Botanical Green Preservatives Like , Campo Plantservatives™,
2 CFR, parts 710 and 720.FDA 2511. FDA 2512. 21 CFR, parts 710 and 720.FDA 2511. FDA 2512
Super-Critical CO2 extracted Simple Natural Gravity Flow Fractionation Botanical Extract (INCI) Lonicera Japonica (Honeysuckle) flower extract CAS223749-79-9, INCI I.D:9690 and Lonicera Caprifolium (Honeysuckle) Flower Extract CAS84603-62-3, INCI I.D:8845.
Compliant:
US FDA-HHS-EPA TSCA CAS8023-93-6 | DTXSID8093734.
US FEMA#4690. US. GRAS PUB#25.
Compliant:
P.R.O.CHINA COMPLIANT FOOD ADDITIVES GB9685. standard GB2760-2011
China: Standards for Uses of Food Additives (Part 1).
China: Standards for Uses of Food Additives (Part 2)
Compliant:
ISO 21149:2017. ISO 21149:2006, ISO 16128-01 & ISO 16128-02. ISO 17516:2014, ISO 11930:2019
Campo Plantservatives’ multi-functional efficacious activities of alternative preservation of various industries – (various Trade Name(s)) in poultry, animal breeding, slaughter housessanitization, botanical food supplements, gas-oil fracking recovery liquid, (Fracking Biological Microbes Infectious Dangers) in life sciences e blood & serum products, and in botanical warfare defenses, with broad p.H range 2.5 to 12 with broad spectrum disinfectant against gram negative and gram positive, fungal-fungi spores and anaerobic endospores-anaerobic exospores.
Endospores – Anaerobic spores- dormant invisible in cosmetic products as bio-burden do not affect the formulations’ nor disintegration nor spoil them, but carry the bio burden spores aspathogens that cause serious even deadly infections, when applied to human skin and human hair.
The Honeysuckle’s Aldose Sugar Group(s) functions saccharolysis e saccharolytic mimic as of the N4- Calcium DPA cross linkages pathways, of a tough outer layer of keratin, that is resistant to chemicals, staining and heat, that enable the spores to survive decades, centuries, even millennium,via desiccation and damage bursting of bacterial endospores, as well as mimics functionality characteristic as of Dipicolinic acid (pyridine-2,6-dicarboxylic acid-PDC- DPA), acts anti-functions as antigen breaching and as localized specific bio-thermite (bio-mimic Al+Iron Oxide).
But more exact localized specific bio-thermite Al+ iodine pentoxide reaction-of the PDC- DPA chemical compound’s role in the heat resistance of the decades or centuries old dormant endospores in hostile environment. Almost all of Botanical Raw-materials for Natural Cosmetics -Topicals carryInvisible Bio Burdens, that cannot be eliminated by INCI Annex Listed standard preservatives (Annex V) nor via autoclave that disintegration the Botanicals.
Campo’s pioneer botanical green preservatives were tested viable successfully with all ATCC listed entities over three decades, as potent botanical warfare defenses material-but a USDA ListedAlien Weeds. tech-
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WITHOUT PREJUDICE
The above mentioned product is manufactured with 100% Natural Vegetal Origin.Campo Plantservative WSr do not contain the EU ALLERGENS nor Other Allergens, as Listed and as Assayed – In Full ICCR Compliant to AND In Full Compliant to PRO CHINA CSAR of “No Toxic -Fatalities Causing Bio-Invisible Endo Spore(s) Microbials (NO)Presence Of In Cosmetics-Topical Brand(s) Imported From EC, USA & Japan and Marketed &Sold In China:-
ICCR4 – 2021 – microbiome and cosmetics – survey of products ingredients terminologies and regulatory approaches.pdf” at:
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:9538347e-942d-4c1c-a64d-9f9c11caf11f
“ICCR_the_importance_of_preservative_in_cosmetics_products_infographic.pdf” at: https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:58a23dea-c4e6-49f9-a796-84e144f52cda
“ICCR Working Group on Cosmetic Product Preservation.pdf” at:
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:1e56f714-17f9-46df-aa58-23ab5d8794be “2019-10_overview_of_key_scientific_elements_and_principles_-_preservatives.pdf” at: https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:9e11f032-b579-4571-a3ff-0c556c2074ae
Campo Reserve The Rights to bring such Fraudulent False Claims to the Notice of the relevant authorities,
in whichevercountries or multiple cross borders countries relevant authorities and to the Attention of The Consumer Safety ProtectionGreen Groups – on their Social Media Platforms.
