Dr Sara Robb

NEMO GmbH
Mergenthalerallee 77
65760 Eschborn
Germany

COSMETIC PRODUCT SAFETY REPORT

GOONGBE • PRI-MMUNE SOOTHING POWDER
REF: GBPMC060924DSR
Issued: 06 SEPTEMBER 2024

Prepared in accordance with ‘The UK Regulation’ Schedule 34 of the Product Safety

and Metrology Statutory Instrument and “Cosmetics Regulation” Regulation (EC) No.
1223/2009

© Dr Sara Robb 2024 1

 CONTENTS
INTRODUCTION
1 Validity of the Cosmetic Product Safety Report
2 Name and description of the cosmetic product
3 Responsible Person(s)

PART A COSMETIC PRODUCT SAFETY INFORMATION

1 Quantitative formulation and qualitative composition of the product
2 Composition: physical and chemical characteristics
3 Microbiological quality and Preservative Efficacy Test (PET)
4 Impurities and prohibited substances
5 Normal and reasonably foreseeable
6 Exposure to the cosmetic product
7 Exposure to the ingredients and Systemic Exposure Dose (SED)
8 Margin of Safety (MoS) and safety assessment of the ingredients
9 Undesirable effects and serious undesirable effects
10 Information on the cosmetic product and packaging

PART B COSMETIC PRODUCT SAFETY ASSESSMENT

1 Assessment conclusions
2 Instructions for use and product warnings
3 Reasoning
4 Safety assessor’s credentials and CPSR approval

REFERENCES

© Dr Sara Robb 2024 2

 INTRODUCTION

1 Validity of the Cosmetic Product Safety Report

This report remains valid until any of the following occur:
Amendments or changes to the regulatory requirements concerning cosmetic products
Reassignment of the Responsible Person
Alteration of the cosmetic product’s quantitative and qualitative formulation
Amendment or changes to the format or contents without the permission of the author
2 Name and description of the cosmetic product
GOONGBE Pri-Mmune Soothing Powder is a cosmetic product that belongs to the “skin
product” category.

3 Responsible Person(s)
European Union (EU)
Responsible Person: NEMO GmbH
Address: Mergenthalerallee 77, 65760 Eschborn Germany

United Kingdom (UK)

Responsible Person: Bath Potions Ltd
Address: 33 Avondale Road, London, N13 4DX, UK

© Dr Sara Robb 2024 3

PART A COSMETIC PRODUCT SAFETY INFORMATION
Part A of the Cosmetic Product Safety Report (CPSR) outlines the data necessary to
demonstrate that the cosmetic product is safe.

1 Quantitative formulation and qualitative composition of the cosmetic product

The composition of the cosmetic product is described below. Both quantitative and qualitative
composition of the cosmetic product are identified. Raw materials and the constituents of the
final product are described by maximum percentage (w/w). Each ingredient’s CAS Number,
and EINECS is provided when available. Intended function(s) are also described and
restrictions are noted.

MSDSs for raw materials are included in the PIF. These provide toxicological details for each
ingredient. Specific suppliers are not specified, however ingredients used to manufacture the
cosmetic product must have identical CAS numbers and INCI names, as well as meet all
purity standards for each ingredient.

Fragrance and perfuming ingredient documentation (essential oil, parfum and aroma) must
be provided in the PIF, including supplier’s identification, IFRA documents and allergen
declarations. Labelling must declare cosmetic allergens as specified by Article 19(1)(g) when
its concentration exceeds: — 0.001 % in leave-on products and — 0.01 % in rinse-off
products.

KAOLIN
Max % (w/w): 54.148900
Cas Number(s): 1332-58-7
EINECS: 310-194-1
Function(s):
Restriction: None

ZEA MAYS STARCH

Max % (w/w): 25.000000
Cas Number(s): 9005-25-8
EINECS: 232-679-6
Function(s): ABRASIVE, ABSORBENT, ANTICAKING, SKIN PROTECTING, VISCOSITY
CONTROLLING
Restriction: None

CAPRYLIC/CAPRIC TRIGLYCERIDE
Max % (w/w): 6.000000
Cas Number(s): 73398-61-5 / 65381-09-1
EINECS: 277-452-2 / 265-724-3
Function(s): FRAGRANCE, PERFUMING, SKIN CONDITIONING
Restriction: None

