An understanding of the regulatory systems that apply to printing inks used on food packages is necessary not only for companies that manufacture these inks, but also for food producers, manufacturers of packaging materials, and converters. 

 

In the European Union (EU), the system of regulating printing inks currently in place can present challenges for those seeking to establish a suitable EU status for a food package, in part, because no single EU-wide regulation specifically clears “ink components” used in food packaging by way of a positive list. 

 

Despite the lack of a positive list for inks at the EU level, printing inks on food packages are regulated at the EU level as food-contact substances; hence, their use is governed by general EU food-contact regulations and, in a somewhat roundabout way, by material-specific EU regulations or directives. 

 

The Framework Regulation, (EC) 1935/2004, establishes general safety requirements for all food-contact materials and articles. These include prohibiting the transfer of their constituents to food in quantities that could endanger human health, result in an unacceptable change in the food’s composition, or negatively impact the food’s organoleptic characteristics. 

 

The GMP Regulation, (EC) 2023/2006, establishes good manufacturing practices for food-contact materials and articles. For printing inks, the regulation specifically requires that they be manufactured in a way to minimize potential migration through the substrate, and that printed material be handled in a way so as to limit transfer of inks to the direct food-contact side of packages through off-set during stacking or rolling.

 

Although the EU Plastics Regulation, (EU) No. 10/2011 does not apply to printing inks, per se, it may govern the use of printing ink in some applications. For example, the Plastics Regulation includes a positive list of substances permitted for use in food-contact plastic materials. While printing inks on plastics may consist of components other than those on that list, printing ink components that are on the positive list and have specific migration limits (SMLs) or other restrictions, should comply with those limitations when used on plastic articles covered by the Regulation. 

 

The Plastics Regulation also has an overall migration limit (OML) of 50 mg/kg food or 10 mg/dm2 surface area, and any migration from printing inks must be taken into account when determining compliance of the finished article with the OML. Printing inks are not subject to the regulation’s Declaration of Compliance (DoC) requirement, but adequate information must be passed on to enable the final manufacturer to ensure that applicable migration limits are met. 

 

Another material-specific directive, the Regenerated Cellulose Film Directive 2007/42/EC specifies that the printed surface of regenerated cellulose film must not come into contact with food.

 

Food-contact printing ink uses not subject to harmonized EU legislation must comply with the appropriate national laws of each Member State, subject to the principle of mutual recognition. Currently, there is no specific Member State legislation regulating printing inks intended for food-contact applications; however, some Member States have purity requirements for colorants used in printing ink applications, and Germany has published a Draft Ordinance on printing inks.

 

Member States with purity requirements for colorants used in printing ink applications include Romania (Ministerial Order No. 869/2006), the Czech Republic (Decree no. 38/2001), and Slovakia. In the Netherlands, revisions of legislation on food packaging that will impact printing inks are underway. In particular, a new chapter XI on colorants to be inserted in Appendix A of the Dutch Packaging and Utensils Regulations, 1979, specifies that migration limits for colorants extend to colorants used in printing inks. 

 

Several other Member States (e.g., Italy, Belgium, the Netherlands and Greece) have purity requirements for colorants used in plastic materials and articles (which may be printed). The Member State purity requirements mainly relate to heavy metals and aromatic amines.

 

While not a member of the EU, Switzerland has specific legislation regulating food-contact printing inks. Swiss Ordinance RS 817.023.21 includes a list of substances that are permitted in inks used to print on food packages. The list includes both evaluated and non-evaluated substances. The non-evaluated substances are only permitted if they do not migrate to food at a level of 0.01 mg/kg or above. The use of unlisted substances must be reported to Swiss Authorities prior to marketing. 

 

The German Draft Ordinance on Printing Inks, when finalized, will amend the German Commodities Regulations. It establishes a positive list – with restrictions, specifications, and purity requirements – of monomers and other starting substances; colorants; solvents; additives; and photoinitiators. Substances not on the positive list may be used if they are not CMR (carcinogenic, mutagenic or toxic to reproduction); do not migrate to food at a level of 10 ppb or above; and are on an “inventory list” that will be published by Germany’s Federal Office on Consumer Protection and Food Safety (BVL). A DoC will be required for the printed food-contact material, the printing ink, and the substances intended to be used in the manufacture of the printing ink. Interestingly enough, the proposed Ordinance only applies to inks that are not used directly in contact with food. Presumably, those components used directly in contact with food are subject to other regulation at the EU or state level. 

