David Savastano, Editor01.16.19
With the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program and the new US’s Toxic Substances Control Act Lautenberg Chemical Safety Act (TSCA LCSA), which was signed into law in 2016, the oversight of chemicals has been on the minds of government.
As a result, there is a lot more research being conducted on occupational safety and health hazards, resulting in more materials being put on various exclusion lists (photoinitiator 369 is one example of this). For ink manufacturers and their suppliers, managing key raw materials, as well as how they impact consumers and employees, is an ongoing challenge.
George Fuchs, director, regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), said that the increased and intense scrutiny of the potential health and environmental effects of very low-level exposures is and will continue to have a significant influence on how printing ink is formulated.
“The more reactive chemical compounds (like PI369) are the current focus but other materials used in ink like Pigment Violet 29 on the TSCA initial priorities list are also being looked at,” Fuchs reported. “The impacts of these evaluations extend beyond the occupational health area in the ink manufacturing and into our customers’ facilities and onto the CPGs in the form of private non-use lists. Ink companies should be following these evaluations (and lists of chemicals for future evaluations) and be prepared to substitute suitable substances.”
“Other photoinitiators will undoubtedly be added to the list along with other materials, some unforeseen,” said Duane Ness, director of EHS and regulatory compliance for INX International Ink Co. “All will be handled on a case by case basis.”
Lisa Fine, technical director, Ink Systems, Inc. and president of RadTech North America, offered her insight into the present state of regulatory mandates for chemicals and how they impact the ink industry.
“The non-objective media and the public assume that if a chemical is present, that constitutes a problem, but they are not considering the fact that exposure is the most critical aspect,” Fine observed. “In considering animal testing results, it should be considered that if you force enough of a substance on a rodent, it will show an effect. The challenge is extrapolating such results to a human at a low level.
“When I talk with printers, I explain that while there are hazards associated with some energy curable materials, these would only manifest in specific instances,” Fine added. “One example would be if a pregnant woman was exposed to an ink containing a reproductive toxin. However, in this case, a sizeable amount of ink would actually have to be ingested – not a probable scenario. So the dominant initiative is using the inks in a safe manner. We have to work with our customers and emphasize that we want to keep everyone safe.”
Michael Gould of Rahn, RadTech North America’s EHS chair, noted that as new toxicological data becomes available on substances, the industry has seen several substances, primarily photoinitiators, being labeled as reprotox hazards.
“This often leads to customers wanting to remove this chemical from their formulations,” Gould pointed out. “Once a chemical is identified as a CMR (Carcinogen, Mutagen or Reproductive Toxin), one of the European member states will nominate for inclusion on the Substances of Very High Concern (SVHC) list. Once listed as an SVHC, the substance would then likely be Authorized in the EU.”
Gould said that TMPTA is one area of concern for energy curable ink manufacturers.
“Our industry is most concerned with the recent classification of technical grade TMPTA as a probable carcinogen to humans by IARC (Group 1B),” Gould added. “Experts believe the data does not support this classification and are working with IARC and the European Commission to try to reverse this classification or at least prove to ECHA that it is incorrect. TMPTA is a workhorse in UV/EB inks, and classification as a CMR would have a significant impact on the industry.”
“Not to be understated is the influence of SNURs (significant new use rules) on recent chemical registrations,” Gould added. “For example, some monomers and oligomers have been regulated such that the use of a NIOSH APF 1000 respirator is required to handle these new materials. Several industry segments are pushing back against this as our focus (under OSHA) is to emphasize effective engineering controls, SOPs and worker education to avoid exposure altogether.”
David Wawer, executive director, Color Pigments Manufacturers Association, Inc. (CPMA), noted that the US Environmental Protection Agency (EPA) has just begun the process of evaluating its inventory of 38,000 existing chemical substances to determine whether or not to place restrictions on their uses.
“New chemicals (those that were not placed on the original 1980s inventory) that have entered the marketplace in the past three decades have been subject to new chemicals risk analysis (PMNs),” Wawer added. “Typically, the new chemical approved by EPA comes with use restrictions, also known as SNURs. This would be the primary US government list with restricted uses. I’m not aware of any EPA exclusion list that would include color pigments. Canadian ministries have been conducting risk evaluations of chemicals for 15 years (CMP - Chemicals Management Plan). After having conducted in-depth risk evaluations of almost 4,500 substances, that government has placed restrictions on a handful of chemicals. Pigment Red 3 is one of them - it is only allowed to be used for paint industry applications (SNAc).”
Dr. Martin Kanert, executive manager, European Printing Ink Association – EuPIA, A sector of CEPE aisbl, reported that EuPIA members are committed to the EuPIA Exclusion Policy for Printing Inks and Related Products.
