EAC Expert Conclusion and State Registration Certificate

“EAC Expert Conclusion” and the “State Registration Certificate” are regulatory documents commonly used within the Eurasian Economic Union (EAEU) to ensure product compliance and safety. Here’s a brief overview of each:

EAC Expert Conclusion

Definition: An EAC Expert Conclusion is a document issued by an accredited certification body or expert organization within the EAEU. It confirms that a product meets the required technical regulations and standards of the EAEU.
Purpose: It is typically used to support the declaration or certification of conformity within the EAC system. It ensures that the product is safe and compliant for distribution in the EAEU market.
Application: This document is often needed for products such as chemicals, machinery, and electrical equipment, among others, which are subject to technical regulations in the EAEU.
Process: The process involves testing, inspection, and sometimes factory audits to verify compliance with the applicable standards.

State Registration Certificate

Definition: The State Registration Certificate is a document that certifies that a product is safe for human health and the environment and is compliant with the sanitary and epidemiological standards of the EAEU.
Purpose: It is mandatory for certain categories of products, such as food products, cosmetics, and chemicals, to enter the EAEU market. It verifies that the product does not pose any harm and meets the hygiene standards set by the EAEU.
Scope: The certificate is valid across all member states of the EAEU, which include Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan.
Process: To obtain the certificate, the manufacturer must submit product samples for laboratory testing and provide detailed documentation about the product’s composition, production process, and other relevant details.

Both documents are essential for manufacturers and exporters aiming to place their products in the EAEU market, ensuring that they comply with the union’s stringent regulations and standards.

What is required EAC Expert Conclusion and State Registration Certificate

To obtain the EAC Expert Conclusion and the State Registration Certificate for your products within the Eurasian Economic Union (EAEU), you must follow specific procedures and provide necessary documentation. Below is a detailed overview of the requirements for each document:

EAC Expert Conclusion Requirements

Product Classification:
- Identify the applicable Technical Regulations of the EAEU (TR CU/TR EAEU) for your product.
- Determine whether your product requires an EAC Declaration or EAC Certification.
Application Form:
- Complete an application form detailing the product name, model, serial number, HS code, and intended use.
- Provide information about the manufacturer and importer.
Technical Documentation:
- Product description and specifications.
- Technical drawings, diagrams, and user manuals.
- Production and quality control procedures.
Test Reports:
- Conduct product testing in an accredited laboratory within the EAEU to confirm compliance with applicable standards.
- Test reports should be recent and relevant to the product in question.
Existing Certificates (if applicable):
- Provide any existing international certificates (e.g., CE, ISO) to support compliance.
Safety Justification:
- Develop a safety justification document detailing the potential risks associated with the product and measures taken to mitigate them.
Product Samples:
- Submit product samples for testing and inspection by the certification body.
Factory Inspection (if applicable):
- Some products may require a factory audit to verify production processes and quality management.

State Registration Certificate Requirements

Application Form:
- Complete an application form that includes product details, manufacturer information, and intended use.
Product Documentation:
- Comprehensive product description, including formulation or composition (for chemicals and food products).
- Manufacturing process description.
- Safety data sheets (for chemicals and hazardous substances).
Health and Safety Justification:
- Justification document explaining the safety of the product for human health and the environment.
- Toxicological, hygienic, and microbiological studies (if applicable).
Test Reports:
- Submit test reports from accredited laboratories within the EAEU confirming that the product meets sanitary and epidemiological standards.
- Tests typically include chemical composition, safety, toxicity, and microbial contamination.
Labeling Information:
- Provide product labels or packaging information that complies with EAEU requirements, including language and safety warnings.
Import and Distribution Agreements (if applicable):
- If the product is being imported, submit agreements between the manufacturer and the importer or distributor.
Product Samples:
- Samples of the product may be required for additional testing and inspection.
Power of Attorney (if applicable):
- If you are applying through a representative, provide a notarized power of attorney granting them the authority to act on your behalf.

