Frequently Asked Questions

Browse our frequently asked questions to get more insight on our services

ASEAN Compliance

Do imported cosmetics require registration before sale in ASEAN?

Yes, most require product notification filing with local health authorities before import and sale.

What documents are required for ASEAN cosmetic notification?

In general, a Product Information File (PIF), ingredient list, safety assessment, labelling, and packaging samples.

China Cosmetics Compliance

How do I register cosmetic products in China and what are the different regulatory pathways?

Cosmetic products in China follow two distinct regulatory pathways based on product type and function:


General Cosmetics Filing:
Applicable Products: Standard cosmetic products including shampoos, lotions, makeup, and basic skincare
Regulatory Process: Filing through the National Medical Products Administration (NMPA) electronic system
Timeline: Processing typically completed within 2-3 months
Documentation Requirements: Product formulation details, safety assessment reports, effectiveness claims support, and quality control standards
Testing Requirements: Product quality testing and safety assessment without mandatory animal testing for qualifying products
Post-Approval: Products receive a filing certificate with a unique identification number required on packaging
Special Cosmetics Registration:
Applicable Products: Products with specialized functions including hair dyes, sunscreens, whitening products, anti-hair loss, and deodorants
Regulatory Process: Formal registration and approval through NMPA with more stringent review
Timeline: Review periods typically extend to 8-12 months
Documentation Requirements: More extensive than general cosmetics, including comprehensive safety data and efficacy testing results
Testing Requirements: More rigorous testing protocols, potentially including animal testing unless qualifying exemptions apply
Post-Approval: Registration certificate with 5-year validity requiring renewal
Key factors determining the appropriate pathway include ingredient composition, product claims, and intended functions. Products making functional claims automatically require the special cosmetics registration pathway regardless of formulation.

 

What is the process for registering new cosmetic ingredients in China?

Registering new cosmetic ingredients in China follows a structured process through the National Medical Products Administration (NMPA):
  1. Preliminary Assessment: Determination of whether the ingredient qualifies as “new” under Chinese regulations, which applies to ingredients not previously used in cosmetics in China
  2. Technical Documentation Preparation: Comprehensive technical dossiers including:
  • Detailed manufacturing information and process controls
  • Chemical structure and compositional analysis
  • Physical and chemical property data
  • Stability testing results
  • Safety data including toxicological profiles
  • Efficacy claims and supporting evidence
  1. Toxicological Testing: Safety testing through NMPA-approved laboratories including:
  • Acute toxicity testing
  • Skin and eye irritation studies
  • Skin sensitization assessment
  • Mutagenicity testing
  • Other specific tests depending on ingredient type and intended use
  1. Risk Assessment Documentation: Detailed risk assessment reports as required by authorities, addressing:
  • Exposure scenarios
  • Margin of safety calculations
  • Risk characterization for different usage scenarios
  1. NMPA Submission Process: Complete application submission through China’s regulatory system
  2. Regulatory Communications: Ongoing interactions with authorities to address questions or requests for additional data
  3. Application Monitoring: Tracking the application throughout the review period, which typically extends 6-12 months

The complexity of this process often results in extended timelines and significant resource investment. Common challenges include differences in testing standards between China and other markets, translation issues in technical documentation, and evolving regulatory requirements.
Knudsen & CRC manages the entire new ingredient registration process for cosmetic brands, leveraging specialized expertise in Chinese regulatory requirements. Our technical team prepares comprehensive documentation, arranges required testing with NMPA-approved laboratories, and maintains ongoing communication with regulatory authorities throughout the review period. This strategic approach has achieved registration approval for innovative ingredients that initially faced regulatory challenges.

What are the mandatory labelling requirements for cosmetic products in China?

