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the webinar will begin momentarily.please stand by.the webinar will begin momentarily.please stand by.hello everyone and welcome to registrar.Corpse webinar entitled how to export.food to the United States and comply.with the US FDA regulations my name is.David Linares vice president at.registrar Corp and I am a presenter and.moderator for today's event the.presentation portion of the webinar will.last approximately 40 minutes we.anticipate having 15 to 20 minutes to.respond to your questions at the end if.we run out of time we are also happy to.respond to your questions by email you.may submit a written question any time.during the webinar by typing in the chat.feature on your webinar screen a.recorded copy of this presentation will.be sent to all registrants I'd like to.introduce our speakers today Anna.Benavente a senior regulatory specialist.at registrar Corp she's been assisting.companies with US FDA regulations since.2009 she has researched over a thousand.products to determine whether they meet.FDA requirements for compliance in.addition miss Benavente has conducted.multiple seminars for industry and trade.associations around the world her areas.of expertise include FDA import alerts.detention without physical examination.and detention assistance product.formulation requirements and labeling.for cosmetics over-the-counter drugs.beverages food dietary supplements and.medical devices this Benavente is based.at registrar Corp headquarters in.Hampton Virginia where she manages a.team of 15 regulatory specialist in.addition we are joined by Bracy par.Gracie par as a regulatory specialist.and project coordinator at registrar.Corp mr. Parr is based in our.headquarters in Hampton Virginia and.developed and manages registrar Korps.FISMA compliance wizard an online tool.that helps facilities determine their.requirements under the Food Safety.Modernization Act mr. Parr speaks fluent.Spanish and has conducted various.webinars and trainings on.yzma requirements both here in the US.and overseas I'd like to go ahead and.begin the first section which will focus.on some of the registration and prior.notice requirements in addition then.we'll talk about the food canning.requirement and a Benavente will speak.about the labeling and lastly Bracy will.cover food safety regulations and at the.end we'll have some time for a question.and answer session so let's just start.off with a very broad overview about how.the FDA works I want to talk about some.of the common myths that people have a.lot of companies people think FDA.approves facilities the FDA approves.products that they require you submit a.label or you have an inspection before.marketing your products and in fact that.is not the case when it comes to food.and beverages FDA does not require that.you have an inspection or you submit the.labeling nor do they approve a.particular product or factory and we'll.talk about what you have to do in.relation to the regulations but FDA.itself does not approve facilities or.products or labeling FDA approves only.certain types of products such as.prescription drugs and certain medical.devices but when it comes to food and.beverages our Congress writes the law.and FDA then is the rule maker they.establish and interpret the the Congress.congressional laws and write the actual.rules they then are in essence the.enforcer or the police of those.regulations to make sure that companies.are following the actual rules that.they've written they do have certain.powers of enforcement in other words.they can conduct inspections of both.domestic and foreign facilities our.webinar today will not.go into depth about inspections however.when it comes to a foreign food facility.FDA is required to provide that facility.with a notice of inspection they can't.simply show up at your factory door and.ask to conduct an inspection there is a.procedure and a process that they go.through when it comes to foreign.facilities unlike with a domestic u.s..facility where they can conduct.unannounced inspections FDA can also.refuse products at our ports of entry so.an import refusal is one of the tools.that they have as part of their.enforcement abilities they can also.issue import alerts or warning letters.they can suspend the registration of a.facility or a factory in other words of.a foreign food or beverage manufacturer.and finally they can issue civil and.criminal penalties for violations of the.regulations now I want to talk a little.bit about some of the basic requirements.registration the u.s. agent requirement.and prior notice firstly FDA's food.facility registration requirement and.I'm going to talk about the requirement.to renew a registration by an early on.even years which just occurred in 2016.so the bioterrorism Act which came about.in 2002 first established the.requirement for firms to register their.facility with FDA the Food Safety.Modernization Act which came about in.2011 put in place the biennial food.facility registration renewal.requirement and more recently FDA issued.a final rule regarding food facility.registration and the 2016 biennial.registration renewal period that was.issued back in the fall in 2016 and I'll.talk about how you can verify if your.FDA register.raishin is still valid in the event.you've already registered whether you.renewed properly or not I'll talk about.how you can determine if your.registration is still valid the.bioterrorism Act again came about after.the events of September 11th in the.United States came into effect in 2002.and in 2003 what's the first time that a.company was required to register under.this new regulation any facility that.manufactures processes packs or stores.food and this includes beverages dietary.supplements agricultural commodities so.this requirement again came about for.the first time in the last quarter of.2003 foreign facilities those located.outside the United States must designate.a u.s. agent for FDA communications the.role of this US agent is to act as a.link between FDA and your factory.overseas FDA will contact the US agent.for example if it wishes to schedule an.inspection or has a question about a.particular shipment to the United States.the US agent must be physically located.in the United States and must be.available 24/7 it may not simply be a.peel box and we certainly recommend that.you if you designate a when you.designate a u.s. agent that it is.someone that you you trust who has.experience in dealing with the Food and.Drug Administration since as your u.s..agent they will be speaking on your.behalf that is the role of the US agent.and we'll talk a little bit more about.that as we get into the biennial renewal.requirements and some of the changes.that affected the u.s. agent.there are some exemptions from.registration of a facility trading.companies personal residences if you're.involved only in transportation if you.operate a farm if you operate a retail.food establishment a fishing vessel if.they are not further processing the.seafood or a USDA regulated facility.those are some of the examples of.factories of facilities that are.considered to be exempt from this.registration requirement when you.register your facility you'll be.providing FDA with information about the.actual activities and contact.information at the physical location.where you are manufacturing processing.packing or warehousing the food or.beverages that will be consumed in the.United States so facility information.like the name and corporate identity the.physical location the trade names used.to do business in the u.s. important.contact information such as the.telephone or email address the emergency.contact as well as product information.there are categories of products that.you choose from so you don't actually.list individual products by name but.instead if you are for example involved.in the confectionery industry there is a.category for confectionery products and.and that again would be what you would.select moving on of flashing ahead we.had the first requirement for that.registration back in 2003 and when FDA.enacted the Food Safety Modernization.Act of 2011 there were some additional.changes that impacted impact the.registration requirement most notably it.instituted the for the first time the.requirement to actually read.to a food facility registration number.so if you were doing business in the.United States back in 2005 or 2008 and.you registered for the first time there.was no renewal requirement until the.first time it was mandated under the.Food Safety Modernization Act which was.the fourth quarter of 2012 so there have.now been three registration renewal.periods 2012 2014 and we just recently.completed the registration renewal.period of 2016 the next one will be in.2018 a couple changes facilities must.consent to FDA inspection during that.renewal process must affirmatively agree.to allow FDA to inspect a facility and.failure to renew will result in a.invalidated registration that is a.prohibited act if you continue to.manufacture process pack or store food.that will be exported and consumed in.the United States FDA recently issued a.final rule regarding food facility.registrations back in 2016 a couple of.these new requirements a unique facility.identifier will be required in 2020 this.will likely be a what's called a Duns.number Duns is a private company down in.Bradstreet they issue numbers tied to.location specific entities and FDA's.indicated that that will likely be a.requirement during the registration.process in 2020 in addition FDA will.only accept electronic submissions in.2020.in addition third-party submission.verification if a registration has been.submitted or updated or renewed or.cancelled and it has not been made by.the owner operator or aged.and in charge FDA will verify that the.third party was indeed authorized to act.on the behalf of the registrants they.will send the registrant an email.and asking them to confirm that the.third party the named third party was.authorized by them to submit any of the.registration data in addition agent.assignment verification is a new.requirement FDA will verify that the.person designated as the US agent for.the foreign facility has agreed to serve.in that role and they will not provide.the facility with the registration.number or confirm the registration.renewal until that person has confirmed.that they agree to serve as the US agent.the confirmation process happens when.FDA sends out an email to the US agent.and again the US agent has to.affirmatively agree or deny to serve as.the US agent FDA has done this because.under the Food Safety Modernization Act.FDA is empowered to charge re-inspection.fees to the US agent for a foreign food.facility inspection so if a FDA inspects.a facility and it does not go well FDA.will classify that inspection as.official action indicated or oai and if.that classification occurs that facility.could be eligible for a rien spec ssin.and under the new FISMA regulations fda.is empowered to charge the US agent for.that rien spec ssin of the foreign food.facility therefore they have implemented.this requirement for the US agent to.affirmative ly accept the.responsibilities of serving as the US.agent for foreign facility FDA also.expanded the food product and activity.categories back in this last quarter.renewal of the fourth quarter of 2016.they have.added made some changes expanded some so.for example warehouse and holding.facilities are divided into three.categories ambient refrigerated and.frozen low-acid and acidified food.processors are divided into two.categories low acid food processors and.acidified and farm mix type facilities.has been added to a list of activities.in addition if you produce self.shellfish they want added categories for.better definitions of what type of self.and shellfish similar changes or.additional changes I should say for.animal free product categories new.product categories for botanical and.herbs direct feed microbials forage.products.technical additives and old categories.were replaced with new ones animal.animal derived products between animal.protein products food processing.byproducts became human food byproducts.not otherwise listed and recycled animal.waste products became processed animal.waste products so again some changes.that they made that we're already.instituted in the fourth quarter of 2016.I mentioned earlier the to verification.steps if you're serving as the US agent.or have a u.s. agent they have to.affirmatively accept that responsibility.and if the registration has been done by.a third party the registrant has to.verify that they authorize the third.party to provide that so both.verification steps apply to new.registration renewal and cancellation.FDA will not confirm any of the.transactions meaning a registration.until both the US agent and the.authorizing individual for a third party.submission has submitted a receipt code.to agree to their respective.designations.so did you renew your registration for.2017 this had to be done starting.October 1st and ended on December 31st.at midnight of 2016.FDA has removed thousands of food.facility registrations from their.database that were not properly renewed.for 2017 they did this on February 1st.so even if you submitted a renewal your.registration expired if your us agent.did not affirmatively agree so many.facilities may not realize their.registration expired until the shipment.is actually detained at the u.s. port of.entry we encourage you to check the.validity of your registration registrar.Corp will verify that your registration.was renewed for you at no cost there's a.link right here where you can submit.information and we will then reach out.to FDA to verify if your registration is.actually valid or FDA actually removed.it from the database so feel free to use.that link and we can assist you moving.on now away from the registration.requirement to what's called prior.notice prior notice also became.effective under the bioterrorism Act.back in 2003 so now that FDA knows who.is producing food both here in the US.and overseas they want to know when food.shipments are actually arriving in the.United States so prior notice requires a.notification be given to FDA.electronically for each and every.shipment of food and beverages and.dietary supplements coming in to the.United States it is required even for.samples if those samples are going to be.consumed so if you're sending samples to.the Fancy Food Show or to Natural.Products Expo West you want to make sure.if those samples are going to be.consumed at the tradeshow which.generally that's what they're there for.you are required to file prior notice.otherwise you risk the product being.detained in the port if FDA is not.issued a prior notice confirmation the.information you.need to