Understanding eSignature Legality for Lodger Agreement in European Union

How to eSign a document: eSignature legality for Lodger Agreement in European Union

foreign ladies and gentlemen my name is Simon simply from the International Food Safety and quality Network I'd like to welcome you to Edition 29 of our weekly webinar series food safety Fridays I'm delighted to say today we're joined by Thomas Dunn managing director at Flex technology LLC uh Tom is going to be talking about a very complex but important subject today um and it's food food packaging compliance it's very important that we have safe and legal packaging not a lot of people understand it so Tom's going to be decoding that for us today and hopefully simplifying it through us we've got about 650 people registered for today's webinar which is great so that tells you what kind of importance people place on this subject I quickly like to thank the sponsors Trace analytics AFS fssc and so food 360 for helping to bring these webinars for you free of charge each week and uh and delivering a free certificate for attendance as well which is nice okay I think Tom's with us in an airport somewhere in the United States hi Tom good morning uh it's nice to have you with us again uh thanks we were cutting it a bit fine we'll work with Tom but we've managed to get to get to you ready to share no no I'm just saying no no it's fine Tom I'm just saying I was just saying hello Tom that's all can you can you hear me okay yes I can I'll come it's fine with your slides up I'll come back to you uh shortly um just to say uh next week we have a webinar again about food packaging uh I'm loading that in the sidebar as we speak next week's webinar is let me just load that sorry food packaging and gfsi standards requirements for compliance and that's with Karen Lee Bingham she's senior project manager Consulting and Technical Services at NSF International so Karen will be decoding the various gfsi standards for food and beverage packaging manufacturers help which will help us in our decision making and certification entertainment to enable us to achieve business success so the theme will be packaging again next week so uh obviously we've got a lot of packaging people here today just click the sign me up button that'll open a new window and you can just enter your email and name you'll be registered even if you can't attend live please do register and then you will get access to the recording slides and the certificate okay today's webinar is being recorded just to let you know um a couple of days in fact probably later today or tomorrow we'll send an email to our registrants with the recording the slides and the certificate so don't worry if you miss anything today I'll be back for the Q a later but for now we'll head over to Tom hi Tom um I was just saying before sorry that you're you're in an airport you've just got off a plane and we've cut it a little bit fine but we've managed to to get hooked up which is great but it's nice to have you with us Tom great uh if you can get your slides up now then we can start the presentation uh and I'll be back for the Q a later okay Tom it's over to you very good okay thank you good day everyone uh Simon suggested uh food packaging material compliance for the European Union in the United States is a complex subject my objective today is to take a complex subject and make it simple and understandable for practitioners in the packaging production and packaging using Industries not in a full legal sense but in a more practical understanding of the details involved so for the content of today's presentation I want to look at what's the same between the European Union and the United States and I say same but the kind of things that are the oxymoronic same but different similar I guess is a better word than the same and then look at some critical differences in the compliance area I divide that into two sub-categories the substantive complex which have to do with basically the fitness for use of the materials involved in a given packaging article and then secondly the procedural details of compliance which are quite different in the EU compared to the US and make all the difference in a world between a successful business Enterprise and they uh disappointed a disappointed customer or disappointment in the marketplace or disappointment in the uh the financial objectives of the organization and finally some of my suggestions on how to manage these issues in the ongoing conduct of manufacturing packaging materials and specifying them for your food products uh looked at a lot of different uh food packaging laws around the world and I'm struck by the commonality and all of them that goes back to what is considered the Hippocratic Oath summarized as premium non-carry in in Latin which is interesting because Hippocrates was from Greece and probably never spoke Latin but the evolution of the um importance of the Latin language in the Classic Education of doctors has given us premium number as the standard for the Hippocratic Oath so above all Do no harm is what we're trying to do with any compliance of packaging materials for for different governmental requirements in the European Union and the United States there are some basic Foundation laws that need to be under stood in terms of I believe I think more importantly in terms of their legal enabling of the detail that follows on that establishes the specific checkpoints for Regulatory Compliance and procedural compliance that are necessary in in the different jurisdictions in the European Union the framework legislation is regulation EC number 1935 2004. the regulation seeks to ensure the effective functioning of the internal Market of the European nations in relation to materials and articles intended to come into direct into into contact directly or indirectly with food the uh critical point in the legislation is the concept of materials and articles materials in this case are typically uh tangible commercial type products that that are exchanged in Industry as value-added products rather than as natural Commodities if the material has what in the U.S would be a CS not Cas number or the comparable European chemical registry number the product is considered a sub substance rather than a material or an article and the definitions will become very uh telling going forward into the Regulatory Compliance area and secondly for the right framework legislation in