Name: PPWR Regulations: What You Need to Know and How NSF Can Support Your Packaging Claims for EU Market Access
Uploaded: 2026-10-08T15:50:08.835Z
Duration: 1 h 13 min 11 s
Description: PPWR Regulations: What You Need to Know and How NSF Can Support Your Packaging Claims for EU Market Access

Transcript for "PPWR Regulations: What You Need to Know and How NSF Can Support Your Packaging Claims for EU Market Access": Good morning, good afternoon, good evening. Welcome, everybody, and thank you for joining us for our webinar on packaging and packaging waste regulations, the PPWR. So in this webinar, we're gonna cover what you need to know about these regulations and how NSF can support your packaging claims for EU market access. First, a little bit of housekeeping. The webinar is scheduled for one hour. This session is live but is being recorded. So you are able to view the recording afterwards, to rewatch any of the sections. You will be able to share the link with other colleagues that maybe you wanna have watched the webinar, and be able to kind of share it internally that way as well. So live translated subtitle... Subtitles are available, in a few different languages. So during the... Via the language selector, at the bottom right hand corner of the window, you have to press that CC button, and then you can select your language. There's kind of an image on the screen here that shows you where that's available. So definitely utilize that as I I know we have quite a global audience here as we kind of go throughout the the webinar. At the end, there will be a q and a session. So on the right hand side of your screen, you can submit questions by using the q and a feature in the top right corner. Type those in, and then at the end, we're gonna be going through and answering all those questions for everyone. As I mentioned, it is being recorded. There will be a recording link shared, in the coming days following the webinar, And there'll also be a post event survey sent via email. We greatly appreciate your feedback, as we continue to host these, and provide information for everyone. We wanna keep taking your feedback into account, as as we update and and work to continue improving these. So just a little bit about everybody who's gonna be on the webinar today. First, my name is Sam Cole. I'm our global director of our food contact evaluation programs. Also joining us is Raul Rădoi. He's our government affairs manager, located in in Brussels in Europe. Carmen Grindatti, our technical scheme our technical scheme lead, for all of our food contact evaluation programs, and Cami Banegas, our client and industry partnership manager. The agenda for the webinar is first, I'm gonna be covering a a little introduction for who is NSF. Right? So a lot of people joining us. You may be unfamiliar with who we are as a company. So sharing just a little bit about who we are, and how we kind of play in the space and how we can help all of our clients navigate. And then understanding the regulation, the EU packaging and packaging waste regulation, PPWR. What is it? What are the requirements? And then covering the testing and declarations of compliance that are required for it. And then touching a little bit on NSF p five two five, the safe food packaging certification protocol followed by any q and a. So starting off, the introduction to NSF. So we were founded in 1944. We've been in business over eighty years. We are a not for profit organization. And since 1944, we have been dedicated to protecting and advancing human health. Our vision, is to be our clients' trusted partner for safety, quality, sustainability, brand protection, and growth, leveraging science based principles, strategic partnerships, and data driven insights. So how we do that is, you know, we are a company in in the tech industry. Right? We we have global labs across the board, where we conduct testing, a number of different audit and inspection based programs, as well as a a lot of different certifications to different standards, either developed by NSF International, or certification to global standards as well as some protocols and guidelines. So our work across food, water, and wellness is grounded in independent science based testing, health risk assessments, inspections, certifications, standard development, and advisory services. Right? So together, these activities protect consumer and brands while supporting our mission of promoting human health across the globe. So you can see as a company, we have over 680,000 different certified products, across all of our division. We complete over 300,000 audits annually. You know, on the right, you can kinda see some of the different pieces. I mentioned, standard writer and developer, over a 160 published standards and protocols, working with a a large number of clients globally. So these are the divisions at NSF International, food, water, and wellness. So in our mission to protect, human wellness, we have a number of different offerings across these different divisions. So in the food division, which is where we where we sit, we really focus on that farm to fork mentality. Right? So we work with everybody from the agriculture space all the way up to the end retail clients and everything in between, including all of the food production facilities, the restaurants, the food growers, and all of those all of those different areas of the the supply chain. So the packaging clients that we work with, you know, we really kind of help fill that space where we understand the needs, from the the food food production clients that are manufacturing the food and the requirements that they have on on the packaging that they use. So the restaurants that are serving that food, and the packaging they use in that space, And then really just understanding all of the global requirements across it so we can help not only the packaging manufacturers, but then all of the end users of that packaging, in meeting all of the different regulations. Here you can kinda see our global footprint. So I mentioned global company. Our headquarters is in Ann Arbor, Michigan, but we have our European headquarters in Brussels, which is where Raul Rădoi will be joining from us. And then a number of locations and labs across the world. So before transitioning, into Raul Rădoi who's gonna cover, those PPWR regulations and requirements, a couple of polls just to kind of gauge, where the audience is at, and as far as their packaging and PPWR journey. So the first poll question is, is your business currently involved in the manufacturing, supply, use, import, distribution, or sales of packaging that is placed in the EU market? Right? So our options are yes, no, not sure. Just definitely looking like yes is leading the way so far. However, part of what we wanna help people understand with this webinar is if you're currently not exporting or selling into Europe, but you're thinking about it, it could be part of your strategy or as part of your future plans, giving you some advanced information of what's coming so that you can understand what the requirements would be as far as development and r and d. And then for all of those that are saying yes, which is the vast majority here, definitely helping you understand those requirements that went into place in August and future requirements that are coming, so that you can continue to make, those adjustments and and decisions, and kind of sorting things out and how you wanna develop and and update products. Okay. That's good for poll one. Yes. Definitely led the way with 80%. So, on to poll question number two, kind of a follow-up to number one. Is so if no, so for the... About 30%, do