submit the prior notice includes.information about the shipment and the.facility and if you're the manufacturer.you will be required to submit a valid.11 digit food facility registration.number prior notice may be filed by you.as the foreign exporter it may be filed.by your u.s. importer or by a third.party such as registrar Corp or a.customs broker here in the United States.another additional requirement I'll.touch upon now is the requirement for a.food canning establishment registration.this requirement actually came about in.the 1970s when food canning became more.popular and presented obviously food.safety risks and so FDA requires that.low acid canned food products with a.final pH of greater than four point six.now water activity of greater than point.zero eight five products typically in.cans or jars tetra Paks pouches that.they obtain a food canning establishment.registration this is a five digit number.other products that are acidified with a.final pH of less than or equal four.point six or water activity of greater.than point eight five will also require.this some examples of products that.might need this registration are green.olives and Bryan artichokes figs and.syrup roasted peppers and literally.hundreds if not thousands of other types.of products on registrar Corpse website.we do have an area where you can.actually see an entire a fairly.exhaustive list I should say of.requirements of products that require.this additional registration in addition.registrar Corp has recently built and.launched what we call our FCE wizard and.rfid verifier the FC wizard will help.identify whether your.products are subject to the FCS ID.regulations you'll input a little bit of.data about the actual products you.produce and you'll receive and be able.to share a PDF report detailing the.possible requirements for FCE and.submission identifier this F ID verifier.which we have also launched is a product.or service that will allow you to verify.for particular submission identifier and.s ID it's currently on file in FDA's.database so if you have an FCE number.you have F ID numbers because you know.you produce a low acid canned food we.can verify that that F idea particular s.ID is currently on file and valid with.FDA this can help avoid detentions which.can be very time-consuming and very.costly at a port of entry so that.concludes my portion of the webinar.again i've touched upon the registration.requirement the u.s. agent requirements.prior notice requirement and the food.canning establishment requirement should.you produce products in the can a jar.tetrapack with a certain ph and water.activity level i'd now like to turn.things over to ana Benavente ana is.going to talk to you about the new.nutrition labeling requirements that.will come into effect soon in the United.States ana okay thank you David before I.get started I just like to just give a.quick announcement because there have.been some questions from people who came.to a slate about emailing that PDF.slides if you've signed up to the.webinar you should be getting an email.that has the PDF of the slides as well.as the recording of the presentation if.you find that you don't receive that.just please feel free to contact us on.our website we have a live chat feature.and we can quickly get that to you for.your information and of course.answer any questions that you might have.so as David said I'm a director of the.product labeling an ingredient review.department here at registrar Corp and so.I'd like to talk about some of the.ground breaking changes that FDA has.made to the mandatory nutrition labeling.that is required on most retail food.products we've also gotten a question.about EU labeling being accepted upon.import for products like salt and.suffice to say that EU labeling is not.considered appropriate by FDA it doesn't.meet to the FDA's mandatory requirements.and therefore even something like salt.which has sodium content clearly will.require the FDA's nutrition labeling be.incorporated into the label on the.product itself now many of you hopefully.may recognize this Nutrition Facts chart.the old Nutrition Facts label stayed.relatively unchanged since the passage.of the nutrition labeling and Education.Act back in 1990 there were some minor.modifications but all in all this is.what has appeared on food products.destined for the US market for many many.years however in 2014 based upon new.research and nutritional data FDA issued.two proposed rules to modify the current.Nutrition Facts label a lot of it had to.do with shifting health concerns based.on the American populace and some of the.nutritional challenges that our.population faces in 2015 there was a.supplemental proposed rule addressing.added sugars which has become a little.bit one on the forefront as a public.health concern so then finally in May of.2016 there were two final rules issued.that mandated the new Nutrition Facts.label okay so the first and more.substantial of the rules dealt with the.content and format of the Nutrition.Facts chart.and then the second smaller rule dealt.with the serving sizes that FDA states.have to be incorporated into the.Nutrition Facts label among the content.changes FDA determined that the new.mandatory declarations should be vitamin.D potassium and added sugar vitamin A.and C are now voluntary because.Americans apparently get enough vitamin.A and C and FDA determined that our.levels of vitamin D and potassium were.of greater concern and they wanted those.to always be declared in the Nutrition.Facts label calories from fat would.determine to not be significant in any.way in terms of presenting that.information in the chart so now it's not.even voluntary you have it can no longer.be declared in a Nutrition Facts chart.they also established in new definitions.the dietary fiber which is more.restrictive so the Declaration of.dietary fiber in that nutrition facts.panel must be based on the fiber as.described in regulation now they also.established some new units for vitamin D.and niacin vitamin A vitamin E and then.the Declaration of folate and Salih Casa.de Nutrition Facts charts based on new.nutritional data FDA also updated the.daily reference value and reference.daily intake values for many of the.nutrients that are incorporated into the.chart so these are some of the primary.ones and the most significant total fat.change from 65 grams to 78 grams.meanwhile total carb was decreased from.300 grams down to 275 they also lowered.the amount of sodium that was considered.to be appropriate for a daily intake.from 2400 milligrams down to 2300.potassium was raised quite significantly.to 4,700 milligrams.calcium and dietary fiber also modified.to 1300 milligrams and 28 grams.respectively.now as part of the new push for added.sugars declarations SBA also established.a DRV for added sugars at 50 grams per.day.which is pretty significant when you.consider the amount of sugar that's.found even in just a typical soda the.amount of sugar in one soda will be a.significant part of this added sugar DRV.and now this will be declared on the.nutrition label that's found on retail.food products destined for the United.States far serving sizes go certain.sizes are actually based on reference.amount customarily consumed that are.established by FDA for multiple food.product categories so for example in a.lot of other areas of the world.nutrition labeling is done per unit or.per 100 grams or per 100 milligrams or.sorry 100 milliliters not in the United.States and this is a common issue that.people run into when they're developing.labeling for the United States the.serving sizes in the charts must be.derived from the rack value for that.food.FDA epicgoose in the FDA surveys.consumption data to determine how much.of a certain food Americans eat and then.they use that to establish the rack.value it's important also to understand.the rack value is not what FDA thinks.people should eat but what they are.actually eating.now some of the notable rap changes that.occurred with the new final rule certain.beverage racks were increased from 240.milliliters which was sort of the.standard beverage rack to 360.millilitres for products such as soda.and coffee and tea.they actually decrease the rack value.for quote-unquote all other candies from.40 grams down to 30 grams they also.increase the ice cream rack established.a new rack category for appetizers as.well as a new rack category for.after-dinner confectionary so given.these changes if you have any of these.products for example the entire content.of your Nutrition Facts label will.change since the size of the serving has.also changed as well so for example if.prior to this rule you had an 85 grand.chocolate bar based on the old rack.value of 40 grams you would have been.declaring your serving size as half a.bar however based on the new rack value.of 30 grams it actually results in a.serving size of one third of a bar so it.actually benefits chocolate.manufacturers and that it does actually.end up decreasing the labeled amount of.calories and fat and so forth per.serving of that type of product now as.far as the format goes you can see this.version of the chart looks fairly.different from what the old version.looked like changes were made to the.order of nutrients changes also made to.the footnote that's at the bottom of.that chart change is made to the font.sizes of the decorations you can see.that the calorie count is pretty much.the largest text size in that label so.that Americans will be cognizant of the.number of calories per serving in the.product they also indicated that.quantitative amounts of certain vitamins.and minerals will have to be required.when you look at that vitamin and.mineral section you'll see instead of.only the percent of the daily value.being declared it also gives the.microgram in milk.amount of those four now mandatory.vitamins and minerals now what other.things a question that we received.actually in the meantime as well was.about servings per container which you.see up there at the top there was a.question about whether you could use the.word about or whether you could use a.range such as eight to nine servings per.container FDA's labeling regulations do.not permit a declaration such as eight.to nine servings per container instead.if it's not an exact number of servings.per container you do have to use the.term about there's one small variation.in that for certain products that are.random weights FDA will permit the.number of servings per container to be.declared as quote unquote varied so this.is a very small subset for random.weighed products like cheese and in some.cases seafood there's some other.additional format changes you can see.those of you who are familiar with the.other versions of the charts that FDA.permits such as the simplified tabular.and linear charts modifications were.made to those formats as well after.those of you not familiar with these.formats.these are formats that are permitted by.FDA either when a product has very.little nutritional content or the size.of the package is below 40 square inches.in terms of total labeling space a brand.new requirement is dual column labeling.for packages or units that are 200 to.300 percent of the rack value for that.food and the idea behind this being that.if you have a package that could in.theory be consumed in one sitting.FDA felt that it was important that.American consumers realize the number of.calories and other nutrients in a.package of that size should they consume.it all at once so if you can see there's.two columns the first column would be.per serving or per unit.second column for the entire package.dietary supplements are actually.categorized as food under the law they.were not as impacted though as.conventional foods and beverages by.these new rules the mandatory nutrient.declarations do mirror those of the.Nutrition Facts label so for example if.you have vitamin A and vitamin C in the.product before the rule you would have.to declare them in a supplement chart.now they're voluntary as well but.vitamin D and potassium became mandatory.as well as added sugars the format.changes were relatively minor though as.you can see from this example the font.sizes didn't change the order of the.serving size and servings per container.did not change it's mostly just a matter.of the added sugars and the new.mandatory vitamins and minerals then.they also have a new disclaimer for.supplements that are intended for.children 1 to 3 years of age because.those percent daily values are based on.a 1,000 calorie diet now primarily.because of the new definitions for.dietary fiber the manner in which folate.and folic acid are declared as well as.the added sugars issue there are new.record-keeping requirements for dietary.fiber companies will need to keep.records to show that their dietary fiber.conforms to the new definition the new.definition in essence says that fibers.that are intrinsic to plants are covered.under the definition as well as a few.other isolated in synthetic fibers FDA.has a manner in which companies can.petition to have other fibers added to.this definition but will need to submit.you know data to prove that they have.beneficial physiological effects on the.human body added sugars has a specific.definition dealing mostly with sugars.that are added.other than being inherent to the product.like you might find in a fruit so for.products that have added sugars mixed.with naturally occurring sugars such as.maybe a dried fruit that's been coated.in sugar companies will need to keep.records to show that the values of added.sugars versus the total number of sugars.have been determined in an accurate way.same goes with vitamin E mixtures and.then also folic acid versus folate this.just inherent to a product versus being.added so these records would have to be.analyses of databases or recipes.ingredients formulations recipes and so.forth batch records now because FDA.understands that these are pretty.groundbreaking and earth-shattering sort.of changes that have to happen to almost.every retail food product in the United.States they do allow time to industry to.incorporate the new rules so these dates.are based on the annual foods sales of.the manufacturer not the importer and.not the distributor but on the.manufacturer so for sales greater for.companies with sales greater than 10.million the compliance date would be.July 26 2018 for those who sales of less.than 10 million they're given until July.26 2019 so what that means is that any.food product that does not have the new.labeling cannot be introduced into u.s..commerce after that date I'd also like.just to make everyone aware that there.will be a Spanish food labeling webinar.Tuesday March 14th at 11:00 Eastern.Standard Time when you receive this.webinar slides and recording via email.you can use the link that's on this.slide to go ahead and register for that.if you're interested in participating in.it.