China’s cosmetic labelling requirements follow specific regulations that differ significantly from other major markets:
 

Mandatory Content Requirements:

  • All required information must appear in simplified Chinese characters
  • Registration or filing number must be prominently displayed
  • Full ingredient list using Chinese INCI names in descending order of concentration
  • Production date and shelf life (expiration date required; Period After Opening/PAO symbols alone are insufficient)
  • Name and address of the domestic responsible agent
  • Country of origin clearly marked
  • Net content in weight or volume according to Chinese measurement standards
  • Function or efficacy claims must be pre-approved for special cosmetics
  • Additional warnings for certain ingredients as specified by NMPA

Format and Presentation Requirements:

  • Labels must be directly printed on or firmly affixed to the immediate container
  • Minimum font size requirements apply to ensure readability
  • Text contrast must meet visibility standards
  • Required information must be prominently displayed in the main visual field
  • Any claims must be consistent with the approved product documentation 

Common Compliance Issues:

  • Direct translation of foreign labels without addressing China-specific requirements
  • Failure to include the domestic responsible agent information
  • Using PAO symbols instead of explicit expiration dates
  • Missing or incorrect registration/filing numbers
  • Claims that exceed approved functions or efficacy

Additional Requirements for Imported Products:

  • Chinese stick-on labels are permitted but must not obscure original information
  • Both original and Chinese labels must have consistent information
  • Imported products must identify the country of origin
  • Compliance with these labelling requirements is essential for successful product registration and market entry in China. Non-compliant labels can result in registration rejection, import delays, or product recalls.
Knudsen & CRC ensures packaging and labelling meet all Chinese requirements through comprehensive review and adaptation of existing designs to comply with local regulations. Our expertise helps brands maintain consistent global branding while satisfying China’s specific labelling requirements.
 

What are the labelling requirements for cosmetics in China?

Chinese labels must show the product name, full ingredient list, efficacy, shelf life/production date or expiry/batch number, applicant/manufacturer/RP details, net weight, usage instructions, and warnings (if any).
 
 

How long does cosmetic filing or registration take in China?

General cosmetic filing: 3–6 months; special cosmetic registration: 12–18 months.
 

 

How long is a cosmetic filing/registration valid in China?

Cosmetic filings and registrations in China remain valid as long as the product is marketed and annual reporting obligations are met. Non-compliance may lead to suspension or cancellation.
 

 

Can I use the same product name in both EU and China?

Yes, but in China the name must include the registered brand/tradename and avoid misleading or non-compliant terms.
 

 

What does “technical review” mean in cosmetic registration in China?

It’s NMPA’s post-market evaluation of the filed product dossier to verify ongoing conformity, requiring corrections or revoking approval if necessary.
 
 

How do EU and China cosmetic labelling requirements compare?

 

EU Labelling Requirements:

  • Ingredient listing using INCI names in descending order of concentration
  • Product function must be clearly stated
  • Durability indication (PAO or expiration date)
  • Country of origin and manufacturer details
  • Responsible Person information with EU address
  • Batch number for traceability
  • Net content in weight or volume
  • All mandatory information in official languages of countries where sold

China Labelling Requirements:

  • Chinese language mandatory for all required information
  • Registration or filing number must be displayed
  • Full ingredient list using Chinese INCI names
  • Production date and shelf life (expiration date required, not PAO)
  • Name and address of the domestic responsible agent
  • Country of origin clearly marked
  • Special cosmetic efficacy claims must be pre-approved
  • Additional warnings for certain ingredients as specified by NMPA

China Cosmetics Manufacturing

Do Chinese cosmetic factories need to register with NMPA?

Yes, all factories producing cosmetics for China must obtain NMPA production licenses.
 

How often are cosmetic factories inspected in China?

Full inspections take place at least once every 5 years, with annual routine checks, and more frequent visits if high-risk products or violations are found.

EU Cosmetics Compliance

What are the current requirements for cosmetic product compliance in the European Union?

