COSMETIC PRODUCT INFORMATION FILE · 2020. 2. 28. · COSMETIC PRODUCT INFORMATION FILE Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009

COSMETIC PRODUCT INFORMATION FILE Regulation (EC) No 1223/2009 of the European Parliament and of the Council of

30 November 2009 on cosmetic products – Article 11 (Official Journal L 342, 22/12/2009)

Trade name HUILE DE TAMANU 125ML

Product - Reference HUILE 100% PURE INOPHYLLUM CALOPHYLLUM

Product code : ID-17/05172

Study n° : 195906

Study code : 4.03

Report date : 03/12/2018

Sponsor

SARL TAHITI OIL FACTORY 32 avenue Tamames Rce Tamames II Entrée Jazquibel 64200 Biarritz France

Responsible person

SARL TAHITI OIL

FACTORY 32 avenue Tamames Rce Tamames II Entrée Jazquibel 64200 Biarritz France

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Produit : ID-17/05172 Etude : 195906 Version : 1 Page : 2/17

CONTENTS

I - DESCRIPTION OF THE COSMETIC PRODUCT

II - COSMETIC PRODUCT SAFETY REPORT

PART A - COSMETIC PRODUCT SAFETY INFORMATION

A.1. QUALITATIVE AND QUANTITATIVE FORMULA A.2. PHYSICAL-CHEMICAL CHARACTERISTICS AND STABILITY OF THE COSMETIC PRODUCT A.3. MICROBIOLOGICAL QUALITY A.4. IMPURITY, TRACES AND PACKAGING MATERIAL A.5. NORMAL AND REASONABLY FORESEEABLE USE A.6. EXPOSURE TO THE COSMETIC PRODUCT A.7. EXPOSURE TO THE SUBSTANCES A.8. TOXICOLOGICAL PROFILE OF THE SUBSTANCES A.9. UNDESIRABLE EFFECTS AND SERIOUS UNDESIRABLE EFFECTS A.10. INFORMATION ON THE COSMETIC PRODUCT

PART B - COSMETIC PRODUCT SAFETY ASSESSMENT B.1. ASSESSMENT CONCLUSION B.2. LABELLED WARNINGS AND INSTRUCTIONS OF USE ON THE PACKAGING B.3. REASONING B.4. ASSESSOR’S CREDENTIALS AND APPROVAL OF PART B

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III – METHOD OF MANUFACTURE, STATEMENT OF COMPLIANCE WITH GMP

IV – PROOF OF EFFECT CLAIMED

V – DATA ON ANIMAL TESTING

ANNEX

Microbiological and physico-chemical specifications

Margins of safety calculation

Substances-Mixtures Toxicological data

Stability / PAO / Microbiological quality

Packaging - Labelling

Certificates

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COSMETIC PRODUCT INFORMATION FILE

This report was carried out based on data and information put at disposal by the Sponsor. It is kept up to date in view of additional relevant information generated subsequent to placing the product on the market (Art. 10 1.c) of the Regulation N°1223/2009).

I - DESCRIPTION OF THE COSMETIC PRODUCT ► Article 11, paragraph 2.a)

Description to establish a link between information file and the intended cosmetic product.

Trade name Notification

reference Formula code Sale code Assay code

HUILE DE TAMANU 125 ML Not available Not available Not available Not available

Informations Générales Personne responsable:

SARL TAHITI OIL FACTORY 32 avenue Tamames Rce Tamames II Entrée Jazquibel 64200 Biarritz France

Fabricant :

SARL TAHITI OIL FACTORY BP 56 36 98716 PIRAE TAHITI

Conditionnement :

SARL TAHITI OIL FACTORY BP 56 36 98716 PIRAE TAHITI

Modifications summary Potential modifications of the initial formula (since the first placing on the market):

- Purposeless

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II - COSMETIC PRODUCT SAFETY REPORT ► Article 10; Annex I

PART A - COSMETIC PRODUCT SAFETY INFORMATION

A.1. Qualitative and quantitative formula The information related to the product HUILE 100% PURE INOPHYLLUM CALOPHYLLUM: trade name of raw materials, chemical identity of substances (chemical name, INCI, CAS, EINECS/ELINCS), intended function, are set in annex.

Regarding the available data, the cosmetic product: is formulated from raw materials in compliance with the European and French legislations, is devoid of substances of animal origin, is devoid of substances intended to be included within the Annex XIV of the EC Regulation 1907/2006, is devoid of CMR 1A / 1B substances (excluding technical unavoidable traces), is devoid of nanomaterials.

A.2. Physical-chemical characteristics and stability of the cosmetic product

Physical and Chemical characteristics

Raw materials (specifications sheets, reference methods): established.

Cosmetic product: established.

Stability under reasonably foreseeable storage conditions

Minimum durability Tested product : HUILE DE TAMANU 100% PURE VIERGE 125 ML (identical to HUILE 100% PURE

INOPHYLLUM CALOPHYLLUM) Référence du rapport : 8.02-43166-ID-17/05172; IDEA Lab; 33652 MARTILLAC Method : Test for 5 months under normal and accelerated conditions (40°C) Results : Comply Conclusion : Minimum durability > 30 Months

Stability after opening: Period After Opening (PAO) If required, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer with indication of a symbol followed by the period (in months and/or years).