[Applause].okay and I'll be turning it over to.Bracy in just a moment thank you thank.Santa for that and it's a real pleasure.to be with y'all today to discuss these.requirements for exporting food to the.United States just want to mention that.we've already got a lot of great.questions.um so please do stay on get some of your.questions answered in our question and.answer session and for those of you who.have been typing us messages asking if.we speak your language yes we do we.speak over 30 languages here at.registrar Corp if you need to write us.an Italian French Spanish Arabic.whatever it is please write us in your.language and we will be able to respond.so I'll be speaking today about the Food.Safety Modernization Act the SMA or.FISMA as we like to call it around here.this is the biggest change to the food.safety system in the United States in.over 70 years just like the labeling.requirements pretty groundbreaking there.have been a lot of questions and.industry we've been helping a lot of our.clients handle this and I'm going to.clarify what exactly you need as a.manufacturer really the core principle.of the FISMA for manufacturers is the.preventive controls rule SMA FISMA.refers to the law passed by Congress you.must comply with a rule that the FDA.published under that law called the.preventive controls rule for human or.animal food and the heart of that.regulation is the requirement to build.and implement a food safety plan again.this is the most important takeaway for.the preventive controls rule a food.safety plan and we do know that many.foreign manufacturers you may have.already implemented hasip you may have.certain certifications such as BRC SS SC.22.thousand any scheme under the GFSI this.is a new standard for all of you who may.be asking well it's my hasit plan.sufficient to cover this we're going to.go over a bit of the separate.requirements the individual requirements.in the food safety plan but just know.that this is a new standard you will.have to modify your existing food safety.plan food safety or have to plan into a.SMA FISMA compliant food safety plan and.now the components of that food safety.plan are here on the screen you can see.the first would be a hazard analysis.much like hasip you need to look at the.biological chemical and physical hazards.of the foods that you produce in your.facility and then next you will need to.implement preventive control these are.different than critical control points.preventive controls ranges from anything.from processed controls you know.temperature to food allergen control.this is particularly a category that FDA.is requiring companies to comply with.you can no longer just say may contain.and then list the eight allergens on.your label FDA wants to see that you.have analyzed the hazards and that if.there are allergen hazards what are you.going to do to segregate those foods.from other non allergen foods.particularly new an interesting.requirement is the supply chain program.if you are a manufacturer for instance.let's say in Italy and you are receiving.product from another Italian producer.that is not registered with the FDA but.you are then going to be using that.product you buy from the other producer.in a product that you are going to send.to the United States you were going to.have to analyze what hazards what risk.might be associated with the food you.are getting from your supplier and then.implement a program to make sure that.that food is safe before it arrives to.your factory or that.somehow you control the risk associated.with that food as well there is a recall.plan requirement if you have a food that.has a certain risk that needs to be.prevented or minimized you will be.required to have a recall plan what are.you going to do to make sure that that.product once it's gotten to the market.is going to be taken off the shelves and.minimize the danger to public health the.last four remaining components are the.preventive controls management component.some verification verifying that your.preventive control is working if it's.heating up for instance a batter to cook.you want to make sure that that.temperature gets that batter to the.right consistency and end and the plates.to to kill the pathogens that you've.identified in the hazard analysis you.need to monitor your preventative.controls to make sure they are still.working and then implement any.corrective actions you see that.something is not working FDA wants to.make sure that you have documented that.you have acknowledged the the.non-compliance and how you have.corrected it and then as well and what.Ana touched on last for the labeling.requirements record-keeping FDA wants to.see that you have done your work when it.comes to these food safety requirements.they don't just want to see you.implement solutions without having done.an analysis and looking at how a plan.from and seeing the development they.want to see the stages of development in.your plan and what are you doing to.ensure the food that you were producing.is safe there are exemptions and there.are modified requirements to this rule.retail establishments such as.restaurants and stores you do not even.need to register with the FDA so this.does not apply to you qualified.facilities don't get confused qualified.facilities does not mean you are.qualified for any sort of extra.requirement or that you need to do.something.this is FDA's way of saying a very small.business on.an exempt business they're looking at.artisanal suppliers.family producers these are very small.businesses doing less than a million.dollars in global sales and inventory.per year let me explain that a little.bit it is the combined value of sales in.your own country plus the sales of food.to the United States plus any other.country in the world.it's your global food sales total food.sales plus the value of any unsold.inventory juice and seafood asset they.continue to just need hasip that is.their requirement they do not need the.new harp seafood safety plan alcoholic.beverages wine beer spirits dietary.supplements USDA products Farms are also.exempt and then if you are a storage.facility you are just a distributor you.are not processing packing the food then.you also do not need the food safety.plan if you are processing or packing.food you do require a food safety plan.and the deadlines for that if you have a.business with more than 500 full-time.employees your deadline was back in.September of last year and if you have a.small business with less than 500.employees you have until September 18th.of this year to get your food safety.plan in order for those companies that.are doing less than a million dollars in.global food sales and inventory they are.not required to have the food safety.plan but rather submit what's called a.qualified facility at Ted station that.will happen in winter of 2018.supposedly around the same time as the.biennial food facility registration if.you are our client and you believe that.you may be a qualified facility we will.be assisting you with that requirement.or offering assistance.come winter 2018 but just make sure to.be keeping good financial records.if FDA inspects they are going to want.to see financial records illustrating.corroborating that you are doing less.than a million dollars in sales and.inventory per year next we'll go to a.second requirement this is another rule.under the SMA it is the food defense the.intentional adulteration rule and really.the heart of this requirement is the.food defense plan it is to prevent any.sort of intentional adulteration in.other words to prevent any sort of.terrorism other forms of intentional.harm done to the consumer and so a.qualified individual someone who is.familiar with food defense with food.safety needs to develop a written plan.for how you're going to mitigate risk.associated with your process and your.feed type so really it almost mirrors.like the food safety but food defense is.for protecting against those who are.trying to do intentional harm via the.food market you need to conduct a.vulnerability assessment so then there.you're going to identify any possibility.that someone could come and contaminate.your food and then you're going to look.at the severity and scale of a potential.impact for instance there's a large t.producer near my house where I live in.some in Virginia here in the United.States and after the events of 9/11 of.September 11th of 2001 that food.facility went on lockdown because they.produce tea for a large amount of.consumers in North America under the.intentional adulteration rule that.company would need to analyze can.someone access RT are there liquid tanks.that are you know not being watched or.not being monitored.if someone able to slip something into a.huge vat or a huge a drying place for.tea leaves that's going to make a lot of.people sick that would be an example of.something a vulnerability assessment the.questions that you would ask.then you need to develop mitigation.strategies these are like your.preventative controls pursue food safety.except they are strategies to prevent.someone from gaining access to the food.product and successfully contaminating.it from the other four requirements for.monitoring corrective actions.verification record-keeping much the.same as those of the food safety plan.you need to monitor your mitigation.strategies and correct any.non-compliances that you see any issues.you need to be keeping records of all of.this as well the exemptions and modified.requirements for this rule for those who.do not need to develop a food defense.plan if you are a very small business.and for this rule this is defined as.less than ten million dollars a year in.sales and inventory you do not need to.develop the food defense plan so be.careful here you may need to develop a.food safety plan because you are doing.more than 1 million dollars in global.food sales and inventory but you may be.exempt from the food defense plan.because you are doing less than 10.million dollars a year in sales and.inventory animal food facilities so any.feed of animal grains you do not need to.develop a food defense plan alcoholic.beverages farms storage facilities.unless you are doing liquid storage if.you have liquid storage tanks you do.need a food defense plan but otherwise.you are exempt and then packing and.labeling facilities where the container.that is in contact with the food remains.intact if you if the food is not.touching a new surface and you are only.Pacolet packing repacking labeling or.relabeling again you don't need to.develop the food defense plan the.deadlines for this for small businesses.with less than 500 employees you have.until May of 2020 and then other.businesses large businesses with more.than 500 employees may of 2019 for the.very small businesses remember that's.less than 10 million dollars per year in.sales and.taury you only need to maintain.financial records that demonstrate your.financial status in case FDA ever wants.to inspect a lot of you then are.probably wondering well if I have to do.all of this as the manufacturer what is.my importer have to do so there you have.your requirements as a manufacturer you.have to have the harp see the hazard.analysis and risk based preventive.controls food safety plan and the food.defense plan your importer needs to have.what is called a foreign supplier.verification program and SS VP don't get.confused the fsvp even though it says.foreign supplier in the name it is what.your importer needs so if any of you.come have emails from your import in the.United States from your buyers your.customers saying they need an SS VP from.you that is incorrect.they need an fsvp you need a food safety.plan feel free to reference them refer.them to us we can explain it for them.and something else I wanted to highlight.is the language of your records.requirement your importer your customers.in the United States are required to be.able to read the language of your food.safety plan if you have a food safety.plan and a not very widely spoken.language you may find it prudent to.translate that into English not only for.your importer but also just in case the.FDA ever comes to inspect and really it.does make it easier to find future.buyers and future customers in the.United States once you've got your.documentation already in English it.helps facilitate the process if anyone.has any questions if afisma FSMA applies.to them we have developed a free online.tool you answer a couple questions and.it gives you a full report of your of.your requirements under the food defense.rule and as well as the food safety plan.the preventive controls rule.and with that I will turn it back over.to David thank you thank you very much.grazie and Anna both of you for the.excellent presentation again I'd like to.announce that we will be sending a.recording copy of this presentation to.all registrants I'd now like to open it.up for questions I will read off these.questions Anna brace and I will do our.best to answer them you may type your.your question in the chat feature found.on the left side of the webinar screen.we did go a little over in the.presentation length I apologize but will.stay on and start to answer some of.these questions that we have received so.if you just stand by one moment first.question is who do we contact to clear.the product from a so called.blacklist as far back as in 2009 an.additive that was not allowed was used.resulted on the company being put on.what they're referring to a blacklist so.Anna did you would you answer that for.us how you know this is what if you get.on this list that FDA has established.yeah be happy to so I presume that.they're talking about import alert.import alerts are ways that FDA identify.companies that have shipped products.that have been in violation and what it.results in is that company's products.being detained without any examination.by FDA and then the burden is on the.importer to prove that the products are.not in violation so for companies they.are very much a disruption to the supply.chain and many companies are very eager.to get off these import alerts so FDA.does allow you to petition if you have.corrected the problem that led to the.initial violation.and you ship and are able to prove that.the products entering are no longer in.violation you can petition FDA and.request removal from an import alert.so FDA has to be convinced that the.problem has been fixed in order for them.to grant the petition registrar Corp.actually has services related to this.the companies are interested it can take.several months and usually a very.lengthy petition is necessary to.convince FDA to remove the company from.the import alert but it can be done and.it can