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)
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