Method : Internal Duration : 12 months (on the labelling)

Particular preservation conditions

None taking into account stability results

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A.3. Microbiological quality

Microbiological specifications of substances or mixtures and cosmetic product

They are described in specifications sheets established by suppliers except the one for which the risk of microbial contamination can be considered as negligible.

Related to the finished cosmetic product specifications are not required (anhydrous product) according to the SCCS* guidelines related to the concerned product category: Category 2

Category Description aerobic mesophyllic microorganisms Maximal amount

Pathogens

1 Children under 3 years In the eye area On mucous membranes

102 cfu/g or ml of product no detectable in 1 g or ml of product

2 Other products 103 cfu/g or ml of product no detectable in 1 g or ml of product

* : SCCS (Scientific Committee on Consumer Safety)

Product category

Taking into account the product category: 1

1. low microbiological risk : no test required 2. single use / no aperture : microbiological quality required 3. other products : challenge test and quality test are required

Challenge test Tested product : HUILE DE TAMANU 100% PURE VIERGE 125 ML (identical to HUILE 100% PURE

INOPHYLLUM CALOPHYLLUM) Non applicable taking into account the anhydrous characteristics of the formula. However an Aw test has been performed: Reference report : 12.80-ID-17/05172; IDEA Lab, 33652 MARTILLAC Results : Aw = 0.39 Conclusion : low risk of yeasts and molds growth

A.4. Impurities, traces and packaging material Impurities, traces (for example: heavy metals, residual solvents, CMR substances, Nitrosamines, Formaldehyde,…)

Substances and mixtures Impurities were not identified.

Finished product Information are not available at this time.

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Packaging material data

Characteristics

Experience confirmed by the Company with similar formulation/packaging combinations already on the market. The following data available at this time have been taking into account for the present assessment:

Packaging characteristics in direct contact with the product

Description and composition 125 ml PET Spray bottle

Supplier PLASTISERD

Regulatory certificate of the supplier related to the packaging in direct contact with the cosmetic product

Available

Heavy metals (according to the Directive 94/62/EC, lead, cadmium, mercury, hexavalent chromium: maximum 100 ppm by weight, except glass or crystal)

Available

Technical substances used during packaging manufacture (coloring agent, UV filters, lubricants…)

Available

Substances included in Annex II of cosmetic Regulation or CMR 1A, 1B, 2 according to CLP Regulation 1272/1228

Available

SVHC substances included in « candidate list » according to REACH Available

Food certificate (According to 1935/2004 Regulation – FDA) Available

European Pharmacopoeia certificate Not available

Toys safety certificate Not applicable

Aerosol (certificate according to the requirements of 75/324/EEC Directive)

Not applicable

Other documentation available - Material Safety Data Sheet - Specifications sheet

Container/Content compatibility Tested product : HUILE DE TAMANU 100% PURE VIERGE 125 ML (identical to HUILE 100% PURE

INOPHYLLUM CALOPHYLLUM) Method : Test for 5 months under normal and accelerated conditions (40°C) Results : the packaging presents a slight permeability from 3 months of study at 40°C and room

temperature which induces an external surface slightly fat

A.5. NORMAL AND REASONABLY FORESEEABLE USE See Annex for the provided labeling of the product HUILE 100% PURE INOPHYLLUM CALOPHYLLUM.

Exposure criteria are described into the following table (As stated on the technical sheet IDEA TESTS of the product).

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A.6. EXPOSURE TO THE COSMETIC PRODUCT

Target or exposed population (adults, children under or above three years of age, elderly people, pregnant and breast-feeding women, persons with compromised immune responses)

Adults Children from 3 years of age

Professionals

Skin type All skin type All skin type

Directions for use Not precised Not precised

Site(s) of application Skin Hands and forearms

Amount applied at each use 5 000 mg (Company data) 5 000 mg (Company data)

Estimated daily amount applied (Based on SCCS guidelines or RIVM report / In use test)

9 360 mg (SCCS) 5 000 mg * 4 = 20 000 mg (Internal data)

Rinsed-off product No Yes (after each care)

Duration and frequency of use Daily 4 times per day (during 1h or more) (Internal data)

Secondary exposure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.) or other that main exposure route

None reasonably foreseeable taking account of the presentation of the product.

None reasonably foreseeable taking account of the presentation of the product.

Possible exposure due to particle size Not applicable Not applicable

A.7. EXPOSURE TO THE SUBSTANCES The daily Systemic Exposure Dose (SED) and the Margin Of Safety (MOS) of each substance have been calculated taking into account the available data (see Annex) based on a maximizing daily exposure in consumer extrapolated to the Professional exposure less sensitive (hands contact and rinse-off).

Margin Of Safety calculation : MOS = NOAEL* / SED

SED = Q (mg/kg/j) x C (%) x A (%) x R Q = daily relative amount applied C = concentration of substance in the formula A = skin absorption of the substance R = retention factor

* No Observed (Adverse) Effects Level

The average body weight used for the calculation is 60 kg per adult. The margin of safety of each substance must be higher than 100 to ensure a sufficient safety. In the absence of NO(A)EL value, the margin of safety has not been calculated. The available toxicological data related to the substance, as well as its experience in some domains (cosmetics, food …) has been considered. In the absence of reliable data on dermal absorption of substances, the maximum threshold of 50 % established according to the last SCCS guidelines (SCCS/1564/15) has been used for the theoretical calculation. In the children, from 3 years old, the method of ratio weight/area has been used with a multiplying ratio of 1.5 is used (until 5 years).

