cosmetic product safety report · sed: systemic exposure dose. ingredient inci name 8....

PRODUCT: Natural Balm

COSMETIC PRODUCT SAFETY REPORT

DATE: 27 November 2017

Pura Vida CBDJennifer Deegan

Otterkoog 16-G

The NetherlandsAlkmaar

Responsible Person:

Oxford Biosciences Ltd.Magdalen Centre, The Oxford Science Park,

Robert Robinson Ave, Oxford OX4 4GA+44 (1844) 238827

CAS Function Limits Amount



1. Quantitative and qualitative composition

Ingredient INCI name

PART A – Cosmetic Product Safety Information

Cocos nucifera oil 8001-31-8 Emollient, hair 48.001Butyrospermum parkii butter 194043-92-0 Skin conditioning, viscosity 29.002Cannabis sativa seed oil 89958-21-4 Emollient, skin conditioning 10.503Cera alba 8012-89-3 Emollient, emulsifying, film 9.634Prunus amygdalus dulcis seed oil 8007-69-0 / Skin conditioning 1.005Tocopherol 1406-66-2 / Antioxidant, masking, skin 0.706Lavandula angustifolia flower extract 90063-37-9 Cleansing, deodorant, 0.507Cannabis sativa flower extract Emollient, skin conditioning 0.378Helianthus annuus seed oil 8001-21-6 Emollient, masking, skin 0.309

Pura Vida CBDCPSR Natural Balm

Allergens present in this product and estimated amounts*:None

* The presence of these allergens must be indicated in the list of ingredients when their concentration exceeds: 0.001% in leave-on products or 0.01% in rinse-off products

2. Physical & chemical properties and stability2.1.1 Physical/chemical properties of ingredients (substances or mixtures) See section 1. Quantitative and qualitative composition – additional specification of ingredients.



Cocos nucifera oilCocos nucifera oil is the fixed oil obtained by expression of the kernels of theseeds of the Coconut, Cocos nucifera L., Palmaceae. The oil is high in saturatedfats therefore it is slow to oxidise and, thus, resistant to rancidification. About60% of the fatty acids in coconut oil are medium chain triglycerides (MCT) 12carbon atoms or shorter.

1Ref. 1.

Butyrospermum parkii butterButyrospermum parkii butter is the fat obtained from the fruit of the Shea tree,Butyrospernum parkii, Sapotaceae. The tree has been recently reclassified asVitellaria paradoxa although the INCI name still remains Butyrospermum parkiibutter.About 85 to 90% of the fatty acid composition is stearic and oleic acids. Typical fatty acid profile: oleic acid (40-60%) stearic acid (20-50%) linoleic acid (3-11%) palmitic acid (2-9%) linolenic acid (<1%) arachidic acid (<1%)In March 2011, the Cosmetic Ingredient Review (CIR) Expert Panel concludedthat Butyrospermum parkii butter is safe in the present practices of use andconcentration described in this safety assessment.

2Ref. 1.

Cannabis sativa seed oilCannabis sativa seed oil is the fixed oil expressed from the seeds of Cannabissativa L., Cannabaceae.The oil has a 3:1 ratio of omega-6 to omega-3 essential fatty acids. Cannabissativa seed oil is comprised of mostly unsaturated fatty acids and is listed as asubstance Generally Recognised as Safe (GRAS) by the US FDA. TheCosmetic Ingredient Review (CIR) Expert Panel evaluated the scientific dataand concluded that Cannabis sativa seed oil is safe for use as a cosmeticingredient.

3Ref. 1.