certainly be beneficial to the.company so that their supply chain is.not disrupted any more all right thanks.very much Anna and again we do have a.service to help with removal from that.list the next question is a labeling.related question two-part should all.nutrition facts be written in black.letters on a white background and are.there requirements at the net weight be.written on the packaging Anna that seems.directed at you so if you could give a.quick answer on that one please.certainly so given the length of the.webinar we weren't able to get into all.the different aspects of labeling that.FDA requires beyond retail and bulk.products being sent to the United States.long story short the net weight does.need to appear on the front principle.display panel in the bottom third of.that panel in a type size that is.mandated based on the size of the entire.package so the larger the package the.larger that net weight statement needs.to be in regards to the chart the.regulation states that the text should.be black or one color type on a white or.neutral contrasting background so.generally speaking we always recommend.black types on a white background all of.FDA's examples are presented that way.some companies want to put them on.different colored backgrounds or use.white type on a blue background we.consider it most prudent to follow FDA's.examples which has a definite benefit.when you're in Port so if a.see a compliance officer sees the black.type on a white background where the.company is following the recommendations.of the agency they're more likely to.understand that the product and its.labeling have been developed in.accordance with FDA's requirements and.you're less likely to have problems in.court if the FBI officer understands.that.all right thanks Anna and another.labeling related question on the.Nutrition Facts serving size is it.allowed to state about eight servings.per container or for example could you.say eight to nine or eight to ten.servings per container can you just very.briefly touch on serving size for us.Anna certainly so the number of servings.per container is not permitted to be.declared as a range so FDA understands.that you will not always have an exact.number of servings per container so they.require that you use the term about and.then round to a specific number of.servings per container so it would be.about eight servings per container okay.perfect thank you Anna I'll answer the.next question and it is is it possible.to have only one FDA number for all of.our facilities and not one fda number.per facility the regulation requires.that each location so each specific.facility that is engaged in.manufacturing processing packing or.warehousing food or beverages for human.or animal consumption in the United.States that they each have their own.individual 11 digit food facility.registration number the logic behind.this is very simple if FDA wants to.inspect a facility they want to know.where exactly that facility is located.they don't want to go to a parent.company to the headquarters or to one.facility in fact a product is being.produced at another one so each facility.is required and in fact many larger.multinational companies may have dozens.of individual food facility registration.numbers the next question I can answer.is well.the question is is GU labeling being.accepted when importing food and.specifically salt products to the US.labeling regulations differ country to.country.so EU labeling is different from.labeling requirements in the United.States and if you're exporting to.another market such as Canada or.Australia or elsewhere they will have.their own labeling requirements as well.so you're best advised to understand.that you will need to develop a.us-centric or specific label next.question I will ask is again a real.abling related question if the Nutrition.Facts can it be on a leaflet.which will can be hang from the neck of.a bottle in case they have a bottle of.olive oil for example Anna so the use of.a hang tag is not specifically addressed.by FDA however the way that the.regulations dictate that the nutrition.labeling be declared they state it must.be declared on a information panel which.by definition is on the container to the.right of the principle display panel so.a hangtag with nutrition information on.it would not meet that requirement and.it is very possible that a product that.comes in to the United States with the.information on a hangtag could be.refused entry at port thanks Anna next.question is we would do not have a.special emergency contact person is it.possible to add only emergency phone.number.FDA does want to know the name of a.person actually add a facility that they.can have contact with in the event of.emergency I believe I would have to.verify if you send a follow-up email we.can verify for you that an emergency.contact person is a mandatory field in.the registration submission next.question is can you please explain about.trading companies and the fact that they.are exempt from registration by.definition a trader is not actually.manual.factoring processing packing or.warehousing a food or beverage they are.simply acting as an intermediary and.because FDA is interested in knowing.where a product is actually produced or.warehouse a trader who is not physically.controlling or producing the product is.exempt so if you're a trader which you.will need to verify is that the.manufacturers you are purchasing your.products from to export to the United.States that they each have their own.food facility registration number.themselves moving on to the next.question who pays for an FDA examination.of a facility specifically for an FDA.inspection of a facility FDA inspects.foreign facilities on a targeted basis.meaning they will select countries and.then facilities based on risk and they.will then conduct inspections of those.facilities the initial inspection of a.foreign food facility is free of charge.FDA does not charge for that inspection.they do not charge for the travel cost.or the time in your factory however if.that factory has a poor inspection in.other words fails FDA's inspection they.may eventually classify that as what's.called official action action indicated.which could make that facility eligible.for a rien spec ssin an FDA does have.authority to charge for re-inspection.fees for the rien spec ssin fees they.also have the authority to build the US.agent that is the individual or company.designated in your food facility.registration as your contact here in the.United States next question I will.address is does FDA accept cooked meat.products from Asia FDA regulates every.who.beverage product type except for meat.and poultry in certain specific game.products otherwise meat and poultry fall.under the US Department of Agriculture.the US Department of Agriculture has.agreements with countries they recognize.certain foreign countries as having an.equivalent food safety system for the.production of meat or poultry and then.those individual countries if they are.on the USDA approved list can submit the.names of the comfortability companies.within their country that those food.safety organizations in the country have.accepted or placed on their their list.their registration lists so it depends.on the country is the answer to that.question next question is if a sample is.not for consumption that you're sending.to the United States do you need to.declare it or to file a prior notice.you're not required to file a prior.notice if you are shipping samples and.they are for testing purposes only or.for example if you're just sending over.packaging the rule stipulates that if.the product is going to be consumed then.it is required that a prior notice be.file.moving on to the next question also.related to prior notice prior notice you.can find forms for us to file prior.notice for you on our website you can go.to prior notice comm and download forms.or you can create an account which will.speed up the submission of prior notices.should you have frequent shipments the.next question is does maple syrup fall.under the food canning requirement maple.syrup is exempt because of the water.activity however if you are producing a.product which is not simply maple syrup.but has other ingredients then I would.recommend.you go to our FISMA wizard it can help.you determine if you indeed may need a.food canning establishment and process.filing submitted let's see gifts of.gifts of products to friends in the USA.such as chocolates and candies do they.need an FDA prior notice the answer is.yes any products coming to the US that.will be consumed food or beverages do.require a prior notice the next question.relates to is an LA CF a related.question acid food like fruit jams which.are exempt are they still in the fssi D.file list as you've indicated it all.depends again on the acidity level some.jams do require an SI D and some jams.indeed are exempt so we would recommend.you go to our f c/e wizard and you'll.enter information about their acidity.level and ingredients and we'll help you.determine that next question is are the.nutrition labeling requirements are they.only active in the US or also for.exporters I'll clarify that they are.required for any company selling food or.beverages in the United States whether.you're located here in the US whether.you're producing a product overseas that.you are exporting to the United States.next question also labeling related our.nutrition labeling requirements.comparable to e requirements for.nutrition labeling Anna could you touch.upon that again certainly um they're.actually very very different we have.very many clients that come to us with.labeling that has been developed for the.EU market and the nutrition labeling.that's required there is very different.in terms of the format of how the.information is presented the content in.terms of the nutrients that must be.declared if they're present the ones.that I have seen often have the nutrient.values.clared per 100 grams 100 milliliters.whereas fda establishes a specific.serving size for a food product that.corresponds to the amount that an.American typically will eat in one.serving so generally we tend to remove.EU nutrition labeling completely from.our clients product labels and replace.it with the nutrition facts chart that.you saw on this presentation that.nutrition facts chart is what must.appear on most retail food labels in the.United States thanks Anna as a follow up.to an earlier question the person who.asked regarding fruit jams is the f ve.and s ID requirement applicable to fruit.products as well if these are just raw.fruit commodities apples pears so forth.no they are not you're not required to.submit obtain an FCN s IDs for those.products again F C and SIDS that.requirement exists for canned bottled.jars products and tetra packs etc next.question relates to again labeling our.Nutrition Facts that our data needed up.for alcoholic drinks in the United.States Anna please.okay so alcoholic beverages are actually.regulated by two different agencies the.TTB regulates most distilled spirits.wine beer and malt beverages and so.those products are not subject to the.nutrition labeling requirements for FDA.however FDA does regulate some alcoholic.beverages such as locale or low alcohol.content wines some other malt beverages.that are not derived from wheat and.barley and things so if you have a.product like a spiked apple cider maybe.where its FDA regulated then that.product will need to have the FDA's.nutrition facts chart on it thanks Anna.next question are labeling.was different if the product is intended.to be used in a b2b sales b2b commerce.the answer is no if you are selling that.product in the United States the the.information that Ana presented is indeed.required so keep that in mind even if.you're selling through web platforms.like Amazon or others next question is.when was or is prior notice required it.was actually required starting in 2003.so it is not a new requirement and you.need to file it before each and every.shipment of food or beverages arrives in.the United States next question is we.could not reach FDA during the renewal.period in 2016 and and are uncertain.about our confirmation of by our US.agent what should we do the best thing.you could do is email us or come on our.website on live chat if you have your.registration number handy we can attempt.to verify if the registration was indeed.successfully renewed or not if it was.not renewed you'll be required to obtain.a new 11 digit food facility.registration number and we can help you.with that as well let's see next.question is label related are these.label requirements specific to food or.is it also the case that they that they.are for feed animal feed I assume as.well Anna you want to touch on animal.feed certainly the nutrition facts chart.that we've been talking about is only.for human ten sorry food intended for.human consumption animal feed labeling.is very different.FDA has some baseline requirements in.terms of declaration of the products.identity net weights ingredients.manufacturer distributor or Packer the.additional labeling requirement that we.often see on animal feed tends to be.dictated by the individual states in.which the product is distributed.often mirrors recommendations that are.made by the Association of American feed.control officials also called ASCO so if.you have actually animal feed products.we are able to assist with the labeling.requirements for those as well if you're.interested in our services generally.speaking most animal feed products will.have both the FDA and the Africa.labeling elements on their labels when.they send them to the United States okay.thanks Anna the next question is does.the US FDA US FDA have regulations on.the import of sweetened condensed.creamers less than 8 percent milk fat in.terms of labeling the short answer I.think Ann is absolutely they do yeah all.all the general requirements will be in.place for sweetened condensed creamers.the nutrition facts panel ingredient.declarations those are required no.matter what the type of product if it's.a food intended for retail sale for.human consumption.perfect thanks Anna just to really.reiterate again yes we will be sending.out a recorded version of this webinar.so you will receive a email with this.webinar attached so that will be sent.out shortly moving on to the next.question.I sent samples in January and didn't.fill out any prior notice it's possible.that either your carrier did that for.you or if you have provided the shipping.details to your importer it's also.possible that your importer had done.that for you moving on to another.question related to milk do importers I.assume you mean a u.s. importer need a.milk import allocation permit for.sweetened condensed milk we would need.to look into that