HiSiaddi is an innovative foreign trade service provider driven by technological transformation and foreign trade services, with an integrated service system of "1+2+3+4=1", supplying acetyl hexapeptide-8 sourced from multiple well-known original manufacturers.
With over ten years of industry experience, HiSiaddi, a technology-driven foreign trade service provider, has accumulated rich experience in raw material compliance processing through technical cooperation with factories. Below is a complete project case of HiSiaddi’s compliance rectification for export of acetyl hexapeptide-8.
If you need to consult more compliance-related issues of acetyl hexapeptide-8 products, please contact HiSiaddi customer service.
The partner is SwissDerm Biological Laboratory based in Zurich, Switzerland, a mid-to-high-end skincare brand with over 30 years of experience focusing on light luxury medical beauty clinics in Switzerland. It specializes in medical-grade anti-wrinkle serums, post-procedure repair essences and anti-aging eye creams, supplying more than 120 private plastic surgery hospitals, high-end medical beauty clinics and organic drugstore collection stores across Western Europe including Switzerland, Germany and Luxembourg. Its products hold EU SCCS safety certification and Swiss Ecocert natural organic certification, and the brand’s raw material procurement standards benchmark original imported raw materials from Spain’s Lipotec.
Acetyl hexapeptide-8 serves as the core functional raw material for four flagship anti-aging products of the brand, with an annual planned procurement volume of 8.5 tons of 20% liquid acetyl hexapeptide-8 exported to Basel Port, Switzerland in 7 batches.
The brand previously purchased original Spanish hexapeptide raw materials for years. In 2025, continuous price hikes and 3+ months delayed scheduling of European local raw materials prompted the brand to launch domestic raw material substitution. Initially, it independently contacted three major domestic peptide factories and finalized the preparation of the first batch of 2.3 tons of liquid acetyl hexapeptide-8. Four fatal compliance problems broke out intensively approaching customs clearance and shipment: supporting raw material documents failed to comply with EU Regulation EC1223/2009 on cosmetics, SDS safety data sheets did not meet the latest CLP specifications, missing raw material impurity test data blocked EU CPNP filing, and trace excessive SVHC substances of high concern were detected in solvent propylene glycol.
After pre-review of documents, the Swiss importer determined that the goods could not clear customs normally. If complete compliance documents could not be supplemented within 40 days, the entire batch of 2.3 tons of goods would have to be shipped back to China, with estimated losses exceeding 120,000 EUR including one-way return freight, warehousing and port detention fees. Meanwhile, the scheduled launch of four new products would be directly delayed, exposing the brand to default compensation risks from downstream medical beauty channels.
The three domestic raw material factories could only issue COA test certificates complying with Chinese national standards, lacking complete compliance archives required for EU market access. The factory technical teams only excel in product production and are unfamiliar with multiple regulatory details including EU cosmetics, REACH, CLP, SCCS and COSMOS, unable to complete document rectification in the short term. The client urgently entrusted Shanghai HiSiaddi, a technology-driven foreign trade service provider, to fully handle full-chain compliance issues.
HiSiaddi has over ten years of experience in supporting import and export compliance of cosmetic peptides. It can link EU-recognized third-party testing laboratories, EU certified safety assessors and overseas compliance agencies to deliver one-stop services covering raw material market access, document compilation, rectification and testing, and EU filing, making it the only third-party compliance service provider the client can rely on.
After taking over the project, HiSiaddi immediately collected existing customs clearance documents, raw material test reports and factory production qualifications, conducting item-by-item verification against current EU cosmetic regulations, REACH (EC1907/2006), CLP (EC1272/2008) and SCCS raw material filing rules. Four compliance loopholes that failed to pass audits by Swiss customs and EU drug regulators were sorted out, which are also the most typical compliance pain points for domestic hexapeptide exported to mid-to-high-end Western European brands:
Factory factory COA only marks the main content of acetyl hexapeptide-8 and routine microbial indicators, lacking four mandatory EU test items: free short peptide impurities, free organic acids, heavy metals (nickel, cobalt, antimony, barium) and residual organic solvents. EU SCCS clearly stipulates that active peptide raw materials for cosmetics must be attached with full-item impurity screening reports. Missing data cannot be compiled into the client’s PIF product information file, blocking CPNP system declaration. Swiss customs explicitly refuses release without complete impurity reports.