you expect your business to become involved in the next twelve months in the European market? So as I've kind of mentioned in the last one, for the no's, it could really be a business opportunity. It may be something like, hey. We're look... We're looking to expand. I mean, the food processing industry as a whole is is growing rapidly, as populations grow, as more restaurants grow, as more grocery stores are opening, the demand both for for packaging in the restaurant space and in the food processing space are growing as well as regulations are rapid... Rapidly updating. So, it's creating a great opportunity for a lot of manufacturers to kind of identify and get into these new markets. So we are looking at, on the answers here, roughly 70% looking to expand into into your... The European Union, into countries in Europe over the next twelve months. So great. You know, the information as we kinda go through this, we'll definitely help you on your endeavor to kind of get into that market. And then NSF International, like I mentioned upfront, just a trusted partner, welcome to help you on that journey, in answering any questions or anything we can kinda do, to support you in that market access. So we can go ahead and close down this poll. And then from there, I'm gonna turn it over to Raul, to talk through understanding the EU PPWR regulations. Thank you. Thank you very much, Sam. Good morning, everyone from, Brussels. Good afternoon in case, you are on our, time zone or or further east. So good morning, good afternoon. It's a pleasure to be with with you today and to provide you an overview, on the European packaging and packaging waste regulation, the so called PPWR. This is a European Union law, which is applying on its entire territory from the 08/12/2026. So from Finland to Italy, from Portugal and Spain, throughout France and Germany, Austria to Romania and Poland, so all over the Europe, this regulation is applicable. It's directly applicable since it's a supranational legislation. It overrules national legislations, and it applies, in the entire European Union. So this legislation sets out harmonized sustainability and labeling requirements for packaging throughout throughout its life cycle, including production, use, and waste management. It aims to prevent unnecessary packaging, reduce packaging waste by minimization, prohibition of certain single use packaging, and promote reuse, refill, and recycling. It harmonizes national measures to avoid trade barriers and competition distortions in the European internal market. It aims to contribute to the circular economy and climate neutrality of the European Union by 2050. The PPWR was adopted as part of EU's, circular economy action plan and is part of the more ambitious European Green Deal. Unlike the previous directive, this is a regulation. So it is applicable exactly like a national law in all the 27 member states. For industry, the PPWR represents more than an environmental or waste management initiative. It introduces requirements that will influence packaging, design, material selection, product stewardship, supply chain management, and market access. Today's presentation will focus on PPWR in general, but also on substances of concern in food contact packaging. Let us briefly look at the main measures introduced by the PPWR across the packaging life cycle. The first area concerns substances in packaging or packaging safety. The PPWR maintains the existing restrictions on heavy metals and introduces additional provisions relating to substances of concern in packaging. Among these measures are the new PFAS restrictions for food contact packaging, which will be the center of today's presentation. The second area focuses on circularity measures. The regulation aims to keep packaging materials for longer through reuse targets, minimum recycled content requirements for certain plastic packaging, and mandatory deposit return for beverage containers. The third area is waste prevention and consumer information. The regulation introduces packaging waste reduction targets, limits the unnecessary empty space in packaging, harmonizes packaging labels for sorting and certain single use packaging while alternatives are considered feasible. The implementation is gradual. By 2030, packaging must meet recyclability requirements, and the EU aims to reduce packaging waste by 5% compared to with the levels, from 2018. By 2035, packaging will need to demonstrate recyclability at scale, and the reduction must increase to 10%. By 02/2040, the packaging waste reduction target reaches 15%. For today's discussion, I would like to focus on the first pillar, substances in packaging, and specifically the new, PFAS, restrictions, provisions for food contact, packaging. But before that, let's have a look into the broader food contact materials framework in the European Union in order to better understand the logic of this regulation and how the food contact materials regulations in the union deal with substance is a very high concern. An important point to underline from the beginning is that the PPWR does not replace existing food contact and legislation, but completes it. Companies will need to comply with FCM regulations, food contact material regulations, and with PPW are in parallel. The cornerstone of EU food contact legislation is the food contact material regulation from 2004, supported by the good manufacturing practice regulation. These regulations establish the general safety principles for all food contact materials. In simple terms, materials and articles intended to come into contact with food must not transfer substances to food in quantities that could endanger human health, cause an unacceptable change in the composition of the food, or adverse have adverse effects in its taste, odor, or quality. They also contain requirements on labeling, presentation, and consumer information. The level of harmonization in the European Union on food contact materials differs depending on the material involved. Only four material groups are covered by specific harmonized EU measures, plastics, ceramics, regenerated cellulose film, and active and intelligent materials. For many other for many other food contact materials, such as paper and board, inks, coatings, rubber, and metals, companies might rely, must rely largely on national legislation. This results in a fragmented regulatory landscape and makes compliance particularly challenging for companies operating across the multiple European, markets. Harmonized EU measures started to address also specific substances or group of substances used in food contact materials. Some examples are epoxy derivatives, nitrocemines, vinyl chloride monomer. The EU has progressively strengthened controls on substances of very high concern, the SVHCs, including endocrine disruptors, carcinogens, and substances toxic reproduction. An important driver has been the scientific work done by EFSA, the European Food Safety Authority. Over the years, EFSA has published scientific opinions and risk assessments on substances of concern that may migrate from food contact materials into food, including phthalates, bisphenol a, or BPA, and more recently, the per and per and polyfluoralky substances, the PFAS. These assessments have been followed subsequently by regulatory action at EU level. The restrictions on PFAS initially focus on the so called legacy PFAS, particularly the PFOS, perfluoro octane sulfonic acid, the PFOA, perfluoroalkanic acid, and the PFHXS, the perfluorohexanesulfonic acid. These were considered among the substances presenting the highest concern. Regulatory attention then extended to related substances and