EU cosmetic compliance requires adherence to Regulation (EC) No 1223/2009, with several critical components:

  • Product Information File (PIF): A comprehensive technical dossier containing formulation details, manufacturing methods, safety assessments, and quality control standards. 
  • Cosmetic Product Safety Report: A detailed safety assessment performed by a qualified safety assessor with specific qualifications outlined in the regulation. 
  • Product Notification via CPNP: Mandatory electronic notification through the Cosmetic Products Notification Portal before placing products on the market. 
  • Responsible Person: A designated EU-based entity with legal responsibility for compliance, including post-market surveillance. 
  • Claims Substantiation: Scientific evidence supporting all product claims according to Regulation (EU) No 655/2013. 
  • Compliant Labelling: Information in appropriate languages including ingredients (INCI names), durability indication, country of origin, and warnings. 
Companies often struggle with these requirements, particularly with the technical complexity of safety assessments and staying current with ingredient restrictions. Since 2012, Knudsen & CRC has guided over 2,000 companies through EU cosmetic compliance, reducing market entry timelines by up to 70% through our specialized approach to PIF preparation and claims substantiation.
 

How do I get my cosmetics compliant with EU regulations?

The EU cosmetics compliance process involves a structured approach to ensure products meet the requirements of European Cosmetics Regulation (EC) No 1223/2009.
This includes:
  • Product Information File (PIF) Preparation: We compile comprehensive documentation including formulation details, manufacturing methods, and safety assessments
  • Cosmetic Product Safety Report: Our experts prepare detailed safety assessments required for all cosmetic products
  • Product Notification via CPNP: We handle the mandatory notification through the Cosmetic Products Notification Portal
  • Responsible Person Appointment: We can serve as your Responsible Person in the EU
  • Claims Substantiation: We verify that all product claims comply with EU regulations
  • Labelling Compliance: We ensure packaging and labelling meet all EU requirements

What are the labelling requirements for cosmetics in the EU?

EU labels must show the RP’s address, nominal content, shelf life/PAO, precautions, batch code, function, and full INCI list.
 

What documents are needed for EU cosmetic compliance?

A Product Information File (PIF), compliant labelling, and CPNP notification.
 

What is the Product Information File (PIF) and why is it required?

The PIF is a mandatory dossier containing safety reports, testing data, formula details, and labelling, to be kept by the Responsible Person.
 

What are the rules for cosmetic claims in the EU?

Claims must follow the EU Common Criteria, meaning they must be truthful, supported by evidence, and not misleading.
 

Do EU regulators take any action against cosmetics with non-permitted substances?

Yes. In 2024, The EU has removed a number of cosmetics containing prohibited ingredients like BMHCA and tightened checks on products sold in stores and online.
 

Ethical Cosmetics Services

Can we market a product as vegan without certification?

Yes, but proof is required that no animal-derived ingredients or testing are used. Certification adds consumer trust.
 

What is the difference between “natural” and “organic” in cosmetics?

“Natural” refers to source of ingredients, while “organic” requires certified farming and processing standards.
 

Is it possible to stay Leaping Bunny certified while entering the China market?

Yes. Through the China Leaping Bunny Certification Programme, Knudsen & CRC as the exclusive partner of Leaping Bunny US in China, can conduct the required audits to help brands maintain their Leaping Bunny status while selling in China.
 

GACC Registration

What are some common reasons for GACC registration rejection

Common reasons for registration rejection include incomplete hazard control documentation, facility conditions not meeting Chinese standards, and product contamination issues identified during verification.
Registration approval typically takes 3-6 months for standard categories and 6-12 months for high-risk categories. Approved registrations receive a unique code valid for 5 years that must appear on all product packaging and shipping documentation.
Knudsen & CRC’s regulatory specialists have successfully completed GACC registrations for over 200 food facilities across multiple categories, with expertise in both competent authority submissions and self-registration processes. Our comprehensive approach includes preliminary gap assessment, documentation preparation, translation services, and direct communication with GACC officials when necessary.
 

What documentation is required for GACC registration under Decree 248 for food exports to China?

