Part 1: Defining project scope & goals…

In the beginning … of an aerosol product development (PD) project, it is crucial to gather as much information as possible to understand the scope more accurately and to establish reasonable expectations and goals among the team members. The PD team must use the skills of a good investigator to gather as much information as possible by asking questions such as:

• Who is the customer? The intended end user should not be considered the only customer. The “customer” may also include the production department, marketing and sales group, supply chain and logistics managers, and even the formulation chemist who comes up with an idea for a new or improved product. All of these people should be considered “customers” who expect a final product that meets their unique requirements.

• What are you selling? What are the projected sales volumes? What are the minimum order quantities (MOQ)? What do you want on the product label? Will this include third-party evaluations/certifications such as Safer Choice, NSF, Green Seal, and/or U.S. Dept. of Agriculture (USDA) BioPreferred certifications and logos? Are there any statements not wanted on the product label, such as Proposition 65 declarations, flammable or poison warnings, etc.?

• Where are you selling the product? Important locations and market categories to consider include domestic or international, retail or non-retail, and/or States where volatile organic compounds (VOCs) and/or chemicals are restricted or banned.

• When do you want the product? Will the development process be completed, and the finished product delivered, before the anticipated launch date?

• Why is this product important? Marketing research/surveys will provide insight into the practicality of developing and launching the product.

• How is the product to be used? If possible, visit the type of facility where the product will be used and perform end-user field trials.

Embracing a thorough understanding of the customer’s needs requires listening to their responses without bias and making sure that everyone on the development team is speaking the same language. Communicating and documenting accurate and current information between the appropriate parties throughout the project timeline will help ensure that the final deliverable meets everyone’s expectations in a timely and cost-effective manner.

Acquiring information
When searching for information on aerosol product formulas, there are a multitude of resources available. Trade organizations—such as the Southern Aerosol Technical Association (SATA), Western Aerosol Information Bureau (WAIB), Eastern Aerosol Association (EAA), Midwest Aerosol Association (MAA) and National Aerosol Association (NAA)—provide valuable information on the industry, including regulatory updates, industry news and events. The Aerosol Handbook by Montfort A. Johnsen is an invaluable reference volume for all things aerosol, from aerosol measurements to Zinc-rich coatings. Trade magazines, such as the one you are currently reading, offer information on the latest trends, products, testing practices and formularies that can help to efficiently develop your formula.

Additionally, component and chemical vendors are always willing and able to provide valuable literature on the function and properties of product components. This includes providing documents such as the chemical safety data sheets (SDS), technical data sheets, component specifications and any relevant regulatory information. The internet is also a great source of information, with materials and ingredients search engines such as ChemSpider, SpecialChem and UL Prospector providing access to information on product ingredients, regulatory compliance and competitor pricing. Wikipedia can also be a useful source of information, although it should be used with caution as it may not always be reliable. Finally, evaluating comparable product samples will provide valuable insights into the formulation of different product classes.

Determining project limitations
When developing aerosol products, it is important to consider the various resource limitations that can impact the project’s success. These include the desired product performance, project duration and hours set aside for the project, cost of the finished product, product complexity, the capabilities and limitations of the production unit, chemical and component cost and availability evaluation, regulatory constraints, quality control requirements and potential patent infringement issues.

The expected product performance, the duration and hours delegated to the project, and the cost of the finished product, will have an impact on the project’s budget and timeline, as well as the product’s success, profitability and competitiveness in the market. Performance, time and cost all exert competing pressure on the available project development resources. A decision regarding which of these has a high, medium or low priority should be made early in the development process.

Marketing surveys & field testing
Market surveys and field testing play a crucial role in shaping the development of a product. They both empower businesses to make informed decisions, tailor products to customer needs and enhance overall success. Marketing surveys can uncover information about user preferences, pain points and unmet needs, as well as gauge how much customers are willing to pay for a product. Field testing allows products to be evaluated outside of the controlled laboratory environment, exposing them to diverse conditions, different environments, user behaviors and unexpected challenges. It also identifies potential hazards, ensuring that the product doesn’t pose risks to users or the environment.

Product complexity
The figure below displays what could be considered “typical” aerosol product components. Each of these has a particular cost, a MOQ and supply chain lead time that will impact the project timeline, budget and feasibility. Also, developing new, innovative components will dramatically increase the project timeline due to the additional planning and testing required, as well as to ensure the component(s) will meet performance and safety expectations. Because of this, it is a good idea to minimize component complexity to that which is necessary and consistent with the project goals and customer expectations.

Production facility capabilities & safety considerations
Formula development must consider the capability of the manufacturing production equipment and personnel. Consider the size, power and types of mixing equipment available to your compounding unit. Also, make sure your compounding personnel have the training and expertise to scale up the batching process from the lab to the plant. If either the equipment or personnel are lacking, either the formula must be adjusted not to exceed the capabilities of the manufacturing unit, or the capabilities of the equipment and personnel must be upgraded. Such upgrades can be quite expensive, so this information must be incorporated into the overall project feasibility equation. Additional manufacturing capabilities and limitations to consider when developing the product formula include workplace ventilation systems, grounding and spark suppression equipment, temperature control capabilities for chemical storage and batch processing, gas house capabilities and the storage/removal of hazardous waste. Ignoring any of these can have a detrimental impact on the safety, quality and productivity of the manufacturing process.

Always remember, you will be working with highly flammable, toxic and/or explosive chemicals/gases. Each day you potentially put yourself and your co-workers in danger. Make safety your first priority!

The Quoting Process: Product cost, availability & MOQ
To provide the customer with a realistic quoted price, lead time estimate and MOQ for a product, the PD team must consider the cost, availability, MOQ and lead time of each individual chemical and component of the said product.

The formulation chemist and/or packaging engineer can work together to consolidate chemical and component inventories. Consolidating materials that are functional equivalents can take advantage of high-volume discounts from vendors and reduce warehouse inventory pressures. This strategy is particularly useful in reducing the overall cost and MOQ issues for solvents, propellants and valves.

