No. NIZONA has an extensive network of Japan Government licensed sub-contract manufacturers.
We select the most suitable sub-contract manufacturer depending on our customers’ needs, size and particular situation.
Generally, NIZONA provides the basic text for the label/box as per the knowledge that we've gained with experience. In addition, we offer image design services as extra service for our customers.
In any case, if NIZONA makes label designs/language, the customer has to approve them before the labels or packages are printed.
As OEM contract manufacturer, NIZONA encourages its customers to carefully evaluate their local labeling/product claims regulations and notes that ultimately, it is the customer’s responsibility to carefully prepare all import procedures, customs, labeling and distribution regulations in his own country.
First, NIZONA needs to know your needs. We break down your needs in basics such as: Use, presentation, brand, esthetics, components, target consumer audience, marketing concept, etc. (please see OEM Matrix in last page) all within the context of a mutually agreed “price band” and MOQ.
We then consult you regarding technical feasibility of the product concept and submit samples for your approval.
After the “product development” contents and objectives are set, we will work exclusively within the agreed parameters in order to assure effective use of the customers’ time and resources while maintaining customers duly informed of the product development process, if applicable.
This is addressed via the method outlined above. NIZONA always submits the prospective list of ingredients to clients in advance.
The clients are very well aware and particular about any problematic ingredients in the beginning. We always look to avoid these ingredients from the beginning while keeping you informed at all times.
Over time, NIZONA has come to understand which ingredients are difficult due to both regulation and Religion but ultimately, it is the customers who give the final approval to our formulations prior to placing their orders.
Yes. We understand and support our customers being reasonable during the initial orders. The extent of flexibility will depend however on the specifics of the product and the required packaging.
No. NIZONA doesn't keep your private brand finished product in inventory. At the level of our subcontractors however, we sometimes maintain an inventory of components, including labels, bottles, boxes, ingredients, etc. for two reasons:
a. Because sometimes the minimum purchase of certain materials is higher than the size of your order (e.g. the minimum purchase of private branded metal cans to pack your product may be 10,000 units; however, your order is of only 7,000 finished products. Therefore, in order to meet the MOQ of the metal manufacturer, we must purchase 10,000 units, out of which, 3,000 will remain in our warehouse till your next order)
b. Upon your request to reduce supply lead-time of future orders. Please note that inventory of materials such as recipients, aluminum foil (to pack powders in sticks/sachets with your private brand) etc. is your property and cannot be kept in our warehouse indefinitively.
The usual limit is 3-6 months.
We have already an extensive network of subcontractors in Japan.
This allows us to respond to each customer’s needs exactly depending on their situation, size, market and import regulatory needs of their country.
In summary, upon understanding your needs, we can determine which manufacturing line is more suitable for you. Rest assured, GMP/ISO certified factories are common in Japan and the Japan Ministry of Health is one of the strictest controllers of safety and hygiene of healthcare products in the world.
They are our direct manufacturing partners in Japan. We do not see the members of our manufacturing network as simple “subcontractors” we use and discard.
Our relationship with them is transparent and personal as well because without a real “team effort” from all the stakeholders (suppliers, laboratory, logistics, regulatory, commercial, design artwork, packaging, etc.), the OEM manufacturing cycle cannot be complete in the way we want it: Without loose ends and without any quality or regulatory point of concern.
So, our relationship with them is transparent and we work in tandem with dozens of Japanese factories. Therefore, we are not a simple exporting company! As per the contractual relationship, NIZONA has a direct relationship with each manufacturer and sells the product to you as end user.
The customer is NIZONA’s buyer. Hence, the contractual relationship of seller and buyer is between the customer and NIZONA. Subcontractor in Japan is a factory engaged by NIZONA for the manufacture of the product for you, our customer.
There is no direct contractual relationship between you and the Japanese subcontractor.
Please understand that we do not supply products that we simply take out of a shelf in a warehouse, but we develop and manufacture a product exclusively for you as an OEM subcontractor.
Therefore, our products are made practically ‘from zero’ and based on each specification point agreed with you from formulation to packaging and logistics.
As a result, the finished product is the result of a complex chain of supply and factory labor that needs to be carefully calculated each time before giving a quotation to you.