Under China’s Decree 248 (effective January 2022), all overseas food manufacturers must register with the General Administration of Customs China (GACC) before exporting to China. The required documentation varies based on product category:

For High-Risk Categories (18 specific food types including meat, dairy, seafood, etc.): 

  • Application form with facility details and production capacity
  • Company business license or registration certificate
  • Official recommendation letter from the competent authority in the exporting country
  • Facility layout and production flow diagrams
  • Water quality testing reports
  • Hazard analysis and critical control points (HACCP) documentation
  • Product testing reports from accredited laboratories
  • Labels of products intended for export to China
  • Statement of compliance with Chinese food safety laws and standards
  • Completed self-assessment checklist against Chinese requirements

For Standard-Risk Categories (all other food products):

  • Basic facility information through the CIFER system
  • Business license or registration certificate
  • Statement of compliance with Chinese food safety requirements
  • Product information including ingredients and specifications
  • Label samples in Chinese and original language

All documents must be submitted in Chinese or with certified Chinese translations. High-risk category registrations must be submitted through the competent authority of the exporting country, while standard categories can self-register through GACC’s online system.

Can one GACC registration cover multiple factories?

No, each factory must apply separately.
 

What documents are required?

HACCP/GMP certificate, process flow, product label and other details depending on the product category.
 

Do CBEC products require GACC?

Not always; exemptions may apply for particular CBEC categories and CBEC pilot zones.
 

What happens if GACC expires?

Shipments will be blocked or returned.
 

What may cause GACC registration rejection?

Wrong HS codes, missing certificates, or inconsistent details.
 

Global Claims Testing

What evidence is required to substantiate cosmetic claims in China?

Substantiating cosmetic claims in China requires specific types of evidence that meet the National Medical Products Administration (NMPA) requirements:

Types of Claims Requiring Substantiation:

  • Efficacy claims (moisturizing, oil control, anti-aging, etc.)
  • Functional claims for special cosmetics (sunscreen, whitening, etc.)
  • Performance claims (long-lasting, waterproof, etc.)
  • Sensory claims (when presented as objective benefits)
  • Comparative claims (when referencing product performance)

Required Evidence by Claim Type:

  1. Basic Efficacy Claims:
  • Laboratory testing using standardized methods
  • Results from NMPA-certified testing institutions
  • Test sample sizes meeting statistical significance standards
  1. Special Cosmetic Function Claims:
  • More extensive clinical studies with larger sample sizes
  • Testing must be conducted by NMPA-certified laboratories
  • Pre-approval required before marketing
  1. Ingredient-Based Claims:
  • Scientific literature supporting ingredient efficacy
  • Concentration verification showing effective levels
  • Stability testing confirming ingredient integrity throughout shelf life
  1. Consumer Experience Claims:
  • Consumer perception studies with appropriate methodology
  • Statistically significant sample sizes
  • Clear relationship between subjective assessments and claimed benefits

Documentation Requirements:

  • Comprehensive test reports from qualified institutions
  • Detailed methodology descriptions
  • Statistical analysis of results
  • Raw data supporting conclusions
  • Evidence of test facility qualifications
 
Non-compliant claims or insufficient substantiation can result in registration rejection, required labelling modifications, or potential penalties for misleading consumers.
Knudsen & CRC assists brands with comprehensive claims substantiation through scientific evidence collection, arrangement of market-specific testing with NMPA-certified laboratories, and strategic claim wording optimization that maximizes marketing impact while maintaining regulatory compliance. Our approach has successfully substantiated claims for numerous international brands entering the Chinese market, ensuring their marketing materials effectively communicate product benefits while meeting all regulatory requirements.
 

How can you help me substantiate cosmetic claims for global markets?

Successful cosmetic claims substantiation requires a strategic approach tailored to each market:
  1. Scientific Evidence Collection: We compile robust scientific data including clinical studies, in-vitro testing, and ingredient research
  2. Market-Specific Testing: We arrange specialized testing that meets specific regional requirements:
    • EU: Evidence must comply with Regulation (EU) No 655/2013 on common criteria for claims
    • China: Claims testing must be conducted by NMPA-certified laboratories
    • UK: Post-Brexit regulations require UK-specific documentation
  3. Consumer Perception Studies: We design and implement consumer studies that meet regulatory standards
  4. Competitor Claims Analysis: We evaluate market positioning while ensuring regulatory compliance
  5. Claim Wording Optimization: We refine marketing claims to maximize impact while meeting legal requirements
  6. Documentation Preparation: We create comprehensive claim substantiation files for regulatory submissions

Can scientific literature be used to support simple efficacy claims globally?