Manufacturing efficiency can be improved, and production cost decreased, by reducing production line downtime due to the product changeover process. Cost reductions can be achieved by formulating products so that line and equipment flushing duration and the cost/volume of cleanout solvents are decreased. This also reduces the need to store and dispose of excessive hazardous materials generated during the cleaning process. The cost of increased line cleaning complexity and/or of adding dedicated equipment to the production process should be incorporated into the overall cost of the final product.

QC requirements
Quality control (QC) is essential for ensuring product quality and preventing defects. However, if not managed properly, it can lead to increased manufacturing costs and delays. The PD and manufacturing teams need to work together to determine the quality assurance/quality control (QA/QC) practices necessary to consistently deliver a final product that meets the customer’s expectations.

Generating QC specifications that the production team cannot achieve, due to equipment or personnel limitations, will inevitably lead to defective items, wasted materials and increased labor costs. On the other hand, inadequate QC overview will result in similar consequences—with the added cost of losing the trust of the customer due to inferior products arriving at their facility. It is important to find the appropriate level of QC to prevent product defects while eliminating the cost of a prolonged QC process, unnecessary testing equipment and excess laboratory labor.

Regulatory compliance
Ensuring regulatory compliance is arguably the biggest challenge faced by the PD team. Aerosols are one of the most heavily regulated products due to their environmental impact and potential health risks. As a result, there are a multitude of regulations that aim to control their use, minimize VOC emissions and protect both human health and the environment. These regulations include:

• Federal, State and regional VOC/ Maximum Incremental Reactivity (MIR) regulations
• Federal, State and local chemical restrictions/bans
• California Proposition 65 cancer and reproductive harm warnings
• CA SB-258 and New York State Dept. of Environmental Conservation (NYDEC) ingredient disclosure requirements
• U.S. Environmental Protection Agency (EPA) and U.S. Food & Drug Administration (FDA) product registration and labeling requirements
• Consumer product labeling requirements
• U.S. Dept. of Transportation (DOT) and U.S. Occupational Safety & Health Administration (OSHA) hazard communication requirements
• National Fire Protection Association (NFPA) aerosol storage requirements
• And many more…

Attempting to comply with the various regulations will often have an impact by lengthening the project’s timeline and dampening expectations of what is possible to achieve as a final objective.

Patent infringement
Patent infringement is another constraint that must be considered, as it can have an impact on the project’s legal status and profitability. To avoid patent infringement issues, it is important to take several steps. First, look for relevant patents related to your product. Second, review the claims of those patents that you found. Third, modify your product design around those patent claims. Trademarking your brand’s names and logos, as well as applying for design and utility patents for each product, can help protect your intellectual property.

In a nutshell
It is the responsibility of the PD team to ensure that the final product is delivered in a safe, timely and cost-effective manner while meeting or exceeding the expectations of the customer. The most important part of this process is promptly providing accurate information and status updates to all project stakeholders. Secondary roles that may alleviate unnecessary stress and avoid unpleasant surprises include managing expectations, maintaining focus and accepting that there may be changes in the project goals based on new information. While the challenges the team will face are significant, the reward of a satisfied customer, a job well done and the bragging rights gained when friends and family see one of “your” products on store shelves certainly make the struggle worthwhile.

Part Two of this article will focus on the testing performed on aerosol products and how the results can be interpreted to improve product performance. Part Three will focus on the typical aerosol product laboratory setup, equipment and safety considerations. SPRAY

As manufacturers and marketers of aerosol products know, there are many laws, regulations, standards and codes to comply with, such as ingredient disclosure, transportation regulations, and volatile organic compound (VOC) standards. Fire and building codes don’t immediately come to mind when discussing the most influential requirements, but these model codes, which are developed by the National Fire Protection Association (NFPA) and International Code Council (ICC), are adopted into law and enforced by Federal, State and local governments to regulate the construction and maintenance of buildings and control storage, use and handling of hazardous materials. In fact, they define all aspects of a building where aerosol products are manufactured, stored, sold or used, including building size, construction materials, exiting, sprinkler protection and ventilation. Aerosol product quantities, flammability classification, location in buildings, storage height, sprinkler protection and display layout are also detailed in building and fire codes.

Building and fire codes will be discussed at the upcoming ICC Committee Action Hearings for the next edition of the International Fire Code (IFC). Currently, there are three proposals to amend the fire codes for aerosol products in the IFC during this code cycle, two of which are from the Household & Commercial Products Association (HCPA) to align the IFC with recent amendments to the NFPA 30B, Code for the Manufacture & Storage of Aerosol Products. However, the third proposal, which was not introduced by Industry, is quite concerning.

Fire officials are proposing to amend a number of codes for a variety of products and materials within the IFC, including for aerosol products, to align with the Globally Harmonized System of Classification & Labeling of Chemicals (GHS) for flammability. Their rationale is that the Safety Data Sheet (SDS) is typically the only available information they have about flammability to verify the proper design of buildings and warehouses. While several industries have concerns about this kind of change, the aerosol products industry is uniquely positioned to argue against it.

The HCPA has been an active participant in the development of building and fire codes since the early 1980s. This involvement came about when the regulatory community attempted to severely restrict the storage and sales of aerosol products through draconian construction requirements and rigorous limits on the quantity of product in storage and sales after major fires caused by aerosols. To combat these requirements, the aerosol industry conducted numerous fire tests to develop a set of controls for the safe storage and sale of aerosol products. The HCPA has recommended many amendments to the U.S.’s complex system of fire and building codes, which are based on data developed from fire tests to ensure that HCPA’s positions are credible and compelling to fire officials, fire insurers and fire engineering professionals.

From this data, we know that alignment with GHS is not appropriate for aerosol products and, if adopted, would lead to inadequate fire protection systems. The amendments could also lead to confusion and would require significant retraining; it would also be costly to review and recategorize each aerosol product.