Process for Both Documents

Submission:
- Submit the required documents and application to an accredited certification body or expert organization within the EAEU.
Evaluation and Testing:
- The certification body will evaluate the documentation and conduct necessary testing and inspections.
Expert Conclusion / Certificate Issuance:
- If the product meets all requirements, the EAC Expert Conclusion or the State Registration Certificate will be issued.
Registration and Validity:
- The State Registration Certificate is registered with the unified register and is valid indefinitely unless there are significant changes to the product.
- The EAC Expert Conclusion validity depends on the type of product and certification (usually 1 to 5 years).

Additional Considerations

Translation: All documentation must be in Russian or a language accepted by the certification body.
Local Representative: For foreign manufacturers, having an authorized representative within the EAEU is usually mandatory.

These steps are crucial for legal market entry into EAEU countries. Ensuring compliance with all requirements will help avoid delays and legal issues in the certification process.

Who is required EAC Expert Conclusion and State Registration Certificate

The EAC Expert Conclusion and the State Registration Certificate are required for different entities and products entering the Eurasian Economic Union (EAEU) market. Here’s who typically needs these documents:

1. EAC Expert Conclusion

The EAC Expert Conclusion is necessary for the following:

Who Needs It:

Manufacturers: Both local and foreign manufacturers producing products that need to comply with the Technical Regulations of the EAEU (TR CU/TR EAEU).
Importers and Distributors: Companies importing or distributing products in EAEU countries (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan) must ensure that the products they bring into the market have the necessary compliance documents.
Authorized Representatives: Foreign manufacturers often appoint an authorized representative within the EAEU to handle certification and compliance processes.

Products Requiring EAC Expert Conclusion:

Electrical and Electronic Equipment: Appliances, machinery, and devices subject to TR CU 004/2011 and TR CU 020/2011.
Machinery and Equipment: Industrial and consumer machinery that falls under TR CU 010/2011.
Personal Protective Equipment: Clothing, helmets, and other safety equipment regulated by TR CU 019/2011.
Toys and Children’s Products: Products for children, including toys and clothing, under TR CU 008/2011.
Chemicals and Hazardous Substances: Certain chemicals and products containing hazardous substances as per TR CU 041/2017.

2. State Registration Certificate

The State Registration Certificate is mandatory for products that impact human health and safety.

Who Needs It:

Manufacturers: Both domestic and foreign manufacturers of products that are subject to sanitary and epidemiological regulations in the EAEU.
Importers and Distributors: Entities importing products that require a State Registration Certificate must ensure they have this document before customs clearance and distribution.
Authorized Representatives: Foreign manufacturers usually appoint a local representative to handle the registration process and maintain compliance.

Products Requiring State Registration Certificate:

Food Products and Dietary Supplements: Includes ingredients, additives, and certain finished products.
Cosmetics and Personal Care Products: Skin care, hair care, and other cosmetic items.
Household Chemicals: Cleaning agents, detergents, and other household chemical products.
Hygiene Products: Sanitary products, diapers, and other personal hygiene items.
Water Supply Products: Bottled water and water purification systems.
Certain Types of Equipment: Products in contact with food or water that may influence human health.

When and Why These Documents Are Required:

EAC Expert Conclusion:
- Required for product certification or declaration of conformity.
- Ensures compliance with the EAEU Technical Regulations before the product can be marketed and sold.
State Registration Certificate:
- Required before customs clearance for the relevant product categories.
- Confirms that the product meets EAEU sanitary and epidemiological standards.

These documents are crucial for legal market entry and sale within the EAEU. Not having the necessary certification can result in fines, product recalls, or bans on the product.

When is required EAC Expert Conclusion and State Registration Certificate

The EAC Expert Conclusion and the State Registration Certificate are required at different stages and for different types of products to ensure compliance with the regulatory requirements of the Eurasian Economic Union (EAEU). Below is a detailed explanation of when each document is required:

1. EAC Expert Conclusion

When is it Required:

Before EAC Certification/Declaration: The EAC Expert Conclusion is often a prerequisite for obtaining an EAC Certificate or EAC Declaration, especially for products with complex compliance requirements. It is issued based on the results of tests, inspections, and sometimes factory audits.
High-Risk Products: Required for products that have potential risks to health, safety, or the environment, and need additional validation of compliance with EAEU Technical Regulations.
Mandatory Technical Regulations Compliance: For products covered under specific EAEU Technical Regulations (TR CU/TR EAEU) such as electrical equipment, machinery, and certain consumer products.