Example: Your formulation includes ingredients supplied by various ingredient manufacturers, who have their own MOQs, pricing policies, etc.
The same applies for packaging materials. Finally, labor and machinery cost in the factory is a separate chapter in a product cost that greatly varies depending on the size of your order and the adjustments you may request in the final product.
For all these reasons, we request your patience and understanding in the fact that our quotations are never a random number, but the result of careful calculations, which is in itself a significant amount of work.
The Japanese healthcare segment is clearly divided between the large manufacturers and the small/mid-size manufacturers:
a) Large manufacturers are few and usually have their own brands and run their own operations and distributions worldwide and/or in partnership with other major companies. Their international distribution channels are strictly controlled and set.
For this reason, these companies are as a principle difficult to reach and would usually not entertain “middle sector” business proposals from outside of Japan.
b) Small/Mid-sized manufacturers are hundreds and in many cases they work as sub-contractors of large manufacturers’ brand products.
They have excellent manufacturing expertise. However, due to tradition or limited capacity/intention, their business model is in most cases focused exclusively on manufacturing and not in sales/marketing and/or foreign markets.
These companies rely heavily on traditions, established practices and relationships and for these and the above reasons, in most cases their business is limited to selling within Japan and hence, difficult to reach and manage from outside of Japan.
NIZONA sells high quality of Japanese products while taking care of all the challenges described above: We create, develop and sell Japanese products to the world by filling the gap and adding value in the supply chain: We solve the language and communication gap.
We solve the regulatory and document drafting gap. We solve the product design concept gap (because we are able to understand foreign customers’ needs).
We consult in marketing aspects of the product. We provide technical support. Finally, in cases where a customer requires the development of several products, he does not need to deal with the administration of handling several factories, which have different requirements simultaneously.
For this and many other reasons, NIZONA is not a simple trading company, but a true professional in the industry who provides cost-sensitive added value to our customers.
As mentioned before, we specialize in OEM manufacturing.
Therefore, most of the products we supply are “order made” exclusively designed for each of our customers. For this reason, the brands, image, etc. are by default the exclusive property of each customer within the limits of the applicable laws.
As per the product itself, exclusivity will always depend on mutual agreement regarding the following key elements:
Product/s: Well defined and with a finalized, confirmed formulation and specification.
Territory: A specific country or region where you want the exclusivity.
Term: A specific amount of time during which exclusivity is granted.
Purchase Targets: A specific amount of purchases during a given period of time must be decided to keep the exclusivity.
Finally, note that the above applies for products which are not especially subject to formal patents. For cases where ingredients or the final formulation may be subject to patent/s and/or any other specific intellectual property right in a given territory/country, special considerations must be made.
“Flavoring” is a term used for general labeling text purposes and in initial discussions.
Because we handle somany products in so many different forms, using so many different formulations, it is difficult to give one single answer without knowing the specific product in question.
However, in general we may say that when it comes to drinks, fruit extracts in addition to natural sweeteners or pure honey may be used to determine thedesired taste.
The fine details of the components at a technical level however can only be disclosed once discussions are concrete and a base formulation has been agreed upon.
Moreover, please note that in general, the specifications cannot be fully confirmed until laboratory trials are completebecause the flavors and other excipients will largely depend on the specific formulation in question.
Finally, please understand that achieving an enjoyable flavor while not adding calories AND masking the traces of ingredients such as collagen etc. is a very complex technical process that requires extensive know-how. Labs are protective of such trade secrets at initial stages.
Additives are used in foods since ancient times to conserve foods and/or enhancing its durability or flavor (example: vinegar to conserve vegetables, salt to conserve meat, spices to add flavor, etc.). Hence, additives does NOT equal “artificial”
We cherish the natural and high quality of our products. Our products are majorly made in ancient locations within Japan with a long tradition of herbal medicine stemming from hundreds of years.
Additives in the 21st Century: In current days, additives are used to assure the stability, safety and in other cases, the flavor, color, taste and consistency of a product. Additives can be either natural or artificial but in any event, all additives used are in line with Japanese and international standards and we shall never use any additive that may pose a risk to human health, as safety is and will always be our priority number one.