“2020-12- updated annex of report international standards in cosmetics.pdf” at: https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:6724f4d6-bbc9-44fd-b39d-88e723a07474
The Genetic Analysis of Botanical DNA Core Standards of Each Plant species to guarantee the botanical authenticity, geographical origin,ensuring the traceability, safety, and quality of the natural botanical-Extracts BOTANICAL DNACORE STANDARD(S) OF EACH INCI DICTIONARY EDITION 18TH,
LISTED PLANTBOTANICAL(s) AND THE PROTOCOL(S) OF GENETIC ANALYSIS AVAILABLE
Guaranteeing the authenticity of plant raw materials for Botanical Natural Cosmetics, Botanical Foods, Botanical Bio-Pharmaceutical, Botanical Bio-Molecules, and Botanical Health-Foods through Plants Botanical DNA-COREanalysis. https://www.iccr-cosmetics.org/
Compliant US.FDA 21 CFR 11 Part (US FDA Revision March 2017) –Botanical Identities–(Natural Cosmetics)
The Manufacturer Ensure That The Final Users Compliance of The BotanicalMaterial(s) are certified Botanical
Material, Botanical zA Core and Allergens Assayed and The Additive/Addition Level(s) as Declared in the Mandatory Listing Finished Consumer Retail Shelf Products-ConsumerSafety-Accordance to(ICCR).
https://www.fda.gov/cosmetics/cosmetics-international-activities/international-cooperation-cosmetics-regulation-iccr
Campo Plantservative WSr
FDA 2511. FDA 2512
Campo Plantservative WSr – JAPAN-USE IN USA e CANADA
All of PDF file attachments – are loaded in CAMPO Adobe Cloud Link
You Can Click (or Copy and Paste the Link on your Browser) and Download AND Save the PDF Files for your Review.
Quality Culture: Eliminating Microbes in the Cosmetic Manufacturing Gemba* (Part I). CLICK URL
Quality Culture: Eliminating Microbes in the Cosmetic Manufacturing Gemba* (Part I) (cosmeticsandtoiletries.com)
Quality Culture: Eliminating Microbes in the Cosmetic Manufacturing Raw Materials* (Part II). CLICK URL https://cosmeticsandtoiletries.texterity.com/cosmeticsandtoiletries/may_2021/MobilePagedReplica.action?ajs_uid=7354E5900023D1Q&oly_enc_id=735 4E5900023D1Q&utm_source=newsletter-html&utm_medium=email&utm_campaign=CT+E-Newsletter+05-06-2021&absrc=img&pm=2&folio=42#pg57
Quality Culture: Eliminating Microbes in the Cosmetic Manufacturing Bulk Production (Part III). CLICK URL
https://cosmeticsandtoiletries.texterity.com/cosmeticsandtoiletries/june_2021/MobilePagedArticle.action?articleId=1696447&app=false#articleId1696447
JAPAN USA T e c h n i c a l C a t a l o g Campo Plantservative WSr Product No# 95-180-3004 PLANTWSr,p
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:6cdd0890-dd09-4aba-a337-8805b34dd196
“TDS UN GHS SDS Campo Plantservative WSr -P# 95-180-3004 PLANTWSr,p 2021.pdf” at:
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:2990ab88-c0f3-4de9-aa4c-427846bef289
JAPAN USA 2021-Vegetal Origin -ISO GIGRA NO ALLERGENS – Campo Plantservative WSrp”
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:6f193c5a-f8f1-465d-808b-2439a6b16d5b
“Reprint.PLANTSERVATIVE.Pg107-123 Jn Cos Science March-April 2010.pdf”
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:ed5d66c5-32fa-4474-9861-534917151cd8
Personal Care Article Honeysuckle – Barbara Olioso PersonalCare.pdf”
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:c8ea03e5-add4-412f-a0ab-2ca7c07f133d
“report result – ref 14 a 052017 Moisturization of stratum corneum assay.pdf”
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:c8334ecf-2c43-4994-a0b8-2201e3cad0c3
“report results- ref 14 b 092017 mositurization of stratum corneum.pdf”
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:472830d2-14f0-4426-8a55-b2bfb774b69c
“Material Safety and Consumer Product Safety Testing – Campo Plantservative WSr.p (Faxed Scan).pdf”
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:56694b47-28a8-4182-9ab7-193ff539d78c
