Dossier technique et réglementaire / Technical and regulatory Mai 2022 / Mai

document 2022
MYRISTATE D’ISOPROPYLE-RSPO-MB

INCI: Isopropyl myristate

N°CAS: 110-27-0
N°EINECS/ELINCS: 203-751-4

DESCRIPTION / DESCRIPTION :
Ester de l’alcool isopropylique et de l’acide myristique / Ester of isopropyl alcohol and myristic acid
Matière première conforme à la Pharmacopée Européenne en vigueur / Raw material according to the
European Pharmacopoeia in force

CARACTERISTIQUES GARANTIES / GUARANTEED SPECIFICATIONS :

CARACTERISTIQUES SPECIFICATIONS

Pureté / assay ≥ 98%

Indice d’acide / Acid value ≤ 1 mg KOH /g
Indice de saponification / Saponification value 202-212 mg KOH /g
Indice d’iode / Iodine value ≤ 1 g I2/ 100g
Teneur en eau / Water content ≤ 0.10 %
Indice de réfraction à 20°C / Refractive index at 20°C 1.432 – 1.437
Viscosité à 20°C / Viscosity at 20°C 5 – 6 mPa.s
Couleur Apha ≤ 50
Cendre sulfurique / sulfate ash ≤ 0.1
Ces éléments seront repris sur nos BA / these elements will be on our CoA

CARACTERISTIQUES A TITRE D’INFORMATION / ADDITIONAL INFORMATION :

Densité à 20°C / Density at 20°C: 0.846 – 0.855 g/ml
C 14 : ≤ 2 %
C 18 : ≤ 2 %
Ce produit est végétalien / This product is suitable for vegan

APPLICATIONS :
Préparations cosmétiques / Cosmetic preparations (emollient, skin conditioning, solvent)

CONDITIONNEMENT STANDARD / STANDARD PACKAGING :

Tonnelet de 25/50 kg – Fût de 175 kg / 25/50kg keg – 175kg drum
A conserver à une température comprise entre 15 et 25°C. A conserver dans l'emballage d'origine à l'abri de la
lumière du soleil, de l'humidité et des températures extrêmes / Store at a temperature between 15 and 25°C.
Keep closed in original packaging away from sunlight, moisture and extreme temperatures.

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 Dossier technique et réglementaire / Technical and regulatory Mai 2022 / Mai
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MYRISTATE D’ISOPROPYLE-RSPO-MB

Additives Additives are not added to this product during the manufacturing process, therefore
these substances are not monitored analytically.
Allergen Ingredients which are listed as allergens according to annex III (no. 67 – 92)
regulation (EC) No.1223/2009 are not used for production of this product. Therefore,
these ingredients are not monitored analytically.
This product is not derived from any gluten containing cereals; the used raw
materials do not represent a source for gluten; therefore, gluten is not monitored
analytically.
This product is not derived from nuts (allergen associated); traces of nut allergens are
not monitored analytically
Animal Testing This product has not been tested on animals in terms of regulation (EC)
No.1223/2009, Article 18
BSE - Bovine Spongiform This product is derived from vegetable and petrochemical/synthetical raw materials
Encephalopathy and does therefore not represent a source for BSE/TSE pathogens
California Prop 65 Substances listed in California Proposition 65 are not used as ingredients
Carcinogenic, Mutagenic This product is not rated as a CMR (category 1A, 1B, and 2) and doesn’t contain any
and Reprotoxic (CMR) ingredients rated as CMR (category 1A, 1B, and 2) according to regulation (EC)
No.1223/2009 in association with regulation (EC) No.1272/2008
Composition > 99 % isopropyl myristate
Cosmetic This product is not cited in annex II or III of regulation (EC) No.1223/2009, therefore
the application in cosmetic preparations is not prohibited or restricted according to
this regulation
Cosmos / Ecocert Due to isopropanol, this product is not accepted by Ecocert or Cosmos
Danger This product is not classified as dangerous in accordance to CLP and ADR
Dioxane A contamination with 1, 4-dioxane is not expected to be present as the
manufacturing process doesn’t include an ethoxylation step. Therefore 1,4-dioxane is
not monitored analytically
Ecolabel No data available
European Pharmacopeia This product is compliant to the European Pharmacopeia
Food Is not food grade product
Genetically Modified This product doesn’t contain GMO and is not derived from a GMO. PCR analyses, to
Organisms (GMO) determine GMO traces are therefore not performed
Inventories Compliant with China IECSC, USA TSCA, New Zealand NZIoC, Taiwan TCSI and NCSI,
Philippines PICCS, Japan ENCS, Korea KECI, Australia AICS, Canada DSL
Geographic origin (for South east Asia
plant)
Glycol ether Glycol ether are not added to this product during the manufacturing process. The
process itself doesn’t expect the formation of glycol ether, therefore this product is
not monitored analytically
Halal This product complies to halal requirements
Heavy Metals Elemental impurities as listed in the “ICH guideline Q3D on elemental impurities”
(EMA/CHMP/ICH/353369/2013) and in the Ph. Eur. General Text “5.20. Metal
catalyst or metal reagent residues are not intentionally added or used during the
manufacturing process of this product. Therefore, it is unlikely that elemental
impurities are present in this product in appreciable amounts.
However, this product is analyzed on heavy metals including Cd, As, Pb, Hg, Ni, and
Sb on a periodical basis. The sum of heavy metals, expressed as Pb, doesn’t exceed
10 ppm
HS code 2915907090
Irradiation / ionization This product has not been treated with ionizing radiation during or after the
manufacturing process
Kosher This product is kosher certified
Latex No data available

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Manufacturing location South east Asia

Microbiological data This product is not monitored on microbiological parameters. High processing
temperatures and very low water content of the final product decrease the risk of
microbial contamination
Nanomaterials This product doesn’t contain any ingredients classified as nanomaterials according to
Commission Recommendation 2011/696 and regulation (EC) No. 1223/2009
Nutritional data For 100g : Energy 900Kcal, fat 0g, fat 100g which saturates 99g
Origin ~ 75-80% Myristic acid is derived from vegetable (palm oil)
~ 20-25% Isopropanol is from petrochemical/synthetic origin
Pesticide This product is not monitored on pesticides. A presence of pesticides in the finished
product is not expected to be present, with respect to the used raw materials and the
production process
Phthalate Phthalates are not added to this product during the manufacturing process. The
process itself doesn’t expect the formation of phthalates, therefore this product is
not monitored analytically
Preservative Preservatives are not added to this product during the manufacturing process,
therefore not monitored analytically
Process Fatty acid (myristic acid) + alcohol (isopropanol) → mixing → esterification → post
treatment → packaging
REACH This product is registered 01-2119541806-35
Residual Solvents The class 3 solvent isopropanol is used as a starting material for the production of
this product. The residue of this solvent is monitored with a threshold value of 50
ppm
RSPO This product is RSPO-MB certified, see our certificate on our website
www.interchimie.fr
Shelf Life before re-check 2 years
Substances of Very High Substances cited in the current SVHC candidate list or already included in annex XIV
Concern (SVHC) of regulation (EC) No 1907/2006, are not used as ingredients
Volatiles organic This product doesn’t show a vapor pressure above or equal to 0.01 kPa at 20°C and
compounds (VOC) needs therefore not to be classified as a VOC according to EU directive 1999/13 and
Swiss VOCV

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Ce document annule et remplace tous documents techniques et réglementaires précédents / This document
cancels and replaces all technical and regulatory previous documents.