Asia Personal Care & Cosmetics Market Guide 2016

COSMETICS MARKET READINESS ASSESSMENT
EUROPEAN COMMUNITY
Cosmetics Definition
Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of
the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors. Includes sunscreens and antiperspirants.
Requirements Notes
Local Registration
No
Legal Representative Yes See notes on identifying a Responsible Agent below.
Product Registration or Notification
Both
Frequency Once Once manufacturers register their products, via the EU Cosmetic Product Notification Portal (CPNP), only required to update if there is a change.
By Product or Product Group Product By Product Group
Product Specification Requirements
Safety Assessment
Yes
In the EU, this is labeled as the “Cosmetic Product Safety Report,” which is filed as part of the Product Information File or (PIF). For normal and
foreseeable use. EU regulations list risk endpoints required and array of tests that can be used to assess the safety in terms of hazard and
exposure of both the final product and the substances in the formula. roducts intended for children under 3 years, to be used in the eye area and
on mucous membranes, have different specifications.
Raw Material Registration
Formula: Quantative, Qualitative or Both
Both
All raw materials should be registered per REACH.
All substances supplied as raw materials (including directly added preservatives, antioxidants, chelators, buffering agents, solvents, other
additives, etc.) should be identified and quantified in ascending order down to 0.01%. For fragrances: composition name and code number,
identity of the supplier List substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 1A , 1B or 2 under part 3 to
Regulation (EC) No 1272/2008
Annexes II, III, IV, V and VI of the EU Cosmetics Regulation identify substances that are either banned from products destined for sale within in the
EU, subject to restrictions or, in the case of colorants, preservatives and UV filters, are expressly permitted. For restricted materials, a special
dossier, notified to Commission is required six months prior to placing a product on market.
Safety Data Sheet: Raw Materials Yes Note the EC PIF does not require these, but the information can be used to answer some sections.
Safety Data Sheet: Product Yes Note the EC PIF does not require these, but the information can be used to answer some sections.
Preservative Efficacy
Yes
Nationally Certified Testing Facility Yes The EU adheres to the OECD Test Guidelines allowing for the use of lab results from foreign labs certified in Good Laboratory Practice.
Animal Testing
No
EC cosmetic legislation prohibits marketing of finished products containing ingredients or combinations of ingredients that have been subject to
animal testing after 2013.
Packaging Assessment
Yes
Details on the criteria and methods used to assure that the type of containers and packaging do not impact product stability, including potential
leaching of packaging substances into the product.
Product Stability Yes Includes storage conditions, date of durability and expiration date.
Good Manufacturing Practice
Yes
GMP self-certification accepted, should follow ISO or European Committee for Standardization (CEN) standards. Responsible agent and importer
should keep on file, in case requested.
Proof of Claims Yes When justified by a claimed effect, supporting technical information required.
Trademark Registration
No
Product Sample
Labeling
Country of Origin
Yes
Nominal Content: Weight or Volume (?) Yes Both weight or volume allowed. Metric, with dual labeling allowed
Registration Number
Yes
Language Requirement Yes By country