MAGNESIUM STEARATE
Max % (w/w): 5.000000
Cas Number(s): 557-04-0
EINECS: 209-150-3
Function(s): ANTICAKING, BULKING, COLORANT, MOISTURISING
Restriction: IV/150 –

© Dr Sara Robb 2024 4

ZINC OXIDE
Max % (w/w): 5.000000
Cas Number(s): 1314-13-2
EINECS: 215-222-5
Function(s): ANTIMICROBIAL, BULKING, COLORANT, LIGHT STABILIZER, ORAL CARE,
SKIN PROTECTING, UV ABSORBER, UV FILTER
Restriction: IV/144 IV/144 Not to be used in applications that may lead to exposure of the
end-user's lungs by inhalation. VI/30 25% Maximum concentration in ready for use
preparation- In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not
exceed the limit of 25%

SILICA
Max % (w/w): 3.000000
Cas Number(s): 7631-86-9 / 112945-52-5 / 60676-86-0
EINECS: 231-545-4 / 262-373-8 /310-060-2
Function(s): ABRASIVE, ABSORBENT, ANTICAKING, BULKING, OPACIFYING,
VISCOSITY CONTROLLING
Restriction: None

CALCIUM CARBONATE
Max % (w/w): 1.000000
Cas Number(s): 471-34-1
EINECS: 207-439-9 -- 215-279-6
Function(s): ABRASIVE, BUFFERING, BULKING, OPACIFYING, ORAL CARE
Restriction: IV/124 Purity criteria as set out in Commission Directive 95/45/EC (E 170)

1,2-HEXANEDIOL
Max % (w/w): 0.400000
Cas Number(s): 6920-22-5
EINECS: 230-029-6
Function(s): SKIN CONDITIONING, SOLVENT
Restriction: None

GLYCERYL CAPRYLATE
Max % (w/w): 0.200000
Cas Number(s): 26402-26-6
EINECS: 247-668-1
Function(s): SKIN CONDITIONING - EMOLLIENT, SURFACTANT - EMULSIFYING
Restriction: None

DIMETHYLIMIDAZOLIDINONE RICE STARCH

Max % (w/w): 0.100000
Cas Number(s): 223239-90-5
EINECS:
Function(s): ABSORBENT, VISCOSITY CONTROLLING
Restriction: None

ALLANTOIN
Max % (w/w): 0.100000
Cas Number(s): 97-59-6
EINECS: 202-592-8
Function(s): SKIN CONDITIONING, SKIN PROTECTING, SOOTHING
Restriction: None

© Dr Sara Robb 2024 5

PARFUM
Max % (w/w): 0.020000
Cas Number(s):
EINECS:
Function(s): FRAGRANCE, PERFUMING
Restriction: None

PANTHENOL
Max % (w/w): 0.010000
Cas Number(s): 81-13-0 / 16485-10-2
EINECS: 201-327-3 / 240-540-6
Function(s): ANTISTATIC, HAIR CONDITIONING, SKIN CONDITIONING
Restriction: None

CANDIDA BOMBICOLA/GLUCOSE/METHYL RAPESEEDATE FERMENT

Max % (w/w): 0.004250
Cas Number(s):
EINECS:
Function(s): ANTI-SEBUM, ANTIMICROBIAL, CLEANSING, DEODORANT, SKIN
PROTECTING, SURFACTANT - CLEANSING
Restriction: None

CERAMIDE NP
Max % (w/w): 0.004100
Cas Number(s): 4354-88-6; 100403-19-8
EINECS: -;277-140-6
Function(s): HAIR CONDITIONING, SKIN CONDITIONING - MISCELLANEOUS
Restriction: None

DIPROPYLENE GLYCOL
Max % (w/w): 0.004000
Cas Number(s): 110-98-5 / 25265-71-8
EINECS: 203-821-4 / 246-770-3
Function(s): FRAGRANCE, PERFUMING, SOLVENT, VISCOSITY CONTROLLING
Restriction: None

MORUS ALBA LEAF EXTRACT

Max % (w/w): 0.001010
Cas Number(s): 94167-05-2
EINECS: 303-403-2
Function(s): SKIN CONDITIONING
Restriction: None