CPSR: Pura Vida CBD Natural Balm




Cera albaCera alba, beeswax, is a natural wax produced in the bee hive of honey bees ofthe genus Apis. It is mainly esters of fatty acids and long-chain alcohols. Anapproximate chemical formula for beeswax is C15H31COOC30H61. Its maincomponents are palmitate, palmitoleate, and oleate esters of long-chain (30–32carbons) aliphatic alcohols, with the ratio of triacontanyl palmitate CH3(CH2)29O-CO-(CH2)14CH3 to cerotic acid CH3(CH2)20/06/2014COOH, the two principalcomponents, being 6:1.Typical wax profile: Wax content type Percentage Hydrocarbons 14% Monoesters 35% Diesters 14% Triesters 3% Hydroxy monoesters 4% Hydroxy polyesters 8% Acid esters 1% Acid polyesters 2% Free fatty acids 12% Free fatty alcohols 1%

4Ref. 1.

Prunus amygdalus dulcis seed oilPrunus amygdalus dulcis oil, Sweet almond oil, is the fixed oil obtained from theripe seed kernel of the sweet almond tree, Prunus amygdalus var. dulcis,Rosaceae. The oil comprises approximately 62% monounsaturated oleic acid(an omega-9 fatty acid), 29% linoleic acid (a polyunsaturated omega-6 essentialfatty acid), and 9% saturated fatty acid.

5Ref. 1.

TocopherolTocopherol is a series organic compounds with vitamin E activity consisting ofvarious methylated phenols which feature a chromanol ring, with a free hydroxylgroup on the aromatic ring that can donate a hydrogen atom to reduce freeradicals, and a hydrophobic side chain which allows for penetration intobiological membranes.The Food and Drug Administration (FDA) includes Tocopherol on its list ofnutrients considered Generally Recognized As Safe (GRAS).

6Ref. 1.

Lavandula angustifolia flower extractLavandula angustifolia flower extract is an extract of the flowers of the Lavender, Lavandula angustifolia, Labiatae.

7Ref. 1.

Cannabis sativa flower extractCannabis sativa flower extract is the extract of the flowers of Cannabis sativa L., Cannabaceae.

8Ref. 1.





Helianthus annuus seed oilHelianthus annuus seed oil is the edible oil expressed from the seeds of theSunflower, Helianthus annuus L., Compositae.Sunflower oil is a monounsaturated (MUFA)/polyunsaturated (PUFA) mixture ofmostly oleic acid (omega-9)-linoleic acid (omega-6) group of oils. Sunflower oilis mainly a triglyceride edible oil which the FDA has classed as GRAS. TheBritish Pharmacopoeia lists the fatty acid profile as: Palmitic acid (saturated): 4–9% Stearic acid (saturated): 1–7% Oleic acid (monounsaturated omega-9): 14–40% Linoleic acid (polyunsaturated omega-6): 48–74%In March 2011, the Cosmetic Ingredient Review (CIR) Expert Panel concludedthat Helianthus annuus seed oil is safe in the present practices of use andconcentration described in this safety assessment.

9Ref. 1.




2. Physical & chemical properties and stability

2.1.2 Physical/chemical properties of the cosmetic product

AppearanceColourAromapH

Cream/Paste/GelOlive green Floral4.5

Pura Vida CBD

BBE period.

BBE

3. Microbiological quality 3.1.1 Microbiological specification of ingredients (substances and mixtures).

Based on available information from the ingredient specification (see section 1. Quantitative andqualitative composition– specification of ingredients), the ingredients used can be assessed asmicrobiologically safe.

PART A – Cosmetic Product Safety Information continued

continued

*RP: Responsible Person:

2.2 Stability of the cosmetic productThe ingredients used in the production of the cosmetic product comply with the relevant legalregulations.

Both the product and constituent ingredients are stable under normal use and warehousingconditions during the entire time of the

2.2.1 Pura Vida CBD confirms that all product stability tests reflect the stabilityof the product which is to be placed on the market.

2.2.2 uses aPura Vida CBD based on the results of's stability testing, including shelf life stability testing.Pura Vida CBD

2.2.3 A Preservative Efficacy Test was not necessary since this is not a water-based product.




3.1.2 Microbiological specification of the finished product

The given cosmetic product can be regarded as microbiologically safe for consumers’ healthunder the ISO 29621:2010 standard “Cosmetics -- Microbiology -- Guidelines for the risk assessmentand identification of microbiologically low-risk products”.The microbiological harmlessness of the ingredients and the cosmetic product is assessedaccording to COLIPA: Guideline for Microbiological Quality Management (MQM).