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A.8. Toxicological profile of the substances The general toxicological profile of the substance (local tolerance, systemic toxicity) of the product formula HUILE 100% PURE INOPHYLLUM CALOPHYLLUM is based on the available information and is described in Annex (information supplied by the Company, Internal data base, SCCS's opinions, CIR's conclusions, literature, supplier’s data...).

The cosmetic product HUILE 100% PURE INOPHYLLUM CALOPHYLLUM is not perfumed.

A.9. Undesirable effects and serious undesirable effects

With the evaluated formula Number of units sold : 3 000 Duration of sale : for 5 years Geographic area : Worldwide

Undesirable effects At this time none adverse effects have been reported to the cosmetovigilance services of the Company related to the cosmetic product HUILE 100% PURE INOPHYLLUM CALOPHYLLUM.

Serious undesirable effects At this time none serious adverse effects have been reported to the cosmetovigilance services of the Company related to the cosmetic product HUILE 100% PURE INOPHYLLUM CALOPHYLLUM.

A.10. Information related to the cosmetic product

Local tolerance

Non clinical and clinical tolerance tests have been carried out with the cosmetic product HUILE DE TAMANU 100% PURE VIERGE 125 ML (identical to HUILE 100% PURE INOPHYLLUM CALOPHYLLUM). Cutaneous compatibility assessment after single application under occlusive patch for 48 hours Tested product : HUILE DE TAMANU 100% PURE VIERGE 125 ML Report reference : 1.01_48H – ID-17/05172; IDEA Clinic, 33652 MARTILLAC CEDEX Volunteers : 11 Application : pure Skin type : normal Conclusion : not skin irritating under the adopted experimental conditions Results similar to those obtained for the same class test items.

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PART B - COSMETIC PRODUCT SAFETY ASSESSMENT

The safety assessment of the finished cosmetic product HUILE 100% PURE INOPHYLLUM CALOPHYLLUM was performed on behalf of SARL TAHITI OIL FACTORY, within the framework of its use under normal or reasonably foreseeable conditions of use, in adults and children from three years of age, from the available documentary and experimental data, especially those described in Part A (supplied by the Company and/or the safety assessor), and in compliance with the article 10 - chapter III of the Regulation N° 1223/2009.

This assessment is based on the following main reference texts:

- The Regulation (EC) N° 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJEU L342, 22 December 2009) and its successive modifications,

- The Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products,

- Scientific Committee on Consumer Safety (SCCS) guidance in force today relating to the safety assessment of cosmetic ingredients,

- Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (OJEU L353, 31 December 2008).

B.1. Assessment conclusion

All the available information related to the safety of the product, as well about raw material as the finished product, taking account of the current knowledge and of the European and French legislations of cosmetic products in force today, particularly Regulation (EC) N° 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, allows the undersigned to consider the finished cosmetic product

HUILE 100% PURE INOPHYLLUM CALOPHYLLUM

As safe for human health when applied under normal condition of use or reasonably foreseeable, in adults (Consumers and Professional) and children from three years of age, subject to specific individual sensitivity and adaptation of the labelling (B2.)

If the cosmetic product leads thereafter to significant undesirable reactions declared to the cosmetovigilance offices, following its use by the consumers, including children from three years of age, particularly local irritation reactions or allergenic reactions, the undersigned should be informed in order to consider a potential new safety assessment.

The present assessment is only appropriate for a use in conformity with the recommendations of the manufacturer, and for the considered formulation in the container and packaging provided at the time of this assessment. Any change of the formulation cancels the present evaluation.

Change of conditions of use, target, claims, evolution of the legislation, new scientific findings or toxicological data related to substances/mixtures or any new data likely to affect the safety of the product may justify, if necessary, a new safety assessment for the cosmetic product above mentioned.

B.2. Labelled warnings and instructions of use

The labelling (see Annex) of the product HUILE 100% PURE INOPHYLLUM CALOPHYLLUM is not suitable with the directions of use as defined by the Responsible Person; directions of use are not mentioned.

In absence of appropriate clinical test and toxicological data on the ingredient CALOPHYLLUM INOPHYLLUM SEED OIL, this product is not recommended for children under 3 years and pregnant or breastfeeding women. Thus, the following mention must be affixed on the labelling “Not recommended for children under 3 years and pregnant or breastfeeding women “

Following mention is recommended: “Avoid eye contact” Moreover, the mention “used for skin infections, burns or insect bites” should be removed from the

labelling in order to comply with cosmetic regulation N°1223/2009.

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B.3. Reasoning ► The formula of the product HUILE 100% PURE INOPHYLLUM CALOPHYLLUM as supplied (100% Calophyllum inophyllum seed oil) complies with the European cosmetic legislation in force and for the target population: children from three years of age.

