challenge for biocompatibility.

ENVIRONMENTAL PRODUCT LABELS


b) Blauer Engel (Blue Angel) Blue Angel started in 1978 in Germany, as one of the first eco labels worldwide. The Blue Angel guarantees that a product or service meets high standards when it comes to its environmental, health and performance characteristics. In the cycle. Criteria are developed for each individual product group and those criteria must be fulfilled by those products and services awarded with the Blue Angel. Blue Angel is an environmental label organized by the federal government of Germany for the protection of people and the environment. In order to reflect technological advances, the Federal Environmental Agency reviews these criteria every three to four years. This process requires companies to constantly improve the environmental friendliness and safety of their products over time. The product group for print products was established relatively recently in 2014 (website link: https://www.blauer-engel.de/en/products/paper-printing). The award criteria not only cover the quality of the paper, but also the various printing processes. Thus Blue Angel certifies paper (RAL UZ 14, RAL UZ 56 and RAL UZ 72), printed matter (RAL UZ 195) and printing devices i.e. office printer (DE-UZ 205). The label promotes the usage of post-consumer paper products, the use of environmentally safe printing and printing services and the use of sustainable managed virgin fibers. In particular, it calls for the elimination of critical substances in all processed materials from prepress, printing and further processing, as well as the emission limitation of volatile organic compounds (VOC) from paints, varnishes, cleaning-, washing- and dampening agents. As far as printing inks are concerned, this requires, among other things, the use of mineral oil and cobalt-free inks. Further information can be found here: Flyer "Der Blaue Engel für Druckerzeugnisse" (Link: http://www.umweltbundesamt.de/publikationen/der-blaue-engel-fuer-druckerzeugnisse) and on the website by Blue Angel (www.blauer-engel.de). RAL UZ 14 “Recycled Paper/ Recyclingpapier“: since 2014

RAL-UZ 56 "Recycled Cardboard/ Recyclingkarton": since 2014

RAL UZ 72 “Printing and Publication Papers/ Druck- und Pressepapier überwiegend aus Altpapier“: since 2014

RAL UZ 195 “Printed Matter/ Druckerzeugnisse”:

Comparison with the C2C standard:

Blue Angel certification for printed products is comparable to Cradle to Cradle Silver level in terms of health (toxicological) requirements: the restricted chemicals according to Blue Angel are also restricted at C2C Silver level, however C2C Gold has additional criteria with respect to the ink ingredients and their toxicity for human and environmental health (see point 1-5). In addition to material composition issues, Blue Angel is in several aspects stricter than Cradle to Cradle Silver level, because it addresses some items more specifically than C2C certifications (see points 6- 9).


1) For Blue Angel and for Silver and Gold Cradle to Cradle certified printed products, the inks may not contain CMR (carcinogenic, mutagenic or reprotoxic) substances . However, the thresholds are different. For Cradle to Cradle certification, individual substances > 0.01% (100 ppm) are identified and assessed, for Blue Angel the toxicity of the mixture (and its labelling) is relevant. One example of a CMR substance commonly used in offset printing inks is cobalt as drying agent. Cobalt is not allowed according to Blue Angel, and not allowed for C2C Silver and C2C Gold certification. C2C bronze certified inks may contain CMR substances, however a plan is required for substitution by better alternatives.

2) The toxicological evaluation for obtaining a Cradle to Cradle certification at Bronze, Silver and Gold level is more rigorous because the toxicological properties of each individual substance > 100 ppm are assessed while Blue Angel focusses on the toxicity of the ink mixture (and therefore lower thresholds are applied).

3) Toxic (but non-CMR) substances are still allowed for C2C Silver, and for Blue Angel certification such substances are not allowed if listed on a MSDS of the ink. Therefore, Blue Angel could be stricter in some cases compared to Cradle to Cradle Silver for substances >0.1% in the ink.

4) Blue Angel, C2C Silver and C2C Gold have restrictions for azo pigments based on carcinogenic amines.

5) PTFE wax (to improve abrasion resistance) is not allowed in C2C certified inks at all >0.1% as PTFE is a banned list substance, but it is not restricted by other labels.