The aerosol industry would support amendments that are supported by data and show improved fire protection. How could Industry say no to these improvements? However, administrative changes that are not based on testing and that fundamentally change how fire protection is determined cannot—and should not—be accepted.

The HCPA is working on potential modifications to the proposed amendments that represent the aerosol industry’s best interests and we are hopeful to arrive at a common sense solution. However, if Industry’s interests are not considered, HCPA will object. Fire protection is important to everyone—we cannot go backward and Industry has data to demonstrate the most effective codes to be implemented.

For more information about fire and building codes for aerosol products, please contact me at ngeorges@thehcpa.org. SPRAY

New York
On March 13, the State of New York held a webinar to accept comments on amendments to 6 NYCRR Part 494 on the use of hydrofluorocarbon substances (HFCs). This affects aerosol products and small containers of automotive refrigerants. The amendments mainly align with the newly-finalized Technology Transitions Program by the U.S.
Environmental Protection Agency (EPA).

The main comments affecting aerosols made during the webinar were:

• Industry recommends that the Department of Environmental Conservation (DEC) use the 100-year Global Warming Potential (GWP) instead of the 20-year GWP numbers
• Supports alignment with EPA’s American Innovation & Manufacturing (AIM) Act Technology Transition Rule
• Oppose the restriction of low GWP compounds in Aerosol Products
• Industry requests clarity on labeling

Now we wait to see if any changes are made.

CARB
On March 20, Industry met with the California Air Resources Board (CARB) to discuss upcoming activities. As we have reported for months, there was no news on the upcoming survey. However, a new wrinkle has presented itself: Liang Liu, one of the managers under Chief Ravi Ramalingam took another position within CARB, leaving Ramalingam without a manager to oversee the development of the survey. Currently, the survey is moving forward, but Ramalingam does not plan to have the survey released until the new manager is in place. This could take a while as the hiring protocol for CARB is extensive. The process has been going on since January and will likely not finish until at least the end of April, if not longer.

In the meantime, Industry can only speculate on what will be on the survey. Products containing parachlorobenzotrifluoride (PCBTF), or other toxic compounds, will likely be surveyed, as well products used heavily during the COVID-19 pandemic, such as cleaners, disinfectants and sanitizers. Some other likely candidates for the survey are paint strippers, floor strippers, aerosol sunscreens and other products dropped in the last rulemaking.

Industry then discussed the issue of reactivity. CARB staff is in the process of developing a new way to formulate reactivity limits for product categories. It will take a significant effort to develop this process; however, the good news is that the concept of reactivity
appears to be finally being taken seriously as an available alternative way to regulate volatile organic compounds (VOCs) in consumer products. The use of reactivity has two positive benefits. First, reactivity typically provides more flexibility for consumer products formulators as many more compounds are available for use rather than just exempt compounds, LVPs and water. Second, any reduction in the Maximum Incremental Reactivity (MIR) means an actual reduction in ozone formation, which reduces smog. This is the goal of VOC reduction as the reduction in VOC percentage does not necessarily reduce ozone formation.

The last topic discussed with Ramalingam was that the current list of MIR values would likely need to be updated. How CARB plans to do this is not known at this time. We will monitor this closely.

EPA American Innovation & Manufacturing Act (AIM)
Less than a year from now, HFCs in aerosols will have restrictions. As a reminder, effective Jan. 1, 2025, EPA is restricting the use of all HFCs with a GWP greater than 150 in aerosol products except for the categories listed on p. 40, which will have until Jan. 1, 2028. This includes an extension for the use of HFC-43-10 mee and HFC-245fa in aerosols until January 1, 2028.

Categories with extensions include:

• Cleaning products for removal of grease, flux, and other soils from electrical equipment or electronics;
• Refrigerant flushes;
• Products for sensitivity testing of smoke detectors;
• Lubricants and freeze sprays for electrical equipment or electronics;
• Sprays for aircraft maintenance;
• Sprays containing corrosion preventive compounds used in the maintenance of aircraft, electrical equipment or electronics, or military equipment;
• Pesticides for use near electrical wires or in aircraft, in total release insecticide foggers, or in certified organic use pesticides for which EPA has specifically disallowed all other lower-GWP propellants;
• Mold release agents and mold cleaners;
• Lubricants and cleaners for spinnerets for synthetic fabrics;
• Duster sprays specifically for removal of dust from photo-graphic negatives, semiconductor chips, specimens under electron microscopes, and energized electrical equipment;
• Adhesives and sealants in large canisters;
• Document preservations sprays;
• Topical coolant sprays for pain relief; and
• Products for removing bandage adhesives from skin.

Remember HFC-152a has a GWP of less than 150 GWP, thus it is not restricted under this rule. Lastly, products manufactured or imported before their respective effective date of 1/1/25 or 1/1/28 have a three-year sell-through period. SPRAY

Hello, everyone. In March, we covered defects in polymer and tinplate coatings and their relationship with corrosion. The April column covered defects in laminated film bags, along with those found in traditional steel aerosol containers.

Most of the material defects in spray packages are very small, but can still be seen with the unaided eye. There are also microscopic defects that can lead to package corrosion and subsequent failure (leaking, clogged valves, etc.).

The metals used for aerosol spray containers are not pure metals. Instead, they are alloys that are mixtures of metals, plus non-metals, such as carbon and oxygen.

Metal/non-metal compounds, such as metal oxides or metal carbides, are insoluble in the host metal (i.e. aluminum and steel) and form microscopic precipitate particles. These particles are called inclusions and are dispersed throughout the host metals. Inclusions can be flattened and elongated when the metal is rolled from ingots into the sheets for package fabrication (typically for steel containers) and when the metal is extruded from slugs into a container (typically for aluminum containers).

Figure 1 provides a photomicrograph with examples of inclusions in steel. The arrows show the locations for only a few of the many different defects. The dark spots are inclusions and the thin, dark line is a row of inclusions, referred to as a stringer.

 

Please keep in mind that inclusions are not impurities. Inclusions are material defects resulting from the alloying of a metal with different elements to obtain physical properties, such as the strength and formability needed to form metals into containers.