Europe while providing the basis for a high level of protection of human health and the interest of consumers the United States has a very different Foundation legislation for its governance of packaging materials in the delivery of food to the marketplace the federal Food Drug and cosmetic act actually goes back to the early part of the 20th century it's been amended and modified and regulatorily refreshed if you will many times over the course of the uh the last century but that the core of food packaging law in the United States is the notion of a food additive which is part of this um legal reference USC refers to U.S code in chapter 21 um section 9 paragraph 321 which defines a food additive as a substance whose use results or may reasonably be expected to result directly or indirectly and it's becoming a component or otherwise affecting the characteristics of any food and that goes on to expand that definition to indicate that that includes any substance intended for use in packaging so there we have the third term in this critical packaging compliance World substance distinct from the reference in the European regulation to materials and articles so the the sort of bottom line is of the packaging regulatory framework in the United States is to the effect that engine real component substance if you will has a reasonable chance of becoming part of the food inside that package the Food and Drug Administration does not have any legal jurisdiction to um do anything to either prevent or to approve the use of that substance in in the food packaging application uh back to the details of the European framework legislation the framework legislation allow uh requires good manufacturing practices to avoid transfer of constituents in quantities that endanger Health unacceptably change the composition of the food or deteriorate the flavor and the Roma characteristics of the food and it also allows for specific measures for groups of materials and articles those measures will consist of authorized lists of component substances typically called the positive list and these are substances which have a relatively well-defined chemical identity and probably a chemical identification number in One race through the other in framework legislation envisions overall migration limits for packaging materials and articles which represents the mass transfer of anything in that material from the material to a a food that would be in the package as measured by one or another of various um laboratory simulations of that package and food product interaction in in the course of delivering a product to the marketplace similar to omls in concept but very different in quantitative definition are specific migration limits these are migration limits in terms of the specific substance itself and how much of that substance can leave the packaging material and go into the food again under some very specified laboratory simulation um experimentation and then there are other specifications limitations associated with those specific groups of materials and articles that have to be recognized in in the course of making packaging materials for different uh applications so those specific measures um are not in place for many kinds of packaging formats right now when they are not present the member states of the European Union may have their own National rules that control the um requirements for those kinds of packaging materials and articles in which case those member states May enforce their own rules for packaging materials and packaged food in their borders in ways that create um specific requirements in that country but it has the the benefit of the European Union in terms of reciprocity is called that allows a legal component in one country ing to that country's laws to be legal in other countries in the European Union by sort of a an umbrella legislative effect and the other aspect of the legislative the framework legislation that's of interest is this icon for food contact which is appropriate for any materials that are compliant with the European Union framework legislation these are the specific measure categories of materials and articles that apply to the um framework legislation only the categories for which I've indicated a sterisk here which are Ceramics active intelligent packaging materials printing Plastics and regenerated cellulose have had these specific measures for them which is to say they have their um definitions of limitations and requirements they're positive lists identified overall migration limits specified and specific migration limits specified and because the Plastics legislation specific measure is so well defined and worked out after years of development and accumulation that the rest of this will be discussing compliance with with packaging materials that contain all or some plastic materials so at this point I want to split up between the sort of substantive notion of compliance between the European Union and the United States and the more procedural aspects of compliance in terms of uh the paperwork if you will so here's the substantive requirements these uh are the result of scientific um findings in terms of the health and safety of the the public the consuming public when it comes to food that's been packaged in various food packaging materials in the European Union this uh specific measure for plastic material is officially referred to as number 10 2011 and it addresses plastic materials and articles in contact with food intended or reasonably expected to uh to contact food so that includes uh single and multi-layer Plastic Products printed or coated plastic films Plastics and caps enclosures of rigid plastic containers and the plastic that might be in multi-layer multi-material materials and articles such as some packaging structures such as paper adhesive aluminum foil and then a plastic heat seal layer on the inside that plastic adhesive layer as an as a material is subject to the kind of restrictions under EU 10 2011 that uh 100 plastic material would be but importantly the multi-layer material itself is not legally required to comply with the the Plastics um legislation and there is a list of authorized substances the positive list if you will with specifications and restrictions on those substances the standard overall migration limit for packaging materials and then specific migration uh limits that apply to a variety of substances that might be found in one of these uh