broader PFAS subgroups, including PFCAs, the perfluorocarboxylic acids. Authorities perfluorocarboxylic acids. Authorities also recognized the risk of what it often called regrettable substitution, where one restricted PFAS is replaced by another chemically similar PFAS. This led to increased scrutiny of substances, such as perfluorohexanoic acid, the PFHXA, so the so called short chain PFAS and the related, compounds. We can see that the regulatory approach evolved from targeting individual PFAS substances to addressing broader PFAS groups and increasingly specific uses of PFAS, such as firefighting foams, textiles, consumer products, and food packaging. Besides the PPVWR, a recent example is the restrictions under the European chemical regulation, the reach of the perfluorohexanoic acid. This measure, brand new, restricts its use in several consumer applications, including textiles, cosmetics, certain food packaging, and firefighting forms. It introduces very low concentration limits, 25 parts per billion for, this, substance and will start applying in phases from this month, actually. The overall trend is clear. Regulation is progressively evolving from individual PFAS restrictions toward broader controls and potential phased out strategies. PPWRs, PFAS provisions should therefore be seen as part of this wider regulatory revolution. Looking ahead, the discussion goes even further. The European Chemicals Agency is currently evaluating a proposed universal PFAS restriction under the the chemicals regulation, the rich regulation, which was submitted a few years ago by five European Union member states. The final ECHA evaluation is expected end of two thousand twenty six, and it reflects a shift towards regulating PFAS as a class and will provide most probably the basic basis for, regulation on behalf of European Union in this, in this sense in, in the future. Let's now turn to the specific PFAS requirements introduced by the PPWR. Article five established a general principle that packaging should be designed and manufactured so as to minimize the presence and concentration of substances of concern throughout its life cycle. For food, contact packaging, the regulation goes a step further and introduces specific PFAS units. These are applicable from 08/12/2026. There are three different, thresholds that were, that were established. The first threshold concerned individual PFAS substances, which are limited to 25 parts per billion. Second, the limit for the sum of a defined list of individual PFAS substances that are specifically measured and quantified is 250 parts per billion. And the third threshold concerns total PFAS, which takes a broader approach. Rather than looking only at the predefined substances, it aims to capture the overall PFAS content, including known and unknown PFAS and PFAS precursors. The limit here is 50 parts per million. An important aspect is that limits apply both to intentionally added and unintentionally present PFAS. This includes packaging materials themselves, as well as coatings, printing inks, varnishes, adhesives, laminates, and other packaging components. Businesses should therefore not assume that PFAS will only be found in the primary packaging material. Understanding the entire packaging structure and supply chain is thus very important. PPWR maintains the existing limits for heavy metals. This deserves being, recalled, including on lead, cadmium, mercury, and hexavalent, chromium. The combined concentration for these four metal must remain below 100 per kilogram. And the compliance is the same as in the directive, so it's the same, report on guidelines. Finally, it is important to know that PPWR does not provide a stock exhaustion period for non compliant packaging. This means that packaging already placed on the market before 08/12/2026 may remain on the market. But packaging first placed on the market after that date must comply with the new requirements. How can compliance with the PFAS limits be demonstrated? There is currently no harmonized EU methodology for PFAS testing in food contact packaging. In its June 2026 guidance, the European Commission recommends that interim stepwise analytical approach. The first step is the measurement of total flooring. In... If total flooring is below 50 milligram per kilogram, so pass per million, the packaging can generally be considered compliant. If total flooring exceeds the threshold, a second step may be used to determine whether the flooring detected is organic, so associated PFAS, or inorganic flooring from other sources. Techniques such as paralysis, gas chromatography, mass spectrometry may be used for this purpose. If necessary, a third step may involve more targeted PFAS analysis, including direct total oxidizable precursors analysis to assess compliance with the limits in the PPWR, so 25 parts per billion for individual PFAS and two fifty parts per billion for the sum of PFAS. An interesting observation of the Commission in its guidance is that based on the evidence currently available, all samples that complied with step one, meaning total flooring below 50 milligram per kilogram, were also compliant with the more detailed analysis performed in steps two and three. The commission has also established a dedicated work stream involving member states, industry, civil society, and European Union affairs laboratory for full contact materials, so the joint research center. It's a, let's say, the the scientific arm of the European Commission, to develop a future harmonized testing protocol and enforcement approach. We'll follow closely these developments and we'll let you know about the, about the news. Commission recognizes that many commercial university laboratories already offer total flooring and total organic flooring testing and expects further capacity to be developed as PPWR implementation, progresses. Having discussed these PFAS requirements themselves, let's look at what companies need to do in practice. The regulation follows a familiar product compliance approach built around four key steps, assess, document, demonstrate conformity, and retain evidence. The first step is assessment. Manufacturers must determine which PPWR requirements apply to their packaging and establish the procedures to evaluate the compliance. For food contact packaging, this includes understanding whether PFAS, heavy metals, or other substances of concern may be present and got... And gathering the necessary information from the supply chain. The second test step is documentation. So regulation requires manufacturers to maintain technical documentation describing the packaging, its materials, and components applicable, applicable, requirements, including by conducting conformity assessment themselves through, through the conformity assessment values. They must prepare a declaration of conformity. Compliance is not a one time exercise. Please note that when materials, formulations, suppliers, or packaging designs change, compliance may need to be reassessed. Likewise, manufacturers must take corrective action, recall, or withdraw packaging if noncompliance is suspected and always inform the surveillance, authorities. The fourth step is retaining data and ensuring traceability. Documentation declaration of conformity must be kept available for these surveyors authorities. This differ from one state to the other, but there is a, complete list on the commission's website, and we can, of course, provide this to you. PPWR requires retention period of five years for single use packaging and ten years for reusable packaging. Manufacturers must also ensure traceability throughout the supply chain, and this is particularly