Functional Ingredient Solutions

functional ingredient solutions
PRODUCT INFORMATION FILE
Prepared according to EC 1223/2009
Product Name:
Tiddley Pom Organic Massage Oil 50ml1
Product Code:
CU000375281
Product Name:
Tiddley Pom Organic Massage Oil 150ml
Product Code:
CU00068642
Responsible Person:
Tiddley Pom Ltd, 15 Rose Hill, Dorking, Surrey, RH4 2ED,
UK.
1 – Tiddley Pom Organic Baby Massage Experience (Product Code CU00068643) is
a “gift set” containing the products below:
Tiddley Pom Organic Nappy Balm 30ml (Product Code CU00068641)

Tiddley Pom Organic Soothing Lotion 50ml (Product Code CU00037529)
Tiddley Pom Organic Massage Oil 50ml (Product Code CU00037528)
Tiddley Pom Organic Baby Wash 50ml (Product Code CU00037530)
Inovia International, a division of Stan Chem International Ltd.

Manufacturing Site: Unit 11, Kings Cliffe Industrial Estate,
Wansford, Peterborough, Cambridgeshire, PE8 6PB.
Tel: 01780 – 782 319 Fax: 01780 – 781 398
Email: sales@inoviainternational.co.uk
CONTENTS
Volume 1
A statement confirming the name and place of manufacture
A statement confirming compliance with good manufacturing practice (GMP) and referring to
a description of the method of manufacturing
A statement confirming that no animal testing is performed by the manufacturer, his agents
or suppliers, relating to the safety of this product
Composition of the Product
Physical / Chemical Characteristics
Raw Material Quality / Purity
Stability
Microbial Quality – Ingredients
Microbial Quality – Finished Product
Finished Product Safety
Challenge Test Data
Packaging Information
Allergens Declaration
IFRA Statement
Wording or Artwork for the Pack Labelling
Undesirable Effects and Serious Undesirable Effects
Appendix 1 – GMP Certificate
Volume 2
Cosmetic Product Safety Assessment and Cosmetic Product Safety Report according to
Regulation (EC) No. 1223/2009

Tel: 01780 – 782 319 Fax: 01780 – 781 398
VOLUME 1
Name and Place of Manufacture
The products are manufactured at:
Inovia International, Unit 11, King’s Cliffe Industrial Estate, Wansford, Peterborough,
Cambridgeshire, PE8 6PB.
Good Manufacturing Practice Statement

The management system of Inovia International has been assessed by SGS United
Kingdom Ltd and certified as meeting the requirements of ISO 22716:2007,
Cosmetics – Guidelines on Good Manufacturing Practices (GMP). A copy of the
certificate can be seen in Appendix 1.
It is confirmed that the products are manufactured to Cosmetic Good Manufacturing

Practice (GMP).
A description of the method of manufacturing is held on file at Inovia International.
Animal Non-testing Declaration

It is confirmed that the products, and the individual ingredients in the products, have
not been the subject of animal testing or retesting since 31 December 1990.
It is also confirmed that no animal testing is carried out via third parties on behalf of
the company.
Composition of the Product

The detailed quantitative formulation (exact % of each ingredient) is held on file at
Inovia International.
Physical/Chemical Characteristics
The raw material specifications and the finished product specifications are held on
file at Inovia International.

Tel: 01780 – 782 319 Fax: 01780 – 781 398
Raw Material Quality/Purity

Raw Material Manufacturers’ material safety data sheets, specifications and
certificates of analysis are held on file at Inovia International.
Stability
The stability of the product is acceptable.
Tiddley Pom Organic Massage Oil 50ml and 150ml is a single ingredient (100%
sunflower oil). Certificates of analysis for each batch, that show the production date
and the expiry date, are held on file at Inovia International.
Microbial Quality - Ingredients

It is a requirement that all raw materials / ingredients meet a microbial quality of <
100 cfu/gram for infant products (from the SCCS Notes of Guidance for the Testing
of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, 2012). All the raw
materials / ingredients comply with this requirement.
Microbial Quality – Finished Product

It is a requirement that the finished product meets a microbial quality of < 100 cfu /
gram for infant products and zero harmfuls (from the SCCS Notes of Guidance for
the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, 2012).
The finished products comply with this requirement.
Finished Product Safety

The microbial content (Total Viable Count) at time of manufacture must be within
recognised limits: nmt 1000 cfu and zero harmfuls / gram (from the SCCS Notes of
Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th
Revision, 2012). The microbial content at time of manufacture complies with these
recognised limits.
Challenge Test Data

The product will pass a Microbial Challenge Test. As the formulation of the product
is water-free, it is considered that it will not require a preservative and will not pose a
microbiological hazard.

