INOPP Forum
CosmetoVigilance requirements in the EU/EEA
Quote from VigiServe Admin on November 29, 2020, 7:50 AMResponsible Person in EU
Article 4 of the Cosmetics Regulation establishes that only cosmetic products with an appointed Responsible Person may be placed on the market. In other words, a Responsible Person is essential to market your cosmetics.
The Responsible Person has many obligations and responsibilities, especially to:
•Ensure that the cosmetic product placed on the market is safe for human health, and,
•Ensure compliance with Cosmetics Regulation obligations for each cosmetic product placed on the market
COSMETIC PRODUCT SAFETY REPORT (CPSR)
EU Specific Requirement. The Sections include:
Part A:
Cosmetic Product Safety Information
This section requires product information and test data.
Quantitative and qualitative composition
Physical/chemical characteristics and stability
Microbial quality
Impurities, traces in the product and information on the packaging material
Normal and foreseeable use
Exposure to the product
Exposure to the ingredients
Toxicological profile of the ingredients
Undesirable effects of the product
Other
Part B:
Cosmetic Product Safety Assessment
A safety assessor’s expert opinion as to why the product is safe to be placed on the market.
Contact points in charge of SUE in European Union / EEA
Country E-mail address
AT kosmetik@bmg.gv.at
BE cosmetovig@health.fgov.be
BG DZK@mh.govemment.bg
CY cosmetovig@phs.moh.gov.cv
CZ mzcr@mzcr.cz
DA cosmetovig@mst.dk
DE sue-cosmetic@bvl.bund.de
EE kesk@terviseamet.ee EL mitrop@eof.gr
ES cosmetovigilancia@aemps.es
FI kosmetiikka sue@tukes.fi
FR cosmetovigilance@ansm.sante.fr
HR kozmetovigilancija@miz.hr
HU kozmetika.snh@oeti.antsz.hu
IE cosmetics@hpra.ie
IT cosmetovigilance.italv@sanita.it
LT vvspt@vvspt.lt
LU cosmet@ms.etat.lu
LV vi@vi.gov.lv
MT helpdesk.mccaa@mccaa.org.mt
NL vwa.dtalert@vwa.nl
PL inspektorat@gis.gov.pl
PT pchc@infarmed.pt
RO sparvu@ms.ro
SK suesk@uvzsr.sk
SL gp-ursk.mz@gov.si
SV cosmetovig@mpa.se
NO postmottak@mattilsvnet.no
Responsible Person in EU
Article 4 of the Cosmetics Regulation establishes that only cosmetic products with an appointed Responsible Person may be placed on the market. In other words, a Responsible Person is essential to market your cosmetics.
The Responsible Person has many obligations and responsibilities, especially to:
•Ensure that the cosmetic product placed on the market is safe for human health, and,
•Ensure compliance with Cosmetics Regulation obligations for each cosmetic product placed on the market
COSMETIC PRODUCT SAFETY REPORT (CPSR)
EU Specific Requirement. The Sections include:
Part A:
Cosmetic Product Safety Information
This section requires product information and test data.
-
Quantitative and qualitative composition
-
Physical/chemical characteristics and stability
-
Microbial quality
-
Impurities, traces in the product and information on the packaging material
-
Normal and foreseeable use
-
Exposure to the product
-
Exposure to the ingredients
-
Toxicological profile of the ingredients
-
Undesirable effects of the product
-
Other
Part B:
Cosmetic Product Safety Assessment
A safety assessor’s expert opinion as to why the product is safe to be placed on the market.
Contact points in charge of SUE in European Union / EEA
Country E-mail address
CZ mzcr@mzcr.cz
EE kesk@terviseamet.ee EL mitrop@eof.gr
FI kosmetiikka sue@tukes.fi
FR cosmetovigilance@ansm.sante.fr
HU kozmetika.snh@oeti.antsz.hu
IT cosmetovigilance.italv@sanita.it
LU cosmet@ms.etat.lu
LV vi@vi.gov.lv
MT helpdesk.mccaa@mccaa.org.mt
RO sparvu@ms.ro
NO postmottak@mattilsvnet.no
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