Common Scenarios for Requirement:

Launching New Products: When introducing a new product to the EAEU market that falls under mandatory certification categories.
Modifications to Products: If there are significant changes in product design, materials, or manufacturing processes.
Market Entry for Foreign Manufacturers: Required for foreign products entering the EAEU market to demonstrate compliance with EAEU regulations.

Documentation Purpose:

It serves as a formal expert assessment confirming that the product meets the applicable standards and regulations. This document is used to support the application for an EAC Certificate or Declaration.

2. State Registration Certificate

When is it Required:

Before Customs Clearance: The State Registration Certificate is required for customs clearance of specific categories of goods into the EAEU territory. It confirms that the product complies with the sanitary and epidemiological regulations.
Health and Safety Impact: For products that directly impact human health, safety, or the environment. This includes products that come into contact with food, water, or the human body.
Products with Special Regulatory Requirements: Certain products like food, cosmetics, household chemicals, and hygiene products must have this certificate before they can be legally sold within the EAEU.

Common Scenarios for Requirement:

Import of New Products: When importing new products into the EAEU that fall under the scope of mandatory sanitary and epidemiological standards.
Changes in Product Composition: If there are significant changes to the product’s composition or intended use.
Establishing Market Presence: For both local and foreign manufacturers wishing to place regulated products on the EAEU market.

Documentation Purpose:

It verifies that the product meets all necessary sanitary, epidemiological, and hygienic standards. This certificate is necessary for customs clearance and market authorization.

Key Differences in Requirement Timing:

EAC Expert Conclusion is typically needed before applying for EAC certification or declaration, especially for products with complex compliance requirements.
State Registration Certificate is required before customs clearance and market entry for products that have health and safety implications.

Ensuring the proper documentation is obtained at the appropriate stage is crucial for smooth market access and avoiding legal complications in the EAEU countries.

Where is required EAC Expert Conclusion and State Registration Certificate

The EAC Expert Conclusion and the State Registration Certificate are required within the member states of the Eurasian Economic Union (EAEU). The EAEU includes the following countries:

Russia
Belarus
Kazakhstan
Armenia
Kyrgyzstan

These documents are mandatory for the legal import, customs clearance, and distribution of regulated products within the EAEU territory. Below is a detailed overview of where and how these documents are used within these countries:

1. EAC Expert Conclusion

Where It Is Required:

Within All EAEU Member States: The EAC Expert Conclusion is recognized across all EAEU countries. It is a critical part of the EAC certification or declaration process, which ensures that a product complies with the relevant EAEU Technical Regulations.
Accredited Certification Bodies: The conclusion is typically issued by accredited certification bodies or testing laboratories within the EAEU. These bodies are located in EAEU countries and are responsible for verifying product compliance.
Manufacturers and Importers: It is required by manufacturers (both domestic and foreign) and importers when applying for EAC certification or declaration for products like machinery, electrical equipment, toys, and more.

Use Cases:

Customs Clearance: The EAC Expert Conclusion supports the EAC Certificate or Declaration, which is required for customs clearance of the product.
Market Access: It allows products to be sold legally within all EAEU member states.
Regulatory Compliance: It serves as evidence that the product has undergone necessary testing and meets EAEU regulations.

2. State Registration Certificate

Where It Is Required:

Within All EAEU Member States: Like the EAC Expert Conclusion, the State Registration Certificate is also recognized across all EAEU countries. It is required for products that must comply with the EAEU’s sanitary and epidemiological standards.
Health and Safety Regulatory Authorities: The certificate is issued by authorized bodies responsible for sanitary and epidemiological supervision within the EAEU countries. These include institutions like Rospotrebnadzor in Russia.
Manufacturers and Importers: Both local and foreign manufacturers, as well as importers of products such as food, cosmetics, and chemicals, need this certificate before they can distribute or sell these products within the EAEU.