So, it goes without saying that every ingredient used is admitted under Japanese food safety standards which are in line with European and North American standards and the Codex Alimentarius (set by the World Health Organization and the Food and Agriculture Organization of the United Nations)
Example, if you wish your product to enjoy a longer expiration date, we will use conservatives (usually, the standard conservative is sodium benzoate and/or butyl paraben). In cases where you wish certain taste in a soft drink or a jelly, we will use honey some low calorie sweetener to meet your demand; etc.
Making a product with an enjoyable taste while meeting requirements of healthy ingredients, low calories, reasonable cost, etc. is a technically difficult task.
There are many methods to achieve the product taste that are internal know how of our laboratories. However, we can say that depending on the product (whether it is a powder, liquid, jelly, etc.) we recur to fruits extracts and juices, honeys and sweeteners.
When it comes to sugar, the USA, European and Japanese industry generally utilize High Fructose Corn Syrup15 (AKA: “Glucose Fructose Syrup"). As its name indicates, it derives from corn and it contains less than 50% glucose.
In cases where customers wish to label their products as “sugar free” we may utilize sucralose as a sugar replacement. In either case, the amount of calories per unit is usually rather low (e.g. a bottle of collagen drink can have anywhere from 40 to 75 kilocalories per bottle).
Yes, each product is tested in accredited in-house or third-party laboratories and the respective certificate of analysis is issued in consequence.
Health supplements or food supplements have different rules regarding expiration date as compared with cosmetics or drugs.
Drugs have very strict expiration dates based on complex tests which are performed before the product is released in the market and these need to be approved by the Japanese Ministry of Health.
Cosmetics, on the other hand sometimes have no expiration date, but a “recommended term of use”, or a “best before” date (usually in year/month rather than an exact date).The majority of our products are food supplements.
The usual expiration date of these is three years but there is no specific limit or rule established by the Japanese Ministry of Health regarding the expiration date of products.
For this reason, expiration date is usually established by the product manufacturer based on technical expertise, experience always based on the Food Sanitary Law regulations of Japan.
Food supplements therefore have a “Best –if consumed- Before” date rather than an established strict deadline for consumption as in the case of prescription drugs. “Best Before” date is determined based on two points:
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b. Physical properties: Meaning taste, consistency, flavor, appearance such as color, etc.
Physical properties may change as months pass on by. Whether these changes make a product “acceptable or unacceptable” is largely based on the judgment of the manufacturer and the brand owner (example: A person may judge that a slight discoloration in a tablet or powder is acceptable after 3 years.
However, another person may judge that discoloration of the pigment is unacceptable and hence, the “best before” date should be established prior even if in both cases, safety-wise the product is still safe in principle).
When a product is launched for the first time, there is no opportunity to determine what will be the effect of the time in the physical properties of the product unless an acceleration test is done.
However, even when a product sample underwent an acceleration test, the “judgment” regarding the physical properties of the sample is always based on the experience and opinion of quality assurance.
Quality assurance will judge: “Did the color change? And if it did, do I think the product still should be in the shelf?”, “Did the consistency of the product worsen?” “Did the product loose its flavor?” At all times, of course the assumption is that the product is bacteria-wise safe.
Having said the above, the simple general rule is:
Food supplements in liquid form such as wellness drinks, etc.
18 months from manufacturing date if no conservatives are used.
3 years from manufacturing when conservatives are used (usually, the standard conservative is sodium benzoate and/or butyl paraben) Food supplements in solid form such as tablets, pills, powders, etc.: 3 years from manufacturing.
The specific expiration date of a product may differ depending on the ingredients used and the final acidity (pH) level.
For expiration date of jelly sticks, please see relevant section.
We sometimes offer “bulk-shared” products. In Japan, smaller and mid-sized factories sometimes join in groups and manufacture product batches in order to penetrate different market levels and be able to supply to customers who cannot meet large industrial MOQs.
This is called “bulk-shared” manufacturing lots.
“Bulk-shared” products are therefore, a single manufacturing lot which is shared by several companies jointly. There are several products which are available as “bulk-shared”.
What are the benefits of “bulk-shared” products?
Bulk Shared products allow our customer to buy smaller amounts of product but still customize the packaging and labeling.
Example: A customer can purchase a small amount of say 20,000 capsules from a “bulk-shared” lot and even so, having his own label and packaging; while if the same customer was required to purchase a real, complete manufacturing lot, he would have to place an order of at least 100,000 capsules to meet the factory’s MOQ.