SALIX ALBA BARK EXTRACT

Max % (w/w): 0.001010
Cas Number(s): 84082-82-6
EINECS: 282-029-0
Function(s): ASTRINGENT, HAIR CONDITIONING, SKIN CONDITIONING, SOOTHING,
TONIC
Restriction: None

© Dr Sara Robb 2024 6

PRUNUS MUME FRUIT EXTRACT
Max % (w/w): 0.001010
Cas Number(s): -
EINECS: -
Function(s): HUMECTANT
Restriction: None

PRUNUS PERSICA LEAF EXTRACT

Max % (w/w): 0.001010
Cas Number(s): 84012-34-0
EINECS: 281-678-7
Function(s): MOISTURISING, SKIN CONDITIONING, SKIN CONDITIONING - EMOLLIENT
Restriction: None

SOPHORA JAPONICA ROOT EXTRACT

Max % (w/w): 0.001010
Cas Number(s): 90131-19-4
EINECS: 290-329-8
Function(s): SKIN PROTECTING
Restriction: None

HYDROGENATED LECITHIN
Max % (w/w): 0.001000
Cas Number(s): 92128-87-5
EINECS: 295-786-7
Function(s): SKIN CONDITIONING, SURFACTANT - EMULSIFYING
Restriction: None

AQUA
Max % (w/w): 0.000897
Cas Number(s): 7732-18-5
EINECS: 231-791-2
Function(s): SOLVENT
Restriction: None

MACADAMIA TERNIFOLIA SEED OIL

Max % (w/w): 0.000750
Cas Number(s): 128497-20-1 / 129811-19-4
EINECS: - / -
Function(s): SKIN CONDITIONING - EMOLLIENT
Restriction: None

GLYCERYL STEARATE
Max % (w/w): 0.000500
Cas Number(s): 31566-31-1
EINECS: 250-705-4/286-490-9
Function(s): SKIN CONDITIONING - EMOLLIENT, SURFACTANT - EMULSIFYING
Restriction: None

© Dr Sara Robb 2024 7

CHOLESTEROL
Max % (w/w): 0.000100
Cas Number(s): 57-88-5
EINECS: 200-353-2
Function(s): LIGHT STABILIZER, SKIN CONDITIONING, SKIN CONDITIONING -
EMOLLIENT, SURFACTANT - EMULSIFYING, VISCOSITY CONTROLLING
Restriction: None

CHAMAECYPARIS OBTUSA WATER

Max % (w/w): 0.000100
Cas Number(s): 91745-97-0
EINECS: 294-769-1
Function(s): FRAGRANCE
Restriction: None

CERAMIDE NS
Max % (w/w): 0.000100
Cas Number(s): 100403-19-8
EINECS:
Function(s): HAIR CONDITIONING, SKIN CONDITIONING
Restriction: None

CERAMIDE AS
Max % (w/w): 0.000100
Cas Number(s): 100403-19-8
EINECS: 309-560-3 (I)
Function(s): HAIR CONDITIONING, SKIN CONDITIONING
Restriction: None

CERAMIDE AP
Max % (w/w): 0.000100
Cas Number(s): 100403-19-8
EINECS: 309-560-3
Function(s): HAIR CONDITIONING, SKIN CONDITIONING
Restriction: None

TRITICUM VULGARE GERM OIL

Max % (w/w): 0.000050
Cas Number(s): 68917-73-7 / 8006-95-9
EINECS: - / 281-689-7
Function(s): HUMECTANT, SKIN CONDITIONING, SKIN CONDITIONING - EMOLLIENT
Restriction: None

CAPRYLYL GLYCOL
Max % (w/w): 0.000002
Cas Number(s): 1117-86-8
EINECS: 214-254-7
Function(s): DEODORANT, HAIR CONDITIONING, SKIN CONDITIONING, SKIN
CONDITIONING - EMOLLIENT
Restriction: None

© Dr Sara Robb 2024 8

CAPRYLHYDROXAMIC ACID
Max % (w/w): 0.000001
Cas Number(s): 7377-03-9
EINECS: 230-936-7
Function(s): CHELATING
Restriction: None

GLYCERIN
Max % (w/w): 0.000001
Cas Number(s): 56-81-5
EINECS: 200-289-5
Function(s): DENATURANT, HAIR CONDITIONING, HUMECTANT, ORAL CARE,
PERFUMING, SKIN CONDITIONING, SKIN PROTECTING, SOLVENT, VISCOSITY
CONTROLLING
Restriction: None