6) At C2C Gold, also the after-use scenarios such as recycling, composting and incineration are considered, for example by restricting carbon bound halogenated pigments and additives with environmental toxicity. Chlorinated pigments are not restricted by other ecolabels.

7) VOC emissions at the printing facility are addressed in Blue Angel (with specific criteria), but within the C2C certification program only if these are part of the final product. C2C Certification at Silver/Gold level focuses on the material health aspects of those chemicals, which remain in the final product. The process chemicals are reviewed as well, however more in the context of aquatic toxicity and not for occupational exposure. The occupational health of process chemicals are addressed at C2C Platinum level only.

8) Blue Angel has requirements for the sourcing of renewable raw materials, it must be certified that they are not sourced from genetically modified plants or from rainforest deforestation. C2C certification addresses supply chain issues at Silver and/or Gold certification, and providing certificates (e.g. FSC, organic farming) related to sourcing is optional but not mandatory. At minimum, a plan is required to address issues related to sourcing at the C2C Gold level.


9) Blue Angel has specific requirements for the aromatic content of mineral oil. The C2C Standard has no specific requirements, but mineral oils are assessed for their content during C2C certification, and a rating is assigned based on that actual content. However, EPEA has published a position paper on the challenges of MOSH & MOAH. The recommendation is to ban MOAH in printing inks (unless it can be proven the MOAH fraction consists of non-problematic components) and apply a limit value of 1% for MOSH in printing inks. The timeline for implementation is still in discussion at EPEA.

10) Blue Angel has requirements for de-inking in the frame of paper recyclability. De-inkability is currently not covered in the C2C certification standard, but is being discussed for inclusion in the upcoming version 4.0.

c) Nordic Ecolabel/ Nordic Swan

The Nordic Swan was established in 1989 by the Nordic Council of Ministers. The multi attribute certification can be applied for 60 different product groups. The Ecolabel on a printed paper products (including packaging) confirms that resources have been used efficiently and that environmentally suitable production methods have been employed. The raw materials used in the product have been evaluated by Nordic Ecolabelling and only raw materials of a specific quality in environmental terms may be used in Nordic Eco labelled products. The Nordic Swan Ecolabel is the official ecolabel of the Nordic countries (Denmark, Sweden, Finland, Norway and Island).

Comparison with the C2C Standard:

The Nordic Swan requirements are stricter than Cradle to Cradle Bronze in terms of health (toxicological) requirements (see point 1). However, it is not equal to Cradle to Cradle Silver and Blue Angel (see point 2 and 5). The focus of the Nordic Swan is more at the facility level and related processes while Cradle to Cradle Certification considers both product and processes. Blue Angel has additional requirements for sourcing.

1) For Nordic Swan and for Silver and Gold Cradle to Cradle certified printed products, the inks may not contain CMR (carcinogenic, mutagenic or reprotoxic) substances. However, the thresholds are different. For Cradle to Cradle certification, individual substances > 0.01% (100 ppm) are identified and assessed, for Nordic Swan the toxicity of the mixture (and its labelling) is relevant. One example of a CMR substance commonly used in offset printing inks is cobalt as drying agent. Cobalt is not allowed according to Nordic Swan, and not allowed for C2C Silver and C2C Gold certification.


C2C Bronze certified inks may contain CMR substances, however a plan is required for substitution by better alternatives.

2) The toxicological evaluation for obtaining a Cradle to Cradle certification at Bronze, Silver and Gold level is more rigorous because the toxicological properties of each individual substance > 100 ppm are assessed while Nordic Swan focusses on the toxicity of the ink mixture (and therefore lower thresholds are applied).

3) Toxic (but non-CMR) substances are still allowed for C2C Silver, and for Nordic Swan certification such substances are not allowed if listed on a MSDS of the ink.

4) At C2C Gold, also the after-use scenarios such as recycling, composting and incineration are considered, for example by restricting the use of carbon bound halogenated pigments and additives with environmental toxicity. Chlorinated pigments are not restricted by other ecolabels.

5) For Nordic Swan, residues of primary aromatic amines in printing inks are restricted to a certain level. This is less strict compared to Blue Angel, C2C Silver and C2C Gold for which azo pigments based on carcinogenic amines are not allowed, regardless of the residual level (content) of the carcinogenic amine in the pigment, since these may be formed as well under certain conditions (e.g. during recycling). PTFE wax (to improve abrasion resistance) is not allowed in C2C certified inks at all >0.1% as PTFE is a banned list substance, but it is not restricted by other labels.

