cosmetic product safety report

Issued: 20 Oct 2015 Report: SZHH00 981335

Formulation Ref:

Buyer/Final

Retailer:

Manufacturer:

N/A

PRODUCT FORMULATION The chemical names shown below refer to the raw materials used to formulate this product. The identity of the raw materials is not necessarily based on

the International Nomenclature of Cosmetic Ingredients (INCI) and does not represent the INCI listing that must be shown on

the product label and is for assessment purposes only. An outline INCI label can be prepared on request.

Active in

Chemical Name Conc % Active Product CAS No Einecs No

AQUA (WATER) 50 100 50 7732-18-5 231-791-2

SORBITOL 15 100 15 50-70-4 200-061-5

SILICA 15 100 15 7631-86-9 / 112945-52-5 /

60676-86-0 /63231-67-4

231-545-4/ -/ 262-373

-8

GLYCERIN 12 100 12 56-81-5 / 8013-25-0 200-289-5

PROPYLENE GLYCOL 3 100 3 57-55-6 200-338-0

SODIUM LAURYL SULFATE 1 100 1 151-21-3 / 68585-47-7 /

68955-19-1 / 73296-89-6 /

85586-07-8

205-788-1 / 277-362-3

/287-809-4

CELLULOSE GUM 1 100 1 9004-32-4 POLYMER

SODIUM FLUORIDE 0.21 100 .21 7681-49-4 231-667-8

PARFUME-GUM-PT08-397014(SYM) 1 100 1 MIXTURE MIXTURE

SODIUM SACCHARIN 1 100 1 128-44-9 / 6155-57-3 OR

82385-42-0

204-886-1

HYDROXYETHYLCELLULOSE 2 100 2 9004-62-0 POLYMER

XANTHAN GUM 0.3 100 .3 11138-66-2 234-394-2

TITANIUM DIOXIDE (CI 77891) 0.4 100 .4 13463-67-7/1317-70-0/1317

-80-2

236-675-5/205-280

-1/215-282-2

CETYLPYRIDINIUM CHLORIDE 0.05 100 .05 123-03-5 204-593-9

DIPOTASSIUM GLYCYRRHIZATE 0.01 100 .01 68797-35-3 272-296-1

MSDS/SDS, CoA/TDS and toxicity profile (where applicable) were listed in the Appendix 1

The following perfume ingredients must, under the 7th amendment to the EU Directive on the Safety of Cosmetics, be declared on the product label

Eugenol

Limonene (d-and l-Limonene)

Linalool

LABELLED WARNINGS & INSTRUCTIONS OF USE

GUM TOOTHPASTE, 3G/5G/6G/9G/14G

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Cosmetic Product Safety Report


This safety assessment relates to the formulation described below. If the information below is incorrect, please amend and resubmit for reassessment.


CONSUMER EXPOSURE

Product Class: Toothpaste

IFRA Product type: Toothpaste

IFRA Category: Category 6

Targeted Population: Adult Female & Adult Males Mean value 60kg

Amount per application/g: 1.39

Skin Surface Area of Application/cm2: 216.8

Number of applications per day: Twice a day

Physical form: Paste

Total Amount applied per day/g: 2.75

Estimated Daily Exposure mg/kg/day: 2.16

Amount Per Unit Area of Skin per day mg/cm2/day: 1.25

Retention factor: 0.05

Part of body exposed to undiluted

Dilution Factor

Part of body exposed to diluted product

Lips, the lining of the mouth and

Diluted 1 to 10 with water

mouth

Exposure Time Neat: 0.08g Ingested (Adults); 0.53g Ingested (Children 12.5kg

Exposure Time Dilute: 5 minutes

Exposure time Solvent Inhalation: Not Applicable

Exposure time Aerosol Inhalation: Not Applicable

MICROBIOLOGICAL QUALITY

To comply with "Guidelines on Microbiological Quality of the Finished Cosmetic Product" under SCCS's Notes of Guidance, the following limits apply to

this product:

Category 1: Products specifically intended for children under 3 years, eye area and mucous membranes. TVC should not exceed 100 cfu/g or ml in 0.5 g

or ml of the product. Pseudomonas aeruginosa, Staphylococcus aureus and Candida albicans must not be detectable in 0.5 g or ml of the cosmetic

product

Microbiological specifications for the product have been supplied and meet the industry requirements specified therein for this type of product.

Microbiological specification test report or data was listed in the Appendix 2-1

Preservative challenge test results for this product have not been supplied at this time and will need to be reviewed by the safety assessor in order to

fully comply with Article 3 and 10 of Cosmetic Regulation (EC) No 1223/2009.

STABILITY OF COSMETIC PRODUCT Stability test result was not supplied at the time of safety assessment. The stability of the product under reasonably foreseeable storage conditions

needs to be evaluated in order to comply with Article 3 and 10 of Cosmetic Regulation (EC) No 1223/2009.

PACKAGING COMPATIBILITY

It is assumed that the responsible person has identified the most applicable testing required to determine the packaging stability and its interaction with

the cosmetic product contained within it. Taking into consideration the information supplied to the assessor, there appears to be no immediate health

concern due to the characteristics of packaging materials in direct contact with the final product.

Package Compatibility Test Report and/or data was listed in the Appendix 4

SERIOUS / UNDESIRABLE EFFECTS

The supplier has confirmed that no undesirable effects or serious undesirable effects of this cosmetic product have been reported or, where relevant,

cosmetic products with a similar formulation.

Serious/ Undesirable Effects of Cosmetic Product Declaration was listed in Appendix 5

FRAGRANCE COMPOSITIONS

The supplier has provided an IFRA certificate or similar which confirms that the fragrance has been safety assessed by the fragrance manufacturer and

meets the requirements of the most recent amendments to the IFRA Code of Practice.

IFRA Certificate, MSDS/SDS and Allergen declaration were listed in the Appendix 6

According to Cosmetic Regulation (EC) No. 1223/2009, a complete cosmetic product safety report shall, at a minimum, contain cosmetic product safety

information and cosmetic product safety assessment. The former includes raw materials and packaging material specifications, toxicological profile of

substance (taking into account of purity of substance) contained in the cosmetic product and any known undesirable effects of the cosmetic product.


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TOXICOLOGICAL & REGULATORY REVIEW

This product is intended to be used on the area of mouth. Based on the NOAEL which is available for all chemical ingredients

except Dipotassium Glycyrrhizate, the Margin of Safety (MoS) has been calculated as greater than 100 taking into consideration any

known data on dermal absorption and bioavailability.

The dipotassium salt of glycyrrhizic acid, which is one of the active agents of licorice extract which is claimed to have anti

inflammatory properties. The CIR concluded that Dipotassium Glycyrrhizate is safe for use in cosmetic formulations in the practices

of use and concentration as described in this safety assessment.

The concentration of some of the allergens in the perfume are above 0.01% and therefore must be declared on the product label in

accordance with the EU Cosmetics Regulation. The safety of the fragrance has been evaluated by the manufacturer in accordance

with IFRA standards and considered safe at concentration used in this category of cosmetic product. These values have been

weighted against the mode of use and taking into consideration this information, this product is considered not to pose a

sensitization risk for the majority of users. However, the possibility cannot be discounted that a small number of users may

experience an allergic reaction or other idiosyncratic reaction to an ingredient in the formulation if they have been previously

sensitized to the ingredient. Taking into account how this product is intended to be used, the toxicological profiles of the individual

ingredients and well reported history of safe use in cosmetic products, this formulation is considered as safe for use for the majority

of the general population.

