/>iI. Introduction
The European Commission (EC) has placed on hold its work on a measure proposing to harmonize the regulation of printed food-contact materials (FCMs) in the European Union (EU) firmly on hold, pending the completion of its evaluation assessing the overall effectiveness, efficiency, relevance, coherence, and EU-added value of EU food-contact legislation more broadly. Oversight of printing inks in the EU remains frozen, as it was prior to 2014, when Germany first pushed the EU to greater oversight of these materials. As then, Switzerland stands alone as the only country in Europe with national legislation specifically regulating printing inks, as Germany also halted its work on its draft Printing Inks Ordinance in 2016 when the EC announced its plan to work on a draft harmonized measure on printed FCMs.
To understand better the possible direction in which the EU may be headed, we first provide an overview of how food-contact printing inks are currently regulated in the EU. We also detail the main provisions of the Swiss Printing Inks Ordinance and the last draft of the German Printing Inks Ordinance. Finally, we highlight some of the main concepts floated in 2017 by the Commission as it contemplated drafting a harmonized measure on printed FCMs and potential next steps towards regulating food-contact printing inks in the EU.
II. Overview of the Regulation of Printing Inks in the EU
The regulation of printing inks on FCMs is not fully harmonized at the EU level. Under EU food-contact legislation, printing inks must legally comply with the Framework Regulation (EC) No. 1935/2004 and the GMP (Good Manufacturing Practices) Regulation (EC) No. 2023/2006. Once this is established, food-contact printing inks may be placed on the market throughout the EU, subject to Member State legislation and the principle of mutual recognition.
The Framework Regulation, which regulates all FCMs placed on the EU market, establishes, among other provisions, a general safety requirement, and specifies that FCMs must be manufactured in accordance with GMP so that they do not transfer their constituents to foodstuffs in quantities that could endanger human health or bring about an unacceptable change in the composition of the food or its organoleptic properties.
The GMP Regulation applies to all FCMs at all stages of production, apart from the manufacture of starting substances, and sets forth general rules on GMP, including the establishment of quality assurance and quality control systems and the adequate documentation of those systems. Specific requirements for printing inks applied on the non-food contact side of FCMs (and only intended for that purpose) are detailed in the Annex to the GMP Regulation. These requirements include, for example, a prohibition on unsafe levels of components of these inks transferring by set-off or otherwise to the food-contact side. Direct contact of inks with food is thus not contemplated under the Annex to the EU GMP Regulation.
While the EU has not established harmonized legislation specifically governing the use of printing inks as a category of FCM, some EU regulations do impact the use of printing inks. For example, broad requirements for printing inks are included in the Regenerated Cellulose Film Directive, 2007/42/EC. More specifically, Article 5 prohibits contact between the printed surfaces of regenerated cellulose film and food.
Further, while printing ink components are not subject to the positive list requirement of the Plastics Regulation (EU) 10/2011, this Regulation indirectly sets requirements for printing inks, as specific migration limits (SMLs) for components in the Plastics Regulation’s Union List apply to the final printed plastic article regardless of whether the component is only a part of a printing ink. In other words, migration of components from both a plastic substrate and a printing ink must be considered when determining whether an applicable restriction is met under the Plastics Regulation. Further, since the Plastics Regulation imposes an overall migration limit (OML) of 10 mg/dm2 (or 60 mg/kg in certain circumstances) from the final food contact article, contributions from the printing inks must absolutely be considered when determining compliance with the OML.
Critically, the principle of mutual recognition allows FCMs to be placed on the market in an EU Member State when first lawfully manufactured or marketed in another Member State, even if the products do not fully comply with the specific technical requirements in the country of destination. This is relevant to printing inks, as certain Member States, such as the Netherlands, set purity requirements applicable to colorants in printing inks, although they do not regulate printing inks per se. For example, if one is producing colorants in the Netherlands and then placing them on the market in the Netherlands, then compliance with the purity specifications applicable to colorants in the Netherlands is mandated. However, if the colorants are lawfully manufactured outside the Netherlands for use in a printing ink being placed on the Dutch market thereafter, then mutual recognition may possibly allow the use of such colorants, even where compliance with the Dutch purity specifications has not been established.[1] Although, the colorants would need to comply with the safety requirement in Article 3.1a of the Framework Regulation. Further, under the principle of mutual recognition, business operators must otherwise comply with any applicable prior-authorization procedures, assuming such procedures are consistent with the requirements of the Treaty on the Functioning of the EU, as construed by the Court of Justice of the European Union.
