COSMETIC PRODUCT SAFETY REPORT

for cosmetic product – SHOWER CREAM-GEL “GREEN TEA AND CUCUMBER”

(TRADE MARK: DALAS)

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PART A – Cosmetic product safety information

1. COSMETIC PRODUCT INFORMATION
Trade Mark: DALAS
Product name: SHOWER CREAM-GEL “GREEN TEA AND CUCUMBER”
Safety report version: 1.00
Class of cosmetic product: Personal skin care product. Rinse-off product.
The manufacturer: LLC “UKRAINIAN-GERMAN COMPANY “2K”,
Address: Passage by Yuri Kozlovsky, 7/1, 29016, Khmelnytskyi, Ukraine
Assessors: SIA “SVS CosMedLab”, Address: Kartupelu street 45-3, Riga, Latvia,
LV-1058
Raw materials:
Raw material trade name / Manufacturer/supplier %
(INCI Name)
LLC “UKRAINIAN-GERMAN COMPANY
Boдa питна (водопровiдна) / (Aqua) 75.0 – 85.0
“2K”
SULFOROKAnol L270/1 / (Sodium Laureth Sulfate
PCC Exol SA, Poland 12.5 – 13.9
(and) Aqua)
ROKamina K30 / (Aqua (and) Cocamidopropyl Betaine
PCC Exol SA, Poland 8.0 – 10.5
(and) Sodium Chloride)
Prisma Comercial Exportadora de Oleoquimicos
Glycerin / (Glycerin) 2-5
Ltda., Brazil
ROKAcet KO300G / (PEG-7 Glyceryl Cocoate) PCC Exol SA, Poland 1-4
Fragrance: Bamboo and Cucumber CFB 35648 /
“Aroma Ukraine” Ltd., Ukraine 0.1 - 1.0
(Parfum)
Sodium chloride dry / (Sodium Chloride) CIECH Soda Polska S.A., Poland 0.1 - 1.0
Экстракт огурца / (Aqua (and) Glycerin (and) Research-and-Production Company “Vilarus”
0.1 - 1.0
Cucumis Sativus Fruit Extract (and) Sodium Benzoate) Ltd., Ukraine
Green tea extract / (Camellia Sinensis Leaf Extract) Changsha Huir Biological-tech Co., Ltd., China 0.1 - 1.0
Amides, coco, N-(hydroxyethyl) / (Cocamide MEA) Spak Orgochem (India) Pvt., Ltd., India 0.1 - 1.0
Guangzhou Tinci Materials Technology Co.,
Tinci (R) POLYQUATA 550 / (Polyquaternium-7) 0.1 - 1.0
Ltd., China
Euperlan® PK 3000 AM / (Aqua (and) Glycol
Distearate (and) Laureth-4 (and) Cocamidopropyl
BASF T.O.V. LLC, Ukraine 0.5 – 2.0
Betaine (and) Sodium Chloride (and) Glycerin (and)
Formic Acid)
Citric Acid Monohydrate / (Citric Acid) Weifang Ensign Industry Co., Ltd., China 0.1 - 1.0
Euperlan® PCO / (Styrene/Acrylates Copolymer (and)
BASF T.O.V. LLC, Ukraine 0.1 – 0.5
Coco-Glucoside (and) Citric Acid (and) Benzoic Acid)
EDTA 4Na / (Tetrasodium EDTA) Shijiazhuang Jackchem Co., Ltd., China 0.1 - 0.4
Salimix MCI / (Aqua (and) Methylchloroisothiazolinone
Suppl. “ROSCOSMETICA” Ltd., Ukraine <0.1
(and) Methylisothiazolinone)
Amount: 100.00

2. QUANTITATIVE AND QUALITATIVE COMPOSITION OF THE COSMETIC PRODUCT

Amount, %
INCI CAS No. EC No. FUNCTION
(max.)
75 - 100
Aqua 7732-18-5 231-791-2 Solvent
(98.5220)

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Surfactant-Cleansing,
9 – 10
Sodium Laureth Sulfate 68891-38-3 500-234-8 Foaming,
(10.0000)
Emulsifying
Humectant,
Skin Conditioning,
2–5
Glycerin 56-81-5 200-289-5 Skin Protecting,
(5.0000)
Solvent,
Viscosity Controlling
Surfactant-Cleansing, Antistatic,
263-058-8/ Hair Conditioning, 3–4
Cocamidopropyl Betaine 61789-40-0
931-296-8 Foam Boosting, (4.0000)
Viscosity Controlling
Surfactant-Cleansing, 1–4
PEG-7 Glyceryl Cocoate 68201-46-7 -
Surfactant-Emulsifying (4.0000)
0.1 – 1.0
Parfum - - Perfuming
(1.0000)
0.1 – 1.0
Sodium Chloride 7647-14-5 231-598-3 Viscosity Controlling
(1.0000)
0.1 – 1.0
Cucumis Sativus Fruit Extract 89998-01-6 289-738-4 Skin Conditioning - Emollient
(1.0000)
Antioxidant, Humectant,
Camellia Sinensis Leaf Skin Conditioning, 0.1 – 1.0
84650-60-2 283-519-7
Extract Emollient, (1.0000)
Skin Protecting, Tonic
Surfactant – Foaming Boosting, 0.1 – 1.0
Cocamide MEA 68140-00-1 268-770-2
Viscosity Controlling (1.0000)
Antistatic,
0.1 – 1.0
Polyquaternium-7 26590-05-6 - Film Forming,
(1.0000)
Viscosity Controlling
Opacifying,
Skin Conditioning – Emollient, 0.1 – 1.0
Glycol Distearate 627-83-8 211-014-3
Surfactant – Emulsifying, (0.8000)
Viscosity controlling
77-92-9/ 0.1 – 1.0
Citric Acid 5949-29-2
201-069-1 Buffering, Chelating
(1.0000)
27306-39-4/
25034-86-0/ Opacifying, 0.1 – 1.0
Styrene/Acrylates Copolymer 25085-34-1/
-
Film Forming (0.2500)
9010-92-8
5274-68-0 226-097-1 Antistatic,
0.1 – 1.0
Laureth-4 9002-92-0 500-002-6 Surfactant – Cleansing,
68439-50-9 500-213-3 (0.4000)
Surfactant - Emulsifying
Chelating, 0.1 – 1.0
Disodium EDTA 139-33-3 205-358-3
Viscosity Controlling (0.4000)
≤0.1
Coco-Glucoside 110615-47-9 - Cleansing, Foaming, Surfactant
(0.1000)
<0.1
Benzoic Acid 65-85-0 200-618-2 Preservative
(0.0025)
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<0.1
Formic Acid 64-18-6 200-579-1 Preservative
(0.0060)
<0.1
Sodium Benzoate 532-32-1 208-534-8 Preservative
(0.0008)
Methylchloroisothiazolinone 26172-55-4 247-500-7 <0.0015
Preservative (CMI:MI=3:1)
Methylisothiazolinone 2682-20-4 220-239-6 (0.0015)
Limonene* 5989-27-5 227-813-5 Perfuming 0.0100
*The presence of the substance must be indicated in the list of ingredients referred to in Article
19(1)g when its concentration exceeds:
- 0.001% in leave-on products
- 0.01% in rinse-off products
Cosmetic product contains the allergen (Limonene) that must be declared on the product label in
the ingredients section according to EU Cosmetic Regulation.

