David Savastano, Editor02.01.21
Ink industry regulatory officials have their hands full when it comes to regulatory matters. It seems like the standards vary between regions, and the targets are ever-changing.
Meanwhile, stakeholders ranging from government leaders to brand owners are keeping pressure on.
For example, there are a number of substances that are under various levels of scrutiny by federal and/or state government, including titanium dioxide (TiO2), perfluorooctanoic acid (PFOA) and per- and poly-fluoroalkyl substances (PFAS), and polychlorinated biphenyls (PCBs). Rebecca Lipscomb, director, global regulatory affairs for INX International Ink Co., noted that INX is receiving inquiries on these substances.
George Fuchs, director – regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), noted that in many cases, substance-specific issues like these take a little time before they reach the brands and public.
“Regardless, most ink manufacturers are aware of the issues and have been preparing for possible ‘restrictions’ issued in the downstream supply chain,” he added.
Titanium Dioxide
Titanium dioxide is critical to the production of inks. David Wawer, executive director, Color Pigments Manufacturers Association, Inc. (CPMA), said that the scrutiny about TiO2, for example, emanates specifically from the EU and its chemicals agency, ECHA.
“That is where NGOs lobbied extensively to the EU Science Advisory Panel, over a period of three years, to persuade the EU to classify TiO2 as a probable carcinogen,” Wawer said.
He added that CPMA monitored the progress of this EU initiative through one of its sister European color pigments trade associations, Eurocolour.
“When it was determined that the EO TiO2 industry association and allied EU trade associations such as CEFIC had been procedurally outmaneuvered by the NGOs in the lobbying effort to oppose classification as a probable carcinogen, EU industry trade associations were then successful in narrowing the scope of the regulatory impact on their industry,” Wawer added.
“What remains uncertain are labeling requirements from downstream industry sectors, such as color pigments. Since this is an EU government initiative, it has zero impact on chemicals laws in the US, Canada, and Mexico. One of the challenges for the North American color pigments industry, when the EU labeling regulations and guidance documents are finalized, is determining how to treat this EU-specific regulation with respect to other global regions where color pigments are sold,” Wawer said.
Keller and Heckman LLP, a law firm in Washington, D.C. that specializes in food and drug and environmental law, has indicated that colorant suppliers are reporting a recent and increased focus on TiO2 and carbon black, particularly as it relates to nano-size particles, for both packaging and medical device applications.
Further, according to Catherine Nielsen and Jeff Keithline at the firm, TiO2, per se, has experienced heightened scrutiny in part due to France’s one-year suspension on the use, import and marketing of any food product containing TiO2 as a food additive during 2020. A 2017 French scientific study had highlighted the potential carcinogenic risks of nanoparticles of TiO2, even though the European Food Safety Agency stated in 2016 that TiO2 posed no health concerns.
The European Commission’s 2019 classification of titanium dioxide in powder form as a category 2 carcinogen (based on inhalation hazard) has also clouded the marketing and sales of printing inks containing the widely used pigment. The harmonized Classification, Labelling and Packaging of Substances and Mixtures (CLP) classification applies to powder TiO2 and mixtures placed on the market “in powder form containing 1% or more of TiO2 which is in the form of, or incorporated in, particles.”
Michael Gould, technical key account manager, energy curing USA for RAHN USA, serves as EHS chair for RadTech. He said that TiO2 has “definitely” come into “the crosshairs” of global regulators. Gould noted that exposure risks for inhalation hazards can be addressed effectively by engineering controls, and PPE recommendations to mitigate respiratory exposure will be communicated to users via safety data sheets.
“We do not believe this new classification will cause a disruption in the use of TiO2,” added Gould. “However, there are still lingering questions concerning downstream liability.
If a converter fully cures a TiO2-containing ink and far downstream in the consumer or post-consumer value chain someone is exposed to dust as that ink is abraded from the substrate, is the converter liable for potential adverse health effects? Is the ink supplier potentially liable? The manufacturer of the TiO2?