“INSTRUMENTAL EVALUATION OF SKIN HYDRATION AND SKIN DEEP WSr hydrating Gel.pdf”
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:803b19b5-211c-40aa-89e8-155f30273542
Vitroscreen INVITRO CLINICAL Study Report RS 22-07
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:7891cb3e-cfe7-4e67-81da-d950ac13de18
Vitroscreen INVITRO CLINICAL Study Reports RS 4-06 (1-2-3)
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:7891cb3e-cfe7-4e67-81da-d950ac13de18
KRR STANDARD-allergenschecklist 2021.pdf” at:
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If you do not have An ADOBE PDF Reader – CLICK HERE TO DOWNLOAD THE PROGRAM
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FEATURED PRODUCT
Versatile, Nature-derived Preservation
March 29, 2021 Campo Research USA Inc.
The recipe for successful preservation calls for two main ingredients working synergistically together:GMP and a versatile, effective and easy-to-use preservative system. Campo Research has been supplying Plantservative WSr (INCI: Lonicera Japonica Flower Extract (and) Lonicera Caprifolium Flower Extract) for more than 30 years to small and large manufacturers who have utilizedits versatility, broad antimicrobial performance and green chemistry profile.
Completely absent of EC allergens, Plantservative WSr is upcycled from wildly cropped honeysuckleplants that are classified as weeds. It is also GRAS (GRN No. 13), has a Natural Origin Index of 1 according to ISO 16128 and is COSMOS- and NATRUE-compliant, supporting “100% naturally derived”claims while effectively preserving natural formulas.
Plantservative WSr is nonionic and thus compatible with cationic and anionic ingredients. It does not impact the sensorial properties of cosmetic formulations, i.e., color and odor, and it imparts antimicrobial protection in a broad pH range (2.5-12), providing reliable protection in several cosmeticapplications—including mineral-based products such as sunscreens, clay masks, etc., where the pH drifts to 7 and above.
Plantservative WSr is also temperature-resistant up to 95°C (208°F), making its addition during different stages of production possible, such as the cooling stage or at the beginning before heat isapplied. Heat does not impact its concentration as the ingredient is not volatile. Given its alkaline nature, it is best to pre-neutralize Plantservative WSr with lactic acid before adding it to the main production vessel.
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The first installment of the peer-reviewed article by Kao appears in the April edition of C&T (pp 42-49) along with Campo Research Sponsorship.
QUALITY CULTURE – GREEN PRESERVATION PART 1 C&T
QUALITY CULTURE – GREEN PRESERVATION PART 2 C&T
Botanical Oil-soluble Preservation
Campo Plantservatives WMr (JOJOBA OIL) – CAMPO-A.I CLOUD 1.5-dated 23 Jan 2021.pdf” https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:b69211cd-8c5e-419c-ac0f-18ab15e85d20
Campo Plantservative WMr (JOJOBA OIL) – TDS SDS 2021.pdf”
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:9d36216f-24c5-4c8f-9e7f-1bf0a4599126
Vitroscreen Study Report RS 22-07
https://documentcloud.adobe.com/link/track?uri=urn:aaid:scds:US:7891cb3e-cfe7-4e67-81da-d950ac13de18
Vitroscreen Study Reports RS 4-06 (1-2-3)
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GREEN CHEMISTRY NATURAL OIL SOLUBLE PRESERVATIVES
Quite often, producers focus on contamination caused by water-based ingredients, taking forgranted that oils, being free from water, are fine and safe to use in production. However, oils manufactured under poorly controlled conditions can still carry dormant spores that come to life once in the presence of water during bulk production. This extra microbial load may exhaust the preservative system and even cause other contamination issues in the production plant.
