Our Cosmetics Regulatory Services
COSMETIC PRODUCTS REGULATION
Tests and Analyses
Product Classification
Product classification Formula compliancen
Stability and compatibilty test Challenge test
Product file preparation
Product Notification
ISO 22716-GMP Animal testingn Product labellingt.
ÜTS CPNP
AUTHORIZATION
IN TURKEY / EUROPE
Responsible person
Safety assessment
Responsible Person Responsible Technical Personnel
Product Safety and Compliance Safety Assessor's Conclusion Required Usage Warnings and Precautions Safety Assessor's Identification and Approval
OUR SERVICES
Our Cosmetics Regulatory Services
Required Information and Documents
Cosmetic Product Classification
Not all products we commonly think of as cosmetics in daily life are classified as such under EU and TR regulations. Similarly, a product considered cosmetic in the USA may not meet the same classification in the EU or TR. We assist you in accurately determining whether your product qualifies as a cosmetic. For more details on the EU and TR definitions of cosmetics, please contact us.
Ingredient List (INCI)
Responsable Person in EU/TR
Physical and Chemical Properties
Application Area
Labeling and Packaging Information
Intended Use
Regulatory Compliance
Turkish Documents & Notery Approval
Our Cosmetics Regulatory Services
Product file preparation
A description of the cosmetic product
Information on Animal Testing
Manufacturing Process Details
Product Labeling Information
Evidence Supporting Product Claims
Cosmetic Product Safety Report
Our Cosmetics Regulatory Services
Safety assessment
Safety Assessor's Conclusion Scientific reasoning that leads the security assessor to a qualified conclusion.
Safety Assessor's Identification and Approval The identification details and approval of the safety assessor involved in the evaluation.
Required Usage Warnings and Precautions A comprehensive list of usage warnings and precautions that must be included on the product label.
Product Safety and Compliance A summary of whether the product is deemed safe and compliant with cosmetic regulations
Tests and Analyses
Stability and compatibilty test Cosmetics stability and compatibility test indicates the relative stability level of a product under the various conditions that it can be subjected to from the moment it is manufactured until the end of its validity as well as the product’s compatibility with its packaging. Stability and compatibility test is a base for determining the shelf life of a cosmetic product.
Challenge test Challenge test or preservative efficacy test (PET) is one of the parts of the Product Information File and of the Cosmetic Product Safety Report. Challenge test is required for most cosmetic products with the exception of microbiologically low risk products.
Our Cosmetics Regulatory Services
Product Notification
Contact Information
Cosmetic Product Information
Responsible Person’s Information
Presence of Nanomaterials
Import Information
CMR Substances
Product Formulation
Market Information
Packaging Information
Our Cosmetics Regulatory Services
Responsible person
Responsible Person
Responsible Technical Person
The individual or entity responsible for the marketing of the product.
A technical personnel specialized in the formulation and safety of cosmetic products.
The presence of substances in the form of nanomaterials.
A photograph of the relevant packaging, provided the original labeling is reasonably readable.
The contact details of the individual to be reached if necessary.
The country of origin in case of import.
The member state where the cosmetic product will be placed on the market.
Supporting evidence for any claims made regarding the product's effectiveness, where applicable.
An overview of the cosmetic product, including its purpose and key features.
Comprehensive details on product labeling requirements..
The inclusion of the Cosmetic Product Safety Report, which outlines the safety assessment.
The category of the product, its physical form, type of packaging, and specific identifying name or names.
Responsible Person
- Collecting and maintaining product information.
- Ensuring compliance with legal regulations for products.
- Monitoring and responding to market feedback.
- Assuming responsibility and legal obligations related to the product.
The product formula or framework formulation that allows for rapid and appropriate medical treatment in case of emergencies.
Documentation regarding any animal testing associated with the product..
The name and address of the responsible person who ensures easy access to the Product Information File.
A description of the manufacturing process along with either a Good Manufacturing Practice (GMP) certificate or a declaration of compliance with GMP standards (specifically, ISO 22716 in the EU).
Responsible Technical Person
- Developing and optimizing product formulations.
- Conducting product safety assessments.
- Collecting and analyzing relevant scientific data.
- Ensuring compliance with Good Manufacturing Practices (GMP) standards.