3. PHYSICAL/CHEMICAL CHARACTERISTICS AND STABILITY OF THE COSMETIC PRODUCT

Purity and analytical specifications of raw materials are contained on the relevant Certificates of
Analysis / Sales Specifications, which are held by the manufacturer.
Raw material physical characteristics and suppliers’ hazard classifications are given in the safety
data sheets, which are held by the manufacturer.
The physical/chemical specification of the ingredients are well known and commonly used in
similar products. Their inclusions in the finished product at the specified concentrations do not
give rise to any concerns.
Physical/Chemical characteristics of the finished cosmetic product:

Parameter Method Specification

(ТУ У 20.4-37915506-002:2019)
Appearance Visual. Complies with the reference model. Homogeneous viscous gel mass. Pearlizing
agent is allowed.
Colour Visual. Complies with the reference model. White
Smell Organoleptic. Complies with the reference model. Characteristic
pH value pH meter 3.5 – 8.5 (tests result: 5.38)

The manufacturer (LLC “UKRAINIAN-GERMAN COMPANY “2K”, Ukraine) confirms

that the product is stable for 30 months from the manufacture date.
Samples of the SHOWER CREAM-GEL “GREEN TEA AND CUCUMBER” (TRADE
MARK: DALAS) were tested to assess the product’s stability. Samples of the product were
tested in at recommended temperature from +5 °C to +25 °C. Observations of the samples’
appearance, colour, odour, pH were made and recorded. The manufacturer confirms the stability
of the product within 30 months according to the technical specification (ТУ У 20.4-37915506-
002:2019 «Засоби косметичнi для очищення шкiры та волосся. Технiчнi умови» dated
07.10.2021).
The product is stable under reasonably foreseeable conditions of use during its shelf-life – 30
moths from the manufacture data.

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It was concluded that the product is stable under reasonably foreseeable conditions of use during
its shelf-life. The quality of goods is warranted under condition of their proper storage at
recommended temperature from +5 °C to +25 °C.

4. MICROBIOLOGICAL QUALITY

The objective of Hygiene Norm is to define microbiological qualitative and quantitative limits
for finished cosmetic products in order to ensure their microbiological safety.
Skin and mucous membranes are protected from microbial attack by a natural mechanical barrier
and various defence mechanisms. However, these may be damaged and slight trauma may be
caused by the action of some cosmetics that may enhance microbial infection. This may become
of particular concern when cosmetics are used around the eyes, on mucous membranes in
general, on damaged skin, on children under 3 years, on elderly people and persons with
compromised immune system. Consequently, two separate categories of cosmetic products are
defined in the microbiological quality control limits:
Category 1: Products specifically intended for children under 3 years, to be used in the eye area
and on mucous membranes.
Category 2: Other products.
Microbiological limits for SHOWER CREAM-GEL “GREEN TEA AND CUCUMBER”
(TRADE MARK: DALAS) are belong to Category 2.
Microbiological properties of the SHOWER CREAM-GEL “GREEN TEA AND
CUCUMBER” (TRADE MARK: DALAS) were tested by Laboratorija AUCTORITAS, Ltd,
Latvia, Test report No. 11817/22 (Sample delivered to laboratory in original packaging) dated
25.11.2022 with satisfactory results.
Microbiological test results:

Types of microorganism Regulatory Method Test Result

limit
Total Aerobic Mesophilic Microorganisms <1·103 LVS EN ISO 21149:2017 <1·101
(Bacteria plus yeast and mould) (CFU per 1 g)
Candida albicans (in per 1 g/ 1ml) Absent LVS EN ISO 18416:2016 Absent
Staphylococcus aureus (in per 1 g/ 1 ml) Absent LVS EN ISO 22718:2016 Absent
Pseudomonas aeruginosa (in per 1 g/ 1ml) Absent LVS EN ISO 22717:2016 Absent
Escherichia coli (in per 1 g/ 1ml) Absent ISO 21150:2015 Absent

A challenge test has been performed to test the efficacy of the preservation system of this
product. Evaluation of the antimicrobial protection of the product was tested by Laboratorija
AUCTORITAS, Ltd, Latvia, Test report No. 11817/22 (Sample delivered to laboratory in
original packaging) dated 25.11.2022 with satisfactory results. The product conforms to
specification LVS EN ISO 11930:2020, criterion A (Staphylococcus aureus, Escherichia coli,
Candida albicans, Aspergillus brasiliensis) and to specification LVS EN ISO 11930:2020,
criterion B (Pseudomonas aeruginosa).

5. IMPURITIES, TRACES, INFORMATION ABOUT THE PACKAGING MATERIAL

Cosmetic product SHOWER CREAM-GEL “GREEN TEA AND CUCUMBER” (TRADE

MARK: DALAS) contains preservatives Methylchloroisothiazolinone (and)
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Methylisothiazolinone (Salimix MCI) with two impurities (stabilizers): Magnesium Chloride

(max 0.8 %) – 0.0008 % (8 ppm) and Magnesium Nitrate (max 1.4 %) - 0.0014 % (14 ppm).
These ingredients are not prohibited and does not have restrictions in cosmetic products
according to the REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 30 November 2009 on cosmetic products. These two ingredients
are not prohibited, but as impurities in very small concentrations (8 and 14 ppm) are not declared
on the label.

Heavy metals:
The cosmetic regulation 1223/2009 prohibits the use of heavy metals such as lead, arsenic and
mercury unless they are present at trace levels and their presence is inevitable from correct
manufacturing processes. No heavy metals are listed in the product (ТУ У 20.4-37915506-
002:2019 «Засоби косметичнi для очищення шкiры та волосся. Технiчнi умови» and
ТУ У 20.4-42281913-002:2020 «Засоби косметичнi для догляду за шкiрою та волоссям.
Технiчнi умови». The highest percentage of input in the product is allocated to water (more than
75%). Water contains < 0.01 ppm Lead (Pb), < 0.01 ppm Arsenic (As), < 0.01 ppm Zinc (Zn), <
0.03 ppm Copper (Cu) - Boдa питна (водопровiдна), LLC “UKRAINIAN-GERMAN
COMPANY “2K”, Test report No. 2077 from 07.11.2022, conducted by the company ПП
НЦЛД « Еталон», Ukraine.
LLC UKRAINIAN-GERMAN COMPANY “2K” confirms that packaging complies with the
requirement&regulations which state that packaging may be safely used for cosmetic product
packaging.

Packaging materials:
Product packaging - primary Documentation
Colored HDPE Bottle (500 ml or 1000 ml) Material for bottles: HDPE (High Density
Polyethylene), Manufacturer: JV “Uz-Kor Gas
Chemical” LLC Republic of Uzbekistan, MSDS
dated 28.04.2021.
Colored prefabricated polymer bottle pump Manufacturer: Multipack Ltd., Ukraine.
white dispenser Pump dispenser material: PP (Polypropylen)
resin, MSDS dated 04.08.2021, Applicant: Fujian
Refining&Petrochmical Company Limited,
China.
Dyes: Dyes: Pearlizing agent, Article PE 1112 F,
Manufacturer: Private enterprise “Taycoon”,
Ukraine, MSDS and Quality Certificate No. 936
from 16.11.2022.

The product is packaged in suitable for the cosmetic hermetic package. Packaging material is
stable under normal conditions of use.

6. NORMAL AND REASONABLY FORESEEABLE USE

SHOWER CREAM-GEL “GREEN TEA AND CUCUMBER” (TRADE MARK: DALAS)

500 g (or 1000 g)
Shower cream-gel “Green Tea and Cucumber” nourishes and moisturizes skin, tones up it, please
it with a gentle and bright aroma. Green tea extract helps fight free radicals in skin and has a

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calming effect. The product gently cares for body.