This problem can be prevented altogether by using an antimicrobial that can lower the oil’smicrobial count to within acceptable limits before its use in production. Perhaps the only oil-soluble, broad- spectrum and naturally derived antimicrobial available to achieve this is Plantservative WmR Jojoba, from Campo Research.
This extract is derived through green chemistry from wildly cropped honeysuckles
(Lonicerajaponica and Lonicera caprifolium in jojoba oil) sourced via a reliable and sustainable supplychain.
Plantservative Wmr Jojoba is compliant with COSMOS and Natrue standards,
and holdsvegan accreditations. The ingredient is effective between pH levels of 2 and 12, and can withstand temperatures as high as 95°C or 203°F, giving great flexibility of use andincorporation.
Plantservative WmR Jojoba can also be used as a preservative booster in the oil phases ofemulsions, as well as in facial oils and other oil-based cosmetics.
For more information or to request a sample, visit:
http://www.campo-research.com/ www.campo-research.org
Quality Culture Part III: Bulk Production
Cosmetics & Toiletries – June 2021 – PART 3 Quality Culture (texterity.com)
The Genetic Analysis of Botanical DNA Core Standards of Each Plant species to guarantee the botanicalauthenticity, geographical origin, ensuring the traceability, safety, and quality of the natural botanicalextracts.
BOTANICAL DNA CORE STANDARD(S) OF EACH INCIDICTIONARY EDITION 18TH, LISTED PLANT BOTANICAL(s) AND THE PROTOCOL(S) OF GENETIC ANALYSIS AVAILABLE –
Guaranteeing the authenticity of plant raw materials for BotanicalNatural Cosmetics, Botanical Foods, Botanical Bio-Pharmaceutical,Botanical Bio-Molecules, and Botanical Health Foods through PlantsBotanical DNA-CORE analysis.
The Green Chemist’s Handbook for Cosmetic Preservation v1.0
Thank you for purchasing this e-book. Dra Barbara Oliso ensure you will find it helpful in your formulation work
Start now https://gcc.learnworlds.com/course?courseid=handbook
Ask about our Herbal Natural Products Chemistry Consultancy Services -Product Registration EEC/UK New Drug Development (NDA-US); Quasi-Drug Topicals (MOHW Japan); Development of Standards, Analysis & Profiles of Phytochemicals; Literature searches, Cultivation of Medicinal Plants, Clinical-Trials, Development of new uses for Phytochemicals and Extracts; Contract Research and Development Work in Natural Products for Novel Drugs, New Cosmetic Active Ingredients for Active Topical/OTC Cosmetic with functionality and Consumer- perceivable immediate- results, New Food Ingredients for Nutraceuticals & Functional Foods.
21 CFR, parts 710 and 720.FDA 2511. FDA 2512. 21 CFR, parts 710 and 720.FDA 2511. FDA 2512
BOTANICAL GREEN PRESERVATIVES
GROWING BOTANICAL RED BLOODY MEATS FROM FOOD BOTANICAL PLANTS
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A QUICK SUMMARY OF SERVICES:
The relevant tests listed below are studies that KKR performs regularly: (SEE BELOW)
- RIPT’s- Shared Panel (induction application patches for 24 or 48 hours ) Panel sizes 50/100/200
- Hypoallergenic- 200 subject
- Primary irritation (24 & 48 hours)
- Follicular Biopsies for non-comedogenicity
- Safety in Use (SIU)
- Dermatological, Comedogenicity, Ophthalmology, Pediatric, Gynecological
- Ocular Instillation
- Sunscreens (US FDA Monograph, Colipa Method, SPF Water resistant, ISO 24444)
- UVA Testing (ISO 24442, Broad Spectrum, ISO 24443)
- Phototoxicity (PT)
- Photoallergy (PA)
- Claims
- Moisturization
- Cell Renewal -Dansyl Chloride
- Long Lasting
- Anti-Aging
- AP/Deo testing
- Supplement Testing (in Vivo)
- Home Panel Consumer user trials
These are not all of our capabilities, but it does provide a visual array of services that we can offer you and your company.