III. National Printing Ink Requirements
A. The Swiss Printing Inks Ordinance
Although not an EU Member State, Switzerland is the only country in Europe that currently has legislation in place specifically regulating food packaging printing inks. The Swiss Ordinance has become, de facto, an important standard by which many companies evaluate printing inks in the EU, in the absence of harmonized EU law. By way of background, Swiss Ordinance RS 817.023.21 on materials and articles establishes specific provisions for several types of FCM, including food packaging printing inks. The most recent (substantially revised) version of this Ordinance has been in force since May 1, 2017, subject to some transitional provisions that are discussed in further detail below. At the outset, note that the Swiss Printing Inks Ordinance does not apply:
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to printing inks directly in contact with food;
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if migration of the ink substances to food is “impossible” (for example, in the case of printing inks on the outside of an aluminum can); and
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if set-off or transfer via a gas phase can be ruled out.
The positive list of components that may be used in printing inks pursuant to the Ordinance consists of substances listed in Annex 2 (Plastics)[2] and Annex 10 (Printing Inks). Annex 10 is comprised of positive lists for binders (monomers), colorants and pigments, solvents (including energy curing monomers), additives (which includes polymer production aids, but does not include substances used in the preparation of pigments nor does it include aids to polymerization), and photoinitiators. Further, substances subject to the positive list requirement that are deliberately engineered to nanoform must be listed as such in nanoform, while colorants and pigments containing nanoparticles may only be used if migration of nanoparticles to foodstuffs does not occur.
The positive lists in Annex 10 are further divided into Part A (evaluated substances) and Part B (non-evaluated substances). The non-evaluated substances may only be used if no transfer to food occurs at a detection limit of 0.01 mg/kg and they are not carcinogenic, mutagenic, or toxic to reproduction (CMRs). However, substances subject to the positive list requirement must be listed in either Part A or Part B (or in Annex 2) before they may be used in printing inks intended for use and/or sale in Switzerland.
While the Swiss Printing Inks Ordinance does not specifically require business operators to provide a Declaration of Compliance (DoC) for printing inks, a DoC is required under Swiss law for printed plastic materials and articles, printed regenerated cellulose film, and printed active and intelligent packaging. Further, supporting documentation for compliance of the printing inks should be kept on file, which the law mandates is to be made available to enforcement authorities upon request.
A transitional period of four years from May 1, 2017 applies to the composition, labeling, and advertising of FCMs falling within its scope (subject to limited exceptions). In other words, FCMs complying with the Swiss compositional, labeling, and advertising requirements prior to May 1, 2017 may continue to be placed on the Swiss market until May 1, 2021, and may be provided to consumers even after the expiration of the transitional period, until the exhaustion of stocks.
1. Petitioning for Listings of Printing Ink Components
The Swiss and German authorities have been, and continue to, informally collaborate on printing ink matters, even in the wake of the Germans’ announcement that its draft Ordinance is “on hold.” With respect to updates to the Swiss printing ink positive list (or draft positive list in the case of Germany), if a business operator seeks listing of a component in the Part A lists (evaluated substances) of the Swiss Printing Inks Ordinance, a petition has to be submitted in parallel to both the Swiss Federal Food Safety and Veterinary Office (FSVO) and the German Institute of Risk Assessment (BfR). We understand that this informal practice (but in reality required by both authorities) is expected to continue in the foreseeable future, with the BfR and Swiss FVSO meeting twice yearly to jointly evaluate petitions for components of printing inks, even though, again, work on the draft German Printing Inks Ordinance has been temporarily halted. If the review is favorable, then the substance is added to the Swiss list.
The Swiss Printing Inks Ordinance outlines that a petition for a food contact printing ink should include the following data:
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the identity of the substance;
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the physical and chemical properties of the substance;
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the intended use of the substance;
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authorizations applicable to the substance;
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the migration of the substance (residual concentration in the FCM, nature and concentration of the components that may migrate, analytical methods); and
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the toxicity of the substance, as well as its impurities and degradation products.
In other words, the data requirements in the Swiss Ordinance are closely aligned with those of the European Food Safety Authority (EFSA)’s Note for Guidance for Petitioners.[3]
B. The Draft German Printing Inks Ordinance
Germany suspended its work on the so-called “Draft Printing Inks Ordinance” (formally, the "Twenty-first Ordinance amending the Consumer Goods Ordinance"), in response to the EC’s announcement in November 2016 that it planned to develop a harmonized EU measure on printed FCMs. However, given that the EC’s work on this harmonized measure is currently on hold and the different standstill periods have elapsed, Germany is free to resume work on this Draft Ordinance.[4] Germany has not indicated as yet that it intends to do so, although we understand that the BfR is working on a guideline for petitions for new substances to be added to the (draft) German Printing Inks Ordinance.[5]
By way of background, the draft German text was notified to the EC on July 5, 2016 and proposed to apply to printing inks and printing varnishes applied on both the food-contact and non-food-contact sides of food packaging. Varnishes other than printing varnishes were excluded from its scope, as were colorants to dye FCMs, as well as decorative inks for ceramic FCMs applied in a combustion process.