The raw materials used to formulate this product are all well known cosmetic product ingredients. They are present at

typical concentrations where they are unlikely to cause irritation but may cause allergy in a small percentage of the

Limits of heavy metals were satisfied legal requirements and testing report was listed in the Appendix 7

No existing studies from human volunteers were provided.

Provided the product is rinsed well off the skin after use, this product should be well received.

Effects of the product as supplied on the skin

The formulation as supplied may cause slight skin irritation especially if exposure is prolonged and/or repeated. However,

under normal conditions of use, exposure time will be short and the likelihood of causing skin irritancy will be very low.

There are low concentrations of substances present in this product which have allergenic activity. The concentrations

present are sufficiently low for the level of use to ensure that people do not become sensitised. However, people who

are already sensitised to a substance may react adversely to any product containing that substance even when present

at extremely low concentrations.

Exposure to this product is unlikely to result in phototoxic effects.

Unlikely to cause damage to internal organs following absorption through the skin.

Effects on the skin, of the product as diluted for use

Contact with the dilute solution is unlikely to cause skin irritation even if contact is prolonged and/or repeated.

Effects of the product as supplied on the eye

Accidental exposure of the eye to the formulation as supplied may result in slight eye irritation.

Effects on the eye, of the product as diluted for use

Accidental exposure of the eye to the diluted product may result in minimal eye irritation.

Effects following ingestion of the product as supplied

The formulation as supplied if swallowed may cause slight, transient irritation to the mouth and upper digestive tract.

Effects on ingestion, of the product as diluted for use

The diluted product if swallowed is unlikely to cause harm.

Effects of inhaling the product

Inhalation is an unlikely route of exposure

Overall Assessment Conclusion

The ingredients are legally permitted as per Cosmetic Regulation (EC) No 1223/2009 and its amendments and the safety

assessment has been carried out in accordance to this regulation. They must comply with the relevant purity standards for

cosmetic ingredients. It is assumed that these ingredients do not contain any undisclosed impurities/contaminants that

would affect the conclusions reached. The product must be manufactured in accordance with EU Guidance on Good

Manufacturing Practice.

Under normal or reasonably foreseeable conditions of use, product made to this formulation is unlikely to produce an

abnormally high number of adverse reactions. The product will give users the level of safety they can reasonably expect.


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Cosmetic Regulations Product Safety Assessor

Zhongrui Li BSc, MSc in Toxicology, MBTS

Intertek Testing Services Shenzhen Limited

7/F, Shekou Technology Main Building, Industrial 7th Road. Shekou, Nanshan District Shenzhen, China

Date:

20 Oct 2015


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SUMMARY OF TOXICOLOGICAL INFORMATION OF SUBSTANCES

Chemical Substance: AQUA (WATER)

EU INCI NAME:AQUA

CAS: 7732-18-5

EINECS 231-791-2

Appearance: Liquid

Function: Solvent

Melting Point: 0

Boiling Point: 100

Water Solubility: highly soluble

Cosmetic Regulatory Summary:

EU Cosmetics Status: Not controlled

Regulatory Summary:

EU DSD/DPD Classification> Unclassified

EU CLP Harmonised Classification> Unclassified

Systemic Exposure Dosage / Margin of Safety:

SED Adult mg/kg bw/day: 1.145

SED Child mg/kg bw/day: 4.116

SED Baby mg/kg bw/day: 11.652

Toxicological Summary:

No NOAEL Available

No NOAEL Available

No NOAEL Available

NOAEL mg/kg bw day: -

NOAEL test method: -

Function : Solvent. Simply water unlikely to cause irritation, allergy or harm. Used in many cosmetic products as a solvent and necessary to sustain biological life. The source of water should be known, monitored to GMP and either a deionised or high purity grade free from toxins, pollutants and bacteriological contamination should be used in cosmetic products.

Chemical Substance: SORBITOL

EU INCI NAME:SORBITOL

CAS: 50-70-4

EINECS 200-061-5

Appearance: solid

Log Kow: -2.20

Function: Humectants/Plasticizer/Skin Conditioning

Melting Point: 111

Water Solubility: 690



Regulatory Summary:

EU DSD/DPD Classification> unclassified

EU CLP Harmonised Classification> unclassified


Chemical Structure:





MoS - Adult 60kg: 21818.1

MoS - Child 16.7kg: 6072.7

MoS - Baby 5.9kg: 2145.4

NOAEL mg/kg bw day: 7500

Cosmetic Functions : Humectant / Plasticiser /Skin Conditioning / Flavoring Agent / Fragrance Ingredient. Reported in products such as cleansing and moisturizing leave-on products as well as bath, shower and hair rinse-off products along with mouthwashes and breath fresheners. Considered a food additive sweetener with no reported ADI. A simple sugar alcohol with low potential to cause irritation or allergy.

Chemical Substance: SILICA

EU INCI NAME:SILICA

CAS: 7631-86-9 / 112945-52-5 / 60676-86-0 /63231-67-4

EINECS 231-545-4/ -/ 262-373-8

Appearance: solid

Function: Abrasive / Absorbent / Anticaking / Bulking / Opacifying /

Viscosity Controlling

Water Solubility: insoluble



Regulatory Summary:









MoS - Child 16.7kg: 7271.0

MoS - Baby 5.9kg: 2568.8


NOAEL test method: Repeated dose toxicity study on rat by dietary for 26 weeks (CIR, 2009)

Cosmetic Functions : Abrasive / Absorbent / Anticaking / Bulking / Opacifying /Viscosity Controlling / Suspending Agent / Nonsurfactant. This hydrated silica is inert and of a size likely to be inhaled. Synthetic Amorphous silica (SAS) is not a skin or eye irritant, and is not a sensitiser. May cause mechanical irritation of the eye and is known to result in drying and possibly cracking of the skin following repeated exposure. The data available concerning repeated dose toxicity confirm the absence of significant toxicity by oral and dermal routes of exposure. LOAEL 1 to 50 mg/m3; NOAEL 0.5 and 10 mg/m3. NOEL(rats chronic, 6 month) 500mg/kg bw/day. Moreover, this substance produce no adverse effects to rats when fed at dose levels up to 8980 mg/kg bw/day (CIR, 2009). SAS are rapidly eliminated from the lung tissue whereas crystalline silica (Crystobalite) accumulates and may result in tumours. after ingestion, there is limited accumulation of SAS in body tissues and rapid elimination occurs. SASs injected subcutaneously are subjected to rapid dissolution and removal. Not mutagenic in vitro in bacteria or yeast, or in mammalian cells. No chromosomal aberrations were observed in cultured mammalian cells did not induce developmental toxicity. No specific study has been carried out on fertility. However, no adverse effects on reproductive organs were found in chronic or carcinogenic studies. Essentially non-toxic in humans via the oral, dermal/ocular and inhalation routes of exposure and no data exist on systemic effects in humans. No evidence of cancer or other long-term respiratory health effects (for example, silicosis) in workers employed in the manufacture of SAS.