CERAMIDE EOP
Max % (w/w): 0.000001
Cas Number(s):
EINECS:
Function(s): HAIR CONDITIONING, SKIN CONDITIONING
Restriction: None

7-DEHYDROCHOLESTEROL
Max % (w/w): 0.000001
Cas Number(s): 434-16-2
EINECS: 207-100-5
Function(s): EMULSION STABILISING, SKIN CONDITIONING, VISCOSITY CONTROLLING
Restriction: None

© Dr Sara Robb 2024 9

2 Physical/ chemical characteristics and stability of the cosmetic product
The physical and chemical characteristics of the cosmetic product are described below. The
stability of the cosmetics product under reasonably foreseeable storage conditions.

Name: GOONGBE Pri-Mmune Soothing Powder

Appearance: Pressed-Powder
Colour: Beige
Odour: Characteristic
pH: –

Variations: None
Storage conditions: Ambient conditions
Stability of the cosmetic product: The minimum durability for the cosmetic is 36 months,
with a Period After Opening (PAO) of 12 months.

3 Microbiological quality and Preservative Efficacy Test (PET)

The microbiological quality satisfies the requirement for products intended to be used on
children under 3 years old. Following the guidelines set in ISO 29621 on the risk assessment
and identification of microbial risk to cosmetic products, the cosmetic product, GOONGBE
Pri-Mmune Soothing Powder is a product that required PET. The cosmetic product is
expected to remain free of microbial contamination through the period of minimum durability
when stored under appropriate conditions.

4 Impurities and prohibited substances

Any impurities present in the raw materials were determined to be minimal and are found in
only trace amounts in the finished product. Based on the available information, no traces of
prohibited substances are expected to be present in the finished product.
5 Normal and reasonably foreseeable use
GOONGBE Pri-Mmune Soothing Powder is intended to be applied to the skin (body).
Suitable for newborns (3 months) and above in age when used as directed in the instructions
detailed in the PIF.
6 Exposure to the cosmetic product
The calculation of the exposure for the cosmetic product considers the amount applied,
applications per day and body weight.

Exposure type: Leave-on

Normal and reasonably foreseeable exposure route(s): Dermal
Values used for the cosmetic product
Amount of cosmetic product applied per use: 0.75 g
Frequency of application: 2.0 time/day
Amount of cosmetic product applied per day: 1.5 g
Retention factor: 100.0%
Body weight: 60.0 kg

© Dr Sara Robb 2024 10

7 Exposure to the ingredients and calculation of Systemic Exposure Dose (SED)
The Systemic Exposure Dose (SED) of a cosmetic substance estimates the amount
expected to be systemically available, reported as milligram per kilogram body weight per
day. The SED is determined using dermal absorption, which is reported as a percentage of
the amount of cosmetic product applied. Additionally, the quantity applied and frequency of
application of the cosmetic product are considered.

The following equation is used to calculate SED (mg/kg bw/day)

SED = A (mg/kg bw/day) x C (%)/100 x DA (%)/100 x Fret (%)/100

A (mg/kg bw/day) - mg applied per kg body weight per day

C (%) - Maximum percentage concentration of the substance in the cosmetic product
DA (%) 50% Dermal Absorption was used to assess the cosmetic product
Fret - Retention Factor of the cosmetic product. When reference values are unavailable a retention
factor of 100% is used for leave-on products and 1% for rinse-off products. For cosmetics products
with reduced surface area exposure (liquid-saturated masks, waxing products…) 10% may be
used.

The SED for each ingredient in the cosmetic product is shown below.

