George Fuchs, Director Regulatory Affairs and Technology, NAPIM05.20.19
Printing inks are formulated from a very wide array of organic and inorganic chemical compounds. Although generally a mixing and blending type industry, it is a subset of the larger chemical manufacturing sector.
Beginning in the late 1960s (some Federal regulations predate this by decades) and continuing through today, the chemical manufacturing sector has evolved into one of the most regulated areas of all commercial activity in the US. Printing ink companies understood, early on, their environmental, health and safety (EHS) stewardship responsibilities in this regard and have developed their compliance and stewardship functions as a key component of their operations.
The following is a high-level, non-inclusive review of environmental, health and safety compliance considerations for US-based ink manufacturers.
A US-Centric Perspective
EHS compliance considerations for ink manufacturers generally focus on two areas:
• Manufacture/Formulation;
• Usage (printing)
In this regard, Federal (and in some cases, state) regulations regarding air quality, water quality, waste generation/disposal and employee health/safety (including New TSCA) are the primary concerns.
More recently, additional concerns have arisen related to the end use of printed materials/substrates. These come in three basic areas:
• Food packaging safety (e.g. potential for migration and applicability of the FDA Threshold of Regulation and attendant requirements, etc.). Note here that the US FDA regulations are specific to the US and are substantially different from other countries’ equivalent regulations. It is incorrect to assume that complying with any foreign country’s food packaging safety rules would necessarily meet US FDA compliance requirements for food packaging;
• Consumer Product Safety Commission (CPSC) third-party testing and certification 16 CFR Part 1303;
• Recyclability (non-regulatory) concerns include “deinkability” and impact of dried ink on compostability
and biodegradation.
The rules/regulations/practices applicable to these areas are fairly well understood and ink company compliance policies/procedures have (or should have) evolved to address them. NAPIM has developed, over many decades, white papers, guidance documents, bulletins, webinars, presentations, etc. covering all of these issues.
A Global Perspective
Compliance with foreign EHS (non-transportation) regulatory requirements is a relatively recent consideration for US ink manufacturers. The transportation and import/export regulations notwithstanding, the need to comply with foreign regulations arises in two general areas:
• Inks manufactured in the US and used (exported) outside of the US –Inks manufactured in the US and exported to a foreign country need to comply with the destination country EHS rules and regulations. Typically, compliance involves:
o Proper labeling, marking and packaging according to US and international transportation regulations applicable to the mode of transportation used.1
o Communicating health, safety and environmental data usually via a Globally Harmonized System (GHS)-compliant safety data sheet (SDS). It is important to note that an SDS that complies with the US/OSHA Hazard Communication Standard may not comply with the destination country’s rules and regulations.
Ink companies exporting finished inks for use in a foreign country must check the destination country’s EHS regulations to ensure compliance.
Understanding the print application is also important, as individual foreign countries may have application-specific EHS requirements. This is particularly important with food packaging applications.
At a minimum, China, Japan and European (eastern/western) have food packaging safety-related requirements which may be applicable to food packaging components (e.g. inks, adhesives, substrates, etc.). At present, there is no consistency or harmonization among these national/foreign regulations. Moreover, it is important to note that at present, there are no harmonized/EU-wide food packaging safety regulations.
• Ink used on printed products sold outside the US (primarily exported food packaging).
In most cases, printed substrate, lacking a potential for exposure, would be treated as an “article” (e.g. the EU REACh regulations provide an exclusion for printed articles, no US OSHA Hazard Communication applicability, etc.) and, as such, does not inherently require compliance as noted above with the notable exception of food packaging applications (see note above regarding food packaging applications).
Conclusions
Compliance with EHS regulations both in and outside of the United States has become increasingly complex. With the limited exception of the Globally Harmonized System for Classification and Labelling of Chemical (GHS), there is little global equivalency or harmonization of EHS and food safety regulatory requirements. Each country, even within the EU, sets and enforces its own EHS and food packaging safety regulations.
Trade associations (e.g. NAPIM, EuPIA, etc.) will continue to play important roles in guiding their memberships in complying with the regulatory requirements of their countries and advising/informing government agencies on industry-specific issues and promoting the industry to its customer base. However, trade associations do not set national or international policy or regulatory requirements.
References:
1) The Pipeline and Hazardous Materials Safety Administration (PHMSA) proposes to amend the Hazardous Materials Regulations (HMR) to maintain alignment with international regulations and standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. These revisions are necessary to harmonize the HMR with recent changes made to the International Maritime Dangerous Goods Code, the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the United Nations Recommendations on the Transport of Dangerous Goods—Model Regulations. Additionally, PHMSA proposes several amendments to the HMR that would allow for increased alignment with the Transport Canada, Transportation of Dangerous Goods (TDG) Regulations.