Method of use: apply cream-gel on a washcloth or palm, lightly foam and spread it over body,
then rinse foam with water.
Warning: Keep out of reach of children. For external use only. Avoid contact with eyes. In case
of contact with eyes, rinse immediately with plenty of water. In case of any adverse reactions,
stop using and seek for medical advice.
Storage conditions: Store in the packaging of the manufacturer at a temperature of +5ºC to
+25ºC away from direct sunlight and air humidity 50-80%, as well as not less than 1 meter away
from heating devices.
Shelf life: 30 months. Use before: (month,day) and Batch number to be specified on the package.
INGREDIENTS: Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, PEG-7
Glyceryl Cocoate, Coco-Glucoside, Parfum, Sodium Chloride, Cucumis Sativus (Cucumber)
Fruit Extract, Cocamide MEA, Styren/Acrylates Copolymer, Camellia Sinensis Leaf Extract,
Polyquaternium-7, Glycol Distearate, Citric Acid, Benzoic Acid, Formic Acid, Tetrasodium
EDTA, Laureth-4, Sodium Benzoate, Methylchloroisothiazolinone, Methylisothiazolinone,
Limonene.
Normal (as shower gel, 1.43 times a day) use 18.67 g/day and reasonably foreseeable (hand wash
soap, 10 times a day) use 20 g/day.
Normal application area: total body area
Reasonably foreseeable application area: area hands

7. EXPOSURE TO THE COSMETIC PRODUCT

Cosmetic product application areas: total body area and hands area
Normal area of skin contact: 17500 cm2 (SCCS 11th Revision*)
Reasonably foreseeable area of skin contact: 860 cm2 (SCCS 11th Revision*)
Duration of contact: Rinse-off product.
Quantity of product used at application: 18.67 g normal use; 20 g – reasonably foreseeable
use. (SCCS 11th Revision*)
Frequency of application: for normal use 1.43 times a day, for reasonably foreseeable
application use 10 times a day. (SCCS 11th Revision*)
Normal use way: body skin cleansing
Reasonably foreseeable use way: hand skin cleansing
Consumer target group: adults
Name Short name, unit Explanation
Systemic Exposure Dose (d. Dermis) SED (mg/kg bw/day) Per 1 kg body weight to day 1
Dermal Absorption DAp (%) Accepted as 100
Retention Factor Fret (-) 0.01 (don't have unit)
Frequency of application of the finished F (1/day) or (day -1) 1.43 (as shower gel)
product 10 (hands soap)
Skin Surface Area expected to be treated SSA (cm2) 17500 (as shower gel)
with the finished cosmetic product 860 (hands soap)
Body weight (adults) kg 60 kg – default human body weight
Mode of application Specific exposure
Normal use As shower gel – 1.43 times a day
Reasonable use As hands soap – 10 times a day
*The Scientific Committee on Consumer Safety Notes of Guidance for The Testing of Cosmetic Ingredients and
Their Safety Evaluation 11th Revision SCCS/1628/21. The SCCS adopted this quidance document at its plenary
meeting on 30-31 March 2021.

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8. EXPOSURE TO THE SUBSTANCES

EXPOSURES OF RAW MATERIALS CALCULATION:

SED = Eprod. x C/100 x DAp/100
SED (mg/kg bw/day) – Systemic Exposure Dosage
Eprod. (mg/kg bw/day) – Estimated daily exposure to a cosmetic product per kg body weight,
based upon the amount applied and the frequency of application
C (%) - concentration of the substance under study in the finished cosmetic product on the
application site
DAp (%) - Dermal Absorption expressed as a percentage of the test dose assumed to be applied
in real-life conditions.
In the case of no dermal absorption data available, 100% dermal absorption is used.

DAp , Normal use Reasonably foreseeable use

INCI name C, % Eprod. SED (mg/kg*d) Eprod. SED (mg/kg*d)
% (mg/kg bw/day) (mg/kg bw/day)
Aqua 98.5220 100 2.79 2.748764 3.33 3.280782
Sodium Laureth Sulfate 10.0000 100 2.79 0.279000 3.33 0.333000
Glycerin 5.0000 100 2.79 0.139500 3.33 0.166500
Cocamidopropyl Betaine 4.0000 100 2.79 0.111600 3.33 0.133200
PEG-7 Glyceryl Cocoate 4.0000 100 2.79 0.111600 3.33 0.133200
Parfum 1.0000 100 2.79 0.027900 3.33 0.033300
Parfum contains:
Limonene 0.0100 100 2.79 0.000279 3.33 0.000333
Sodium Chloride 1.0000 100 2.79 0.027900 3.33 0.033300
Cucumis Sativus Fruit Extract 1.0000 100 2.79 0.027900 3.33 0.033300
Camellia Sinensis Leaf Extract 1.0000 100 2.79 0.027900 3.33 0.033300
Cocamide MEA 1.0000 100 2.79 0.027900 3.33 0.033300
Polyquaternium-7 1.0000 100 2.79 0.027900 3.33 0.033300
Glycol Distearate 0.8000 100 2.79 0.022320 3.33 0.026640
Citric Acid 1.0000 100 2.79 0.027900 3.33 0.033300
Styrene/Acrylates Copolymer 0.2500 100 2.79 0.006975 3.33 0.008325
Laureth-4 0.4000 100 2.79 0.011160 3.33 0.013320
Disodium EDTA 0.4000 100 2.79 0.011160 3.33 0.013320
Coco-Glucoside 0.1000 100 2.79 0.002790 3.33 0.003330
Benzoic Acid 0.0025 100 2.79 0.000070 3.33 0.000083
Formic Acid 0.0060 100 2.79 0.000167 3.33 0.000200
Sodium Benzoate 0.0008 100 2.79 0.000022 3.33 0.000027
Methylchloroisothiazolinone
0.0015 100 2.79 0.000042 3.33 0.000050
Methylisothiazolinone
Stabilizers of Methylchloroisothiazolinone & Methylisothiazolinone:
Magnesium Chloride (0.8 %) 0.0008 100 2.79 0.000022 3.33 0.000027
Magnesium Nitrate (1.4 %) 0.0014 100 2.79 0.000039 3.33 0.000047

MARGIN OF SAFETY (MoS) CALCULATION:

MoS = PODsys/SED of raw materials

(If MoS>100 indicates that a cosmetic ingredient is considered safe for use)

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PODsys - is a dose descriptor for the systemic exposure to a substance and is calculated from the
oral POD by use of the proportion of the substance systemically absorbed. In this equation,
PODsys is NOAEL or LOAEL.

INCI nosaukums NOAEL, SED of raw SED of raw materials MoS MoS
mg/kg/day materials (Reasonably (Normal use) (Reasonably
(Normal use) foreseeable use) foreseeable use)
Aqua Not toxic 2.748764 3.280782 Not toxic Not toxic
Sodium Laureth Sulfate 225 0.279000 0.333000 806 676
Glycerin 1280 0.139500 0.166500 9176 7688
Cocamidopropyl Betaine 750 0.111600 0.133200 6720 5631
PEG-7 Glyceryl Cocoate 3000 0.111600 0.133200 26882 22523
Parfum Not
0.027900 0.033300 Not applicable Not applicable
applicable
Parfum contains::
Limonene 215 0.000279 0.000333 770609 645646
Sodium Chloride 2533 0.027900 0.033300 90789 76066
Cucumis Sativus Fruit Extract Not toxic 0.027900 0.033300 Not toxic Not toxic
Camellia Sinensis Leaf Extract Not toxic 0.027900 0.033300 Not toxic Not toxic
Cocamide MEA 750 0.027900 0.033300 26882 22523
Polyquaternium-7 2000 0.027900 0.033300 71685 60060
Glycol Distearate 1000 0.022320 0.026640 44803 37538
Citric Acid 4000 0.027900 0.033300 143369 120120
Styrene/Acrylates Copolymer 200 0.006975 0.008325 28674 24024
Laureth-4 500 0.011160 0.013320 44803 37538
Disodium EDTA 500 0.011160 0.013320 44803 37538
Coco-Glucoside 1000 0.002790 0.003330 358423 300300
Benzoic Acid 500 0.000070 0.000083 7168459 6006006
Formic Acid 400 0.000167 0.000200 2389489 2002002
Sodium Benzoate 300 0.000022 0.000027 13440860 11261261
Methylchloroisothiazolinone
2.8 0.000042 0.000050 66906 56056
Methylisothiazolinone
Stabilizers of Methylchloroisothiazolinone & Methylisothiazolinone:
Magnesium Chloride 140 0.000022 0.000027 6272401 5255255
Magnesium Nitrate 1500 0.000039 0.000047 38402458 32175032