Inclusions are sites for pitting corrosion and stress cracking. Stress cracking rarely occurs in spray packages. The chemical composition of a formula determines whether or not pitting corrosion occurs at inclusions.

Metals form regular arrangements of atoms, and these atomic arrangements form bulk formations referred to as crystal planes. Crystal planes are often not perfect, and, in some instances, include fragments of planes imbedded among complete planes. The fragments are referred to as dislocations.

Figure 2 provides an example of multiple dislocations that pile-up when a metal is rolled into a sheet. Figure 2 also shows that dislocations could be sites for the initiation of pitting corrosion.

Steel and aluminum metals and alloys all have dislocations. Indeed, there are approximately one million dislocations per square centimeter of metal surface. The chemical composition of a formula determines whether or not pitting corrosion occurs at dislocations.

Figure 3 provides a scanning electron micrograph of tinplated steel, after the tin coating was removed by mechanical polishing. Several different types of defects are noted in Figure 3:

• Different crystal planes form structures referred to as grains, and different types of grains corrode more rapidly than others
• The chemical composition of the boundary between two different types of grains is typically different from the chemical composition of the grains
• The boundary between different grains is not always metallic—the boundary could be either, metallic (dark shadows between grains) or non-metallic (white lines between grains)
• Non-metallic inclusions are also noted in Figure 3 (white particles inside grains)
• Iron carbide compounds are also present in the steel grains—(darker spots)

All material defects in Figure 3 could cause or contribute to spray package corrosion. Aluminum and steel both typically have more than one of the material defect types shown in Figure 3.

The chemical composition of a formula determines whether or not the material defects in Figure 3 contribute to or cause spray package metal corrosion. Hence, corrosion testing is essential for reducing the risk of costly surprise spray package corrosion.

Thanks for your interest and I’ll see you in June. Contact me at 608-831-2076; rustdr@pairodocspro.com or from our two websites: pairodocspro.com and aristartec.com. SPRAY

Having worked in the industry for more than 15 years, I can’t help but notice the marketing claims on products as I walk the aisles of my local grocery store. Recently, I’ve seen more frequent claims about what ingredients a product doesn’t use, such as “BPA free,” “No GMOs” and “Phthalate free.”

For most products, these claims fall under the jurisdiction of the Federal Trade Commission (FTC) and the Guides for the Use of Environmental Marketing Claims,i better known as the Green Guides. The 2012 version added a section for “free-of” claims,ii which advise that, even if true, claims that a product is “free-of” a substance may be deceptive if:

1. The item contains substances that pose the same or similar environmental risk as the substance not present, or
2. The substance has not been associated with the product category.

The Green Guides also clarify that a “free-of” claim may, in some circumstances, be non-deceptive even though the product contains a “trace amount” of the substance. Since these statements can be confusing, HCPA submitted comments to the FTC last year requesting updated examples of “free-of” claims for inclusion in the next update of the Green Guides.

While the FTC manages “free-of” marketing claims for most products, the U.S. Environmental Protection Agency (EPA) evaluates “absence of an ingredient” claims for products registered under the Federal Insecticide, Fungicide & Rodenticide Act
(FIFRA). Similar to the FTC, the EPA will not allow false or misleading statements;iii however, in certain instances, where information indicates that these types of claims are not misleading, the EPA will allow these types of claims.

Under FIFRA, the EPA reviews a product’s master label as part of the registration process. As part of the EPA’s Label Review Manual,iv the EPA has provided limited guidance since the early 2000s on claims about the absence of an ingredient. However, this guidance, and subsequent updates, have focused on misbranding and did not provide a good pathway for registrants to utilize such claims.

The EPA has approved plenty of pesticide registrations containing a variety of “absence of ingredient” claims on a case-by-case basis; however, the regulated community has long sought clarity on whether and how “free-of” claims can be made and approved by the EPA.

To assist companies, the EPA recently publishedv new guidance for commonly proposed claims, including “bleach free,” “phosphate free” and “DEET free.”

Regarding “bleach-free” claims, the EPA understands that companies typically do not say “bleach-free” for safety reasons, but to inform consumers in situations where bleach may cause damage (e.g., clothing). However, to accurately make this claim, companies should avoid chlorinated chemistries that, when added to a solution, can break down into free available chlorine.

Phosphates are not typically listed as active ingredients, so “phosphate-free” claims are meant to inform consumers that this substance is not an inert ingredient in a product’s formulation since inert ingredients aren’t listed on the product label. Further, some States have restricted the use of phosphates and, in the case of New Yorkvi, there are labeling provisions, so the EPA would not consider such a claim to be misleading (provided that the product does not contain any phosphate[s]).

For companies that manufacture bug sprays, the EPA will also allow an “absence of DEET” claim as long as it’s accompanied by a qualifying statement such as, “Not a safety claim.” The EPA recognizes that consumers have concerns with DEET (N,N-Diethyl-meta-toluamide), despite it being used for many decades and its proven safety when used according to directions on the label.

Within this guidance, the EPA also discusses its applicability to minimum risk pesticides, or 25(b) products. While it has exempted minimum risk pesticides that meet all requirements from FIFRA registration, many States still have some type of registration.vii However, this exemption provides a provisionviii that requires the product to “not include any false or misleading labeling statements…” Accordingly, to the extent that an “absence of an ingredient” claim is not false or misleading, a “free-of” claim would not disqualify an otherwise qualified minimum risk pesticide from exemption.