“This, in a nutshell, captures the greatest threat to a healthy and competitive chemical industry, of which UV/EB is a small subset,” he pointed out. “At some point, tort reform must establish how much liability companies can face when they comply with all laws and regulations in commerce. Liability for activity far-removed from the intended use of materials cannot fairly be determined through litigation; it must be established through statute.”
PFOA and PFAS
PFOA and PFAS are also in the crosshairs. Rachel Bond at Keller and Heckman LLP noted that per- and poly-fluoroalkyl substances (PFAS) continue to face enhanced scrutiny at the federal and state level.
According to Bond, it is not surprising to see the supply chain add PFAS to the growing list of “chemicals of concern,” triggering inquiries about the presence of such compounds in the products they purchase.
FDA’s focus has been on C6 fluorotelomer compounds cleared in narrow food contact applications (grease-proof papers); other types of PFAS without the toxicity concerns surrounding C6 fluorotelomers are authorized by FDA for use in food processing equipment, non-stick cookware, processing aids in food contact polymers, and other paper and paperboard applications.
FDA’s concerns regarding PFAS have evolved over the last few years, with worries first expressed regarding safety data gaps, growing into concerns regarding potential biopersistence of short-chain C6-based fluorotelomer compounds.
Bond added that with new toxicity data becoming publicly available, in July 2020, FDA announced a voluntary phase-out of a certain type of short-chain PFAS containing 6:2 fluorotelomer alcohol from the US food-contact marketplace. Affected manufacturers of C6 fluorotelomer grease proofing agents used in the production of paper and paperboard have committed to phase-out marketing of these products beginning in 2021 and ending in 2023, with exhaustion by the supply chain expected to occur within 18 months. Although the restrictions on use have focused on the short-chain PFAS containing 6:2 fluorotelomer alcohol, FDA is more broadly seeking pharmacokinetic (PK) data on fluoropolymers generally due to general biopersistence concerns.
Meanwhile, state-level initiatives have targeted PFAS more broadly. Although the scope is largely limited to food packaging or paper-based food packaging, proposed and enacted state bans have defined PFAS to include any substance with at least one fully fluorinated carbon atom.
As an example, New York State Gov. Andrew Cuomo signed legislation on Dec. 3, 2020, that prohibits the sale of food packaging containing intentionally added perfluoroalkyl and polyfluoroalkyl substances, effective Dec. 31, 2022.
And, Keller and Heckman notes, the Toxics in Packaging Clearinghouse (TPCH), a coalition of US states that has developed model legislation to support states in the implementation of toxics in packaging laws, issued a proposal this past summer to update the group’s model legislation.
While the current model legislation limits the presence of metals (cadmium, lead, mercury, and hexavalent chromium) in all finished packaging and packaging components, the proposed changes would add per- and polyfluoroalkyl substances (PFAS) and ortho-phthalates as regulated chemicals, and considers how to identify other “chemicals of high concern” relative to packaging. Specifically, the intentional use of PFAS would be prohibited in packaging, and “ortho-phthalates may only be unintentionally present in packaging up to 100 ppm.”
Keller and Heckman LLP reports that printing inks containing polychlorinated biphenyls (PCBs) have been named as priority consumer products under Washington State’s Safer Products Program.
The law identified the first set of priority chemical classes as including per- and polyfluoroalkyl substances (PFASs), PCBs, phenolic compounds, and phthalates. The Washington State Department of Ecology’s (DoE) final legislative report on Priority Products under the Safer Products for Washington program, issued this past summer, identifies 11 priority products that the department considers to be a significant source of or use of priority chemicals, including printing inks containing PCBs. Concerning printing inks, the report notes that they are a significant source of unintentionally generated PCBs.
The report concludes that pigments and other compounds can become contaminated with PCBs because of non-specific chlorination processes in heated reactions involving carbon and chlorine. The report specifically mentions diarylide yellows, phthalocyanines, and titanium dioxide as affected pigments.
At this point, the state plans to accept information and data from manufacturers, and from there, determine if safer alternatives are available. If the priority chemicals remain in the priority products, the state will then assess whether a restriction or reporting requirement should be adopted.
