欧洲

• 欧洲 CE/MDD(MDR)
• 欧洲 CE/IVD(IVDR)
• 欧洲化妆品CPNP

What is a cosmetic as defined by CE?

Article 2.1(a) of EC 1223:2009 defines cosmetics as follows:
“Cosmeceutical means cleaning the surface of the human body (epidermis, hair, hands/nails, lips or external genitalia) or teeth or oral mucosa for the main purpose of cleaning only or for the main purpose of cleaning, or for improving fragrance, changing the appearance, protecting, Any substance or mixture intended for contact for the purpose of maintenance or correction of body odor.”
However, it states that products that are absorbed, penetrated, or implanted through the human digestive or respiratory tract are not cosmetics. Unlike the FDA, skin whitening products, anti-wrinkle products, and sunscreen creams are also recognized as cosmetics, but products with ambiguous boundaries require confirmation of whether the product meets the definition of cosmetics.

Standards to acquire CE mark for cosmetics

EC 1223:2009
This regulation sets out the regulatory requirements that must be complied with in order to market cosmetics within the territory of the European Union. Designation of Responsible Persons in Europe and implementation of Good Manufacturing Practices (GMP) are required. In particular, it is strongly required that a product information file be always available at at least one location of responsible personnel in Europe, and that information on cosmetics placed on the market be reported to the relevant administrative authorities.
The regulation consists of a total of 10 chapters, 40 clauses and 8 attachments. The main contents include designation of a responsible person, implementation of good product management (GMP), preparation of safety evaluation reports and product information files, prohibited substances and restricted substances, prohibition of animal testing, and requirements for labels.

Categories of cosmetics as defined by CE

Certification procedure for CE mark acquisition

Required conditions for obtaining CE mark

• Product Information File (PIF)

Composition: cosmetic description, cosmetic safety report, manufacturing process diagram and description, ISO 22716 certificate or declaration, Product efficacy or effectiveness, labeling and photos, whether or not tested on animals (prohibited items), Cosmetic Safety Report (CPSR)

• Cosmetic Safety Report (CPSR)

• Label Requirements

Product features

Cosmetic ingredients

Precautions before use

Name of the responsible representative;

Country of origin of the product

Product quantity and capacity

유효 Validity

serial number

Product efficacy and effect

• CPNP (Cosmetic Products Notification Portal)

Cosmetic registration is submitted by the responsible agent to the relevant committee through electronic submission before the product is marketed (EC 1223:2009 Paragraph 13.1).

Registration is possible only when pre-market requirements, responsible agent (RP), registration information, and advance notification of nanomaterials are completed  책임대리인

• Responsible Representative

According to the CE regulations, “Only cosmetics that have designated legal persons or natural persons as responsible data within the member countries should be marketed.” is descriptive.

Responsible representative must be a natural or legal person, and in the case of a corporation, only a company established in Europe can be designated. It is impossible to distribute cosmetics to Europe without a designated responsible person. In addition, one responsible representative must be designated per product.

a major role
* Ensuring product safety and compliance with laws and regulations
* When a risk is discovered, it is reported to the relevant regulatory body
* If necessary, take necessary measures to prove product conformity
* In case of serious side effects, register with the relevant regulatory body
* On request, in cooperation with the regulatory body of the European Union