Tel: 01780 – 782 319 Fax: 01780 – 781 398
Packaging Information
Packaging Information is held on file at Inovia International.
Allergens Declarations
sunflower oil) and the product contains no allergens.
IFRA Statement
sunflower oil). According to the IFRA Standards, sunflower oil is not restricted.
Wording or Artwork for the Pack Labelling

The following pack labelling artworks are held on file at Inovia International.
Artwork PDF file name “Box_Step 2__Organic Massage Oil 150ml - CU00068642”
Artwork PDF file name “Label_Step 2_Organic Massage Oil_150ml - CU00068642”
Artwork PDF file name “TP Gift Set - Tiddley Pom_4 Step Massage_Box_Base -
CU00068643”
Artwork PDF file name “TP Gift Set - Tiddley Pom_4 Step Massage_Box_Top -
CU00068643”
Artwork PDF file name “TP Gift Set Labels_Step 1-2-3_50ml - CU00068643”
Undesirable Effects and Serious Undesirable Effects

Inovia International is not aware of any available data on undesirable effects and
serious undesirable effects relating to the product, or other similar cosmetic
products.
……………………………
Technical and Regulatory Department
For Inovia International
17th March 2014

Tel: 01780 – 782 319 Fax: 01780 – 781 398
Appendix 1 – GMP Certificate

Tel: 01780 – 782 319 Fax: 01780 – 781 398
VOLUME 2

Tel: 01780 – 782 319 Fax: 01780 – 781 398
The Elms · Oxford Rd · Chieveley · Newbury · RG20 8RT· United Kingdom
Telephone: +44 1635 248830 Fax: +44 1635 247206
Email: innova47@aol.com
SAFETY ASSESSMENT/
CONSUMER PRODUCT SAFETY REPORT
Product Name: Tiddley Pom Organic Massage oil 50ml

Ref: CU 00037528
Product Name: Tiddley Pom Organic Massage Oil 150ml
Ref: CU 00068642
our ref: K1293
PART A, SAFETY REPORT
This Safety Report/Assessment is conducted to EC1223-2009.

It takes account of the requirements of the EC 1223/2009 for a special assessment
for baby products.
The Assessment is conducted in accordance with the principles of Good

Laboratory Practice referred to in Article 1 of Council Directive 2004/10/EC on the
applications of the principles of good laboratory practice and the verification of their
application for tests on chemical substances.
This assessment takes account of:

a) the general toxicological profile of each ingredient used:
b) the chemical structure of each ingredient:
c) the level of exposure of each ingredient;
d) the specific exposure characteristics of the areas on which the cosmetic
product will be applied;
e) the specific exposure characteristics of the class of individuals for whom the
cosmetic product is intended.
REVIEW OF INGREDIENTS
All of the ingredients have a history of use in cosmetic and toiletry products.
Ingredients that are:
1
• Prohibited under EU Cosmetics Regulations
• Restricted when used beyond the allowed authorised conditions
• With toxicological data incompatible with the intended concentration and
use
• Which have insufficient toxicological data nor safety in use experience
• Which are not properly characterised with regard to purity and analytical
composition are excluded.
ASSESSMENT
Assessment is based on ingredient safety review and information on the final

formulation, including the intended and reasonably foreseeable use, the physico-
chemical and microbiological specifications of the raw materials and the finished
product, stability and a history and record of any reported undesirable effects
linked to the use of the product.
DESCRIPTION OF THE PRODUCT
This is a leave-on product for application to infant whole body as a skin protectant
and moisturiser.
DESCRIPTION OF INTENDED AND REASONABLY FORESEEABLE USE
The product may reasonably be typically used up to 1-2 times daily as required,
QUALITITATIVE COMPOSITION OF THE PRODUCT
A FULL QUANTITATIVE VERSION OF THIS ASSESSMENT IS HELD ON FILE