“In fact, it has been an important code protecting the health and safety of workers in the ink and printing industries, as well as the end users of printed materials,” Dr. Kanert added. “In 1996, the European sector group of the printing ink industry took over existing national stewardship initiatives to create the Exclusion List for Printing Inks and Related Products. It applied stricter rules to the manufacture and marketing of inks than the existing legal regulations would have required. In taking this responsibility, the European ink industry took a proactive lead for the world. Since 2003, the European printing ink industry is represented by EuPIA and maintains such important tasks through its Technical Committee, which over the years has amended and adopted the Exclusion List from time to time.
“Until 2016, the criteria of the Exclusion List were simply hazard-based. But to assess the risk, it must also be taken into account how the substance is used and whether there is any exposure. The combination of toxicological data as well as data on uses and exposure is needed to properly assess risk for the use of a substance. With the regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals - REACH - more and more of these data will be available,” Dr. Kanert continued.
“REACH addresses not only the hazard properties of chemicals but also their potential impact on human health and the environment, considering their intended uses and exposure scenarios,” added Dr. Kanert. “One core element is the demand to communicate measures for using a substance safely. Taken together, data and proper information will make the handling of chemicals much safer. REACH came into force in 2007 and will only be fully implemented after more than a full decade because it is the most complex and strictest law for chemicals regulation throughout the world. More than 140,000 chemical substances have been pre-registered, and the greater part was registered by the third registration deadline in May 2018. In time, all substances will have been assessed and the most hazardous will be subject to appropriate regulatory controls in Europe as per their uses and exposure. When fully implemented, this would mean that an Exclusion List will not be needed anymore.”
“All substances that were excluded for the manufacture of printing inks in the former EuPIA Exclusion List will remain excluded in the Exclusion Policy,” Dr. Kanert observed. “The EuPIA Exclusion Policy, to which all EuPIA member companies have agreed, maintains the hazard-based approach from the former list. However, elements of exposure-based risk assessment and management have been introduced which shall apply in cases where existing raw material is re-classified and thus fulfills exclusion criteria. For these raw materials, rules are defined on how the procedures of substitution may be handled or, if not replaceable in the short term, under which circumstances a safe continued use may be possible (time-limited where appropriate). In this way, negative impacts on customers’ processes or business continuity can be mitigated, while still striving to uphold the highest standards of health and safety.”
When all is said and done, Fine noted that you can’t brand all chemicals as bad things.
“You have to understand that risk assessment is necessary for determining the true impact. It is an oversimplification to just tacitly remove ingredients from a product just because they might be problematic in a particular circumstance. The elements of that circumstance must be critically evaluated in order to decide whether removal is indeed necessary. There are definitely some ingredients that should not be in inks, such as heavy metals, but such things are long gone. Now there is a clamor to remove ingredients that may not be problematic under the actual conditions of use. We will get to the point where there will not be enough functional materials left to actually make an ink!”
As a result, there is a lot more research being conducted on occupational safety and health hazards, resulting in more materials being put on various exclusion lists (photoinitiator 369 is one example of this). For ink manufacturers and their suppliers, managing key raw materials, as well as how they impact consumers and employees, is an ongoing challenge.
George Fuchs, director, regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), said that the increased and intense scrutiny of the potential health and environmental effects of very low-level exposures is and will continue to have a significant influence on how printing ink is formulated.
“The more reactive chemical compounds (like PI369) are the current focus but other materials used in ink like Pigment Violet 29 on the TSCA initial priorities list are also being looked at,” Fuchs reported. “The impacts of these evaluations extend beyond the occupational health area in the ink manufacturing and into our customers’ facilities and onto the CPGs in the form of private non-use lists. Ink companies should be following these evaluations (and lists of chemicals for future evaluations) and be prepared to substitute suitable substances.”
“Other photoinitiators will undoubtedly be added to the list along with other materials, some unforeseen,” said Duane Ness, director of EHS and regulatory compliance for INX International Ink Co. “All will be handled on a case by case basis.”
Lisa Fine, technical director, Ink Systems, Inc. and president of RadTech North America, offered her insight into the present state of regulatory mandates for chemicals and how they impact the ink industry.
“The non-objective media and the public assume that if a chemical is present, that constitutes a problem, but they are not considering the fact that exposure is the most critical aspect,” Fine observed. “In considering animal testing results, it should be considered that if you force enough of a substance on a rodent, it will show an effect. The challenge is extrapolating such results to a human at a low level.
“When I talk with printers, I explain that while there are hazards associated with some energy curable materials, these would only manifest in specific instances,” Fine added. “One example would be if a pregnant woman was exposed to an ink containing a reproductive toxin. However, in this case, a sizeable amount of ink would actually have to be ingested – not a probable scenario. So the dominant initiative is using the inks in a safe manner. We have to work with our customers and emphasize that we want to keep everyone safe.”
Michael Gould of Rahn, RadTech North America’s EHS chair, noted that as new toxicological data becomes available on substances, the industry has seen several substances, primarily photoinitiators, being labeled as reprotox hazards.
“This often leads to customers wanting to remove this chemical from their formulations,” Gould pointed out. “Once a chemical is identified as a CMR (Carcinogen, Mutagen or Reproductive Toxin), one of the European member states will nominate for inclusion on the Substances of Very High Concern (SVHC) list. Once listed as an SVHC, the substance would then likely be Authorized in the EU.”