Meanwhile, the client focuses on organic skincare products requiring supporting COSMOS organic raw material pre-review certificates, which none of the three factories can provide, failing to support the brand’s natural ingredient marketing claims.
The original 16-section SDS compiled by raw material factories follows domestic chemical specifications with massive missing contents including hazard classification, toxicological data, ecotoxicity and REACH regulatory entries. Warning terms, pictograms and risk statements on CLP labels all contain errors. Current EU customs regulations mandate that SDS for imported cosmetic raw materials must be compiled by EU certified engineers. Non-compliant SDS will result in goods being detained in bonded warehouses at Swiss ports with high detention fees incurred.
This batch of liquid hexapeptide adopts petrochemical industrial propylene glycol as solvent. Initial third-party screening detected trace phthalate SVHC substances of high concern in propylene glycol at a content of 0.13%, exceeding the mandatory threshold of 0.1% for single SVHC substances requiring notification to the European Chemicals Agency (ECHA) under REACH. Raw materials without completed notification are prohibited from circulation and use within the EU. If the client’s finished products are launched in Switzerland, they will face product removal and heavy fines up to 20% of the cargo value.
In accordance with Regulation EC1223/2009, all functional cosmetic raw materials imported into the EU require independent raw material safety assessment documents as core supporting materials for finished product CPSR safety reports. Domestic factories have no EU certified SCCS assessors and cannot issue compliant safety assessment documents. Key documents are missing from the PIF files of the client’s four skincare products, blocking product filing with the Swiss drug regulatory authority. Even if raw materials clear customs smoothly, they cannot be filled and produced.
The superposition of four compliance issues directly trapped the entire batch of goods at the customs clearance stage, nearly halting the client’s new product launch scheduled for 45 days later. The three raw material factories can only cooperate with production rectification, lacking the capacity to independently supplement complete compliance documents.
HiSiaddi set up a special team consisting of regulatory specialists, third-party testing coordinators and EU compliance agents, formulating a 38-day time-limited rectification schedule. It delivered rectification from four dimensions: raw material re-testing and modification, compilation of complete compliance documents, rectification and declaration of REACH excessive substances, and overseas EU filing, fully coordinating with the client’s Swiss R&D department, Swiss import agent and EU certified testing institutions throughout the process:
1. Coordinate the three raw material factories to suspend feeding of industrial propylene glycol and replace it with EU-certified corn fermented plant-based propylene glycol, fundamentally blocking the mixing of phthalate SVHC substances of high concern.
2. Entrust a third-party laboratory with EU CNAS recognized qualifications to conduct full-item testing on samples taken from the entire 2.3-ton batch of hexapeptide in accordance with SCCS standards, adding four special screenings for free peptides, heavy metals, residual solvents and sensitizing impurities. Reissue bilingual Chinese-English EU-version COA reports with all indicators meeting the limit standards of Swiss Ecocert organic raw materials. After re-testing, all SVHC substance contents dropped below 0.02%, complying with REACH control requirements.
3. To meet the client’s organic marketing claims, assist one cooperative factory in supplementing raw material pre-review documents and obtaining COSMOS raw material pre-review receipts to support compliant labeling of high-end organic product lines.
HiSiaddi linked local EU certified chemical engineers to recompile the complete 16-section English SDS in accordance with GHS 7th edition specifications, supplementing missing entries including toxicology, ecotoxicity, waste disposal and corresponding EU regulatory clauses. Meanwhile, prepare bilingual Chinese-English outer carton warning labels and product small labels in accordance with CLP regulations, correcting erroneous pictograms, risk statements and precautionary statements in the original version. The new SDS passed pre-review by the Swiss importer and fully met customs clearance declaration requirements.