Beginning in the late 1960s (some Federal regulations predate this by decades) and continuing through today, the chemical manufacturing sector has evolved into one of the most regulated areas of all commercial activity in the US. Printing ink companies understood, early on, their environmental, health and safety (EHS) stewardship responsibilities in this regard and have developed their compliance and stewardship functions as a key component of their operations.
The following is a high-level, non-inclusive review of environmental, health and safety compliance considerations for US-based ink manufacturers.
A US-Centric Perspective
EHS compliance considerations for ink manufacturers generally focus on two areas:
• Manufacture/Formulation;
• Usage (printing)
In this regard, Federal (and in some cases, state) regulations regarding air quality, water quality, waste generation/disposal and employee health/safety (including New TSCA) are the primary concerns.
More recently, additional concerns have arisen related to the end use of printed materials/substrates. These come in three basic areas:
• Food packaging safety (e.g. potential for migration and applicability of the FDA Threshold of Regulation and attendant requirements, etc.). Note here that the US FDA regulations are specific to the US and are substantially different from other countries’ equivalent regulations. It is incorrect to assume that complying with any foreign country’s food packaging safety rules would necessarily meet US FDA compliance requirements for food packaging;
• Consumer Product Safety Commission (CPSC) third-party testing and certification 16 CFR Part 1303;
• Recyclability (non-regulatory) concerns include “deinkability” and impact of dried ink on compostability
and biodegradation.
The rules/regulations/practices applicable to these areas are fairly well understood and ink company compliance policies/procedures have (or should have) evolved to address them. NAPIM has developed, over many decades, white papers, guidance documents, bulletins, webinars, presentations, etc. covering all of these issues.
A Global Perspective
Compliance with foreign EHS (non-transportation) regulatory requirements is a relatively recent consideration for US ink manufacturers. The transportation and import/export regulations notwithstanding, the need to comply with foreign regulations arises in two general areas:
• Inks manufactured in the US and used (exported) outside of the US –Inks manufactured in the US and exported to a foreign country need to comply with the destination country EHS rules and regulations. Typically, compliance involves:
o Proper labeling, marking and packaging according to US and international transportation regulations applicable to the mode of transportation used.1
o Communicating health, safety and environmental data usually via a Globally Harmonized System (GHS)-compliant safety data sheet (SDS). It is important to note that an SDS that complies with the US/OSHA Hazard Communication Standard may not comply with the destination country’s rules and regulations.
Ink companies exporting finished inks for use in a foreign country must check the destination country’s EHS regulations to ensure compliance.
Understanding the print application is also important, as individual foreign countries may have application-specific EHS requirements. This is particularly important with food packaging applications.
At a minimum, China, Japan and European (eastern/western) have food packaging safety-related requirements which may be applicable to food packaging components (e.g. inks, adhesives, substrates, etc.). At present, there is no consistency or harmonization among these national/foreign regulations. Moreover, it is important to note that at present, there are no harmonized/EU-wide food packaging safety regulations.
• Ink used on printed products sold outside the US (primarily exported food packaging).
In most cases, printed substrate, lacking a potential for exposure, would be treated as an “article” (e.g. the EU REACh regulations provide an exclusion for printed articles, no US OSHA Hazard Communication applicability, etc.) and, as such, does not inherently require compliance as noted above with the notable exception of food packaging applications (see note above regarding food packaging applications).
Conclusions
Compliance with EHS regulations both in and outside of the United States has become increasingly complex. With the limited exception of the Globally Harmonized System for Classification and Labelling of Chemical (GHS), there is little global equivalency or harmonization of EHS and food safety regulatory requirements. Each country, even within the EU, sets and enforces its own EHS and food packaging safety regulations.
Trade associations (e.g. NAPIM, EuPIA, etc.) will continue to play important roles in guiding their memberships in complying with the regulatory requirements of their countries and advising/informing government agencies on industry-specific issues and promoting the industry to its customer base. However, trade associations do not set national or international policy or regulatory requirements.
References:
1) The Pipeline and Hazardous Materials Safety Administration (PHMSA) proposes to amend the Hazardous Materials Regulations (HMR) to maintain alignment with international regulations and standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. These revisions are necessary to harmonize the HMR with recent changes made to the International Maritime Dangerous Goods Code, the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the United Nations Recommendations on the Transport of Dangerous Goods—Model Regulations. Additionally, PHMSA proposes several amendments to the HMR that would allow for increased alignment with the Transport Canada, Transportation of Dangerous Goods (TDG) Regulations.