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9. TOXICOLOGICAL PROFILE OF THE SUBSTANCES

INGREDIENTS CAS No. Introduction,% Acute oral Subchronic Dermal irritation, CMR toxicity Remarks
(INCI Name) by quantity toxicity, LD50 toxicity, sensitisation, (Carcinogenic,
(maximum) mg/kg NOAEL, Acute dermal toxicity - mutagenic,
mg/kg/day LD50 mg/kg reprotoxic)
Not skin irritant and -
Aqua 7732-18-5 98.5220 Not toxic Not toxic
not sensitising
Not toxic

>2000 Causes serious eye

Sodium Laureth No evidence of
Sulfate
68891-38-3 10.0000 4100 >225 Causes skin irritation.
CMR toxicity
damage.
Not sensitising.
56750 (guinea pig) -
No evidence of
Glycerin 56-81-5 5.0000 >11500 1280 (rat) Not skin irritant and
CMR toxicity
not sensitising
>2000 (rabbit) Causes serious eye
Cocamidopropyl No evidence of
Betaine
61789-40-0 4.0000 >2000 750 Not skin irritant and
CMR toxicity
damage.
not sensitising
-
>2000
PEG-7 Glyceryl 66105-29-1/ No evidence of
Cocoate 68201-46-7
4.0000 >2000 3000* Not skin irritant and
CMR toxicity
not sensitising
>2000 (not classified)
>2000 (not not Causes skin irritation. No evidence of Causes serious eye
Parfum - 1.0000 classified) applicable May cause an allergic CMR toxicity irritation.
skin reaction.
Parfum contains:
> 5000 (rabbit) Allergen
Causes skin irritation. No evidence of
Limonene 5989-27-5 0.0100 >2000 215
May cause an allergic CMR toxicity
skin reaction.
>10000 (rabbit)
No evidence of
Sodium Chloride 7647-14-5 1.0000 3550 2533** Not skin irritant and
CMR toxicity
-
not sensitising
>2000 (not classified) -
Cucumis Sativus >2000 (not No evidence of
Fruit Extract
89998-01-6 1.0000 classified)
Not toxic Causes skin irritation.
CMR toxicity
Not sensitising.
>2000 (not classified) Food additive.
Camellia Sinensis >2000 (not No evidence of
Leaf Extract
84650-60-2 1.0000 classified)
Not toxic Not skin irritant and
CMR toxicity
not sensitising
>2000 Causes serious eye
No evidence of
Cocamide MEA 68140-00-1 1.0000 >5000 (rat) >750 Causes skin irritation.
CMR toxicity
damage.
Not sensitising.

>2000 (rat) -
No evidence of
Polyquaternium-7 26590-05-6 1.0000 >5000 (rat) 2000 (rat) Not skin irritant and
CMR toxicity
not sensitising

>2000 (rat) -
No evidence of
Glycol Distearate 627-83-8 0.8000 >2000 (rat) 1000 (rat) Not skin irritant and
CMR toxicity
not sensitising
>2000 Causes serious eye
77-92-9/ No evidence of
Citric Acid
5949-29-2
1.0000 >3000 4000 Not skin irritant and
CMR toxicity
irritation
not sensitising
27306-39-4/ -
>2000
Styrene/Acrylates 25034-86-0/ No evidence of
Copolymer 25085-34-1/
0.2500 >2000 200 Not skin irritant and
CMR toxicity
not sensitising
9010-92-8
>3000 (rabbit) -
No evidence of
Laureth-4 68439-50-9 0.4000 >2000 (rat) 500 (rat) Not skin irritant and
CMR toxicity
not sensitising
>2000 (rat) -
No evidence of
Disodium EDTA 139-33-3 0.4000 2800 (rat) >500 (rat) Not skin irritant and
CMR toxicity
not sensitising

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>2000 (rabbit) Causes serious eye
No evidence of
Coco-Glucoside 110615-47-9 0.1000 >5000 (rat) 1000 Causes skin irritation.
CMR toxicity
damage.
Not sensitising
>2000 (rat) Causes serious eye
No evidence of
Benzoic Acid 65-85-0 0.0025 >2000 500 (rat) Causes skin irritation.
CMR toxicity
damage.
Not sensitising.
>2000 (rat) -
Causes severe skin No evidence of
Formic Acid 64-18-6 0.0060 730 (rat) 400 (rat)
buns and eye damage. CMR toxicity
Not sensitising.
>2000 (rat) Causes serious eye
No evidence of
Sodium Benzoate 532-32-1 0.0008 10500 (rat) 300 (rabbit) Not skin irritant and
CMR toxicity
damage.
not sensitising
Maximum allowed
Methylchloroiso- Calc. 117,82
26172-55-4 concentration
thiazolinone Causes severe skin
No evidence of 0.0015%, rinse-off
0.0015 50 – 78.5 2.8 burns and eye damage.
CMR toxicity products only.
Methylisothiazo- May cause an allergic
2682-20-4 Causes serious eye
linone skin reaction.
irritation
Stabilizers of Methylchloroisothiazolinone & Methylisothiazolinone:
2000 (rat) -
Magnesium No evidence of
Chloride
7786-30-3 0.0008 5000 (rat) 140 (rat) Not skin irritant and
CMR toxicity
not sensitising
5000 (rat) -
Magnesium No evidence of
Nitrate
10377-60-3 0.0014 2000 (rat) 1500 (rat) Not skin irritant and
CMR toxicity
not sensitising
* As PEG-8 caprylic/capric glycerides
** As LOEL

Comments: The calculation was made taking into account the information provided by the
manufacturer and authoritative literature sources.
Documents from manufacturer LLC “UKRAINIAN-GERMAN COMPANY “2K”:
1. Aqua: Boдa питна (водопровiдна), LLC “UKRAINIAN-GERMAN COMPANY “2K”, Test
report No. 2077 dated 07.11.2022. Test report from ПП НЦЛД « Еталон», Ukraine.
2. SULFOROKAnol L270/1 / (Sodium Laureth Sulfate (and) Aqua) - MSDS (PCC Exol SA,
Poland) dated 01.10.2019, version No. 4.
3. ROKamina K30 / (Aqua (and) Cocamidopropyl Betaine (and) Sodium Chloride) - MSDS
(PCC Exol SA, Poland) dated 22.11.2019., version No. 2.
4. Glycerin / (Glycerin) - MSDS (Prisma Comercial Exportadora de Oleoquimicos Ltda., Brazil)
dated 28.04.2014, version No. 0.1.
5. ROKAcet KO300G / (PEG-7 Glyceryl Cocoate) - MSDS (PCC Exol SA, Poland) dated
04.09.2020, version No. 3.
6. Fragrance: Bamboo and Cucumber CFB 35648 / (Parfum) - MSDS (“Aroma Ukraine”
Ltd., Ukraine) dated 06.05.2021, Version No. EN 4.6 and List of Allergen, Version En4.6 dated
18.10.2022.
7. Sodium chloride dry / (Sodium Chloride) – Product Specification (CIECH Soda Polska S.A.,
Poland) No SP/ZLJ/05 dated 22.12.2016.
8. Экстракт огурца / (Aqua (and) Glycerin (and) Cucumis Sativus Fruit Extract (and) Sodium
Benzoate) - MSDS (Research-and-Production Company “Vilarus” Ltd., Ukraine) dated
30.06.2022, Red.: 1.
9. Green tea extract / (Camellia Sinensis Leaf Extract) - MSDS (Changsha Huir Biological-tech
Co., Ltd., China) dated 16.11.2017.
10. Amides, coco, N-(hydroxyethyl) / (Cocamide MEA) - MSDS (Spak Orgochem (India) Pvt.,
Ltd., India) dated 14.12.2017.