materials or articles or another and it is up to the seller of the material if it's a perhaps an aluminized oriented polyester film which is a plastic film that has a coating on it or it's a multi-layer lamination of that aluminized oriented polyester film to a polyethylene layer that comprises a packaging article that will be the exact material that contacts the food in its entirety those compliance with the overall migration limit and the specific migration limit of those materials in one case and articles in the other case must be documented and defensible by the uh the person selling those materials in the marketplace into one case a metalizing operation selling into a printer laminator packaging material converter and in this second case a the packaging material converter herself selling to a food processor the the finished packaging material ready to use with food in addition to the the specific substances requirements in the European Union there is a very important regulation uh concerning the uh the practice of good manufacturing practices in the conduct of manufacturing the packaging material this is regulation number 2023 2006. it seeks to establish Implement and secure adherence to an effective and documented quality assurance system it requires that the provider establish and maintain an effective quality control system and that along with the equality assurance and quality control systems adequate documentation is present in that manufacturer that allows uh the control of specifications that um definition of the manufacturing quantities and sequences involved in the actual process conditions associated with um putting a converting materials into articles or in some cases converting substances into materials this documentation is also critical in order to provide traceability of raw materials going forward into the marketplace towards the food processors or backwards if the food processor finds a problem with the packaging material that allows the supply chain to understand where all of the substances and materials in that packaging material originated in the supply chain before they were actually converted into the the finished packaging article by the packaging converter herself uh importantly that GMP regulation applies to all sectors and all stages of the manufacturer processing and distribution of materials and articles as defined in the framework legislation up to but including the production of starting substances so for example ethylene gas that might be used to polymerize a plastic called polyethylene the ethylene gas is not regulated by the GMP regulations in Europe but the polyethylene itself which is a a material is regulated in the European framework of things in addition the uh the GMT regulation has a detailed Annex that identifies good manufacturing practices for printing inks and in that case the ink definition extends to Coatings and overprint varnishes another um 100 percent coverage related aspects of converted flexible packaging and the second Annex that provides detailed good manufacturing practices for the use of recycled plastic into food contact packaging both of those Xanaxes represent specific cases where the um European Union food safety Community felt the need to respond to Marketplace events with specific good manufacturing practices in these industry sectors that provide specific guidance to the participants in those sectors for ensuring the safety of their products going forward importantly if you participate in this supply of food packaging materials in the European Union you must have this good manufacturing documentation available on request to competent authorities be the national authorities from one country or another or from European Union Representatives themselves and certainly your food processing customers are going to want to have that documentation because they are required to have that if they place that material into Commerce in terms of distribution and storage before it actually gets to a retail stage so step back now on this substantive requirements for the United States and indirect additives which is the generic term that describes the food packaging materials in the United States it's it's not an ingredient in food directly which are the direct additives in U.S food law but they become part of the food indirectly as a consequent to their presence in these food contact materials and these are what in the United States are called regulations and codified under a group of um administrative law called the code of federal regulations abbreviated CFR and in some expression of Sanity the chapter 21 of the CFR regulations are the ones that are authorized by the legislation contained in chapter 21 of the U.S code so there is some logic between the the chapters of the the two basic bodies of legal compliance in the packaging world of the U.S law 21 CFR addresses indirect additives by saying that first they must be made with good manufacturing practices to ensure that no more than the amount needed for the intended physical or technical effect is added to that packaging material that those indirect additives are a suitable Purity for food packaging and that they impart no odor or taste to a specific food product unfortunately in the United States there is very little additional guidance for good manufacturing practices to manufacturers of materials or articles in the states or of food packaging packaging food sold in the United States Beyond this uh very oblique reference to Do no harm if you will to the food inside the package if those good manufacturing practices are observed by the supply chain then the additives in that packaging material have clearance from one of five General categories of positive lists if you will and I think it's the um the fact that there are some they're on this great number of different positive lists that Define what's acceptable in the when the good manufacturing practice requirement is met that the basic structure of the United States food packaging requirements is so confusing so uh think of the second bullet point as the list of positive lists for packaging materials in the United States and I'll try to go through them one through five and give you a sense of uh what they represent in terms of a list of one sort of the other or how somebody with the need to know may be able to determine whether the substances and materials in his food packaging are cleared for use in the United States so