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Chemical Substance: GLYCERIN

EU INCI NAME:GLYCERIN

CAS: 56-81-5 / 8013-25-0

EINECS 200-289-5

Appearance: liquid

Log Kow: 1.76

Water Solubility: miscible with water



Regulatory Summary:




Function: Denaturant / Humectant / Perfuming / Solvent / Fragrance Ingredient / Hair & Skin Conditioning Agent / Oral Care Agent / Skin Protectant / Viscosity Decreasing Agent

Melting Point: ~180C

Boiling Point: 2900C

Vapour Pressure: <0.01 mm Hg @ 20






MoS - Child 16.7kg: 8096.9

MoS - Baby 5.9kg: 2860.6


NOAEL test method: 2-year repeated dose study in rats

Function: Denaturant / Humectant / Solvent /Conditioner, Viscosity Decreasing Agent. If ingested in massive amounts it may induce osmotic effects in the gastro-intestinal tract manifesting as tremour and hyperaemia with LD50 in excess of 4000 mg/kg bw for both oral and dermal toxicity (Toxnet search - author anonymous. Screening Information Data Set for High Production Volume Chemicals. 2005, 178. Abstract). Repeated ingestion may produce localised GI irritation. It is a polyhydric alcohol with a minimum potential to irritate the skin and the eye. Human and animal data and the wide exposure to Glycerol indicate that it is not a skin sensitiser. Free from structural alerts, which raise concern for mutagenicity & does not induce gene mutations in bacterial strains, chromosomal effects in mammalian cells or primary DNA damage in vitro. Experimental data from a limited 2 year dietary study in the rat does not provide any basis for concerns in relation to carcinogenicity. No effects on fertility and reproductive performance were observed in a two generation study with glycerol administered by gavage (NOAEL 2000 mg/kg bw/day). No maternal toxicity or teratogenic effects were seen in the rat, mouse or rabbit at the highest dose levels tested in a guideline comparable teratogenicity study (NOAEL 1180 mg/kg bw/day), For inhalation exposure to aerosols, the NOAEC for local irritant effects to the upper respiratory tract is 165 mg/m3 and 662 mg/m3 for systemic effects. Canada, Hotlist March 2011; Manufacturers of oral and leave-on products containing glycerin must ensure the raw material used is within the specifications of an accepted pharma-copoeia with respect to diethylene glycol (DEG) impurities (e.g. Glycerin Official Monograph in the most current edition of the USP). As well as in cosmetics, Glycerin finds wide application in various sector of life such as pharmaceuticals, tobacco, food and drinks and many other products such as paints, resins and paper. Specific consumer exposure is through the oral and dermal routes, inhalation route may also occur following intake particularly from smoking. Consequently exposure to this substance is extensive however, it has been associated with a low hazard potential.

In the United States, it may be used as an active ingredient in OTC drug products and as a cough remedy. Typical suitable amounts for adults are 10 ml in water 4 times per day. For children 1-4 years 2.5ml diluted in water 3-4 time a day. In Canada, Cosmetic Ingredient Hotlist September 2009 states; Manufacturers of oral and leave-on products containing glycerin must ensure the raw material used is within the specifications of an accepted pharmacopoeia with respect to diethylene glycol (DEG) impurities (e.g. Glycerin Official Monograph in the most current edition of the USP).

QSAR predictions and weight of evidence have led t the conclusion that Glycerol (Glycerin) has low toxicity to aquatic organisms Toxnet search - author anonymous. Screening Information Data Set for High Production Volume Chemicals. 2005, 178. Abstract). . Experiments have provided the lowest LC50 for fish is a 24-h LC50 of >5000 mg/l for Carassius auratus (Goldfish) and for aquatic invertebrates, a 24h EC50 of >10000 mg/l for Daphnia magna is the lowest EC50. A calculated half-life for photo-oxidation have been obtained as approximately 7 hours without it being susceptible to hydrolysis ( Data suggest that it is readily biodegradable under aerobic conditions and Fugacity modelling predicts that it partitions 100% to aquatic compartment and is not expected to bioacumulate Toxnet search - author anonymous. Screening Information Data Set for High Production Volume Chemicals. 2005, 178. Abstract).

Chemical Substance: PROPYLENE GLYCOL

EU INCI NAME:PROPYLENE GLYCOL

CAS: 57-55-6

EINECS 200-338-0

Appearance: liquid

Log Kow: -0.92

Function: Humectant/Solvent

Skin Conditioning/Viscosity Controlling

Melting Point: -60

Boiling Point: 187

Water Solubility: miscible



Regulatory Summary:




Vapour Pressure: 0.07 mm/Hg






MoS - Child 16.7kg: 11344.2

MoS - Baby 5.9kg: 4007.8


NOAEL test method: Chronic Tox rat

Functions : Humectant / Solvent / Skin Conditioning. Widely used cosmetic solvent. In most cases a low irritation potential substance but can enhance the irritancy of soap mixtures especially in patch tests. CIR review states irritation and sensitization at 10% under occlusion and 2% in dermatitis patients. Essentially non-irritating to the eye. Evidence suggests that propylene glycol is more toxic to children than it is to adults due to the reduce levels of alcohol dehydrogenase in children and is contraindicated for children under 5 years of age. There is a report of ingestion of approximately 75 ml of a 2% concentration of propylene glycol (1.5g propylene glycol) giving rise to narcosis and acidosis in a 2 year old child. Also, there is a report of central nervous system toxicity associated with ingestion of propylene glycol in an 11 year old patient who developed repeated seizures from Propylene Glycol vehicle given in oral form (Arulanantham K and Genel M.K. 1978). NOAEL from chronic toxicity study in the dog was 2000 mg/kg bw/day and 1600 mg/kg bw/day in the rat, respectively. Dermal absorption rate across intact skin is likely to be slow. Propylene glycol ingestion causes d-lactic acidosis (M.M. Christopher, J.H.Eckfeldt and J.W.Eaton, 1990) and increased liver glycogen and blood lactic acid were shown in many in-vitro tests. Estimate of Acceptable daily intake (ADI) for man according to the WHO Committee is 0 to 25 mg/kg bw . A NOAEL of 1700 mg/kg bw/day in male rats was determined based on a chronic oral toxicity study where only minimal changes following administration of up to 5% w/w in the diet was observed [SIDS, 2001]. A NOAEL of 2100 mg/kg bw/day in female rats was determined based on a chronic oral toxicity study where only minimal changes following administration of up to 5% w/w in the diet was observed [SIDS, 2001].

Critical evaluation of propylene glycol by EMEA: Propylene glycol is of low acute toxicity; oral LD50 21-32 g/kg (rat). Subcutaneous LD50 25-28g/kg (rat). No chronic effects (carcinogenicity) at 10 g/kg/d in a 105 week feeding study. Non teratogenic (rabbit) , Non mutagenic in in vitro microbial assay and Ames. Negative in chromosomal aberration assay on Chinese hamster cells. JEFCA concluded that the ADI for an adult of 60 kg to be 0-25 mg/kg bw/day which is equivalent to 1500 mg/day for a 60 kg adult. Propylene glycol is also used for medical applications for the intravenous administration of drugs up to 40%. Systemic toxicity was reported as uncommon but lactic acid acidosis, hypersensitivity and CNS depression are reported. In humans propylene glycol is rapidly absorbed from the GI tract and metabolised to substances of low toxicity ultimately lactic acid and glucose and then excreted. Its half life for elimination in the GI tract is 4 hours (EMEA/MRL/130/96/FINAL, July 1996).

