PureCycle to Receive Expanded FDA No Objection Letter for PureFive(TM) Resin Use in Cosmetics, Personal Care and Food Applications
PureCycle Technologies (NASDAQ:PCT) announced that it received an expanded Letter of No Objection (LNO) from the FDA for its PureFive™ Ultra-Pure Recycled resin, allowing its use in food-contact applications. This approval covers all food types under FDA's Conditions of Use A through H, equating PureFive™ resin with virgin polypropylene. The expansion permits PureCycle to use a broader range of feedstocks, including curbside materials sorted for food-grade applications. This development follows extensive testing and feedstock evaluation. CEO Dustin Olson highlighted the significance of this approval for broadening the company's impact and supporting global brand owners and processors in food packaging.
- FDA approval expands to all food types under Conditions of Use A through H.
- PureFive™ resin now has the same Conditions of Use as virgin polypropylene.
- Approval permits the use of broader feedstock range including curbside materials.
- This development supports wider adoption in food packaging, benefiting global brand owners.
- Extensive component challenge-testing and feedstock evaluation underscore thorough preparation.
- Enhanced market potential for PureCycle's PureFive™ resin in both personal care and food applications.
- Potential increased costs associated with sourcing and processing wider range of feedstocks.
- Dependency on consistent quality and supply of curbside and other feedstocks.
Insights
The FDA's expanded Letter of No Objection (LNO) has significant implications for PureCycle Technologies' financial health and growth potential. By allowing PureFive™ to be used in a broader range of food-contact applications, PureCycle can now target a larger market. In particular, the ability to use curbside materials for food-grade applications can reduce input costs and further broaden the company's feedstock sources. This is a positive development for reducing dependency on more expensive food-grade sources, improving margins and potentially increasing profitability.
Short-term, this expanded LNO could boost investor confidence and drive up the stock price as it represents a regulatory milestone, potentially attracting new partnerships and customer contracts. Long-term, the increased versatility and cost-efficiency may lead to sustainable revenue growth. However, the company needs to effectively manage the scale-up of its operations to handle this broader range of materials without compromising quality or incurring excessive costs.
This expanded FDA approval opens up new market opportunities for PureCycle Technologies, particularly in the food packaging industry, which is a substantial and growing sector. The approval means that PureCycle can market its PureFive™ resin for a wide variety of food-contact applications, from frozen storage to microwaveable packaging, rivaling virgin polypropylene. This positions PureCycle as a competitive player in the food-packaging market, which is driven by increasing consumer demand for sustainability.
Brand owners and packaging processors, who are keen to adopt more environmentally friendly materials without sacrificing safety and quality, will likely find this product attractive. This can lead to increased market penetration and stronger brand partnerships. However, the company needs to ensure it scales its production capabilities efficiently to meet this anticipated demand.
From an environmental policy perspective, the FDA's expanded LNO is a important development. It signifies regulatory confidence in PureCycle's technology to effectively recycle polypropylene, which is known to be challenging to purify to food-grade standards. This milestone shows that PureCycle's process can now transform curbside-collected materials into high-purity resin suitable for food contact, potentially diverting significant amounts of polypropylene waste from landfills.
This dovetails with growing regulatory and public pressure for enhanced recycling and waste management solutions. It also aligns with broader environmental goals and could attract more eco-conscious investors. However, PureCycle must continuously ensure its processes remain compliant with stringent FDA standards to maintain this approval and its associated benefits.
ORLANDO, FL / ACCESSWIRE / June 11, 2024 / PureCycle Technologies, Inc. (NASDAQ:PCT), today, announced the receipt of a Letter of No Objection (LNO) from the United States Food & Drug Administration (FDA) confirming that the Company's PureFive™ Ultra-Pure Recycled resin is suitable for use in food-contact applications.
This LNO expands upon a previous no-objection letter to PureCycle from the FDA, confirming that the Agency considers PureFive™ Ultra-Pure Recycled resin to be suitably pure for use in contact with all food types under FDA's Conditions of Use A through H. This expansion provides PureCycle with the same Conditions of Use for PureFive™ recycled resin as virgin polypropylene. The Conditions of Use span from frozen food storage to microwaveable packaging.
The FDA's LNO acknowledges that PureCycle may procure a wider range of feedstock for FDA applications, including curbside materials that are sorted for food-grade. Currently, the Company purchases both food-grade and non-food grade feedstocks for the purification operations. The Company previously received an LNO for all food types under Conditions of Use E through G with only food-grade post-consumer recycled feedstock that was collected at stadiums and other point sources.
"This is another big step for our Company and will allow PureCycle to expand our impact and further support brand owners and processors across the globe," said PureCycle CEO Dustin Olson. "Many of our partners have been waiting for this news and we are excited to work with them to approve this product for their food packaging."
This is the result of months of feed preparation and purification through PureCycle's Feedstock Evaluation Unit, sample-gathering and an extensive component challenge-testing in preparation for the final submission.