Buying from “bulk-shared” lots has advantages but at the same time, the disadvantages are that because such lots are not made by for a single factory, any product can be discontinued at any time by decision of the group. Even so, if a “bulk-shared” product has been discontinued, it still can be purchased as a “full OEM” product as long as the customer meets the MOQ requirements.
a. NB Products are those which already exist in the market under a given brand. These products are available “off the shelf” same as the purchase of any other product in the market. You can purchase these products in retail in a pharmacy, in a supermarket, or in large quantities from a distributor. You cannot change anything from this product, you must take this product as it is and in whatever language the label is written, etc.
b. Bulk Shared products are those explained in the previous FAQ.
We can say that Bulk Shared products are something in between NB Products and OEM products. In simple terms, Bulk Shared products are customizable but only in the labeling and packaging, not in the formulation.
c. OEM Products are those which we specialize in. These are products newly developed and fully custom-made for you. As these products are fresh, new batches, we take great care in making them especially to meet your market needs and are by nature, exclusive to you.
How about MOQs?
By definition, MOQs of NB products are small; you can even purchase one single unit in a pharmacy!
In case of Bulk Shared products, the MOQs are quite reasonable but you cannot change the formulation of the product.
Finally, in case of OEM products, you may do any change you wish and even make a new product from scratch, but you will have to meet certain specific factory MOQ, which is the largest of these three categories.
Even so, we at NIZONA are able to meet specific customers’ needs by only utilizing factories of the size and capability that will match the customer’s purchasing capacity.
NIZONA has technical capacity in regulatory and legal support for producing the documentation required for each specific case/country.
Upon understanding our customers’ needs, we will then select the sub-contract manufacturer which has the required licenses for the country in question in addition to producing all the documents required from NIZONA as an exporter.
However, we always note our customers that the ultimate responsibility for imports and local regulations in country of destination is theirs.
Please also understand that each country has its own style and format for documents and certifications and therefore Nizona cannot warrant that the exact document and/or certification you require will also be available in Japan.
Steps for Document Processing
a. Please provide us with a list of all the documents you will need.
b. Please inform us about which certifications you wish you in your documents.
Nizona will provide you with a “Request Sheet” which you will fill accurately with the above information. Documents processing will require a payment of a “Document Processing Fee” which may or may not be included in your “Development Fee” depending on the case.
As OEM manufacturers, we can certify that a specific product contains no trace of unwanted raw materials.
Moreover, raw materials from river, lake and ocean sources/animals in addition to non-animal sources such as plants, fruits, flowers, wood roots, etc. do NOT require halal certification16. As a general industry note though, Japanese SMEs factories are still not widely familiar with Halal certification.
In fact, there are very few Halal factories in Japan. Hence, although a few ingredients we use are Halal certified, at present, most of our products (as per ‘finished products’) do not have such certification.
Again, in case of need, our subcontractors and we can issue a certified letter assuring the non-existence of unwanted material/s in a specific product upon your request.
At all times, you will be transparently notified and made aware of the product details and ingredients with a complete specification. Regarding ethanol content, our products are all classified as “soft drinks” or “food supplements” under most regulations and therefore do not have alcohol.
However, whenever a product includes flavoring additives, sometimes during the manufacturing process of those additives, ethanol is utilized as a processing agent (the range of ethanol in those cases is 0.1% or less).
But please note that this is 0.1% of one minor ingredient of the product. Even though ethanol is utilized during the manufacturing process of some flavoring additives, the finished product does not contain ethanol.
In every case and whenever required, we can analyze a sample of the finished product and submit an ethanol report. At all times, we encourage you to check the specifications of our product and make a final decision with peace of mind.
Although a few of our products are alcoholic beverages (such as Japanese sake, or shochu, etc.), whenever we supply beverages to our customers, these products are totally classified as soft drinks under Japanese regulations.
Hence, these products can be sold freely in Japan even in supermarkets or convenience stores without any special license (in Japan, a license is required to deal with alcoholic beverages). Hence, as a general principle our products are not alcoholic beverages.
Having said this, in the soft drink industry it is common that some ingredients may contain extremely minuscule traces of alcohol that need to be used during their production for reasons of food safety or are natural result of the fermentation of sugars or fruits, etc.