Yes, scientific literature can support simple claims such as moisturizing or ingredient-related functions in China, but most efficacy claims require human trials, laboratory tests, or consumer studies on the finished product.
 

Is it allowed to use the claim globally such as “protects skin barrier & supports skin regeneration”?

In China, “skin regeneration” is not allowed because it falls outside cosmetic scope, while “skin barrier” is treated as a repair-related claim and requires human trial evidence on the finished product.

Cosmetics Regulatory Compliance

What cosmetic regulatory services do you offer?

Knudsen & CRC offers comprehensive regulatory compliance services for cosmetic brands navigating complex global markets.
Our specialized services include:
  • Cosmetic Product Registration and Filing
  • New Cosmetic Ingredient Registration
  • EU and UK Cosmetics Compliance
  • China Cosmetics Manufacturing
  • Ethical Cosmetics Services
  • Global Claims Testing
As experts in multiple regulatory frameworks, we provide end-to-end support from initial market assessment through registration, product testing, and ongoing compliance monitoring.
 

How do I start the cosmetic compliance process with Knudsen & CRC?

Starting your cosmetic compliance journey is simple:
  1. Initial Consultation: Contact our team for a personalized assessment of your regulatory needs
  2. Product Evaluation: Share your formulations and marketing plans for a preliminary compliance review
  3. Market Strategy Development: Work with our experts to create a tailored regulatory roadmap
  4. Documentation Preparation: Begin compiling necessary technical information and testing data
  5. Timeline Planning: Establish realistic milestones for your market entry strategy
  6. Engagement Formalization: Define the scope of support required for your specific needs

 

General Questions

How do you keep clients updated on regulatory changes?

We publish updates on our website and send direct client alerts on new rules and enforcement actions.
 

What languages does your team support?

We provide services in English, Chinese, Italian, Spanish, and other key business languages.
 

Do you provide online training or workshops?

Yes. We offer various training sessions on compliance, claims, and regulatory updates.
 

Health Food Registration and Filing

How do international supplement brands legally enter the Chinese market?

International supplement brands can legally enter the Chinese market through two primary regulatory pathways:

Health Food Registration Pathway:

  • Required for products with first-time imported ingredients or claiming specific health functions
  • Approval Authority: National Medical Products Administration (NMPA)
  • Timeline: 2-3 years average completion time
  • Testing Requirements: Comprehensive safety and efficacy testing, including toxicology and human trials
  • Allowed Claims: Can make specific claims from China’s list of 27 approved health functions
  • Documentation: Extensive technical dossier including formulation, manufacturing, safety, and efficacy data

Health Food Filing Pathway:

  • Limited to products using ingredients from China’s “positive list” (primarily vitamins and minerals)
  • Approval Authority: Provincial-level FDA offices
  • Timeline: 3-6 months average completion time
  • Testing Requirements: Limited to quality and stability testing
  • Allowed Claims: Only nutrient supplementation claims
  • Documentation: Simplified technical requirements focused on quality and compliance

Alternative Entry Methods:

  • Cross-Border E-Commerce (CBEC): Allows limited sales through approved platforms with simplified requirements
  • Traditional Trade (General Food): For products that can be positioned as conventional foods without health claims
  • The registration pathway, while more time-consuming, offers significant advantages including broader distribution channels and the ability to make functional claims. Many international brands fail in this process due to inadequate testing strategies or formulations containing ingredients restricted in China. 
Knudsen & CRC specializes in strategic market entry assessment, helping brands determine the most appropriate pathway based on formulation analysis and business objectives. Our regulatory experts have successfully guided major international supplement brands through these processes, with a proven track record of reducing registration timelines through precise documentation preparation and testing coordination with NMPA-approved institutions.
 

