HiSiaddi is an innovative foreign trade service provider driven by both technology transformation and foreign trade services. It has established a "1+2+3+4=1" service system and can supply raw materials of Coenzyme Q10 from multiple well-known original manufacturers. Boasting over a decade of market experience as a technology R&D-oriented foreign trade enterprise, HiSiaddi has rich experience resolving product compliance issues through technological transformation cooperation with factories. Below is a case of HiSiaddi handling Coenzyme Q10 export compliance challenges.
If you wish to consult more compliance issues regarding Coenzyme Q10 products, please contact HiSiaddi customer service.
SwissLabs Biological R&D Group based in Switzerland has been deeply engaged in high-end oral anti-aging capsules and medical aesthetic essence raw materials for 29 years. In 2025, it finalized a domestic Coenzyme Q10 annual procurement volume of 6.5 tons, covering three major categories: 99.8% pharmaceutical crystalline powder, 10% organic sunflower oil dispersion liquid and nano-liposome stock solution. Two leading domestic raw material factories were selected for pre-production stocking, yet five major compliance risks emerged right before container loading for shipment: incomplete EU REACH registration, missing SCCS cosmetic raw material filing documents, EFSA dietary raw material indicator exceedances, broken organic traceability chains, and inconsistent data across Chinese and English documents.
Swiss local importers notified the customer that incomplete documents would result in direct detention or return of full containers upon arrival at the port, with daily detention and container fees exceeding 1,800 Euros, forcing a delay in the new product launch plan. The customer immediately entrusted HiSiaddi, a foreign trade service provider, to fully coordinate rectification of full-chain compliance issues.
Previously, the customer cooperated directly with two domestic raw material factories, which could only provide domestic quality inspection reports and production licenses. Lacking familiarity with EU import compliance rules and European regulatory agency filing procedures, the factories only controlled national standard physical and chemical indicators, without knowledge of REACH substance registration, EU Responsible Person filing, SCCS raw material safety assessment report compilation, EFSA heavy metal and solvent residue limits, or Ecocert full-chain organic traceability document issuance. The two factories only took responsibility for their own products and refused to cooperate on integrating full compliance dossiers across manufacturers. The customer’s direct cooperation with European third-party institutions incurred exorbitant costs with a lead time of up to 3 months.
As a chemical raw material, Coenzyme Q10 (CAS: 303-98-0) requires complete registration of the main substance and full SDS safety data sheets under EU REACH regulations for annual imports exceeding 1 ton, alongside filing with an EU local Authorized Representative (EC REP). Domestic supplying factories only completed domestic production filings without REACH registration dossiers or EU compliance agents. Swiss customs explicitly prohibits entry of goods without REACH registration numbers and EU Responsible Person filings.
Microcrystalline powder and nano-liposome products purchased by the customer are used for salon essences. EU Cosmetics Regulation EC1223 mandates full SCCS raw material safety assessment reports for all active raw materials, including toxicological data, skin irritation tests and impurity risk assessments. Domestic factories’ COAs only mark purity and moisture content, lacking toxicology tests and raw material safety dossiers, making filing in Switzerland’s cosmetic raw material system impossible.
High-purity Coenzyme Q10 for oral anti-aging capsules must comply with EFSA limits: lead ≤0.5ppm, cadmium ≤0.3ppm, organic solvent residues <10ppm. Factory factory self-inspection follows national standards (national lead limit ≤2ppm), with tested batches recording lead content of 0.82ppm and n-hexane residues of 17ppm, exceeding EU dietary raw material access limits and failing Swiss food import sampling inspections.
The customer’s finished products bear Ecocert organic certification labeling for the 10% organic sunflower oil carrier stock solution, requiring full-chain organic traceability covering sunflower seed cultivation, oil pressing and Coenzyme Q10 compounding. Domestic factories only provide finished product organic certificates without upstream farm certification and batch circulation ledgers, which European organic institutions do not recognize as fragmented certificates.
Domestic factories used inconsistent labeling for Coenzyme Q10 across Chinese factory delivery documents, English COAs, packing lists: both ubiquinone and reduced ubiquinol were used as product names, conflicting CAS numbers and mismatched batch codes. Swiss customs requires 100% consistency of key information across commercial invoices, COAs, bills of lading and SDS documents; conflicting information triggers manual detention and inspection by customs.
1. HiSiaddi collaborated with domestic REACH compliance firms to access existing stock registration dossiers for Coenzyme Q10 main substances, completing tonnage transfer filing (the full-year 6.5-ton import tonnage was attached to existing REACH registration numbers), eliminating the 6-month lead time and high registration fees for new registration.
2. Assisted the customer in signing with a Swiss local compliance institution as the EU EC REP Responsible Person, completing online filing in the EU ECHA system and issuing official filing receipts.
3. Revised bilingual Chinese-English new-version SDS safety data sheets in accordance with CLP regulations, unifying ingredient classification, storage & transportation warnings and risk descriptions to match Swiss import customs declaration requirements.