relevant for PFAS compliance because information may need to be collected from multi collectors, including material suppliers, converters, ink manufacturers, adhesive suppliers, and packaging producers. What might be retained is actually that while companies may outsource testing, laboratory analysis, certification activities, compliance assessment, the rigor... The legal responsibility for conformity remains with the manufacturer. This naturally leads to the question, who exactly is considered a manufacturer and who is responsible for what under the PTWR? Let's start with manufacturer, article 15, who is not necessarily the company that physically produces the packaging. In many cases, it is the company placing the packaging on the market or placing a packaged product on the market under its own name or trademark. This may include brand owners, retailers, private label businesses, or food producers. Manufacturers carry the primary responsibility for compliance. They are responsible for conducting conformity assessment, ensure proper labeling, maintain technical documentation, and prepare the declaration of conformity. The second group is suppliers, article 16. This includes material suppliers, converters, and component suppliers. Their key role is to provide the information, documentation, and evidence that manufacturers need to demonstrate compliance. This becomes particularly for PFAS compliance, where manufacturers often rely on information concerning raw materials, coatings, inks, and adhesives, etcetera, provided by suppliers for the the the value chain. The third group is importers, articulating Importance placing, packaging or packaging products originating outside the European Union have specific obligations. They must verify that manufacturers have fulfilled, actually, the relevant DPW requirements, including the conformity assessment has been carried out, and that the required documentation exists and that the packaging is accompanied by the, necessary, compliance information. For international companies, this point is specifically, especially important because packaging manufacture outside the Europe, the union must still comply with PPWR before being placed on the EU market. The overall message is that PPWR creates a change of responsibility. However, the primary responsibility for compliance remains with the manufacturer as defined by the regulation. Supplier provide... The suppliers provide information, importers verify compliance, but the manufacturer ultimately bears responsibility for placing a compliant product on the European Union market. Before concluding, it is important to remember that PFAS is only one element of the much broader PPWR framework. I have I have highlighted on these slides only some of the key milestones, but the PPWR contains many other benchmarks, deadlines, and future implementation measures as well as some exemptions. This timeline shows that PPWR is not a single compliance deadline, but a regulatory program that will continue to develop throughout the next decade. The first major milestone is, of course, '20, 08/12/2026, was 08/12/2026 when the regulation started applying. At that point, PFAS concentration limits for food contact packaging became applicable. At the same time, the broader article five obligation to minimize the presence and concentration of substances of concern applies to all packaging placed on the market. The commission and European chemicals agency are already working to identify additional substances of concern that may affect human health, recycling performance, or packaging reuse. The regulatory focus on substances is therefore likely to continue evolving over time. The years before '26 and '29 are primarily about implementation. During this period, we will see the development of harmonized methodologies, recyclability criteria, packaging labels, and reporting approaches. By 2030, the focus shifts on measurable performance outcomes. Packaging will need to meet recyclability requirements, recycle content obligations become operational, waste preventions measure supply, and reuse and deposit return become more widespread. A particularly milestone is 2035 when packaging must not only be designed for recycling, but also demonstrate that it is effectively recycled at scale. This represents a significant evolution in the EU's circular economy approach. The ambition increases further between 2035 and '40 with stricter recyclability requirements, high waste prevention targets, and additional recycled content obligations. Where can NSF support manufacturers, suppliers, and retailers? As we have seen, PPWR introduces obligations that go well beyond the single PFAS limit. Companies need to understand the regulatory requirements, assess their packaging portfolio, gather information across the supply chain, and, well appropriate, generate evidence of compliance. How can NSF support you? Well, first, by testing and certification. This includes testing for PFAS and heavy metals, helping companies assess compliance with the requirements we discussed today. Second, regulatory and compliance support. DPWR is a developing framework with additional guidance, methodologies, and implementation measures that continue to be... To emerge. Support may therefore be needed not only in understanding the current requirements, but also in navigating future developments, technical documentation, and declarations of conformity. NSF is here to monitor for you these changes. From Brussels, I will inform timely my regulatory colleagues on the upcoming regulations, implementation, and norms. Last but not least, NSF can support you with sustainability and circularity programs. As PPWR extends beyond chemical compliance, companies are increasingly looking at issues such as recycled content, recyclability, traceability, and broader assurance across the package, the packaging value chain. Thank you for your attention, and I would like to pass the floor now to Michigan, to my colleague Carmen Grindatti, who will give you more technical details about NSF solutions and programs to support you on PPWR and, PFAS compliance. Thank you, Raul. Let's let me go here. Okay. Now that you've heard about the details of PPWR, I'm going to shift slightly and talk about some of the details that are most pressing right now, specifically the testing and declarations of conformity requirements. But first, I would like to, introduce a quick poll. The question we're asking this time around is where does your company stand with product testing? Are your products tested for chemicals of concern once with no further testing, or are they tested on a regular basis? Or is your company still looking into what testing is needed for your products? Just to give us an idea of where people stand in their testing and, as I go forward talking about it, whether or not, this information look... Makes sense to you. And it looks like a lot of people are still looking into what testing is needed and that makes a lot of sense. There's a lot of different regulations out there for different product and material types. We have quite a few companies that are testing their products on a regular basis, which is awesome. And then there are a few companies out there also that are testing just once and calling it good. We'll give it a couple more seconds to get a few more votes in here, but it does look like overwhelmingly we have a lot of companies that are still trying to figure it out. And the vote... The votes are still going up, so let's go to one more second here. And... Okay. I think that's pretty good. So let's go ahead and, close the poll now, and I'd like to thank everyone for taking time to answer