Gould said that TMPTA is one area of concern for energy curable ink manufacturers.
“Our industry is most concerned with the recent classification of technical grade TMPTA as a probable carcinogen to humans by IARC (Group 1B),” Gould added. “Experts believe the data does not support this classification and are working with IARC and the European Commission to try to reverse this classification or at least prove to ECHA that it is incorrect. TMPTA is a workhorse in UV/EB inks, and classification as a CMR would have a significant impact on the industry.”
“Not to be understated is the influence of SNURs (significant new use rules) on recent chemical registrations,” Gould added. “For example, some monomers and oligomers have been regulated such that the use of a NIOSH APF 1000 respirator is required to handle these new materials. Several industry segments are pushing back against this as our focus (under OSHA) is to emphasize effective engineering controls, SOPs and worker education to avoid exposure altogether.”
David Wawer, executive director, Color Pigments Manufacturers Association, Inc. (CPMA), noted that the US Environmental Protection Agency (EPA) has just begun the process of evaluating its inventory of 38,000 existing chemical substances to determine whether or not to place restrictions on their uses.
“New chemicals (those that were not placed on the original 1980s inventory) that have entered the marketplace in the past three decades have been subject to new chemicals risk analysis (PMNs),” Wawer added. “Typically, the new chemical approved by EPA comes with use restrictions, also known as SNURs. This would be the primary US government list with restricted uses. I’m not aware of any EPA exclusion list that would include color pigments. Canadian ministries have been conducting risk evaluations of chemicals for 15 years (CMP - Chemicals Management Plan). After having conducted in-depth risk evaluations of almost 4,500 substances, that government has placed restrictions on a handful of chemicals. Pigment Red 3 is one of them - it is only allowed to be used for paint industry applications (SNAc).”
Dr. Martin Kanert, executive manager, European Printing Ink Association – EuPIA, A sector of CEPE aisbl, reported that EuPIA members are committed to the EuPIA Exclusion Policy for Printing Inks and Related Products.
“In fact, it has been an important code protecting the health and safety of workers in the ink and printing industries, as well as the end users of printed materials,” Dr. Kanert added. “In 1996, the European sector group of the printing ink industry took over existing national stewardship initiatives to create the Exclusion List for Printing Inks and Related Products. It applied stricter rules to the manufacture and marketing of inks than the existing legal regulations would have required. In taking this responsibility, the European ink industry took a proactive lead for the world. Since 2003, the European printing ink industry is represented by EuPIA and maintains such important tasks through its Technical Committee, which over the years has amended and adopted the Exclusion List from time to time.
“Until 2016, the criteria of the Exclusion List were simply hazard-based. But to assess the risk, it must also be taken into account how the substance is used and whether there is any exposure. The combination of toxicological data as well as data on uses and exposure is needed to properly assess risk for the use of a substance. With the regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals - REACH - more and more of these data will be available,” Dr. Kanert continued.
“REACH addresses not only the hazard properties of chemicals but also their potential impact on human health and the environment, considering their intended uses and exposure scenarios,” added Dr. Kanert. “One core element is the demand to communicate measures for using a substance safely. Taken together, data and proper information will make the handling of chemicals much safer. REACH came into force in 2007 and will only be fully implemented after more than a full decade because it is the most complex and strictest law for chemicals regulation throughout the world. More than 140,000 chemical substances have been pre-registered, and the greater part was registered by the third registration deadline in May 2018. In time, all substances will have been assessed and the most hazardous will be subject to appropriate regulatory controls in Europe as per their uses and exposure. When fully implemented, this would mean that an Exclusion List will not be needed anymore.”
“All substances that were excluded for the manufacture of printing inks in the former EuPIA Exclusion List will remain excluded in the Exclusion Policy,” Dr. Kanert observed. “The EuPIA Exclusion Policy, to which all EuPIA member companies have agreed, maintains the hazard-based approach from the former list. However, elements of exposure-based risk assessment and management have been introduced which shall apply in cases where existing raw material is re-classified and thus fulfills exclusion criteria. For these raw materials, rules are defined on how the procedures of substitution may be handled or, if not replaceable in the short term, under which circumstances a safe continued use may be possible (time-limited where appropriate). In this way, negative impacts on customers’ processes or business continuity can be mitigated, while still striving to uphold the highest standards of health and safety.”
When all is said and done, Fine noted that you can’t brand all chemicals as bad things.
“You have to understand that risk assessment is necessary for determining the true impact. It is an oversimplification to just tacitly remove ingredients from a product just because they might be problematic in a particular circumstance. The elements of that circumstance must be critically evaluated in order to decide whether removal is indeed necessary. There are definitely some ingredients that should not be in inks, such as heavy metals, but such things are long gone. Now there is a clamor to remove ingredients that may not be problematic under the actual conditions of use. We will get to the point where there will not be enough functional materials left to actually make an ink!”