Cooperating with EU registered safety assessors, HiSiaddi compiled dedicated safety assessment documents for acetyl hexapeptide-8 based on full-item re-test data, factory GMP production materials and authoritative toxicological literature of hexapeptide (CIR International Raw Material Safety Report). The documents serve as core attachments to the CPSR safety reports of the client’s four skincare products, filling missing items in PIF product information files and gaining recognition from Swiss drug regulators to complete pre-preparation of product filing documents.
1. Relying on fully rectified COA, safety assessment reports and SDS documents, assist the Swiss client to complete ingredient notification of acetyl hexapeptide-8 on the EU CPNP cosmetic notification system and generate official filing numbers.
2. Simultaneously assist the client to submit pre-declaration of imported raw materials to the Swiss Federal Drug Administration with complete compliance archives, obtain official approval receipts for raw material entry into Switzerland, and completely remove policy barriers for customs clearance.
During document rectification, HiSiaddi coordinated delayed shipment of goods and unified repackaging and relabeling after rectification to avoid detention and return risks. All rectification work was completed in 36 days, closing the compliance loop 4 days ahead of the deadline.
The fully rectified 2.3 tons of acetyl hexapeptide-8 were declared and exported from Shanghai Port as scheduled, with all documents passing one-time inspection by Swiss Basel Customs without detention or objection to sampling. The goods were smoothly warehoused at the client’s Swiss production plant, enabling scheduled production of four new anti-aging products launched across high-end medical beauty channels in Switzerland and Germany. Terminal sales surged by 37% year-on-year in the first quarter after launch.
1. SwissDerm successfully completed domestic substitution of hexapeptide raw materials, with comprehensive raw material procurement costs reduced by 30.2% compared with original Spanish products. The annual 8.5-ton procurement framework contract was fully performed, and the client added demand for domestic procurement of five types of cosmetic peptides including palmitoyl tripeptide and pentapeptide the following year.
2. Supported by this complete set of EU compliance documents, the client no longer needs to invest high costs in repeated compliance testing for subsequent procurement of similar raw materials, shortening the new product project approval cycle.
Relying on this successful compliance case of a high-end Swiss brand, the three domestic peptide factories improved compliance control systems for high-end export grades and standardized the establishment of EU-version COA and SDS document templates. Supported by complete compliance qualifications, they subsequently developed multiple mid-to-high-end skincare brands in Austria and Denmark, with an export premium of 27% for high-end grades.
A standardized full-chain compliance service solution for cosmetic peptides exported to the EU was formed, creating a closed-loop service process: compliance problem identification → raw material testing and rectification → multilingual compliance document compilation → EU CPNP / local drug regulatory filing → customs clearance support. HiSiaddi has continued to undertake peptide compliance implementation orders from more than ten clinic brands in Germany and France thereafter.
Most domestic peptide manufacturers focus on the domestic daily chemical market, with factory documents only meeting national standards and lacking full-chain supporting capacity for EU compliance. Mid-to-high-end European and American clinic skincare brands are restricted by multiple strict EU regulations. Tiny deviations in raw material indicators or missing documents will trigger heavy economic losses including goods detention, return and failure of new product launch.
Relying on neutral third-party compliance service advantages, HiSiaddi opened up the full chain covering raw material production rectification, testing, document compilation and overseas filing. It not only helped mid-to-high-end overseas clients avoid huge compliance losses, but also promoted compliant entry of domestic cosmetic peptides into the high-end raw material supply chain of Western Europe, achieving a three-party win-win for clients, production manufacturers and service providers. If you need to consult more compliance-related issues of acetyl hexapeptide-8 products, please contact HiSiaddi customer service.
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