Like the Swiss Ordinance, the German Draft Printing Inks Ordinance also included positive lists of monomers and other starting substances, colorants (pigments and dyes), solvents, additives, and photoinitiators that could be used in the manufacture of printing inks and varnishes. In addition, certain monomers and additives listed in the Plastics Regulation could also be used in printing inks, subject to any applicable limitations or specifications. Substances in nanoform had to be explicitly permitted for use in nanoform. However, the proposed German positive lists were not identical to the Swiss ones.
The Draft Printing Inks Ordinance provided that substances other than those included in the positive list could also be used in the manufacture of printing inks not intended to come into direct contact with food, provided that certain conditions were met.[6] The draft also included a provisional list of pigments that could be used temporarily in direct contact with food, provided that they were not found to migrate to food using a detection limit of 0.01 mg/kg. Finally, the Draft did not include a DoC requirement.
IV. The EC’s Draft Harmonized Measure on Printed FCMs
Aside from Germany’s work on a Draft Printing Inks Ordinance, and the many objections raised by the EU Member States to this draft text, two other factors prompted the EC’s proposed action to regulate printed FCMs. Firstly, the European Parliament in its Resolution of October 6, 2016 on the implementation of the Food Contact Materials Regulation (EC) No. 1935/2004 (2015/2259 (INI)) urged the EC to prioritize the drawing up of specific EU measures for certain FCMs, including printing inks. In addition, a study by the EC’s Joint Research Centre (JRC) was published in 2016, highlighting levels of primary aromatic amines in printed paper napkins at concentrations "relevant for monitoring".
Further impetus came from the lack of knowledge among business operators and Member State enforcement authorities about the correct application of the principle of mutual recognition—which is intended to facilitate the free movement of goods in non-harmonized areas between the EU Member States—together with the EC’s lack of progress in improving the efficacy of this principle.
A. No Positive List System for Printed FCMs
In the early stages of its work on a draft measure on printed FCMs, the EC rejected the possibility of a ‘positive list’ system as exists for plastic materials and articles. The EC was acutely concerned about the significant resources—both in time and money—necessary to support a positive list system, as well as the necessary long-term oversight and management, in rejecting this approach.
Were a positive list system for printing inks to be adopted, the EC took solid note of the over 700 substances that are listed in the draft German Printing Inks Ordinance and approximately 5,000 that are included in the Swiss Ordinance. Review and approval of these substances alone would constitute a massive undertaking, both for the private sector expected to sponsor dossiers for clearance of the materials and in the years’ long process expected for EFSA evaluation. As to this latter, adding a substance to the Plastics Regulation often takes several years, considering both the time necessary to complete EFSA review and the fact that the Regulation is often updated only once a year. Given EFSA’s current turn-around of approximately eight petition dossier reviews a year, the enormity of a similar undertaking for printing inks has been simply too much to contemplate.
B. Proposal that Designated Bodies would be responsible for Compliance Work
The EC detailed its proposed approach for the regulation of printed FCMs in May 2017. Importantly, in terms of the scope of any new harmonized measure, the EC clarified that it did not intend to regulate substrates on which inks are applied, but merely referenced them because migration of inks necessarily requires assessment after inks are applied to a substrate.
The proposed approach, under further development throughout 2017, was based on a mandatory certification system to be performed by so-called Designated Bodies (DBs). In accordance with this approach, Member States would accredit and supervise the work of the DBs, which, in turn, would be responsible for compliance work through assessment of FCMs at each stage of the manufacturing process. Compliance certificates would be issued by these private bodies to producers of final articles that use printing inks in their manufacture, following DB assessments.
The EC’s privatization of compliance assessments by a limited universe of DBs would, of course, render DoCs moot. Currently required by the Framework Regulation for FCMs covered by EU-wide specific measures, DoCs are based on a self-compliance assessment by producers of FCMs, as opposed to the proposed approach where compliance work would be delegated to private laboratories and consultants (DBs) accredited by individual Member States.
The proposed certification scheme would be mandatory and would also set a presumption of non-compliance of FCMs unless certified “compliant” by DBs. The scheme was intended to apply to final food contact articles (although earlier iterations apparently contemplated application to intermediate FCMs as well).[7] In its public presentations on the contemplated system, the EC proposed that the DBs would be authorized to perform, amongst others, the following tasks:
- identification of (migrating) substances;
- migration testing; and
- safety evaluations confirmed by a certificate of compliance.