1. HiSiaddi coordinated the two raw material factories to supplement raw material toxicology tests (acute skin irritation, subchronic toxicology, impurity risk tests), commissioning EU-accredited laboratories to issue English toxicological data.
2. Cooperated with European licensed toxicologists to compile full-set raw material safety assessment dossiers per SCCS templates, preparing independent dossiers for three products (powder, vegetable oil dispersion liquid, nano stock solution) covering raw material sources, production processes, impurity analysis and safe dosage limits in formulations, completing pre-filing for EU cosmetic raw materials.
1. Coordinated production factories to conduct targeted refining: adding advanced activated carbon heavy metal removal sections and secondary negative pressure desolventization processes to strictly control finished lead ≤0.4ppm and organic solvent residues ≤7ppm, with full-item re-test indicators meeting EFSA limits.
2. Commissioned ILAC-accredited EU third-party laboratories to issue English full-test COAs, clearly marking oxidized ubiquinone and distinguishing non-reduced variants to avoid classification disputes over dietary raw material ingredients.
1. HiSiaddi coordinated upstream sunflower oil pressing factories and organic farms supporting raw material supply to supplement farm organic certificates, oil batch outbound documents and cross-factory circulation records, establishing a complete traceability chain: organic planting → cold-pressed oil → Coenzyme Q10 blending → finished product filling.
2. Assisted manufacturers in updating supplementary Ecocert filing documents to obtain batch traceability certificates recognized by European organic institutions, meeting compliance requirements for organic labeling on the customer’s finished products.
1. HiSiaddi standardized unified product naming across all product lines: fixed English name Ubiquinone (Coenzyme Q10, oxidized form, CAS 303-98-0), unifying all batch codes and purity labeling standards.
2. Conducted item-by-item proofreading of five core customs declaration documents: commercial invoice, packing list, bill of lading, COA and SDS, ensuring complete consistency of product name, CAS number, batch number, net weight and manufacturing factory information to eliminate customs declaration abnormality and detention risks.
1. After rectification, HiSiaddi arranged third-party on-site supervision of loading and sampling inspection, with samples of each raw material specification sent to Swiss laboratories for re-verification, all passing dual Swiss food and cosmetic import access inspections.
2. The full container was successfully shipped from Shanghai Port for split customs clearance in Rotterdam, Switzerland. Customs verified complete REACH, SCCS, COA, organic traceability and EU Responsible Person filing documents without detention or port delay.
3. The 6.5-ton order was fulfilled in four quarterly batches for delivery to Swiss factories.
1. Potential full-container return losses (goods + freight totaling approximately 126,000 Euros) were avoided, enabling scheduled launch of oral capsules and antioxidant essences across over 260 high-end pharmacies and medical aesthetic clinics in Switzerland. Comprehensive procurement costs of domestic raw materials decreased by 33% compared with original Japanese imported raw materials.
2. The brand renewed a 7.8-ton annual framework procurement contract the following year, simultaneously entrusting HiSiaddi to coordinate full EU compliance for high-end active raw materials including resveratrol and ergothioneine.
Leveraging this EU high-end compliance rectification case, a standardized internal control system for Coenzyme Q10 EU export compliance was established, standardizing four categories of export documents: REACH, SCCS, EFSA and organic. With full-set compliance qualifications, customer bases of mid-to-high-end cosmetic brands in France and Italy were successfully expanded, delivering export premiums of over 28% for high-end customized grades.
A standardized EU full-dimension compliance service package for Coenzyme Q10 was established, subdividing two compliance checklists for cosmetic-grade and dietary supplement-grade raw materials, opening a full-chain compliance channel covering domestic raw material factories → EU compliance institutions → overseas importers. Subsequent orders for compliance supporting services of high-end raw materials from premium brands in Norway and Denmark were secured.
1. Pain Points of Mid-to-High-End Overseas Customers: European and American high-end salon/dietary brands operate under superimposed multi-regulation control (REACH + SCCS + EFSA + organic standards). Most domestic raw material factories are only familiar with national standards and lack EU export compliance systems, making it impossible for a single factory to independently compile full-chain compliance documents. Customers face extremely high costs and uncontrollable lead times when handling compliance independently.
2. Shortcomings of Domestic Manufacturers: Most Coenzyme Q10 manufacturers prioritize production while neglecting export compliance, producing raw materials only meeting domestic standards without matching EU subdivided limits for heavy metals, solvents, toxicology and traceability. Full compliance rectification is mandatory for high-end export sales.
3. Core Value of HiSiaddi: As a neutral third party, HiSiaddi coordinates raw material technical transformation, third-party testing, EU compliance filing and standardized document compilation across the full process, bridging gaps between Chinese and foreign regulatory standards. It helps customers resolve cross-border compliance risks at low cost and short lead time, supporting domestic raw materials to smoothly enter European mid-to-high-end supply chains.
If you wish to consult more compliance issues regarding Coenzyme Q10 products, please contact HiSiaddi customer service.
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