Use Cases:

Customs Clearance: The State Registration Certificate is mandatory for customs clearance for specific product categories, ensuring they meet health and safety regulations.
Distribution and Sale: Required for legal distribution and sale within the EAEU, as it confirms the product’s safety for human health and the environment.
Product Registration: It is necessary for registering products like dietary supplements, cosmetics, and household chemicals with the relevant authorities in the EAEU.

Summary of Requirements by Location:

All EAEU Countries: Both documents are recognized and required in all member states of the EAEU. This means they are necessary for product entry, certification, and compliance across Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan.
Local Regulatory Bodies: Each country has designated regulatory bodies for issuing these documents. These include:
- Russia: Rospotrebnadzor (for State Registration Certificate), Federal Accreditation Service (for EAC Certification).
- Belarus: State Committee for Standardization.
- Kazakhstan: Committee for Technical Regulation and Metrology.
- Armenia and Kyrgyzstan: Respective national accreditation and certification bodies.

Acquiring these documents is crucial for any manufacturer or importer aiming to enter and operate within the EAEU market, ensuring compliance with the union’s regulatory framework.

How is required EAC Expert Conclusion and State Registration Certificate

The process of obtaining an EAC Expert Conclusion and a State Registration Certificate involves several steps to ensure compliance with the Eurasian Economic Union (EAEU) regulations. Here’s a detailed explanation of how these documents are required and obtained:

1. EAC Expert Conclusion

How It Is Required:

Step 1: Determine Applicable Technical Regulations
- Identify the relevant EAEU Technical Regulations (TR CU or TR EAEU) that apply to the product. Each product category, such as machinery, electrical equipment, or toys, has specific regulations that outline the compliance requirements.
Step 2: Select an Accredited Certification Body
- Choose an accredited certification body within the EAEU that is authorized to issue the EAC Expert Conclusion. This body will evaluate the product’s compliance based on testing, technical documentation, and, if necessary, a factory inspection.
Step 3: Prepare and Submit Technical Documentation
- Compile all necessary technical documents, which may include:
  - Technical specifications and drawings.
  - Operational manuals.
  - Safety justifications.
  - Test reports from accredited laboratories.
  - Risk assessment documents.
Step 4: Product Testing and Evaluation
- The certification body may require product samples for testing. The tests are conducted in accredited laboratories to verify compliance with the specified Technical Regulations.
Step 5: Issuance of the Expert Conclusion
- If the product complies with all requirements, the certification body issues the EAC Expert Conclusion. This document is then used to support the application for an EAC Certificate or Declaration.
Step 6: EAC Certification/Declaration
- Use the EAC Expert Conclusion to obtain the EAC Certificate or Declaration, which allows the product to be marked with the EAC mark and legally sold in the EAEU market.

2. State Registration Certificate

How It Is Required:

Step 1: Identify if the Product Needs State Registration
- Determine if the product falls under categories requiring State Registration, such as food products, cosmetics, household chemicals, and other items that impact health and safety. Check the EAEU list of products subject to sanitary and epidemiological regulations.
Step 2: Select an Authorized Regulatory Body
- Choose an authorized regulatory body within the EAEU, such as Rospotrebnadzor in Russia, to handle the State Registration process.
Step 3: Prepare the Required Documentation
- Gather all necessary documentation, which typically includes:
  - Product composition and ingredients.
  - Manufacturing process description.
  - Safety data sheets (for chemicals).
  - Test reports from accredited laboratories.
  - Labels and packaging information.
Step 4: Product Testing and Laboratory Analysis
- Submit product samples for testing to accredited laboratories. These tests assess the product’s safety and compliance with sanitary and epidemiological standards.
Step 5: Application Submission
- Submit the application along with all the necessary documentation and test results to the regulatory body. The application should include details about the manufacturer, product specifications, and intended use.
Step 6: Review and Issuance
- The regulatory body reviews the documentation and test results. If the product meets all sanitary and epidemiological requirements, the State Registration Certificate is issued.
Step 7: Customs Clearance and Market Entry
- Once the State Registration Certificate is obtained, it is required for customs clearance and legal sale within the EAEU. The certificate is registered and valid across all EAEU countries.