BY THE ASSESSOR AND THE MANUFACTURER
Ingredients are listed below. Detailed information on the safety and toxicology of
ingredients is presented below.
The above ingredients have been reviewed for potential to be skin irritants,
sensitisers or photo-sensitisers.
Where data is available for systemic and sub-chronic toxicity this has been taken
into account.
A review of the literature and of the structural chemistry has been made for each
ingredient to estimate the likely potential for genotoxicity, reproductive effects and
carcinogenicity.
No animal testing has been conducted on this formulation. All safety data is taken
from existing published sources.
2
EXPOSURE TO THE PRODUCT/ EXPOSURE TO THE SUBSTANCES
MARGINS OF SAFETY
Based on the available toxicological literature or on “read-across” data Margins of

Safety have been calculated for both topical and systemic effects.
The procedure is as described in: THE SCCS NOTES OF GUIDANCE, FOR THE
TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION, 8th
REVISION, 2012.
Dermal Absorption reported as a % of the substance applied:
EXPOSURE TO THE SUBSTANCES
For a typical infant a median bodyweight of 10 kg is selected.
The calculation of the SED is as follows:
SED = A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100

10 kg
SED (mg/kg bw/day) = Systemic Exposure Dosage

A (g/day) = Amount of the cosmetic product applied daily:
see the daily exposure values for different cosmetic product types
C (%) = the Concentration of the ingredient under study in the finished cosmetic
product on the application site
DAp (%) = Dermal Absorption expressed as a percentage
of the test dose assumed to be applied in real life conditions
10 kg = Typical Infant body weight
The calculation of Margin of Safety (MOS): NOAEL

SED
NOAEL data is derived from published literature where available.
Estimated Daily Exposure Levels:
Data for Estimated daily exposure levels is taken from the current Colipa data as
presented in THE SCCS NOTES OF GUIDANCE, FOR THE TESTING OF
COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION, 8th REVISION,
2012.
Table 3: Estimated daily exposure levels for different cosmetic product types according
to Colipa data [SCCNFP/0321/02; Hall et al. 2007, 2011].
Product type Estimated Relative Retention Calculated Calculated

daily amount factor 1 daily relative daily
amount applied exposure exposure
applied (mg/kg (g/day) (mg/kg
bw/day bw/day)
Body Massage 3.0 g 300.0 1.0 3.0 300.0
Oil
3
1 The retention factor was introduced by the SCCNFP to take into account rinsing off and dilution of
finished products by application on wet skin or hair (e.g. shower gels, shampoos, …)
[SCCNFP/0321/00]
It was concluded that all ingredients, when considered both individually and
in combination have an adequate Margin of Safety, ie > 100.
PHYSICAL/CHEMICAL CHARACTERISTICS
The raw material Specifications and the Finished Product Specification are
provided. It is considered that all Specifications meet good standards for safe use
of this product.
See Appendix
RAW MATERIAL QUALITY/ PURITY
All raw materials are from reputable sources of supply and are considered to meet
current standards of purity and quality.
The physical and chemical properties and microbiological of the raw materials
have been reviewed. It is noted that all are to current standards and there are no
banned or restricted materials present.
The Molecular formulae for defined chemical substances are as recorded in the
current Edition of ICID.
Manufacturers Material data sheets/ Certificates are Appended
The raw materials meet current good standards for quality and purity.
Manufacturers Material data sheets/ Certificates are presented in Appendix.
GOOD MANUFACTURING PRACTICE
The product is to be manufactured to adequate standards of Good Manufacturing

Practice and there are to be are adequate controls in regards to Microbial quality
STABILITY
The product is deemed stable under normal and foreseeable conditions of use.
Stability data is summarised in Appendix.
MICROBIAL QUALITY
INGREDIENTS
It is a requirement that all raw materials/ ingredients meet a microbial quality of <
100 cfu/ gram for Infant products
4
FINSHED PRODUCT
It is a requirement that the Finished Product meets a microbial quality of < 100 cfu/
gram for Infant products and zero harmfuls.
CHALLENGE TEST DATA
The product is water-free and no added preservatives are required.
PACKAGING
The packaging is described as: 60 ml size: PET bottle and PP Cap.