The Company also previously received an LNO for all food types under Conditions of Use A-H with the use of food-grade post-industrial recycled materials. PureCycle uses a patented recycling process to remove color, odor, and other impurities from polypropylene plastic waste.
###
PureCycle Contact
Christian Bruey
cbruey@purecycle.com
+1 (352) 745-6120
About PureCycle Technologies
PureCycle Technologies LLC., a subsidiary of PureCycle Technologies, Inc., holds a global license for the only patented solvent-driven purification recycling technology, developed by The Procter & Gamble Company (P&G), that is designed to transform polypropylene plastic waste (designated as No. 5 plastic) into a continuously renewable resource. The unique purification process removes color, odor, and other impurities from No. 5 plastic waste resulting in an ultra-pure recycled (UPR) plastic that can be recycled and reused multiple times, changing our relationship with plastic. www.purecycle.com
Forward-Looking Statements
This press release contains forward-looking statements, including statements about the financial condition, results of operations, earnings outlook and prospects of PCT. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements generally relate to future events or PureCycle's future financial or operating performance and may refer to projections and forecasts. Forward-looking statements are often identified by future or conditional words such as "plan," "believe," "expect," "anticipate," "intend," "outlook," "estimate," "forecast," "project," "continue," "could," "may," "might," "possible," "potential," "predict," "should," "would" and other similar words and expressions (or the negative versions of such words or expressions), but the absence of these words does not mean that a statement is not forward-looking.
The forward-looking statements are based on the current expectations of PureCycle's management and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of this press release. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the section entitled "Risk Factors" in each of PureCycle's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and PureCycle's Quarterly Reports on Form 10-Q, those discussed and identified in other public filings made with the Securities and Exchange Commission by PureCycle and the following: PCT's ability to obtain funding for its operations and future growth and to continue as a going concern; PCT's ability to meet, and to continue to meet, applicable regulatory requirements for the use of PCT's ultra-pure recycled ("UPR") resin in food grade applications (including in the United States, Europe, Asia and other future international locations); PCT's ability to comply on an ongoing basis with the numerous regulatory requirements applicable to the UPR resin and PCT's facilities (including in the United States, Europe, Asia and other future international locations); expectations and changes regarding PCT's strategies and future financial performance, including its future business plans, expansion plans or objectives, prospective performance and opportunities and competitors, revenues, products and services, pricing, operating expenses, market trends, liquidity, cash flows and uses of cash, capital expenditures, and PCT's ability to invest in growth initiatives; the ability of PCT's first commercial-scale recycling facility in Lawrence County, Ohio (the "Ironton Facility") to be appropriately certified by Leidos, following certain performance and other tests, and commence full-scale commercial operations in a timely and cost-effective manner or at all; PCT's ability to meet, and to continue to meet, the requirements imposed upon it and its subsidiaries by the funding for its operations, including the funding for the Ironton Facility; PCT's ability to minimize or eliminate the many hazards and operational risks at its manufacturing facilities that can result in potential injury to individuals, disrupt its business (including interruptions or disruptions in operations at its facilities), and subject PCT to liability and increased costs; PCT's ability to complete the necessary funding with respect to, and complete the construction of, (i) its first U.S. multi-line facility, located in Augusta, Georgia; (ii) its first commercial-scale European plant located in Antwerp, Belgium and (iii) its first commercial-scale Asian plant located in Ulsan, South Korea, in a timely and cost-effective manner; PCT's ability to procure, sort and process polypropylene plastic waste at its planned plastic waste prep facilities; PCT's ability to maintain exclusivity under the Procter & Gamble Company license; the implementation, market acceptance and success of PCT's business model and growth strategy; the success or profitability of PCT's offtake arrangements; the ability to source feedstock with a high polypropylene content at a reasonable cost; PCT's future capital requirements and sources and uses of cash; developments and projections relating to PCT's competitors and industry; the outcome of any legal or regulatory proceedings to which PCT is, or may become, a party including the securities class action and putative class action cases; geopolitical risk and changes in applicable laws or regulations; the possibility that PCT may be adversely affected by other economic, business, and/or competitive factors, including interest rates, availability of capital, economic cycles, and other macro-economic impacts; turnover in employees and increases in employee-related costs; changes in the prices and availability of labor (including labor shortages), transportation and materials, including inflation, supply chain conditions and its related impact on energy and raw materials, and PCT's ability to obtain them in a timely and cost-effective manner; any business disruptions due to political or economic instability, pandemics, armed hostilities (including the ongoing conflict between Russia and Ukraine and the conflict in the Middle East); the potential impact of climate change on PCT, including physical and transition risks, higher regulatory and compliance costs, reputational risks, and availability of capital on attractive terms; and operational risk.
SOURCE: PureCycle Technologies, Inc.
View the original press release on accesswire.com
FAQ
What recent FDA approval did PureCycle Technologies receive?
What are the Conditions of Use for PureFive™ Ultra-Pure Recycled resin?
How does the new FDA approval benefit PureCycle Technologies?
What are the sources of feedstock for PureFive™ resin?
How does PureCycle's recycling process work?