► The physical / chemical and organoleptic characteristics of the substances / mixtures are declared complying with established specifications; those of the cosmetic product are guaranteed by the respect of the good manufacturing practices. Microbiological specifications of raw material and those of the cosmetic product are not required based on the anhydrous characteristics of the formula.

► The physical / chemical and organoleptic stability of the cosmetic product is established; results comply for 5 months under normal and in accelerated conditions. Related to the compatibility of the cosmetic product with the provided packaging, a particular attention should be given about the quality of plastic used for the packaging which presents a slight permeability from 3 months of study. Thus, the Responsible Person should be careful about this topic. The risk of microbiologic contamination can be considered as negligible taking into account the composition of product (anhydrous oil). A water activity test has been realized in order to confirm the absence of risk of bacterial and/or fungic proliferation. Taking into account this result (AW < 0.6), the risk of a microbiologic development is negligible. The date of minimum durability exceeds 30 months; a PAO of 12 months has been established. ► Impurities data for raw materials and / or finished product are not available via transmitted documents. It must be inserted in the report. A follow-up is fulfilled related to the quality and the regulatory compliance of packaging items already used by the company for this type of formula (information available related to the regulatory compliance of the packaging materials). However, based on compatibility data, additional analysis should be performed with the packaging material. ► The toxicological profile of substance and its exposure level has been assessed from the available information (Company data, SCCS opinions, CIR (Cosmetic Ingredient Review), European council, literature….). ► Local tolerance of the finished product

Local tolerance data are related to the evaluated formula. Irritative cutaneous and ocular local tolerance:

The analysis of the results obtained under the experimental adopted conditions, shows the absence of cutaneous irritating potential of the cosmetic product Concerning ocular tolerance, taking into account the product presentation and its composition, the ocular intolerance risk cannot be ruled out in case of accidental contact during its use; cautions of use are recommended on the labelling. Local skin allergenic tolerance:

The product is not perfumed. None allergenic substance must be labelled. Substance is devoid of sensitizing potential, the risk of skin allergenic tolerance can be ruled out under normal or reasonably foreseeable conditions of use subject to particular individual sensitivity.

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► Systemic toxicity

The risk of systemic toxicity can be ruled out taking into account the data related to the substances of the formula (especially when safety margin are above 100) for the intended application under normal and reasonably foreseeable conditions of use at the intended concentrations as well in Consumer as in Professional. Without NOAEL value, margins of safety cannot be calculated. In this case, concerned substances have been toxicologically evaluated taking into consideration other data when available: safety and quality data from raw materials suppliers, data basis, literature data, classification under Regulation (EC) n° 1272/2008, studies from manufacturer, in silico prediction (QSAR), bridging approach, assessments of non-cosmetic uses (food, biocidal products, pharmaceutical products,...), chemical safety reports under Regulation (EC) n° 1907/2006 (REACH), CIR data (Cosmetic Ingredient Review), data from human experience (see toxicological data synthesis in annex).

Moreover, this cosmetic product being intended for children from 3 years old, all the data have been evaluated bearing in mind exposure situation, the intrinsic toxicity of the substance, and the specific conditions of use of the product. ► Significant Marketing data of the formula concerned by this assessment for 5 years (3 000 units sold in worldwide without any cosmetovigilance notices reported at this time), confirms the good cutaneous tolerance of the product for the intended application.

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B.4. Assessor’s credentials and approval of part B

Martillac, Signature / Date:

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III – METHOD OF MANUFACTURE, STATEMENT OF COMPLIANCE WITH GMP ► Article 11, paragraph 2.c

DESCRIPTION OF MANUFACTURING METHOD (SUMMARY) Method available in Annex

BULK STORAGE Not available

PACKAGING OF THE FINISHED PRODUCT

1) Indication of different types of presentation of sales units and of their capacity, materials used in the composition of containers

Method available from the Applicant

2) Method of packaging Not available

GMP COMPLIANCE Declaration according the EN ISO 22716 Standard must be inserted in the report

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IV – PROOF OF EFFECT CLAIMED ► Article 11 paragraph 2.d)

1) From ingredients

Claims mentioned on the packaging and proves are described in the following table

Ingredient Claim Documentary data In vitro experimental data

Clinical experimental data

Tamanu oil 100 % natural

INCI list on the labelling Declared by the Company (IDEA LEGAL sheet)

/

/

2) From finished product

Claims mentioned on the packaging and proves are described in the following table

Claim Documentary data

Clinical experimental data

Frequently used for infection, skin, burns or insect bites

To be removed from the labelling

/

Tested under dermatological

control

/ Title: Cutaneous compatibility assessment after single application under occlusive patch for 48 hours Report reference : 1.01_48H – ID-17/05172; IDEA Clinic, 33652 MARTILLAC CEDEX Conclusion: not skin irritating under the adopted experimental conditions

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V – DATA ON ANIMAL TESTING

► Article 11 paragraph 2.e) “Data related to animal testing performed by the manufacturer, its agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including all animal testing performed to satisfactory the legislative or regulatory requirements of countries not members of the European Union.”