150 ml size: PET Bottle with pump of mixed materials including Nozzle
(Polyoxymethylene - POM); Actuator (Polypropylene - PP); Up piston (Low Density
Polyethylene - LDPE); Stem insert (Low Density Polyethylene - LDPE); Closure
(Ploypropylene - PP); Gasket (NBA); Gasket (Low Density Polyethylene - LDPE);
Ball (Glass); Lower piston (Low Density Polyethylene - LDPE); Housing
(Polypropylene - PP); Spring (Stainless Steel - SS); Dip tube (High Density
Polyethylene - HDPE).
The packaging materials are to meet acceptable standard of purity. Consideration
has been given to interaction between the product and the packaging. It is
considered there is no adverse interaction between product and packaging as
regards safety to the consumer.
FINISHED PRODUCT SAFETY
The above formulation is based on known ingredients with history of safe use in
cosmetic products.
The product is considered to be protected from microbial growth.
It is noted that all ingredients are used within limits as specified in the cosmetics
Directive.
The microbial content (Total Viable Count) at time of manufacture must be within
recognised limits (nmt 1000cfu and zero harmfuls /gm).
This Safety Assessment has taken account of:
1. The Quantitative/Qualitative composition of the product,

2. The intended and reasonably foreseeable use of the product,
3. Margins of Safety for all ingredients considered both individually and in
combination.
4. A review of raw material specifications for purity.
5. Standards of good manufacturing practice
6. A consideration of potential interactions of substances in the formulation.
7. A consideration of the stability of the formulation
5
INGREDIENT TOXICOLOGY PROFILE & SAFETY REVIEW
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL
CAS: 8001-21-6
EINECS: 232-273-9
Sunflower seed oil is a vegetable oil with a safety and toxicity profile similar to
vegetable oil and as described below. The fatty acid profile includes linoleic acid
(63%), oleic acid (23%) and palmitic acid (6%) as the major fatty acids. In common
with other vegetable oils this is a blend of C16-C18 triglycerides.
Limited formal safety data is available since this is a GRAS substance (Generally
Regarded As Safe).
A human repeat insult patch test on vegetable oil on 88 subjects gave no signs of
irritation or sensitisation. The fatty acid profile of Sunflower oil is similar to that of
Coconut oil and Palm oil, and the safety of these oils is relevant to Sunflower oil.
Coconut oil is the subject of a CIR monograph (2010) and of a review in JACT
(1986). It is reported non-irritant to skin and eyes in animals nor is it a sensitiser.
There was no indication that products containing coconut oil were phototoxic nor
were primary irritants.
Palm oil is the subject of a CIR monograph (2010) also shows no adverse toxicity.
The oral LD50 in rats is low at >5g/kg. Short term and sub-chronic feeding studies
showed no evidence of toxicity.
In summary this ingredient is considered to be safe as used in this formulation.
A NOAEL of 2000 mg/kg is established. (3)

REFERENCES
1 Cosmetic Ingredient Review (2010)

2 JACT (1986) 5(3) 103-121
3.http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/dhi_report_app2_081
211_en.pdf
SPECIAL ASSESSMENT FOR INFANTS
It is a requirement of the Regulation that there is a special Assessment for infant

products. This is given below.
In assessing the safety for infants and children consideration has been given to
several factors including the potential for accidental oral ingestion and the potential
for dermal irritation, sensitisation and penetration with possible systemic effects.
6
Accidental Oral Ingestion
The potential of accidental oral ingestion is related to the problem that infants and
children are recognised to eat or drink cosmetic products. It is therefore important
that product formulations have a very low potential for acute toxic effects especially
in infants where the bodyweight is much less than an adult.
Based on the known acute toxicity to rodents of the components of the formulation,
it is estimated that the formulation will have an LD50 of >10gm/kg bodyweight.
This would indicate a very low order of acute oral toxicity. An infant aged 1 year
and typically of weight 10kg, would not be harmed by oral ingestion of 100 gm of
baby massage oil. The potential for systemic adverse effects has been considered.
Ingredients that have the potential for intestinal absorption are readily metabolised
and excreted and are not considered likely to have systemic toxic effects.
Dermal Penetration and Systemic Effects
Consideration has been given to the potential for dermal penetration of the
ingredients of the formulation.
It is recognised that infants are not the same as small adults in assessing the
safety and toxicity potential of materials. In particular the infant has a much greater
surface area/ bodyweight ratio than an adult, resulting in a greater potential for
systemic toxicity.
It is recognised that pre-term (premature) infants have the potential for greater
dermal penetration of any cosmetic ingredient as a result of thinner and immature
skin. In addition, although the skin permeability of full-term infants is essentially
identical to that of adults, occlusion of the scrotum in males and of damaged skin in
the diaper area, may have the potential to increase dermal absorption of certain
cosmetic ingredients.
It is considered that the ingredients are readily metabolised where there is dermal
absorption and are not likely to have adverse systemic toxicity.
Local Dermal Effects, Irritation and Sensitisation Potential
This assessment includes a review of the likely irritancy and sensitisation potential
of each of the ingredients of the formulation. It is considered that there is an
extremely low potential for dermal irritancy or allergenicity.
It can therefore be concluded that the formulation is safe for the intended use and
that there is no significant risk of irritancy or allergy.
7
PART A SAFETY SUMMARY
In reviewing the safety and toxicity profile of the ingredients used and their history
of safe use, it is concluded that there are no likely safety hazards from normal use
of this product and when used as directed or from foreseeable conditions of
misuse.
The product is considered safe for sale in EU Countries.
Dated: March 13th 2014.
Dr. JOHN HOPKINS BSc. PhD. MSB. C Biol.

