MODULE 7 WORK
INTRODUCTION
The aim of this activity is to analyze the safety of a product and the compliance of its label based on the Cosmetic Regulation
1223/2009.
WHAT YOU NEED TO DELIVER FOR THIS ASSIGNMENT:
This report filled in PDF format
PDF of references where you got POD for each substance (NOAEL, BMD, …)
ACTIVITY/CASE STUDY
1. A short safety evaluation will be done for the product detailed. Invent the data that is not provided to fill this table. Create
your own brand, name, responsible person, responsible address… The info I provide you is in blue.
Brand
Product Name
Function Protective balm
Product code 001
Responsible Person (or Company) to place
into the market
Responsible Person address
Manufacturing Company
Manufacturing Address
Contact person
Contact telephone
Contact email
Format presentations Aluminium enclosed tins of 30g
Intended consumer group Adults (from 18 years)
Intended use Hand balm
Category of product
Challenge test results The results of the efficacy of the preservative conclude with
criterion A.
2. Complete the tables:
MSDS and other technical information on the raw materials is attached where you can find CAS, EINECS and Supplier. If
values are not found in the documents, use Google or your preferred database to search for the information. The supplier
information must be extracted from the MSDS.
% Cx
INGREDIENT TRADE % CAS EINECS
INCI INGREDIENT
% COMPONENT ING in FUNCTION SUPPLIER
NAME PROD No. No.
BEESWAX 7.00%
SHEA BUTTER 39.00%
COCONUT OIL 42.00%
HEMP SEED OIL 7.00%
2.00%
ST JOHNS WORT OIL
TURMERIC ESSENTIAL OIL 1.00%
GINGER ESSENTIAL OIL 0.50%
FRANKINCENCE
ESSENTIAL OIL 0.50%
1.00%
VITAMIN E
3. Consider restrictions according to the the annexes of the Regulation (the entry and the restriction from the annex must be
included) You may find this info in COSING referencing EC 1223/2009. So go and check the law online to see the details
of any restriction identified.
ARE THERE ANY RESTRICTIONS FOR ITS COSMETIC USE?
RAW MATERIAL
BEESWAX
SHEA BUTTER
COCONUT OIL
HEMP SEED OIL
ST JOHNS WORT OIL
TURMERIC ESSENTIAL OIL
GINGER ESSENTIAL OIL
FRANKINCENCE ESSENTIAL OIL
VITAMIN E
4. List the ingredients in the order that they must appear in the label according to article 19 of EC 1223/2009
5. Think of the exposure routes:
YES/NO Could it be accidental?
Dermal
Inhalation
Ingestion
Ocular
Secondary
routes Is there other way in which the consumer may get in contact with the product?
6. Fill in this information to evaluate safety: Use the following reference: SCCS Notes of Guidance, 11th revision. (page 24-
26) Get the values from TABLE 3A, 3B and 4
The normal and reasonably foreseeable
1
exposure route(s)
2 Other factors to consider:
1 Product type
2 Surface area for application SSA (cm2)
3 Skin surface area exposed per product category
4 Targeted population
5 Exposed population different from target
6 Site of application
7 Frequency of application (times/day)
8 Calculated Amount of product applied per use
9 Average body weigh considered for calculations (kg)
1
Qx Estimated daily amount applied (g/d)
0
1
Qx/bw Relative daily amount applied (mg/kg/bw/d)
1
1
2 Fret Retention factor
1
3 Eproduct Calculated daily exposure (g/d)
1 Eproduct/bw Calculated relative daily exposure
4 (mg/kg/bw/d)
7. BONUS: Analyse of the safety of the ingredients taking into account an exposure indicated in the previous section,
include references used. Remember to consult: SCCS Notes of Guidance, 11th revision
Note: Please inlude the references in pdf format of where you got the NOAEL or BMD value.
Edermal
Estimated
% Cx dermal NOAEL
%DAp
TRADE NAME INCI ING in daily SED INGR (mg/kg NOAELsist MoS Evaluation
corrected
PROD exposure bw/d)
(mg/kg
bw/d)
BEESWAX 7.00%
SHEA BUTTER 39.00%
COCONUT OIL 42.00%
HEMP SEED OIL 7.00%
ST JOHNS 1.60%
WORT OIL 0.40%
TURMERIC
ESSENTIAL OIL 1.00%
GINGER
ESSENTIAL OIL 0.50%
FRANKINCENC
E ESSENTIAL
OIL 0.50%
0.75%
VITAMIN E
0.50%