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11. Tinci (R) POLYQUATA 550 / (Polyquaternium-7) - MSDS (Guangzhou Tinci Materials
Technology Co., Ltd., China), Version: A/2 dated 19.03.2013.
12. Euperlan® PK 3000 AM / (Glycol Distearate (and) Laureth-4 (and) Cocamidopropyl
Betaine) - MSDS (BASF T.O.V. LLC, Ukraine), Version: 1.0 dated 11.04.2017 and Technical
Information, Revision 8.0 dated 30.01.2020.
13. Citric Acid Monohydrate / (Citric Acid) - MSDS (Weifang Ensign Industry Co., Ltd.,
China) dated 08.11.2017.
14. Euperlan® PCO / (Styrene/Acrylates Copolymer (and) Coco-Glucoside (and) Citric Acid
(and) Benzoic Acid) – Technical Information (BASF T.O.V. LLC, Ukraine), Revision 8.1 and
Composition Sheet, Revision 1.0.
15. EDTA 4Na / (Disodium EDTA) - MSDS (Suppl. “Shijiazhuang Jackchem Co.”, Ltd., China)
dated 16.07.2019, Version No. 1.0.
16. Salimix MCI / (Aqua (and) Methylchloroisothiazolinone (and) Methylisothiazolinone) -
MSDS (Suppl. “ROSCOSMETICA” Ltd., Ukraine), Version No. EN 4.1. from 10.04.2019.

REFERENCE LIST (authoritative literature sources):

(Descriptions, Acute toxicity, NOAEL values, Dermal irritation, other toxicity)

Sodium Laureth Sulfate:

Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
In the test substance was not rinsed off for 48 h. Here 0.9% of the applied test substance was
absorbed through the rat skin. Thus, under these stringent conditions, absorption is considered to
be very low.
Sodium laureth sulfate was demonstrated to be a dermal and ocular irritant but not a sensitizer.
Sodium laureth sulfate is used as shampoo, bath, and skin-cleansing ingredients, primarily
because of both they high degree of foaming and detergency and their “softness” to the skin.
The CIR (Cosmetic Ingredient Review) Expert Panel concluded that ingredient is safe as
cosmetic ingredient in the practices of use and concentrations as described in CIR safety
assessment (Personal hygiene products: Bath soaps and detergent to 47%).
- Final Report of the Amended Safety Assessment of Sodium Laureth Sulfate and Related Salts
of Sulfated Ethoxylated Alcohol. CIR International Journal of Toxicology 29(Supplement 3)
151S-161S, 2010.
- Information from the ECHA website (Sodium Laureth Sulfate):
https://echa.europa.eu/de/registration-dossier/-/registered-dossier/15887

Glycerin:
Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
The CIR (Cosmetic Ingredient Review) Expert Panel concluded that ingredient is safe as
cosmetic ingredient in the practices of use and concentrations as described in CIR safety
assessment (Rinse-off products up to 99.4 %).
- Safety Assessment of Glycerin as Used in Cosmetics. CIR Final Report, January 14, 2015.
- Information from the ECHA website (Glycerin):
https://echa.europa.eu/lv/registration-dossier/-/registered-dossier/14481

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Cocamidopropyl Betaine:
Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
Cocamidopropyl betaine (CAPB) is a zwitterion used primarily as a surfactant in cosmetic
products.
The CIR Expert Panel (the Panel) concluded that Cocamidopropyl Betaine is safe for use in rinse
off cosmetic products at the current levels of use.
- Final Report of the Cosmetic Ingredient Review Expert Panel on the Safety Assessment of
Cocamidopropyl Betaine (CAPB). CIR, Ingredient Journal of Toxicology 31(Supplement 1)
77S-111S, 2012.
- Information from the ECHA website (Cocamidopropyl Betaine):
https://echa.europa.eu/de/registration-dossier/-/registered-dossier/25362

PEG-7 Glyceryl Cocoate:

Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
Groups of 10 male rats were fed a diet containing 0, 2.5, 5.0, or 7.5% of a formulation containing
0.8% PEG-7 glyceryl cocoate for 28 days. All animals survived until study termination. For all
groups, select tissues were weighed at necropsy. Select tissues of animals in the control and
high-dose group were examined microscopically. Spleen weights were significantly decreased in
high-dose animals; although there were no associated microscopic changes, the researchers
stated the change could be associated with dosing. Soft feces, a distended cecum, and enlarged
mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-
observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 glyceryl
cocoate.
The CIR (Cosmetic Ingredient Review) Expert Panel concluded that ingredient is safe as
cosmetic ingredient in the practices of use and concentrations as described in CIR safety
assessment (PEG-7 glyceryl cocoate has the hight rinse-off concentration of use reported, i.e.,
10% in skin cleansing products).
- Information from the ECHA website (PEG-7 Glyceryl Cocoate):
https://echa.europa.eu/de/information-on-chemicals/cl-inventory-database/-/discli/details/125990
- Safety Assessment of PEGylated Alkyl Glycerides As Used in Cosmetics. Cosmetic Ingredient
Review, Final Report, Release Date January 13, 2015.

Parfum (Fragrance):
The perfume composition is a mixtures of natural and/or synthetic origin for which it is not
possible to determine an exact NOAEL value.

Limonene (from Fragrance):

Limonene is fragrance component, very low concentration.
Ingredient is not prohibited in cosmetic products according to the REGULATION (EC) No
1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November
2009 on cosmetic products. Limonene has restriction in REGULATION (EC) No 1223/2009
ANNEX III List of Substances Which Cosmetic Products Must not Contain except subject to the
Restrictions Laid Down, Reference number: 88. The presence of the substance must be indicated
in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds: - 0.001%
in leave-on products or 0.01% in rinse-off products.

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- Information from the ECHA website (Limonene):

https://echa.europa.eu/registration-dossier/-/registered-dossier/15256
- Exposure and Risk Assessment on Lower Risk Pesticide Chemicals, D-Limonene, Special
Review and Reregistration Division Office of Pesticide Programs U.S. Environmental Protection
Agency 1801 South Bell Street Arlington, VA 22202
- Consideration of Aliphatic and alicyclic and aromatic hydrocarbons evaluated by JECFA (63 rd
meeting) structurally related to aliphatic and aromatic hydrocarbons evaluated by EFSA in
FGE.25, Scientific Opinion of the Panel on Food Additives, Flavouring, Processing Aids and
Materials in Contact with Food (AFC), The EFSA Journal (2009) 931, 1-59.

