Until recently the ASTM D-5403 test method was the accepted standard test method for determining the VOC content of UV/EB curing materials. Test Method D-5403A is applicable to radiation curable materials that are essentially 100% reactive but may contain traces (no more than 3%) of volatile materials as impurities or introduced by the inclusion of various additives. Test Method D-5403B is applicable to all radiation curable materials but must be used for materials that contain volatile solvents intentionally introduced to control application viscosity and which are intended to be removed from the material prior to cure. You can purchase a copy of this standard at http://www.astm.org/Standards/D5403.htm.
Recently, a RadTech ad hoc Committee developed a new test method that is particularly suited to thin films of applied wet coating (please contact RadTech for more information). This method is currently under review by ASTM.
Tuesday, July 14, 2009
Thursday, June 25, 2009
We are applying coatings to the inside of metal food storage tanks, but a preferred primer is not FDA compliant. Can we apply a UV curable coating...
that complies with FCN 772 over the primer as a functional barrier to comply with FDA regulations?
A functional barrier must assure that any potential migration of FDA non-compliant substances not in contact with food or beverages is below the “Threshold of Regulation”, i.e. less than 50 ppb in the food. If a coating that complies with FCN 772 is to function as a functional barrier, it must meet three criteria:
1. The UV cured coating must meet all of the composition and extractable monomers and total extractable solids requirements of FCN 772.
2. The UV cured coating must demonstrably prevent migration of any of the uncleared primer components into the food at levels above 50 ppb.
Both of these requirements must be demonstrated by conducting extraction tests with appropriate food simulants as specified in Appendix II, SELECTED MIGRATION TESTING PROTOCOLS, at the FDA Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations web site http://www.cfsan.fda.gov/~dms/opa3pmnc.html#aii.
3. The UV coating must reasonably be expected to continue to serve as an effective functional barrier over the lifetime of the manufactured article (food storage tank).
The design of the tank for the intended application, the compositions of the primer and coatings, and the design and results of the extraction testing protocols and results should be subjected to qualified legal review to assure compliance with FDA regulations.
A functional barrier must assure that any potential migration of FDA non-compliant substances not in contact with food or beverages is below the “Threshold of Regulation”, i.e. less than 50 ppb in the food. If a coating that complies with FCN 772 is to function as a functional barrier, it must meet three criteria:
1. The UV cured coating must meet all of the composition and extractable monomers and total extractable solids requirements of FCN 772.
2. The UV cured coating must demonstrably prevent migration of any of the uncleared primer components into the food at levels above 50 ppb.
Both of these requirements must be demonstrated by conducting extraction tests with appropriate food simulants as specified in Appendix II, SELECTED MIGRATION TESTING PROTOCOLS, at the FDA Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations web site http://www.cfsan.fda.gov/~dms/opa3pmnc.html#aii.
3. The UV coating must reasonably be expected to continue to serve as an effective functional barrier over the lifetime of the manufactured article (food storage tank).
The design of the tank for the intended application, the compositions of the primer and coatings, and the design and results of the extraction testing protocols and results should be subjected to qualified legal review to assure compliance with FDA regulations.
Friday, May 29, 2009
A RadTech member received a question regarding the inclusion of benzophenone in a coating used to protect the surface of a label.
While indirect food contact was not specifically mentioned, I'm sure that's the issue. If I visit the website below, I find benzophenone on the GRAS list and accepted for direct food contact CFR21 172.515 http://vm.cfsan.fda.gov/~dms/eafus.html
This is more a question of whether the benzophenone might affect the flavor and/or odor of the packaged product than food safety. Not only FDA, but also the European authorities have determined that benzophenone is safe in food. Assuming that the customer's product is not affected by the odor of benzophenone, the small amount of benzophenone that could migrate into packaged food from the label should not be a health issue. The RadTech member page has a link to analyses of typical migration of benzophenone into food. A calculation also can be done to estimate the magnitude of the migration and confirm the health safety.
Flavor and odor are another question. Benzophenone should not be used in packaging for chocolate, for example. Chocolate picks up off flavors very easily and would be affected by even the smallest traces of benzophenone. Benzophenone and any other highly odorous materials must be avoided in such cases.