HCPA has been working with the EPA on this guidance for several years and we are pleased to see its publication to include certain clarities. For more information on either the EPA’s guidance or the next update to the FTC’s Green Guides, please contact me at ngeorges@thehcpa.org. SPRAY


i 16 CFR Part 260
ii 16 CFR 260.9
iii 40 CFR 156.10(a)(5)
iv link
v link
vi NY Environmental Conservation Law §35-0105
vii 40 CFR 152.25(f)
viii 40 CFR 152.25(f)(3)(iv)

SCAQMD
In March, the South Coast Air Quality Management District (SCAQMD) in California held its second Work Group meeting on Rule 1151 Motor Vehicle & Mobile Equipment Non-Assembly Line Coating Operations, commonly called the Auto Refinish Rule, to discuss amendments. The Rule is primarily being amended to prohibit the use of two compounds: Para-Chlorobenzotrifluoride (PCBTF or Oxsol) and Tert-Butyl Acetate (TBAC). These two compounds have a volatile organic compound (VOC)-exempt status with SCAQMD; PCBTF is fully VOC-exempt while TBAC is partially exempt in the district. The chemicals are being prohibited due to toxicity concerns. SCAQMD’s sister agency, the Office of Environmental Health Hazard Assessment (OEHHA), has listed these chemicals as Toxic Air Contaminants in the State of California. As an “Air Toxic,” the chemicals have been targeted by the SCAQMD Executive Board to be prohibited from use, even if it means resulting higher VOC emissions.

This is huge, as SCAQMD is willing to possibly raise VOC limits and allow for higher VOC emissions. Staff has released a survey for manufacturers to fill out on how much and where PCBTF and TBAC are are being used in Automotive Coatings.

The survey deadline was March 1, 2024. As we go to press, SCAQMD staff has only received three returned surveys from Industry. However, more submissions are expected.

Staff would like to provide a path for manufacturers to quickly replace these chemicals in Automotive Coatings. It has suggested that it may be willing to allow the temporary use of products that are formulated to comply with National and/or European standards in the SCAQMD. Again, this is another important action by staff. By allowing the use of these other standards, Industry may be able to more quickly transition away from TBAC and PCBTF in Automotive Coatings.

Staff will continue to review the survey data and work with Industry to determine the best way forward. SCAQMD plans to complete this rule in Q4 2024, so time is short.
In addition to Rule 1151, a few other rules in the district are being reviewed for PCBTF and TBAC:

• Rule 1401 (Air Permitting) is in the works;
• Rule 1171 (Degreasing) will likely prohibit these compounds; and
• Rule 1113 (Architectural Coatings) will likely start soon.

This is an important issue for any company that uses PCBTF or TBAC in products. As well, we need to be concerned with how SCAQMD activity will affect other jurisdictions. Will CARB likely look at products containing PCBTF? Remember, TBAC has never been exempted as a VOC by the California Air Resources Board (CARB), so should be of lesser concern for CARB. Stay tuned more to come.

CARB
There is still no news on the release of the CARB Consumer Products VOC survey. Industry has been waiting for months for this survey to be released, as it will trigger the next round of CARB Rule development. Staff has stated the survey will be released in the Spring of 2024, which, I believe, is technically now. We are hoping to see the survey soon.

Other State Activity
The good news is that, so far, there is no news regarding new Consumer Products rulemaking from either Clark County, NV, or the States of Oregon and New Jersey. SPRAY

Hello, everyone. In the last issue, I began a series on material defects in spray packaging and the relationship between these defects and corrosion.

This month, I’ll discuss the more common material defects found in laminated foil bag packages—bag-on-valve (BOV) packaging—as well as both coated and uncoated steel aerosol containers. The final, Part Three discussion will focus on microscopic material defects.

Laminated aluminum foil bag (BOV) packaging
Aluminum foils are laminated on both sides with one or more polymer films and fabricated into bags with an aerosol valve (referred to as bag-on-valve [BOV] packaging) to be inserted into traditional aerosol containers.

Figure 1 shows an example of a micro-bulge on the internal laminate film for a BOV package. This type of material defect is common with this type of packaging. Multiple attempts to obtain a clear cross-sectioning of this defect type have not been successful. Consequently, the properties of micro-bulges and their most likely causes are unknown.

Micro-bulges typically do not contribute to, or cause, laminated aluminum foil bag corrosion. In other words, the probability is not zero, so corrosion tests should be conducted.

Figure 2 provides an example of a polymer film that delaminated at the bag weld. It has been our experience that this type of material defect is rare and can be avoided with optimized welding.

We have not observed instances where this type of material defect contributes to or causes spray package bag corrosion. However, this type of defect could cause metal foil corrosion and bag rupture at the delaminated area.

Figure 3 provides an example of a crack in the aluminum foil under the laminate film. In our experience, this type of material defect is typically random.

We have not yet observed instances where this type of material defect contributes to or causes laminate foil bag corrosion. However, product that diffuses through the inner laminate layer/layers would also be able to diffuse at the crack through the outer film and cause container perforation and leaking. Consequently, corrosion testing should be conducted.

Tinplated steel aerosol containers
Figure 4 provides an example of an area where the tin coating did not cover (wet) the steel substrate. Non-wetting produces holes in the tin coating that expose either the substrate steel or a very thin, iron-tin alloy layer. Numerous holes in tin coatings, such as that in Figure 4, are present in all tinplated steel aerosol containers.

 

There are two different morphologies for the holes in tin coatings. Figure 4 shows the traditional type of hole morphology and Figure 5 shows a newer type of hole morphology that has appeared within the last three decades.

Notice when comparing Figure 4 and Figure 5 that the newer holes are more symmetrical than the traditional holes. Most likely, the newer hole morphology comes from either a new tinplating bath chemistry composition or a new tinplating process.

Holes in tin coatings are potential sites for pitting corrosion and a formula’s chemical composition determines if pitting corrosion will or will not occur in tin coating holes.

It is unknown if either the traditional hole morphology or the newer hole morphology result in different susceptibilities to, and/or magnitudes of, pitting corrosion. Corrosion testing is the only way to determine if a given formula will cause pitting corrosion at holes in a tin coating.

Three-piece steel aerosol container bodies are welded by a diffusion-weld process, using heat and pressure. The heat is produced by an electrical current flowing between the overlapping ends of the tinplated steel sheet used to form the cylindrical container body. In some instances, the combination of pressure and heat is not optimum and a small amount of metal is ejected from under the overlapping ends.

