Considering the special characteristic of cosmetics containing nanomaterials, "Taiwan Food and Drug Administration" released the “Guideline for Risk Assessment of Cosmetics Containing Nanomaterials” to strengthen the management of product safety and standardize the documents requirements.
The guideline is divided into two parts: physicochemical property assessment and safety assessment. It is regulated that the assessment of physicochemical properties shall be conducted prior to safety assessment including the size/size distribution, surface chemistry, surface charge, etc. in order to clarify if the nanomaterial will affect the results of a subsequent safety assessment. The safety assessment covers acute toxicity, irritation and corrosiveness, skin sensitization, etc., which are the same criteria assessed under the regulatory frameworks of Taiwan’s major international counterparts.
Projects of Physicochemical Properties Assessment and Safety Assessment of Cosmetics Containing Nanometer
|
Projects |
Ingredients |
Products |
|
|
Physicochemical Properties |
Solubility/Dispensability |
X |
△ |
|
Size/Size distribution |
◇ |
◇ |
|
|
Shape |
◇ |
◇ |
|
|
Aggregation/Agglomeration in relevant media |
|
◇ |
|
|
Surface chemistry |
◇ |
X |
|
|
Surface charge |
◇ |
X |
|
|
Surface area |
◇ |
X |
|
|
Chemical composition |
◇ |
X |
|
|
Purity |
◇ |
X |
|
|
Crystal structures |
◇ |
X |
|
|
UV absorption |
△ |
X |
|
|
Partition coefficient |
◇ |
X |
|
|
Catalytic activity |
△ |
X |
|
|
Safety Assessment |
Acute toxicity |
◇ |
X |
|
Irritation and corrosivity |
◇ |
◇ |
|
|
Skin sensitization |
◇ |
◇ |
|
|
Dermal/percutaneous absorption |
◇ |
△ |
|
|
Repeated dose toxicity |
◇ |
X |
|
|
Mutagenicity/genotoxicity |
◇ |
X |
|
|
Carcinogenicity |
△ |
X |
|
|
Reproductive toxicity |
△ |
X |
|
|
Toxicokinetics |
◇ |
X |
|
|
Photo-induced toxicity |
◇ |
X |
|
|
Margin of Safety; MoS |
◇ |
X |
|
◇ means mandatory attached documentation; △ means to attach or not to attach depends on each individual case; X means there is no need to attach the documentation.
* Reference Link: TFDA's Circular
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