How long does Health Food registration or filing take?

Filing takes around 6–12 months; registration can take 2–3 years.
 

What testing is required for functional claims?

Human trials, toxicology studies, and other safety tests in qualified Chinese labs/hospitals.
 

Can imported supplements be sold in China without registration?

Some supplements can be qualified or adopted as general food that don’t require registration but with limited claims; alternatively, sell via cross-border e-commerce (CBEC).
 

What are penalties for selling Health Food without approval?

Unapproved products can be banned, recalled, and lead to fines or loss of license.

Leaping Bunny Program

What is the Leaping Bunny China Qualification Program and how can it help our brand enter the Chinese market without animal testing?

The Leaping Bunny China Qualification Program is a ground-breaking initiative that allows cruelty-free cosmetic brands to enter the Chinese market without compromising their ethical standards. As the first company to successfully introduce Leaping Bunny certified cosmetics to China, Knudsen & CRC pioneered this pathway that enables international brands to maintain their cruelty-free status while accessing one of the world’s largest cosmetics markets.
 

How does the program work?

The program involves a comprehensive regulatory strategy that leverages specific pathways in Chinese regulations that don’t require animal testing. This includes:
General Import Filing Pathway:
• For qualifying general cosmetics, the filing process can be completed without triggering mandatory animal testing requirements
• Products must meet specific formulation and safety documentation standards to qualify
• Good Manufacturing Practice (GMP) certification is required for manufacturing facilities
• Safety assessment must be conducted by qualified safety assessors

Cross-Border E-Commerce Channel:
• Allows limited market access without standard registration requirements
• Products sold directly to consumers through approved platforms
• Exempt from pre-market animal testing requirements
• Limited to specified transaction values and quantities

Key Compliance Requirements:
• Comprehensive safety assessment documentation using non-animal testing methods
• Manufacturing facilities must meet Chinese regulatory standards
• Implementation of rigorous post-market surveillance systems
• All product documentation must satisfy Chinese authorities’ requirements without triggering animal testing

Brands must carefully manage both pre-market compliance and post-market surveillance to maintain cruelty-free status while selling in China. The regulatory framework continues to evolve, with China increasingly accepting alternative testing methods for certain product categories.

What real success stories do you have?

Subtle Energies, a luxury natural skincare and wellness brand, successfully entered the Chinese market through our Leaping Bunny China Qualification Program. As their Director of Operations and Brand Development, Nick Irani, states:
“We are truly honoured to have been part of the Leaping Bunny programme since our early days as a brand, the landmark pilot project for brands not tested on animals in China. This would not have been possible without the strong regulatory and business support of the team from Knudsen&CRC, providing a pathway for us to offer our family’s work in luxury natural skincare and wellness to China with the crucial assurance that we are not exposed to animal testing either before or after we hit the market.”
 

What benefits does the program bring to your brand?

  1. Market Access Without Compromise: Maintain your ethical standards while accessing the 78 billion USD Chinese beauty market
  2. Competitive Advantage: Stand out in a growing segment of conscious consumers in China (growing at 12% annually)
  3. Future-Proof Compliance: Our ongoing regulatory monitoring ensures continued compliance as regulations evolve
  4. Brand Integrity Protection: Comprehensive risk assessment and mitigation strategies protect your cruelty-free reputation
  5. Expert Guidance: Access to our specialized team that has successfully guided over 2,000 companies through diverse regulatory landscapes

Why Choose Knudsen & CRC for Leaping Bunny Qualification?

Since 2012, Knudsen & CRC has been at the forefront of supporting international brands in overcoming regulatory barriers in highly regulated markets. We were recognized with the IPWS Change Maker Social Impact Award in 2022 for our founder Mette Knudsen’s work as a regulatory compliance agency founder and animal rights advocate.
Our expertise in Chinese cosmetic regulations is unparalleled, with specialized knowledge in navigating complex requirements like those for nanomaterials and innovative ingredients. Our 24/7 expert support ensures seamless navigation of complex regulatory environments across time zones.