References: Arulanantham K and Genel M.K. 1978. Central nervous system toxicity associated with ingestion of propylene glycol. J Pediatr. 93(3):515-6 EMEA/MRL/130/96/FINAL, July 1996 Weil, C. S., Woodside, S. and Smyth, H. F. Results of feeding propylene glycol in the diet to dogs for two years. Food Cosmet Toxicol 1971; 9: 479-490. The Center For The Evaluation Of Risks To Human Reproduction (CERHR) NTP-CERHR-PG-03 May 2003


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Chemical Substance: SODIUM LAURYL SULFATE

EU INCI NAME:SODIUM LAURYL SULFATE

CAS: 151-21-3 / 68585-47-7 / 68955-19-1 / 73296-89-6 /

EINECS 85586-07-8 205-788-1 / 277-362-3 /287-809-4

Appearance: White to off-white 'needs'.

Log Kow: </= - 2.42 at 20 oC (OECD Guideline 107)

Function: surfactant

Melting Point: N/A

Boiling Point: 187 oC at 1010 hPa

Water Solubility: 400 g/l at 20 oC



Regulatory Summary:

EU DSD/DPD Classification> R22-41/38

EU CLP Harmonised Classification> Acute Tox. 4, Eye Dam. 1, Skin Irrit.2.







MoS - Child 16.7kg: 1214.5

MoS - Baby 5.9kg: 429.0


NOAEL test method: Repeated toxicity study in rat (oral)

Comprehensive evaluations of sodium lauryl sulphate have been conducted by the Cosmetic Ingredient Review (CIR, 1983) and reaffirmed this conclusion in 2002 and concluded that the concentration in leave-on products which will be in contact with skin should not exceed 1%. OECD SIDS 1997 has evaluated the toxicity and NICNAS 2007 has evaluated the literature and prepared a chemical information sheet. These authoritative reviews are appended to this report. Acute Toxicity: CIR concluded that sodium lauryl sulphate is acutely toxic and the oral LD50 was determined to be 1200mg/kg bw. The dermal LD50 in rabbits and guinea pigs is 600 and >1200 mg/kg bw respectively. (CIR, 1983, OECD SIDS, 1997). The acute oral LD50 for mice through oral route is > 2000 mg/kg bw. Inhalation exposure of sodium lauryl sulphate to mice, rabbits and guinea pigs for different time duration 5, 5 and 30 minutes respectively, showed respiratory inhibition (IUCLID Dataset, 2000). Irritation and Corrosivity: Skin : Results of in vivo animal and human studies, demonstrate that sodium lauryl sulphate is mild to moderate irritant when applied to the skin at 0.5 -10%. Corrosive response was observed with detergents containing sodium lauryl sulphate at 10 - 30%. (CIR,1983;IUCLID Dataset, 2000). SLS is also reported to have irritant potential to respiratory tract and the mucous membrane of oral cavity especially in the subjects predisposed to mouth ulcers. (NICNAS 2007). The individuals with atopic dermatitis are more susceptible to the irritant effect of sodium lauryl sulphate (Loffler H and Effendy I, 1999). Eye Irritation :Results of animal studies demonstrated that sodium lauryl sulphate may produce corneal damage, conjunctivitis and severely irritating to eyes if eyes are not irrigated or with delayed irrigation. If irrigated, it showed mild irritant effects (CIR, 1983, NICNAS 2007, IUCLID Dataset 2000). Skin Sensitisation: Not a sensitizer to the guinea pig (IUCLID Dataset 2000). SLS is unlikely to cause sensitization reactions since it is used at 10% in the guideline procedure to cause local irritation for the chemicals which show negative results for sensitization (NICNAS 2007). Dermal/Percutaneous Absorption: In vivo studies with radiolabelled sodium dodecyl sulphate on shaved skin showed percutaneous absorption of 1% of the applied dose at the end of three days of treatment. Dermal absorption study in guinea pigs showed a penetration rate of 0.355% (IUCLID Dataset, 2000). Repeated Dose Toxicity: Results of sub chronic and chronic animal studies indicate that sodium lauryl sulphate is practically non toxic (CIR, 1983, OECD SIDS, 1997; NICNAS 2007). Mutagenicity/Genotoxicity: Genotoxicity assays indicate that sodium lauryl sulphate is not mutagenic (CIR, 1983, NICNAS 2007, IUCLID Dataset 2000). Carcinogenicity: No carcinogenicity potential was observed from SLS in an oral feeding study (dog) with up to 2% (NICNAS 2007, IUCLID Dataset 2000). Similarly no carcinogenicity was observed in rats fed with diet containing SLS at 0.25, 0.5 and 1% for two years (CIR, 1983). Reproductive and Developmental Toxicity: In vivo dietary feeding studies in mice did not show any significant reproduction toxicity and the NOAEL is determined to be 1000 mg/kg bw/day. Developmental toxicity in mouse and rabbit showed maternal toxicity at 300 mg/kg bw/day which is not associated with developmental toxicity. The NOAEL for maternal toxicity was 300 mg/kg bw/day (NICNAS 2007, IUCLID Dataset 2000).Toxicokinetics: Labelled sodium dodecyl sulphate administered intravenously to male rats showed 78.3% of the applied dose excreted with in 24 hours (IUCLID Dataset, 2000). Photo-Induced Toxicity:No photo toxicity was reported (CIR, 1983). Human Data: Although few positive irritant reactions were reported with sodium lauryl sulfate, sodium lauryl sulfate, is not sensitising and photo sensitising (CIR, 1983, IUCLID Dataset, 2000). No-Observed-Adverse-Effect Level (NOAEL) and Rationale: The estimated No-Observed-Adverse-Effect Level (NOAEL) for rat from an oral study is 100 mg/kg/day (IUCLID Dataset, 2000, OECD SIDS, 1997, NICNAS 2007).

Chemical Substance: CELLULOSE GUM

EU INCI NAME:CELLULOSE GUM

CAS: 9004-32-4

EINECS polymer

Function: Film former


Regulatory Summary:


EU CLP Harmonised Classification>






MoS - Adult 60kg: 218181.8

MoS - Child 16.7kg: 60727.2

MoS - Baby 5.9kg: 21454.5


Cosmetic Functions : Binding / Emulsion Stabilising / Film Forming / Masking / Viscosity Controlling / Viscosity Increasing agent-Aqueous. An essentially inert thickening agent also used as a food thickener. Cellulose Gums are modified cellulose polymers. These gums passed unchanged through the gastrointestinal tract following oral administration. Practically nontoxic when administered by inhalation or by oral, intraperitoneal, subcutaneous, or dermal routes. Sub chronic and chronic oral studies demonstrated cellulose gum is non toxic when administered to animals. Not teratogenic or mutagenic. Minimally irritating to rabbit eye and minimally to non irritating to rabbit skin when tested in concentrations to 100%. Non sensitizing, non photo sensitizing and non irritating in clinical studies. Considered safe for use up to 100% in cosmetics.