6) For Nordic Swan, there is an incentive to use renewable energy since you can get points for it but it is not a requirement.

7) Nordic Swan also bans PVC.

8) Low VOC emissions at the printing facility are rewarded by Nordic Swan, but within the C2C certification program only if these are part of the final product. C2C Certification at Silver/Gold level focuses on the material health aspects of those chemicals, which remain in the final product. The process chemicals are reviewed as well, however more in the context of aquatic toxicity and not for occupational exposure. The occupational health of process chemicals are addressed at C2C Platinum level only.

9) Nordic Swan has requirements for de-inking in the frame of paper recyclability. De-inkability is currently not covered in the C2C certification standard, but is being discussed for inclusion in the upcoming version 4.0.


d) EU Ecolabel

To qualify for the EU Ecolabel, products must comply with several environmental criteria, set by a panel of stakeholders, including consumer organisations and industry. EU Ecolabel takes the whole product life cycle into account - from the extraction of the raw materials, to production, packaging and transport, right through to use and disposal. There are specific criteria for printed paper products: Printed paper products include news papers, advertising materials and news sheets, magazines, journals, catalogues, books, leaflets, brochures, posters, business cards and labels.


The European Ecolabel requirements are stricter than Cradle to Cradle Bronze in terms of health (toxicological) requirements (see point 1). However, it is not equal to Cradle to Cradle Silver and Blue Angel (see point 2 and 5). The focus of the European Ecolabel is more at the facility level and related processes while Cradle to Cradle Certification considers both product and processes. Blue Angel has additional requirements for sourcing.

1) For the European Ecolabel and Cradle to Cradle certified at for Silver and Gold level, the inks may not contain CMR (carcinogenic, mutagenic or reprotoxic) substances.. However, the thresholds are different. For Cradle to Cradle certification, individual substances > 0.01% (100 ppm) are identified and assessed, for European Ecolabel the toxicity of the mixture (and its labelling) is relevant.

2) European Ecolabel is less strict compared to Blue Angel and Nordic Swan because Cobalt is allowed up to 0.1% while it is banned in Cradle to Cradle Silver/Gold, Blue Angel and Nordic Swan. C2C Bronze certified inks may contain CMR substances, however a plan is required for substitution by better alternatives.

3) The toxicological evaluation for obtaining a Cradle to Cradle certification at Bronze, Silver and Gold level is more rigorous because the toxicological properties of each individual substance > 100 ppm are assessed while European Ecolabel focusses on the toxicity of the ink mixture (and therefore lower thresholds are applied).

4) Toxic (but non-CMR) substances are still allowed for C2C Silver, and for European Ecolabel such substances are not allowed if listed on a MSDS of the ink.

5) At C2C Gold, also the after-use scenarios such as recycling, composting and incineration are considered, for example by restricting the use of carbon bound halogenated pigments and additives with environmental toxicity. Chlorinated pigments are not restricted by other ecolabels.

6) European Ecolabel has no criteria or restrictions for (azo) pigments.


7) PTFE wax (to improve abrasion resistance) is not allowed in C2C certified inks at

all >0.1% as PTFE is a banned list substance, but it is not restricted by other labels.

8) European Ecolabel also announced that criteria for mineral oil will be addressed in the next version, but the current version 2012/481/EU valid till December 2018no specifics are mentioned.

9) VOC emissions are addressed in European Ecolabel (with specific criteria), within the C2C certification program only if these are part of the final product. Process chemicals are addressed at C2C Platinum level only. C2C Silver/Gold Certification focuses on the material health aspects of those chemicals, which remain in the final product. The process chemicals are reviewed as well, however more in the context of aquatic toxicity and not for occupational exposure.