In summary, it is best to ask the customer what they are packaging and confirm ahead of time that the benzophenone is not a problem for their particular application. You can show them the FDA and EU positive clearances and typical migration analyses if they want more information. If they still are not comfortable with it, take BPO out of the formulation; it will be a continuing concern and may come back to haunt you if the customer later has problems that they decide to blame on BPO.
This is more a question of whether the benzophenone might affect the flavor and/or odor of the packaged product than food safety. Not only FDA, but also the European authorities have determined that benzophenone is safe in food. Assuming that the customer's product is not affected by the odor of benzophenone, the small amount of benzophenone that could migrate into packaged food from the label should not be a health issue. The RadTech member page has a link to analyses of typical migration of benzophenone into food. A calculation also can be done to estimate the magnitude of the migration and confirm the health safety.
Flavor and odor are another question. Benzophenone should not be used in packaging for chocolate, for example. Chocolate picks up off flavors very easily and would be affected by even the smallest traces of benzophenone. Benzophenone and any other highly odorous materials must be avoided in such cases.
In summary, it is best to ask the customer what they are packaging and confirm ahead of time that the benzophenone is not a problem for their particular application. You can show them the FDA and EU positive clearances and typical migration analyses if they want more information. If they still are not comfortable with it, take BPO out of the formulation; it will be a continuing concern and may come back to haunt you if the customer later has problems that they decide to blame on BPO.
Wednesday, May 6, 2009
Q. We are interested in applying UV curable coatings for concrete floors and other concrete surfaces, in some cases where there will be food
preparation involved. Are you aware of any designation or clearances that the coating must have before it can be used for these purposes? Do they require an FDA or USDA label or something similar?
A: The floor and walls of a food preparation or storage area normally are not expected to come into contact with food, so they are not required by regulation to be compliant with specific FDA citations in 21 CFR. This is not the case for food storage, handling and processing equipment. For example, a coating on the inside of a concrete food storage bin (grain bin or water tank, for example), on the other hand, must be FDA compliant, because contact is expected.
Food handling and processing equipment, such as food mixers and counter tops, may fall under the FDA “housewares” exemption, but any coating should be demonstrably safe for the intended application.
Under USDA guidelines, a guaranty is not required for coatings which do not meet the definition of packaging materials, even though there may be food contact. Though not covered under the packaging regulations, such materials may be regulated under other sections of the regulations. For example, performance and sanitation requirements for floors, walls, equipment and utensils are covered under Sections 308.5, 381.48 and 381.53 of the Meat and Poultry Inspection regulations.
Irrespective of regulatory compliance, if the customers demand FDA compliance even for floor coatings, that's their prerogative.
The good news is that it now is possible with FCN 772 to formulate an epoxy floor or concrete coating that specifically complies with FDA regulations, and it is foreseen that a limited amount of new test data on a urethane oligomer, for example, could allow an Alliance member to gain clearance for that type of oligomer and coating.
A: The floor and walls of a food preparation or storage area normally are not expected to come into contact with food, so they are not required by regulation to be compliant with specific FDA citations in 21 CFR. This is not the case for food storage, handling and processing equipment. For example, a coating on the inside of a concrete food storage bin (grain bin or water tank, for example), on the other hand, must be FDA compliant, because contact is expected.
Food handling and processing equipment, such as food mixers and counter tops, may fall under the FDA “housewares” exemption, but any coating should be demonstrably safe for the intended application.
Under USDA guidelines, a guaranty is not required for coatings which do not meet the definition of packaging materials, even though there may be food contact. Though not covered under the packaging regulations, such materials may be regulated under other sections of the regulations. For example, performance and sanitation requirements for floors, walls, equipment and utensils are covered under Sections 308.5, 381.48 and 381.53 of the Meat and Poultry Inspection regulations.
Irrespective of regulatory compliance, if the customers demand FDA compliance even for floor coatings, that's their prerogative.