Additional Considerations:

Authorized Representative: For foreign manufacturers, an authorized representative located within the EAEU is often required to handle the certification and registration processes.
Language Requirements: Documentation must often be provided in Russian or another official EAEU language.
Validity and Renewal: Both the EAC Expert Conclusion and State Registration Certificate have validity periods. The EAC certification typically needs renewal based on product changes, while the State Registration Certificate remains valid unless the product changes significantly.

Summary:

EAC Expert Conclusion is required as part of the EAC certification process to demonstrate product compliance with EAEU Technical Regulations.
State Registration Certificate is required for products impacting health and safety, confirming compliance with sanitary and epidemiological standards.

Obtaining these documents involves selecting the right certification body or regulatory authority, preparing comprehensive technical documentation, and undergoing rigorous product testing to meet EAEU requirements.

Case Study on EAC Expert Conclusion and State Registration Certificate

Case Study: Obtaining EAC Expert Conclusion and State Registration Certificate for a New Cosmetic Product in the EAEU Market

Company Background:

A European cosmetic manufacturer, BeautyGlow Inc., plans to enter the Eurasian Economic Union (EAEU) market with its new skincare product line. The company aims to distribute its products across Russia, Belarus, and Kazakhstan. To do so, it needs to comply with the EAEU regulations, including obtaining an EAC Expert Conclusion and a State Registration Certificate.

Objective:

To understand the step-by-step process and challenges faced in obtaining the necessary certifications for legal market entry and distribution within the EAEU.

Step 1: Product Analysis and Compliance Requirement Identification

Action:

The company’s compliance team first identified the applicable EAEU Technical Regulations and health and safety standards.
The skincare products fall under the EAEU Technical Regulation TR CU 009/2011 “On the Safety of Perfume and Cosmetic Products” and require both an EAC Expert Conclusion and a State Registration Certificate.

Outcome:

It was determined that both documents were necessary for customs clearance and legal sale within the EAEU countries.

Step 2: Selection of Certification Bodies and Regulatory Authorities

Action:

BeautyGlow Inc. chose an accredited certification body in Russia to conduct the product assessment and issue the EAC Expert Conclusion.
The company also selected Rospotrebnadzor, the authorized regulatory body in Russia, to handle the State Registration process.

Outcome:

Establishing contact with reputable and accredited bodies ensured a smoother certification process.

Step 3: Preparation of Technical Documentation and Product Samples

Action:

The company prepared a comprehensive set of documents, including:
- Detailed product composition and ingredient lists.
- Safety data sheets.
- Manufacturing process descriptions.
- Product labels in Russian, compliant with EAEU requirements.
- Test reports from accredited European laboratories.
Samples of the skincare products were sent to both the selected certification body and Rospotrebnadzor for analysis.

Outcome:

The documentation and product samples were accepted for review and testing by both the certification body and regulatory authority.

Step 4: Product Testing and Evaluation

Action:

The certification body conducted the necessary tests on the product samples to verify compliance with TR CU 009/2011. This included:
- Microbiological testing.
- Safety and efficacy evaluations.
- Allergen testing.
Rospotrebnadzor conducted additional tests to ensure the product met sanitary and epidemiological standards.

Challenges Faced:

Documentation Adjustments: The company had to modify some of its documentation to meet specific EAEU requirements, such as labeling and ingredient disclosure in the Russian language.
Additional Testing: Rospotrebnadzor requested additional tests for certain ingredients not commonly used in the EAEU, causing a delay in the process.

Outcome:

After several weeks of testing and adjustments, the product passed all necessary tests and evaluations.