e) (Draft) German Ordinance

The Draft German Draft Ordinance on Printing Inks is valid for food packaging only and will amend the German Commodities Regulations. Products which do not comply with the draft German Printing Ink Ordinance are marketable only if a product-related assessment was applied for at and performed by the Federal Office of Consumer Protection and Food Safety (BVL) and if a general permission was granted provided that there are "no compelling health protection reasons" (procedures according to Section 54 subsection 2 LFGB). This ordinance is still at a draft stage, but meanwhile notified by the EU. It is striving for positive lists for printing inks and distinguishes between inks to be printed on food packaging with direct food contact and on packaging without direct food contact. The substance lists encompass monomers, polymers, additives, pigments, solvents, colorants and photo-initiators, as well as several substances under certain restrictions. The lists of substances: Table 1 (appr. 600 substances) of the ordinance lists “allowed” substances for printing inks used in printed consumer goods in form of a Positive List. Many of the substances with direct food contact are connected to certain migration limit values. For substances not related to defined migration limits, a general value of 60 mg/kg in food is applied, if no other restrictions are defined in table 1 or 3. A lot of substances are related to significant lower migration limits, for instance like 0.05 mg/kg or even “not detectable”. For printing inks which are not in direct food contact different regulations are applied: Other printing chemicals as listed in table 1 are allowed if not qualified as

ORDINANCES IN EUROPEAN COUNTRIES


CMR5 substances according to EU regulation 1272/2008 and if migration is not detectable. Table 2 lists additional pigments, which can be used for printing of consumer goods, which are not in direct contact with food. Table 3 describes limit values for migration mainly of substance-groups. Table 4 lists migration limits for some metals and primary aromatic amines.


A comparison to the Cradle to Cradle certification standard shows that the selection criteria for substances are not similar. The catalogue of “allowed” substances is related to certain limit values for migration (in mg/kg food) and some other restrictions. A brief random check of the lists reveals the presence of potential problematic (X-rated) substances according to Cradle to Cradle in table 1 and 2 (e.g. tin-organics, photo initiators and pigments (chlorinated and azo-pigments cleaving off carcinogenic amines). In the Cradle to Cradle assessment methodology, X-rated substances in printing inks are addressed (if present > 100 mg/kg) regardless of migration. EPEA has not studied the relationship between content and migration.

f) Swiss Ordinance

The Swiss Federal Department of Home Affairs (FDHA) issued a revised version of the Ordinance on Materials and Articles (SR 817.023.21), which came into force on May 1, 2017. Section 12 sets out the provisions relating to printing inks applied on the non-food contact surface of Food Contact Materials (FCMs) (“non-direct food contact FCM inks). Article 35 of this section details the requirement that only permitted substances should be used in the manufacture of inks for Food Contact Materials.

Substances listed as B ‘status’ (unevaluated) in the individual substance lists can be used if:

• the substances are not classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to reproduction’ (CMR substances) of category 1A, 1B or 2 in accordance with the criteria set out in Art. 6 of the Ordinance on Protection against Dangerous Substances and Preparations (ChemO)

5 CMR: cancerogenic, mutagenic, reprotoxic


• the migration of the substance into food or food simulant shall not be detectable measured with statistical certainty by a method of analysis with a limit of detection of 0.01 mg/kg.

If a substance or substances is/are listed in the Ordinance, does it mean that non-direct food contact FCM inks using these substances are safe? No, because listing on the Ordinance simply provides verification that the substance may be used in the manufacture of non-direct food contact FCM inks. To ensure safety according to the law, in end-use the migration limit(s) applicable to the substance(s) must not be exceeded and Good Manufacturing Practices (GMP) for printing inks manufacturing and printing must be used. 6 In a Cradle to Cradle assessment, the approach is to address the content of problematic substances, and not its migration. EPEA has not studied the relationship between content and migration, but instead as a safety net approach assumes in the case of the biological cycle that the content could migrate into biological systems, which include food.

g) Examples of X- substances and their legal status in the Swiss and German

ordinance Benzophenone and its derivatives

Benzophenone is persistent, bio-accumulative and toxic (PBT), linked to cancer (IARC 2B), endocrine disruption, and organ system toxicity.

• Would be X- rated and considered as CMR, not eligible for Silver/Gold certification (> 100 ppm in the ink)

• This substance is in the A-List (evaluated substances) of the Swiss Ordinance, and must fulfil migration limits of 0.6 mg/kg.

