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China Cosmetic Compliance: developing a formula compliant in both Europe and China

The globalisation of cosmetic brands is profoundly reshaping product development strategies. Companies no longer develop formulations solely for their domestic markets. They are now seeking to create products capable of supporting their growth across multiple geographical regions, including Europe, China, Southeast Asia and the Middle East.

In this context, China occupies a strategic position. As the world’s second largest cosmetics market, the country represents a major opportunity for both local brands and international players. However, successful entry into the Chinese market no longer depends solely on the quality of a formulation or the relevance of a marketing strategy. Mastering China cosmetic regulations has become a decisive factor in the success of international expansion projects.

Why are more and more brands developing their cosmetics in France before targeting China?

French cosmetics enjoy a particularly strong reputation worldwide. The Made in France label remains associated with high standards of quality, innovation, safety and performance. This reputation provides a significant competitive advantage among Chinese consumers, as well as distributors, investors and business partners.

Beyond this marketing dimension, French laboratories operate within a highly demanding regulatory environment. The European Cosmetics Regulation imposes rigorous requirements regarding safety, traceability, toxicological assessment and quality control. For many brands, developing a formulation in accordance with European standards provides a solid foundation for building an international expansion strategy.

However, a formulation compliant with European regulations is not automatically compatible with Chinese regulatory requirements.

Can a cosmetic formula compliant with European regulations be marketed in China?

The answer is no, at least not systematically.

A formulation compliant with European Cosmetics Regulation (EC) No 1223/2009 may require adjustments before being placed on the Chinese market. The challenges extend far beyond the compliance of the finished product. The regulatory status of raw materials, the availability of toxicological data, the quality of supplier documentation and the specific requirements of the Chinese authorities can all directly affect the feasibility of a project and its time to market.

In international projects, professionals frequently use a commonly adopted expression: is a raw material or formulation “China compliant”?

Behind this concept lies a much broader reality than regulatory compliance alone. A so called “China compliant” formula is one whose ingredients, suppliers and associated documentation have been selected with Chinese market requirements in mind from the earliest stages of development.

This proactive approach helps secure export projects and reduces the risk of reformulation or regulatory obstacles at a later stage.

CSAR and IECIC: the two essential references of Chinese cosmetic regulations

Since the implementation of the CSAR (Cosmetic Supervision and Administration Regulation), the regulatory requirements applicable to cosmetic products in China have evolved considerably.

CSAR governs registration and notification procedures, product safety assessment obligations, documentation requirements and post market surveillance activities.

Another key component of the Chinese regulatory framework is the IECIC (Inventory of Existing Cosmetic Ingredients in China), which serves as the official reference for determining the regulatory status of cosmetic ingredients.

When an ingredient is listed in the IECIC, it is generally considered an existing cosmetic ingredient. Conversely, an ingredient not included in the inventory may be regarded as a new cosmetic ingredient and may be subject to specific regulatory requirements prior to its use.

For brands, this distinction is far from insignificant. It can directly influence development timelines, regulatory strategy, raw material selection and, in some cases, the overall design of the formulation.

What is a “China compliant” raw material?

In practice, a raw material is not considered suitable for the Chinese market simply because it is authorised in Europe.

A “China compliant” raw material generally meets several essential criteria:

• inclusion in, or compatibility with, IECIC requirements

• availability of the necessary toxicological data

• consistent supplier documentation

• robust traceability

• compliance with technical specifications

• the supplier’s ability to respond to international regulatory requirements

This approach has become a genuine competitive advantage for brands seeking to develop their activities simultaneously in Europe and China.

The 7 most common mistakes made by brands seeking to market cosmetic products in China

Many export projects encounter obstacles not because of the performance or intrinsic quality of the formulation, but because Chinese regulatory requirements were not adequately anticipated during the early stages of development.

The most frequently encountered compliance issues include:

  1. Selecting raw materials without first verifying their regulatory status and compliance in China.
  2. Underestimating the importance of technical and regulatory supplier documentation, including quality dossiers, certificates, safety data and traceability records.
  3. Integrating Chinese regulatory constraints only during the final stages of development instead of considering them from the product design phase.
  4. Overlooking the specific documentation requirements imposed by Chinese authorities for product registration or notification.
  5. Working with suppliers who are insufficiently prepared for international market requirements and Chinese regulatory expectations.
  6. Identifying regulatory or documentation incompatibilities after the formulation has been approved, resulting in delays and costly technical modifications.
  7. Developing a formulation exclusively according to European requirements without incorporating a compliance strategy suitable for future export markets.