for you I don't.believe so but again if you could email.us your question we'll be able to get.back to you on that specific to that.product I'm moving on.do the nutrition labeling laws that do.they only apply to retail products that.are sold to the final consumer does it.apply to the master carton labels in.other words a box of 16 by 1 kg sugar.that is sold directly to restaurants to.be used for preparing meals Anna can you.talk a little bit about bulk products.products that are packaged in in bulk.containers and this also is dealing also.with foodservice because if you can.touch on those two please.certainly the nutrition facts panel is.required for products intended to be.sold directly to the consumer and the.regulations include many exemptions from.the nutrition labeling for products that.are being sold to restaurants or food.facilities hospitals places like.bakeries and delicatessens those.products will be exempted most likely.from the Nutrition Facts label Eng.that's required on retail food products.the remainder of the labeling.requirement such as the product name net.weight ingredients manufacturer and.distributor and path or identity and so.forth do remain so it's very important.that these products still have those.other labeling elements incorporated.into the packaging and it certainly we.always recommend that a clearly outlined.statement that the product is intended.for wholesale or for restaurant use can.be helpful as well so that the product.doesn't end up paned while the FDA.officer determines whether or not it.really does qualify for that particular.exemption if you have the information on.it and there's any chance a consumer.might actually receive the product in.that package it's just best to go ahead.and put a Nutrition Facts chart on it.even if technically speaking you're.exempted alright thanks very much Anna.the next question is keen to have an.understanding of how to apply these.requirements to gift boxes or hampers.that contain multiple products the.answer is if you are shipping gift.baskets to the United States.each of the manufacturers that produce.the individual products need to be.registered with FDA and you then if you.are handling the shipment into the US.you would need to file the prior notice.and submit all of the product.information so if you have ten products.you'll submit one prior notice but it'll.list all of the ten products in that.gift box coming into the US by FedEx or.UPS or however you may be shipping it.the next question is do we need to.declare the manufacturers name and.address on the label some customers.prefer to keep their suppliers names.private enough you could address that.for us certainly the requirements is.that the manufacturer distributor or.Packer appear on the label so companies.do have the freedom and flexibility to.pick one of those so it's very common.for say a private label distributor or.somebody who owns a brand but has.multiple contract manufacturers to only.indicate their company on the label and.that's perfectly fine as far as FDA goes.particularly for companies where they.want to use one label but have you know.five ten twenty different manufacturers.actually producing the product that's.perfectly acceptable all right very good.several more labeling questions here.when is it needed to insert the second.column and a Nutrition Facts and then.also a very general question when do.these changes come into effect that I.believe that was outlined in the.presentation but if you could just.address this two questions quickly Anna.okay so the requirement for the dual.column comes into play when you've got.200 to 300 percent of the rack value in.the container and that is with an eye.towards people who may consume the.entire package in one sitting.FDA would like the number of calories.and other non beneficial nutrients to be.very apparent so that the consumer can.be aware of what they're consuming all.right this this is kind of a carry on or.similar.or to that can you use dual column.labeling even if your product does not.exceed the 200 to 300 percent rack so.the dual column labeling is specific to.those products that fall within the 200.to 300 percent rack and so it must be.incorporated in that case there are some.other provisions within the regulations.for adding columns for things like 100.gram and 100 milliliter servings or.units so if you would like to follow up.with us online you use in our lives.chat and maybe describe your specific.situation we'd be more than happy to go.ahead and do that or you can email us at.info at registrar Corp comm perfect.thanks question from Bulgaria we would.like to export to the USA natural honey.are there exclusions from the general.import rules about half natural honey no.there are not honey is a food considered.a food so all of the requirements we.have discussed today would apply moving.on to the next question.if dried fruit is sweetened with apple.juice instead of sugar would that be.added or would that be added to the.added sugars Anna can you address that.sugar issue okay so in the final rule.fda goes into a lot of detail about what.they consider to be added sugars versus.sugars that are just naturally present a.lot of the rationale behind the -.depends on the nutritional content so.something like fruit or fruit juice.because there are beneficial vitamins.and nutrients in those FDA does not.consider them to be quote unquote added.sugars in most cases when you have a.fruit tooth concentrate that is being.used as a sweetener agent it may be.considered added sugar another.ingredient that's commonly used like.milk products things like way and.proteins those may be excluded from the.added sugars definition even though they.contain lactose because the idea of.really behind it is the addition of.sweeteners into our food and FDA wanting.American consumers to be cognizant of it.alright the next question.Bracey if you just want to address that.we have a question in Spanish is.addressed areas seem a comment are a CSA.seminar EO se puede scooch are a medium.español para el público de habla espan.bamos hacer UN webinar EO el más que.viene el Couture today my d'amato a.sobre el etiquette Apple Valley entonces.si MCCS - aqui Rivera C webinar yo gusta.que hacen las a in la misma presentation.but i Scribus say para para sa webinar.yo gratis okay thanks Gracie do you have.addresses of US agents for registration.FDA does not publish a list of US agents.a registrar Corp serves as a the u.s..agent we represent over 11,000 foreign.food facilities we provide a.professional US agent service so feel.free to reach out to us and we would be.happy to serve in that capacity for you.let's see moving on to the next question.[Music].a couple questions regarding sort of.products that are ingredients packaged.in bulk and you just want to address.that I know you kind of touched upon.that already the question is a new.regulation for labeling is only valid.for product which is ready to consume.but how about supporting material such.as sorbitol which is packed in a drum so.the products such as sorbitol which.would be sent most likely to a food.manufacturer to be incorporated into.another finished product well for other.raw materials that will be part of the.food processing process those are going.to be exempt from the.wireman of the nutrition facts panel.they are not finished foods they don't.have a serving size per se they're going.to be repacked or processed they do not.have to fulfill that requirement so that.answer you've just given Anna would.apply to this other question we just.received our food ingredients such as.flavor aromatic raw materials essential.oils subject to Nutrition Facts those.that would be incorporated and finished.product manufactured in the US so yes.that was the same answer there moving on.the question here is our nutrition.labeling is done by a third-party.laboratory does it have to meet any.specific conditions or regulations the.regulations would be which all of those.that we have just covered so if you're.having someone else handle your labeling.for you you would be prudent it would be.prudent of you to be sure that they.understand these new requirements and.are adjusting your labeling accordingly.moving on which allergens are required.to be declared on labeling and it could.you touch on allergens and how that.works and the categories that require a.declaration so there are eight major.food allergen categories that are part.of the Act that mandates allergen.labeling such as milk wheat eggs soy and.so forth it's important too that.companies are aware that allergens that.are not part of those eight major.categories should not be included in the.allergen statement that fulfills a.requirement so for example things like.celery and sesame we often see declared.as allergy pacifically as allergens but.then we've also seen FDA officers in.port have problems with sesame and.celery being declared as allergens.because technically speaking those.aren't major food allergens according to.da okay perfect thank you next question.we have we are a Portuguese producer.that exports to the US although we sell.directly to our distributors we have a.branch of the company registered in the.u.s. an office with no production this.means that we will need to comply with.the new labeling requirements is that.correct and the answer is yes you will.need to comply with those requirements.next question is relating to the Food.Safety Modernization Act as a Canadian.facility.I'm currently registered with FDA which.requirement do I have to meet may 2017.for fsvp or September 2017 for harp C.Bracy if you can answer that for us sure.so thank you for your question this is.actually very interesting Canada and New.Zealand are two countries that have.received recognition from the FDA that.their systems are equivalent you.actually are subject to the harp C.deadline of 20 September 2017 but due to.the the agreement that the C FIA and FDA.have you do not need to implement the.harp C food safety plan you need to.comply with whatever regulations are in.place from the CFIA your importer is.going to have to verify that you are.CFIA compliant because of that.equivalency recognition perfect and I.understand the FDA is working on.equivalency with some other countries as.you said Canada New Zealand already have.that and they're working with the EU and.sorry Austria Australia as well Thanks.okay this is a question relating to.added sugar I don't understand the.difference between added and natural.included sugar so Anna back to you.regarding a sugar question again how you.deal with it on labeling okay so yeah.the added sugar requirement has caused a.lot of consternation in the food.industry as to what.adding sugar is versus natural included.sugar FDA doesn't use the term natural.included sugar so I presume the question.means a sugar that is just sort of.inherent to the product something like a.fruit or a 100% unconcentrated fruit.juice would be considered a natural.sugar inherent to the product same goes.with milk ingredients such as whey and.milk proteins and things added sugars.really are sugars that are added for the.purposes of sweetening and because of.health concerns given the number of.added sugars in the typical American.diet this is why FDA has mandated the.Declaration of added sugars so for.example if you had a dried strawberry.the sugar that's inherent to the.strawberry would be considered as a.naturally occurring sugar and it would.not count towards the added sugar.declaration however if you coded that.strawberry in sucrose in table sugar the.table sugar would be included in the.added sugars declaration in the.nutrition facts chart ok thanks Anna.another question here in Spanish Gracie.so I'm going to translate this question.into English because it's probably one.most people have we have someone asking.is there a way to see if my supplier is.approved by the FDA and I'm assuming by.approved you mean that they have a good.compliance history with FDA you want to.see you know if they're registered if.they have any warning letters import.alerts anything like that we do offer a.system it's called the FDA compliance.monitor it allows you to receive updates.24/7 if there's any change in the status.and the compliance status of your.supplier so do feel free to give us a.call or to email us about that that is.called the FDA compliance monitor ok.thanks very much we have another food.safety related question we are a bulk.vitamin.in other words an ingredient.manufacturer do we need to implement the.food safety plan I learned from your.presentation that dietary supplements.are exempt from the food safety plan.requirement Bracy could you address that.please sure David it really depends on.what the final product is going to be.when the vitamins arrived to the United.States if you or your importer are.producing dietary supplements under 21.Code of Federal Regulations of 111 which.is the dietary supplements regulation.then no you do not need to implement the.Harpe seafood safety plan however if.those vitamins might be directed towards.food use and not dietary supplements.then yes you would be required to do the.Harpe seafood safety plan all right and.this is a follow up question or another.food safety question I can answer this.quickly how do you prove you have a food.safety plan the answer is.you'll be requested to provide it to.your importer your importer will ask you.for your food safety plan but more.importantly if FDA inspects your.facility they will ask for your food.safety plan they will ask to review your.food safety plan you are not required to.submit your food safety plan to FDA by a.deadline it's not as though you send it.to them and they keep it on file or.review it but it would occur during an.inspection or occur during your normal.course of business where your importer.here in the US may ask for that moving.on we have a question related to the.standard nutrition facts table format.and the size is because the point size.and FDA website are large for our label.area and maybe you can adjust touch on.font size and how do you fit things and.quickly take us through that okay so the.standard format which is the one most.people are familiar with is sort of your.baseline format however.if you have a package that is less than.40 square inches you are permitted to.use what is called the tabular format.which has some smaller type sizes than.the standard format does if you cannot.fit a tabular format you may qualify to.use the linear format which is even.smaller it's important for companies to.be sure that they qualify for the chart.format that they ultimately put on the.package companies also need to be aware.that that 40 square inches that I.mentioned is actually based on the.amount of labeling space available so if.you have a large package but choose