Bioinstrumentation and Summary of Services
The following is a summary of equipment and services offered by (KAMPOYAKI ISRAEL LTD) KKR ConsumerResearch, itis not exhaustive, please enquire for outlines of other services such as anti-ageing, consumer perception trials, market research focus groups, claim support advice, ophthalmological and more.
- Sebumeter® – Courage & Khazaka (Oiliness)
- Corneometer® – Courage & Khazaka (Hydration/Moisturization)
- Tewameter – Courage & Khazaka (Barrier function)
- Skin-pH-Meter – Courage & Khazaka
- Chromameter – Courage & Khazaka (Color)
- Mexameter® – Courage & Khazaka (Melanin and Erythema)
- Cutometer – Courage & Khazaka (Firmness, Elasticity)
- Solar Simulator – Solar Light Co. (SPF studies)
- Laser Doppler Blood Flow Monitor – Moor Instruments (Blood flow)
- HiScope Fiber Optic Microscope – Hirox
- REPLICA: Silflo
- D-Squame – cured
- Visia-CR – Canfield Scientific
- MarkVu
- Colorimeter (Color)
- Thermal Imaging Camera
Digital Photography with Image Management Software:
Digital photography is another powerful tool for assessing and documenting skin condition. High- resolution digitalphotographs, with magnification,
if appropriate, can be compiled in report formfor comparison of before and afterproduct use. Detailed, close-up photographs can be used tovisually convey a products efficacy.
Visual and Tactile Grading:
Visual and tactile evaluations of the skin by a trained assessor, although subjective techniques, are effective methods for determining the condition of skin in terms of irritation, erythema (redness), dryness, appearance of wrinkles, sebum levels, softness, etc. The effect of products onthe skin of whole areas of the body, such as thehands, forearms, legs, and face, can be determined.
Digital Imaging:
A quantitative method for analyzing condition of the skin surface is available in the Visioscan7 VC98, a high-resolution black and white camera with a UVA light source. The UVA light source is wrapped around the camera and evenly illuminates the skin surface. Scales and dandruff appear brightly on the image, while cracks, furrows, and wrinkles have a darker appearance.
The Visioscan7 VC 98 analyzes the skin surface using a method termed Surface Evaluation of the Living Skin(SELS).
SELS is divided in to four clinical parameters; 1) SEsm, 2) SEr, 3) SEsc, and 4)
SEw. SEsm is a measure of the smoothness of the skin. SEr is a measure of roughness of the
skin. SEsc is a measure of the scaliness of the skin. SEw is a measure of the horizontal and verticallines on the skin (wrinkles). The images obtained with the Visioscan7 VC 98 can be saved to a computer disk for future viewing,analysis, or inclusion in a report. Other features of the Visioscan7 VC 98 is the Sebufix7 F 16 and Corneofix F20. Then which measures the sebum contentof skin quantitatively and qualitatively by means of a brief (30 second), glue-free skin contact, thereby reducing occlusion of the skin and any resulting effects.
Total Moisture Content:
The TC 350 Corneometer7 is an instrument that measures the water content of the upper layer of the stratumcorneum or skin surface using capacitance. This instrument has been widely used forhydration measurements of healthy and pathological skin conditions and for quantitative assessment of the efficacy of various moisturizingproducts.
The TC 350 Corneometer7 is ideal for measuring skin moisturization effects of a product that useshumectant properties and actives.
Transepidermal Water Loss:
The TC 350 Tewameter7 is an instrument that measures the rate of water loss through the skin (transepidermal water loss, or TEWL), which is an indication of the water barrier function of the skin. TEWL measurements are an excellent screening technique for early signs of skin irritancy andskin barrier damage. Irritants, such as detergents and solvents, damage the skin by removing the natural water-retaining lipids that provide an integral part of the skin barrier function. This leads toan increased TEWL rate, which can be monitored using theinstrument. This can be used to determine the emollient properties of a product.