INCI- Ingredient name

Max %- Maximum percentage of the ingredient (w/w)
g App- grams per application of cosmetic product
RF- Retention Factor of the cosmetic product.
E mg/d- Exposure to the cosmetic product mg per day (mg/d)

© Dr Sara Robb 2024 11

SED of the Ingredients in the Cosmetic Product
INCI Max % (w/w) g/app RF SED
KAOLIN 54.148900 0.812234 100% 13.537225
ZEA MAYS STARCH 25.000000 0.375000 100% 6.250000
CAPRYLIC/CAPRIC TRIGLYCERIDE 6.000000 0.090000 100% 1.500000
MAGNESIUM STEARATE 5.000000 0.075000 100% 1.250000
ZINC OXIDE 5.000000 0.075000 100% 1.250000
SILICA 3.000000 0.045000 100% 0.750000
CALCIUM CARBONATE 1.000000 0.015000 100% 0.250000
1,2-HEXANEDIOL 0.400000 0.006000 100% 0.100000
GLYCERYL CAPRYLATE 0.200000 0.003000 100% 0.050000
DIMETHYLIMIDAZOLIDINONE RICE STARCH 0.100000 0.001500 100% 0.025000
ALLANTOIN 0.100000 0.001500 100% 0.025000
PARFUM 0.020000 0.000300 100% 0.005000
PANTHENOL 0.010000 0.000150 100% 0.002500
CANDIDA BOMBICOLA/GLUCOSE/METHYL 0.004250 0.000064 100% 0.001062
RAPESEEDATE FERMENT
CERAMIDE NP 0.004100 0.000062 100% 0.001025
DIPROPYLENE GLYCOL 0.004000 0.000060 100% 0.001000
MORUS ALBA LEAF EXTRACT 0.001010 0.000015 100% 0.000252
SALIX ALBA BARK EXTRACT 0.001010 0.000015 100% 0.000252
PRUNUS MUME FRUIT EXTRACT 0.001010 0.000015 100% 0.000252
PRUNUS PERSICA LEAF EXTRACT 0.001010 0.000015 100% 0.000252
SOPHORA JAPONICA ROOT EXTRACT 0.001010 0.000015 100% 0.000252
HYDROGENATED LECITHIN 0.001000 0.000015 100% 0.000250
AQUA 0.000897 0.000013 100% 0.000224
MACADAMIA TERNIFOLIA SEED OIL 0.000750 0.000011 100% 0.000188
GLYCERYL STEARATE 0.000500 0.000007 100% 0.000125
CHOLESTEROL 0.000100 0.000002 100% 0.000025
CHAMAECYPARIS OBTUSA WATER 0.000100 0.000002 100% 0.000025
CERAMIDE NS 0.000100 0.000002 100% 0.000025
CERAMIDE AS 0.000100 0.000002 100% 0.000025
CERAMIDE AP 0.000100 0.000002 100% 0.000025
TRITICUM VULGARE GERM OIL 0.000050 <0.000001 100% 0.000012
CAPRYLYL GLYCOL 0.000002 <0.000001 100% <0.000001
CAPRYLHYDROXAMIC ACID 0.000001 <0.000001 100% <0.000001
GLYCERIN 0.000001 <0.000001 100% <0.000001
CERAMIDE EOP 0.000001 <0.000001 100% <0.000001
7-DEHYDROCHOLESTEROL 0.000001 <0.000001 100% <0.000001

© Dr Sara Robb 2024 12

8 Toxicological profiles of the substances
To evaluate the safety of the finished cosmetic product, the available toxicological data for all
substances was considered by the safety assessor. Scientific literature was used to assess the
toxicological profile of each ingredient, including the No Observable Adverse Effects Level
(NOAEL). Exposure to the raw materials and cosmetic product were also considered and used
to determine a Margin of Safety (MoS) for each component. Combined, this data led the safety
assessor to the conclusion that the ingredients pose insignificant risk.
Calculation of the Margin of Safety (MoS)
The Margin of Safety (MoS) is a measure of the probability a substance will cause harm to the
human body. The Margins of Safety were calculated for each ingredient in the cosmetic
product using following equation:

MoS = NOAEL where SED represents the Systemic Exposure Dosage

SED

The Margin of Safety (MoS) is calculated using the Systemic Effect Dose (SED) and the No
Observable Adverse Effects Level (NOAEL). An ingredient is considered safe if the MoS is
greater than 100 (>100).

In some cases, the MoS could not be calculated because the ingredient did not have a
NOAEL. When NOAEL was unavailable for an ingredient, Cosmetic Ingredient Review (CIR) of
ingredients was consulted.

In cases where the ingredient does not have a determined NOAEL and has not been
evaluated for safety by the Cosmetic Ingredient Review, the safety assessor has consulted the
available scientific literature to make a judgement about the ingredient’s suitability for the
ingredient to be used in cosmetics and safety.