the questions. So let's dive in. For many organizations, the heavy metals requirement in article five of the PPWR is not new. As Raul stated, the same limits existed under the previous packaging and packaging waste directive. So historical test data does continue to provide valuable support for demonstrating compliance to the current regulation. You may have noticed that the PPWR does not prescribe a specific analytical method for measuring how the heavy metals should be tested. However, the guidance document does recommend that companies refer to the SIN report 13695 dash 1, which provides an approach or several approaches for measuring and verifying the four heavy metals, lead, cadmium, mercury, and hexavalent chromium. In practice, many laboratories, including NSF, use inductively coupled plasma mass spectrometry or ICPMS, which is widely recognized as the industry standard for trace metals analysis. The objective is straightforward. Determine the concentration of each of the four regulated heavy metals in the packaging, add those results together, and confirm that the combined concentration really means below the limit specified in the regulation. As a practical example, if a company is evaluating a paperboard package with inks and coatings, the complete packaging system would be analyzed for the four metals, and the individual results would then be summed up and compared against the PPWR limit to confirm compliance. The next class of chemicals specifically mentioned in the regulation is PFAS. As discussed earlier, the regulation established limits for PFAS in packaging or in food packaging, while the guidance document provides additional context on how those limits may be evaluated and identifies potential testing approaches. One of the key challenges in this area is that there is currently no harmonized EU test method for PFAS and packaging materials. Much of the analytical work on PFAS was originally developed to address environmental and human health concerns, so many established methods were designed for matrices such as water, blood, and soil. As PFAS regulations continue to expand into packaging and other food contact materials, the industry is working to adapt and develop methods that are suitable for these more complex materials. Packaging materials can present different analytical challenges than environmental samples requiring different extraction and measurement approaches. Another important consideration is analytical sensitivity. Many PFAS methods for water and biological samples can detect PFAS at very low levels, often in the parts per billion or even parts per trillion range. However, PFAS testing methods for food contact materials such as packaging are generally less sensitive and often operate in the parts per million range. This difference in analytical capabilities is one of the reasons the regulatory limits established for packaging are significantly higher than the limits commonly seen for drinking water regulations. The guidance document identifies several potential approaches, including the pyrolysis GCMS and direct top analysis. However, the use of these methods is not required, and they are not the only methods available. But the but the analytical landscape continues to evolve as laboratories and regulators gain more experience with PFAS testing and packaging applications. PFAS compliance is currently an area of active development. While regulatory limits have been established, standardized testing approaches for packaging are still maturing, and companies should expect testing methodologies and guidance to continue to evolve over time. Earlier, Raul provided the recommended approach for determining PFAS concentrations in food packaging. As As he described, the guidance document provides a tiered approach to evaluating PFAS. Rather than immediately testing for specific PFAS compounds, the process starts with a broader fluorine screening method and becomes more targeted as needed. In step one, total fluorine is measured. This is typically done using a combustion ion chromatography, and in this method, the sample is combusted at high temperatures and any fluorine present is captured in solution, and the fluorine content is then quantified. This provides a measure of all fluorine in the sample regardless of where... Whether it comes from PFAS or other fluorinated substances. And if a product does not pass in step one, meaning it has more than the allowed levels of PFAS, companies can then move to step two and determining the levels of total organic fluorine. To do this, the concentration of inorganic fluorine is measured using techniques such as ion chromatography for liquids or an ion selective electrode for, for solids, and the inorganic fluorine result is then subtracted from the total fluorine result, which then gives you the amount of fluorine associated with organic compounds, AKA PFAS. And finally, if additional investigation is required, step three involves targeted PFAS testing. This step uses PFAS specific analytical methods to identify and quantify individual PFAS compounds that may be present in the packaging materials. Conformity is the mechanism manufacturers will use to demonstrate that their packaging complies with the applicable requirements of PPWR. Under article 39, the declaration must confirm compliance with article five through 12. However, some requirements have not been finalized, and compliance is not required for several years yet. Accordingly, only the implemented section needs to be documented. The declaration must follow the format specified in the regulation, including the required supporting information and identify all relevant EU legislation, which the packaging complies. In practice, this may be a single declaration or a dossier that brings together multiple supporting declarations and compliance documents from across the supply chain. The conformity assessment procedure is outlined in annex seven of the PPWR. The regulation uses module a, internal production control, which means that the manufacturer is responsible for assessing and documenting compliance without requiring the involvement of an external body. Under this approach, manufacturers must compile and maintain technical documents demonstrating that the packaging meets the applicable requirements of the regulation. This documentation forms the basis for the declaration of conformity and should contain the evidence used to support compliance claims. Another important acts... Aspect of annex seven is the document retention requirement, which Raul Rădoi outlined earlier and I have listed here. The declaration must contain enough information to clearly identify both the packaging and the manufacturer. This includes a unique unique identification of the packaging, the manufacturer's name and address, and a description of the packaging itself. These elements help ensure that the declaration can be traced to a specific product and responsible economic operator. The declaration must also reference the relevant EU legislation and any applicable technical specifications that were used to assess compliance. This is important because the PPWR does not exist in isolation. Packaging may also need to comply with other requirements, such as food contact, chemical, or product specific product specific regulations, depending on its intended use. Finally, the declaration must be signed by an authorized representative of the manufacturer. The signature serves as a formal statement that the manufacturer has completed the necessary conformity assessment and the documentation... And has documentation available to support the compliance claims being made. The key takeaway is that