to.put a very small label on it FDA will.not consider that to be appropriate FDA.is not really concerned with the size of.the label that you want to put on that.package their regulations regarding the.smaller package label formats are.predicated on the actual size of the.container and the amount of labeling.space on the container itself so if you.have to use a standard Nutrition Facts.chart you cannot shrink the type sizes.in any of that those are written into.regulation at that size sounds a little.compliment complicated keep in mind we.do have a service to help with reviewing.your labeling so feel free to reach out.to us and we can provide you with a.quotation for that service.the next question is there's someone in.South Africa that can help us with a.food safety plan and a food defense plan.the answer is we have a food safety team.we do it remotely from here we can help.you develop or review a an existing food.safety plan and also help you develop a.food defense plan so that is something.we can do for you.from our headquarters here in the United.States the next question is FISMA.related could you elaborate on the.qualified facility attestation Bracy.sure David the qualified facility at.test station is the form that companies.that are doing less than a million.dollars in goo.we'll sales and inventory annually we'll.need to submit to FDA for human food.facilities and 2018 I'm in late 2018 and.then for animal food facilities in late.2019 I'm in the form that would attest.to your financial status that you are.doing less than a million dollars and.would just need to be submitted to FDA.next year all right.Bracey this is a follow on a follow on a.FISMA question do I need to pass a PT Qi.course to be FISMA compliant maybe you.can talk about that class that.certification and and what can replace.that if you don't take that course sure.so this is a question that we are.receiving a lot do you need to go to a.preventive controls qualified individual.course to be FISMA compliant the answer.is no the FDA defines a preventive.controls qualified individual either as.someone who is qualified to handle food.safety and goes to the PC Qi course or.someone with the knowledge and.experience necessary to be able to.develop a food safety system based on.preventive controls that means you do.not need to attend that course it is not.mandatory if you're receiving emails.from institutions in your home country.saying that you need a PC Qi course.certificate to be able to export to the.United States that is untrue you just.need someone who is able to read and.understand the requirements in the.preventive controls rule and be able to.develop the food safety plan from that.all of our food safety specialists for.instance RPC Qi certified so for example.if you have a plant manager who's been.in your factory for 20 years perhaps.doesn't have a advanced degree in food.safety or food science but has been.involved for years in the production.they could be considered to be a.qualified individual that's exactly.right.okay thanks Gracie next question is I.sell bulk frozen snow crab in a 30 pound.box do I need a label now the only.ingredients are salt and snow.have Anna that kind of goes back to that.question about packaging and bulk not.for retail okay yes and there's actually.a follow-up from the same attendee this.is normally repackaged in a smaller case.to be sold to the consumer so long story.short the 30 pound box does not need to.have the nutrition facts panel on it.since it will be repackaged into a.smaller case the smaller case that sold.to the consumer however must have the.nutrition facts panel on it all right.thanks very much next question is FISMA.related is hasip our half of documents.are they enough to comply with the FISMA.requirements brace do you want to spend.a moment on that to differentiate sure.David so as I mentioned before has this.new harp sea hazard analysis and.risk-based preventive controls har PC is.different it is a new standard you may.be able to rely on your existing.documentation and processes we're seeing.that clients might have anywhere from 30.to 60% of their food safety system.remain mostly the same but there are new.elements you'll be required to.incorporate so the answer to your.question is yes and no it will be.sufficient for a bit but you will need.to do additional work to make sure that.you can migrate your existing hasit plan.to harp C all right a question from the.UK I produce a product made by a.manufacturer but I add a carton to help.sell the item who becomes a registered.supplier and who needs to register with.FDA my company or the manufacturer the.answer to that question really certainly.the manufacturer they're producing the.product and and secondly if you it.depends on how you re packing it if.you're simply you know putting it in a.master carton if you're not doing other.activities you may be exempt but it.would likely be prudent for you to be.registered as well because you likely.have a warehouse where you're storing.the product in order to be able to.repack it in which case that.location would also need to be.registered.let's see moving on let's see we've got.quite a few questions still I work for.an organic chocolate company with with.less than 50 employees do we need FISMA.or do we need to comply with FISMA or.what do we need to do to comply with.FISMA gracie 50 employees is the size.and again their actual manufacturers so.this would depend on your global sales.and inventory numbers per year if you.were doing more than 1 million dollars.in global sales that means to the u.s..in your own country and any other.country in the world then yes you do.need to comply with FISMA you require a.harp see food safety plan and then.because you have less than 500 employees.you would have until September 18th of.this year to have that food safety plan.developed all right the next question is.what happens if we miss the facility.renewal deadline in December of 2016 and.we just submitted the request does the.FDA take a long time to approve it I'm.not sure what you mean by you submitted.the request if you've emailed FDA it.could be quite a while before you hear.from them the answer though to your.question ultimately is you need to.submit a new registration your old.number is gone if you did not renew in.time or your US agent did not accept the.designation as US agent so you simply.should go ahead and re-register feel.free to contact registrar Corp we can do.the registration for you we can serve as.the US agent and we can get that process.for you generally speaking within 24 to.48 hours.the next question is we are a spice.manufacturing facility in Canada next.or some spices to the US we have an FDA.number do we need to comply with the.food facility registration renewal the.answer is yes if you missed the December.31st deadline of renewing your.registration it has since been cancelled.and you will need to obtain a new 11.digit number and again registrar Corp.can help you do that quickly and serve.as your US agent the next question comes.from a gentleman we have not yet started.to sell our products in the USA do we.have to follow all these deadlines.beforehand they're Greek producer of.processed meat based products and the.question there would be if you are only.doing meat products you may actually.fall under the requirements of the US.Department of Agriculture and not FDA.again I would encourage you to email us.and tell us a little more about your.products the answer is if you are under.the jurisdiction of FDA then yes you.will need to register and follow all.these various requirements before you.actually start producing and exporting.to the US next question is how do you.determine the serving size is this is a.labeling question Anna would you please.answer that for us okay certainly so the.serving size is dependent on the.reference amount that FDA has.established for that particular type of.product so for example for candy it's 30.grams for certain beverages it's 240.milliliters for other types of beverages.it can be 360 milliliters that's the.baseline reference amount so then the.regulations that FDA has published for.serving size state you use that as your.reference point and then based on the.amount of product in your packaging it.will determine what your serving size.maybe there are other regulations if you.have something like Pete.or something where you're going to.divide it into fractional slices FDA has.ways to determine the serving size for.products like that same goes with non.discrete bulk products like cereal and.flour and things like that so you.there's no easy quick answer because it.varies widely depending on the type of.product but the constant is that rack.value that reference amount that FDA has.established for that particular like.type of product and you around the.number up or around or down.it depends yeah it can also depend.whether you've got a product in discrete.units like muffins or if it's non.discreet like cereal or if you know it's.varied like fish fillets where the size.can vary there are a lot of different.regulations in our code that basically.walk you through the process of.determining how you're going to be.declaring the serving size of your.particular type of product all right.thanks Anna and the next question.question regarding our fees for.compliance services all of our pricing.is available on our website it's all at.a fixed cost we do not charge hourly.fees but feel free to email us info at.registrar Corp comm if you have a.specific service and a price quotation.you would like to receive the next.question again is labeling our popsicles.are handcrafted is it accepted to use.about or around X grams so the.regulations don't specifically permit.using about or around when you're.talking about the weight of a product.however depending on the type of product.if it's in a unit like this you may be.able to simply declare it as one.popsicle to be frank I would have to go.look at the regulation to see if the.category for products like that permit.that it would be very much dependent on.what FDA says the proper declaration for.the serving size of a popsicle or an ice.pop might be all right thanks Anna.next question from Ynez we're online.registrations of.when he's accepted done in December of.2016 I think the question there is if a.company registered in December of 2016.where those registrations accepted only.if you're u.s. agent affirmatively.agreed to serve in that capacity would.your registration be valid I would.recommend you go to our website contact.us we can verify if indeed your.registration is valid we're going to.take just one or two more questions.we've gone quite a bit over I appreciate.those of you have stayed on but I'll.just go ahead and answer one or two more.questions here when is the new labeling.requirement coming to into effect I will.have I have products that will be on the.USA shelves in July I assume they mean.of July 2017 sorry they mean 2018 so.enough you can just reiterate that again.certainly the compliance dates for the.new Nutrition Facts label.in to effect in July of 2018 for.manufacturers that have more than 10.million dollars in sales and then 2019.july 2019 for manufacturers that have.less than 10 million dollars and so the.what that means is that you cannot.introduce into u.s. commerce a product.that does not have a nutrition facts.panel the new one on or after that date.all right a question from Lois companies.factories facilities have to register.with FDA what about their products could.they have a registration as well and the.answer is individual products are not.registered during the registration.process of the facility you submit.categories you indicate what categories.of products you produce at that.particular facility next question is how.does the US FDA verify claims on the.label such as new and improved best.tasting quality assured.etc question for you Anna that the.interesting question and and and I'll.let you talk about that for a moment yes.so statements such as those aren't.really written into regulation FDA.requires that labeling be truthful and.not misleading but they do not have.specific regulations dealing with those.types of what we call romance copy.statements FDA does have regulations.dealing with things like high in fiber.low fat healthy other types of claims.that deal with the actual nutrient.nutrient content of a product or claims.that are made about the products such as.how it may affect the body and be.healthy and so forth.alright thanks Anna I work for a.chocolate company in Ecuador with less.than 50 employees in less than 1 million.dollars in sales do we require are we.required to have a food safety plan.thanks David for that question um and.thank you who Leone for coming back with.some clarification no you do not require.the food safety plan because you are.doing less than 1 million dollars per.year in sales in inventory you would be.required to submit the qualified.facility at test station in late 2018.alright thanks very much if our facility.is USDA regulated is this an advantage.when it comes to FDA registration well.in essence if you are only solely.regulated by USDA meaning you're.producing a meat or poultry then you are.not required to meet any of the FDA.requirements that I outlined USDA has.their own requirements regarding.labeling regarding your name being on a.USDA approved list of foreign.establishments so I suppose that might.be considered an advantage let's see the.next question is if we want to export to.the u.s. ice fruit sorbets with no dairy.content do we need registration in the.FISMA to clarify you would need to.register.your facility with FDA because you're.producing a product with regards to.FISMA that would depend on the size of.your facility your annual sales and.inventory so again if you give us more.specifics by email we will be happy to.come back and answer them I think we'll.go ahead and take one last question and.end on this one.do you offer nutritional facts service a.service to review the nutrition facts.the answer is yes we do have a service.to review labeling we will give you back.a report and we will give you a print.ready graphic file that indicates what.your label should look like in order to.meet FDA regulation so it's a it's an.excellent service and feel free again to.contact us to receive more information.on that.I'd like to repeat that a copy of this.presentation will be sent to all of the.registrants today a recorded copy so.you'll get to hear some of the answers.if we did not get to answer your.question please feel free to email us.info at registrar Corp comm and we will.do our best to reply with an answer to.your question this concludes our webinar.on how to export food to the USA and.comply with US FDA regulations thank you.for joining us today.goodbye.