4. Impurities, trace amounts of forbidden substances, & information about packaging material

4.1 Impurities and trace amounts of forbidden substancesAccording to specifications (see section 1. Quantitative and qualitative composition – specificationof ingredients) submitted by ingredient suppliers, the ingredients do not contain impurities or traceamounts of forbidden substances.

4.2 Information about packaging material

The packaging material applied is suitable for the given type of cosmetic product and meets thepredictable use requirements.

ContainerContainer MaterialAirless Container

JarPETNo

The available research suggests that the concentration of phthalates in the contents of PETbottles varies as a function of the contents of the bottle, with phthalates leaching into lower pHproducts. Temperature also appears to influence the leaching both of phthalates and of antimonyfrom PET, with greater leaching at higher temperatures.The evidence also suggests that PET bottles may yield endocrine disruptors under conditions ofcommon use, particularly with prolonged storage and elevated temperature.Therefore it is advisable, in using PET containers, to ensure a minimum pH of 4.0 and to storeproducts at cooler temperatures using a shorter BBE period.

confirms that the results of reference sample monitoring show noPura Vida CBDreaction between the packaging material and the product during the product’s stated minimumuseable life. During that life no changes to physical and chemical properties of the product werenoticed that would affect its usability and safety.

A Preservative Efficacy Test was not necessary since this is not a water-based product.




The current label advice:5. Normal and reasonably foreseeable use

Apply topically to skin as needed.The label of this cosmetic product should include this special note regarding its use, incompliance with Article 19(1)(d) of Cosmetic Regulation (EC) No. 1223/2009:

6. Exposure to the cosmetic product

Area of applicationProduct type: Leave-on or Rinse-offDuration and frequency

Possible additional routes of exposureEstimated skin surface area (cm2)Estimated amount of the product appliedaccording to the SCCS (g/day)Estimated retention factor according tothe SCCSTarget groupCalculated relative daily exposure according to the SCCS (mg/kg bw/day)

Leave On2.28

Face156707.82 g

1

Adult123.2

For external use only. Keep out of reach of children.

Body



7. Exposure to the ingredients

Concentration SED



1 Cocos nucifera oil 0.48000 59.136002 Butyrospermum parkii butter 0.29000 35.728003 Cannabis sativa seed oil 0.10500 12.936004 Cera alba 0.09630 11.864165 Prunus amygdalus dulcis seed oil 0.01000 1.232006 Tocopherol 0.00700 0.862407 Lavandula angustifolia flower extract 0.00500 0.616008 Cannabis sativa flower extract 0.00370 0.455849 Helianthus annuus seed oil 0.00300 0.36960


SED: Systemic Exposure Dose


8. Toxicological profile of the ingredients in the formulation

MOS



338.203501 Cocos nucifera oil559.785002 Butyrospermum parkii butter773.036503 Cannabis sativa seed oil421.437304 Cera alba

4058.441605 Prunus amygdalus dulcis seed oil5797.773706 Tocopherol3246.753207 Lavandula angustifolia flower extract

10968.761008 Cannabis sativa flower extract13528138.528109 Helianthus annuus seed oil


MOS: Margin of Safety



8. Toxicological profile of the ingredients in the formulation - continued

After its launch, the cosmetic product will be further monitored by Pura Vida CBD

The cosmetic product with a similar composition has been supplied to the market in the long termand until nowadays, no undesired effects to human health have been noticed in relation to the use ofthis product. Therefore, no undesired effects are anticipated at the common and reasonablypredictable application of the given cosmetic product.

in accordance to procedures detailed in Cosmetic Regulation (EC) No 1223/2009. The safety of theproduct should be reviewed on a regular basis. To that end, undesirable and serious undesirableeffects on human health during in market use of the product should be filed (complaints duringnormal and improper use, and the follow-up done) and details forwarded to the safety assessor.The safety assessor will then update the Cosmetic Product Safety Report (CPSR) based on the newfindings and the adopted corrective measures.