compliance under the PPWR is not limited to meeting the technical requirements themselves. Companies must also maintain the appropriate records to demonstrate compliance and be prepared to provide that documentation if requested by surveillance authorities. Effective documentation management will therefore be a critical part of the PPWR compliance program going forward. And with that, I would like to turn over the presentation to my colleague, Cami Banegas. Thank you so much, Carmen. Okay. So now that you've heard about the PPWR regulation and how NSF International conducts PFAS and heavy metals testing, we also want to share with you about our certification for safe food packaging to NSF International International Protocol P525. So, what is NSF International International P five twenty five? It is a certification for single use primary and secondary packaging that's intended to come into contact with food and or beverages. Packaging categories in the scope of the protocol include but are not limited to cartons, bottles, boxes, pouches, wrappers, etc. Essentially, most of the packaging that you see in the grocery store or takeout containers from a restaurant would fall under the scope. At this time, packaging that's intended to be reused is not within the scope of this certification. NSF International has taken a bit of a different approach with this certification protocol compared to many of the standards and protocols that we've developed so far, and that the companies that are applying for certification can choose what option or options they want to pursue from the three services offered: regulatory compliance, material safety testing, or chemicals of concern claims testing. This allows manufacturers and specifiers to decide and prioritize what aspects are most critical to them depending on where and how their packaging products are used. It also gives them flexibility based on the packaging type to address what are the highest risks and concerns for that material. So now we're going to go into more details about these three services. This diagram gives you an overall picture of the process for certification. We start by assigning you a dedicated project manager who will be your first point of contact throughout the process, and we collect information on your packaging and supporting documentation on the materials used. Each certification option then has review or testing that can run-in parallel. And at the conclusion of that, we provide you a compliance report and the test data. We then review your proposed labeling and marketing materials to ensure your claims match up to what we verified. We conduct an initial audit of your manufacturing facility. And once all of that is done and any findings have been resolved, we conduct a final QC of your project and issue the certification, which is published in our online listings. Then as part of the certification of the packaging, we conduct periodic testing to ensure ongoing compliance. Down at the bottom, we've provided some estimated timelines for the different phases of the certification. These timelines all assume that the documentation and samples are provided promptly within one or two weeks by the client and suppliers. For the first p 05/25 certification option, the regulatory compliance option, the packaging manufacturers can choose which compliance option they want. The EU one based on EC nineteen thirty five two thousand and four, or The US one based on FDA 21 CFR, or both options. For this certification, we go beyond the one time material tests since both The EU and The US regulations include formulary requirements and testing requirements. Products that are within the scope of this offering include polymeric materials such as PET, polypropylene, polyethylene, glass, ceramic, and non coated metals. For each product, we collect the formulation or declaration of compliance from the formulator or supplier. We review this information against the applicable European or US FDA food contact material regulation. In addition to the formulary review, we verify the client's good manufacturing practices at the station. Once the initial review is completed, we provide the client with a quote for any chemical testing that may be required. Once accepted, we provide a shipping form for the material samples needed. The EU regulation requires migration testing, in other words, exposing the material to liquid and seeing what leaches out of it. The US 21 CFR regulation requires extraction testing. In other words, chopping up the material and seeing what's in it. So in either case, the testing takes eight to ten weeks and the data review after that is another two weeks. Once completed, we issue both a compliance report and a declaration of compliance template for the EU or 21 CFR statement for the specific packaging trade designation. So for the regulatory compliance phase, the overall turnaround time is sixteen to twenty weeks. Next, we have the material safety testing certification option. Products that fall under the scope of this option are the same as those for regulatory compliance: polymeric materials, glass, ceramic, and non coated metals. We start by asking the packaging manufacturer for their end use conditions, such as the type of food used in the packaging, whether the packaging can be heated, how long the food is kept in it. This information is then used to determine the worst case conditions needed for the chemical migration testing. The migration testing is based on FDA chemistry recommendations for food contact notification submissions. Once the testing is completed, the results are evaluated to ensure that the established acceptable daily intake, ADI, value is not exceeded for each analyte tested. At the end of the process, we provide the manufacturer with a safety assessment report that shows the pass or fail outcome as well as the actual test data. And the turnaround time for the material safety phase is six to ten weeks. For the third certification option, the chemicals of concerned claims testing option, the materials we can verify are polymeric materials including PET, polypropylene, polyethylene, polystyrene, and PVC or CPVC, glass, ceramic, and non coated metals. For this option, we go straight to setting up the testing based on the freeform claims that are being requested, and we issue a shipping form for the packaging samples needed. We conduct total content extraction testing, and we measure the chemical analytes in question against established thresholds. The test method used will vary based on the specific chemical of concern. It includes ICP MS or GCMS, HPLC, and GCF ID. Here again, the deliverable is a passfail report in addition to the test data report. The chemicals of concern phase turnaround time is six to eight weeks. A few more aspects that are included in the certification, regardless of which option is chosen. The initial audit of the manufacturing facility is intended as an educational visit to prepare the on-site staff for what documentation needs to be maintained. We essentially train the staff on our policies and set them up for success for the future annual audits which are unannounced. The label review requires the manufacturer to submit the external packaging artwork and any marketing literature for the certified packaging, which we then review to ensure correct use of the NSF five twenty five mark, and you see the three examples of that mark here. We also check that the company name and trade designation match up to what will be published in the official listing, that the date coding will be in sync with the certification, and that any claims made are in line with what NSF has tested and verified. Last