these are generally recognized as safe for direct food additives as food ingredients generally recognize the safe for packaging use in food packaging and those generally recognized as safe as abbreviated grass in the uh the state's law there's a set of materials that were reviewed and approved for use prior to a date in 1958 that are called uh prior sanctions materials at the main source of approved materials for food packaging materials in the States is listed in the code of federal regulations chapter 21 sections 175 through 178 and a special subsection of 179 that I'll show you in a second here and finally there's a new list of materials that uh has limited application that results from what's called a food contact notification administrative process in the United States and it's worth looking at these in a little more detail so the grass substances whether grass for direct food additive status or for indirect food contact material status represent opinions of trained experienced experts that are qualified to evaluate the safety of substances that are directly or indirectly added to food and deemed them safe for such uses and those opinions have to be based on scientific procedures unless they were in common use of food before the first of January 1958 particularly in the area of grass materials for direct food addition as food ingredients there is a movement in the United States to review some of these grandfathered uses that were present before January 1958 and look at new scientific evidence and and confirm that in fact they are still generally recognized as safe by the experts involved in food safety it's important to put in perspective that the grass list is maintained by the Food and Drug Administration but it's not an exhaustive list there are other materials that are considered safe for use in food and food packaging that are not listed by the Food and Drug Administration and it's possible to do your own determination with the trained and qualified experts and their review of the scientific literature to make your own determination of a grass application in one case or the other and it's then the option of that manufactured to seek formal review and approval or formal review of that determination by the Food and Drug Administration the Food and Drug Administration will not approve any of these self-determinations but they may and will issue a a letter of uh non-objection which basically says that they agree with the the safety opinion of the experts documented in in the self-determination prior sanction is a very limited list of substances informally granted by the Food and Drug Administration prior to the 6th of September 1958 a very precise date went up amendment to that food drug and cosmetic act legislation was passed in a way that basically said that's the end of these informal Food and Drug Administration opinions about the safety of materials if they've done it and it's a written opinion they can still be used as prior sanction materials there is a partial list available through the Food and Drug Administration but there are bio doors on file drawers around the United States from both manufacturers and from the law firms representing those manufacturers that will have these informal FDA opinions on file that allow them to continue to use that in the present day it's important to note that there will be no additions to the prior sanction list as difficult as it is to pin that fire sanction list down and no self-determination of self of Prior sanction materials as possible because the door is closed on that kind of pre-clearance for materials and packaging in the states the basic list of the pre-cleared packaging materials the United States is listed in chapter 21 under code of federal regulations and these are listed as a result of an administrative rulemaking procedure that the Food and Drug Administration terms the food additive petition process or fap process it was a formal rulemaking process that required a lot of time and a lot of Staff involvement and because of the the time and the labor involved in the process is essentially obsolete now the law allows an applicant to submit the petition for the food additive approval but the agencies not going to allocate resources to actually reviewing that application to that petition I should say in any uh time in the near future there are these listed individual chapters in 21 CFR that have to do with adhesives and Coatings components for packaging materials and articles things like can Coatings and adhesive Coatings that might go on flexible plastic films or aluminum materials used in packaging applications a separate chapter on paper and paper board components pulp for paper itself is generally recognized a safe substance as listed by the Food and Drug Administration but all the different additives that go into paper and paper board to make them functional packaging materials must comply with the lists in 176. 177 is a long chapter with specific polymers listed in it and those polymers May well be defined by the monomers that are reacted together to make those polymers in various molecular weights and melt indices and other kinds of specifications that are listed in what is cleared for different kinds of use in the list of chapter 177 polymers chapter 178 is sort of a catch-all of different things that defy classification otherwise it's adjuvants basically functional additives to one kind of packaging component or the other production age that may help the manufacturer produce the materials efficiently and safely and then sanitizers that have more to do with the food contact materials that are used in the food industry itself and the kinds of surfaces where bacterial contamination May grow within our properly sanitized by soaps and sanitizers that are safe to use if they transfer to food materials in the process of processing food after the sanitation has been completed and then this special 179 section has to do with packaging materials where pre-packaged food is pure is sterilized using irradiation there's a very few packaging materials that are approved for a limited amount of a radiation exposure in order to sterilize the products the food products inside those packages the last category is the food contact notification in the united this is a process introduced about 10 years ago as a sort of streamlined food application petition process it involves a proprietary submission by one manufacturer who will