Melanin and Erythema Measurements:
The Mexameter MX 187 is an efficient instrument for measurement of the melanin and erythema indices of the skin under a variety of physiological, pathological, and experimental conditions. Measurement is based on light absorption. The Mexameter MX 187 enables quick, accurate andreproducible determination of skin color and condition. The device specifically measures the content of melanin and hemoglobin (erythema) in the skin whichare responsible for the skin color.
Any change in the skin color or any formulation of erythema can be monitored. The Mexameter MX 187is ideallysuited for the determination of the redness potential, skin color (damage), and improvement in appearance of skin pigmentation properties resulting from product use.
End-User Product Evaluations:
While a product may have excellent objective performance and efficacy as determined by independent measures, anextremely important aspect of product evaluation is end-user perception and acceptance. Questionnaires can be used to determine the subject’s perceptionof their skin condition before and after product. Questionnaires can alsobe used to assess acceptability and preferences for product attributes. Comparative studies can be carried out using benchmark or competitive products.
PERFORMANCE CLAIMS:
- HYPOALLERGENIC
· DERMATOLOGIST TESTED
- OPHTHALMOLOGIST TESTED
DERMATOLOGICALLY TESTED CLAIM:
We are able to provide board-certified dermatologists for studies of productsrequiring “dermatologist tested” claims.
- Improves skin hydration
- Improves moisturization
- Improves skin condition
- Improves skin barrier
- Reduces fine lines and wrinkles (anti-aging)
- Improves texture
- Reduces skin oiliness
- Improves skin softness
- Improves rate of skin turnover (desquamation rate)
- Improves skin hydration
- Improves moisturization
- Improves skin condition
- Improves skin barrier
- Reduces fine lines and wrinkles (anti-aging)
- Improves texture
- Reduces skin oiliness
- Improves skin softness
- Improves rate of skin turnover (desquamation rate)
- Reduces dead cells (skin exfoliation)
- Improves appearance of sun damage of skin
- Reduces skin pigmentation variation
- Improves skin luminosity
- Improves skin color/skin tone
- Improves self-tanning color, evenness and application time
- Improves appearance of scars
- Reduces pruritic reaction
- Reduces irritation and erythema (redness)
- Controls skin flora
- Assurance of in-use safety
- Dermatologically tested
HAIR PRODUCT CLAIMS:
- ANTI-DANDRUFF
- STRENGTHENING
- CONDITIONING DETANGLING
- VOLUMIZING
- SHINE
ORAL PRODUCT CLAIMS:
- FRIZZ REMOVAL
- BOUNCE
- MANAGEABILITY
- COLOR
- FEEL
· PLAQUE REDUCTION
- ODOR REDUCTION
· WHITENING
Cosmetic claims or personal care product claims, presented as advertisements, can be contested by the FederalTrade Commission, the ASA, and other relevant bodies for the marketregion, and the manufacturers must have data to substantiate those.
Also, manufacturers may desire testing to determine the relative performance of several formulations
the Sponsorhas in development or the performance of a formulation comparativelywith the products of competitors.
FDA REGULATED or NOT!?!?!??:
Cosmetic products that make no claims that they “change” in any substantive way the structureor functionalcomposition of the human body (or, at least, make claims that are sufficiently vague), they are not “drugs” and arenot directly regulated by the FDA.
SENSITIZATION TESTING:
Sensitization testing is conducted using the Modified Draize Test in accordance with the FDA/CDER Guidance for Industry, Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products, December 1999. During the Induction Phase of testing, test materials are applied to skin sites on the upper backs of 200 subjects and patched three times per week for three weeks, the same sites of application each time, for a total of nine applications. Patches remain inplace 48 hours at a time on weekdays and 72 hours on weekends. Evaluation and scoring of skin reactions are performed and recorded at the time of each patch removal. The Induction Phase isfollowed by a RestPhase of two weeks duration, during which no product applications are performed. Then, during the Challenge Phase, materials are applied to new skin sites on the backand patched for a 48-hour period of exposure, at the end of which patches are removed. The challenge sites are evaluated 30 minutes and 24, 48, and 72 hours after patch removal forevidence of allergic reaction.