Sodium Chloride:
Ingredient not prohibited and does not have restrictions in cosmetic products accordance
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
Sodium chloride is a naturally occurring material, and is a normal part of the human body. At
low concentrations as used in bathing, or at higher amounts in salt scrub products, there is no
skin irritation. It is considered that sodium chloride is safe as used in the current application.
Sodium chloride has been used to flavor and preserve foods for thousands of years.
- Information from the ECHA website (Sodium Chloride):
https://echa.europa.eu/de/registration-dossier/-/registered-dossier/15467

Cucumis Sativus Fruit Extract:

Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
Cucumber fruit is composed mostly of water; that is, more than 96% of the edible unpeeled fruit
is water. Other constituents of C sativus L are vitamins, minerals, amino acids, phytosterols,
phenolic acids, fatty acids, and cucurbitacins. According to another source, traces of essential oil,
amino acids, pectins, starch, sugars, vitamin C, and cucurbitacins are found in cucumbers.
Glycosides, steroids, flavonoids, carbohydrates, terpenoids, and tannins were identified in an
aqueous extract of the cucumber fruit.
Cucumis sativus (cucumber) fruit extract. A single insult patch test was performed on 20 patients
with C sativus (cucumber) fruit extract composed of 54.8% water, 45% butylene glycol, and
0.2% cucumber. The extract was diluted in water to 1% and 15 mL were applied for 24 hours
under an occlusive patch. No erythema or edema was observed at 24 or 48 hours. To test for
dermal irritation, cosmetic formulations containing 0.5% to 2.5% ethanol extract of C sativus
were prepared as oil-in-water emulsion-based creams, with stearic acid as the emulsifier. The pH
of the 7 formulations that were prepared ranged from 6.4 to 6.9. The irritancy was evaluated by
applying the creams to a 1 cm2 area on the dorsal surface of the hand and observing signs of
irritation for 24 hours. (The number of patients tested was not stated.) No irritation, erythema, or
edema was observed.
Summary data from a 21-day use study in which 21 patients applied an eye gel containing 5% C
sativus (cucumber) fruit extract 1 to 2 times daily were provided to the CIR. Eight patients
reported sensations of discomfort (primarily stretching) after application but no clinically
significant cutaneous reactions were observed. Dermal assessments were performed, and it was
concluded that the eye gel was well tolerated. (No other details or raw data were provided).
A 28-day use study was performed to determine the dermal irritation potential of an eye lotion
containing 1% C sativus (cucumber) fruit extract. Thirty female patients were instructed to apply
the test material under the eye area and to the eyebrow area, avoiding the eyelid, up to 2 times

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daily for 4 weeks. The skin in the eye area was evaluated for dermal effects. One patient reported
slight itching on the eyelids almost daily. The eye lotion containing 1% C sativus (cucumber)
fruit extract did not demonstrate a potential for eliciting dermal irritation in the eye area.
- Cucumis Sativus (Cucumber)-Derived Ingredients as Used in Cosmetics, CIR, March 16, 2012.

Camellia Sinensis Leaf Extract:

Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
The CIR Expert Panel concluded that ingredient is safe as cosmetic ingredient in the practices of
use and concentrations as described in CIR safety assessment (Camellia Sinensis Leaf Extract
was reported to be used in rinse-off products up to 2%).
- Safety Assessment of Camellia sinensis- Derived Ingredients As Used in Cosmetics. CIR,
International Journal of Toxicology 2019, Vol. 38(Supplement 3) 48S-70S.

Cocamide MEA:
Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
Most of the ethanolamides are reported (the CIR (Cosmetic Ingredient Review) Expert Panel) to
function in cosmetics as hair-conditioning agents, skin-conditioning agents, and surfactant—
foam boosters. Cocamide MEA has the highest frequency of use. Cocamide MEA is reported to
be used at up to 18% in rinse-off formulations and at up to 5% in leave-on formulations.
- Safety Assessment of Ethanolamides as Used in Cosmetics. CIR, International Jouranl of
Toxicology 2015, Vol. 34(Supplement 1) 18S-34S.
- Information from the ECHA website (Cocamide MEA):
https://echa.europa.eu/de/information-on-chemicals/cl-inventory-database/-/discli/details/114617

Polyquaternium-7:
Ingredient is not prohibited in cosmetic products according to the REGULATION (EC) No
1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November
2009 on cosmetic products. Polyquaternium-7 have restriction in REGULATION (EC) No
1223/2009 ANNEX III List of Substances Which Cosmetic Products Must not Contain except
subject to the Restrictions Laid Down, Reference number: 66. Maximum residual acrylamide
content 0.5 mg/kg. Dermal exposure of rats to 2.25 ml/kg per day for 14 weeks was nonirritating
to both intact and abraded skin. Dermal exposure of rabbits to an 8% solution produced no
irritation, and ocular exposure showed mild irritation that cleared after 24 h. Polyquaternium-7
was not mutagenic in an Ames test. Repeated insult patch test data suggest that 8%
Polyquaternium-7 is at best a mild cumulative irritant, but not a sensitizer. Clinical tests with an
8% solution indicated that Polyquaternium-7 is not a photosensitizer. Given its structure, this
material is considered not likely to be significantly absorbed in the skin and therefore is unlikely
to produce general toxicity, developmental toxicity, or mutagenic/carcinogenic effects under use
conditions. The presence of unreacted acrylamide monomer is considered sufficiently low so as
to have no toxicologic significance. Based on the available data, it is concluded that
Polyquaternium-7 is safe for use in cosmetic formulations. The CIR (Cosmetic Ingredient
Review) Expert Panel concluded that ingredient is safe as cosmetic ingredient (Shampoo from
0.04 % to 1 %).
- Information from the ECHA website (Polyquaternium-7):
https://echa.europa.eu/lv/substance-information/-/substanceinfo/100.113.772

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- Information from the Journal of rhe American College of Toxicology (Polyquaternium-7):

https://journals.sagepub.com/doi/pdf/10.3109/10915819509010307

Glycol Distearate:
Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
- Information from the ECHA website:
https://echa.europa.eu/de/registration-dossier/-/registered-dossier/15184

Citric Acid:
Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
The CIR Expert Panel considered that the oral safety of citric acidm has been well substantiated
in that this ingredients is food additives.
Available repeated insult patch testing at the highest leave-on concentration of 4% citric acid
demonstrated an absence of both dermal irritation and sensitization, suggesting that these
ingredients would not be irritants in formulation.
- Safety Assessment of Citric Acid, Inorganic Citrate Salts, and Alkyl Citrate Esters as Used in
Cosmetics. CIR, International Journal of Toxicology 2014, Vol. 33(Supplement 2) 16S-46S.
- Information from the ECHA website (Citric Acid):
https://echa.europa.eu/de/registration-dossier/-/registered-dossier/15451/1

Styrene/Acrylates Copolymer:
Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
The CIR (Cosmetic Ingredient Review) Expert Panel concluded that ingredient is safe as
cosmetic ingredient in the practices of use and concentrations as described in CIR safety
assessment (Total up to 8.2%).
- Safety Assessment of Styrene and Vinyl-type Styrene Copolymers as Used in Cosmetics. CIR,
Final Report, October 2, 2014.

Laureth-4:
Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
- Information from the ECHA website:
https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16040/7/3/1

Disodium EDTA:
Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
Dermal absorption was investigated for human volunteers indicating only 0.001 % absorption for
CaNa2EDTA. It is concluded that systemic exposure via dermal route is negligible. This
conclusion is supported by the independent evaluation of the MAK Commission for the
Investigation of Health Hazards of Chemical Compounds in the work area.

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The CIR (Cosmetic Ingredient Review) Expert Panel concluded that ingredient is safe as
cosmetic ingredient in the practices of use and concentrations as described in CIR safety
assessment (Total concentration ranges to 0.3%).
- Final Report on the Safety Assessment of EDTA, Calcium Disodium EDTA, Diammonium
EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium
EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA. CIR, International Journal of
Toxicology, 21(Suppl. 2):95-142, 2002.