Meanwhile, stakeholders ranging from government leaders to brand owners are keeping pressure on.
For example, there are a number of substances that are under various levels of scrutiny by federal and/or state government, including titanium dioxide (TiO2), perfluorooctanoic acid (PFOA) and per- and poly-fluoroalkyl substances (PFAS), and polychlorinated biphenyls (PCBs). Rebecca Lipscomb, director, global regulatory affairs for INX International Ink Co., noted that INX is receiving inquiries on these substances.
George Fuchs, director – regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), noted that in many cases, substance-specific issues like these take a little time before they reach the brands and public.
“Regardless, most ink manufacturers are aware of the issues and have been preparing for possible ‘restrictions’ issued in the downstream supply chain,” he added.
Titanium Dioxide
Titanium dioxide is critical to the production of inks. David Wawer, executive director, Color Pigments Manufacturers Association, Inc. (CPMA), said that the scrutiny about TiO2, for example, emanates specifically from the EU and its chemicals agency, ECHA.
“That is where NGOs lobbied extensively to the EU Science Advisory Panel, over a period of three years, to persuade the EU to classify TiO2 as a probable carcinogen,” Wawer said.
He added that CPMA monitored the progress of this EU initiative through one of its sister European color pigments trade associations, Eurocolour.
“When it was determined that the EO TiO2 industry association and allied EU trade associations such as CEFIC had been procedurally outmaneuvered by the NGOs in the lobbying effort to oppose classification as a probable carcinogen, EU industry trade associations were then successful in narrowing the scope of the regulatory impact on their industry,” Wawer added.
“What remains uncertain are labeling requirements from downstream industry sectors, such as color pigments. Since this is an EU government initiative, it has zero impact on chemicals laws in the US, Canada, and Mexico. One of the challenges for the North American color pigments industry, when the EU labeling regulations and guidance documents are finalized, is determining how to treat this EU-specific regulation with respect to other global regions where color pigments are sold,” Wawer said.
Keller and Heckman LLP, a law firm in Washington, D.C. that specializes in food and drug and environmental law, has indicated that colorant suppliers are reporting a recent and increased focus on TiO2 and carbon black, particularly as it relates to nano-size particles, for both packaging and medical device applications.
Further, according to Catherine Nielsen and Jeff Keithline at the firm, TiO2, per se, has experienced heightened scrutiny in part due to France’s one-year suspension on the use, import and marketing of any food product containing TiO2 as a food additive during 2020. A 2017 French scientific study had highlighted the potential carcinogenic risks of nanoparticles of TiO2, even though the European Food Safety Agency stated in 2016 that TiO2 posed no health concerns.
The European Commission’s 2019 classification of titanium dioxide in powder form as a category 2 carcinogen (based on inhalation hazard) has also clouded the marketing and sales of printing inks containing the widely used pigment. The harmonized Classification, Labelling and Packaging of Substances and Mixtures (CLP) classification applies to powder TiO2 and mixtures placed on the market “in powder form containing 1% or more of TiO2 which is in the form of, or incorporated in, particles.”
Michael Gould, technical key account manager, energy curing USA for RAHN USA, serves as EHS chair for RadTech. He said that TiO2 has “definitely” come into “the crosshairs” of global regulators. Gould noted that exposure risks for inhalation hazards can be addressed effectively by engineering controls, and PPE recommendations to mitigate respiratory exposure will be communicated to users via safety data sheets.
“We do not believe this new classification will cause a disruption in the use of TiO2,” added Gould. “However, there are still lingering questions concerning downstream liability.
If a converter fully cures a TiO2-containing ink and far downstream in the consumer or post-consumer value chain someone is exposed to dust as that ink is abraded from the substrate, is the converter liable for potential adverse health effects? Is the ink supplier potentially liable? The manufacturer of the TiO2?