The good news is that it now is possible with FCN 772 to formulate an epoxy floor or concrete coating that specifically complies with FDA regulations, and it is foreseen that a limited amount of new test data on a urethane oligomer, for example, could allow an Alliance member to gain clearance for that type of oligomer and coating.
Monday, March 23, 2009
Does RadTech have any information on the proper disposition of 100% solids UV/EB waste?
I’m sure it probably needs to be incinerated or something, but I’m looking for a document or something “official” to show the powers that be at my company.
By definition, EPA determined that some specific wastes are hazardous. These wastes are incorporated into lists published by the Agency and are organized into three categories:
1. The F-list (non-specific source wastes). This list identifies wastes from common manufacturing and industrial processes, such as solvents that have been used in cleaning or degreasing operations. Because the processes producing these wastes can occur in different sectors of industry, the F-listed wastes are known as wastes from non-specific sources. Wastes included on the F-list can be found in the regulations at 40 CFR §261.31 .
2. The K-list (source-specific wastes). This list includes certain wastes from specific industries, such as petroleum refining or pesticide manufacturing. Certain sludges and wastewaters from treatment and production processes in these industries are examples of source-specific wastes. Wastes included on the K-list can be found in the regulations at 40 CFR §261.32 .
3. The P-list and the U-list (discarded commercial chemical products). These lists include specific commercial chemical products in an unused form. Some pesticides and some pharmaceutical products become hazardous waste when discarded. Wastes included on the P- and U-lists can be found in the regulations at 40 CFR §261.33 .
Waste that have not been specifically listed may still be considered a hazardous waste if exhibits one of the four characteristics defined in 40 CFR Part 261 Subpart C - ignitability (D001), corrosivity (D002), reactivity (D003), and toxicity (D004 - D043).
1. Ignitability - Ignitable wastes can create fires under certain conditions, are spontaneously combustible, or have a flash point less than 60 °C (140 °F). Examples include waste oils and used solvents. For more details, see 40 CFR §261.21 . Test methods that may be used to determine ignitability include the Pensky-Martens Closed-Cup Method for Determining Ignitability (Method 1010A) (PDF) (1 pg, 19K) , the Setaflash Closed-Cup Method for Determining Ignitability (Method 1020B) (PDF) (1 pg, 17K) , and the Ignitability of Solids (Method 1030) (PDF) (13 pp, 116K) .
2. Corrosivity - Corrosive wastes are acids or bases (pH less than or equal to 2, or greater than or equal to 12.5) that are capable of corroding metal containers, such as storage tanks, drums, and barrels. Battery acid is an example. For more details, see 40 CFR §261.22 . The test method that may be used to determine corrosivity is the Corrosivity Towards Steel (Method 1110A) (PDF) (6 pp, 37K) .
3. Reactivity - Reactive wastes are unstable under "normal" conditions. They can cause explosions, toxic fumes, gases, or vapors when heated, compressed, or mixed with water. Examples include lithium-sulfur batteries and explosives. For more details, see 40 CFR §261.23 . There are currently no test methods available.
4. Toxicity - Toxic wastes are harmful or fatal when ingested or absorbed (e.g., containing mercury, lead, etc.). When toxic wastes are land disposed, contaminated liquid may leach from the waste and pollute ground water. Toxicity is defined through a laboratory procedure called the Toxicity Characteristic Leaching Procedure (TCLP) (Method 1311) (PDF) (35 pp, 288K) . The TCLP helps identify wastes likely to leach concentrations of contaminants that may be harmful to human health or the environment. For more details, see 40 CFR §261.24 .
Unless the UV/EB curing formulation is diluted with solvents, it typically does not meet the “ignitability” characteristic. UV/EB curing formulations also typically do not exhibit the EPA “corrosivity” criteria. UV/EB curing materials generally do not meet the “toxicity” characteristic, but formulations that contain toxic components, such as certain solvents or heavy metal pigments, may be identifiable as “toxic”.
Most UV/EB formulations do not meet the “reactivity” characteristic, but a few that comprise or contain mostly highly functional acrylates, such as PETA, DiPETA, DiTMPTA etc., have been known to react with the evolution of heat and fumes. These should be evaluated to determine whether they meet the “reactivity” criteria. If in doubt, they should be disposed of as potentially “reactive” wastes.
