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Safety AssessmentsSafety Assessments

o n y C. D

BSc CChem CSci FRSC FLS FRSPHConsultant

© Dweck Data 2011

Established 1998

Assessments need a lot of computing power and vast amounts of data!

Formulaedata base Assessment

softwareRaw material

data baseNaturals

data base

Legislation

Coffee

Physical library650 volumes

TV

Router No.1

Router No.2

Server

Function and Chemistry

Isoflavone

FormononetinDaidzein

α-Amyrin

β-Amyrin

Boswellic acid

Ergosterol

Cholesterol

Fucosterol

Lanosterol

H

H

OAc

CO2H

H

HO

HOFusidic acid

Diosgenin

Estrone

Ferulic acid O

OH

O

HOH

Ferutinin

Sarsapogenin

Catechin

Why do we need a safety assessment?This is a lady who burnt her skin using a self-heating face mask

Excerpt from the assessment

• The margin of safety is 100, we aim for 200

• The material is highly exothermic

• The warnings have to be made very clear

• There are materials in the formula with limited topical history of use

Who does What?

Product Development

Formula1 and 2

Perfume Calculation

This is supplied by the perfume house

3

INCI list (descending)4

Stability Testing5

Manufacturing Instructions6

Specification7

Label Information8

Challenge Test9

Weight or Volume10

11 Claim substantiation• Test results from trials• Instrumental results e.g. corneometer, cutometer,

Mexameter etc.

• Supplier data results used at same percentage.

Proposed Pack Copy• Clinically tested• Dermatologically tested• Ophthalmologically tested• X out of Y consumers tested……• Before and after comparisons• Certified

12

Additional Claims• Natural • Biodegradable• Organically Certified• Fair Traded• Sustainable• Environmental• Not tested on animals

Typical raw material claims

Ingredient Trends - negative

• No petrochemicals• No sulfates (USA for SLES, SLS etc)• No SLS• No preservatives• No synthetic perfume• No parabens

• No synthetic sunscreen (use ZnO, TiO2)

• No animal derivatives (e.g. tallow, gelatin)

Product After Opening13

Period of Minimum DurabilityThe old Best Before or Use By date….

• Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer. However, this requirement should not apply where the concept of the durability after opening is not relevant, that is to say for single-use products, products not at risk of deterioration or products which do not open.

• The date of minimum durability shall be clearly expressed and shall consist of either the month and year or the day, month and year, in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.

• Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product is safe and can be used without any harm to the consumer. This information shall be indicated, except where the concept of durability after opening is not relevant, by the symbol shown in point 2 of Annex VII followed by the period (in months and/or years)

Once this is all assembled - you should receive ……

14a

Product Safety Report

Customer copyCPNP copySummary

Justification of each raw material

Exposure summary

Suggested Warnings

Assessor’s clarifications

and a Product Safety Report.How did we get there?

What is in the red tabs?

26 Potential Allergens

Will contain allergens

14b

Allergens to declare on INCI list

From the Essential Oil calculation

From the Perfume Calculation

This is supplied by the perfume house

3

This was part of the package you sent us!

These are the perfume allergens

This is the IFRA category

Tells if within safety limitsMaximum allergen level for category

Choose the product

Now we have to look at the exposure to the product and consider what type of product we have e.g. rinse off or leave on and the risk factor.

The numbers in the boxes drive the software

Different products fit into different IFRA categories and change the tolerated allergen levels

This is the number of allergens present

The allergen levels are shown by category in this table.Cat 9 in this example

Margin of Safety and ExposureNo Observable Adverse Effect Level

Calculated Margin of SafetyProduct exposure

Toxicology values based on LD50

Cosmetic Ingredient Review (CIR) panel gives a further check on safety BONUS

Check the level used against the CIR

Canada

14b

Warnings and Precautions to be observed in use

Assessor recommendations

15

CAS

EINECSFormula entry

Check formula entry against software data

base Function

Summary of the toxicological function and

argument for safe use

European Regulations checks against Annex III, IV, V16a

Legally required warningsLimitations

USA Regulations16b

BONUS information

Japanese Regulations

16cBONUS information

Australian Regulations16d BONUS information

Summary of the PIF File

Picture of the product17

IFRA Perfumery Compliance

• The toxicologist should have checked the product class versus the allergens content, but the IFRA conformance certificate gives maximum levels in each and is a double check.

18

MSDSs19

Another source of safety data often exaggerated!

GMP20

Good Manufacturing

Practice shown to be practiced

BATH ESSENCE

Contains: No petrochemicals, No sulfates. No SLS, No preservatives, No parabens, No synthetic sunscreen, No animal derivatives. No synthetic perfume. Alcohol free.

Label made of recycled paper, bottle made from recycled plastic. Biodegradable. Suitable for vegans and vegetarians.

Kosher.

Instructions: Add a cupful to the bath and add water

WARNINGS: Avoid contact with the eyes, in the event of contact, wash with copious volumes of water. Keep out of

the reach of children. Do not ingest. In the case of irritation discontinue use and consult your doctor.

250ml

INGREDIENTS: Aqua (Water), Aloe Barbadensis Leaf Juice, Sorbic Acid, Potassium Sorbate. Citric Acid,

Benzoic Acid, Anthocyanins.

Heals all skin diseases, is clinically proven to remove toxins, remove wrinkles, restore youth, and perform

miracles. Organically certified, fair traded, from sustainable plantations. Endorsed by the Palace and used

by her Majesty the Queen.

PACK COPY

Always check your copy against MHRA

guidelines

Are all your statements true?12 review

Cost for Product Safety Report

• Costs vary widely between £65-£450

• Many charge for “Extras”– INCI list– CIR reports– Individual foreign compliance

• The more you complete the cheaper the costs!

Additional tests

• Microbiology Challenge test - £165

• RIPT Skin Patch Test - £125

• Physical tests, e.g. viscosity - £18

• Stability testing – £50 plus

• Testing in vitro for safety - £50 to £150

Formulating Natural Cosmetics

Format Details• Hardcover • 673 Pages • Published 2010 • ISBN-10: 1-932633-75-8

• ISBN-13: 978-1-932633-75-7

Handbook of Cosmetic Ingredients - their use, safety and toxicology

• Use on Kindle reader or get the free App for iPhone, iPod, iPod-Touch, or get Kindle for PC (free software) for PC or laptop. Note: download software or App first then buy the book through the application or software if not using a Kindle Reader.

eBook £4.10 (5)

56

Handbook of Natural Ingredients- their use, folklore and chemistry

Use on Kindle reader or get the free App for iPhone, iPod, iPod-Touch, or get Kindle for PC (free software) for PC or laptop. Note: download software or App first then buy the book through the application or software if not using a Kindle Reader.

eBook £4.10 (5)

Thank youThank you

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