Step 5: Issuance of EAC Expert Conclusion and State Registration Certificate

Action:

The certification body issued the EAC Expert Conclusion, confirming that the products complied with TR CU 009/2011.
Rospotrebnadzor issued the State Registration Certificate, verifying that the products met all sanitary and epidemiological requirements.

Outcome:

With both documents in hand, BeautyGlow Inc. was able to proceed to the next step of the process.

Step 6: Customs Clearance and Market Entry

Action:

The company used the EAC Expert Conclusion and State Registration Certificate for customs clearance, enabling the legal import of their skincare products into Russia, Belarus, and Kazakhstan.

Challenges Faced:

Customs Delays: Initial customs clearance was delayed due to inconsistencies in product labeling between what was submitted for certification and what was present on the shipped products. This required relabeling and re-submission of documents.

Outcome:

After addressing the issues, the products were successfully cleared through customs and entered the EAEU market.

Step 7: Distribution and Sale

Action:

The company was able to distribute its products across retail stores and online platforms in the EAEU.
BeautyGlow Inc. conducted a marketing campaign to promote the new product line, emphasizing its compliance with EAEU safety and quality standards.

Outcome:

The successful certification and registration process enabled BeautyGlow Inc. to establish a strong presence in the EAEU market.

Key Learnings and Best Practices:

Early Preparation: Starting the certification process well in advance, especially for complex products like cosmetics, is crucial to avoid delays.
Accurate Documentation: Ensure all technical documentation and product labels comply with EAEU standards to prevent issues during the certification and customs clearance process.
Local Representation: Having a local representative or partner familiar with EAEU regulations can streamline communication with regulatory bodies and certification agencies.
Proactive Communication: Regularly communicate with certification bodies and regulatory authorities to promptly address any issues that arise during the certification process.

Conclusion:

BeautyGlow Inc.’s experience highlights the complexities and challenges of obtaining EAC Expert Conclusion and State Registration Certificate for products entering the EAEU market. By following a structured approach and being prepared for regulatory requirements, the company successfully navigated the process and achieved its goal of market entry and distribution within the EAEU.

White Paper on EAC Expert Conclusion and State Registration Certificate

White Paper: EAC Expert Conclusion and State Registration Certificate – An Overview and Guide to Compliance in the EAEU

Executive Summary

The Eurasian Economic Union (EAEU) consists of member states including Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. To ensure the safety, quality, and compliance of products entering this market, regulatory frameworks have been established. Two critical documents for products regulated under EAEU standards are the EAC Expert Conclusion and the State Registration Certificate. This white paper provides a comprehensive guide on the purpose, process, and requirements for obtaining these certifications, focusing on helping businesses navigate the complexities of regulatory compliance within the EAEU.

1. Introduction

The EAEU aims to create a unified regulatory space that ensures the safety and quality of goods within its territory. Companies intending to introduce products to this market must meet strict compliance requirements, often necessitating the acquisition of the EAC (Eurasian Conformity) Expert Conclusion and the State Registration Certificate. Understanding the purpose, application, and regulatory framework of these documents is crucial for successful market entry and legal product distribution.

2. Understanding EAC Expert Conclusion

2.1. Purpose and Scope

The EAC Expert Conclusion is a document that certifies a product’s conformity with EAEU Technical Regulations (TR CU or TR EAEU). It serves as a foundational assessment document required for obtaining EAC certification or declaration, depending on the product type. The conclusion confirms that the product meets all safety, quality, and performance standards specified by the applicable technical regulation.

2.2. Products Requiring EAC Expert Conclusion

Industrial Machinery and Equipment: Products such as heavy machinery, industrial tools, and manufacturing equipment.
Electrical and Electronic Goods: Devices including consumer electronics, appliances, and IT equipment.
Construction Materials: Items like building materials and structural components.
Personal Protective Equipment (PPE): Products such as safety gear, gloves, and protective clothing.