Potential consequences

These issues may result in significant delays to market launch, additional costs associated with reformulation or raw material requalification, and even a partial or complete reassessment of the original export strategy.

An integrated regulatory approach from the earliest stages of development is now a key lever for securing access to the Chinese market and optimising commercialisation timelines.

Why has regulatory documentation become just as important as the formulation itself?

In recent years, the cosmetics industry has faced a new reality: the performance of a formulation alone is no longer sufficient to guarantee the success of an international project.

Under Chinese cosmetic regulations, authorities require detailed information regarding the ingredients used, including their composition, origin, manufacturing process and safety characteristics.

Document consistency is equally critical. INCI names, technical specifications, declared concentrations and regulatory information must be fully aligned across all supporting documents.

Even a minor inconsistency can delay regulatory procedures or complicate product registration and notification processes.

Today, the selection of a raw material depends as much on its technical performance as on the supplier’s ability to provide complete and reliable regulatory documentation.

Regulatory analyses to anticipate during development

Beyond the quality of raw material documentation, certain regulatory requirements also involve analytical testing designed to demonstrate product safety and compliance before market entry.

Within the framework of regulatory procedures applicable in China, several parameters may be subject to specific controls:

• heavy metals such as lead, arsenic, cadmium and mercury, which must comply with applicable regulatory limits;

• preservatives, to verify compliance with authorised positive lists and maximum permitted concentrations;

• UV filters used in sunscreen products, which are subject to specific safety and compliance requirements;

• chemical and microbiological contaminants that may compromise product quality or safety;

• certain regulated substances subject to restrictions or specific conditions of use.

These controls highlight the importance of rigorous raw material selection from the earliest stages of development.

How can a formula be developed to comply with both European and Chinese requirements from the design phase?

The most experienced laboratories no longer wait until the regulatory stage to assess a product’s compatibility with the Chinese market.

Export requirements are now integrated from the technical brief and the earliest formulation stages.

This approach includes:

• selecting raw materials compatible with target markets

• verifying the regulatory status of strategic ingredients

• assessing the availability of technical, toxicological and safety data

• evaluating the quality of supplier documentation

• identifying potential points of attention related to CSAR and IECIC

• anticipating constraints likely to affect product registration or commercialisation

This methodology helps reduce reformulation risks, optimise development timelines and secure future export strategies.

Why has collaboration between R&D and Regulatory Affairs become strategic?

The development of a cosmetic product intended for multiple markets no longer relies solely on formulation performance.

As regulatory frameworks become increasingly complex, collaboration between R&D and Regulatory Affairs teams has become a decisive factor in the success of international projects.

The objective is no longer simply to develop an effective formula compliant with a specific market. It is also to ensure that every decision made throughout development remains aligned with the regulatory requirements of all target regions.

This approach helps anticipate regulatory constraints, optimise time to market and develop product ranges capable of supporting long term international growth.

Developing a cosmetic product for China: anticipate today to accelerate tomorrow

In an environment where regulations evolve rapidly and international development strategies are becoming increasingly ambitious, regulatory compliance can no longer be viewed as a final step in the development process.

The early integration of Chinese market requirements, a thorough understanding of CSAR and IECIC constraints, and the rigorous selection of raw materials now make it possible to develop robust, scalable formulations aligned with international growth ambitions.

For companies seeking to expand simultaneously in Europe and China, regulatory anticipation has become a genuine competitive advantage and a strategic driver of sustainable growth.

Private Label Manufacturing | Cosmetics and Dermo-cosmetics

The Research and Development division of Laboratoire Orescience offer OEM Private Label | manufacturing solutions. Do you have a project ? Would you like to develop your own line of cosmetics, dietary supplements, haircare and perfumes ? Do you want to distribute our brands Orescience, Dermoskin and Exo Keratin ? Do not hesitate to contact us.