Safety Assessor
PART B
SAFETY ASSESSMENT SUMMARY

According to EC1223-2009.
SUMMARY
Reasoning:
This Assessment has considered the safety and toxicological profile of all raw
materials and any trace components present. Consideration has been given to
parameters of weight of evidence (particularly for long established materials) and
also published toxicity data for NOAEL’s allowing calculations of Margins of Safety,
based on established use of the product. Margins of Safety have been calculated
to confirm safety from a systemic aspect.
Assessment for local effects, including skin and eye irritation, dermal sensitization
and photoallergenicity was evaluated based on established safe use for dermal
safety, derived from manufacturers data, and data published by CIR and also in
the public domain.
Assessment for systemic effects including target organ toxicity, effects on maternal
and reproductive toxicity and a review of genotoxic and carcinogenic safety was
evaluated based on established safe use and from manufacturers data, and data
published by CIR and also in the public domain.
Established use and consumer exposure is derived from data produced by SCCS
in Notes of Guidance.
8
The above formulation is based on known ingredients with history of safe use in
cosmetic products.
The Assessment has considered the safety of the individual ingredients both
separately and in combination to produce the final formulation.
A review of the data relating to raw material purity indicates that all materials and
packaging have a satisfactory physical and chemical profile. There are no
unacceptable levels of prohibited substances or impurities.
The product is deemed to have adequate stability.

The product is considered to be adequately preserved.
The finished product specification is considered to meet current standards for
Microbial quality.
This Safety Assessment has taken account of:
1. The Quantitative/Qualitative composition of the product,

2. The intended and reasonably foreseeable use of the product,
3. Margins of Safety for all ingredients considered both individually and in
combination.
4. Standards of good manufacturing practice
5. A consideration of potential interactions of substances in the formulation.
6. A consideration of the stability of the formulation.
Conclusion
In reviewing the safety and toxicity profile of the ingredients and their history of
safe use, raw material standards and labelling, it is concluded that there are no
likely safety hazards from normal use of this product and when used as directed or
from foreseeable conditions of misuse.
The product is considered safe for sale in EU Countries.
Dated: March 13th 2014.
Dr. JOHN HOPKINS BSc. PhD. MSB. C Biol.
Safety Assessor
9
The Elms ! Oxford Rd ! Chieveley ! Newbury ! RG20 8RT! United Kingdom
Telephone: +44 1635 248830 Fax: +44 1635 247206
Email: innova47@aol.com
JOHN HOPKINS
CURRICULUM VITAE
Academic Qualifications.
BSc (Honours) Biochemistry/Chemistry.

University of St Andrews, UK.
PhD Pharmacology/Toxicology.
University of Dundee, UK.
Membership of Societies
Member of Institute of Biology. MSB. C Biol.

Membership number 004007934
A Founder member of British Toxicology Society 1979.
Member Company of CTPA
Qualifications as a professional Toxicologist in respect of Directive 93/35/EEC

Art 7a(1)(e) and Regulation EC 1223/2009
The Diploma C Biol. is within the meaning of Regulation 2 (1) of the

European Communities (Recognition of Professional Qualifications)
Regulations, 1991(b).
The holder is recognised under European Community law to be a Safety
Assessor for products under the Cosmetics Directive.
Relevant Experience
2000- current, Director and Principal of Innovant Research Ltd, an

independent Consultancy in Toxicology, Risk Assessment and Product
Safety. Emphasis on the safety of chemicals, cosmetics and medical device
products.
1
1976-1999. Employed by Johnson and Johnson.
Several positions from Toxicology head, Head of Medical Dept, and
R&D Director in UK and Director in the USA.
1974-1976. Toxicologist for Smith Kline Beecham Pharmaceuticals,