Finished product : None animal test has been performed (Certificate available on 24 July 2018)

Ingredients : None animal test has been performed (Certificate available on 24 July 2018)

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ANNEX

PRODUCTIDENTIFICATIONCommercialname: TAMANUOILstabilizedwithVitE

Properties: Non-foodvegetableoilSUPPLIER TAHITIOILFACTORY Email:[email protected]

POBOX5636PIRAE98716TAHITI,FrenchPolynesiaPhone:+68940549940

Lot#: 2300118/TANALYSIS: Manufacturingdate:07/08/2018Expirydate: 07/08/21COMPONENTS: ColdpressedtamanuoilINCINAME:

CAS# 2018.1129-1ORGANOLEPTIC SPECIFICATIONS RESULTScolor: yellowtogreen passodor: stronganddistinctive passappearance: darkoilyliquid pass

CHEMICALDATA LIMITS RESULTSRelativedensityat25°C pass 0,928g/cm3*Solubility insolubleinwater,solubleinoil passmeltingpoint: 24°C-26°C 25°C*disturbingpoint: 18°C passliquefactionpoint: pass passsaponificationindex: pass 190mgKOH/g*acidityindex pass 28mgKOH/g*peroxideindex: 10meqoxy/kg passrefractionindex: 1445-1450 pass

MICROBIOLOGICALDATATotalaerobicflora <1000N/g passPathogenicbacteria none passvalues*:analysis2018.1129-1byNFENISOcertifiedlaboratory,InstitueLouisMalardé

KAUEHIHERFRAYQualitysupervisor

SARLTAHITIOILFACTORY

CERTIFICATEOFANALYSISTAMANUOILwithVITE

CalophyllumInophyllumSeedOil–Tocopherol–HelianthusAnnuus(Sunflower)SeedOil

Among our information sources:- SCCS Notes of Guidance- Cosmetic Ingredient Review- RIVM report- Literature- internal data basis

n/aCALOPHYLLUM INOPHYLLUM SEED OIL 100 50,00 % 2,5 n/a

Face and body care

Product category

(mg)

Daily amount applied

(mg/kg/d)(Q)

Relative amount applied

(R)

Retention factor

500,00 0,01 5,0000

(mg/kg/d)(E = Q x R)

Daily exposure

20000,00

EU INCI Name Concentration %(C)

Absorption transcutaneous

factor (A)

SED(mg/kg/d)

C x E x A / 100

NO(A)EL(mg/kg/d)

MOS

n/a: not availableMOS= NO(A)EL/SEDMOS: Margin Of SafetyNO(A)EL: Non Observable (Adverse) Effect Level SED: Systemic Exposure DosageA : Allergen Labelled

A

from 3 years oldTarget population

© Isotys Cosméo Version 1.0.0.164 IDEA Legal

Margins of safety #11437-195906-Professional Page 1/1

Among our information sources:- SCCS Notes of Guidance- Cosmetic Ingredient Review- RIVM report- Literature- internal data basis

n/aCALOPHYLLUM INOPHYLLUM SEED OIL 100 50,00 % 117 n/a

Face and body care

Product category

(mg)

Daily amount applied

(mg/kg/d)(Q)

Relative amount applied

(R)

Retention factor

234,00 1,00 234,0000

(mg/kg/d)(E = Q x R)

Daily exposure

9360,00

EU INCI Name Concentration %(C)

Absorption transcutaneous

factor (A)

SED(mg/kg/d)

C x E x A / 100

NO(A)EL(mg/kg/d)

MOS

n/a: not availableMOS= NO(A)EL/SEDMOS: Margin Of SafetyNO(A)EL: Non Observable (Adverse) Effect Level SED: Systemic Exposure DosageA : Allergen Labelled

A

from 3 years oldTarget population


Margins of safety #10123-195906-Consumer Page 1/1

Toxicological dataSourceData

Acute dermal toxicity (LD50) non toxic GOLGEMMA MSDS 2010Acute oral toxicity (LD50) non toxic GOLGEMMA MSDS 2010Eye irritation non irritant GREENTECH MSDS 2012Genotoxicity Ames non mutagenic GREENTECH MSDS 2012Sensitization non sensitizing GREENTECH MSDS 2012Skin irritation non irritant GREENTECH MSDS 2012

CAS : /CALOPHYLLUM INOPHYLLUM SEED OIL


Page 1/1#10123-195906-INCI data

Groupe IDEA TESTS - IDEA Lab www.groupeideatests.com – [email protected]

SARL au capital de 10 000 € RCS BORDEAUX 353 989 684 APE 7120B TVA FR 66 353 989 684

Site Martillac : Technopôle Montesquieu 5, rue Jacques Monod CS 60077 33652 MARTILLAC CEDEX Tél. 05 56 64 82 33 Fax. 05 56 64 82 11

Site Brest : Technopôle Brest-Iroise 90, rue René Descartes 29280 PLOUZANE Tél. 02 98 05 19 70 Fax. 02 98 05 09 73

Elément d’essai / Test item

HUILE DE TAMANU 100% PURE VIERGE 125 ML

Détermination de la Date de Durabilité Minimale d’un

produit cosmétique par une étude de vieillissement accéléré en

étuve à 40 °C

Determination of the Date of Minimal Durability of a cosmetic product with an

accelerated ageing study, in incubator at 40 °C

RAPPORT FINAL / FINAL REPORT

Directeur d’Etude / Study Director : Francoise QUEFFURUS (1)