Figure 6 has an example of a small particle of metal ejected from a weld. This phenomenon is referred to as weld spatter. Weld spatter is typically not common. However, pitting corrosion could occur if weld spatter produces a small cavern in the weld and the chemical composition of a formula determines if pitting corrosion will occur in a weld splatter cavern.

 

This column, and the previous one, both contain examples of macro-defects that can be seen with either the unaided eye or a light microscope. Next month, I’ll complete this series with a discussion of microscopic defects that cannot be seen with the unaided eye and their relationship to spray package corrosion.

Thanks for your interest and I’ll see you in May for Part Three. Contact me at 608-831-2076; rustdr@pairodocspro.com or from our two websites: pairodocspro.com and aristartec.com. SPRAY

Hello, everyone. There is no such thing as defect-free spray package materials. There are always potential concerns as to whether or not defects will contribute to, or cause, spray package corrosion and if corrosion at the point of defect will cause spray packages to fail (leak).

This issue starts a three-part discussion on material defects and their relationship to package corrosion. Material defects in traditional aluminum aerosol containers will be discussed here, and material defects in laminated foil bags in aerosol containers and tinplated steel aerosol containers will be discussed in the next two issues.

Figures 1–6 provide examples of material defects in coated aluminum aerosol containers.

All metal alloys have inclusions in the metal matrix. Inclusions are typically microscopic spherical particles of non-metal components of the aluminum alloy and aluminum/non-metal compounds. Spherical inclusions become distorted and flattened when the metal is formed into a container. Figure 1 has an example of an alloy material inclusion in aluminum aerosol container metal.

I’ve only observed rare instances when inclusions like the one in Figure 1 cause container pitting corrosion. However, corrosion could rapidly perforate containers when corrosion occurs around this type of defect.

Small pieces of metal (divots) are removed from aluminum during the container-forming process. Figure 2 has an example of a divot found in an aluminum aerosol container.

Notice in Figure 2 that the coating backfilled the divot. I have only observed rare instances where this type of metal defect contributes to or causes container corrosion. However, corrosion tests should be used to qualify all new and derivative container-formula systems.

 

Aluminum aerosol containers are formed with multiple extrusion stages. The containers resemble long tubes open at the top with a bottom during one of the later stages.

The coating is sprayed inside the open tubes with a nozzle that moves from the bottom of the tube to the top during the coating application. In some instances, coating drips from a nozzle after spraying. Figure 3 has an example of a coating drip in an aluminum aerosol container (referred to as a drool). Corrosion caused by drools is rare, but corrosion testing is still needed.

Entrained air in the bulk coating material sometimes causes a coating nozzle to instantaneously eject the air with a small amount of excess coating. The excess coating on the container surface is referred to as a spit, examples of which are shown in Figure 4. Notice that there are two spits at two different locations inside this example.

Figure 4 also shows variations in coating color. Coating color variations could be caused by variations in the thickness of the coating—a well-known phenomenon in the coatings industry.

 

Spits are very common in aluminum aerosol containers. Coating color variations also noted in Figure 4 are caused by coating thickness variations. These variations are also common and I have observed instances where they caused or contributed to random container failures (leaking).

High temperatures are used to cure aerosol container coatings. Coatings and coating components are dissolved in solvents that evaporate during the curing process and small bubbles can form during solvent evaporation. Sometimes these bubbles harden, producing solvent pops like the one in Figure 5.

Solvent pops rarely contribute to, or cause, corrosion. However, pitting corrosion inside solvent pops could occur when there is also extensive coating corrosion surrounding a solvent pop.

Holes in coatings are very common. Figure 6 has an example of a small area where a coating did not wet (cover) the container metal, resulting in a hole that exposes metal.

This type of defect typically causes pitting corrosion when there is also coating corrosion around the hole.

One or several of the defects shown in Figures 1–6 are present in virtually all aluminum aerosol containers. Consequently, corrosion testing is needed to determine when these defects will contribute to, or cause, container corrosion that leads to failure.

In the next issue, we’ll continue this discussion on material defects in bag-on-valve (BOV) packaging and traditional steel aerosol containers.

Thanks for your interest and I’ll see you in April for Part Two. Contact me at 608-831-2076; rustdr@pairodocspro.com or from our two websites: pairodocspro.com and aristartec.com. SPRAY

ECHA enforcement projects find significant non-compliance

The European Chemicals Agency (ECHA) Enforcement Forum coordinates various projects in Europe to harmonize enforcement in each Member State and check the current level of compliance regarding obligations under European Union (EU) hazardous products regulations. A significant proportion of non-compliance was found during recent enforcement projects BPR-EN-FORCE-2 (BEF-2) and REACH-EN-FORCE-10 (REF-10).

Under the BEF-2 project, national enforcement authorities in 29 countries checked over 3,500 biocidal products for compliance in the EU, European Economic Area (EEA) and Swiss markets. The BEF-2 project focused on non-allowed active substances in biocidal products, approval of the active substance suppliers, and obligations related to labeling, packaging and advertising of biocidal products. Overall, approximately 60 substances that are not permitted in biocides were found and 37% of the evaluated products exhibited non-compliance with the Biocidal Products Regulation (BPR).

Eighteen percent of checked products were non-compliant with fundamental requirements that affect their safe use. For the most part, these either lacked a product authorization or included non-permitted active substances. The product types that were the biggest offenders included disinfectants, insecticides and repellents/attractants. All products that lacked authorization or contained prohibited active substances were withdrawn from the market and, in some cases, criminal complaints or fines were issued.

The remaining 19% of non-compliant products had minor deficiencies that do not affect safe use, such as missing supplier information. National enforcement authorities gave advice or administrative orders to correct these minor issues.

Under the REF-10 project, national enforcement authorities in 26 EU countries checked over 2,400 products intended primarily for consumers. Of the products checked, more than 400 were found to be non-compliant according to EU chemical regulations. The worst offenders were electrical devices, 52% of which were found to contain restricted chemicals such as lead in solders, phthalates in soft plastic parts or cadmium in circuit boards. Other product types—including sports equipment, toys and fashion products—had instances of non-compliance in the 15–18% range due to the presence of chemicals of concern such as phthalates, short-chain chlorinated paraffins (SCCPs) and polycyclic aromatic hydrocarbons (PAHs).