DBs would be required to conduct safety evaluations conservatively and based on the general criteria set forth in EFSA’s guidelines. Substances that failed to meet the conservative evaluation of the DBs, due to high exposure or a specific concern, would be subject to an evaluation by EFSA to determine whether they should be included in a positive list. This was intended to be the exception, rather than the rule.
The system, as envisioned, would be supported by a centralized database of dossiers submitted by FCM manufacturers. Significantly, FCM manufacturers and other food business operators would only have access to basic information on parameters used for the control and identification of an FCM, as well as non-confidential compositional information. Selected information would be available to the general public, such as basic information on the materials, DBs, and FCM manufacturers, including information that manufacturers might wish to make available. However, the EC also outlined that the provision of partial information might be "misleading" because it would be incomplete.
National enforcement authorities would oversee the compliance work performed by the DBs, and, if need be, overrule decisions made by them. However, no information was provided regarding the process by which a challenge to a DB’s certification would occur, or what would happen in cases where products were placed on the market in reliance upon the initial certificate granted by the DB.
Industry groups raised numerous objections to the proposal, concerned that it would result in an inefficient, ineffective, and unworkable system, while introducing unnecessary costs and an unwieldy and unnecessary bureaucracy in the supply chain. Further, some critics argued that the proposal was disproportionately severe when compared to other sectors, such as cosmetics and even foodstuffs, where more robust oversight is seemingly warranted. For further details and analysis of the DB proposal, see our October 2017 article titled, “European Commission activities on printed food contact materials” (available HERE).
C. Work on the Draft Measure on Printed FCMs on Hold
Ultimately, the EC put its work on the Draft Measure on Printed FCMs on hold as the Commission is now fully absorbed with its broader effort to evaluate the EU food-contact legislation as a whole, to assess its overall effectiveness, efficiency, relevance, coherence, and EU added value. The EC will not conduct any further work on the Draft Measure on Printed FCMs, until such time as it has completed the evaluation of EU food-contact legislation more broadly. The current timeline for the completion of this latter evaluation is early 2020.
V. Conclusion
At the moment, and for the foreseeable future, the Swiss Printing Inks Ordinance is the most complete piece of national legislation in Europe regulating substances intended for use in printing inks that are not intended to directly contact food. While currently the only legal standard of its kind in Europe, the Swiss Ordinance only directly applies to companies selling their products in Switzerland, although it is often used as a useful reference by other business operators operating outside of the country and especially in the EU to support the demonstration of compliance with the safety requirement of Article 3 of the Framework Regulation.
Although the EC has conducted work on a Draft Measure on Printed FCMs, this work is now tabled, and it is uncertain when/if it will be completed. Finally, Germany had placed its Draft Printing Inks Ordinance on hold due to the work being undertaken at the EU level. Now that the EU efforts have been tabled, the Germany authorities could re-commence this work on its draft ordinance, although, at this time, they have not opted to do so.
[1] Colorants manufactured outside of the EU/European Economic Area (EEA)/Turkey would need to be lawfully marketed in another EU Member State/EEA/Turkey prior to be placed on the market in the Netherlands to avail of the mutual recognition principle. The EEA consists of the 28 EU Member States, Norway, Iceland, and Liechtenstein.
[2] Annex 2 lists the monomers/starting substances, additives and polymer production aids that may be used in the manufacture of plastic materials and articles in Switzerland.
[3] Note for Guidance for the Preparation of an Application for the Safety Assessment of a Substance to be used in Plastic FCMs (last updated on May 8, 2017).
[4] The suspension of work on the German draft Ordinance is consistent with Article 6.3 of Directive (EU) 2015/1535 (laying down a procedure for the provision of information in the field of technical regulations and of rules on information society services). Article 6.3 requires Member States to postpone adoption of a draft technical regulation for 12 months following the EC’s receipt of the draft, if, within three months of that date, the EC announces its intention to propose or adopt a directive, regulation, or decision on the matter (although, strictly speaking, the EC made this announcement after the expiration of the initial 3 month standstill period).
[5] See, for instance, presentation by Dr. Stefan Merkel, BfR, at the EFSA’s FIP Network meeting on July 11, 2018 (https://www.efsa.europa.eu/sites/default/files/event/180710-p-16.1.pdf). More recently, a German language version of the draft guideline was circulated to certain experts and organizations for comment.
[6] For example, the unlisted substances could not be CMRs and were not permitted to migrate to food at a detection limit of 0.01 mg/kg.
[7] For example, while the EC’s May 5, 2017 presentation outlines that the scheme would be applicable to both intermediate and final FCMs, a later EC presentation of September 14, 2017 only refers to final FCMs.