Exposure to water (INCI Aqua) poses little risk and is thereby considered safe to use as a
cosmetic ingredient. Noted as SAFE.

None of the assessed raw materials are classified as Carcinogenic, Mutagenic or Genotoxic
(CMG) ingredients.

In conclusion, there are no reported adverse toxicological issues relating to the ingredients
used to make the cosmetic.

© Dr Sara Robb 2024 13

Safety of the Ingredients in the Cosmetic Product
INCI Max % (w/w) SED MoS/Assessment
KAOLIN 54.148900 13.537225 > 100
ZEA MAYS STARCH 25.000000 6.250000 CIR SAFE
CAPRYLIC/CAPRIC TRIGLYCERIDE 6.000000 1.500000 > 100
MAGNESIUM STEARATE 5.000000 1.250000 CIR SAFE
ZINC OXIDE 5.000000 1.250000 > 100
SILICA 3.000000 0.750000 > 100
CALCIUM CARBONATE 1.000000 0.250000 CIR SAFE
1,2-HEXANEDIOL 0.400000 0.100000 > 100
GLYCERYL CAPRYLATE 0.200000 0.050000 CIR SAFE
ALLANTOIN 0.100000 0.025000 > 100
DIMETHYLIMIDAZOLIDINONE RICE STARCH 0.100000 0.025000 -
PARFUM 0.020000 0.005000 -
PANTHENOL 0.010000 0.002500 > 100
CANDIDA BOMBICOLA/GLUCOSE/METHYL 0.004250 0.001062 -
RAPESEEDATE FERMENT
CERAMIDE NP 0.004100 0.001025 CIR SAFE
DIPROPYLENE GLYCOL 0.004000 0.001000 > 100
PRUNUS PERSICA LEAF EXTRACT 0.001010 0.000252 -
SOPHORA JAPONICA ROOT EXTRACT 0.001010 0.000252 -
PRUNUS MUME FRUIT EXTRACT 0.001010 0.000252 -
SALIX ALBA BARK EXTRACT 0.001010 0.000252 -
MORUS ALBA LEAF EXTRACT 0.001010 0.000252 -
HYDROGENATED LECITHIN 0.001000 0.000250 CIR SAFE
AQUA 0.000897 0.000224 SAFE
MACADAMIA TERNIFOLIA SEED OIL 0.000750 0.000188 CIR SAFE
GLYCERYL STEARATE 0.000500 0.000125 CIR SAFE
CERAMIDE AP 0.000100 0.000025 CIR SAFE
CERAMIDE AS 0.000100 0.000025 CIR SAFE
CHOLESTEROL 0.000100 0.000025 CIR SAFE
CERAMIDE NS 0.000100 0.000025 CIR SAFE
CHAMAECYPARIS OBTUSA WATER 0.000100 0.000025 -
TRITICUM VULGARE GERM OIL 0.000050 0.000012 > 100
CAPRYLYL GLYCOL 0.000002 0.000001 > 100
CAPRYLHYDROXAMIC ACID 0.000001 0.000001 -
GLYCERIN 0.000001 0.000001 > 100
CERAMIDE EOP 0.000001 0.000001 CIR SAFE
7-DEHYDROCHOLESTEROL 0.000001 0.000001 -

© Dr Sara Robb 2024 14

9 Undesirable effects and serious undesirable effects
No undesirable effects or serious undesirable effects have been reported resulting from the
application of the cosmetic product, under normal and reasonably foreseeable use.
10 Information on the cosmetic product and packaging
GOONGBE Pri-Mmune Soothing Powder is supplied in cosmetic or food grade packaging. The
cosmetic product’s formulation, packaging material, and environmental exposure are expected
to have no significant effect of the safety of the finished product.

PART B COSMETIC PRODUCT SAFETY ASSESSMENT

Part B of Annex I describes the reasoning used to assess the safety of the product and
provides the conclusions made by the qualified safety assessor.

1 Assessment conclusions
GOONGBE Pri-Mmune Soothing Powder meets the safety criteria specified in ‘The UK
Regulation’ Schedule 34 of the Product Safety and Metrology Statutory Instrument and
“Cosmetics Regulation” Regulation (EC) No. 1223/2009.