 

In 2005, the Council of Europe (CoE) Committee of Ministers of the Partial Agreement in the Social and Public Health Field adopted Resolution ResAP (2005)2 on packaging inks applied to the non-food contact surface of food packaging. This resolution served as the basis for Swiss Ordinance RS 817.023.21 on printing inks. It also includes lists of evaluated and nonevaluated substances that are permitted in inks to be used on food packages. 

 

A few years later in 2009, the European Printing Ink Association (EuPIA) published a guidance on food printing inks, which it updated in 2011. In one response to a list of “Frequently Asked Questions,” EuPIA stated that it could not support the CoE Resolution because “[t]he substance inventory lists were not sufficiently comprehensive, and did not provide protection for consumer health or reflect current practices.”

 

The EuPIA guidance provides recommendations on selection of raw materials used in packaging inks, and provides guidance on assessing potential migration of ink components to food. It also prohibits CMRs, heavy metal-based colorants, and dangerous and toxic substances.

 

Maybe of even more importance, EuPIA has published a guidance to help converters and end users assess the compliance of printed packaging using information provided by an ink supplier. It recommends that the converter obtain 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.

 

French Guidelines on “Inks, coatings and varnishes for printing on the non-food contact side of materials” were updated in September 2012. They provide steps to be taken in safety assessments of food packaging printing inks, and list legislation, CoE resolutions, and other guidance documents that can be referenced when conducting the assessments.

 

The Nordic Guidelines on Printing Inks, developed by Norway, Sweden, Finland, Denmark and Iceland, were published in 2012. They include details of printing ink composition and processes; an overview of relevant legislation and guidelines; and check lists for drafting DoCs, including instructions for use of printing inks and supporting documentation.

 

Demonstrating the safety and regulatory compliance of printing inks on food packages in the EU is a multi-faceted process and requires cooperation throughout the supply chain.  

 

Keller and Heckman LLP

(202) 434-4000; www.khlaw.com

An understanding of the regulatory systems that apply to printing inks used on food packages is necessary not only for companies that manufacture these inks, but also for food producers, manufacturers of packaging materials, and converters. 

 

In the European Union (EU), the system of regulating printing inks currently in place can present challenges for those seeking to establish a suitable EU status for a food package, in part, because no single EU-wide regulation specifically clears “ink components” used in food packaging by way of a positive list. 

 

Despite the lack of a positive list for inks at the EU level, printing inks on food packages are regulated at the EU level as food-contact substances; hence, their use is governed by general EU food-contact regulations and, in a somewhat roundabout way, by material-specific EU regulations or directives. 

 

The Framework Regulation, (EC) 1935/2004, establishes general safety requirements for all food-contact materials and articles. These include prohibiting the transfer of their constituents to food in quantities that could endanger human health, result in an unacceptable change in the food’s composition, or negatively impact the food’s organoleptic characteristics. 

 

The GMP Regulation, (EC) 2023/2006, establishes good manufacturing practices for food-contact materials and articles. For printing inks, the regulation specifically requires that they be manufactured in a way to minimize potential migration through the substrate, and that printed material be handled in a way so as to limit transfer of inks to the direct food-contact side of packages through off-set during stacking or rolling.

 

Although the EU Plastics Regulation, (EU) No. 10/2011 does not apply to printing inks, per se, it may govern the use of printing ink in some applications. For example, the Plastics Regulation includes a positive list of substances permitted for use in food-contact plastic materials. While printing inks on plastics may consist of components other than those on that list, printing ink components that are on the positive list and have specific migration limits (SMLs) or other restrictions, should comply with those limitations when used on plastic articles covered by the Regulation. 

 

The Plastics Regulation also has an overall migration limit (OML) of 50 mg/kg food or 10 mg/dm2 surface area, and any migration from printing inks must be taken into account when determining compliance of the finished article with the OML. Printing inks are not subject to the regulation’s Declaration of Compliance (DoC) requirement, but adequate information must be passed on to enable the final manufacturer to ensure that applicable migration limits are met. 