Responsible for antibiotic safety program.
At Smith Kline Beecham Pharmaceuticals, developed methods for rapid

evaluation of potential renal damage due to cephalosporin and penicillin
antibiotics. Also developed methods to assess safety of anti-depressant
medicines.
At Johnson & Johnson, was responsible for safety of both medical devices
and skin and hair care products in the European business. Developed
methods for cell culture evaluation of shampoo and detergent products as an
alternative to the rabbit eye test.
Also cell culture methods for safety evaluation of implantable medical devices.
Also developed methods for human dermal evaluation of skin-care products to

assess for potential irritation and sensitisation.
Developed methods for safety evaluation of bone repair plates, carbon fibre
and polyester ligament repair systems, prior to human clinical studies.
In positions of Research Director in Johnson & Johnson, was responsible for
new product development for both adult and infant care areas of business.
PUBLICATIONS
Hopkins J and Tudhope GR. Glutathione peroxidase in Human Red Cells in

Health and Disease. British J. Haematol. 25:563 (1973).
Hopkins J and Tudhope GR. Red Cell Glutathione in Anaemia. Scottish

Medical Journal 18:177 (1973)
Hopkins J and Tudhope GR. Glutathione Peroxidase deficiency with

increased susceptibility to erythrocyte Heinz Body formation. Clin Sci. &
Mol.Med.47: 643 (1974)
Tudhope GR and Hopkins J. Plasma tocopherol levels and the susceptibility

of Erythrocytes to Heinz Body formation. Clin.Sci.& Mol.Med. 46: 635 (1974)
Tudhope GR and Hopkins J. Lipid Peroxidation in Erythrocytes. Acta

Haematologica 51: 29 (1974)
Hopkins J and Tudhope GR. The effects of Drugs on erythrocytes in vitro. Brit.
J. Clin. Pharmac. 1:191 (1974)
Hopkins J. Baby Powder- exploring the Myths and Realities. Brit.J. Midwifery
9 (9) 545-547 (2001).
2
Hopkins J. The safe and effective use of baby powder. RCM Midwives Journal
4 (9) 285-286 (2001).
Bertin C, Zunino H, Pittet J-C, Beau P, Pineau P, Massonneau M, Robert C,

Hopkins J. A double-blind evaluation of the activity of an anti-cellulite product
containing retinol, caffeine and ruscogene by a combination of several non-
invasive methods. J.Cosmet. Sci 52, 199-210 (2001).
Hopkins J., Baby Powder – Dusting off the Myths. Chemist & Druggist, 15th
Dec 2001. pp 32-33 (2001)
Hopkins J. The Safe use of Fragrance in Cosmetics. Chemist & Druggist, 3rd
August.2002, p 30 (2002).
Hopkins J. Essentials of newborn skin care. Brit. J. Midwifery 12 (5) 314-317.

(2004).
PUBLISHED PROCEEDINGS
Meeting of the Scottish Society for Experimental Medicine. Reported as

Hopkins J and Tudhope GR. Erythrocyte Glutathione Peroxidase in patients
with anaemia. Scot. Med. J. 17:376 (1972).
Meeting of the Scottish Society for Experimental Medicine. Reported as

Hopkins J and Tudhope GR. Vitamin E and the Red Blood Cell.
Scot.Med.J.18: 216 (1973)
PATENTS
Application filed 1998: Composition for the Treatment of Prickly Heat Rash in
Infants.
Application filed 1999: Composition for the treatment of seborrheic dermatitis

and dandruff in infants and children.
Application filed 1999: Composition for a body wash with skin moisturising
benefits.
POSTERS /ORAL PRESENTATIONS
Johnson and Johnson Skin Care Symposium, Hamburg, Germany. 1992.

Role of D- Panthenol and Phytantriol when combined to increase the strength
of human hair (poster). Hopkins 1992.
Johnson & Johnson Skin Care Symposium, New Brunswick, USA. Role of
Zinc oxide in the treatment of Nappy rash, studies in a rat model and human
infant evaluation (poster). Hopkins J. 1994.
3
European Soc. Dermatology. June 1999, London. Efficacy of the association
of retinol and lactose and hydroxy acid on the signs of skin ageing. Clinical
study with comparison to placebo (poster). Bertin C, Hopkins J.
21st Congress of International Federation of the Societies of Cosmetic