• In the German ordinance, Benzophenone &, its derivates are grouped and must fulfil migration limits of 0.6 mg/kg

Pigment Yellow 74 This pigment contains a cleavable carcinogenic amine.

• Would be X -rated and considered as CMR, not eligible for Silver/Gold certification.

• This substance is in the B-List of the Swiss Ordinance, and must fulfil migration limits of 0.01 mg/kg.

• This substance is restricted in the German Ordinance, and must fulfil migration limits of 0.01 mg/kg.

Pigment Green 7 This pigment contains organochlorine.

6 http://www.eupia.org/uploads/tx_edm/2017-10-05_Swiss_FCM_Ordinance_-_EuPIA_Q_A_regarding_non-DFC_FCM_Inks.pdf


• Would be X -rated, not eligible for Gold certification. • This substance is in the A-List (evaluated substances) of the Swiss

Ordinance and is not restricted • The pigment is restricted in the German Ordinance. It must fulfil the

migration limit of of 0,01 mg/kg. Principally, it is possible that problematic substances do not fulfil the migration limit, but are present below 100 ppm threshold for C2C certification. Another case could be that substances which pass the C2C assessment have very strict migration limits. Examples of such cases are not known yet.

h) EU legislation

REACH REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007. It is used to evaluate the individual chemicals in products but does not give them a label. REACH is one of the regulatory databases used by certifications like C2C, EU Ecolabel, Nordic Swan, and Blue Angel as well as allowed under Ordinances like the Swiss Ordinance to evaluate the materials health of a printed product. It is also considered in industry guidelines like those developed by EuPIA and CEPI. Due to this, REACH was not considered here as a separate ordinance, also because it does not seem to be a distinguishing factor between labels. REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU. REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate how the substance can be safely used, and they must communicate the risk management measures to the users. If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.

EU food packaging requirements

The EU has established legislation for materials intended for food contact (indirect or direct): EU's definition of Food Contact Materials (FCMs) is very broad. It


includes both food package materials and any other materials and articles (i.e, coffee machine, some food processing machine) that are expected to come into contact with food under normal and foreseeable use conditions. Industry and trade have the obligation to demonstrate safety in use, and the public food inspection has to control it. The legal requirements in EU with relevance for food contact materials are found in different regulations and directives. This includes regulation no. 1935/2004 which sets out general requirements for all FCMs: These general requirements state that FCMs shall, under normal and foreseeable conditions of use, not transfer their constituents into foodstuffs in quantities, which could endanger human health. Compliance with regulation no. 1935/2004 shall be based on risk assessments of the chemicals used in the composition of the printing ink, including evaluation of possible migration or set off of these chemicals into the food. The packaging manufacturer must obtain essential information concerning the design, materials of the packaging and the type of food to be packed, summarise and evaluate the supplier's statements, and demonstrate the packaging’s conformity with the valid rules and regulations. Under current law, it is sufficient that the manufacturer of the packaging issues an appropriate declaration, which is supported by relevant internal documentation.

However the following remarks need to be made:

• There are no specifications for printing inks on how to comply with the general requirement for FCMs.

• A minor part of the substances in printing inks are evaluated by EFSA (European Food Safety Authority) and restricted by a Specific Migration Level (SML). In addition, most of the printing ink chemicals on the industry inventory lists are not fully risk assessed and toxicological data may be sparse. These substances can still be used if not classified as CMR substance and if the migration limit is fulfilled.

• In the absence of specific EU measures, Member States may maintain or adopt their own national provisions on FCMs. National legislation is in place in the majority of EU Member States, setting out individual rules on different materials and substances. These may differ from one Member State to another.

• The establishment of declaration of compliance and documentation for FCMs is an ongoing process.

i) EuPIA The European Trade Association for printing ink makers, EuPIA, has published guidance documents and other information for their member companies.

The EuPIA guidances provide:

• recommendations on selection of raw materials used in food packaging inks


• an exclusion list of substances (colorants, solvents, plasticizers and other compounds) that must be avoided in the production of printing inks. It also prohibits CMRs, heavy metal-based colorants, and toxic substances.

• guidance on assessing potential migration of ink components to food.