describe his manufacturing process in terms of the purity of the materials and the byproducts of that manufacturing process is required to provide some very specific chemical reviews in terms of the extractability and the migration tendency of substances inside those materials into different kinds of packaging and different kinds of food systems and a comprehensive review of toxic logical effects of those materials used in manufacturing the substance or the material I should say that puts special attention on any mutagenic carcinogenic or reproductive hazards associated with the substances used and then there's a sort of a procedural requirement for this kind of why is our rule making in the United States did any kind of environmental aspects of these food contact notifications must be addressed to satisfy a special Environmental Compliance law in the United States when all of that submission is deemed by the Food and Drug Administration to be complete which is no small task based on the precision and accuracy of these chemical and toxicological reports that the agency requires the Food and Drug Administration by law has 120 days to object to that submission if it does not object then that submission is by law ready to be listed online as a food contact material for which the submitter of the the application may use it in in food contact materials it's critical that just because the material the substance itself is listed online with the food contact notification listing only the um submitter of the application and his customers are authorized to use that in their food packaging materials until additional suppliers submit their own request for uh listing on the fcn list there's an exception to all of these which is back to that initial notion in the United States of uh a food additive must be a food additive or else it's not regulated by the Food and Drug Administration the Food and Drug Administration has defined what it considers the threshold of Regulation below which the concept of being a food additive is considered not to apply and it's based on some very different kinds of calculations where the uh the limit of Regulation does not apply if the substance use in the food contact article will not result in a dietary concentration greater than one-half part per billion and that's the dietary concentration which is a very complicated calculation having to do with the um the kind of athlete the kind of food that will be packaged in this kind of packaging article and that caloric consumption by the average citizen in the country and the existing um sources of that substance in in the diet just so that the uh average citizen is not exposed to more than one half part per billion of that substance in the normal daily diet and the the other calculation that that's possible to seek regulation exemption is when the regulated direct food additive is involved in the packaging material and it has a dietary exposure of less than one percent of what's considered the acceptable dietary intake so that um if this is a food additive and it's used in the um food industry already the addition of this use in the packaging material will not increase the except will not increase the exposure of the of the food consuming population more than one percent of its successful dietary intake except that if those materials that might migrate and even at these low levels are heavy metals like lead cadmium or Mercury or they have toxic logical or carcinogenic activity they will not be Exempted from regulation and all of this threshold of Regulation can be demonstrated with a documented self-determination using the right kind of benchtop chemistry and Regulatory reference to the kind of population exposure that the limits uh suggest here and and those self-determination techniques are basically defined in the food contact notification chemistry submission guidelines that apply to that food contact notification submission in the U.S that the good manufacturing practices other than the ones I mentioned earlier for using the clearances associated with the the five categories of positive lists the United States are described in terms of the food processors good manufacturing obligations and in that Universe there are some very specific references to using safe and suitable packaging materials and here's the code of federal regulations reference and basically it requires that the materials conform to the pre-clearance regulations that are listed in the uh the laws and regulations of the Food and Drug Administration the second point of the food processors GMP regulation is that he must conduct his packaging operations using adequate sanitation principles and that's interpreted to mean that not only does that food packaging manufacturer need to observe good manufacturing practices for the product the food product that he is packaging and producing but also the supply chain of ingredients and packaging that uh go into that local food processing operation have to observe adequate sanitation principles or good manufacturing practices otherwise but very little guidance in the United States on what those gmps consist of Mr Page here so now we're going going on to procedural requirements with the the paperwork overload if you will in the European Union there is a very specific declaration of compliance that require that is required it includes four aspects of the identity of the name and address of the business that's making the Declarations the name and address of the business that that actually manufactures or Imports these materials articles intermediate materials or articles or the substances intended for use in food packaging if they're different than the actual person submitting the Declaration and then there's a requirement that the identity of and this was from the Plastics implementation measure the plastic materials and substances used in the production of the materials and articles and then of course the date of the decoration that the um kind of materials for a functional barrier uh the functional barrier exemption does not apply it wasn't um heavy metals it was Nano forms of materials that are not allowed in food packaging in the European Marketplace as sort of a special the detail there the administration of the declaration of compliance in in Europe is uh important also it's it must be available at all marketing stages other than the retail stage where the consumer interacts with that packaging material