The waste generator has responsibility for determining if a waste is a RCRA hazardous waste. (See: 40 CFR 262.11). Four questions must be considered to determine whether the waste is hazardous:
1. Is the material a solid waste? (See: 40 CFR Part 261.2)2. Is the waste specifically excluded form RCRA? (See: 40 CFR Part 261.4)3. Is the waste a listed hazardous waste? (See: 40 CFR Part 261.30) 4. Does the waste exhibit a characteristic of hazardous waste? (See: 40 CFR Part 261.20)
If a UV/EB curing formulation, or UV/EB curing oligomers or monomers or photoinitiators, or clean-up wastes, or contaminated filters, wipes etc. meet any of these criteria, they must be disposed of in full compliance withy all applicable federal, state and local hazardous waste regulations.
If these wastes are not listed hazardous wastes or do not meet any of the hazardous waste characteristics, they may be disposed of as non-hazardous wastes in full compliance with all state and local regulations that apply to similar paints and coatings materials. This may require solidification or other treatment before disposal in a municipal land fill, so disposal as a hazardous waste may be a preferred alternative.
By definition, EPA determined that some specific wastes are hazardous. These wastes are incorporated into lists published by the Agency and are organized into three categories:
1. The F-list (non-specific source wastes). This list identifies wastes from common manufacturing and industrial processes, such as solvents that have been used in cleaning or degreasing operations. Because the processes producing these wastes can occur in different sectors of industry, the F-listed wastes are known as wastes from non-specific sources. Wastes included on the F-list can be found in the regulations at 40 CFR §261.31 .
2. The K-list (source-specific wastes). This list includes certain wastes from specific industries, such as petroleum refining or pesticide manufacturing. Certain sludges and wastewaters from treatment and production processes in these industries are examples of source-specific wastes. Wastes included on the K-list can be found in the regulations at 40 CFR §261.32 .
3. The P-list and the U-list (discarded commercial chemical products). These lists include specific commercial chemical products in an unused form. Some pesticides and some pharmaceutical products become hazardous waste when discarded. Wastes included on the P- and U-lists can be found in the regulations at 40 CFR §261.33 .
Waste that have not been specifically listed may still be considered a hazardous waste if exhibits one of the four characteristics defined in 40 CFR Part 261 Subpart C - ignitability (D001), corrosivity (D002), reactivity (D003), and toxicity (D004 - D043).
1. Ignitability - Ignitable wastes can create fires under certain conditions, are spontaneously combustible, or have a flash point less than 60 °C (140 °F). Examples include waste oils and used solvents. For more details, see 40 CFR §261.21 . Test methods that may be used to determine ignitability include the Pensky-Martens Closed-Cup Method for Determining Ignitability (Method 1010A) (PDF) (1 pg, 19K) , the Setaflash Closed-Cup Method for Determining Ignitability (Method 1020B) (PDF) (1 pg, 17K) , and the Ignitability of Solids (Method 1030) (PDF) (13 pp, 116K) .
2. Corrosivity - Corrosive wastes are acids or bases (pH less than or equal to 2, or greater than or equal to 12.5) that are capable of corroding metal containers, such as storage tanks, drums, and barrels. Battery acid is an example. For more details, see 40 CFR §261.22 . The test method that may be used to determine corrosivity is the Corrosivity Towards Steel (Method 1110A) (PDF) (6 pp, 37K) .
3. Reactivity - Reactive wastes are unstable under "normal" conditions. They can cause explosions, toxic fumes, gases, or vapors when heated, compressed, or mixed with water. Examples include lithium-sulfur batteries and explosives. For more details, see 40 CFR §261.23 . There are currently no test methods available.
4. Toxicity - Toxic wastes are harmful or fatal when ingested or absorbed (e.g., containing mercury, lead, etc.). When toxic wastes are land disposed, contaminated liquid may leach from the waste and pollute ground water. Toxicity is defined through a laboratory procedure called the Toxicity Characteristic Leaching Procedure (TCLP) (Method 1311) (PDF) (35 pp, 288K) . The TCLP helps identify wastes likely to leach concentrations of contaminants that may be harmful to human health or the environment. For more details, see 40 CFR §261.24 .