Chemists, Berlin 2000. An original in-vivo method using uv spectroscopy to
evaluate the performance of a new broadband uv filter (poster) Issachar N,
Bruere V, Cambon M, Castelli D, Robert C, Hopkins J. 2000.
Congress of the Polish Neonatal Society, Mikolajaki, Poland, 2001. Infant Skin
and its special caring needs (lecture). Hopkins J. 2001.
COMMITTEE MEMBERSHIPS AND TEACHING
A Member of several Trade Association technical committees including CTPA

(UK Trade Association) and Colipa (European Trade Association).
Member of Colipa Committee, Brussels to present support to European

Commission SCCNFP for use of salicylic acid at higher-than-preservative
amounts in skin and hair care products (2001-2002).
Member of Colipa Committee to present data to EU Scientific Steering
Committee (SSC) for approval of azoles in non-drug applications in skin and
hair care (2003).
Member of Colipa Zinc Oxide task force to present safety data and support to
European Commission SCCNFP for continued use of zinc oxide in skin care
products (1999-2004).
Member of Colipa Cosmetovigilance Task Force, Brussels 2005-06.
Member of UK CTPA Scientific Advisory Committee (1999-current).
Member of UK CTPA Toxicology Advisory Panel (2000- current)
Member of COLIPA Committee, Brussels, representing CTPA (2010 – 2012)

to draft Colipa Guidelines for format of Safety Assessment/Safety Report
under new legislation Regulation EC 1223/2009 coming into effect June 2013.
Lecturer at University of Surrey MSc Course in AppliedToxicology 2012.
Dated: February 20th 2013.

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functional ingredient solutions

PRODUCT INFORMATION FILE

Prepared according to EC 1223/2009

Tiddley Pom Organic Nappy Balm 30ml (Product Code CU00068641)

Inovia International, a division of Stan Chem International Ltd.

Composition of the Product

Physical / Chemical Characteristics

Raw Material Quality / Purity

Microbial Quality – Ingredients

Microbial Quality – Finished Product

Finished Product Safety

Challenge Test Data

Wording or Artwork for the Pack Labelling

Undesirable Effects and Serious Undesirable Effects

Appendix 1 – GMP Certificate

Inovia International, a division of Stan Chem International Ltd.

Good Manufacturing Practice Statement

It is confirmed that the products are manufactured to Cosmetic Good Manufacturing

A description of the method of manufacturing is held on file at Inovia International.

Animal Non-testing Declaration

Composition of the Product

Inovia International, a division of Stan Chem International Ltd.

Raw Material Quality/Purity

Microbial Quality - Ingredients

Microbial Quality – Finished Product

Finished Product Safety

Challenge Test Data

Inovia International, a division of Stan Chem International Ltd.

Wording or Artwork for the Pack Labelling

Undesirable Effects and Serious Undesirable Effects

Inovia International, a division of Stan Chem International Ltd.

Appendix 1 – GMP Certificate

Inovia International, a division of Stan Chem International Ltd.

Inovia International, a division of Stan Chem International Ltd.

Product Name: Tiddley Pom Organic Massage oil 50ml

our ref: K1293

PART A, SAFETY REPORT

This Safety Report/Assessment is conducted to EC1223-2009.

The Assessment is conducted in accordance with the principles of Good

This assessment takes account of:

Assessment is based on ingredient safety review and information on the final

DESCRIPTION OF THE PRODUCT

DESCRIPTION OF INTENDED AND REASONABLY FORESEEABLE USE

QUALITITATIVE COMPOSITION OF THE PRODUCT

A FULL QUANTITATIVE VERSION OF THIS ASSESSMENT IS HELD ON FILE

Based on the available toxicological literature or on “read-across” data Margins of

Dermal Absorption reported as a % of the substance applied:

EXPOSURE TO THE SUBSTANCES

For a typical infant a median bodyweight of 10 kg is selected.

The calculation of the SED is as follows:

SED = A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100

SED (mg/kg bw/day) = Systemic Exposure Dosage

The calculation of Margin of Safety (MOS): NOAEL

NOAEL data is derived from published literature where available.

Estimated Daily Exposure Levels:

Product type Estimated Relative Retention Calculated Calculated

RAW MATERIAL QUALITY/ PURITY

GOOD MANUFACTURING PRACTICE

The product is to be manufactured to adequate standards of Good Manufacturing

CHALLENGE TEST DATA

The product is water-free and no added preservatives are required.

The packaging is described as: 60 ml size: PET bottle and PP Cap.