Medical Device Registration

What is the process for registering Class II and Class III medical devices in China?

Registering Class II and Class III medical devices in China follows a structured process through the National Medical Products Administration (NMPA):
  1. Classification Verification: Confirm device classification according to China’s risk-based system, as classifications often differ from other markets.
  2. Testing Requirements: Undergo product testing with NMPA-approved laboratories, including electrical safety, EMC, biocompatibility, and performance testing appropriate for the device type.
  3. Clinical Evaluation: For Class II devices, clinical evaluation reports may be sufficient if the device is substantially equivalent to approved products. Class III devices typically require clinical trials in Chinese institutions unless exempted.
  4. Technical Documentation: Prepare comprehensive documentation including device descriptions, raw materials, manufacturing processes, risk analysis, and clinical data according to NMPA formats.
  5. Type Testing: Submit samples to designated testing centers for verification against Chinese standards.
  6. Manufacturing Site Inspection: Foreign manufacturers may undergo on-site inspections or documentation reviews of quality management systems.
  7. NMPA Review Process: Application review typically takes 9-14 months for Class II and 12-18 months for Class III devices, with potential supplementary information requests.
  8. Registration Certificate: Upon approval, certificates are valid for 5 years with renewal applications required 6-12 months before expiration.

A critical challenge in this process is navigating China’s unique technical requirements and communication with regulatory authorities. Knudsen & CRC’s specialized team has successfully registered diverse medical devices across all classifications, achieving approval times averaging 40% faster than industry standards through strategic pre-submission assessment and established relationships with testing laboratories.

Do imported devices need local clinical trials?

Yes, unless the device is on NMPA’s exemption list.
 

How long does NMPA approval take?

Class I – 6 months, Class II – 12–18 months, Class III up to 3 years.
 

How long is device registration valid in China?

It is valid for 5 years and must be renewed before expiry.
 
 

New Cosmetic Ingredient Registration

 

How long is a new cosmetic ingredient considered “new” after registration/filing in China?

A new ingredient is monitored for 3 years after approval, plus about 1 year of review and official issuance by NMPA.
 

Is it possible to register a cosmetic product with an approved new cosmetic ingredient without animal testing in China?

No, animal testing is still mandatory when registering or filing cosmetics that contain a new cosmetic ingredient.

Novel Food Ingredients Registration

How long does novel food approval take in China?

On average 1–3 years, depending on safety data and complexity.
 

Are traditional foods from other countries treated as novel in China?

Yes, unless there is clear evidence of long-term safe consumption in China.
 

Can imported novel foods be sold in China without approval?

No, all new food raw materials must be formally approved by the NHC before import or sale
 

Pet Food

How long does MARA registration take?

On average 12–18 months, depending on the product type and dossier completeness.
 

Do pet treats also require registration?

Yes, all edible pet products (food, snacks, supplements) require approval.
 

Can imported pet food be sold CBEC without registration?

Yes, imported pet food can be sold through CBEC channels without MARA registration, but only in approved pilot zones and in limited quantities
 

What trends are shaping China’s pet food market?

Premium, functional formulations (e.g., joint support, digestion), and demand for natural/organic products.

Pet Grooming Products

Do imported pet grooming products require pre-market approval in China?

No formal approval is needed, but products must comply with general consumer product regulations and labelling rules.

R&D and Product Development

Can you conduct safety assessments during R&D?

Yes, safety assessment and preliminary safety reports are part of our R&D compliance checks.
 

What testing can you coordinate during development?

We manage microbiological, stability, efficacy, challenge, packaging compatibility in accredited labs.
 

Do you provide formulation support for multiple markets at once?

Yes, we assist with formula validation that align with the strictest global regulations, reducing reformulation needs
 

What role does packaging play in R&D compliance?