2.3. Regulatory Framework

The EAC Expert Conclusion is governed by the EAEU’s technical regulations, which outline product-specific requirements. Key regulations include:

TR CU 004/2011 “On the Safety of Low Voltage Equipment”
TR CU 010/2011 “On the Safety of Machinery and Equipment”
TR CU 020/2011 “Electromagnetic Compatibility of Technical Devices”

2.4. Process Overview

Identify Applicable Technical Regulations: Determine which regulations apply based on the product category.
Select an Accredited Certification Body: Choose a recognized body within the EAEU authorized to issue EAC Expert Conclusions.
Documentation Submission: Submit comprehensive technical documentation, including product specifications, safety justifications, and testing protocols.
Product Testing: If required, products must undergo testing in accredited laboratories.
Issuance of EAC Expert Conclusion: Upon successful evaluation, the certification body issues the EAC Expert Conclusion.

3. Understanding State Registration Certificate

3.1. Purpose and Scope

The State Registration Certificate verifies that a product complies with sanitary, epidemiological, and hygiene standards of the EAEU. It is mandatory for certain product categories, especially those that can impact health and safety, such as food products, cosmetics, household chemicals, and items for children.

3.2. Products Requiring State Registration

Food and Beverage Products: Items such as packaged foods, dietary supplements, and drinks.
Cosmetics and Personal Care Products: Skincare, makeup, and hygiene products.
Household Chemicals: Cleaning agents, detergents, and other chemicals.
Products for Children: Toys, baby care products, and clothing for children.

3.3. Regulatory Framework

The State Registration Certificate is governed by several EAEU regulations, including:

TR CU 021/2011 “On Safety of Food Products”
TR CU 022/2011 “Food Products in Terms of Their Labeling”
TR CU 009/2011 “On Safety of Perfume and Cosmetic Products”

3.4. Process Overview

Determine if State Registration is Required: Check if the product category requires state registration.
Choose an Authorized Regulatory Body: Select a regulatory authority such as Rospotrebnadzor in Russia.
Prepare Documentation: Submit necessary documents, including product composition, safety assessments, and manufacturing process descriptions.
Product Testing: Conduct tests in accredited laboratories to verify compliance with health and safety standards.
Issuance of State Registration Certificate: If compliant, the regulatory body issues the certificate, allowing legal sale and distribution.

5. Challenges and Best Practices

5.1. Challenges

Complex Documentation Requirements: Both certifications require extensive documentation, often in the Russian language.
Testing and Evaluation Delays: Testing procedures can be time-consuming, particularly if additional testing is required.
Regulatory Changes: Frequent updates to technical regulations and sanitary standards can complicate compliance.

5.2. Best Practices

Engage Early with Certification Bodies: Start the process early to allow ample time for document preparation and testing.
Use Local Expertise: Utilize local consultants or representatives familiar with EAEU regulatory requirements.
Regularly Monitor Regulatory Changes: Stay updated on changes in EAEU regulations that may impact product compliance.

6. Case Study: Compliance Process for a European Cosmetic Brand

A European cosmetic company, entering the EAEU market, followed a structured approach to obtain both the EAC Expert Conclusion and the State Registration Certificate for its new skincare line. The process involved identifying applicable regulations, selecting a certification body and regulatory authority, preparing extensive documentation, and successfully navigating product testing. Despite initial delays due to labeling discrepancies, the company successfully obtained both certifications and launched its product in the EAEU market.

7. Conclusion

Compliance with EAEU regulations through obtaining the EAC Expert Conclusion and the State Registration Certificate is a complex but essential process for companies aiming to access this significant market. By understanding the regulatory framework, preparing comprehensive documentation, and working with accredited bodies, businesses can achieve successful certification and ensure their products meet EAEU standards.

8. References

Eurasian Economic Commission. (n.d.). EAEU Technical Regulations.
Rospotrebnadzor. (n.d.). Guidelines for State Registration.
TR CU 009/2011, TR CU 021/2011, TR CU 022/2011 – Technical Regulations of the Customs Union.

This white paper serves as a guide for businesses to understand the requirements and processes associated with obtaining the EAC Expert Conclusion and State Registration Certificate for market entry and product distribution within the EAEU.