 

Another material-specific directive, the Regenerated Cellulose Film Directive 2007/42/EC specifies that the printed surface of regenerated cellulose film must not come into contact with food.

 

Food-contact printing ink uses not subject to harmonized EU legislation must comply with the appropriate national laws of each Member State, subject to the principle of mutual recognition. Currently, there is no specific Member State legislation regulating printing inks intended for food-contact applications; however, some Member States have purity requirements for colorants used in printing ink applications, and Germany has published a Draft Ordinance on printing inks.

 

Member States with purity requirements for colorants used in printing ink applications include Romania (Ministerial Order No. 869/2006), the Czech Republic (Decree no. 38/2001), and Slovakia. In the Netherlands, revisions of legislation on food packaging that will impact printing inks are underway. In particular, a new chapter XI on colorants to be inserted in Appendix A of the Dutch Packaging and Utensils Regulations, 1979, specifies that migration limits for colorants extend to colorants used in printing inks. 

 

Several other Member States (e.g., Italy, Belgium, the Netherlands and Greece) have purity requirements for colorants used in plastic materials and articles (which may be printed). The Member State purity requirements mainly relate to heavy metals and aromatic amines.

 

While not a member of the EU, Switzerland has specific legislation regulating food-contact printing inks. Swiss Ordinance RS 817.023.21 includes a list of substances that are permitted in inks used to print on food packages. The list includes both evaluated and non-evaluated substances. The non-evaluated substances are only permitted if they do not migrate to food at a level of 0.01 mg/kg or above. The use of unlisted substances must be reported to Swiss Authorities prior to marketing. 

 

The German Draft Ordinance on Printing Inks, when finalized, will amend the German Commodities Regulations. It establishes a positive list – with restrictions, specifications, and purity requirements – of monomers and other starting substances; colorants; solvents; additives; and photoinitiators. Substances not on the positive list may be used if they are not CMR (carcinogenic, mutagenic or toxic to reproduction); do not migrate to food at a level of 10 ppb or above; and are on an “inventory list” that will be published by Germany’s Federal Office on Consumer Protection and Food Safety (BVL). A DoC will be required for the printed food-contact material, the printing ink, and the substances intended to be used in the manufacture of the printing ink. Interestingly enough, the proposed Ordinance only applies to inks that are not used directly in contact with food. Presumably, those components used directly in contact with food are subject to other regulation at the EU or state level. 

 

In 2005, the Council of Europe (CoE) Committee of Ministers of the Partial Agreement in the Social and Public Health Field adopted Resolution ResAP (2005)2 on packaging inks applied to the non-food contact surface of food packaging. This resolution served as the basis for Swiss Ordinance RS 817.023.21 on printing inks. It also includes lists of evaluated and nonevaluated substances that are permitted in inks to be used on food packages. 

 

A few years later in 2009, the European Printing Ink Association (EuPIA) published a guidance on food printing inks, which it updated in 2011. In one response to a list of “Frequently Asked Questions,” EuPIA stated that it could not support the CoE Resolution because “[t]he substance inventory lists were not sufficiently comprehensive, and did not provide protection for consumer health or reflect current practices.”

 

The EuPIA guidance provides recommendations on selection of raw materials used in packaging inks, and provides guidance on assessing potential migration of ink components to food. It also prohibits CMRs, heavy metal-based colorants, and dangerous and toxic substances.

 

Maybe of even more importance, EuPIA has published a guidance to help converters and end users assess the compliance of printed packaging using information provided by an ink supplier. It recommends that the converter obtain 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.

 

French Guidelines on “Inks, coatings and varnishes for printing on the non-food contact side of materials” were updated in September 2012. They provide steps to be taken in safety assessments of food packaging printing inks, and list legislation, CoE resolutions, and other guidance documents that can be referenced when conducting the assessments.

 

The Nordic Guidelines on Printing Inks, developed by Norway, Sweden, Finland, Denmark and Iceland, were published in 2012. They include details of printing ink composition and processes; an overview of relevant legislation and guidelines; and check lists for drafting DoCs, including instructions for use of printing inks and supporting documentation.

 

Demonstrating the safety and regulatory compliance of printing inks on food packages in the EU is a multi-faceted process and requires cooperation throughout the supply chain.  

 

Keller and Heckman LLP

(202) 434-4000; www.khlaw.com