“This, in a nutshell, captures the greatest threat to a healthy and competitive chemical industry, of which UV/EB is a small subset,” he pointed out. “At some point, tort reform must establish how much liability companies can face when they comply with all laws and regulations in commerce. Liability for activity far-removed from the intended use of materials cannot fairly be determined through litigation; it must be established through statute.”
PFOA and PFAS
PFOA and PFAS are also in the crosshairs. Rachel Bond at Keller and Heckman LLP noted that per- and poly-fluoroalkyl substances (PFAS) continue to face enhanced scrutiny at the federal and state level.
According to Bond, it is not surprising to see the supply chain add PFAS to the growing list of “chemicals of concern,” triggering inquiries about the presence of such compounds in the products they purchase.
FDA’s focus has been on C6 fluorotelomer compounds cleared in narrow food contact applications (grease-proof papers); other types of PFAS without the toxicity concerns surrounding C6 fluorotelomers are authorized by FDA for use in food processing equipment, non-stick cookware, processing aids in food contact polymers, and other paper and paperboard applications.
FDA’s concerns regarding PFAS have evolved over the last few years, with worries first expressed regarding safety data gaps, growing into concerns regarding potential biopersistence of short-chain C6-based fluorotelomer compounds.
Bond added that with new toxicity data becoming publicly available, in July 2020, FDA announced a voluntary phase-out of a certain type of short-chain PFAS containing 6:2 fluorotelomer alcohol from the US food-contact marketplace. Affected manufacturers of C6 fluorotelomer grease proofing agents used in the production of paper and paperboard have committed to phase-out marketing of these products beginning in 2021 and ending in 2023, with exhaustion by the supply chain expected to occur within 18 months. Although the restrictions on use have focused on the short-chain PFAS containing 6:2 fluorotelomer alcohol, FDA is more broadly seeking pharmacokinetic (PK) data on fluoropolymers generally due to general biopersistence concerns.
Meanwhile, state-level initiatives have targeted PFAS more broadly. Although the scope is largely limited to food packaging or paper-based food packaging, proposed and enacted state bans have defined PFAS to include any substance with at least one fully fluorinated carbon atom.
As an example, New York State Gov. Andrew Cuomo signed legislation on Dec. 3, 2020, that prohibits the sale of food packaging containing intentionally added perfluoroalkyl and polyfluoroalkyl substances, effective Dec. 31, 2022.
And, Keller and Heckman notes, the Toxics in Packaging Clearinghouse (TPCH), a coalition of US states that has developed model legislation to support states in the implementation of toxics in packaging laws, issued a proposal this past summer to update the group’s model legislation.
While the current model legislation limits the presence of metals (cadmium, lead, mercury, and hexavalent chromium) in all finished packaging and packaging components, the proposed changes would add per- and polyfluoroalkyl substances (PFAS) and ortho-phthalates as regulated chemicals, and considers how to identify other “chemicals of high concern” relative to packaging. Specifically, the intentional use of PFAS would be prohibited in packaging, and “ortho-phthalates may only be unintentionally present in packaging up to 100 ppm.”
Keller and Heckman LLP reports that printing inks containing polychlorinated biphenyls (PCBs) have been named as priority consumer products under Washington State’s Safer Products Program.
The law identified the first set of priority chemical classes as including per- and polyfluoroalkyl substances (PFASs), PCBs, phenolic compounds, and phthalates. The Washington State Department of Ecology’s (DoE) final legislative report on Priority Products under the Safer Products for Washington program, issued this past summer, identifies 11 priority products that the department considers to be a significant source of or use of priority chemicals, including printing inks containing PCBs. Concerning printing inks, the report notes that they are a significant source of unintentionally generated PCBs.
The report concludes that pigments and other compounds can become contaminated with PCBs because of non-specific chlorination processes in heated reactions involving carbon and chlorine. The report specifically mentions diarylide yellows, phthalocyanines, and titanium dioxide as affected pigments.
At this point, the state plans to accept information and data from manufacturers, and from there, determine if safer alternatives are available. If the priority chemicals remain in the priority products, the state will then assess whether a restriction or reporting requirement should be adopted.
