Product Compliance
filing/registration/consulting/training

With cosmetics go overseas The craze continues to heat up,Southeast Asian market with huge consumption potential,Becoming a key layout direction for many beauty companies.However, there are differences in the cosmetics regulatory systems among Southeast Asian countries,Especially the requirements for the use of raw materials,Directly determine whether the product can be successfully and compliantly launched on the market.
As the core of Southeast Asian regional cooperation,ASEAN has established a unified regulatory framework for cosmetics,on this basis,Vietnam Thailand Indonesia and other major member countries have formulated specific rules based on their own situations.today,Let's sort out ASEAN and Vietnam/Thailand/Requirements for Cosmetics Raw Materials in Indonesia,Help you clarify the key compliance points,Avoiding the Misconceptions of Going Global.
one ASEAN unified requirements Building a regional compliance foundation
ASEAN has passed AGREEMENT ON THE ASEAN HARMONIZED COSMETIC REGULATORY SCHEME ASEAN Unified Cosmetics Regulatory Agreement ,Established a regional cosmetics regulatory framework based on the EU ingredient list,Provide regulatory basis for member states,Simultaneously considering the flexibility of each country.
The core requirements of this framework mainly include two parts One is a unified reference standard for ingredients,Secondly, the authorization mechanism for special raw materials in member countries
1. Reference mechanism for raw material list
ASEAN clearly stipulates,The use of cosmetic ingredients should be referred toEU 76/768/EEC EU Cosmetics Directive List of ingredients in,Ensure the basic safety and consistency of raw material usage within the region Although the current cosmetics regulations in the European Union have been updated to Regulation (EC) No 1223/2009,but ASEAN Cosmetic Directive Still in use 76/768/EEC the structure of,and pass through ACC/ACSB Gradually update the ingredient list based on the latest scientific assessment by the European Union.At the same time, a list of substances allowed for use in ASEAN was formulated AttachmentVIII ASEAN Cosmetic Ingredient Handbook,hereinafter referred to as AttachmentVIII .This is also the basic compliance prerequisite for enterprises to enter the ASEAN market.
2. Member State Special Raw Material Authorization Mechanism
Outside the unified list,ASEAN allows member countries to grant temporary authorization at the national level for specific raw materials,But three requirements must be met
The maximum authorization period shall not exceed three years,If overdue, reapply or apply for inclusion in the unified list
Member states must conduct official inspections on cosmetics produced from authorized raw materials,Ensure that the product meets safety standards
This type of cosmetics must bear the special identification specified in the authorization document,Easy for regulation and consumer identification.
Furthermore,Member states must do so within two months after the authorization decision takes effect,Transfer the decision text to the ASEAN Secretariat and other member states,Realize information exchange.
Before the expiration of the three-year authorization period,Member countries can submit their requests to the ASEAN Cosmetics Committee ACC Submit an application,Include non listed raw materials approved by the country in the attachmentVIIImiddle,And sufficient technical or safety supporting materials must be provided,Explain the reasons for inclusion and the intended use of the raw materials.InACCJust include it in the attachmentVIIIBefore making a decision on the application,The authorization from this country can continue to be valid,To avoid affecting the normal production and operation of the enterprise.
two Vietnam Thailand Indonesian member states request analysis
Under the unified framework of ASEAN,Vietnam Thailand Indonesia's three countries combine their own regulatory needs,More detailed suggestions have been put forward for cosmetic raw materials More targeted requirements,It is a core market that enterprises need to focus on when going global to Southeast Asia. one Vietnam standardized naming+safety control
Vietnam through Cosmetics Management Regulations Notice on Standardizing Cosmetics Management ,Naming of cosmetic ingredients Clear requirements for prohibited situations and security data.
Raw material naming conventions The ingredient names must use the latest version of the international cosmetic ingredient names specified in publications INCI ,for reference International Dictionary of Cosmetics Ingredients British Pharmacopoeia United States Pharmacopeia Waiting for authoritative information Plants and their extracts must use scientific names belong to kind writing,Plant genus names can be abbreviated Animal derived ingredients need to be accurately labeled with animal scientific names.