CUMULATIVE IRRITATION – HRIPT
HUMAN REPEAT INSULT PATCH TEST (HRIPT):
We perform the Human Repeat Insult Patch Test (RIPT) for cumulative skin irritation in accordancewith the
FDA/CDER Guidance for Industry, Skin Irritation and Sensitization Testing of Generic
Transdermal Drug Products, December 1999. The method requires that the product and its vehiclebe tested, along with a high-irritancy control material and a low-irritancy control material by applying small quantities of thematerials to single sites on the skin of the upper back of
30 or moresubjects each day for 21 days and occlusively patching each site while the material is wet. The degree of irritation at the sites is scored by a trained evaluator for degree of erythema/vesiculation/peripheral extension each day prior to reapplication of the materials.
Method Requirements:
The method requires that the product and its vehicle (product without active principle) be tested,along with a high-irritancy control material, sodium lauryl sulfate (SLS; also known as sodium dodecyl sulfate, or SDS), and a low-irritancy control material, 0.9% saline, by applying small quantities to a single site on the skin of the upper back of 30
or more subjects each day for 21 days and occlusively patching each site while the applied material is wet.
If the testing is for an ANDA in which bioequivalency data are necessary, a fifth material, the so-called “Innovatorpatch,” is also tested, and the outcome for the test material is compared withthat for the Innovator (i.e., the product already approved to market to which the test material claims equivalency).
The degree of irritation at the sites is scored by a trained evaluator (BSLI personnel and/or a licensed dermatologist, depending on circumstances) for degree of erythema/vesiculation/peripheral
extension each dayprior to reapplication of the materials. For purposes of FDA approval, the test material must display some level of irritation, but less than that produced by the positive control (SLS). That is, if the product shows no irritating properties, the FDA will declare the results conclusive.
A problem with the FDA requirements for RIPT testing is that test materials be occlusively patchedwhile still wet. Many products used for preoperative and/or preinjection preparation that are quite irritating when patched wet are much less so if allowed to dry prior to patching, and under normal circumstances of use, these products wouldvirtually never be occlusively patched while wet. Even so, the FDA requires that they be tested wet. A common solution to this dilemma is to add a limb to the study in which the product is permitted to dry for some specifiedperiod prior topatching the site of its application.
Note that the RIPT can be performed in combination with theModified Draize Test, described above.
EU ALLERGENS nor Other Allergens
Ask about our Herbal Natural Products Chemistry Consultancy Services -Product Registration EEC/UK New Drug Development (NDA-US); Quasi-Drug Topicals (MOHW Japan); Development of Standards, Analysis & Profiles of Phytochemicals; Literature searches, Cultivation of Medicinal Plants, Clinical- Trials, Development of new uses for Phytochemicals and Extracts; Contract Research and Development Work in Natural Products for Novel Drugs, NewCosmetic Active Ingredients FDA 2511. FDA 2512for Active Topical/OTC Cosmetic with functionality and Consumer-perceivable immediate- results, New Food Ingredients for Nutraceuticals & Functional Foods.21 CFR, parts 710 and 720.FDA 2511. FDA 2512. 21 CFR, parts 710 and 720.FDA 2511. FDA 2512 www.kampoyaki-research.co[email protected] www.kampoyaki-research.org
GROWING BOTANICAL RED BLOODY MEATS FROM FOOD BOTANICAL PLANTS
[email protected]
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The Genetic Analysis of Botanical DNA Core Standards of Each Plant species to guarantee the botanical authenticity, geographical origin, ensuring the traceability, safety, and quality of the natural botanical extracts.
BOTANICAL DNA CORE STANDARD(S) OF EACH INCI DICTIONARY EDITION 18TH, LISTED PLANT BOTANICAL(s) AND THE PROTOCOL(S) OF GENETIC ANALYSIS AVAILABLE
Guaranteeing the authenticity of plant raw materials for Botanical Natural Cosmetics, Botanical Foods, Botanical Bio-Pharmaceutical, Botanical Bio-Molecules, and Botanical Health Foods through Plants Botanical DNA-CORE analysis.
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