Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1
12-Apr-13

Issue Date

Generic

Training Exercise Face Cream

Sponsor

Generic

Part A
Section 1 - Quantitative and Qualitative Composition
Ingredient

CAS Number

%w/w

Mineral oil

8012-95-1, 8020-83-5, 804247-5

49.200

Aqua(Purified water)

7732-18-5

33.300

Cera alba

8012-89-3

16.600

Sodium Borate

1330-43-4 / 1303-96-4

0.700

Methylparaben

99-76-3

0.200

Quantities below third decimal place not reported on this table, but have been used in
calculations later in the report.
Fragrance allergens are quoted as additional items so percentages may not add up to
100.

Colin's Cosmetic Consultancy

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Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1

Issue Date

12-Apr-13

Generic

Section 2 - Product Characteristics

Ingredient List
Mineral oil, Aqua(Purified water), Cera alba, Sodium Borate, Methylparaben
Frame Formulation Number Skin Care Cream Lotion, Gel 1.1
IFRA Category

Hand cream

Adult or Child

Adult

Colin's Cosmetic Consultancy

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Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1

Issue Date

12-Apr-13

Generic

Section 3 - Microbiological Quality

This product has passed the Ph Eur Challenge test and is therefore considered to be
adequately perserved for normal and foreseeable use.

Section 4 - Impurities and packaging

This formulation does not contain any toxicologically relevant impurites.
There are no known or likely interactions with the pack that have any safety implications.

Section 5 - Normal and Foreseeable Use

This product is intended for topical application to a limited body area in small quantities.

Section 6 - Exposure
This product is applied to the skin

Where Used

2g

Estimated Daily
Amount Used

Daily

Frequency Of Use
Assumed Body Weight

60 Kg
Leave On

Rinse Status

Section 7 - Exposure to Ingredients

Ingredient

CAS Number

%w/w

Dose

SED

Mineral oil

8012-95-1, 802083-5, 8042-47-5

49.200

1.0

Aqua(Purified
water)

7732-18-5

33.300

0.7

Colin's Cosmetic Consultancy

NOAEL

MoS

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Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1
12-Apr-13

Issue Date

Generic
Cera alba

8012-89-3

16.600

0.3

Sodium Borate

1330-43-4 / 130396-4

0.700

0.0

200

14285.7

Methylparaben

99-76-3

0.200

0.0

1000

250000

The Margin of Safety (MoS) is calculated by working out the maximum feasible
exposure and comparing it to the level at which no adverse effect is observed ( the
NOAEL). If the MoS is 100 then the use level is one hundredth the level at which any
effect is observed. Any level above 100 is considered to be acceptable.

Colin's Cosmetic Consultancy

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Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1

Issue Date

12-Apr-13

Generic

Section 8 - Toxicological Profile of Ingredients

Aqua(Purified water)

7732-18-5

Water does not have any toxicological significance in a formulation of this nature.

Cera Alba

8012-89-3

Cera Alba is the latin name for Beeswax. Beeswax has a very long history of use in
cosmetics, pharmaceuticals and in many other traditional applications. There are no toxicity
issues associated with it. The FDA recognise it as Generally Recognised as Safe (GRAS).
The nature of beeswax is such that it is extremely unlikely to penetrate the skin nor to cause a
significant number of allergic reactions.
The CIR Expert Panel reviewed the safety data on Beeswax finding it produced no toxicity in
acute or subchronic studies . It was not mutagenic when tested. In skin irritation tests,products
containing it caused no irritation. When tested alone Beeswax was not irritating to the eyes. In
clinical studies, products containing Beeswax were practically nonirritating in 21-day
cumulative patch tests, and repeat insult patch tests. No phototoxicity of a product containing
10% Beeswax was seen. Additionally, a product containing 4% Beeswax was not sensitizing to
the skin.
There are no restrictions on its use in topical products in either cosmetic or pharmaceutical
regulations. There are no direct toxicity issues related to it and there is no reason to suppose
that this ingredient poses any risk of any kind.
A pharmaceutical grade is used to ensure impurities are controlled at an acceptable level
JACT 3(3):1-41, 1984 Final Report on Safety of Beeswax confirmed 06/03 IJT 24(S1):48-52, 2005

Colin's Cosmetic Consultancy

Page 5 of 11

Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1

Issue Date

12-Apr-13

Generic
Methylparaben

99-76-3

Methylparaben has a long track record of safe use in cosmetics dating back to the 1930s.
During this history there have been numerous evaluations of the safety of this chemical,
usually in conjunction with other related homologues. A very thorough recent review was
carried out in 2008 which was reported in the International Journal of Toxicology.
This study uses a no observed adverse effect level (NOAEL) of 1000 mg/kg per day for the
most toxic member of the paraben family, i.e., butylparaben. In order to reach this level of
exposure a consumer would need to use very high level of the product indeed. This level of
use is clearly considerably greater than any reasonably foreseeable pattern of usage. Even in
this unlikely event the nature of the formulation would mitigate against it posing any risk to the
end user. The oil content of this product would prevent the bulk of the methylparaben from
being available. The logP of methylparaben is quoted in the literature as 2.00 so the amount
theoretically in solution could be calculated, but as the total level already has a more than
adequate safety margin this has not been done.
The risks of parabens as class have been questioned widely in the media since 2004 leading
to widespread public concern with a perception that use of parabens in personal care products
can lead to an increased risk of breast cancer. This issue was considered in great detail by
the EU's Scientific Committee on Consumer Safety. The conclusion drawn was that there was
no evidence to support this risk. This conclusion has been confirmed by subsequent
published discussions, most recently in 2013.
Although the whole class of parabens is usually included in discussions of the risks of cancer,
the proposed mechanism by which the carcinogenic behaviour is supposed to be mediated is
as a result of estrogenic activity. Methylparaben does not show any estrogenic activity in
recognised tests and so despite the similarity in its name there is no particular reason to
suppose that methylparaben would behave in the same way as other parabens.
Int J Toxicol. 2008;27 Suppl 4:1-82. Final amended report on the safety assessment of Methylparaben,
Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben
SCCS/1514/13 Scientific Committee on Consumer Safety Opinion on Parabens Updated request for a scientific
opinion on propyl- and butylparaben 2013