2 Instructions for use and product warnings

Instructions for use are detailed in the PIF. Warnings to be printed on the label:
1) Use only as directed
2) For external use only
3) Do not use on broken skin
4) Discontinue use if irritation occurs
5) Consult a physician if irritation persists

3 Reasoning
The product’s safety assessment was based on the evaluation of the individual safety profile of
each ingredient present in the formulation and the final composition of the cosmetic products.
GOONGBE Pri-Mmune Soothing Powder is manufactured using safe ingredients that are
unlikely to cause adverse effects under normal and foreseeable use.
4 Safety assessor credentials
Dr Sara Robb, the author of this report has the qualifications required in the pharmaceutical
and toxicological areas, according to the defined in Regulation (EC) 1223/2009.

Qualifications:
B.A. Iowa State University USA
M.A. University of South Dakota, USA
Ph.D. The Pennsylvania State University, USA

Winner of the Marian Kies Award

Post-doctorate Research Fellow

University of Dundee, UK
University College London, UK

Member of the Society for Cosmetic Scientists & the Cosmetic, Toiletry and Perfumery
Association

VUB Certificate for completing the European Registered Toxicologist- accredited course
“Safety Assessment of Cosmetics in the EU” offered by Vrije Universiteit Brussel.

© Dr Sara Robb 2024 15

CPSR APPROVED on 6 Septemner 2024
GOONGBE Pri-Mmune Soothing Powder is safe for human health when used under normal or
reasonably foreseeable conditions of use as set out in ‘The UK Regulation’ Schedule 34 of the
Product Safety and Metrology Statutory Instrument and Article 3 of “Cosmetics Regulation”
Regulation (EC) No. 1223/2009.

Dr Sara J Robb (VUB)

© Dr Sara Robb 2024 16

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SCCNFP/0389/00: Opinion concerning the 1st update of the inventory of ingredients employed in cosmetic
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SCCP/1086/07 (Scientific committee on consumer products), Opinion on homosalate (Colipa n° S12), adopted by
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SCCP/1171/08 (Scientific committee on consumer products), SCCS, SCHER, SCENIHR Joint Opinion on the
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SCCS/1348/10 (Scientific Committee on Consumer Safety), Opinion on parabens, 14 December 2010, revision of
22 March 2011, SCCS/1348/10

SCCS/1358/10 (Scientific Committee on Consumer Safety), basic criteria for the in vitro assessment of dermal
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SCCS/1392/10 (Scientific Committee on Consumer Safety), memorandum (addendum) on the in vitro test
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SCCS/1446/11 (Scientific Committee on Consumer Safety), Clarification on Opinion SCCS/1348/10 in the light of
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three years of age, 10 October 2011, SCCS/1446/11

SCCS/1459/11 (Scientific Committee on Consumer Safety), opinion on fragrance allergens in cosmetic products,
13-14 December 2011, SCCS/1459/11

SCCS/1479/12 (Scientific Committee on Consumer Safety), Opinion on toluene-2,5-diamine and its sulfate, 26-27
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SCCS/1484/12 (Scientific Committee on Consumer Safety), Guidance on safety assessment of nanomaterials in

cosmetics, adopted by the SCCS at its 15th plenary meeting of 26-27 June 2012, SCCS/1484/12

SCCS/1486/12 (Scientific Committee on Consumer Safety), Opinion on NDELA in cosmetic products and
nitrosamines in balloons, adopted at its 15th plenary meeting on 26-27 June 2012, SCCS/1486/12

SCCS/1501/12 (Scientific Committee on Consumer Safety), The SCCS's Notes of Guidance for the testing of
cosmetic ingredients and their safety evaluation - 8th revision, adopted by the SCCS during the 17th plenary
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SCCS/1509/13 (Scientific Committee on Consumer Safety), Memorandum on hair dye Chemical Sensitisation,
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SCCS/1514/13 (Scientific Committee on Consumer Safety), Opinion on Parabens - Updated request for a
scientific opinion on propyl-and butylparaben (Colipa no P82), adopted by written procedure on 3 May 2013,
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SCCS/1524/13 (Scientific Committee on Consumer Safety), Memorandum on "Relevance and Quality of Data in
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SCCS/1532/14 (Scientific Committee on Consumer Safety), Addendum to the SCCS's Notes of Guidance (NoG)
for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, adopted by the SCCS by written
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