Coco-Glucoside:
Ingredient is not prohibited and does not have restrictions in cosmetic products according to the
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 30 November 2009 on cosmetic products.
In clinical testing, the sensitization potential of 0.5%, 0.75%, and 1.8% ai decyl glucoside (in
formulation), 5% ai aq decyl and lauryl glucoside, and 1% ai aq coco-glucoside was evaluated in
a human repeated insult patch test (HRIPT). These ingredients were not irritating or sensitizing.
The CIR (Cosmetic Ingredient Review) Expert Panel concluded that ingredient is safe as
cosmetic ingredient in the practices of use and concentrations as described in CIR safety
assessment (Rinse-off products from 0.2 % to 15 %).
- Information from the ECHA website (Coco-Glucoside):
https://echa.europa.eu/es/registration-dossier/-/registered-dossier/14407
- Safety Assessment of Decyl Glucoside and Other Alkyl Glucosides as Used in Cosmetics, CIR

Benzoic Acid:
Benzoic Acid is included in the REGULATION (EC) No. 1223/2009 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products, Annex
V (List of preservatives allowed in cosmetic products), reference number 1 - Maximum
concentration in ready for use preparation (Rinse-off products, except oral products ) is 2.5%.
The results, presented only in scientific papers, are from studies both on volunteers and patients
from dermatological clinics. 2% benzoic acid in petrolatum over 46h did not irritate intact skin
of healthy volunteers. 24h application of 30% benzoic acid in ethanol was found to be the lowest
irritating concentration.
Chamber test (20 min/occlusive), open test (30 min): 15 µl of 5 % benzoic acid in petrolatum, 15
atopic and 16 non-atopic patients. The atopics showed redness in both the chamber test, (73 %)
and the open test, (80 %). Non-atopics showed 80% redness in both the chamber test and in the
open test. There was no statistical difference between atopics and non-atopics.
8 out of 627 patients (1.3%) from dermatological clinics showed positive reactions to 5 %
benzoic acid, in petrolatum under an occlusive dressing for 24 or 48 h. At this concentration, the
authors suggest that these results could be interpreted as marginally irritating, rather than
allergic.
In the United States, benzoic acid and sodium benzoate are on the FDA list of substances that are
generally recognized as safe (GRAS). Both may be used as antimicrobial agents, flavouring
agents and as adjuvants with a current maximum level of 0.1% in food. The FDA has not
determined whether significantly different conditions of use would be GRAS. The FDA has
sought fully up-to-date toxicology information.
- Information from the ECHA website (Benzoic Acid):
https://echa.europa.eu/lv/registration-dossier/-/registered-dossier/13124
- Safety Assessment of Benzyl Alcohol, Benzoic Acid and its Salts, and Benzyl Benzoate, CIR,
International Journal of Toxicology 2017, Vol. 36(Supplement 3) 5S-30S

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- Opinion of The Scientific Committee on Cosmetic Products and Non-Food Products Intended
for Consumers, Benzoic Acid and Sodium Benzoate, SCCNFP/0531/01
- Scientific Committee on Consumer Products SCCP, Opinion on Benzoic Acid and Sodium
Benzoate, SCCP/0891/05

Formic Acid:
Formic Acid and its sodium salt are included in the REGULATION (EC) No. 1223/2009 OF
THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on
cosmetic products, Annex V (List of preservatives allowed in cosmetic products), reference
number 14 - Maximum concentration in ready for use preparation is 0.5 % (as acid).
- Safety Assessment of Formic Acid and Sodium Formate as Used in Cosmetics. International
Journal of Toxicology 2016. Vol. 35(Supplement 2) 41S-54S.
- Information from the ECHA website (Formic Acid):
https://echa.europa.eu/lv/registration-dossier/-/registered-dossier/15127

Sodium Benzoate:
Sodium Benzoate is included in the REGULATION (EC) No. 1223/2009 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products, Annex
V (List of preservatives allowed in cosmetic products), reference number 1 - Maximum
concentration in ready for use preparation (Rinse-off products, except oral products ) is 2.5% (as
acid).
The total maximum concentration of preservative in the final product does not exceed 0.01 %.
Sodium Benzoate concentration in this cosmetic product is safe for consumers under normal and
reasonably predictable use (MoS ratio is over 100).
- Information from the ECHA website (Sodium Benzoate):
https://echa.europa.eu/lv/registration-dossier/-/registered-dossier/14966
- Safety Assessment of Benzyl Alcohol, Benzoic Acid and its Salts, and Benzyl Benzoate, CIR,
International Journal of Toxicology 2017, Vol. 36(Supplement 3) 5S-30S

Methylchloroisothiazolinone and Methylisothiazolinone:

Reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one
(3:1) (CAS No. 55965-84-9, Index Number: 613-167-00-5).
Methylchloroisothiazolinone and Methylisothiazolinone mixture in the ratio 3:1 not prohibited in
cosmetic products accordance REGULATION (EC) No 1223/2009 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products.
Methylchloroisothiazolinone and Methylisothiazolinone mixture in the ratio 3:1 have restriction
in REGULATION (EC) No 1223/2009 ANNEX V List of Preservatives Allowed in Cosmetic
Products, Reference number: 39. Maximum concentration in ready for use preparation 0.0015%,
use rinse-off products only.
The mixture of 5-chloro-2-methylisothiazol-3(2H)-one (CMIT) and 2-methylisothiazol-3(2H)-
one (MIT), CMIT/MIT, is a preservative in cosmetics. CMIT/MIT is a highly effective
preservative; however, it is also a commonly known skin sensitizer. The concentration 0.0015%
of CMIT/MIT is the maximum MIT level allowed in current products. The no observed adverse
effect level (NOAEL) for CMIT/MIT was 2.8 mg/kg bw/day obtained from a two-generation
reproductive toxicity test, and the skin sensitization toxicity standard value for CMIT/MIT.
The SCCS concluded that the mixture of Methylchloroisothiazolinone and
Methylisothiazolinone in a ratio of 3:1 does not pose a risk to the health of the consumer when
used as a preservative up to a maximum authorised concentration of 0,0015 % in rinse-off
cosmetic products, apart from its skin sensitising potential. The SCCS indicated that induction

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and elicitation would be less likely in a rinse-off product than when the same concentration is
present in a leave-on product.
- Risk Assessment of 5-Chloro-2-Methylisothiazol-3(2H)-One/2-Methylisothiazol-3(2H)-One
(CMIT/MIT) Used as a Preservative in Cosmetics. Toxicological Research 2019;35:103-117.
- OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-
methylisothiazolin-3(2H)-one, COLIPA n° P56. The SCCS adopted this opinion at its 5th
plenary meeting of 8 December 2009.
Stabilizers:
1. Magnesium Chloride - Information from ECHA website:https://echa.europa.eu/registration-
dossier/-/registered-dossier/15140
2. Magnesium Nitrate - Information from ECHA website:https://echa.europa.eu/registration-
dossier/-/registered-dossier/16076/6/2/2

Information provided are from publicly available sources: CosIng (European Commission
database with information on cosmetic substances and ingredients), SCCS (Scientific Committee
on Consumer Safety), CIR (Cosmetic Ingredient Review), ECHA (European Chemicals Agency)
and other relevant scientific literature.

10. UNDESIRABLE EFFECTS AND SERIOUS UNDESIRABLE EFFECTS

Undesirable effects are not expected during normal and reasonably foreseeable use of cosmetic
product.

11. INFORMATION ON THE COSMETIC PRODUCT

No additional information is provided.