Instances of non-compliance were more prominent in products originating from outside the EEA or with unknown origin. Inspectors have taken enforcement measures in the cases where non-compliant products were found, resulting in the withdrawal of many such products from the market.

Research priorities for hazardous chemical regulation
ECHA published a new report, Key Areas of Regulatory Challenge 2023, identifying areas where research is needed to protect people and the environment from hazardous chemicals and highlighting where new methods are needed to support the shift away from animal testing. ECHA asserts that scientific research must deliver data that is relevant to regulating chemicals to further improve chemical safety. As a result, the following areas have been identified as priorities:

• Hazard identification for critical biological effects that currently lack specific and sensitive test methods (developmental and adult neurotoxicity; immunotoxicity and endocrine disruption)
• Chemical pollution in the natural environment (bioaccumulation; impact on biodiversity; exposure assessment)
• Shift away from animal testing (read across under Registration, Evaluation, Authorization & Restriction of Chemicals [REACH]; move away from fish testing; mechanistic support to toxicology studies, e.g. carcinogenicity)
• New information on chemicals (polymers; nanomaterials; analytical methods in support of enforcement)

The report also highlights why these topics are of regulatory importance and how the new scientific knowledge is expected to be used in the EU’s chemicals management.

The priorities were developed under the European Partnership for the Assessment of Risks from Chemicals (PARC). PARC is a seven-year, EU-wide research and innovation program under Horizon Europe that aims to advance research, share knowledge and improve skills in chemical risk assessment. The list of research needs is not exhaustive; they are meant to inform and inspire the scientific community and are expected to evolve over time. The next update to the report is anticipated this Spring.

EU Commission 2024 Work Programme
The 2024 European Commission Work Programme, which was adopted on Oct. 17, 2023, details initiatives for the year with an emphasis on simplifying rules for citizens and businesses across the EU. Previously, the Commission set a target to reduce reporting requirements by 25%, without undermining the objectives of the concerned initiatives. The motivation to reduce the administrative burden of compliance is reflected in the proposals, which are in alignment with the strategy to boost the EU’s long-term competitiveness and provide relief to small and medium-sized enterprises (SMEs) that are disproportionately affected by the various chemical compliance obligations.

Ahead of the 2024 European elections, the Commission outlined 26 new proposals in the Programme. The plan aims to deliver on the outstanding commitments, of which fewer than 10% remain, that are yet to be delivered under the 2019 Political Guidelines and to address emerging challenges.

The main approaches to streamline reporting requirements will include the removal of duplication and the use of digitalization. The Commission also plans to expand e-platforms for data management to ensure standardization and to develop artificial intelligence tools and language models.

Annex I to the Work Programme identifies the new initiatives and Annex II, entitled Significant proposals and initiatives to rationalize reporting requirements and evaluations and fitness checks, covers various regulatory reform proposals. Of those nominated to undergo reforms, the regulation on detergents and surfactants might be one for SPRAY readers to keep an eye on. The proposed changes would simplify and digitize reporting requirements for detergent products by introducing a digital product passport and ingredient data sheet for hazardous substances.

Annex III to the Work Programme for “Pending Proposals” includes a proposal for the revision to the regulation (1272/2008) on the Classification, Labeling & Packaging (CLP) of substances and mixtures, as well as amendments to the packaging and packaging waste laws. The CLP update is discussed further in the final section.

Absent from the Work Programme and its annexes is any mention of the anticipated revision to the EU REACH regulation (1906/2007). It is unclear why this update is not included since it is part of the EU Chemicals Strategy for Sustainability.

Annex IV features intended withdrawals of pending proposals. The European Commission has released two fact sheets entitled Commission Work Programme 2024 explained and Reducing burden & rationalizing reporting requirements that provide a concise summary of the Commission’s strategy for 2024.

EU authorities reach provisional agreement for revised EU CLP regulation
In line with the Work Programme and the Chemicals Strategy for Sustainability, the EU Council and Parliament have reached an agreement on the text for the revision to the EU CLP regulation. This update is in addition to the new hazard classifications that were discussed in the June 2023 issue of SPRAY.

The legislation that amends the existing 2008 EU regulation attempts to improve communication of chemical hazards, address legal deficiencies and clarify rules in relation to online sales and labeling of hazards products. Digital labeling is a new topic that will be covered under CLP, which will provide rules for the use of voluntary digital labeling and related technical requirements to ensure accessibility for users.

Once the update comes into effect, there will be new standards for the font size of warnings and minimum size requirements for label pictograms appearing on packages. More flexibility is welcomed as the new rules permit broader use of fold-out labels.

Advertisements for hazardous mixtures will no longer be allowed to include difficult to prove “Green claims” such as “non-toxic,” “non-harmful,” “non-polluting,” “ecological” or any other statements that are inconsistent with the classification. The updated legislation will also create the opportunity for the Commission, Member States and industry to expedite the process for identifying hazardous substances and making new classification proposals.

The timeline for implementation is not yet known because both the EU Parliament and Council need to formally approve the agreement before it can enter into force.

As always, feel free to reach out to us at Nexreg Compliance Inc. with your EU compliance questions. SPRAY

Do you remember what you made for dinner last night? What about a week ago? It might be even more difficult to remember each ingredient that went into making the meal and when/where you got it. What if you had to remember these details for every dinner going back almost 14 years?

This is exactly the situation that manufacturers and processors are currently experiencing under the Toxic Substances Control Act (TSCA) Section 8(a)(7) rulei for retrospective reporting for per- and polyfluoroalkyl substances (PFAS) that is required by the 2020 National Defense Authorization Act (NDAA).ii This rulemaking has undergone significant stakeholder feedback over the past several years, through both the extensive rulemaking process and a small business panel review created to assist the U.S. Environmental Protection Agency (EPA) and the regulated community in understanding the significance of this undertaking.