Unless the UV/EB curing formulation is diluted with solvents, it typically does not meet the “ignitability” characteristic. UV/EB curing formulations also typically do not exhibit the EPA “corrosivity” criteria. UV/EB curing materials generally do not meet the “toxicity” characteristic, but formulations that contain toxic components, such as certain solvents or heavy metal pigments, may be identifiable as “toxic”.
Most UV/EB formulations do not meet the “reactivity” characteristic, but a few that comprise or contain mostly highly functional acrylates, such as PETA, DiPETA, DiTMPTA etc., have been known to react with the evolution of heat and fumes. These should be evaluated to determine whether they meet the “reactivity” criteria. If in doubt, they should be disposed of as potentially “reactive” wastes.
The waste generator has responsibility for determining if a waste is a RCRA hazardous waste. (See: 40 CFR 262.11). Four questions must be considered to determine whether the waste is hazardous:
1. Is the material a solid waste? (See: 40 CFR Part 261.2)2. Is the waste specifically excluded form RCRA? (See: 40 CFR Part 261.4)3. Is the waste a listed hazardous waste? (See: 40 CFR Part 261.30) 4. Does the waste exhibit a characteristic of hazardous waste? (See: 40 CFR Part 261.20)
If a UV/EB curing formulation, or UV/EB curing oligomers or monomers or photoinitiators, or clean-up wastes, or contaminated filters, wipes etc. meet any of these criteria, they must be disposed of in full compliance withy all applicable federal, state and local hazardous waste regulations.
If these wastes are not listed hazardous wastes or do not meet any of the hazardous waste characteristics, they may be disposed of as non-hazardous wastes in full compliance with all state and local regulations that apply to similar paints and coatings materials. This may require solidification or other treatment before disposal in a municipal land fill, so disposal as a hazardous waste may be a preferred alternative.
Monday, March 16, 2009
We are a printer of food contact packaging. We read about the RadTech Food Contact Notification (FCN) Alliance.
If we buy our inks in accordance and compliance with this new regulation would that be okay? What is necessary to be done? Do we need to become an Alliance member ourselves?
The raw material suppliers that are members of the FCN Alliance submitted to FDA extensive data on the composition, impurities and manufacturing processes of their products in order to have them cleared for use in food packaging under FCN 772. Raw materials from other suppliers have not been reviewed by FDA for safety in this way, and therefore can not qualify for use in food packaging under FCN 772, even if they nominally have the same composition. In order for formulations to be cleared under this FDA regulation, they must use only the raw materials purchased from the FCN member materials suppliers. If you can obtain certification that products comply with FCN 772 and all other FDA regulations that apply for the intended use, it would be cleared for use in food packaging in the USA. Please also visit http://www.radtech.org/whats_new/FCN.html.
The raw material suppliers that are members of the FCN Alliance submitted to FDA extensive data on the composition, impurities and manufacturing processes of their products in order to have them cleared for use in food packaging under FCN 772. Raw materials from other suppliers have not been reviewed by FDA for safety in this way, and therefore can not qualify for use in food packaging under FCN 772, even if they nominally have the same composition. In order for formulations to be cleared under this FDA regulation, they must use only the raw materials purchased from the FCN member materials suppliers. If you can obtain certification that products comply with FCN 772 and all other FDA regulations that apply for the intended use, it would be cleared for use in food packaging in the USA. Please also visit http://www.radtech.org/whats_new/FCN.html.
I have heard about an issue with 4-MBP in Europe, can you tell me more?
4-methylbenzophenone (MBP) was recently detected in a breakfast cereal in Europe, leading to publicity concerning this substance. RadTech has prepared a public statement, as well as background data and information for members concerning this issue. Please visit:
http://www.radtech.org/documents/RadTech%204-MBP%20publicstatementfinal.pdf
http://www.radtech.org/documents/RadTech%204-MBP%20publicstatementfinal.pdf
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