Non component definition Clarify that three types of substances are not considered as cosmetic ingredients Impurities in raw materials Auxiliary raw materials used for technical purposes but not present in the finished product As an essential raw material for essence solvent or carrier,Prevent enterprises from misjudging compliance boundaries.
Prohibited situation Prohibit the use of cosmetic ingredients that have been declared prohibited from circulation by the producing country,Simultaneously prohibit imports Operating such raw materials and related cosmetics.
Security data requirements Raw material safety data needs to be provided,Can be based on information provided by suppliers Published data,Or the European Union Scientific Committee on Consumer Products Reports from authoritative organizations such as the American Cosmetic Ingredient Evaluation Committee,Ensure the safety and traceability of raw materials.
two Thailand Notification management+Subdivision requirements
Thailand based on Cosmetics Law Guidelines for Cosmetics Notification and Review 2021Annual revised edition ,Propose relevant management and requirements for cosmetic raw materials.
1. Requirements for raw material notification Specially used raw materials for cosmetics production,Notification must be made in accordance with cosmetic product standards,Ensure that raw materials can be regulated.
2. Quality certification requirements The raw materials must be accompanied by quality inspection results Specification inspection result document or analysis certificate,Prove that the quality of raw materials meets the standards.
3. fateName requirements The name of the raw material must be usedINCIname,Consistent with international standards,Easy to review and supervise.
4. Reference requirements When reviewing raw materials,main referenceCTFAmanual COSINGdatabase,And academic documents published in credible academic journals and approved by relevant working groups.
5. Special scenario requirements
Raw materials not listed in authoritative literature Other credible academic documents can be attached,Provide a detailed explanation of the concentration used and its role in the formula,Can accelerate the speed of notification and review
Pharmaceutical ingredients Like alcohol turmeric essential oil Ingredients such as urea that have been used for drug registration,Additional explanation is required to clarify that the product is classified as a cosmetic,The concentration of this ingredient in the product must be lower than the registered concentration of the drug,And indicate the concentration percentage,The product label should be clearly labeled as cosmetics,Do not mislead consumers
Prohibited ingredients Contains Bai Qian oil CAJEPUT OIL product,Not classified as cosmetics,Prohibited from selling cosmetics
Animal derived raw materials Using cows goat Raw materials sourced from sheep Non prohibited substances ,A certificate of origin issued by the manufacturer or government agency of the producing country is required.
three Indonesia Safety first+Approval control
Indonesia through Technical requirements for cosmetic ingredients ,with safety efficacy quality core,Propose regulatory requirements and management systems for cosmetic raw materials,Strengthen the standardization and supervision of cosmetics,Enhance product safety.
1. Principles of raw material usage except Technical requirements for cosmetic ingredients Except for restricted raw materials in Appendix 1,Other raw materials as long as they meet safety requirements Efficacy and quality requirements,Can be used,But scientific or empirical evidence is required,And this proof needs to be included in the product information document.
2. Approval of special raw materials Used as a coloring agent preservative Ingredients outside Appendix I of Sunscreen and Natural Ingredients from Indonesia,Need to obtainBPOMApproval from the director is required before use.
3. Application Requirements Enterprises need toBPOMDirector submits application for safety assessment of cosmetic raw material use,Simultaneously submit administrative documents Application Form And technical documents Raw material safety Quality support and other data ,Ensure the safety and controllability of raw materials.
three summary Compliant Going Global,grasp unification+difference core
For cosmetics companies planning to expand into the Southeast Asian market,Need to address none firstINCIName of raw materialsPCPCapplyINCIname,Subsequently, mastering the unified requirements of ASEAN to establish a solid compliance foundation,Combined with Vietnam Thailand Specific details of target markets such as Indonesia,Targeted sorting of raw material usage and declaration process,Continuously monitor the updates of regulations in various countries,To avoid products being unable to be marketed or punished due to non compliant raw materials.
Only by accurately grasping the raw material requirements of each country,Only then can we smoothly open up the Southeast Asian market,Realize compliance in going global Steady development.