Etude n°/ Study # : 8.02-43166-ID-17/05172

Donneur d’Ordre Sponsor

Installation d’Essai / Test Facility : IDEA Lab

SARL POEHANI

BP 56 36

98716 PIRAE

TAHITI

Site d’essai de Martillac Martillac test location

Technopôle Montesquieu

5, rue Jacques Monod

CS 60077

33652 MARTILLAC

FRANCE

Site d’essai de Brest (1) Brest test location

Technopôle Brest-Iroise

90 rue René Descartes

29280 PLOUZANE

FRANCE

http://www.groupeideatests.com/

mailto:[email protected]

IDEA Lab

Identification : Page :

8.02-43166-ID-17/05172 2/8

Sommaire / Table of content

1 Objectif de l’étude / Study objective .............................................................................................. 3

2 Elément d’essai / Test item ............................................................................................................ 3

3 Déroulement de l’étude / Study course ......................................................................................... 3

3.1 Présentation des paramètres contrôlés / Presentation of controled parameters ................... 4 3.1.1 Evaluation des critères organoleptiques / Assessment of Organoleptics Criteria ............................... 4 3.1.2 Contrôle du poids d’un produit fini / Final product weight control .................................................... 5 3.1.3 Compatibilité macroscopique avec le contenant / Macroscopic compatibility with the vial ............... 5

4 Date de l’étude / Study date : ......................................................................................................... 5

5 Matériel utilisé / Material used ..................................................................................................... 5

6 Résultats / Results .......................................................................................................................... 5

7 Conclusion / Conclusion ............................................................................................................... 5

7.1 Observations / Observation ..................................................................................................... 5

7.2 Recommandations / Recommendations ................................................................................... 6

ANNEXE 1 ............................................................................................................................................. 7

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8.02-43166-ID-17/05172 3/8

1 OBJECTIF DE L’ETUDE / STUDY OBJECTIVE

A la demande de la société SARL POEHANI, nous avons étudié la stabilité du produit HUILE DE

TAMANU 100% PURE VIERGE 125 ML par vieillissement accéléré en étuve afin de déterminer la

date de durabilité minimale de ce produit.

Selon l’article 19 du règlement (CE) N° 1223/2009 (Règlement Cosmétique) : « La date de durabilité

minimale est la date jusqu’à laquelle le produit cosmétique, conservé dans des conditions appropriées,

continue à remplir sa fonction initiale et reste sûr pour la santé humaine. »

Si la durabilité du produit cosmétique n'excède pas 30 mois : l'indication de la date de

durabilité est obligatoire.

Si la durabilité du produit cosmétique excède 30 mois : l'indication de la date de durabilité

minimale n'est pas obligatoire. Une estimation de la Période Après Ouverture (PAO) doit

alors être réalisée.

At the SARL POEHANI society request, we have studied the stability of the product HUILE DE TAMANU 100%

PURE VIERGE 125 ML with accelerated ageing method in an incubator in order to define the date of minimal

durability of this product.

According to the article 19 of the regulation CE N 1223/2009 (Cosmetic Regulation): "The date of minimal

durability is the date until which the cosmetic product, kept in appropriate conditions, continues to fill its initial

function and remains safe for the human health. "

If durability is inferior to 30 months: indication of durability date is compulsory.

If durability is superior to 30 months: indication of durability date is not compulsory. An estimation of

“Period After Opening" (PAO) must be performed.

2 ELEMENT D’ESSAI / TEST ITEM

Dénomination / Name : HUILE DE TAMANU 100% PURE VIERGE 125 ML

Code interne / Internal code : ID-17/05172

Numéro de lot / Batch number : Non défini / Not defined

Présentation / Aspect : Liquide / Liquid

Couleur / Color : Vert / Green

Conditionnement / Packaging : Flacon spray en plastique / Plastic spray vial

Conditions de stockage / Storage conditions : Température ambiante / Room temperature

Nature de l’élément d’essai / Test item nature : Produit fini cosmétique / Finished cosmetic product

Date de péremption / Expiry date : Non défini / Not defined

Les données relatives à l’identité, à la pureté et à la stabilité de l’élément d’essai sont sous la

responsabilité du donneur d’ordre. La fiche de données techniques de l’élément d’essai a été fournie

par le donneur d’ordre.

Information linked to the identification, purity and stability of the test item are under the responsibility of the

sponsor of the study. The technical data sheet of the test item was provided by the sponsor of the study.

3 DEROULEMENT DE L’ETUDE / STUDY COURSE

L’étude est menée selon le principe du vieillissement accéléré dans une étuve à 40°C ± 2°C.

L’étude est réalisée pendant 5 mois selon la règle pour laquelle un mois en vieillissement accéléré à

40 °C équivaut à 6 mois en conditions réelles de conservation (sauf indication contraire du Donneur

d’Ordre).

La température de la pièce est contrôlée à chaque début de série de mesure.

La température de l’étuve est contrôlée chaque jour d’utilisation.

Les échantillons sont comparés avec un témoin, conservé à température ambiante, à l’abri de la

lumière.

Les mesures sont effectuées avec une périodicité de 1 mois.

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L’étude du vieillissement du produit se réalise dans la mesure du possible dans le flacon de

commercialisation, afin de pouvoir évaluer la compatibilité du flacon avec le produit.