Packaging materials must meet safety standards and generally undergo migration and compatibility testing.
 

Do you support innovation projects like “clean beauty” or “sustainable” formulas?

Yes, we help validate formulas for eco-friendly, natural, vegan, or other relevant clean standards
 

UAE Compliance

What are labelling requirements for cosmetics in the UAE?

Labels must include Arabic text, product name, ingredients, batch number, country of origin, manufacturer details, and warnings.
 

Do imported cosmetics require local testing in the UAE?

Yes, safety and microbiological testing may be required before registration approval.
 

How long does cosmetic registration in the UAE take?

On average 2–4 months, depending on dossier completeness and product category.
 

How long is cosmetic registration valid in the UAE?

Registrations are valid for 5 years and must be renewed before expiry.
 

Can cosmetics be imported into free zones without registration?

Yes, but to sell in the local UAE market, products must be registered with Dubai Municipality/ESMA

Why Knudsen?

Can you share success stories of brands you’ve helped with cosmetic compliance?

Bulldog Skincare:
Bulldog Skincare, a leading men’s skincare brand, successfully entered the Chinese market through our expertise.
“Knudsen&CRC worked extremely hard to ensure Bulldog was the first international Leaping Bunny approved brand to launch in mainland China. We have a great relationship with the whole team, and we look forward to working with them on future opportunities in this unique and complex market.”
– Antonia Cadbury, Head of New Product Development & Technical
Sukin:
Sukin, an Australian natural skincare brand, overcame complex regulatory hurdles with our guidance.
“We can’t thank the Knudsen team enough for your patience, hard work and support throughout the last couple of years! Can’t believe that we first met in 2019 and finished the last registrations in 2023… For sure, we could not make it without your guidance and support! The Knudsen team rocks!”
– Angela Ma, General Manager of Sukin China
 

What benefits will my cosmetic brand get from working with Knudsen & CRC?

Working with Knudsen & CRC brings measurable advantages to cosmetic brands:
  • Market Access Expertise: Navigate complex regulatory landscapes across EU, UK, China, Middle East, and ASEAN markets
  • Time and Cost Efficiency: Reduce market entry timelines by up to 70% with our strategic approach
  • Risk Mitigation: Prevent costly compliance issues that affect over 60% of cosmetic brands entering new markets
  • Ethical Market Entry: Join the 200+ brands we’ve helped enter China while maintaining cruelty-free status
  • Competitive Advantage: Access the $78 billion USD Chinese beauty market ahead of competitors
  • Local Expertise: Benefit from our team of 40+ regulatory specialists across 3 global offices, including China
  • Proven Track Record: Join over 2,000 companies we’ve successfully guided through diverse regulatory landscapes

Why should I choose Knudsen & CRC over other regulatory consultants?

Since 2012, Knudsen & CRC has established unparalleled expertise in cosmetic regulations:
  • Pioneer in Ethical Cosmetics: First company to successfully introduce Leaping Bunny certified cosmetics to China
  • Industry Recognition: Recipients of the IPWS Change Maker Social Impact Award and Community Member of the Year 2022 from the Australian Chamber of Commerce
  • Specialized Expertise: Unmatched knowledge in nanomaterials, innovative ingredients, and cross-market compliance
  • Comprehensive Support: 24/7 expert assistance across global time zones
  • Exceptional Success Rate: 98% approval rate for cosmetic registrations in challenging markets
  • Exclusive Industry Connections: Direct relationships with regulatory authorities in key markets
  • Time-Efficient Processing: Average 40% faster approval times compared to industry standards

If you still have more questions, contact us at info@knudsencrc.com and we’ll be sure to get back to you

add_filter( 'wp_get_attachment_image_attributes', 'remove_lazy_load_attribute', 10, 3 ); function remove_lazy_load_attribute( $attributes, $attachment, $size ) { if ( isset( $attributes['class'] ) && strpos( $attributes['class'], 'lazy-free' ) !== false ) { unset( $attributes['loading'] ); } return $attributes; }