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Chemical Substance: SODIUM FLUORIDE

EU INCI NAME:SODIUM FLUORIDE

CAS: 7681-49-4

EINECS 231-667-8

Function: oral care agents


EU Cosmetics Status: Controlled

Regulatory Summary:

EU DSD/DPD Classification> R23/24/25-32-36/38








MoS - Child 16.7kg: 578.3

MoS - Baby 5.9kg: 204.3

NOAEL mg/kg bw day: 10 (F)

NOAEL test method: Two-generational dietary study in rats on ne effects on reproduction; NOAEL of 250 mg NaF/1, equivalent to atom 10 mg F-/kg bw/day

Cosmetic Functions : Antiplaque / Oral Care. A source of fluorine to help prevent tooth decay. As supplied classified as toxic by ingestion, irritating to eyes and skin and may give off very toxic gas in the

presence of acid. A US-FDA two-generational dietary study in rats to determine effects on reproduction, derived a NOAEL of 250 mg NaF/1, equivalent to atom 10 mg F-/kg bw/day)1

with similar NOAEL of

11.12 mg F7kg b.w./d result for NaF (Sodium Fluoride) derived from three studies using the OECD-414 like-guideline and OECD 416 guideline.2 The former study observed no changes with regards to

weight of reproductive organs nor in histopathology although some embryotoxicity has been noted in other studies and is described as a "NOAEL for effects on fertility".2

The NOAEL of 11.12 mg F7kg b.w.

/d using the OECD guildelines noted some maternal toxicity such as mild dental whitening,changes in dentine and enamel structure as well as some hyperkeratosis in the upper gastrointestinal tract.2 When

diluted to less than 0.33% based on Sodium fluoride contains ~45% fluoride) in a formulation unlikely to cause damage to internal organs if swallowed or irritancy. Maximum authorized concentration is 0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% for EU. Products containing sodium fluoride must be labelled "Contains Sodium Fluoride".

For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor”. (Amendment 2009/129/EC).

References 1. Maurer et al. 1993 cited in Hydrogen Fluoride. Anonymous authors. European Union risk assessment report Vol:8

(2001) 121 p. 2. Hydrogen Fluoride. Anonymous authors. European Union risk assessment report Vol:8 (2001) 121 p.

Chemical Substance: PARFUME-GUM-PT08-397014(SYM)

CAS: mixture

EINECS mixture

Function: Flavour



EU DSD/DPD Classification>







No NOAEL Available

No NOAEL Available

No NOAEL Available

NOAEL mg/kg bw day: --

As supplied classified R43. When used at not more than 9.59% in a leave-on product the concentration of each allergen will be at least 10 times lower than that shown not to induce allergy in human volunteers.

Chemical Substance: SODIUM SACCHARIN

EU INCI NAME:SODIUM SACCHARIN

CAS: 128-44-9 / 6155-57-3 or 82385-42-0

EINECS 204-886-1

Appearance: White crystalline powder or colourless crystals; efflorescent in dry air.

Function: Masking

Melting Point: 226 - 230

Water Solubility: Soluble



Regulatory Summary:









MoS - Child 16.7kg: 6072.7

MoS - Baby 5.9kg: 2145.4


NOAEL test method: This is derived by applying a 100-fold safety factor to the NOEL

of 1% in the diet (500 mg/kg bw) for bladder tumours in the rat

Cosmetic Functions: Masking / Oral Care / Flavoring Agent / Fragrance Ingredient. It is an organic compound belonging to heterocyclic compounds (International Cosmetic Ingredient Dictionary and Handbook, 2008, 12 Ed.) and widely used in pharmaceutical companies and in animal feeds as a low calorie substitute for cane sugar. There are two types of saccharin - soluble and insoluble; the Sodium, Ammonium and Calcium salts are soluble and are as sweet as the acid form (WHO Food Additive Series 17). The Sodium form is commonly used as a cosmetic ingredient. Previously, diet studies on rats indicated that saccharin and its salts may be Group 3 carcinogens (not classifiable as to their carcinogenicity to humans, 1999 IARC), however, it was delisted based on the determination that bladder tumours observed in rats arose from a mechanism not relevant to humans (2000 NTP Report on Carcinogens). Consequently, the ADI for the free acid (MW 183) was set as 0-3.8 mg/kg bw and for the Sodium Saccharin at 0-5 mg/kg bw (Opinion On Saccharin and its Sodium, Potassium And Calcium Salts; expressed on 2 June 1995, Scientific Committee For Food). Reviews have determined safe use of Saccharin for human consumption (Joint Expert Committee on Food Additives (JECFA) of the World Health Organization and the Scientific Committee for Food of the European Union) with the result that its ADI (acceptable daily intake) has been double, setting it to 1% (Chung, M S et al, 2005 Food Addit Contam., 22(11):1087-97, Abstract). JECFA also noted that previous data from the animal studies that raised concern about saccharin were not considered relevant to humans. Saccharin has thus been extensively researched and well established artificial sweetening agent used widely in food. It is most unlikely to cause problems when used in a toothpaste, lip product or oral hygiene product.


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Chemical Substance: HYDROXYETHYLCELLULOSE

EU INCI NAME:HYDROXYETHYLCELLULOSE

CAS: 9004-62-0

EINECS polymer

Function: binders / emulsion stabilisers / film formers / viscosity controlling agents



Regulatory Summary:









MoS - Child 16.7kg: 14028.2

MoS - Baby 5.9kg: 4956.3


NOAEL test method: Wistar rat, dietary feed, 2 years = 2310 mg/kg bw/day (maximum concentration tested) (CIR, 2009).

Cosmetic Functions : Binding / Emulsion Stabilising / Film Forming / Stabilizing / Viscosity Controlling / Viscosity Increasing Agent-Aqueous. A modified cellulose polymer which contains hydroxyethyl side chains. Cellulose Gums are modified cellulose polymers. These gums passed unchanged through the gastrointestinal tract following oral administration. Practically non toxic when administered by inhalation or by oral, intraperitoneal, subcutaneous, or dermal routes. Sub chronic and chronic oral studies demonstrated cellulose gum is non toxic when administered to animals. Not teratogenic or mutagenic. Minimally irritating to rabbit eye and minimally to non irritating to rabbit skin when tested in concentrations to 100%. Non sensitizing, non photo sensitizing and non irritating in clinical studies. Considered safe for use up to 100% in cosmetics. The NOAEL was found to be more than 5000 mg/kg BW, which was the highest dosage tested. A NOAEL (Wistar rat, dietary feed, 2 years) = 2310 mg/kg bw/day (maximum concentration tested) (CIR, 2009) was recorded and is used for the MoS calculation.

Chemical Substance: XANTHAN GUM

EU INCI NAME:XANTHAN GUM

CAS: 11138-66-2

EINECS 234-394-2

Appearance: Cream coloured powder

Log Kow: Data not available

Function: binders / emulsion stabilisers / viscosity controlling agents

Melting Point: Data not available

Boiling Point: N/A

Water Solubility: Soluble



Regulatory Summary:




Vapour Pressure: N/A





MoS - Adult 60kg: 145454.5

MoS - Child 16.7kg: 40484.8

MoS - Baby 5.9kg: 14303.0


NOAEL test method: Long-term feeding studies with rats (MSDS from CP Kelco, a Huber Company and/or from the scientific literature).