In summary, the rule requires manufacturers, including importers, to retrospectively report any PFAS chemicals identified by the rule with numerous data elements from Jan. 1, 2011. (Note: Section III.B.2 of the rule defines “Manufacture for commercial purposes” to include the import, production or manufacturing of a chemical substance or mixture containing a chemical substance to obtain an immediate or eventual commercial advantage for the manufacturer. This includes, but is not limited to, the manufacture of chemical substances or mixtures for commercial distribution, including test marketing, or for use by the manufacturer itself as an intermediate or for product research and development. “Manufacture for commercial purposes” also includes the coincidental manufacture of byproducts and impurities that are produced during the manufacture, processing, use or disposal of another chemical substance or mixture. As described in Unit III.B.1, simply receiving PFAS from domestic suppliers or other domestic sources is not considered manufacturing PFAS for commercial purposes. Entities that process and use PFAS only need to report on the PFAS they have manufactured [including imported], if any.)

Manufacturers or importers of chemical substances that meet the definition of PFAS under TSCA must report on PFAS information by site, in any quantity (no threshold applies), for each calendar year from 2011 through 2022. The reporting also includes PFAS imported as part of articles, although streamlined reporting is available; PFAS imported or manufactured solely for research and development (R&D), but streamlined reporting is available only for PFAS imported or manufactured for R&D in a quantity below 10 kilograms per year (< 10 kg/year); PFAS imported or manufactured as byproducts, impurities or polymers; and PFAS manufactured as non-isolated intermediates. Each entity subject to reporting must retain records that document any information reported to the EPA for five years beginning on the last day of the submission period. The reporting opens on Nov. 12, 2024, and closes six months later on May 8, 2025. However, “small manufacturers” who have to report solely due to having imported PFAS as part of articles have an extra six months to report (until Nov. 10, 2025).

While this rule is based on the Chemical Data Reporting Rule, it includes additional data elements for each reportable substance. The rule defines PFAS as any chemical substance or mixture containing a chemical substance that structurally contains at least one of the following three sub-structures:

1. R-(CF2)-CF(R’)R”—where both the CF2 and CF moieties are saturated carbons.
2. R-CF2OCF2-R’—where R and R’ can either be F, O or saturated carbons.
3. CF3C(CF3R’R”—where R’ and R” can either be F or saturated carbons.

As of February 2023, the EPA has identified at least 1,462 substances that can be defined as PFAS under TSCA that could be covered by the final rule,iii 770 of which are listed on the TSCA Inventory with active commercial status designations. As of December 2023, the EPA’s Office of R&D has identified a much broader list of 11,409 specific PFAS that could be covered by the final rule.iv Given that these lists are non-exhaustive, companies are encouraged to compare against these lists but also perform their own due diligence to ensure no other substances meet the definition of PFAS. It’s important to note that HFC-152a is not within the rule’s scope for the aerosol industry, but other Hydrofluorocarbons (HFCs) and Hydrofluoroolefins (HFOs) meet this definition, so it’s essential to verify.

You may be thinking, “We don’t manufacture PFAS, so would we still need to report?” Therein lies the challenge. While many companies do not need to report, it’s still critical to have documentation of this fact.

To provide a better appreciation for the impact of the rule, when it was originally proposed by the EPA, the economic impact was estimated at a little over $10 million.v However, after stakeholders, especially small business entities, provided feedback, the EPA increased the economic impact to more than $800 million.vi This change was primarily driven by the due diligence that would be required by companies to determine if they have reporting obligations. This is particularly complicated for companies with product formulations or product functionality that may have or likely required PFAS technology or companies that imported ingredients for formulations over the past 14 years.

What should be done to establish due diligence? What records should you have or maintain? How should you document the steps taken to determine whether or not you have ingredients within the scope of the rule? What happens if you don’t have these records? Each of these questions needs to be carefully considered when determining reporting requirements—whether or not you have them.

Important things to consider as you perform due diligence include:

1. Do you meet the definition of manufacturer, including imports? If so, do you have a process, standard operating procedure (SOP) or checklist that documents the steps to determine compliance?
2. Have you utilized raw materials that are/were likely PFAS? If so, were these raw materials from domestic sources or imported?
3. Do you have products within the scope of other regulations, such as personal care products, cosmetics or pesticides? If so, do they contain any PFAS ingredients that might be considered within the scope of TSCA?
4. Do you have the records documenting these raw materials?
5. Do you have a record retention policy?
6. What reasonable efforts can be taken to obtain this information from suppliers?

This one-time reporting rule will clearly impact a majority of companies in the household and commercial products space, including aerosol products. There may also be situations where suppliers or customers will pose questions about your reporting or recordkeeping in response to their own compliance obligations. This is a very significant rule—and one that requires a high level of due diligence to comply. While many companies will have reporting obligations, this will require a similar level of effort from companies to demonstrate that they do not have any reportable PFAS substances.

If you have any questions concerning this information to help determine PFAS reporting requirements, please contact me at sbennett@thehcpa.org. SPRAY


i In the Oct. 11, 2023, Federal Register, EPA finalized a reporting and recordkeeping rule for PFAS to implement TSCA § 8(a)(7). The final rule took effect on Nov. 13, 2023 and is codified as the new 40 C.F.R. pt. 705. link
ii Section 7531 of the National Defense Authorization Act for Fiscal Year 2020, Pub. L. 116–92, added new paragraph 8(a)(7) to TSCA.
iii Public List of TSCA PFAS for 8(a)(7) Rule, link
iv link
v Draft Economic Analysis for the Proposed TSCA Section 8(a) Reporting & Recordkeeping Requirements for Perfluoroalkyl & Polyfluoroalkyl Substances, link
vi Economic Analysis for the Final Rule entitled: “TSCA Section 8(a)(7) Reporting & Recordkeeping Requirements for Perfluoroalkyl & Polyfluoroalkyl Substances” link