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Registered Buyer Permit 2016 2018 Form FAQs

Some of the confused FAQs related to the Registered Buyer Permit 2016 2018 Form are:

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How can I fill out the FY 2015-16 and 2016-17 ITR forms after the 31st of March 2018?

Now you can not file your income tax returns for the financial years 2015-!6& 2016–17. Now you wait for the notices under section 142 or 148 from the income tax department, in compliance which you may filed the returns. If no notice sent by the department you forgate the filing the returns.

How do I fill out 2016 ITR form?

First of all you must know about all of your sources of income. In Indian Income Tax Act there are multiple forms for different types of sources of Income. If you have only salary & other source of income you can fill ITR-1 by registering your PAN on e-Filing Home Page, Income Tax Department, Government of India after registration you have to login & select option fill ITR online in this case you have to select ITR-1 for salary, house property & other source income. if you have income from business & profession and not maintaining books & also not mandatory to prepare books & total turnover in business less than 1 Crores & want to show profit more than 8% & if you are a professional and not required to make books want to show profit more than 50% of receipts than you can use online quick e-filling form ITR-4S i.s. for presumptive business income. for other source of income there are several forms according to source of income download Excel utility or JAVA utility form e-Filing Home Page, Income Tax Department, Government of India fill & upload after login to your account. Prerequisite before E-filling. Last year return copy (if available) Bank Account number with IFSC Code. Form 16/16A (if Available) Saving Details / Deduction Slips LIC,PPF, etc. Interest Statement from Banks or Others Profit & Loss Account, Balance Sheet, Tax Audit Report only if filling ITR-4, ITR-5, ITR-6, ITR-7. hope this will help you in case any query please let me know.