Cosmetic Functions : Binding / Emulsifying / Emulsion Stabilising / Gel Forming / Skin Conditioning / Surfactant / Viscosity Controlling / Viscosity Increasing Agent-Aqueous. A polysacharide gum with low potential to cause irritancy. Widely used as a dosing vehicle for sensitising tests and toxicity studies (Yokota, M and Maibach, H I. 2006. Moisturizer effect on Irritant Dermatitis: an overview. Contact Dermatitis 2006: 55: 65-72; Lewis, RW, Moxon ME and Botham PA. 1997. Evaluation of oral dosing vehicles for use in developmental toxicity studies in the rat and rabbit. Toxicologist, 36 (1 of 2):259-60). At the 0.5% in 0.1% Polysorbate 80, it was considered a suitable vehicle for use in developmental toxicity gavage studies in rats / rabbits and was not found to cause adverse maternal or embryo/foetal effects (Lewis et al, 1997). High molecular weight heteropolysaccharide gum one production method described as a pure-culture fermentation of a carbohydrate with Xanthomonas campestris. Also widely used as a thickener in food. Unlikely to cause adverse effects at typical concentrations used in cosmetic products.

Chemical Substance: TITANIUM DIOXIDE (CI 77891)

EU INCI NAME:TITANIUM DIOXIDE

CAS: 13463-67-7/1317-70-0/1317-80-2

EINECS 236-675-5/205-280-1/215-282-2

Appearance: Solid

Log Kow: N/A

Function: Opacifying / UV Absorber / UV Filter

Melting Point: 1843

Boiling Point: 2500 - 3000 oC (Calculated value).

Water Solubility: Insoluble ( <0.1mg/L)


EU Cosmetics Status: Approved UV filter

Regulatory Summary:




Vapour Pressure: N/A





MoS - Adult 60kg: 2618181.8

MoS - Child 16.7kg: 728727.2

MoS - Baby 5.9kg: 257454.5


NOAEL test method: The no-observed effect level (NOEL) through oral gavage is >24, 000 mg/kg (REACH Dossier)

Titanium dioxide is unlikely to cause adverse effects at the typical concentrations used in cosmetics. Available as a micronised product which may present a respiratory irritation hazard when handled in bulk. Use of such grades is generally restricted to liquid formulations where the likelihood of the formation of respirable atmospheres is low. Can be produced in either anatase or rutile crystal form. Rutile TiO2 produces higher opacity and greater scatter than anatase since the rutile crystal has a higher index of refraction; anatase is less abrasive than rutile, but is also used with UV brighteners, since rutile reduces the efficiency of the brighteners due to UV absorption in the same wavelength range. Generally, rutile is preferred for coatings due to its higher opacity . Titanium dioxide was found to be non toxic for both oral and dermal in rat and mice. Poor dermal penetration. Non irritating to the skin and eyes, non sensitizing in animal and human and non photo toxic. Reported as non mutagenic and practically non toxic in repeated dose toxicity studies. IARC classification: Group 2B (possibly carcinogenic to humans). All the four forms of titanium dioxide are not found to be accumulated in the tissues. No-Observed-Adverse-Effect Level (NOAEL) and Rationale: In a repeated 28-day toxicity study in rats dosed orally through gavage with titanium dioxide suspended in water at concentration of 24,000 mg/kg showed no effects in any of the endpoint tested. The no-observed effect level (NOEL) through oral gavage is >24, 000 mg/kg (REACH Dossier)


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Chemical Substance: CETYLPYRIDINIUM CHLORIDE

EU INCI NAME:CETYLPYRIDINIUM CHLORIDE

CAS: 123-03-5

EINECS 204-593-9

Function: antimicrobials / antistatic agents / deodorant agents / emulsifying agents / surfactants


Regulatory Summary:

EU DSD/DPD Classification> R25, R26, R38








MoS - Child 16.7kg: 2356.2

MoS - Baby 5.9kg: 832.4

NOAEL mg/kg bw day: 9.7

NOAEL test method: 90-day oral study, female rats

Cosmetic Functions : Antimicrobial / Antistatic / Deodorant / Emulsifying / Hair Conditioning / Oral Care / Surfactant. As supplied it is toxic and significantly irritating to the skin and eye. The SCCP are due to review the findings of cetylpyridium chloride and a recent submission to the SCCP proposing a safe level in Annex VI on the below, the dossier submitted was inadequate for further evaluation. a) 0.1% (in mouthwashes) b) 1.0% (in all other oral hygiene products) c) 0.2% (in skin lotions & creams) d) 2.0% (in anti-perspirant deodorants) Based on these findings it is recommended that the level of Cetylpyridinium chloride is reduced to 0.1% in a mouthwash product for example, until further information becomes available. At typical levels of use unlikely to cause skin or eye irritation and unlikely to cause sensitisation. CPC is not mutagenic in the salmonella-mutagenicity test. H ighly irritating to the skin and there are signs of a caustic potential. It can cause permanent eye damage. Based on a 90-day oral study, a NOAEL for female rats of 9.7 mg CPC/kg body weight and day is deduced. Reference B UA Repor t 2 (October 2003) S. HirzelWissenschaftliche Verlagsgesellschaft 200547

Chemical Substance: DIPOTASSIUM GLYCYRRHIZATE

EU INCI NAME:DIPOTASSIUM GLYCYRRHIZATE

CAS: 68797-35-3

EINECS 272-296-1

Function: Humectant/Skin conditioning



Regulatory Summary:








No NOAEL Available

No NOAEL Available

No NOAEL Available

The dipotassium salt of glycyrrhizic acid, which is one of the active agents of licorice extract which is claimed to have anti inflammatory properties. Can cause a rise in blood pressure and inhibit the metabolism of prostaglandins which results in decreased acid production in the stomach. Widely used as a food and medicine. Unlikely to cause irritancy or allergy when used at up to 1% in a cosmetic product.

Note: In the absence of NOAEL data, the Margin of Safety (MoS) has not been calculated. Unless otherwise determined and in the absence of literature or other experimental data, a Dermal Absorption (DAp) of 100% is taken as the worst case scenario. NOAEL: No Observed Adverse Effect Level; MoS: Margin of Safety; SED Systemic Exposure Dosage Calculation of Margin of Safety: MoS = NOAEL / SED

Reference for skin surface area, exposures and application quantities are derived from: 1. RIVM Report 320104001/2006 2. References sited in Dermal Sensitization Quantitative Risk Assessment (QRA) For Fragrance Ingredients, 2006 revision 3. Exposure factors handbook 2009 Update 4. The SCCS's Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation 8th Revision SCCS/1416/11 5. Colipa Data SCCNFP/0321/02 6. McNamara et al, Food Chem. Tox; 2007, 45, 2086 7. Loretz et al, Food Chem. Tox; 2008, 46, 1516 N.B. Exposure times have been taken from RIVM Report 320104001/2006 8. Body weights taken from Exposure factors handbook 2009 Update and mean values have been used unless specified otherwise 9. ConsExpo database 10. New default values for the spray model, RIVM, March 2010

This formulation has been safety assessed by Intertek with reference to Articles 3 and 10 of Cosmetic Regulation (EC) No. 1223/2009. The safety assessment is based on the chemical specification and toxicological profile of the ingredients as supplied at the time of assessment. The supplier to this safety assessment is advised to ask for a new safety evaluation if any change in formulation occurs, change in raw materials used, abnormally high number of adverse events are recorded, changes in recommended uses or other circumstances that may affect the safety of this product.