Example, fruit flavor extracts used in some drink products may contain traces of alcohol because alcohol is used in their preparation17.
As a result, a soft drink product may still contain an extremely small amount of alcohol: A 50ml bottle of a collagen drink for example may contain 0.1% of alcohol, which less than the standard amount allowed in a soft drink: According to the US Electronic Code of Federal Regulations §7.71, paragraphs (e) and (f), (c) “The term “non-alcoholic” may be used on malt beverage products, provided the statement “contains less than 0.5 percent (or .5%) alcohol by volume” 18. Whereas in most of Europe, drinks containing up to 0.5% alcohol are classed simply as alcohol-free.
Did you know?
A normal glass of fresh orange juice can naturally contain up to 0.5% alcohol.
Malt vinegar is about 0.2% alcohol.However, in cases where Halal regulations or marketing requires less than such amount, we may be able to use flavorings which contain no alcohol traces.
Please consult us if that is a requirement of your product and we will evaluate the feasibility based on the particulars of your desired formulation (flavor will of course differ depending on the type of flavoring used).
Please note that depending on the specifics of your formulation (ingredients desired, flavor desired, etc.) we may NOT be able to produce a drink with less than 0.1% alcohol.
Not in principle. We are based in Japan and are exporters. We are not importers.
Hence, we understand and take care of all procedures related to Japan only.
However, of course we will always give you all required support (information, documents, etc.) for you to prepare and obtain all required import permits/licenses/quotas of your country19, as long as you advise us beforehand of the requirements applicable to your country.
In other words, ultimately, all import procedures in the country where the product is to be imported/sold must be taken care by you.
We will always provide the product specifications so that you, based on that information, can carefully check any possible import or distribution requirement of your country, which we strongly suggest to do in advance with the aid of professionals.
In Japanese law, products taken orally are largely classified into drugs and foods.
Our products are mainly under the “food” category. Therefore, “dietary supplements”, “supplements”, “nutraceuticals”, etc. are all consider legally as “foods” unless other classification applies.
For such reason, there is usually no special instruction as per the consumption of these products22 because the ingredients of our products are in many cases, essentially healthy ingredients that are present in general food but that we tend not to eat enough of due to busy or sedentary lifestyles.
In Japanese law, products taken orally are largely classified into drugs and foods. Dietary supplements including vitamins and foods for specified health use (FOSHUs) are regarded as foods and regulated by the Japan Food Sanitation Act and Health Promotion Act. However, these acts are not as stringent as the Pharmaceutical Affairs Act applied to drugs.
This means that dietary supplements have no stringent safety standards compared to drugs.
IN NIZONA’s CASE:
We plan, manufacture, sell and distribute food supplements. Although legally “foods” our products are made under pharmaceutical standards by pharmaceutical manufacturing lines which follow the standards of the Pharmaceutical Affairs Act.
Products made under food standards are made in factories approved by the Japanese government as per the Japanese Food Sanitary Act. The standards are very high but not as strict as in the case of manufacturing of drugs or medicines.
Hence, some flexibility is there and cost may be lower but note that some ingredients may not be able to be utilized in this kind of products because of technical limitations. These factories are issued certificates such as ISO, FSSC, JAS, etc. (GMP not available)
Products under the pharmaceutical category are made in factories approved by the Japanese government as per the Pharmaceutical Affairs Law.
The standards of hygiene and handling of all materials including packaging and inspections are very strict; and although the cost may be higher than in the case of “food standards” there is more technical capacity to mix a larger number of nutraceutical ingredients. These factories are issued Japanese Ministry of Health GMP certificates.
Our products are almost always “food products”; however, they can be either made under “food standards” or “pharmaceutical standards” depending on the selected subcontractor.
Please note that classification of products greatly varies between countries23 and we cannot represent the classification of any product in any country other than Japan because we are not the importers.
Having said that, of course we have experience in multiple countries and are ready to share that experience with you; however, that should not be taken as official customs/regulatory advice and you should always consult with a professional in advance to avoid import issues.
During development and/or in the proper time in advance, we will always provide the product specifications (mainly ingredients), for you to determine carefully the classification of this product in your county.