As a future potential buyer, how do I sign up for Alibaba.com without a registered company name? Should I just fill out the form with a fantasy name?

No you should not: Alibaba.com Rules Center 3. MEMBER RESPONSIBILITIES 3.1 Each Member hereby represents, warrants and agrees to (a) provide true, accurate, current and complete information about itself and its business references as may be required by Find quality Manufacturers, Suppliers, Exporters, Importers, Buyers, Wholesalers, Products and Trade Leads from our award-winning International Trade Site. Import & Export on alibaba.com and (b) maintain and promptly amend all information to keep it true, accurate, current and complete. Each Member hereby grants an irrevocable, perpetual, worldwide and royalty-free, sub-licensable (through multiple tiers) license to Find quality Manufacturers, Suppliers, Exporters, Importers, Buyers, Wholesalers, Products and Trade Leads from our award-winning International Trade Site. Import & Export on alibaba.com to display and use all information provided by such Member in accordance with the purposes set forth in this Agreement and to exercise the copyright, publicity, and database rights you have in such material or information, in any media now known or not currently known.

How do I fill out form 26QB for TDS in case of more than one buyer and seller?

Hi, Please select Yes in the column of Whether more than one Buyer/seller as applicable, and enter the Primary Member details in the Address of Transferee/Transferor & no need of secondary person details. The reason to include this is to know whether the agreement includes more than one buyer/seller, so the option is enabled. Hope it is useful.

How do you find the wholesale price?

If by “find the wholesale price of used cars” you mean all costs at the wholesale level, or the cost of one particular used car, the answer is you really can’t most of the time and it is irrelevant to what it is selling for all of the time. Auctions of cars are usually private services that only publish sales results privately or to a private clearing house like NADA or Kelly which uses the information to analyze what values have been paid at the wholesale level and what that projects to at the retail level. A subscription to a service that publishes used car auction,” results is helpful, if y Continue Reading

Can I buy wholesale without a business?

If a wholesaler is willing to sell to the public, you certainly can. The first time I bought from a wholesaler you had to have a special card (usually because of where you worked). My sister was one such person and she allowed me to use her card. I remember saving about 33% on my purchases. That’s 50 years ago. I still have most of the things I bought.

Are temporary tags waterproof?

Can temporary tags be extended? A single temporary tag expires on the exact date that it says it will expire. You might need a second temporary tag because your permanent one has not arrived, but the original one won’t get extended.

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