Les paramètres mesurés ou évalués sont variables en fonction du type de produit et définis dans le

tableau 1.

The study is performed according to the principle of the ageing accelerated during 5 months in an incubator at

40°C ± 2°C. The study is carried out with the rule according to which one month in accelerated ageing at 40°C

is equivalent to 6 months in real conditions of preservation (unless otherwise specified of the Sponsor).

The temperature of the laboratory is controlled before of each series of test.

The incubator temperature is controlled before of each day of use.

Samples are compared with a control product, stored at room temperature, without light.

The measurements are performed every month.

The study of the accelerated ageing is performed, if possible, in the commercial vial, in order to study the vial

compatibility with product.

Measured or evaluated parameters are variable according type of product and are defined in Table 1.

Type de produit / Product

Critères organoleptiques / Organoleptic criteria

pH / pH

Masse Totale

de

l'échantillon

(sur PF non

ouvert) Total weight (on

unopened flask)

Densité / Density

Viscosité / Viscosity

Compatibilité

Flacon ou

Contenant / Flask

compatibility

Compatibilité

Bouchon ou

Accessoires / Cap or

accessories

compatibility

Aspect / Aspect

Couleur / Colour

Odeur/ Odor

Huile de soin et Huiles

essentielles / Care oil or

Essential oil X X X X X X

Lotion aqueuse / Aquous

lotion X X X X X X X

Lotion bi-phase/ Bi-phase

lotion X X X

X X X

Lotion alcoolique / Alcoolic

lotion X X X

X X X

Cosmétique blanche (Crème

/ Sérum / Masque …)/ White

cosmetics (Cream / serum /

Mask…)

X X X X X X X X X

Poudres (Enveloppement,

Alginate de moulage…) / Powders

X X X X X X

Maquillage : Pâtes et

liquides / Make-up : Pastes

and liquids X X X X X X

Maquillage : Poudres/ Make-

up : Powders X X X X X X

Shampooing - Gel douche -

Bain - Savon Liquide / Shampoo – Shower gel – Bath –

Liquid soap

X X X X X X X X X

Savon solide - Sels de bain / Solid soap – Bath salts

X X X X X X

Produits solaires / Sun

products X X X X X X X X X

Mousses / Foam X X X X X X X X X

Tableau 1 / Table 1: Paramètres mesurés ou évalués en fonction du type de produit / Measured or

evaluated parameters according type of product

3.1 Présentation des paramètres contrôlés / Presentation of controled parameters

3.1.1 Evaluation des critères organoleptiques / Assessment of Organoleptics Criteria

Les critères organoleptiques (aspect/couleur/odeur) sont évalués à partir d’un témoin placé à

température ambiante à l’abri de la lumière.

Organoleptics criteria (aspect/color/odor) are assessed according to a control stored at room temperature

without light.

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3.1.2 Contrôle du poids d’un produit fini / Final product weight control

Lorsque le produit étudié est dans son emballage de commercialisation, le poids d’un échantillon non

ouvert est mesuré à chaque temps, afin d’évaluer la perte de produit causée par une éventuelle

perméabilité du contenant.

When product is studied in its commercial packaging, weight of unopened sample is measured at each time, in

order to estimate the loss of product induced by a potential packaging permeability.

3.1.3 Compatibilité macroscopique avec le contenant / Macroscopic compatibility with the vial

Lorsque le produit étudié est dans son emballage de commercialisation, ce dernier est observé à

chaque temps afin d’évaluer une éventuelle incompatibilité macroscopique de l’emballage avec le

produit.

When product is studied in its commercial packaging, this one is observed at each time in order to assess a

potential macroscopic incompatibility between the packaging and the product.

4 DATE DE L’ETUDE / STUDY DATE :

L’étude a été réalisée du 16/01/2018 au 13/06/2018.

The investigation was carried out from 16/01/2018 to 13/06/2018.

5 MATERIEL UTILISE / MATERIAL USED

Etuves à 40°C ± 2°C / incubator at 40°C ± 2°C

Thermomètres / Thermometers

Balance analytique / Analytical weight

6 RESULTATS / RESULTS

Les paramètres mesurés ou évalués au cours de l’étude sont présentés dans le tableau en annexe.

Measured or assessed parameters during the study are shown in table in annex.

7 CONCLUSION / CONCLUSION

7.1 Observations / Observation

L’élément d’essai HUILE DE TAMANU 100% PURE VIERGE 125 ML code ID-17/05172, vieilli

5 mois en étuve à 40°C (correspondant à 30 mois de conservation en temps réel, sauf indication

contraire du Donneur d’Ordre), présente une bonne stabilité au niveau des paramètres mesurés ou

évalués pour le vrac. En revanche, on remarque au niveau de l'emballage une légère perméabilité du

flacon à partir de 3 mois d’étude (à 40°C et à température ambiante), induisant une surface extérieure

légèrement grasse.

The test item HUILE DE TAMANU 100% PURE VIERGE 125 ML code ID-17/05172, aged 5 months in

incubator at 40°C (corresponding to 30 months in real time unless otherwise advise by Sponsor) shows a good

stability regarding measured or evaluated parameters for the bulk. However, we can notice on vial a slight

permeability from 3 months of study (at 40°C and at room temperature) which induces an external surface

slightly fat.