it must provide easy identification of the materials and the source of those materials going through the supply chain for traceability it needs to be renewed when there are substantial changes that bring about changes in the migration from the materials or the Articles or if new scientific data about the safety of those substances or materials becomes available and it the documentation that supports that declaration including the conditions and results of testing the calculations modeling or other analysis in lieu of testing regarding safety or other conclusion about compliance must be available for those competent authorities in Europe in the United States the comparison is with what's called a letter of guarantee I want to look at the first descending of that letter it's a guarantee under the law itself section 303 that the packaging material is not adulterated or misbranded ing to the law and it's not comprised of any substance or material that's forbidden by the law it can either be a limited guarantee to the specific shipment or delivery of that article in which case it would go along with the delivery of that article as sort of an invoice or bill of sale might go along with it or more commonly it will be a general and continuing guarantee that applies to the shipment and delivery of that article as so named and identified at any given shipping and delivery date in the future the important part of this can guarantee is on the receiving end of it where that guarantee must be available for any on-site inspections by FDA inspectors to confirm that the packaging material in a food processing plant does have pre-clearance for food contact application that letter must reference the kind of food typing processed in that application and the kind of use conditions that the processor expects the food and the packaging to encounter going forward in the marketplace it is limited to the goods as shipped by the supply without so it does not apply to any adulteration or contamination that might incur inside that food processing operation and it basically depends upon a daisy chain of pre-clearance statements that extend backward from that food processor through the whole supply chain of Packaging articles materials and substances that allows the traceability of those materials if there's an issue going forward about the safety of it so just to sort of review in wrapping up here on the substances side both Europe and United States have references to good manufacturing practices both forbid the deterioration of food by the packaging both had positive list of in Europe substances in United States substances and substances and materials in Europe materials and articles must comply with the overall migration limit and specific migration limits that are indicated in the um regulations and in the United States article compliance is demonstrated through the compliance of materials as guaranteed by the suppliers of those materials and the notion of overall migration limits and specific migration limits do not apply procedurally Europe requires the declaration of compliance the United States the letter of guarantee in Europe documented gmps must be available for the producers of the materials and articles and in the United States the notion of GMP compliance is very um nominal and and relaxed if you will so just in terms of that living with these differences most if not all of the Plastics that had FDA pre-clearance meet the requirements of the European Union Plastics implementation measure there may be some acceptance with things like vinyl that I'm not that familiar with my own practice the European obligation for article level compliance has no U.S counterparts so that converters who produce articles in the United States find themselves in a very different regulatory uh procedural situation for materials that will end up in the European Marketplace the low intensity procedures in the United States for the declaration of compliance and GMP documentation are not acceptable in the European Union and the lack of acceptable Declarations of compliance and GMP documentation will stop imported packaging materials and package products at Borders going into the European Union so the the design impacts are minimal in terms of the design of materials fit for use the documentation impacts and the Regulatory Compliance are significantly different so my recommendation is to consider um the subject of next week's ifsqn um webinar about the global food safety initiative and the general notion of food safety Management Systems under ISO 22000. in both of these cases the underlying requirement is comply with all legal requirements supported by the additional requirement that if you participate in the packaging market for food that you understand what your legal requirements are and if you comply with gfsi or the iso standard if those best practices will satisfy them the challenging European Union documentation requirements so that you can issue the necessary declaration of compliance legally and confidently Bob just a preview of next week if you will the notion of equality and a safety management system are very similar so if you know ISO 9000 Quality Management Systems say what you do do as you say record what you did compare the actual results to expected results and then act on any differences between actual actual and expected and repeat the cycle to to container to obtain a continuous Improvement in your operation so with that I'm going to thank you for your attention and uh ask if there's any questions okay tell me you can stop sharing now thanks very much for that okay we'll do it is a very uh it is a very complex subject um but you did manage to get the key points over I just have a couple of questions based on your knowledge of both EU and us um which do you think is the most effective because it ultimately trying to achieve um safety uh food so which is do you think is the most effective in doing that and secondly which you think is the most efficient in other words for the packaging companies the simplest is it eurus or which is the most effective and which is the most efficient as let's say right I'll say that the European framework and regulations do add complexity to the compliance picture for converters in the United States compared to the sort of the status quo which is to say that the overall coverage of the U.S regulations is is not as expansive as the European regulations are but on the