but not least, as part of the ongoing certification of the packaging, we will conduct periodic testing every year for the chemicals of concern option and every three years for the regulatory compliance and material safety options. In case of failures, manufacturer will need to, submit a proposed corrective action And once approved, any retesting will also need to take place. Okay. So now coming back to the requirements of the PPWR that Raul Rădoi and Carmen Grindatti covered and how to connect those back to our p five twenty five safe food packaging certification. So for the regulatory compliance requirements of PPWR, the packaging manufacturers can choose the EU regulatory compliance option of P five twenty five, and NSF will verify that the formulation meets all applicable EC nineteen thirty five and PPWR food contact material requirements, and we'll provide you with a template declaration of compliance. For the PFAS and heavy metals testing requirement of PPWR, manufacturers can choose the chemicals of concern option of P five twenty five for PFAS free and heavy metals free testing, and you will receive a passfail report and test data to support your claims. For the recycled content requirement, this is not currently part of the p five twenty five certification, but NSF's sustainability team can work with you to verify that your claims about use of recycled or sustainable materials and ensure that your packaging carries the correct labeling that's required. So with p five twenty five certification and a declaration around recycled content, you can meet the PPWR requirements. Now, we also want to remind you that NSF is not just a certification body. With our global network of labs, we can offer test only services for all your specific needs. That is how certification started. Grocery stores and QSR sent NSF their packaging for us to verify and validate its safety. We built upon that validation testing to create the comprehensive certification offering of p five twenty five. But we realize not everyone may want full certification right off the bat. So our messaging to you is whatever your company's individual concerns, wherever you're at with budgetary and timeline constraints, know that NSF has both the depth and the flexibility to meet your needs, and we would love to become your testing laboratory of choice. So please contact us for more information on how we can assist you. Once you provide us some specifics on what your packaging materials are, what foods it's used for, we can provide you a cost estimate and confirm next steps for PPWR compliance. Here you have our colleague, Caitlin Mountains contact information to initiate any further conversation or quote request for p five twenty five certification or for any individual food contact material review or testing that you're interested in. Feel free to scan the QR code with your phone to initiate an email to Caitlin. Whichever region you're located in, please start with Caitlin and we will triage and assign your request to our applicable local team as needed. Okay, now we are going to turn it back over to Sam who's been kind of monitoring the questions. We welcome all of your questions, so please add them in the Q and A if you haven't already. I am going to come back to the previous slide with Caitlin's, information just so that you have that on the screen if you need it. Back to you, Sam. Okay. Thank you very much, Cami. So being aware of time, we have had quite a few questions come in. So we're gonna jump in and start answering. We can definitely go over a little bit, but also want to be just aware of everybody's time who is watching. So if there are any questions that we cannot get into, we're definitely gonna be reaching out individual... Like, individually to provide those answers, to who asked them. So, I mean, with the volume of questions, it might be easier just to have everybody kinda come back out so I can kinda rapid fire, and just ask the questions, especially, some of these may have, a few people who wanna weigh in. So the first question, is the PPR applicable for only food or pharmaceutical products? So, Raul and or Carmen, I think you're best suited to answer that question. Thank you, Sam, and thank you for the questions. Very interesting questions. I... We started to answer a few of them, I mean, briefly on... In the chat. The packaging and packaging regulation, the scope is the... It's all tech. Some of the provisions that we mentioned, for instance, the restrictions on PFAS concern food packaging. So restrictions in substances of concern as a whole concern the entire, packaging category, so all packaging. But PIFA specifically is done in food contact packaging, if this is sufficient to. Okay. Thank you very much, Raul. Next question. As PCR requirements for packaging in the EU increase, Feedstock for plastic food contact packaging are likely to have multiple sources. Would this scenario require PFAS heavy metal testing for every batch or lot of the PCR resin used for manufacturing food contact plastics? Raul or Carmen, I think you're probably best suited. Yes. Thank you, Sam. I will the regulation does not specify. However, I'm going to say yes. You want to test every every supplier that comes in because you don't know what kind of contamination issues they may have within their facility. And if you are able to, going to a lot or batch test would be even better. You would have that much more, security knowing that your products actually do comply with the regulations. Okay. Thank you very much, Carmen. Okay. So the next question is, is this regulation also applicable to food ingredients packed, in the packaging material to be supplied into the EU? Again, this covers all packaging no matter which area. Right? So the manufacturers have to be compliant with this regulation for all types of packaging that they are producing, be it for toys, for food, for, food ingredients. When it comes to food, obviously, food contact materials, this has, the packaging has to comply to the specific, to the specific provisions related to food contact, materials. Related... Regarding food ingredients, we will have to check with the with the food control material regulation, but this is maybe a question that, we could we could answer, subsequently. In any case, it just depends what and how much of the PPWR is applicable... Is applying to this, to this packaging that was mentioned for food ingredients. In any case, the regulation applies. Okay. Thank you very much. Raul or Carmen, I think this next one is probably for you. How how to define individual PFAS, sum of PFAS, and total PFAS? Okay. How to define individual PFOS, total PFOS, and the sum of... sum of PFAS. Okay. So total PFOS is easy. That's just the total fluorine. You could then do the subtraction of the inorganic fluorine, and then you're... There you've got your total total organic fluorine that would cover all PFAS. The sum of the PFAS and the individual PFAS, you're going to have to look at your your formulation. You're gonna have to look at what your suppliers do to figure out what specific PFAS may be relevant to your products. That is definitely the harder route to go because there are thousands of PFAS out there. Raul, do you have anything you would like to add to that? No. No. I'm just, I think myself with hands or Sam Cole's hands to be, you know, in case he has other questions for me. No. No. Absolutely not. Thanks. Okay. Perfect. Carmen, I think this one is probably for you. So should the d o... The DOC shall be made for packaging type, example, cardboard or boxes, or should it be made per product, example, bag, box, label? All of those components are part of