10. Additional information on the productNo additional information is available and no additional studies were carried out.

In line with WHO guidelines, recommending a minimum value of 100, it is generally accepted that theMoS should at least be 100 to conclude that a substance is safe for use. Since the ingredient used inthis formulation are edible and have an MOS value above 100 then the conclusion is that they are safefor use in this formulation.

Based on the calculation of MoS (Margin of Safety) for ingredients that can be classified as hazardousto human health, the product does not contain ingredients with toxicologically significant profiles interms of consumer health.An ingredient with an MoS above 1000 is considered safe. An ingredient with an MoS above 100 butlower than 1000 must be further considered by the assessor.

9. Undesirable effects and serious undesirable effects




11. References

• THE SCCS'S NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC SUBSTANCES AND THEIR SAFETYEVALUATION 8TH REVISIONhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF

• MSDS of ingredients

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

• SCCS - Opinionshttp://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/index_en.htm

• CosIng: the European Commission database on cosmetic substanceshttp://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.simple

• REGULATION 1223/2009 ANNEXEShttp://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=ref_data.annexes_v2




Allergens present in this product and estimated amounts*:

PART B – Cosmetic Product Safety Assessment

1. Assessment conclusionBased on the information supplied, the cosmetic product detailed in this report is safefor human health when used in common or reasonably predictable conditions incompliance with the instructions provided for the consumer.This conclusion is only applicable to this cosmetic product with the composition, properties,purpose, and method of use of which are detailed in this documentation, and laboratory testsattached to this assessment, including the detailed production and labelling which has beenassessed as meeting the requirements of Cosmetic Regulation (EC) No. 1223/2009 effectiveon the date this report was issued.

2. Labelled warnings and instructions of use

The label of this cosmetic product should include this special note regarding its use, in compliance with Article 19(1)(d) of Cosmetic Regulation (EC) No. 1223/2009:

For external use only. Keep out of reach of children.

3. Reasoning

Based on the formulation of this cosmetic product, its qualitative and quantitative compositionaccording to its INCI ingredients, basic physical and chemical characteristics and microbiology,Preservation Challenge Test performed, classification of the cosmetic product type, including itspurpose and method of application, and available toxicological information and safety sheets of theingredients used, the cosmetic product safety has been assessed for the consumer by assessing thetoxicological profile of all ingredients, their chemical structure, exposure level and Margin of Safety(MoS) depending on the purpose of use in this cosmetic product.This cosmetic product contains only the allowed ingredients in allowed concentrations. For ingredientswith safety limits as specified in Annexes to Cosmetic Regulation (EC) No. 1223/2009, no ingredientexceeds the allowable safety limit therefore is a safe concentration in this cosmetic product. Theevaluation of the entire composition and applied ingredient concentrations indicate that as a whole thecomposition of this cosmetic product complies with the requirements of Cosmetic Regulation (EC) No.1223/2009 of the European Parliament and of the Council.

None* The presence of these allergens must be indicated in the list of ingredients when their concentration exceeds: 0.001% in leave-on products or 0.01% in rinse-off products. Only the allergen, not the estimated amount, is required on the label.




4. Assessor's credentials and approval of Part B

Safety Assessor: Allison WildOxford Biosciences Ltd.The Oxford Science ParkMagdalen CentreOxfordshireOX4 4GA

Experience and qualifications:

o MSc in Clinical Pharmacology, University of Oxfordo 10+ years experience formulating cosmetic productso Full member of the Society of Cosmetic Scientists (SCS)o Member of the British Pharmacological Society

Signature Date27 November 2017


cosmetic product safety report · sed: systemic exposure dose. ingredient inci name 8....

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