In case any sort of registration is required, you should let us know well in advance so that we can prepare and provide the information/documents which are applicable to us as exporters/manufacturers in as much as possible.
NIZONA is the exporter and seller of the products to customers. As such, NIZONA is able to produce all export-related documents. Regarding manufacturing, all our sub-contractors are GMP-ISO certified.
Example documents are below:
a) GMP Certificate24
b) ISO Certificate25
c) Certificate of registration
d) Health Certificate26
e) Free Sale Certificate
f) Certificate of Analysis27
g) Certificate of Origin
h) Product Declaration
i) Product Specifications
j) Product Formulation Sheet
k) Manufacturing flowchart certificate
l) Radiation Certificate
m) Veterinary Certificate (for animal products)28
n) Phytosanitary Certificate (for plant & vegetable products)29
o) Others upon request
Yes. We can provide attestation (seal and signature) of documents from the following:
a) From NIZONA as exporter
b) From the subcontractor (factory)
c) From Japanese notary
d) From Japan Ministry of Health
e) From Japan Ministry of Justice
f) From Japan Ministry of Foreign Affairs
g) From your country’s local Embassy/Consulate
Licenses or certifications can apply to two cases:
a. License regarding the product itself
b. License regarding the factory where the product is made.
In the great majority of cases, only the factory where the product is made is licensed and NOT the product or part of the product itself.
There are caseshowever, when individual products require licenses, but this happens only in cases of prescription drugs, not for general food supplements.
As a result, we can provide only certificates and licenses regarding our manufacturing lines, not regarding each individual product itself.
Having said the above, many of our products, although food supplements, they are made in pharmaceutical premises under the same standards of safety as prescription drugs.
In Japan, the “Organic Certification” is regulated by the Ministry of Agriculture, Fisheries and Forestry of Japan (MAFF). The applicable standards are officially called “Japanese Agricultural Standards” (JAS).
In general, the classification of “organic” is not applicable for most of our products, which are classified as pharmaceutical grade processed foods & drinks. Having said that, of course our products are made of natural ingredients; and in case additives are utilized, we shall only utilize additives that are permitted under Japanese and international standards.
There are cases however when a particular ingredient in our formulations can be classified as “organic”.
That is the case of green tea (or “matcha”), which bears the Japan Agricultural Standards (JAS) seal in each shipment.
In cases where we deliver green tea as such, we can provide a certification assuring the tea is organic. However, when such tea is used not as a finished product for consumption, but as an ingredient of another product, in that case, the finished product cannot be legally classified or labeled as “organic”.
Finally, other individual ingredients such as different types of vitamins, etc. are not included amongst the items that are able to be classified as organic (refer to MAFF’s list of organic items in website).
NIZONA deals primarily (though not exclusively) with products classified as food or dietary supplements under most countries. Of course, depending on the ingredients contained in the specific product, your country may consider some of them as medicines.
Unless strictly necessary, we always try to avoid such classification in order to avoid import customs and regulatory administration red-tape. In order to do so, we have the capacity to modify the products formulations to make them match your country’s regulations as food supplements.
As a consequence, the documents mentioned above are not regularly available because they are mostly related to medicines or are standards for factories which handle dangerous chemicals (such as the MSDS or material safety data sheet), which is not our case. However, in some exceptional cases if required, we can still provide some form of additional tests but that will bring an extra cost.
How about the Material Safety Data Sheet (MSDS)?
We have experience in a few cases where this document was requested. It is important to highlight that MSDS in most cases has been requested because the customs authorities simply did not understand and/or the product intended for import was not classifiable in the existing categories of the country in question.
In general, the MSDS is NOT available for finished and NB products. However, the MSDS may be available for some raw ingredients or materials, such as collagen peptide as a powder, or bulk. In the event required, we can supply general safety handling guidelines for specific products if the case allows.
Alternatively, the Free Sale Sanitary Certificate is always available and this document contains declarations regarding the safety of the product and its availability in the Japan market as a food supplement.