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PART B – Cosmetic product safety assessment

1. ASSESSMENT CONCLUSION

The safety assessment has been prepared for a cosmetic product that is meant for adults. All
calculated MoS values higher than 100. The calculation was made on Rinse-off product.
Through research and calculations, it was shown that the product SHOWER CREAM-GEL
“GREEN TEA AND CUCUMBER” (TRADE MARK: DALAS) is safe.
Product components in the given concentrations and product meet generally recognized as safe
in accordance with Regulation (EC) No 1223/2009.
Cosmetic product SHOWER CREAM-GEL “GREEN TEA AND CUCUMBER” (TRADE
MARK: DALAS) is safe for human health when used under normal or reasonably foreseeable
conditions of use.
This assessment is based on information that has been published in recognizing authoritative
literature, however, taking into account the accuracy of the information, the undersigned person
can not be held responsible for the submitted erroneous information that could be used in the
preparation of this assessment.
The safety assessment is based on information currently available and may be revised as soon as
new information becomes available.

2. LABELLED WARNINGS AND INSTRUCTIONS OF USE

SHOWER CREAM-GEL “GREEN TEA AND CUCUMBER” (TRADE MARK: DALAS)

500 g (or 1000 g)
Shower cream-gel “Green Tea and Cucumber” nourishes and moisturizes skin, tones up it, please
it with a gentle and bright aroma. Green tea extract helps fight free radicals in skin and has a
calming effect. The product gently cares for body.
Method of use: apply cream-gel on a washcloth or palm, lightly foam and spread it over body,
then rinse foam with water.
Warning: Keep out of reach of children. For external use only. Avoid contact with eyes. In case
of contact with eyes, rinse immediately with plenty of water. In case of any adverse reactions,
stop using and seek for medical advice.
Storage conditions: Store in the packaging of the manufacturer at a temperature of +5ºC to
+25ºC away from direct sunlight and air humidity 50-80%, as well as not less than 1 meter away
from heating devices.
Shelf life: 30 months. Use before: (month,day) and Batch number to be specified on the
package.
INGREDIENTS: Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, PEG-7
Glyceryl Cocoate, Coco-Glucoside, Parfum, Sodium Chloride, Cucumis Sativus (Cucumber)
Fruit Extract, Cocamide MEA, Styren/Acrylates Copolymer, Camellia Sinensis Leaf Extract,
Polyquaternium-7, Glycol Distearate, Citric Acid, Benzoic Acid, Formic Acid, Tetrasodium
EDTA, Laureth-4, Sodium Benzoate, Methylchloroisothiazolinone, Methylisothiazolinone,
Limonene.

There are no extra labelling requirements for this product.

In accordance with Regulation (EC) No. 1223/2009, article 19, there must be warnings stated on
the label: None.
The evaluation of the functional properties of the product declared by the manufacturer is not
part of this assessment.
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3. REASONING

The safety report for the product SHOWER CREAM-GEL “GREEN TEA AND
CUCUMBER” (TRADE MARK: DALAS) was done based on information from the suppliers
and other information publicly available. The available data do not suggest for the product
hazard.
This assessment is based on toxicological profile of the ingredients, toxicological/dermatological
documentations of the raw materials, level of exposure based on the conditions of applications,
material safety data sheets, legal regulations. The safety of the cosmetic product is based on the
safety of its ingredients and results of the clinical study, the product stability data. This cosmetic
product contains only the allowed ingredients in allowed concentrations.
The ingredients are not prohibited as per Cosmetic Regulation (EC) No. 1223/2009 and its
amendments and the safety assessment has been carried out in accordance with this regulation,
Annex I.
The calculation of the exposure to the product and to each of the ingredients in the cosmetic
product was carried out according to the “SCCS’s Notes of Guidance for the testing of cosmetic
ingredients and their safety evaluation, 11th revision SCCS/1628/21”. A retention factor of 0.01
is used, as this is a Rinse-off product.
In the case of raw materials which the results of chronic toxicity were available (NOAEL)
margin of safety (MoS) was calculated. Values are > 100, recommended as safe. All calculated
The Margins of Safety (MoS) of ingredients above 100, which supports the safety of the
cosmetic product.
NOAEL values are not applied to some components of this cosmetic product.
NOAEL value is not applied to fragrance composition. The manufacturer's recommendations are
followed. Fragrance is used in low concentration and is not expected to pose a risk to human
health.
NOAEL values are not applied to Cucumis Sativus Fruit Extract and Camellia Sinensis Leaf
Extract of this cosmetic product. Cucumis Sativus Fruit Extract and Camellia Sinensis Leaf
Extract are not toxic and are not classified according to the CLP Regulation. Cucumis Sativus
Fruit Extract and Camellia Sinensis Leaf Extract have a long history of use in cosmetic industry
and are well-known in cosmetics, the good researched ingredients, and these components is
widely used today in the manufacture of cosmetics. The manufacturer of the raw materials
guarantees that these ingredients are safe in the given concentration.
Cucumis Sativus Fruit Extract and Camellia Sinensis Leaf Extract are not prohibited and do not
have restrictions in cosmetic products according to the REGULATION (EC) No. 1223/2009 OF
THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on
cosmetic products. Cucumis Sativus Fruit Extract and Camellia Sinensis Leaf Extract are listed
Cosmetic ingredients database (CosIng).
It is not expected that any of the raw materials would pose a risk to human health at the intended
use frequency.
There were no incompatibility in the recipe.
Undesirable effects are not expected during normal and reasonably foreseeable use of cosmetic
product.
The manufacturer (LLC “UKRAINIAN-GERMAN COMPANY “2K”) confirms that the product
is stable for 30 months from the manufacture date.
It was concluded that the product is stable under reasonably foreseeable conditions of use during
its shelf-life. The quality of goods is warranted under condition of their proper storage at
recommended temperature from +5 °C to +25 °C.
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The manufacturer (LLC “UKRAINIAN-GERMAN COMPANY “2K”) confirms that packaging

complies with the requirement&regulations which state that packaging may be safely used for
cosmetic product packaging.
Microbiological properties of the SHOWER CREAM-GEL “GREEN TEA AND
CUCUMBER” (TRADE MARK: DALAS) were tested by Laboratorija AUCTORITAS, Ltd,
Latvia, Test report No. 11817/22 (Sample delivered to laboratory in original packaging) dated
25.11.2022 with satisfactory results.
A challenge test has been performed to test the efficacy of the preservation system of this
product. Evaluation of the antimicrobial protection of the SHOWER CREAM-GEL “GREEN
TEA AND CUCUMBER” (TRADE MARK: DALAS) was tested by Laboratorija
AUCTORITAS, Ltd, Latvia, Test report No. 11817/22 (Sample delivered to laboratory in
original packaging) dated 25.11.2022 with satisfactory results. The product conforms to
specification LVS EN ISO 11930:2020, criterion A (Staphylococcus aureus, Escherichia coli,
Candida albicans, Aspergillus brasiliensis) and to specification LVS EN ISO 11930:2020,
criterion B (Pseudomonas aeruginosa).
Cosmetic product SHOWER CREAM-GEL “RASPBERRY AND MINT” (TRADE MARK:
DALAS) is safe.
Cosmetic product SHOWER CREAM-GEL “RASPBERRY AND MINT” (TRADE MARK:
DALAS) complies with Regulation (EC) No. 1223/2009 of the European Parliament and of the
Council of 30 November 2009 on cosmetic products and The SCCS's Notes Of Guidance For
The Testing Of Cosmetic Ingredients And Their Safety Evaluation 11th Revision SCCS/1628/21.

4. ASSESSOR'S CREDENTIALS AND APPROVAL OF PART B

ASSESSOR: SIA “SVS CosMedLab” chemist J. Visnevska,

Riga Technical University, Engineering Master's degree in chemical technology
Diploma: Series PD E No. 0906, issued in Riga on 1 July 2011 (in the Annex No 1)
Work experience in chemistry: 16 years.

(J. Visnevska)

(signature)

Date: 10st February 2023

This safety report is based upon information available at this date. The safety of the product
should be reviewed on a regular basis. Reviews of this assessment should be conducted when
new information becomes available.

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