Safety Assessments - Anthony Dweck€¦ · · 2015-01-10Safety Assessments BSc CChem CSci FRSC...
Transcript of Safety Assessments - Anthony Dweck€¦ · · 2015-01-10Safety Assessments BSc CChem CSci FRSC...
Assessments need a lot of computing power and vast amounts of data!
Formulaedata base Assessment
softwareRaw material
data baseNaturals
data baseLegis lation
Coffee
Physical library650 volumes
TV
Router No.1
Router No.2
Server Server
Function and Chemistry
Isoflavone
FormononetinDaidzein
α-Amyrin
β-Amyrin
Boswellic acid
Ergosterol
Cholesterol
Fucosterol
Lanosterol
H
H
OA c
CO 2H
HHO
HO
Fusidic acid
Diosgenin
Estrone
Ferulic acidO
OH
O
HOH
Ferutinin
Sarsapogenin
Catechin
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•
11 Claim substantiationTest results from trials•Instrumental results e.g. corneometer, cutometer, •Mexameter etc.
Supplier data results used at same percentage.•
Proposed Pack CopyClinically tested•Dermatologically tested•Ophthalmologically tested•X out of Y consumers tested……•Before and after comparisons•Certified•
12
Additional ClaimsNatural •Biodegradable•Organically Certified•Fair Traded•Sustainable•Environmental•Not tested on animals•
Typical raw material claimsENDORSEMENTS
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)•
This is absolute nonsense
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)
14a
Product Safety Report
Customer copyCPNP copySummary
Justification of each raw material
Exposure summary
Suggested Warnings
Assessor’s clarifications
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 allergensThis 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
Margin of Safety and ExposureNo Observable Adverse Effect Level
Calculated Margin of SafetyProduct exposure
Cosmetic Ingredient Review (CIR) panel gives a further check on safety BONUSCheck the level used against the CIR
15
CAS
EINECSFormula entry
Check formula entry against software data
base Function
Summary of the toxicological function and
argument for safe use
IFRA Perfumery ComplianceThe 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
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-£400•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 DetailsHardcover •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)
Thank you
Web: www.dweckdata.comEmail:[email protected]
Tel: 01722 331805 01722 416206
Mob: 07850 438581