We can provide detailed certificate of analysis (CoA) regarding any of our products in basically the four below categories:
Almost the same process explained above for food supplements applies for cosmetics, in terms of the work flow. However, documentation is different mainly because cosmetics are not classified as foods under the law:
a. Cosmetic Products regularly do NOT have CoA:
Nutritional facts cannot be measured because the product is not for eating. Specifications including safety and microbial assessments can be provided along with a specification of the product, containing the product’s ingredients CAS number, etc.
b. Cosmetic Products by GMP factories:
Cosmetic Products are regularly NOT made by GMP factories. In Japan, GMP applies only for the manufacturing of medicines, not cosmetics. There are of course cases where a pharmaceutical company also makes cosmetics.
In such case, the factory has GMP certificate though even in that case the cosmetic product itself has a very different manufacturing process than that of a medicine.
However, whenever a cosmetic product is made by a purely cosmetics company, the GMP certificate will not be available. Rather, we can submit a cosmetics manufacturing certificate.
When we fall sick, our body creates thousands of microbes. We have to take antibiotics to kill those thousands of microbes. Antibiotics tend to have side-effects on our kidneys and liver.
Capsules are made of gelatin (which is usually from non-vegetarian sources).
Falling sick can lead to surgeries in which sutures (catgut) need to be used.
These sutures are made from intestinal linings of sheep Collagen Protein works at the cell level and builds up your immunity.
Better immunity means lesser chance of sicknesses and diseases and hence lesser consumption of medicines and lesser surgeries. i.e. lesser harm to living organisms and animals.
Although collagen is classified as food supplement, it can be used by vegans and vegetarians as a safe medicine (protein) to increase their immunity levels and avoid sicknesses.
Collagen Protein is made of fish skin/scales and not whole fish. Apart from building immunity, it has great proven benefits for skin, hair, nails, eyes, bones and joints.
Please include Collagen Protein in your daily diet to live long and healthy.
It is a primary requirement that a local person/company is the importer of the product. This person/company is called the ‘responsible person’ (meaning the person/company who will import the product and make sure that the product meets the local regulations). We of course from Japan must ensure that the ‘responsible person’ has access to all documentation necessary to do the imports.
As for the documentation:
a. We must ensure and prove that our product does not contain any prohibited substance in your country. For that, we can submit the ‘Product Specification Sheet’. With such a document, we recommend you to contact a customs broker and ask her whether the product formulation is accepted in your country or if it needs any adjustment (example, eliminating any ingredient that is not accepted in your country of import)
b. Manufacturing standards: The product is made in a Japan Ministry of Health approved facility, which issues a license to that effect. We can submit a translation of the document and certify it if required.
c. Other documents regarding safety: Such as CoA, Ingredient List, Formulation, MSDS, etc. (certificate of analysis, material safety data sheet), are also available.
In summary, we can provide the above documents but we need to work closely with you/your customs broker to complete the required set of documents for smooth and successful imports.
a. Yeast Species: Our glutathione is derived from yeast extracts that occur naturally in Torula yeast. Please find in detail information here.
b. Media growth of hyaluronic acid (HA): HA is mainly produced via microbial fermentation where the following agents were utilized: Ethanol, Sodium hydroxide, Activated carbon, Diatomaceous earth, acetic acid and salt. This ingredient is officially recognized in the US FDA as “GRAS” (generally recognized as safe) Please note that too many details are not possible to provide because that may violate secret corporate information and trade and technology secrets.
We have sweetener (aspartame and L-phenylalanine compound)
If you wish we can add sucralose as a sweetener which is safe for the diabetic patients also.
We can also use Stevia as a sweetner.
We Please find below details of Sucralose
The sweetener Sucralose is many times sweeter than sugar but does not add any significant amount of calories
Sucralose can be safely consumed my diabetics and non-diabetics. It does not affect insulin levels.
Sucralose has been accepted as a safe ingredient by several national and international food safety regulatory bodies, including the FDA, The Joint FAO/WHO Expert Committee Report on Food Additives, the European Union's Scientific Committee on Food, Health Protection Branch of Health and Welfare Canada, and Food Standards Australia New Zealand.
Results from over a hundred animal and clinical studies in the FDA approval process unanimously indicated a lack of risk associated with sucralose consumption.
The bulk of sucralose ingested is not absorbed by the gastrointestinal (GI) tract and is directly excreted in the feces, while 11–27% of it is absorbed. The amount absorbed from the GI tract is largely removed from the blood stream by the kidneys and eliminated in the urine, with 20–30% of the absorbed sucralose being metabolized.