The REACH dossier, IUCLID Datasheet, OECD SIDS and EU RAR often include unpublished data, not otherwise available; however, it must be noted that the authorities have issued legal disclaimers for the databases. The declaimer, among other cautions, stressed that the data in the dossier, datasheet, data set or report are not necessarily comprehensive, complete, accurate or up-to-date. Use of the data may also be subject to copyright laws. Therefore, data from the such resource are used as supporting information.

This report is made solely on the basis of your instructions and/or information and materials supplied by you. It is not intended to be a recommendation for any particular course of action. Intertek does not accept a duty of care or any other responsibility to any person other than the Client in respect of this report and only accepts liability to the Client insofar as is expressly contained in the terms and conditions governing Intertek’s provision of services to you. Intertek makes no warranties or representations e ither express or implied with respect to this report save as provided for in those terms and conditions. We have aimed to conduct the Review on a diligent and careful basis and we do not accept any liability to you for any loss arising out of or in connection with this report, in contract, tort, by statute or otherwise, except in the event of our gross negligence or willful misconduct.


of 10

SZHH00981335

Appendixes of Cosmetic Product Safety Report

For


The testing report, declaration letter, SDS/MSDS, TDS, CoA, IFRA Certificate and other supportive

document listed in this appendix were provided from client and delivered to risk assessor to

conduct the CPSR, it is supplier’ s responsibility to make sure the accuracy of the documents.

SZHH00981335

Appendix 1- Toxicological Profiles of Substances

1. Toxicity summary

2. MSDS/SDS

3. TDS/CoA

Appendix 2- Microbiological Quality Test Report of Cosmetic Product

1. Microbiological specification test report or data

2. Preservative challenge test report or data

Appendix 3- Stability Test Report or Data of Cosmetic Product

Appendix 4- Packaging Compatibility Test Report and/or data

1. Container data

2. Outer Packaging material

Appendix 5- Serious/ Undesirable Effects of Cosmetic Product Declaration or Report

Appendix 6- Fragrance

1. IFRA Certificate

2. MSDS/SDS

3. Allergen declaration

Appendix 7- Heavy Metal Test Report of Cosmetic Product

Appendix 8- Human Volunteers Studies

1. Human volunteers study for the cosmetic product

2. Human volunteers study for raw material

Appendix 9- Assessor’s credentials

SZHH00981335

Appendix 1- Toxicological Profiles of Substances

1. Toxicity summary

Substance toxicological summary was listed in this report and detailed data are stored in Intertek

owned in house database, could provide on specific request.

2. MSDS/SDS

See below report(s) if available

3. TDS/CoA


SZHH00981335

Appendix 2- Microbiological Quality Test Report of Cosmetic Product

1. Microbiological specification test report or data


2. Preservative challenge test report or data


Test Report Number: SZHH00985591

Applicant:

Attn: RICHARD KWOK

Sample Description: One (1) style of submitted sample said to be : Item Name : 3g/5g/9g/14g Gum Toothpaste. Vendor : Buyer : Country of Origin : Japan.

**************************************************************************************************************************************

Tests conducted: As requested by the applicant, refer to attached page(s) for details.

********************************************************************************************************************************** To be continued

Authorized by: For Intertek Testing Services Shenzhen Ltd.

Ben N.L. Lin General Manager

Intertek Testing Services Shenzhen Ltd.- Hardlines

深圳天祥质量技术服务有限公司–轻工产品事业部 301A, 302B, 6/F. 7/F Shekou Technology Main Bldg. and Room 1E of Nanshan Building,

Nanhai Ave., Nanshan District, Shenzhen, China 深圳市南山区南海大道科技大厦 301A、302B、六层、七层、南山大厦 1 楼 1E 房

Tel: (86-755) 2602 0111 Fax: (86-755) 2683 7118/9 Postcode: 518067 www.intertek.com www.intertek.com.cn China Toll-Free:400 886 9926

Attention is

http://www.intertek.com/

http://www.intertek.com.cn/


drawn to the terms and conditions printed overleaf.

*SZHJ985591* Page 1 of 5


Conclusion:

Tested Sample Standard Result Tested components of submitted samples

European Cosmetic Regulation (EC) No.1223/2009 Annex I PartA 3,, Microbiological control criteria of the cosmetic products.

Pass

With reference to the Notification of the German Federal Health Office Centre up to 1996 on Toxic elements analysis for cosmetics

Meet

94/62/EC and amendment 2004/12/EC & 2005/20/EC Directive (packaging waste) for toxic elements test

Pass

European Commission Regulation No. 10/2011 and Regulation 1935/2004 on overall migration

Pass

*********************************************************************************************************************************






Tel: (86-755) 2602 0111 Fax: (86-755) 2683 7118/9 Postcode: 518067 www.intertek.com www.intertek.com.cn China Toll-Free:400 886 9926 Attention is drawn to the terms and conditions printed overleaf.





Tests Conducted

1 Microbiological examination of non-sterile products : Microbial Enumeration Tests and tests for specified

microorganisms

With reference to British Pharmacopoeia (2013), Appendix XVI B2 & B1 and European Pharmacopoeia 7.5 Edition, Chapter 2.6.12 & 2.6.13.

Test Item Result Limit

(5) Category (A):

(1) Total Aerobic Microbial Count (per g) <10CFU# (1) + (2)

should be

(2) Moulds and Yeasts Count <10CFU# 100 CFU

Tested components: See component list in last section of this report.

Remark : # = No colony was detected at the one-tenth dilution of the sample CFU= Colony Forming Unit = Less than or equal to

The limit for test item (1) and (2) is with reference to the notes of guidelines on microbiological quality of the finished cosmetic products adopted by Scientific Committee on Consumer Safety (SCCS, 8

th Rev., 2012)

of the European Commission, Microbiological Quantitative Limits for Category A Cosmetic Products.

Category A: Cosmetic products specifically intended for children under 3 years, eye area and mucous membranes.

Category B: Other cosmetic products.

Sample received condition: sample in unopened original package.

Date sample received: Aug 04, 2015 Testing period: Aug 04, 2015 to Aug 12, 2015

**************************************************************************************************************************************

Intertek Testing Services Shenzhen Ltd.- Hardlines 深圳天祥质量技术服务有限公司–轻工产品事业部

301A, 302B, 6/F. 7/F Shekou Technology Main Bldg. and Room 1E of Nanshan Building, Nanhai Ave., Nanshan District, Shenzhen, China

深圳市南山区南海大道科技大厦 301A、302B、六层、七层、南山大厦 1 楼 1E 房 Tel: (86-755) 2602 0111 Fax: (86-755) 2683 7118/9 Postcode: 518067 www.intertek.com www.intertek.com.cn China Toll-Free:400 886 9926 Attention is drawn to the terms and conditions printed overleaf.

