Cosmetics - EC Cosmetics Regulation 1223/2009
-Manufacturing of cosmetics must comply with Good Manufacturing Practice (GMP) / EN ISO 22716.
-Each cosmetic product must have on file a Cosmetic Product Safety Report (CPSR) based on the safety assessment of the cosmetic formulation, taking into account toxicological profiles of all the ingredients, plus characteristics and quality of the cosmetic product and primary packaging.
-CPSR forms the core of the Product Information File (PIF), a legal document required to be maintained by the responsible person importing the product.
-The safety assessment of cosmetic now requires due consideration of no observable adverse effect level (NOAEL) of ingredients and calculation of margin of safety (MoS).
-New requirements on impurity and stability of primary packaging.
-New control on nano-material as ingredients in cosmetics.
-A new centralized e-notification system.
Cosmetic Product Safety Report (CPSR)
Checklist
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1 |
Ingredient list with CAS no., composition %, function of each ingredients. |
|
2 |
MSDS or COA of each ingredient |
|
3 |
IFRA Certificate, Allergen declaration analysis, and
MSDS of the fragrance |
|
4 |
Microbiological quality test |
|
5 |
Preservative challenge test (PET) report |
|
6 |
Product stability test report |
|
7 |
Package compatibility test report, The material information and the heavy metal test report of the immediate container material- 94/62/EC |
|
8 |
Heavy metal test report for the product (formulation),includs Pb,As,Hg,Sb,Cd,Ni. |
|
9 |
Physical/chemical characteristics of the finished cosmetic product. |
|
10 |
Product photo & Label artwork for finished product |
|
11 |
GMP / ISO 22716 Certificate |
|
12 |
Information of any nanomaterials used in the formulation. |
|
13 |
Any undesirable effects |
Cosmetic Product Labelling - EU
Article 19 of the EU Cosmetics Regulation (EC) No. 1223/2009 specifies the labelling requirements for finished cosmetic products placed on the market anywhere in the EU.
|
|
Primary Container (Inner Packaging) |
Secondary Container (Outer Packaging) |
|
Name and Address of the Responsible Person |
yes |
yes |
|
Country of Origin |
|
|
|
Nominal Content |
yes |
yes |
|
Best Before Date/ Period After Opening |
yes |
yes |
|
Warnings and Precautions |
yes |
yes |
|
Batch Number |
yes |
yes |
|
Function of the Product |
yes |
yes |
|
Ingredients List |
no* |
yes |
NOTES
Name and Address of the Responsible Person: The address can be abbreviated to company name and postcode if space is limited.
Declared quantity of contents: Fill size can be declared by volume (ml) or weight (g). The "e" symbol
should follow the fill size when over 5ml/g to indicate compliance with the Average Fill System. Best Before Date: If the shelf life of the product is less than 30 months it must be labelled with a best before date (date of minimum durability). Expiration date can be indicated with: ‘Best before’ or preceded by the hourglass symbol.
If the shelf life is greater than 30 months best before date is not required, and the Period After Opening (PAO) must be indicated using the “open jar” symbol 
. Ingredient List: Ingredients are to be listed in descending order of concentration. Ingredients present at concentrations below 1% may be listed in any order. INCI (International Nomenclature of Cosmetic
Ingredients) should be used in listing ingredients (consult the European Community CosIng database
http://ec.europa.eu/growth/tools-databases/cosing/ ). By convention fragrance allergens are listed at the end, followed by any colourants which may be present.