Colin's Cosmetic Consultancy

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Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1

Issue Date

12-Apr-13

Generic
Mineral oil

8012-95-1, 8020-83-5, 8042-47-5

Mineral oil is a very inert material with a long track record of safe use in cosmetics in general,
and has not been problematic with this product.
Paraffinum liquidum or light liquid paraffin has a long history of use in cosmetics and
pharmaceuticals. It is an inert material that would not be expected to give rise to toxicity
issues.
The nature of light liquid paraffin is such that it is extremely unlikely to penetrate the skin nor to
cause a significant number of allergic reactions.
There are no restrictions on its use in topical products in either cosmetic or pharmaceutical
regulations. There are no direct toxicity issues related to it, though excessive consumption is
anticipated to lead to digestive problems. This theoretical risk has not been investigated
widely, though an LD50 has been established in mice. The material is officially considered to
be Generally Recognised as Safe (GRAS) in the US. There is no reason to suppose that this
ingredient poses any risk of any kind.
A pharmaceutical grade is used to ensure impurities are controlled at an acceptable level.
FDA GRAS Assessment of Mineral Oil

Colin's Cosmetic Consultancy

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Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1

Issue Date

12-Apr-13

Generic
Sodium Borate

1330-43-4 / 1303-96-4

Sodium borate has been used in cosmetic products since ancient times. It is a component of
one of the oldest published cold cream formulations, attributed to Galen but almost certainly
predating him by many centuries.
The use of borax and related compounds in cosmetic products was reviewed in 1998 by the
EU's scientific committee, who proposed a number of restrictions on its use though without
publishing their reasoning. It has also been the subject of a Cosmetic Ingredient Review by
the American College of Toxicology which proposed very similar restrictions.
That review reported that sodium borate is poorly absorbed through intact skin, but is
absorbed through broken skin. Sodium Borate is relatively nontoxic when tested orally. A 5%
Sodium Borate water solution was mildly or moderately irritating to the skin, and practically
nonirritating when instilled in the eyes. It would be anticipated that in a cold cream formulation
the enhanced barrier function as a result of the high oil content would reduce absorbtion still
further leading to an even lower level of irritation.
Dose levels of Boric Acid much higher than in personal care products caused reproductive
effects. Boric Acid was nonmutagenic in a bacterial test system. Boric Acid induced genetic
effects in fruit flies. Limited carcinogenic and developmental toxicity studies did not indicate
any effects.
In clinical studies, cosmetic products containing up to 0.2% Sodium Borate were nonirritating
to moderately irritating and nonsensitising when applied to human skin. Photopatch testing of
formulations containing 1.1% or 1.7% Sodium Borate were negative.
Under Annex III of the cosmetic regulation EU 1223/2009 the limit for this kind of product is
3%, and 1.5% for products intended for irritating skin, expressed as borate content. For
sodium borate decahydrate these limits are 3.2% and 1.6%. This product's level of sodium
borate is considerably below these limits and is therefore compliant with the regulations. The
regulations do forbid the use of sodium borate at any level in products intended for children
under the age of three. The oily nature of the product suggests that this formulation would be
unlikely to enhance and would probably suppress any adverse effects from sodium borate.
EU's scientific committees opinion on borates 2010
CIR Review of Sodium Borate and Boric Acid
NPIC Technical Fact Sheet on Boric Acid (N.b., Figure expressed as boron)

Section 9 - Undesirable Effects

Colin's Cosmetic Consultancy

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Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1

Issue Date

12-Apr-13

Generic
This product does not attract an unusually high level of adverse reactions.

Colin's Cosmetic Consultancy

Page 9 of 11

Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1

Issue Date

12-Apr-13

Generic

Part B
Section 1- Assessment Conclusion
This product will give users the level of safety they can reasonably expect when used under
reasonable and foreseeable circumstances.

Section 2- Labels and Warnings

Sodium borate's safety for children has been questioned. Add a warning that the product is
unsuitable for use on children and should be kept away from them.
Period After Opening

12M

Section 3- Reasoning
This product is a standard one that uses normal ingredients with a long track record of safe use.
There is therefore no reason to suspect that this product will present any issues in normal use.

Signed

Colin Sanders

Colin's Cosmetic Consultancy

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Colin's Cosmetic Consultancy Ltd

5 Lombard Street
Petworth
West Sussex
GU28 0AG

Product Safety Assessment

Reference

Training Exercise Face Cream

Issue

CS001
1

Issue Date

12-Apr-13

Generic

Appendix - Credentials of Assessor

Colin Sanders Bsc(Hons) FSB Dip SCS
Date of Birth 19.5.1960
Academic Qualifications
Bachelor of Science in Environmental Science from Leicester Polytechnic, lower second with
honours awarded in 1983.
Diploma in Cosmetic Science awarded by the Society of Cosmetic Science awarded in 1985
Membership of Professional Bodies
Society of Cosmetic Scientists
Society of Biology
Experience
Development Chemist at Intergen Cosmetics 1983-1987
Quality Assurance W.M.Stills 1987-1990
Formulation Scientist/Formulation Laboratory Manager 1990-2004
Head of Product Formulation Medex/Montagne Jeunesse 2004-2013

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