Brief Description of Regulatory Background

EU Cosmetics Regulation 1223/2009 was officially announced on December 11, 2009. It is the main regulatory regulation for cosmetics placed on the EU market. It fully replaced the EU Cosmetics Directive (Directive No. 76/768/EC) on July 11, 2013. . Scope of application: In addition to EU member states, there is also the European Economic Area, namely Norway, Iceland and Liechtenstein.

The UK Cosmetics Regulations were first introduced in 1978 and have been revised several times since then, most recently after Brexit in 2021. The current version of the regulation is based on EU Cosmetics Regulation (EC) No. 1223/2009 and includes additional requirements for the UK.

The EU cosmetics regulations /UK Cosmetics Regulations stipulate that for every cosmetic placed on the EU /UK market, the responsible person needs to be responsible for its compliance.

Who is Responsible?

The responsible person refers to the individual or company responsible for the supervision of cosmetics in the EU .

When the manufacturer is within the EU, the manufacturer is the responsible person;

When the manufacturer is outside the EU and the product is imported into the EU, the importer is the responsible person;

When the manufacturer is outside the EU and the distributor puts the cosmetics on the market under its trademark, the distributor can be the responsible person;

The responsible person can also be a third party organization or individual within the EU through written authorization from the manufacturer or importer.

Responsible Person’s Compliance Obligations

The regulations stipulate the core obligations of the "responsible person": 1) Obligated to ensure the safety and legal compliance of the product from raw materials to finished products and use; 2) Responsible for monitoring adverse reactions and response after adverse reactions occur; 3) After the product is put on the market, take measures such as regulation and recall of the problematic products; 4) Cooperate to provide relevant information and documents of cosmetics to the regulatory authorities (including product safety reports, production methods, proof of relevant efficacy (if any), and shall Keep the above documents for at least 10 years so that they can be provided at any time upon request from authorities or consumers.

In order to fulfill these obligations, the responsible person needs to have relevant legal knowledge and be able to effectively manage and maintain product data.

Compliance Process 

Information Required for Cosmetic Products Notification Portal (CPNP)

1.Product name and category;

2.Information and contact information of the responsible person;

3.Product country of origin;

4.The first country of destination to which the product will be sold;

5.Product formula;

6.Product packaging pictures.

Information Required for Certified Product Safety Representative (CPSR)

1.Basic product information table, such as product name, product description (such as physical status, color, intended use) information;

2.Complete recipe list ;

3.MSDS( Material Safety Data Sheet )& COA(certificate of analysis) for all ingredients;

4.80 kinds of allergen information and IFRA (International Fragrance Association) certificate, flavor MSDS;

5.Product test reports on microorganisms, heavy metals, and risk substances ;

6.Preservative challenge test reports for products;

7.Product stability test report;

8.Product packaging material compatibility test report, inner packaging material information, heavy metal test report;

Materials Required for Product Information Document (PIF)

1. Certified Product Safety Representative (CPSR);

2. Production process description ( brief process description);

3. Declaration of Good Manufacturing Practice ( GMP ) compliance or GMP certificate;

4. Non-Animal Testing Statement;

5. Data or test reports collected to support product claims;

6. Original image of the label on the product's internal and external packaging.

ZOOP’s Professional Services

1. Product classification definition services

2. CPNP&SCPN Notification

3. Formula review

4. Label and claim review

5. Website details page review

6. Testing and Certified Product Safety Representative (CPSR) required to demonstrate product safety

7. Review and organize PIF documents

8. Responsible person within the EU (if required)

9. EU Cosmetics Regulation Compliance Training

Why Choose ZOOP

Since its establishment in 2010, ZOOP has focused on product compliance-related services. The audit teachers of the company's cosmetics division are all from medium and large-scale cosmetics manufacturers, and have related professional backgrounds in biology, medicine, cosmetics, chemistry, etc.

Our advantages are:

1. Professional and mature team, service cycle guarantee;

2. Reasonable prices, high-quality services throughout the process, and worry free;

3. With outlets in Shenzhen, Guangzhou, Shanghai and Beijing, communication is convenient;

4. One-stop service for makeup, disinfection and medical devices, efficient and cost-effective;

5. Can provide services in full English to meet the needs of domestic and foreign customers ;

Responsible for customers and quality service are the consistent business philosophy of ZOOP. We hope to serve more quality-focused customers and grow with you!