The name and Chemical Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) in categories 1A or 1B according to Section 3 of Annex VI of Regulation (EC) No 1272/2008.
Cosmetic Product Authorization Process in Turkey Draft
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Transcript
Our Cosmetics Regulatory Services
COSMETIC PRODUCTS REGULATION
Tests and Analyses
Product Classification
Product classification Formula compliancen
Stability and compatibilty test Challenge test
Product file preparation
Product Notification
ISO 22716-GMP Animal testingn Product labellingt.
ÜTS CPNP
AUTHORIZATION
IN TURKEY / EUROPE
Responsible person
Safety assessment
Responsible Person Responsible Technical Personnel
Product Safety and Compliance Safety Assessor's Conclusion Required Usage Warnings and Precautions Safety Assessor's Identification and Approval
OUR SERVICES
Our Cosmetics Regulatory Services
Required Information and Documents
Cosmetic Product Classification
Not all products we commonly think of as cosmetics in daily life are classified as such under EU and TR regulations. Similarly, a product considered cosmetic in the USA may not meet the same classification in the EU or TR. We assist you in accurately determining whether your product qualifies as a cosmetic. For more details on the EU and TR definitions of cosmetics, please contact us.
Ingredient List (INCI)
Responsable Person in EU/TR
Physical and Chemical Properties
Application Area
Labeling and Packaging Information
Intended Use
Regulatory Compliance
Turkish Documents & Notery Approval
Our Cosmetics Regulatory Services
Product file preparation
A description of the cosmetic product
Information on Animal Testing
Manufacturing Process Details
Product Labeling Information
Evidence Supporting Product Claims
Cosmetic Product Safety Report
Our Cosmetics Regulatory Services
Safety assessment
Safety Assessor's Conclusion Scientific reasoning that leads the security assessor to a qualified conclusion.
Safety Assessor's Identification and Approval The identification details and approval of the safety assessor involved in the evaluation.
Required Usage Warnings and Precautions A comprehensive list of usage warnings and precautions that must be included on the product label.
Product Safety and Compliance A summary of whether the product is deemed safe and compliant with cosmetic regulations
Tests and Analyses
Stability and compatibilty test Cosmetics stability and compatibility test indicates the relative stability level of a product under the various conditions that it can be subjected to from the moment it is manufactured until the end of its validity as well as the product’s compatibility with its packaging. Stability and compatibility test is a base for determining the shelf life of a cosmetic product.
Challenge test Challenge test or preservative efficacy test (PET) is one of the parts of the Product Information File and of the Cosmetic Product Safety Report. Challenge test is required for most cosmetic products with the exception of microbiologically low risk products.
Our Cosmetics Regulatory Services
Product Notification
Contact Information
Cosmetic Product Information
Responsible Person’s Information
Presence of Nanomaterials
Import Information
CMR Substances
Product Formulation
Market Information
Packaging Information
Our Cosmetics Regulatory Services
Responsible person
Responsible Person
Responsible Technical Person
The individual or entity responsible for the marketing of the product.
A technical personnel specialized in the formulation and safety of cosmetic products.
The presence of substances in the form of nanomaterials.
A photograph of the relevant packaging, provided the original labeling is reasonably readable.
The contact details of the individual to be reached if necessary.
The country of origin in case of import.
The member state where the cosmetic product will be placed on the market.
Supporting evidence for any claims made regarding the product's effectiveness, where applicable.
An overview of the cosmetic product, including its purpose and key features.
Comprehensive details on product labeling requirements..
The inclusion of the Cosmetic Product Safety Report, which outlines the safety assessment.
The category of the product, its physical form, type of packaging, and specific identifying name or names.
Responsible Person
The product formula or framework formulation that allows for rapid and appropriate medical treatment in case of emergencies.
Documentation regarding any animal testing associated with the product..
The name and address of the responsible person who ensures easy access to the Product Information File.
A description of the manufacturing process along with either a Good Manufacturing Practice (GMP) certificate or a declaration of compliance with GMP standards (specifically, ISO 22716 in the EU).
Responsible Technical Person
The name and Chemical Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) in categories 1A or 1B according to Section 3 of Annex VI of Regulation (EC) No 1272/2008.