the packaging, so you're going to want documentation for all of it. But how you how you silo it, I think is up to you and your company and what makes the most sense for how you operate. But you're gonna want documentation for everything. So... Yeah. It's for everything, but can be piecemeal or it can be whole product. Okay. Perfect. Thank you. And some of these are pretty specific. So if we don't have an answer directly, we can definitely reach out. So for this next one, Raul and Carmen, I'll go ahead and ask. And if we need to get back to them, we can. But I am a BRCGS food and IFS food auditor. During audit, should I ask if the company complies with PPWR, is it regards to PFAS? PPWR is a regulation issued to protect the environment and not for food safety. So I'm afraid the request should be out of BRCGS food audit objectives. Is that something we should have somebody on our food production audit team that specifically handles the BRCGS program maybe reach out and provide an answer for? I I think so because I'm not familiar with their requirements. I mean, all packaging does need to comply with this requirement, but whether or not it is in or out of scope of the BCGRS audit, I'm not I'm not sure. Okay. So we will definitely get an answer for you on that one. Next question. Can overall migration test used as testing show compliance with PPWR heavy metal content? No. The quick answer is no. No. It cannot. The overall migration test is too broad, and it doesn't cover content as specific migration, whereas the heavy metals test is we're looking at for the content, the heavy metal content of the packaging. So, no, they are not the same and and are not interchangeable. Okay. Next question is, if I have already conducted a migration test with another testing body, can NSF review the report and tell me if it's PPWR ready, with kind of a for free on it? So, I mean, just in general general guidance, if they reach out to Caitlin and provide that, could we take a look at this and just kinda let them know if they're on the right track, not on the right track, or is it more than just reviewing a test report and and maybe we just have to have a a bigger conversation with some of these people? It depends on the test. I mean, if we're talking for PFAS and heavy metals, that would be a quick and easy. But if we're looking at other testing that they want to use, that may take a little bit more effort on our part. So we would have to look at it and see. Okay. So I think in any of those situations, the best would be just to kind of reach out, and kinda get that conversation started. Is the NSF P25 packaging certification intended for food packaging manufacturers or for food product managers? So, Cami, do you wanna answer that one? Yeah. So, really, the P25 certification is intended for the packaging itself, not, the food inside the packaging. Now who, applies for certification? You know, we can... Our our goal for the certification is to work with the packaging manufacturers themselves, but we are anticipating that, food companies who supply from from multiple packaging manufacturers may want to start specifying P25 from their packaging suppliers. But ultimately, in order to, to test and review the formulation, that information typically is is gonna come from the packaging manufacturer themselves. Okay. Perfect. And we still got the questions coming in. Just being aware of everybody's time. I'm gonna try to get to one or two more, but then we'll kind of have to reach out to everybody afterwards, and kind of provide some of the rest of the answers here. But, where can we find a full list of SOC, PFAS to compare lab reports for any missing... That's where the question stops. So I don't know, Raul or Carmen, if you kinda understand what's being asked there and can kinda provide an answer. I'm not sure if I completely understand, but right now, to the best of my knowledge, the only full database of PFAS compounds is held by OECD. But again, there's there's thousands of PFAS out there, but they do have a database that has at least as many that are currently known as far as I understand. Okay. When it comes to retail food manufacturers, is this related only to finished product packaging or raw material packaging as well? And... So... Yep. Okay. Oh, Nope. go ahead, let Raul. answer. No. I agree. I agree, Carmen. I agree with your position. I think we had this on, on one of one of our slides, if I'm not mistaken. So the the manufacturer is not necessarily the company that physically is producing the packaging. Many cases, it can be a company that places packaging or packaged product on the market under its own name or trademark. So this may include vendors, retailers, private label business of producers included in the manufacturer category. But that's, of course, has to be decide... Evaluated case by case. If we would know more about your, your specific situation, we can, of course, analyze that. Okay. Then last question, and then we are gonna have to cut it off as we've run well over. However, an email will be sent kind of with an FAQ and q and a, for all of these questions, when the email and the recording come out. So we will definitely get, copies of all of these answers out to everybody. But the last question is we export our products to EU market for food product and sauces. Do we require these packaging material testing and certificate, or are packaging and material suppliers required, to get these testing and certificates? The obligations from the packaging and packaging waste, I mean, it it depends from which angle do you you you look at this question because the obligations are definitely concerning the entire supply chain. Right? So it's for the entire supply chain. So manufacturers have... Are the main the main, carrier of responsibility. Suppliers, of material and component suppliers, packaging makers, converters, these have to provide information needed to demonstrate conformity, so provide compliance evidence. So in case you are a supplier, even if you are abroad, you have to provide this kind of information. And the importers, obviously, from exporters, right, have to, get to verify manufacturer compliance, technical fines. But this is obviously with you because there there would be then, a verification of these, of these elements. Yes. Everybody is is concerned in case its products will, arrive on the EU market. Okay. Perfect. Thank you, Raul. And I think, in general, what I would say there is as we kind of started talking about, we work across the entire supply chain. Right? So working directly with raw material manufacturers, the packaging manufacturers, working with retail establishments and restaurant establishments as well as food producers directly to either help the food producer or the retailers develop programs to make sure they're in compliance with what their procurement teams are purchasing, or with the individual manufacturers of of the raw ingredients or the packaging supplier. So definitely, would love to keep those conversations going. You know, reach out if you have questions on how we could help or support for there. Unfortunately, we kind of have to cut it off on the questions for now, but we will reach out directly. And then like I said, in the email that follows, have some FAQs going, with answers to what we have answered and additional FAQs for all of the questions that we weren't able to get to. So thank you everyone, for joining us. It has been great presenting this information. Look forward to a lot of additional conversations on how NSF can support everyone on their journey. And I hope everyone has a great morning, evening, or afternoon. Have a great day, everyone.