other hand particularly with respect to some things I haven't talked about today um good manufacturing practice requirement in the European Union are much more effective in protecting the uh the public health and safety and I think the uh some of the new gfsi standards that have to do with the compliance of labeling declarations for things like allergens and other sensitive uh components for sensitive parts of the population provide a much better protection for the consuming public yeah that's a good point actually you know when you talk about gmps the big one of the big things obviously you've got to have a quality print management quality Etc but one of the big things is what they call Prince set off into transfer of printing to the food contact side so if you haven't got effective curing or drying of the inks then that can transfer to the food contact style in large quantities um so yeah those are the Marketplace experiences that generated the special annexes for inks and and printing of inks on food contact packaging in the in the GMP regulation in Europe so it was uh it was not foreseen but the response I think is very appropriate given the uh the impact of the commercial experience yeah is there anything coming through in the U.S related to GMP of food packaging or is is it's not actually covered in the food safety modernization act is it packaging I don't think food packaging other than the traceability responsibilities coming back from a food incident in the marketplace there is no change contemplated it in the laws affecting food contact packaging materials in the United States but the expectation of the global food processors are pushing U.S participants to take advantage of the gfsi Benchmark standards and basically live up to the the Best in Class kind of um practices that are identified globally yeah yeah okie dokie thanks for that uh a couple of questions uh Tom before you leave us uh Luca Luke is asking can you give us a reference for GMP in the code of federal regulations CFR does that mean anything to you right right yes yeah they are very I'll have to um slide here it was at the beginning um if you don't have it cool okay it is um okay the um gmps are required in the food processor under 21 CFR 130.3 d and 21 CFR 110.8 those specifically mentioned packaging in food processing operations and by legal extension extend back into the um the world of the packaging manufacturer okay that's that's in the slide what page is that one in the slides uh Thomas because that one was on page 19. right well we will be circulating this slide so Luke you'll be able to pick that up off the slides um [Music] I don't know if it's tea Southeast has asked what do you see as the current and future role of gfsi certification I am very much an advocate of gfsi certification for food packaging Manufacturing I think that the public safety and Welfare as well as the supply chain integrity are much better protected by those voluntary um contractual expectations between buyer and seller in the marketplace because every lot of material is police that way by the the contractual agreements the ability of any government European or United States to police all these regulations in their complexity and their expansiveness is very difficult now in the United States there's uh there seems to be a a government sort of um challenge to the sort of the dependability of the third party auditing process and I'll take the opportunity here to point out that gfsi is very different from the experience the United States of inspections for sanitary practices gfsi is not an inspection it is a certification to a management system and as such there are some very explicit requirements for the evidence of awareness and management and actions to ensure the safety of the public and the the supply chain Integrity with gfsi that are not present in in the historical sanitation inspections that I think U.S has been satisfied to call good manufacturing practice in the past yeah and they and they're getting more and more uh demanding as well I mean the latest version of the BS BRC packaging version five five which I've just conducted actually a gap analysis from version four to five and it is on the ifsqn website um very demanding and it's got additional um a lot more additional print controls required specifically so they are they are you know uh becoming very demanding and driven obviously by customer demand and and gfsi food standards you know flush flush batteries that's that's a product of the management system is the continuous Improvement the recognition of mitigation needed mitigation that's needed for newly recognized risks so it's a an ongoing learning process and improvement process to the benefit of the public health and the economic health of the participants in the food supply chain yeah thank you yeah that's great spot on that Thomas right um I don't think we have any more we've gone past the hour anyway so um I'd just like to say on behalf of myself and the ifsqn and all the food safety Friday's attendees and registrants thanks very much Tom thank you all for your time I know just to tell the audience you you've been straight hot off a plane and you're actually not you're not in a bathroom there you're in like some sort of room in the airport so uh you've under extreme circumstances you've done a great job so thanks very much Thomas okay thank you I apologize for the urgency on my end no worries no problem whatsoever thanks very much someone else I'll speak to you soon cheers bye now bye ladies and gentlemen um the certificate now is in the sidebar uh you'll be waiting for that uh you might have noticed at the top of the chat as well uh if you did if you did attend food safety live last week we there was no food safety Friday's webinar last week but there was food safety live that was last Wednesday we had six hours of debate with 14 speakers um please visit the ifscum Forum and do give us feedback on that you know if it was parts or a job didn't enjoy uh ideas for next time you know please do give us feedback on that and we'll help to improve the experience for you next year okay so that's it um that was great from Tom thanks very much to Tom thanks to the sponsors again uh thanks for you for attending live um it does make a difference with your questions and comments all there is to say is have a lovely weekend have a food safe day and I'll see you next Friday okay take care everybody have a nice weekend