EuPIA has published a guidance to help converters and end users to assess the compliance of printed food packaging using information provided by an ink supplier. It recommends that the converter obtains a Statement of Composition (SOC) for a printing ink, which lists the substances (and amount) in the inks with the potential to migrate, and the applicable migration limits. These migration limits may come from the Plastics Regulations, the Swiss Ordinance on printing inks, or another recognized authority such as an opinion from the European Food Safety Authority (EFSA). The converter may then calculate the amounts of potentially migrating substances based on the actual usage of the printing ink.


The comparisons above lead to the following conclusions:

• C2C gold is superior to other labels except in areas like sourcing, occupational health related to the use of process chemicals in the print house and deinking properties.

• C2C gold is the only certification that addresses toxicity during use and after use (e.g in recycling, incineration, composting processes).

• Blue Angel is in several aspects stricter than Cradle to Cradle Silver, since it addresses mineral oil content, sourcing, occupational exposure to process chemicals, and deinking.

• Nordic Swan requirements with respect to content of problematic

substances are stricter than C2C Bronze but not comparable to C2C Silver.

• The European Ecolabel requirements with respect to content of problematic substances are stricter than Cradle to Cradle Bronze. However, it is not comparable with Cradle to Cradle Silver. European Ecolabel is less strict compared to Blue Angel and Nordic Swan.

• The approach taken by the Swiss and German ordinance is different to a

Material Health assessment according the Cradle to Cradle assessment methodology, because it addresses what is potentially migrating, and not what is in a printed product.

Toxic substances are regulated if they exceed the respective migration limit, however they can still be used as long as the respective thresholds are met. Other after-use scenarios for printed matter such as the return of paper sludge to the biosphere via incineration or composting is not addressed by these regulations.

Among the various certifications, labels and standards, Cradle to Cradle is the only certification that allows for continuous improvement through graduated levels of certification. Gold and Platinum level certifications are the only ones that clearly evaluate if a printing product is designed to be biocompatible for the biological cycle according to transparently published criteria.

The table on the next page provides a brief summary of these conclusions. A more extensive background document is available in Excel.

CONCLUSIONS


Cradle to Cradle Bronze EU Ecolabel Nordic Swan Blauer Engel Cradle to Cradle Silver Cradle to Cradle Gold

Ecolabel scheme aspects

Independent assessment ü ü ü ü ü üTransparent methodology ü ü ü ü ü ü

Continious optimization required ü O O O ü üScope

Printed paper products: news papers, advertising materials, magazines, journals, ü ü ü ü ü ü

Packaging ü O ü O ü üMaterials

Ingredients known up to 0,01% product weight O O O ü üToxicity during use evaluated ü partially * partially * partially * ü ü

Toxicity after use (recycling, incineration and composting) evaluated ü O O O ü ü

Biocompatible (safe during use and safe for incineration and composting) O O O O O ü

Harmful (CMR) substances excluded O ü ü ü ü üHeavy metal free (including cobalt) O cobalt <0,1% ü ü ü ü

restrictions for pigments with life cycle issues (e.g. azo pigments, organochlorine pigments) O O partially ü ü ü

restrictions for VOC emissions at printer O ü rewarded but not mandatory ü O OPVC free (laminates) ü O ü ü ü ü

Deinking (recyclability) O ü ü ü O OSourcing

Sustainable source of paper O ü ü ü encouraged but not mandatory encouraged but not mandatory

Renewable content in inks O O rewarded O rewarded but not mandatory rewarded but not mandatory

Sustainable source for vegetable oil in inks O O O ü encouraged but not mandatory encouraged but not mandatory

Processes

Energy reporting ü ü ü ü ü üRenewable energy use O O rewarded O 5% 50%

Water consumption reporting O O ü ü ü üWater quality requirements for water effluent at

the printer O partially partially partially O üSocial self audit ü O O O ü ü

Waste management O ü ü ü O O

* partially because evaluation is based on MSDS and REACH data only. Cradle to Cradle

assessments are based on toxicological evalutation of each chemical in the product >0.01%

COMPARISON OF PRINTING-RELATED LABELS AND …...To obtain an OK Compost certification by TUV Austria...

Documents

Transcript of COMPARISON OF PRINTING-RELATED LABELS AND …...To obtain an OK Compost certification by TUV Austria...