*SZHJ985591*

Page 3 of 5

(per g) (3) Bile-Tolerant Gram-Negative Bacteria Absent Absent

(per g) (4) Escherichia coli Absent Absent

(per g) (5) Salmonella Absent Absent

(per 10g) (6) Pseudomonas aeruginosa Absent Absent

(per g) (7) Staphylococcus aureus Absent Absent

(per g) (8) Clostridia Absent Absent

(per g) (9) Candida albicans Absent Absent

(per g)




Tests Conducted

2 Toxic Element Analysis

Acid digestion followed by Inductively Coupled Plasma Mass Spectrometry for Antimony (Sb), Arsenic (As), Cadmium (Cd), Lead (Pb) and Mercury (Hg) analysis; perspiration simulant extraction followed by Flame Atomic Absorption Spectrometry for Soluble Nickel (Ni) analysis

result :

Test item

Antimony (Sb) content

Result (ppm) (5)

<0.1

Limit#

10 ppm Arsenic (As) content <0.1 5 ppm Cadmium (Cd) content <0.1 5 ppm Lead (Pb) content <0.1 20 ppm Mercury (Hg) content <0.1 1 ppm Soluble nickel (Ni) content <0.1 10 ppm

ppm = Parts per million or milligrams per kilogram # = The limit is with reference to The Notification of the German Federal Health Office Centre, Pg 28,

No.7, July 1985 and no.7/1992 and No.4/1996 for Cosmetics.

Tested Components: see component list in the last section of this report

Date sample received : Aug 04, 2015 Testing period : Aug 04, 2015 to Aug 08, 2015

3 Toxic Elements Analysis

As per 94/62/EC and amendment 2004/12/EC & 2005/20/EC Directive on packaging and packaging waste, acid digestion method was used and toxic elements contents were determined by Inductively Coupled Argon Plasma Spectrometry, and Hexavalent Chromium content was determined by UV-Visible Spectrophotometry.

Lead (Pb)

Result (ppm) (1)to(4)

<5

Limit (ppm)

-- Cadmium (Cd) <5 -- Mercury (Hg) <5 -- Chromium VI (Cr (VI)) <1 -- Sum of Pb, Cd, Hg and Cr (VI) <16 100

ppm = part per million

Tested components :See component list in the last section of this report


**************************************************************************************************************************************





*SZHJ985591*

Page 4 of 5




Tests Conducted

4 Overall Migration Test

As per Commission Regulation (EU) No. 10/2011 and its amendments.

I. Test condition:

Aqueous food simulant: Test no. Time and temperature

OM2 10 days at 40 °C

II. Test Results :

Food Simulant Result(mg/dm²) Reporting Limit Limit

(3)to(4) (mg/dm²) (mg/dm²)

10% (v/v) Ethanol ND 1 10

ND = Not detected

Remark : As per client’s request, the above condition and food simulant were used for the test.

Ratio of food contact surface area to volume used to establish the compliance of material or article = 1.0dm

2 : 100mL.


Date sample received : Aug 04, 2015 & Aug 10, 2015 Testing period : Aug 04, 2015 to Aug 24, 2015

*********************************************************************************************************************************

Components list :

(1) Coatings on plastic sheet (cover of toothpaste tube). (2) Transparent plastic sheet excluding coatings (cover of toothpaste tube). (3) Snow white PE plastic (body of toothpaste tube). (4) White PP plastic (lid of toothpaste tube). (5) White paste (toothpaste).

********************************************************************************************************************************** End of report

This report is made solely on the basis of your instructions and/or information and materials supplied by you. It is not intended to be a recommendation for any

particular course of action. Intertek does not accept a duty of care or any other responsibility to any person other than the Client in respect of this report and only

accepts liability to the Client insofar as is expressly contained in the terms and conditions governing Intertek's provision of services to you. Intertek makes no

warranties or representations either express or implied with respect to this report save as provided for in those terms and conditions. We have aimed to conduct the

review on a diligent and careful basis and we do not accept any liability to you for any loss arising out of or in connection with this report, in contract, tort, by statute

or otherwise, except in the event of our gross negligence or wilful misconduct.




*SZHJ985591*

Page 5 of 5



SZHH00981335

Appendix 3- Stability Test Report or Data of Cosmetic Product


SZHH00981335

Appendix 4- Packaging Compatibility Test Report and/or data

1. Container data

1.1 Basic information

HDPE TUBE

INCI/Chemical Name * EINECS/ELINCS No CAS / CI No. * %*

LDPE -- 9002-88-4 1

Total 1.00

1.2 Stability data of Container

Very stable

2. Outer Packaging material

2.1 Basic information

INCI/Chemical Name * EINECS/ELINCS No CAS / CI No. * %*

PVC -- 9002-86-2 1

Total 1.00

2.2 Stability data of Outer packaging

2.3 Evidence for technical unavoidability of traces of prohibited substances



Applicant:

Attn: RICHARD KWOK


**************************************************************************************************************************************


********************************************************************************************************************************** To be continued











Conclusion:



Pass


Meet


Pass


Pass

*********************************************************************************************************************************











Tests Conducted


microorganisms



(5) Category (A):


should be





th Rev., 2012)






**************************************************************************************************************************************




*SZHJ985591*

Page 3 of 5








(per g)




Tests Conducted



result :

Test item


Result (ppm) (5)

<0.1

Limit#








Lead (Pb)


<5

Limit (ppm)





**************************************************************************************************************************************





*SZHJ985591*

Page 4 of 5




Tests Conducted



I. Test condition:



II. Test Results :


(3)to(4) (mg/dm²) (mg/dm²)


ND = Not detected



2 : 100mL.



*********************************************************************************************************************************

Components list :


********************************************************************************************************************************** End of report










*SZHJ985591*

Page 5 of 5



SZHH00981335

Appendix 5- Serious/ Undesirable Effects of Cosmetic Product Declaration or

Report


SZHH00981335

Appendix 6- Fragrance

1. IFRA Certificate


2. MSDS/SDS


3. Allergen declaration


SZHH00981335

Appendix 7- Heavy Metal Test Report of Cosmetic Product



Applicant:

Attn: RICHARD KWOK


**************************************************************************************************************************************


********************************************************************************************************************************** To be continued











Conclusion:



Pass


Meet


Pass


Pass

*********************************************************************************************************************************











Tests Conducted


microorganisms



(5) Category (A):


should be





th Rev., 2012)






**************************************************************************************************************************************




*SZHJ985591*

Page 3 of 5








(per g)




Tests Conducted



result :

Test item


Result (ppm) (5)

<0.1

Limit#








Lead (Pb)


<5

Limit (ppm)





**************************************************************************************************************************************





*SZHJ985591*

Page 4 of 5




Tests Conducted



I. Test condition:



II. Test Results :


(3)to(4) (mg/dm²) (mg/dm²)


ND = Not detected



2 : 100mL.



*********************************************************************************************************************************

Components list :


********************************************************************************************************************************** End of report










*SZHJ985591*

Page 5 of 5



SZHH00981335

Appendix 8- Human Volunteers Studies

1. Human volunteers study for the cosmetic product

No existing studies from human volunteers for finish product were provided

2. Human volunteers study for raw material

No existing studies from human volunteers for raw material(s) were provided

SZHH00981335

Appendix 9- Assessor’s credentials

cosmetic product safety report

Documents