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7.2 Recommandations / Recommendations

Au regard des résultats obtenus, nous pouvons estimer que la durabilité minimale est supérieure à

30 mois et qu’une estimation de la Période Après Ouverture est possible pour l’élément d’essai

HUILE DE TAMANU 100% PURE VIERGE 125 ML code ID-17/05172. Une attention

particulière devra être portée sur la qualité du plastique utilisé pour le conditionnement du produit.

At the light of the results obtained, we can estimate that minimal durability is superior to 30 months, and that an

estimation of the Period after Opening is possible for the test item HUILE DE TAMANU 100% PURE

VIERGE 125 ML code ID-17/05172. A particular attention should be given about the quality of plastic used for

the packaging of the product.

Françoise QUEFFURUS

Directeur d´Etude / Study Director Ingénieur en Microbiologie / Microbiology Engineer

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8.02-43166-ID-17/05172 7/8

ANNEXE 1

Etude de vieillissement accéléré en étuve : 5 mois

Accelerated ageing study, in incubator:5 months

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8.02-43166-ID-17/05172 8/8

This certificate is issued by computer and is valid without signature

Groupe IDEA TESTS - IDEA Lab - www.groupeideatests.com - [email protected] SARL au capital de 10 000 € • RCS BORDEAUX 353 989 684 • APE 7120B • TVA FR 66 353 989 684

Siège social : Technopôle Montesquieu 5, rue Jacques Monod CS 60077 33652 MARTILLAC CEDEX • Tél. 05 56 64 82 33 • Fax 05 56 64 82 11

Si la croissance des bactéries est très restreinte pour des Aw ≤ 0,75, les levures et les moisissures peuvent se développer à des valeurs

inférieures allant jusqu’à 0,60. En outre, ce paramètre ne doit pas être utilisé comme seul indicateur pour déterminer si le produit nécessite des

essais microbiologiques.

If the growth of bacteria is very restricted for Aw ≤ 0.75, yeasts and molds can growth at values lower as 0,60. Besides, this parameter must not be used as only

indicator to determine if the product requires microbiological assays.

Directeur d’Etude / Study Director

IDEA Lab – Caroline PERSON

Site de Brest

Technopôle Brest Iroise

90, rue René Descartes 29 280 PLOUZANE

Tél : 02 98 05 19 70 - [email protected]

Ce certificat est émis informatiquement et est valable sans signature

12.80 Aw-mètre HYGROPALM23 ROTRONICMesure de l'activité de l'eau (Aw) Measurement of water activity (Aw)

0,39

Risque microbiologique (norme ISO 29621)Microbiologic hazard (ISO 29621 standard)

NONNO

/ 45590 195895 05/01/2018

Code étudeStudy Code

Paramètre mesuréMeasured parameter

MéthodeMethod

RésultatsResults

Lot / Batch:

Date de réception / Reception Date: 07/06/2017

N° de cde client Order sponsor N°

N° de cde IDEAIDEA Order N°

N° de l'étudeStudy N°

Date d'analyseStudy date

Analyse physico-chimiquePhysico-chemical analysis

Client / Sponsor: SARL POEHANI

Code produit / Product code: ID-17/05172

Désignation / Designation: HUILE DE TAMANU 100% PURE VIERGE 125 ML

SARL TAHITI OIL FACTORY

ZI FARATEA HANGAR 3� TARAVAO, 98719� Téléphone : +689 40 54 99 40 � Télécopie : +689 40 54 99 41 Adresse de messagerie : [email protected] RC 11257 B – N°TAHITI A03670

Le 24 juillet 2018 Madame, Monsieur, La société SARL TAHITI OIL FACTORY située à la ZI de Faratea, Hangar 3 à TARAVAO atteste par la présente ne jamais utiliser d’animaux dans l’ensemble de ses processus de fabrication ,de développement ,de validation ou de tests sur l’intégralité de ses gammes cosmétiques des marques TEVI TAHITI,VAHINE DE TAHITI,MONOI ROYAL ainsi que REVA DE TAHITI. Merci de votre compréhension Je vous prie d'agréer, Madame/Monsieur, l'expression de ma considération distinguée Jeremy Biau Gérant

SARL TAHITI OIL FACTORY

ZI FARATEA HANGAR 3� TARAVAO, 98719� Téléphone : +689 40 54 99 40 � Télécopie : +689 40 54 99 41 Adresse de messagerie : [email protected]

Certificate of Origin

Product :

Tamanu (Calophyllum Inophyllum) virgin Oil stabilized with natural Vitamin E

Sarl TAHITI OIL FACTORY attests that Tamanu (Calophyllum Inophyllum) virgin Oil delivered to:

DKSH JAPAN

is extracted over a cold process from the specie Calophyllum Inophyllum, from our factory located to RAIATEA island. The treated part of the plant is the dried kernel nut. This plant is from morphological type “tree”, located in the geographic area of the French Polynesia.

Taravo 19th june 2018 Kauehi Herfray Technical Manager

BIAU Jeremy

C

Documents

COSMETIC PRODUCT INFORMATION FILE · 2020. 2. 28. · COSMETIC PRODUCT INFORMATION FILE Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009